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Sample records for events appraise trial

  1. Formalization of Event Perception and Event Appraisal Process

    Directory of Open Access Journals (Sweden)

    Shikha Jain

    2015-06-01

    Full Text Available Integration of emotion in a virtual agent is a topic of research to depict human-like behavior in a simulated environment. For the last few decades, many researchers are working in the field of incorporating emotions in a virtual agent. In the emotion model, the behavior of an agent depends upon how the event is perceived by the agent with respect to the goal. Hence, perception of the event while considering the past experience, importance of event towards achieving goal, agent’s own capabilities and resources is an important process which directly influences the decision making and action selection. The proposed models, till date, are either too complex to adapt or are using a very few parameters to describe the event. So, in this paper, we propose an extension of perception process in an existing emotion model, EMIA and suggest the formalization of event perception and appraisal processes to make it adaptable. This has been carried out using five parameters for event description along-with fuzzy logic which makes the process more effective yet simple.

  2. Appraisals of Negative Divorce Events and Children's Psychological Adjustment.

    Science.gov (United States)

    Mazur, Elizabeth; And Others

    Adding to prior literature on adults' and children's appraisals of stressors, this study examined relationships among children's negative cognitive errors regarding hypothetical negative divorce events, positive illusions about those same events, the actual divorce events, and children's post-divorce psychological adjustment. Subjects were 38…

  3. Sex differences in the appraisal of traumatic events and psychopathology.

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    Kucharska, Justyna

    2017-09-01

    The current study is an investigation of the relationship between the appraisal of traumatic events and mental disorder symptoms: internalizing symptoms and externalizing/substance-abuse symptoms. Cumulative trauma over the lifetime was taken into account. Also, specific effects related to traumatic events of various types (i.e., betrayal trauma, accident involving a family member, physical violence, and natural disaster) were assessed. Participants, 190 young men and 277 young women, were asked to evaluate the strength with which the traumatic event impacted their lives. It was hypothesized that the relationship between traumatic experiences and mental disorder symptoms would be stronger in women than in men, and also that cognitive appraisal, in interaction with gender, would be related to the severity of the symptoms. Women showed higher levels of internalizing symptoms, but lower levels of externalizing/substance-abuse symptoms than men. Still, the correlation between cumulative trauma and both types of symptoms was stronger in women. For all types of trauma, women reported a stronger negative appraisal of the event than men. Interaction of sex and cognitive appraisal was demonstrated to be related to the severity of internalizing disorders. In the present study, women, as compared with men, evaluated traumatic events more negatively (for all types of trauma) and the relationship between trauma and mental disorder symptoms was also stronger in women. These results show the importance of the appraisal of trauma in the development of psychiatric symptoms in women and men following trauma. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  4. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial.

    Science.gov (United States)

    Alexander, John H; Becker, Richard C; Bhatt, Deepak L; Cools, Frank; Crea, Filippo; Dellborg, Mikael; Fox, Keith A A; Goodman, Shaun G; Harrington, Robert A; Huber, Kurt; Husted, Steen; Lewis, Basil S; Lopez-Sendon, Jose; Mohan, Puneet; Montalescot, Gilles; Ruda, Mikhail; Ruzyllo, Witold; Verheugt, Freek; Wallentin, Lars

    2009-06-09

    After an acute coronary syndrome, patients remain at risk of recurrent events. Apixaban, an oral direct factor Xa inhibitor, is a novel anticoagulant that may reduce these events but also poses a risk of bleeding. Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) was a phase 2, double-blind, placebo-controlled, dose-ranging study. Patients (n=1715) with recent ST-elevation or non-ST-elevation acute coronary syndrome were randomized to 6 months of placebo (n=611) or 1 of 4 doses of apixaban: 2.5 mg twice daily (n=317), 10 mg once daily (n=318), 10 mg twice daily (n=248), or 20 mg once daily (n=221). Nearly all patients received aspirin; 76% received clopidogrel. The primary outcome was International Society of Thrombosis and Hemostasis major or clinically relevant nonmajor bleeding. A secondary outcome was cardiovascular death, myocardial infarction, severe recurrent ischemia, or ischemic stroke. At the recommendation of the Data Monitoring Committee, the 2 higher-dose apixaban arms were discontinued because of excess total bleeding. Compared with placebo, apixaban 2.5 mg twice daily (hazard ratio, 1.78; 95% confidence interval, 0.91 to 3.48; P=0.09) and 10 mg once daily (hazard ratio, 2.45; 95% confidence interval, 1.31 to 4.61; P=0.005) resulted in a dose-dependent increase in major or clinically relevant nonmajor bleeding. Apixaban 2.5 mg twice daily (hazard ratio, 0.73; 95% confidence interval, 0.44 to 1.19; P=0.21) and 10 mg once daily (hazard ratio, 0.61; 95% confidence interval, 0.35 to 1.04; P=0.07) resulted in lower rates of ischemic events compared with placebo. The increase in bleeding was more pronounced and the reduction in ischemic events was less evident in patients taking aspirin plus clopidogrel than in those taking aspirin alone. We observed a dose-related increase in bleeding and a trend toward a reduction in ischemic events with the addition of apixaban to antiplatelet therapy in patients with recent acute coronary syndrome

  5. The role of attributions in the cognitive appraisal of work-related stressful events : An event-recording approach

    NARCIS (Netherlands)

    Peeters, MCW; Schaufeli, WB; Buunk, BP

    1995-01-01

    This paper describes a micro-analysis of the cognitive appraisal of daily stressful events in a sample of correctional officers (COs). More specifically, the authors examined whether three attribution dimensions mediated the relationship between the occurrence of stressful events and the

  6. Appraisal of measuring economic impact of sport events | Saayman ...

    African Journals Online (AJOL)

    Sport events are big business, attracting not only a large number of participants, spectators and sponsorships, but also wide media coverage. The hosting of sport events have led to increased rivalry between nations, regions and cities. Sport events range from mega events, such as the Olympic Games and the FIFA Soccer ...

  7. A micro-analytic exploration of the cognitive appraisal of daily stressful events at work: The role of controllability

    NARCIS (Netherlands)

    Peeters, M.C.W.; Buunk, B.P.; Schaufeli, W.B.

    1995-01-01

    Employing a daily event-recording method the present study focuses onthe nature of stressful events of secretaries, their outcomes and theintervening cognitive appraisal process. With regard to the latter, five factors were selected that may constitute the cognitive appraisal of a stressful event:

  8. A MICROANALYTIC EXPLORATION OF THE COGNITIVE APPRAISAL OF DAILY STRESSFUL EVENTS AT WORK - THE ROLE OF CONTROLLABILITY

    NARCIS (Netherlands)

    PEETERS, MCW; BUUNK, BP; SCHAUFELI, WB

    1995-01-01

    Employing a daily event-recording method the present study focuses on the nature of stressful events of secretaries, their outcomes and the intervening cognitive appraisal process. With regard to the latter, five factors were selected that may constitute the cognitive appraisal of a stressful event:

  9. Elevated Appraisals of the Negative Impact of Naturally Occurring Life Events: A Risk Factor for Depressive and Anxiety Disorders

    Science.gov (United States)

    Espejo, Emmanuel Peter; Hammen, Constance; Brennan, Patricia A.

    2012-01-01

    The tendency to appraise naturally occurring life events (LEs) as having high negative impact may be a predisposing factor for the development of depression and anxiety disorders. In the current study, appraisals of the negative impact of recent LEs were examined in relationship to depressive and anxiety disorders in a sample of 653 adolescents…

  10. Adverse event development in clinical oncology trials

    NARCIS (Netherlands)

    Walraven, I.; Aaronson, N.; Sonke, J.-J.; Verheij, M.; Belderbos, J.

    Gita Thanarajasingam and colleagues' Article1 in The Lancet Oncology reports on a novel longitudinal approach for adverse event analysis and reporting. Comprehensive adverse event reporting in clinical oncology trials is essential to monitor tolerability of new cancer treatments. In view of the

  11. Elevated Appraisals of the Negative Impact of Naturally Occurring Life Events: A Risk Factor for Depressive and Anxiety Disorders

    Science.gov (United States)

    Espejo, Emmanuel P.; Hammen, Constance; Brennan, Patricia A.

    2012-01-01

    The tendency to appraise naturally occurring life events (LEs) as having high negative impact may be a predisposing factor for the development of depression and anxiety disorders. In the current study, appraisals of the negative impact of recent LEs were examined in relationship to depressive and anxiety disorders in a sample of 653 adolescents who were administered diagnostic and life stress interviews at ages 15 and 20. Participants’ appraisals of the negative impact of LEs reported at age 15 were statistically adjusted using investigator-based ratings to control for objective differences across LEs. Higher appraisals of the negative impact of LEs were associated with both past and current depressive and anxiety disorders at age 15 and predicted subsequent first onsets of depressive and anxiety disorders occurring between ages 15 and 20. In addition, appraisals of the negative impact of LEs were particularly elevated among those experiencing both a depressive and anxiety disorder over the course of the study. The findings suggest that systematically elevated appraisals of the negative impact of LEs is a predisposing factor for depression and anxiety disorders and may represent a specific risk factor for co-morbid depression and anxiety in mid-adolescence and early adulthood. Keywords: depression; anxiety; stress appraisals; prospective study; PMID:21845380

  12. Admissibility of hearsay evidence in criminal trials: an appraisal of ...

    African Journals Online (AJOL)

    Despite Ethiopia following a common law approach regarding evidentiary principles, rules and procedural safeguards in criminal trials, the country does not have a codified and compiled evidence law. This problem might partly be attributable to the difficulty of concepts involved in evidences such as hearsay. Because of ...

  13. Species trials for biomass plantations in Hawaii: a first appraisal

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    Thomas H. Shubert; Craig D. Whitesell

    1985-01-01

    Species trials have been conducted in Hawaii since the 1870's. Many species have been successfully established and harvested, whereas native species have failed in numerous reforestation projects. Since the early 1960's silviculture research concentrated on developing methodology for establishing and developing forest stands for timber production.

  14. Randomized, double-blind trial to evaluate the safety of apixaban with antiplatelet therapy after acute coronary syndrome in Japanese patients (APPRAISE-J).

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    Ogawa, Hisao; Goto, Shinya; Matsuzaki, Masunori; Hiro, Shintaro; Shima, Daisuke

    2013-01-01

    Concomitant anticoagulant therapy may further reduce the risk of thrombotic events in patients with acute coronary syndrome (ACS) when given in addition to current standard antiplatelet therapies. This Phase II, randomized, double-blind, placebo-controlled study in Japanese patients with ACS assessed the bleeding risk of apixaban compared with placebo when given in combination with standard antiplatelet therapy, and followed a similar design to APPRAISE-1, the larger global Phase II study. Patients with recently diagnosed ACS were randomized to receive apixaban 2.5mg twice daily (BID; n=49), apixaban 5mg BID (n=50), or placebo (n=52) in addition to standard antiplatelet therapy for 24 weeks. The composite primary endpoint of major or clinically relevant nonmajor bleeding occurred in 2 patients (4.1%) in each apixaban treatment group and 1 patient (2.0%) in the placebo group, and a dose-dependent increase was seen in all bleeding events. No hemorrhagic strokes occurred in either apixaban treatment group. This study was terminated before completion because the APPRAISE-2 global Phase III trial was stopped based on the recommendation of the Data Monitoring Committee, following an increase in bleeding events without a counterbalancing reduction in ischemic events. The bleeding profile of apixaban in Japanese patients with ACS was similar to that found in the global APPRAISE-1 study, supporting the safety of apixaban in Japanese patients.

  15. Neural correlates of self-appraisals in the near and distant future: an event-related potential study.

    Directory of Open Access Journals (Sweden)

    Yangmei Luo

    Full Text Available To investigate perceptual and neural correlates of future self-appraisals as a function of temporal distance, event-related potentials (ERPs were recorded while participants (11 women, eight men made judgments about the applicability of trait adjectives to their near future selves (i.e., one month from now and their distant future selves (i.e., three years from now. Behavioral results indicated people used fewer positive adjectives, more negative adjectives, recalled more specific events coming to mind and felt more psychologically connected to the near future self than the distant future self. Electrophysiological results demonstrated that negative trait adjectives elicited more positive ERP deflections than did positive trait adjectives in the interval between 550 and 800 ms (late positive component within the near future self condition. However, within the same interval, there were no significant differences between negative and positive traits adjectives in the distant future self condition. The results suggest that negative emotional processing in future self-appraisals is modulated by temporal distance, consistent with predictions of construal level theory.

  16. Equipoise in the enhanced supression of the platelet IIb/IIIa receptor with integrilin trial (ESPRIT): a critical appraisal.

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    Mann, Howard; London, Alex John; Mann, Jeffrey

    2005-01-01

    Enhanced Supression of the Platelet IIb/IIIa Receptor with Integrilin Trial (ESPRIT) was a multicenter randomized controlled clinical trial in which participants were randomized between eptifibatide and placebo. A "clinical hold" was initially placed on the trial by the US Food and Drug Administration (FDA), which was concerned about the placebo-only control arm. The hold was lifted after additional information concerning the use of platelet glycoprotein IIb/IIIa inhibitors in clinical practice, derived from a survey of interventional cardiologists, was provided. The trial's principal investigator and colleagues have described how these issues were resolved, and advance a claim of equipoise for the trial. In this critical appraisal we examine the information and arguments proffered in support of the trial design and conclude that they evidence a misunderstanding of equipoise. We believe that a placebo-only control arm was not justified by the information provided by the trialists.

  17. Number and appraisal of daily hassles and life events in young adulthood: the association with physical activity and screen time: a longitudinal cohort study.

    Science.gov (United States)

    Uijtdewilligen, Léonie; Singh, Amika S; Chinapaw, Mai J; Koppes, Lando L J; van Mechelen, Willem; Twisk, Jos W R

    2014-10-13

    Young adults face radical life changes regarding residence, marriage, family and work that may negatively impact their health behaviours. Therefore, we investigated the associations of the number of daily hassles and life events and their subjective appraisal with physical activity and screen time in young adulthood. Data came from participants of the Amsterdam Growth and Health Longitudinal Study (AGAHLS). Self-reported physical activity (min/wk) was used from wave 6 (1991; mean age 27), wave 7 (1993; mean age 29), wave 8 (1996/1997; mean age 32) and 9 (2000; mean age 36). Self-reported screen time (h/wk) was assessed in waves 8 and 9. The number and the appraisal of daily hassles and major life events were assessed with the Everyday Problem Checklist and Life Events List, respectively (including five life event domains, i.e.: health, work, home/family, personal/social relations, and finances). The final sample included 474 participants for the physical activity analyses and 475 participants for the screen time analyses. To test the longitudinal associations of daily hassles and life events with physical activity and screen time, univariable and multivariable Generalised Estimating Equations were performed. Effect modification by gender was tested. Physical activity levels were higher in those who had experienced more daily hassles. People who reported higher subjective appraisal in the work and finances life event domains also had higher levels of physical activity, although only the subjective appraisal in the finances domain remained significant in the multivariable model. No significant associations between number and subjective appraisal of daily hassles and life events and screen time were observed. The occurrence of specific life events may be more influential for people's physical activity behaviour than their respective sum or emotional tone. Still, the assessment of daily hassles may be a relevant addition in this research field. Finally, we suggest that

  18. Adverse event reporting in cancer clinical trial publications.

    Science.gov (United States)

    Sivendran, Shanthi; Latif, Asma; McBride, Russell B; Stensland, Kristian D; Wisnivesky, Juan; Haines, Lindsay; Oh, William K; Galsky, Matthew D

    2014-01-10

    Reporting adverse events is a critical element of a clinical trial publication. In 2003, the Consolidated Standards of Reporting Trials (CONSORT) group generated recommendations regarding the appropriate reporting of adverse events. The degree to which these recommendations are followed in oncology publications has not been comprehensively evaluated. A review of citations from PubMed, Medline, and Embase published between Jan 1, 2009 and December 31, 2011, identified eligible randomized, controlled phase III trials in metastatic solid malignancies. Publications were assessed for 14 adverse event-reporting elements derived from the CONSORT harms extension statement; a completeness score (range, 0 to 14) was calculated by adding the number of elements reported. Linear regression analysis identified which publication characteristics associated with reporting completeness. A total of 175 publications, with data for 96,125 patients, were included in the analysis. The median completeness score was eight (range, three to 12). Most publications (96%) reported only adverse events occurring above a threshold rate or severity, 37% did not specify the criteria used to select which adverse events were reported, and 88% grouped together adverse events of varying severity. Regression analysis revealed that trials without a stated funding source and with an earlier year of publication had significantly lower completeness scores. Reporting of adverse events in oncology publications of randomized trials is suboptimal and characterized by substantial selectivity and heterogeneity. The development of oncology-specific standards for adverse event reporting should be established to ensure consistency and provide critical information required for medical decision-making.

  19. Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations.

    Science.gov (United States)

    Smith, Shannon M; Jones, Judith K; Katz, Nathaniel P; Roland, Carl L; Setnik, Beatrice; Trudeau, Jeremiah J; Wright, Stephen; Burke, Laurie B; Comer, Sandra D; Dart, Richard C; Dionne, Raymond; Haddox, J David; Jaffe, Jerome H; Kopecky, Ernest A; Martell, Bridget A; Montoya, Ivan D; Stanton, Marsha; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

    2017-11-01

    Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation. Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

  20. Challenges in coding adverse events in clinical trials

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C

    2012-01-01

    Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation...

  1. Number and appraisal of daily hassles and life events in young adulthood: the association with physical activity and screen time: a longitudinal cohort study

    OpenAIRE

    Uijtdewilligen, Léonie; Singh, Amika S.; Chinapaw, Mai J; Koppes, Lando LJ; van Mechelen, Willem; Twisk, Jos WR

    2014-01-01

    Background Young adults face radical life changes regarding residence, marriage, family and work that may negatively impact their health behaviours. Therefore, we investigated the associations of the number of daily hassles and life events and their subjective appraisal with physical activity and screen time in young adulthood. Methods Data came from participants of the Amsterdam Growth and Health Longitudinal Study (AGAHLS). Self-reported physical activity (min/wk) was used from wave 6 (1991...

  2. Increasing young adults' condom use intentions and behaviour through changing chlamydia risk and coping appraisals: study protocol for a cluster randomised controlled trial of efficacy.

    Science.gov (United States)

    Newby, Katie V; French, David P; Brown, Katherine E; Lecky, Donna M

    2013-05-30

    Chlamydia is the most commonly diagnosed sexually transmitted infection (STI) in England and has serious public health consequences. Young people carry a disproportionate burden of infection. A number of social cognition models identify risk appraisal as a primary motivator of behaviour suggesting that changing risk appraisals for STIs may be an effective strategy in motivating protective behaviour. Meta-analytic evidence indicates that the relationship between risk appraisal and health behaviour is small, but studies examining this relationship have been criticised for their many conceptual and methodological weaknesses. The effect of risk appraisal on health behaviour may therefore be of larger size. The proposed study aims to examine the efficacy of an intervention to increase condom use intentions and behaviour amongst young people through changing chlamydia risk and coping appraisals. Coping appraisal is targeted to avoid the intervention being counterproductive amongst recipients who do not feel able to perform the behaviour required to reduce the threat. An experimental design with follow-up, a conditional measure of risk appraisal, and analysis which controls for past behaviour, enable the relationship between risk appraisal and protective behaviour to be accurately assessed. The proposed study is a two-arm cluster randomised controlled trial using a waiting-list control design to test the efficacy of the intervention compared to a control group. Participants will be school pupils aged 13-16 years old recruited from approximately ten secondary schools. Schools will be randomised into each arm. Participants will receive their usual teaching on STIs but those in the intervention condition will additionally receive a single-session sex education lesson on chlamydia. Measures will be taken at baseline, post-intervention and at follow-up three months later. The primary outcome measure is intention to use condoms with casual sexual partners. As far as the authors

  3. Adaptive parametric prediction of event times in clinical trials.

    Science.gov (United States)

    Lan, Yu; Heitjan, Daniel F

    2018-01-01

    In event-based clinical trials, it is common to conduct interim analyses at planned landmark event counts. Accurate prediction of the timing of these events can support logistical planning and the efficient allocation of resources. As the trial progresses, one may wish to use the accumulating data to refine predictions. Available methods to predict event times include parametric cure and non-cure models and a nonparametric approach involving Bayesian bootstrap simulation. The parametric methods work well when their underlying assumptions are met, and the nonparametric method gives calibrated but inefficient predictions across a range of true models. In the early stages of a trial, when predictions have high marginal value, it is difficult to infer the form of the underlying model. We seek to develop a method that will adaptively identify the best-fitting model and use it to create robust predictions. At each prediction time, we repeat the following steps: (1) resample the data; (2) identify, from among a set of candidate models, the one with the highest posterior probability; and (3) sample from the predictive posterior of the data under the selected model. A Monte Carlo study demonstrates that the adaptive method produces prediction intervals whose coverage is robust within the family of selected models. The intervals are generally wider than those produced assuming the correct model, but narrower than nonparametric prediction intervals. We demonstrate our method with applications to two completed trials: The International Chronic Granulomatous Disease study and Radiation Therapy Oncology Group trial 0129. Intervals produced under any method can be badly calibrated when the sample size is small and unhelpfully wide when predicting the remote future. Early predictions can be inaccurate if there are changes in enrollment practices or trends in survival. An adaptive event-time prediction method that selects the model given the available data can give improved

  4. The Impact of Two Workplace-Based Health Risk Appraisal Interventions on Employee Lifestyle Parameters, Mental Health and Work Ability: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Addley, K.; Boyd, S.; Kerr, R.; McQuillan, P.; Houdmont, J.; McCrory, M.

    2014-01-01

    Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental…

  5. Rosuvastatin and the JUPITER trial: critical appraisal of a lifeless planet in the galaxy of primary prevention.

    Science.gov (United States)

    López, Antonio; Wright, James M

    2012-01-01

    In November 2008, the JUPITER trial was published in the New England Journal of Medicine. JUPITER is an acronym for Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin. It was an AstraZeneca sponsored randomized double-blind trial comparing rosuvastatin 20 mg with placebo in 17,802 apparently healthy men and women with LDL cholesterol JUPITER trial have been widely publicized, and based on the trial, the main regulatory agencies have approved rosuvastatin for the indication of primary prevention of vascular events. However, the interpretation and clinical implications of the JUPITER trial have been questioned and remain controversial. The objective of this commentary is to evaluate the relevance, design, results, and conclusions of the JUPITER study.

  6. Single-trial normalization for event-related spectral decomposition reduces sensitivity to noisy trials

    Directory of Open Access Journals (Sweden)

    Romain eGrandchamp

    2011-09-01

    Full Text Available In EEG research, the classical Event-Related Potential (ERP model often proves to be a limited method when studying complex brain dynamics. For this reason, spectral techniques adapted from signal processing such as Event-Related Spectral Perturbation (ERSP – and its variant ERS (Event-Related Synchronization and ERD (Event-Related Desynchronization – have been used over the past 20-years. They represent average spectral changes in response to a stimulus.These spectral methods do not have strong consensus for comparing pre and post-stimulus activity. When computing ERSP, pre-stimulus baseline removal is usually performed after averaging the spectral estimate of multiple trials. Correcting the baseline of each single-trial prior to averaging spectral estimates is an alternative baseline correction method. However, we show that this method leads to positively skewed post-stimulus ERSP values. We eventually present new single-trial based ERSP baseline correction methods that perform trial normalization or centering prior to applying classical baseline correction methods. We show that single-trial correction methods minimize the contribution of artifactual data trials with high-amplitude spectral estimates and are robust to outliers when performing statistical inference testing. We then characterize these methods in terms of their time-frequency responses and behavior when performing statistical inference testing compared to classical ERSP methods.

  7. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection.

    Science.gov (United States)

    Guimarães, Patrícia O; Lopes, Renato D; Stevens, Susanna R; Zimerman, André; Wruck, Lisa; James, Stefan K; Haque, Ghazala; Giraldez, Roberto Rocha C V; Alexander, John H; Alexander, Karen P

    2017-04-24

    End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. In the Apixaban for Prevention of Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary syndrome were randomized to apixaban or placebo for the prevention of recurrent ischemic events. Suspected end points (myocardial infarction, stroke, or bleeding) were adjudicated by an independent clinical events classification committee. Safety criteria were collected for suspected end points and AEs. Patient-level event rates per 100 patient-days of follow-up, modeled using Poisson regression, explored the influence of region and patient characteristics on event reporting. Overall, 13 909 events were reported by 858 sites in 39 countries; 8.4% (n=1166) were suspected end points, and 91.6% (n=12 743) were AEs. Overall, 66.0% of suspected end points were confirmed by the clinical events classification committee. Most clinical events classification committee-confirmed end points met criteria to be classified as serious (94.0%); many clinical events classification committee-negated end points also did (63.2%), but fewer AEs met seriousness criteria (17.9%). The most common seriousness criterion was hospitalization (79.9%, n=2594). Region explained 28.7% of end point- and 26.4% of serious AE-reporting variation, and patient characteristics explained an additional 25.4% of end point and 13.4% of serious AE variation. Nonserious AE-reporting variation was not explained by adjustment. An integrated collection of end points and serious AEs is feasible in a multinational trial and illustrates the shared characteristics of events. Tailoring event collection to fit the phase and purpose of the trial is achievable and informative. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00831441. © 2017 The

  8. Clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events (review of Technology Appraisal No. 90): a systematic review and economic analysis.

    Science.gov (United States)

    Greenhalgh, J; Bagust, A; Boland, A; Martin Saborido, C; Oyee, J; Blundell, M; Dundar, Y; Dickson, R; Proudlove, C; Fisher, M

    2011-09-01

    Occlusive vascular events such as myocardial infarction (MI), ischaemic stroke and transient ischaemic attack (TIA) are the result of a reduction in blood flow associated with an artery becoming narrow or blocked through atherosclerosis and atherothrombosis. Peripheral arterial disease is the result of narrowing of the arteries that supply blood to the muscles and other tissues, usually in the lower extremities. The primary objective in the treatment of all patients with a history of occlusive vascular events and peripheral arterial disease is to prevent the occurrence of new occlusive vascular events. To assess the clinical effectiveness and cost-effectiveness of clopidogrel and modified-release dipyridamole (MRD) alone or with aspirin (ASA) compared with ASA (and each other where appropriate) in the prevention of occlusive vascular events in patients with a history of MI, ischaemic stroke/TIA or established peripheral arterial disease. To consider the clinical effectiveness and cost-effectiveness of clopidogrel in patients with multivascular disease. This review is an update of the evidence base for the National Institute for Health and Clinical Excellence (NICE) guidance Technology Appraisal No. 90 (TA90) entitled Clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events (2005). Four electronic databases (EMBASE, MEDLINE, Web of Science and The Cochrane Library) were searched for randomised controlled trials (RCTs) and economic evaluations. Submissions to NICE by the manufacturers of the interventions were also considered. A systematic review of clinical effectiveness and cost-effectiveness was conducted. To manage heterogeneity between trials, indirect analysis (using a mixed-treatment methodology) was performed on selected clinical outcomes. A new economic model was developed to assess incremental costs per life-year gained [quality-adjusted life-years (QALYs)]. For evidence of clinical effectiveness, four RCTs were

  9. Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.

    Science.gov (United States)

    Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J

    2017-10-01

    Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

  10. A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa.

    Science.gov (United States)

    Limaye, Dnyanesh; Langer, Janka Marisa; Rühling, Tjorben; Fortwengel, Gerhard

    2015-08-31

    To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. USA, the EU, India and South Africa. Percentage of completed randomised clinical trials for an Investigational Medicinal Product (IMP) leading to new drug approval in India and South Africa. A total of 622 eligible randomised controlled trials were identified as per search criteria for India and South Africa. Clustering them for the same sponsor and the same Investigational New Drug (IND) resulted in 453 eligible trials, that is, 224 for India and 229 for South Africa. The distribution of the market application approvals between the EU/USA as well as India and South Africa revealed that out of clinical trials with the participation of test centres in India and/or South Africa, 39.6% (India) clinical trials and 60.1% (South Africa) clinical trials led to market authorisation in the EU/USA without a New Drug Application (NDA) approval in India or South Africa. Despite an increase in clinical trial activities, there is a clear gap between the number of trials conducted and market availability of these new drugs in India and South Africa. Drug regulatory authorities, investigators, institutional review boards and patient groups should direct their efforts to ensuring availability of new drugs in the market that have been tested and researched on their population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  11. A critical appraisal of clinical trials conducted and subsequent drug approvals in India and South Africa

    OpenAIRE

    Limaye, Dnyanesh; Langer, Janka Marisa; Rühling, Tjorben; Fortwengel, Gerhard

    2015-01-01

    Objectives: To assess the relation between the number of clinical trials conducted and respective new drug approvals in India and South Africa. Design: Construction and analysis of a comprehensive database of completed randomised controlled clinical trials based on clinicaltrials.gov from 1 January 2005 to 31 December 2010 and drug approval data from 2006 until 2013 for India and South Africa. Setting: USA, the EU, India and South Africa. Main outcome measures: Percentage of compl...

  12. Trial development of the Cognitive Appraisal Scale for Infertility (CASI) (version 1).

    Science.gov (United States)

    Saito, Yoshiko; Matsuo, Hiroya

    2009-06-01

    To develop the Cognitive Appraisal Scale for Infertility (CASI) and assess it for reliability and validity. Cross-sectional and longitudinal study. A private fertility institute in Japan. 223 infertile women being treated at the institute. Administration of questionnaire at initial consultation and 6 months later. A self-rating questionnaire of perceptions and feelings about infertility on a four-point Likert scale, the State-Trait Anxiety Inventory (STAI), and the Self-rating Depression Scale (SDS). Internal consistency (Cronbach's alpha), test-retest reliability coefficients, and concurrent validity correlations. Factor analysis identified eight factors with 35 items: difficulty accepting infertility, decrease in self-esteem, acceptance/coming to terms with new self-identity, despair, loss of libido and erosion of marital relationship, guilt, denial, and self-imposed isolation. Internal consistency for factors 1 and 2 was 0.88 and 0.82, for factors 3 to 8 was from 0.68 to 0.58. Test-retest reliability coefficients were 0.90 to 0.72. Concurrent validity correlations between CASI and STAI, and SDS ranged from 0.54 to 0.29. The CASI, a new and potentially useful scale to assess emotional responses to infertility, is still in development. Further refined CASI and standardized scores of each subscale could be efficient for clinical practice.

  13. Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials

    Science.gov (United States)

    Fletcher, Mark A.; Fritzell, Bernard

    2012-01-01

    Streptococcus pneumoniae is the predominant otitis media pathogen and its prevention through effective vaccination could diminish childhood illness and antibiotic use. This paper reviews 5 pneumococcal conjugate vaccine (PCV) trials that used otitis media as an endpoint: Northern California Kaiser Permanente (NCKP; vaccine, 7-valent PCV [PCV7]-CRM); Finnish Otitis Media (FinOM; vaccines, PCV7-CRM or PCV7-OMPC); Native American Trial (vaccine, PCV7-CRM); Pneumococcal Otitis Efficacy Trial (POET; vaccine, 11-valent PCV [PCV11]-PD). For the microbiological endpoint, vaccine efficacy against vaccine-serotype pneumococcal otitis media was about 60% across trials. Against the clinical endpoint of all episodes, vaccine efficacy was 7% (PCV7-CRM/NCKP), 6% (PCV7-CRM/FinOM), −1% (PCV7-OMPC/FinOM), and −0.4% (PCV7-CRM/Native American Trial); 34% against first episodes of ear, nose, and throat specialist-referral cases (PCV11-PD/POET). Both follow-up through 2 years of age, for the 5 trials, and long-term follow-up, for PCV7-CRM/NCKP and PCV7-CRM/FinOM, demonstrated greater vaccine efficacy against recurrent AOM and tympanostomy-tube placement, suggesting that vaccination against early episodes of AOM may prevent subsequent episodes of complicated otitis media. Although study designs varied by primary endpoint measured, age at follow-up, source of middle-ear fluid for culture, case ascertainment, and type of randomization, each clinical trial demonstrated vaccine efficacy against microbiological and/or clinical otitis media. PMID:22701486

  14. Improving question formulation for use in evidence appraisal in a tertiary care setting: a randomised controlled trial [ISRCTN66375463

    Directory of Open Access Journals (Sweden)

    Rajendran Meera

    2001-11-01

    Full Text Available Abstract Background The specificity of clinical questions is gauged by explicit descriptions of four dimensions: subjects, interventions, comparators and outcomes of interest. This study determined whether adding simple instructions and examples on clinical question formulation would increase the specificity of the submitted question compared to using a standard form without instructions and examples. Methods A randomised controlled trial was conducted in an evidence-search and appraisal service. New participants were invited to reformulate clinical queries. The Control Group was given no instructions. The Intervention Group was given a brief explanation of proper formulation, written instructions, and diagrammatic examples. The primary outcome was the change in the proportion of reformulated questions that described each the dimensions of specificity. Results Fifty-two subjects agreed to participate in the trial of which 13 were lost to follow-up. The remaining 17 Intervention Group and 22 Control Group participants were analysed. Baseline characteristics were comparable. Overall, 20% of initially submitted questions from both groups were properly specified (defined as an explicit statement describing all dimensions of specificity. On follow-up, 7/14 questions previously rated as mis-specified in the Intervention Group had all dimensions described at follow-up (p = 0.008 while the Control Group did not show any changes from baseline. Participants in the Intervention Group were also more likely to explicitly describe patients (p = 0.028, comparisons (p = 0.014, and outcomes (p = 0.008. Conclusions This trial demonstrated the positive impact of specific instructions on the proportion of properly-specified clinical queries. The evaluation of the long-term impact of such changes is an area of continued research.

  15. Trial-by-Trial Fluctuations in the Event-Related Electroencephalogram Reflect Dynamic Changes in the Degree of Surprise

    NARCIS (Netherlands)

    Mars, R.B.; Debener, S.; Gladwin, T.E.; Harrison, L.M.; Haggard, P.; Rothwell, J.C.; Bestmann, S.

    2008-01-01

    The P300 component of the human event-related brain potential has often been linked to the processing of rare, surprising events. However, the formal computational processes underlying the generation of the P300 are not well known. Here, we formulate a simple model of trial-by-trial learning of

  16. Performance Appraisal Applied to Leadership

    Science.gov (United States)

    Jefferson, Anne L.

    2010-01-01

    Performance appraisal is a measurement process of how well an individual is doing her or his job. In most organisations, this appraisal is an annual event. Generally, it is done to encourage job performance, to flag areas that need attention, to inform both parties as to expectations. Much of the literature speaks to this process in terms of the…

  17. Appraisal Report

    DEFF Research Database (Denmark)

    Schleimann, Finn; Enemark, Ulrika; Vagnby, Bo Hellisen

    Appraisal of continued support to Ghana's health sector for a third phase covering 2003 - 2007. Funding recommended with DKK 340 million over five years.......Appraisal of continued support to Ghana's health sector for a third phase covering 2003 - 2007. Funding recommended with DKK 340 million over five years....

  18. Control charts for monitoring accumulating adverse event count frequencies from single and multiple blinded trials.

    Science.gov (United States)

    Gould, A Lawrence

    2016-12-30

    Conventional practice monitors accumulating information about drug safety in terms of the numbers of adverse events reported from trials in a drug development program. Estimates of between-treatment adverse event risk differences can be obtained readily from unblinded trials with adjustment for differences among trials using conventional statistical methods. Recent regulatory guidelines require monitoring the cumulative frequency of adverse event reports to identify possible between-treatment adverse event risk differences without unblinding ongoing trials. Conventional statistical methods for assessing between-treatment adverse event risks cannot be applied when the trials are blinded. However, CUSUM charts can be used to monitor the accumulation of adverse event occurrences. CUSUM charts for monitoring adverse event occurrence in a Bayesian paradigm are based on assumptions about the process generating the adverse event counts in a trial as expressed by informative prior distributions. This article describes the construction of control charts for monitoring adverse event occurrence based on statistical models for the processes, characterizes their statistical properties, and describes how to construct useful prior distributions. Application of the approach to two adverse events of interest in a real trial gave nearly identical results for binomial and Poisson observed event count likelihoods. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  19. A Review of Instruments on Cognitive Appraisal of Stress.

    Science.gov (United States)

    Carpenter, Roger

    2016-04-01

    The purpose of this paper is to present a review of theoretically based measures of cognitive appraisal, and discuss psychometric strengths and limitations. Understanding how an individual appraises stressful events becomes important when faced with alterations in mental health. Cognitive appraisals influence how an individual copes with stressful events and life crises that leads to changes in mental health. Measures on how an individual appraises a stressful event lack conceptual soundness and are limited by weak psychometric properties. Health and Psychosocial Instruments (HAPI) electronic database was searched using combinations of the key words cognitive appraisal, primary appraisal, secondary appraisal, appraisal of illness, appraisal of health, and stress appraisal. The quality of these instrument sources was assessed by published psychometric data in the primary source. Five instruments were found that measure cognitive appraisal as theoretically described: the Meaning of Illness Questionnaire, the Stress Appraisal Measure, the Appraisal of Illness Scale, the Cognitive Appraisal of Health Scale, and the Primary Appraisal/Secondary Appraisal scale. A description of each tool, including purpose, scoring, and psychometric support, is provided. There are a limited number of instruments that measure cognitive appraisal as theoretically described. Theoretically sound instruments with established psychometric support are needed to make accurate inferences about the role of cognitive appraisal in the mental and physical health of individuals experiencing stress. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  1. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial.

    Science.gov (United States)

    Hess, Connie N; James, Stefan; Lopes, Renato D; Wojdyla, Daniel M; Neely, Megan L; Liaw, Danny; Hagstrom, Emil; Bhatt, Deepak L; Husted, Steen; Goodman, Shaun G; Lewis, Basil S; Verheugt, Freek W A; De Caterina, Raffaele; Ogawa, Hisao; Wallentin, Lars; Alexander, John H

    2015-08-18

    Bleeding limits anticoagulant treatment in patients with acute coronary syndromes (ACS). We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS. This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo. In a post-hoc analysis, we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate. At baseline, of 7,364 patients, 16.3% (n = 1,202) were on aspirin alone, and 79.0% (n = 5,814) were on aspirin plus clopidogrel. A total of 19.2% (n = 1,415) switched antiplatelet therapy during follow-up. No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death, myocardial infarction, and ischemic stroke in patients taking aspirin (12.21 per 100 patient-years vs. 13.21 per 100 patient-years; adjusted hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.62 to 1.32) or aspirin plus clopidogrel (13.22 vs. 14.24; adjusted HR: 0.95; 95% CI: 0.78 to 1.14; p(interaction)= 0.84). Compared with placebo, apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin (1.48 vs. 0.25; adjusted HR: 6.62; 95% CI: 0.75 to 51.73) and in patients taking aspirin plus clopidogrel (2.58 vs. 1.02; adjusted HR: 2.44; 95% CI: 1.34 to 4.45; p(interaction)= 0.41). Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention. Post-ACS treatment with apixaban versus placebo showed no efficacy, but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel. (Apixaban for Prevention of Acute Ischemic Events 2 [APPRAISE-2]; NCT00831441

  2. Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

    Directory of Open Access Journals (Sweden)

    P R Srijithesh

    2014-01-01

    Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

  3. Appraising Loftus and Palmer (1974) post-event information versus concurrent commentary in the context of sport.

    Science.gov (United States)

    Goldschmied, Nadav; Sheptock, Mark; Kim, Kacey; Galily, Yair

    2017-11-01

    Two experiments were conducted to examine framing effects in sport. In Experiment 1, a conceptual replication [Loftus, E. F., & Palmer, J. C. (1974). Reconstruction of automobile destruction: An example of the interaction between language and memory. Journal of Verbal Learning and Verbal Behavior, 13(5), 585-589], participants watched a hockey collision, with the hit described later in a written format as a "contact", "bump", or "smash". This manipulation resulted in no differences in participants' report of how fast the players were skating, their intentions, and the outcome of the hit. In Experiment 2, participants watched the same video clip with ongoing commentary. Those who heard the announcer describing the event as "contact" estimated a higher skating speed than participants who were exposed to the "smash" commentary. Participants who were exposed to the "bump" commentary rated the repercussions of the collision as less severe than did those exposed to the other commentaries. These findings show that the perception of magnitude hierarchy may be domain specific and suggest future avenues for exploring framing effects when one is exposed to visual stimuli.

  4. Consultant appraisals. Appraise where due.

    Science.gov (United States)

    Ledgard, Anna; Thomas, Beverly; McClelland, Siobhan; Robbé, Iain

    2002-11-21

    A study of consultant appraisal in Welsh trusts revealed concerns about lack of protected time and uncertainty about how issues raised should be handled. The research showed it is important to ensure that issues raised are addressed by the organisation. Resources must be made available to trusts to offer protected time for the process, and adequate training.

  5. Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    NARCIS (Netherlands)

    Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao-Yin; Cooper, Mark E.; de Zeeuw, Dick; Eckardt, Kai-Uwe; Ivanovich, Peter; Kewalramani, Reshma; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet; McMurray, John J. V.; Parfrey, Patrick; Parving, Hans-Henrik; Remuzzi, Giuseppe; Singh, Ajay K.; Solomon, Scott D.; Toto, Robert; Uno, Hajime

    Background: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and

  6. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2014-01-01

    intravenous administration of the same drug, resulting in bias favouring the control intervention, RHR 1.33 (0.98 to 1.82). Seven trials of cytomegalovirus retinitis, tibial fracture and multiple sclerosis compared experimental interventions with standard control interventions, e.g. placebo, no-treatment......BACKGROUND: We wanted to evaluate the impact of nonblinded outcome assessors on estimated treatment effects in time-to-event trials. METHODS: Systematic review of randomized clinical trials with both blinded and nonblinded assessors of the same time-to-event outcome. Two authors agreed on inclusion...... or active control, resulting in bias favouring the experimental intervention, RHR 0.73 (0.57 to 0.93), indicating an average exaggeration of nonblinded hazard ratios by 27% (7% to 43%). CONCLUSIONS: Lack of blinded outcome assessors in randomized trials with subjective time-to-event outcomes causes high...

  7. Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nancy Kassam-Adams

    2013-07-01

    Full Text Available Background: Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives: To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method: Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification in the hospital and will be instructed on how to complete modules 2 (Appraisals and 3 (Avoidance online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results: Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life. Discussion: Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a

  8. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse......,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though...... this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat...

  9. Population Analysis of Adverse Events in Different Age Groups Using Big Clinical Trials Data.

    Science.gov (United States)

    Luo, Jake; Eldredge, Christina; Cho, Chi C; Cisler, Ron A

    2016-10-17

    Understanding adverse event patterns in clinical studies across populations is important for patient safety and protection in clinical trials as well as for developing appropriate drug therapies, procedures, and treatment plans. The objective of our study was to conduct a data-driven population-based analysis to estimate the incidence, diversity, and association patterns of adverse events by age of the clinical trials patients and participants. Two aspects of adverse event patterns were measured: (1) the adverse event incidence rate in each of the patient age groups and (2) the diversity of adverse events defined as distinct types of adverse events categorized by organ system. Statistical analysis was done on the summarized clinical trial data. The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41%, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76%. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09%, significantly higher (Pgroup. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (Page group (older

  10. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Brown, Benjamin; Lystad, Reidar P

    2016-09-01

    Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately. This study aimed to describe the extent of adverse events reporting in published RCTs involving SMT, and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement. This is a systematic literature review. The Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analyzed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analyzed using tests for equality of proportions with continuity correction. There was no funding obtained for this study. The authors declare no conflict of interest. Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events

  11. Correlating eligibility criteria generalizability and adverse events using Big Data for patients and clinical trials

    Science.gov (United States)

    Sen, Anando; Ryan, Patrick; Goldstein, Andrew; Chakrabarti, Shreya; Wang, Shuang; Koski, Eileen; Weng, Chunhua

    2016-01-01

    Randomized controlled trials can benefit from proactive assessment of how well their participant selection strategies during the design of eligibility criteria can influence the study generalizability. In this paper, we present a quantitative metric called generalizability index for study traits 2.0 (GIST 2.0) to assess the a priori generalizability (based on population representativeness) of a clinical trial by accounting for the dependencies among multiple eligibility criteria. The metric was evaluated on 16 sepsis trials identified from ClinicalTrials.gov, with their adverse event reports extracted from the trial results section. The correlation between GIST scores and adverse events was analyzed. We found that the GIST 2.0 score was significantly correlated with total adverse events and serious adverse events (weighted correlation coefficients of 0.825 and 0.709, respectively, with P < 0.01). This study exemplifies the promising use of Big Data in electronic health records and ClinicalTrials.gov for optimizing eligibility criteria design for clinical studies. PMID:27598694

  12. Correlating eligibility criteria generalizability and adverse events using Big Data for patients and clinical trials.

    Science.gov (United States)

    Sen, Anando; Ryan, Patrick B; Goldstein, Andrew; Chakrabarti, Shreya; Wang, Shuang; Koski, Eileen; Weng, Chunhua

    2017-01-01

    Randomized controlled trials can benefit from proactive assessment of how well their participant selection strategies during the design of eligibility criteria can influence the study generalizability. In this paper, we present a quantitative metric called generalizability index for study traits 2.0 (GIST 2.0) to assess the a priori generalizability (based on population representativeness) of a clinical trial by accounting for the dependencies among multiple eligibility criteria. The metric was evaluated on 16 sepsis trials identified from ClinicalTrials.gov, with their adverse event reports extracted from the trial results sections. The correlation between GIST scores and adverse events was analyzed. We found that the GIST 2.0 score was significantly correlated with total adverse events and serious adverse events (weighted correlation coefficients of 0.825 and 0.709, respectively, with P Big Data in electronic health records and ClinicalTrials.gov for optimizing eligibility criteria design for clinical studies. © 2016 New York Academy of Sciences.

  13. Evaluation and registration of adverse events in clinical drug trials in migraine

    DEFF Research Database (Denmark)

    Tfelt-Hansen, P.; Bjarnason, N.H.; Dahlof, C.

    2008-01-01

    Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be indi...... be indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given Udgivelsesdato: 2008/7......Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may...

  14. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    Science.gov (United States)

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs. Copyright © 2014 International Association for the Study of Pain. All rights reserved.

  15. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2011-03-01

    Full Text Available Abstract Background In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. Methods This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Results Among the 1968 patients, 74 patients (3.76% suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Conclusions Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs were related to the patients' gender and age and the local

  16. Analysis of time to event outcomes in randomized controlled trials by generalized additive models.

    Directory of Open Access Journals (Sweden)

    Christos Argyropoulos

    Full Text Available Randomized Controlled Trials almost invariably utilize the hazard ratio calculated with a Cox proportional hazard model as a treatment efficacy measure. Despite the widespread adoption of HRs, these provide a limited understanding of the treatment effect and may even provide a biased estimate when the assumption of proportional hazards in the Cox model is not verified by the trial data. Additional treatment effect measures on the survival probability or the time scale may be used to supplement HRs but a framework for the simultaneous generation of these measures is lacking.By splitting follow-up time at the nodes of a Gauss Lobatto numerical quadrature rule, techniques for Poisson Generalized Additive Models (PGAM can be adopted for flexible hazard modeling. Straightforward simulation post-estimation transforms PGAM estimates for the log hazard into estimates of the survival function. These in turn were used to calculate relative and absolute risks or even differences in restricted mean survival time between treatment arms. We illustrate our approach with extensive simulations and in two trials: IPASS (in which the proportionality of hazards was violated and HEMO a long duration study conducted under evolving standards of care on a heterogeneous patient population.PGAM can generate estimates of the survival function and the hazard ratio that are essentially identical to those obtained by Kaplan Meier curve analysis and the Cox model. PGAMs can simultaneously provide multiple measures of treatment efficacy after a single data pass. Furthermore, supported unadjusted (overall treatment effect but also subgroup and adjusted analyses, while incorporating multiple time scales and accounting for non-proportional hazards in survival data.By augmenting the HR conventionally reported, PGAMs have the potential to support the inferential goals of multiple stakeholders involved in the evaluation and appraisal of clinical trial results under proportional and

  17. Assessing Teacher Appraisals and Stress in the Classroom: Review of the Classroom Appraisal of Resources and Demands

    Science.gov (United States)

    McCarthy, Christopher J.; Lambert, Richard G.; Lineback, Sally; Fitchett, Paul; Baddouh, Priscila G.

    2016-01-01

    Stress research increasingly emphasizes the role of appraisal in determining which events are perceived as stressful. The Classroom Appraisal of Resources and Demands (CARD) was developed to measure teachers' appraisals of their classroom demands and resources in order to assess their risk for experiencing occupational stress. The present purposes…

  18. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials

    DEFF Research Database (Denmark)

    Keus, F; Wetterslev, J; Gluud, C

    2009-01-01

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...... of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability...... in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero...

  19. Evaluating the Quality of Randomized Controlled Trials that Examine the Efficacy of Natural Health Products: A Systematic Review of Critical Appraisal Instruments

    Directory of Open Access Journals (Sweden)

    Anne Marie Whelan

    2009-01-01

    Full Text Available The purpose of this project was to conduct a systematic review to identify instruments designed to evaluate the quality of randomized controlled trials (RCTs of natural health products (NHPs. Instruments were examined for inclusion of items assessing methods, identity and content of the NHP, generalizability of results and instructions for use. Online databases, websites, textbooks and reference lists were searched to identify instruments. Relevance assessment and data extraction of articles were completed by two investigators and disagreements were settled by the third investigator. Data were analyzed using descriptive statistics. Of the 4442 citations identified, 29 were potentially relevant with 16 meeting the criteria for inclusion. None of the instruments stated they were validated; content in the four areas of interest varied considerably. The most common items included randomization sequence generation (100%, blinding (100%, allocation concealment (75% and participant flow (75%. Only nine of the NHP instruments included at least one item to appraise the specific content of the NHP. The CONSORT Statement for Herbal Interventions most closely addressed the four areas of interest; however, this instrument was specific for herbs. There is a need for the development of a validated instrument for assessment of the quality of RCTs that would be useful for herbs as well as other NHPs.

  20. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis.

    Science.gov (United States)

    Belknap, Steven M; Aslam, Imran; Kiguradze, Tina; Temps, William H; Yarnold, Paul R; Cashy, John; Brannigan, Robert E; Micali, Giuseppe; Nardone, Beatrice; West, Dennis P

    2015-06-01

    Two meta-analyses conclude that finasteride treatment of androgenic alopecia (AGA) is safe but do not assess quality of safety reporting. To assess safety reporting for clinical trial reports of finasteride for AGA. MEDLINE, ClinicalTrials.gov, and a clinical data repository for an academic medical center. Published clinical trial reports for finasteride treatment of AGA. For each trial, we assessed quality of adverse event reporting, extracted the number and type of adverse events in treatment and placebo groups, and assessed duration of safety evaluation and adequacy of blinding. Two observers independently extracted the data; differences were resolved by consensus. We assessed generalizability in a large cohort of men prescribed finasteride, 1.25 mg/d or less, by assessing for eligibility in the finasteride-AGA pivotal trials. Quality was assessed as adequate, partially adequate, inadequate, or no events reported. We used funnel plots of the hazard ratio to assess bias. Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic underdetection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for AGA with finasteride, 1.25 mg/d or less, for AGA, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer's full prescribing information and 33% took finasteride for more than 1 year. Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of AGA, most would

  1. Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

    DEFF Research Database (Denmark)

    Pfeffer, Marc A; Burdmann, Emmanuel A; Chen, Chao-Yin

    2009-01-01

    BACKGROUND: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics......-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia....... with another erythropoiesis-stimulating agent targeting greater hemoglobin levels had either a neutral or adverse effect on clinical outcomes. STUDY DESIGN: Randomized trial. SETTING & PARTICIPANTS: 4,044 participants with type 2 diabetes, CKD (defined as estimated glomerular filtration rate of 20 to 60 m...

  2. Analysis of recurrent events: a systematic review of randomised controlled trials of interventions to prevent falls.

    Science.gov (United States)

    Donaldson, Meghan G; Sobolev, Boris; Cook, Wendy L; Janssen, Patti A; Khan, Karim M

    2009-03-01

    there are several well-developed statistical methods for analysing recurrent events. Although there are guidelines for reporting the design and methodology of randomised controlled trials (RCTs), analysis guidelines do not exist to guide the analysis for RCTs with recurrent events. Application of statistical methods that do not account for recurrent events may provide erroneous results when used to test the efficacy of an intervention. It is unknown what proportion of RCTs of falls prevention studies have utilised statistical methods that incorporate recurrent events. we conducted a systematic review of RCTs of interventions to prevent falls in community-dwelling older persons. We searched Medline from 1994 to November 2006. We determined the proportion of studies that reported using three statistical methods appropriate for the analysis of recurrent events (negative binomial regression, Andersen-Gill extension of the Cox model and the WLW marginal model). fewer than one-third of 83 papers that reported falls as an outcome utilised any appropriate statistical method (negative binomial regression, Andersen-Gill extension of the Cox model and Cox marginal model) to analyse recurrent events and fewer than 15% utilised graphical methods to represent falls data. RCTs that have a recurrent event end-point should include an analysis appropriate for recurrent event data such as negative binomial regression, Andersen-Gill extension of the Cox model and/or the WLW marginal model. We recommend that researchers and clinicians seek consultation with a statistician with expertise in recurrent event methodology.

  3. Wheeze as an Adverse Event in Pediatric Vaccine and Drug Randomized Controlled Trials: A Systematic Review

    Science.gov (United States)

    Marangu, Diana; Kovacs, Stephanie; Walson, Judd; Bonhoeffer, Jan; Ortiz, Justin R.; John-Stewart, Grace; Horne, David J.

    2016-01-01

    Introduction Wheeze is an important sign indicating a potentially severe adverse event in vaccine and drug trials, particularly in children. However, there are currently no consensus definitions of wheeze or associated respiratory compromise in randomized controlled trials (RCTs). Objective To identify definitions and severity grading scales of wheeze as an adverse event in vaccine and drug RCTs enrolling children Vaccines made up the majority (90%) of interventions, particularly influenza vaccines (65%). Only 15 trials provided explicit definitions of wheeze. Of 24 studies that described severity, 11 described wheeze severity in the context of an explicit wheeze definition. The remaining 13 studies described wheeze severity where wheeze was defined as part of a respiratory illness or a wheeze equivalent. Wheeze descriptions were elicited from caregiver reports (14%), physical examination by a health worker (45%) or a combination (41%). There were 21/58 studies in which wheeze definitions included combined caregiver report and healthcare worker assessment. The use of these two methods appeared to have the highest combined sensitivity and specificity. Conclusion Standardized wheeze definitions and severity grading scales for use in pediatric vaccine or drug trials are lacking. Standardized definitions of wheeze are needed for assessment of possible adverse events as new vaccines and drugs are evaluated. PMID:26319071

  4. Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials.

    Science.gov (United States)

    Lebwohl, Mark G; Papp, Kim A; Marangell, Lauren B; Koo, John; Blauvelt, Andrew; Gooderham, Melinda; Wu, Jashin J; Rastogi, Shipra; Harris, Susan; Pillai, Radhakrishnan; Israel, Robert J

    2018-01-01

    Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  5. Resilience as positive coping appraisals: Testing the schematic appraisals model of suicide (SAMS).

    Science.gov (United States)

    Johnson, J; Gooding, P A; Wood, A M; Tarrier, N

    2010-03-01

    The Schematic Appraisals Model of Suicide (SAMS) suggests that positive self-appraisals may be important for buffering suicidal thoughts and behaviours, potentially providing a key source of resilience. The current study aimed to explore whether positive self-appraisals buffered individuals from suicidality in the face of stressful life events. 78 participants who reported experiencing some degree of suicidality were recruited from a student population. They completed a battery of questionnaires including measures of suicidality, stressful life events and positive self-appraisals. Positive self-appraisals moderated the association between stressful life events and suicidality. For those reporting moderate or high levels of positive self-appraisals, raised incidence of stressful life events did not lead to increases in suicidality. These results support the SAMS framework, and suggest that positive self-appraisals may confer resilience to suicide. Positive self-appraisals may be a promising avenue for further resilience research, and an important area to target for suicide interventions. 2009 Elsevier Ltd. All rights reserved.

  6. Exogenous testosterone, cardiovascular events, and cardiovascular risk factors in elderly men: a review of trial data.

    Science.gov (United States)

    Carson, Culley C; Rosano, Giuseppe

    2012-01-01

    Increasing interest in the use of supplemental testosterone has led to a heightened focus on the safety of testosterone in elderly males, with a particular emphasis on cardiovascular risk. To evaluate, based on available clinical trial data, whether exogenous testosterone administration in middle-aged to elderly men increases cardiovascular risk, and to assess whether these effects differ in hypogonadal vs. eugonadal subjects. MEDLINE search from 2004 to present of all meta-analyses and randomized, controlled clinical trials of testosterone administration in male subjects ≥ 45 years old that included measurements of cardiovascular outcomes or known cardiovascular risk factors before and after treatment with testosterone. The effects of testosterone treatment on cardiovascular events and cardiovascular risk factors were assessed. In clinical trials where testosterone has been used in patients with preexisting cardiovascular conditions, the effect on disease symptoms has typically been either neutral or beneficial. Based on clinical trial data, testosterone treatment has minimal effect on cardiovascular risk factors with the exception of an increase in hematocrit, which is consistently seen with testosterone treatment, and a decrease in high-density lipoprotein cholesterol, which is an inconsistent response. Responses of hypogonadal and eugonadal men to testosterone treatment in terms of cardiovascular risk are generally similar. Testosterone treatment has not been reported to increase the incidence of cardiovascular events with the possible exception of one trial in frail elderly men. Available clinical trial data indicate that the use of testosterone in middle-aged to elderly men does not increase cardiovascular risk nor does it unfavorably modify cardiovascular risk profile. Prospective data from large, well-designed, long-term trials of testosterone treatment are lacking and will be required to verify the cardiovascular efficacy/safety of chronic treatment.

  7. Withdrawal-related adverse events from clinical trials of clobazam in Lennox-Gastaut syndrome.

    Science.gov (United States)

    Tolbert, Dwain; Harris, Stuart I; Bekersky, Ihor; Lee, Deborah; Isojarvi, Jouko

    2014-08-01

    To assess withdrawal-related adverse event (AE) rates following abrupt clobazam discontinuation in Phase I trials and gradual clobazam tapering (2-3 weeks) following discontinuation from III trials met the criteria for potential/III trials, we evaluated AE data from four multiple-dosage Phase I trials (duration: 8-34 days). Therapeutic (20 and 40 mg/day) and supratherapeutic clobazam dosages (120 and 160 mg/day) were administered. Adverse events (AEs) were also assessed for patients with Lennox-Gastaut syndrome enrolled in Phase II (OV-1002) and Phase III (OV-1012) studies (duration ≤15 weeks) and in the open-label extension (OLE) trial OV-1004 (≤5 years). Potential withdrawal-related AEs were identified by preferred terms, provided that the AEs occurred ≥1 day following and ≤30 days after the last clobazam doses, or were deemed withdrawal symptoms by investigators. Clinical Institute Withdrawal Assessment for Benzodiazepines (CIWA-B) scale was used to evaluate withdrawal intensity in three of the four Phase I trials. A total of 207 participants in Phase I trials received steady-state clobazam dosages of 20-160 mg/day, 182 received clobazam dosages of ≥40 mg/day, and 94 received clobazam dosages of ≥120 mg/day. Abrupt clobazam discontinuation led to 193 withdrawal-related AEs for 68 Phase I participants. Nearly 50% of AEs occurred after discontinuation of clobazam dosages of ≥120 mg/day. Adverse events were mild or moderate and included headache (14% of Phase I participants), insomnia (12.6%), tremor (10.1%), and anxiety (8.7%). The CIWA-B scores varied (range: 0-59). Most scores were benzodiazepine withdrawal. III trials met the criteria for potential/III patients received clobazam dosages of ≤40 mg/day, and those in the OLE trial received clobazam dosages of ≤80 mg/day. Eighty-seven patients discontinued clobazam and were gradually tapered. No withdrawal-related AEs or incidences of status epilepticus were reported. Withdrawal-related AEs

  8. The relationship between meteorological conditions and index acute coronary events in a global clinical trial.

    Science.gov (United States)

    Ezekowitz, Justin A; Bakal, Jeffrey A; Westerhout, Cynthia M; Giugliano, Robert P; White, Harvey; Keltai, Matyas; Prabhakaran, Dorairaj; Tricoci, Pierluigi; Van de Werf, Frans; Califf, Robert M; Newby, L Kristin; Armstrong, Paul W

    2013-10-03

    Considerable uncertainty exists concerning the interaction between climate and human health. We explored this issue by evaluating the relationship between meteorological events and acute coronary syndrome (ACS) events. 9406 patients in 29 countries at 440 Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) clinical trial sites were linked to a weather station by location. Temperature, barometric pressure, precipitation, wind speed and combined temperature and relative humidity were normalized by location for the 37 days prior to the index ACS event that precipitated study enrollment. A meteorological event was defined as a change in any weather metric that was expected to occur in less than 10% of the exposure intervals: four separate 48-hour intervals within the seven days prior to an ACS event (T1, day of event and -1 day; T2, -2 to -3 days; T3, -4 to -5 days; and T4, -6 to -7 days). Results are reported as ratio of observed to expected events for the meteorological parameter. There were 10% more drops in temperature observed in T4 (95%CI: 3-17%), and more increases in temperature observed during T1 (4%; 95%CI -2-9%). An excess number of wind speed increases (9%;95%CI 2-16%) and relative humidity increases (6%; 95%CI 0.1-14%) occurred during T4. Additionally, female patients in this cohort presented less often than male patients following drops in average temperature. Using a new method for integrating meteorological data into a clinical trial dataset, we identified associations between changes in weather conditions and the likelihood of an ACS event. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  9. Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

    Science.gov (United States)

    Federer, Callie; Yoo, Minjae; Tan, Aik Choon

    2016-12-01

    Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

  10. An appraisal of innovative meloxicam mucoadhesive films for periodontal postsurgical pain control: A double-blinded, randomized clinical trial of effectiveness.

    Science.gov (United States)

    Rajeswari, S Raja; Gowda, Triveni M; Kumar, Tarun A B; Thimmasetty, J; Mehta, Dhoom Singh

    2015-01-01

    Transmucosal analgesic delivery is a promising approach to periodontal postoperative pain management. The purpose of this clinical trial is to appraise the effectiveness of transmucosal drug delivery system with meloxicam films and to identify its minimum effective dosage via this route after periodontal flap surgery. The analgesic mucoadhesive films were formulated using meloxicam and hydroxypropyl methyl cellulose polymer by solvent casting method. The sample size consisted of 60 chronic periodontitis patients who require periodontal flap surgery. The subjects were randomized using lottery method into four groups (Group A - 45 mg; B - 30 mg; C - 20 mg; D - 10 mg meloxicam per film). After periodontal flap surgery, the respective meloxicam mucoadhesive films were placed over the surgical site and were removed on 4(th) day of postsurgery. The primary outcome measure was postsurgical pain level and recorded at 1(st), 2(nd), 3(rd), 4(th), 5(th), 24(th), and 48(th) h using a 0-10 mm visual analog scale with markings from 0 = no pain to 10 = extreme pain. The postoperative pain control observed in Groups A and B was found to be effective, and the patient comfort level was very satisfactory. Whereas in Group C, it was found to be high in the first 3 h postsurgically, after which adequate pain relief was seen. Group D exhibited inadequate pain relief. No adverse reactions were noted after applying the film in any of the groups. Transmucosal delivery of meloxicam was found to be effective and safe in postsurgical pain control of periodontal flap surgery. The minimum effective dosage via this route for meloxicam was found to be with 30 mg mucoadhesive films.

  11. Statistical methods for cost-effectiveness analyses that use data from cluster randomized trials: a systematic review and checklist for critical appraisal.

    Science.gov (United States)

    Gomes, Manuel; Grieve, Richard; Nixon, Richard; Edmunds, W J

    2012-01-01

    The best data for cost-effectiveness analyses (CEAs) of group-level interventions often come from cluster randomized trials (CRTs), where randomization is by cluster (e.g., the hospital attended), not by individual. for these CEAs need to recognize both the correlation between costs and outcomes and that these data may be dependent on the cluster. General checklists and methodological guidance for critically appraising CEA ignore these issues. This article develops a new checklist and applies it in a systematic review of CEAs that use CRTs. The authors developed a checklist for CEAs that use CRTs, informed by a conceptual review of statistical methods. This checklist included criteria such as whether the analysis allowed for both clustering and the correlation between individuals' costs and outcomes. The authors undertook a systematic literature review of full economic evaluations that used CRTs. The quality of studies was assessed with the new checklist and by the "Drummond checklist." The authors identified 62 papers that met the inclusion criteria. On average, studies satisfied 9 of the 10 criteria for the checklist but only 20% of criteria for the new checklist. More than 40% of studies adopted statistical methods that completely ignored clustering, and 75% disregarded any correlation between costs and outcomes. Only 4 studies employed appropriate statistical methods that allowed for both clustering and correlation. Most economic evaluations that use data from CRTs ignored clustering or correlation. Statistical methods that address these issues are available, and their use should be encouraged. The new checklist can supplement generic CEA guidelines and highlight where research practice can be improved.

  12. An appraisal of innovative meloxicam mucoadhesive films for periodontal postsurgical pain control: A double-blinded, randomized clinical trial of effectiveness

    Directory of Open Access Journals (Sweden)

    S Raja Rajeswari

    2015-01-01

    Full Text Available Background and Objective: Transmucosal analgesic delivery is a promising approach to periodontal postoperative pain management. The purpose of this clinical trial is to appraise the effectiveness of transmucosal drug delivery system with meloxicam films and to identify its minimum effective dosage via this route after periodontal flap surgery. Materials and Methods: The analgesic mucoadhesive films were formulated using meloxicam and hydroxypropyl methyl cellulose polymer by solvent casting method. The sample size consisted of 60 chronic periodontitis patients who require periodontal flap surgery. The subjects were randomized using lottery method into four groups (Group A - 45 mg; B - 30 mg; C - 20 mg; D - 10 mg meloxicam per film. After periodontal flap surgery, the respective meloxicam mucoadhesive films were placed over the surgical site and were removed on 4 th day of postsurgery. The primary outcome measure was postsurgical pain level and recorded at 1 st , 2 nd , 3 rd , 4 th , 5 th , 24 th , and 48 th h using a 0-10 mm visual analog scale with markings from 0 = no pain to 10 = extreme pain. Results: The postoperative pain control observed in Groups A and B was found to be effective, and the patient comfort level was very satisfactory. Whereas in Group C, it was found to be high in the first 3 h postsurgically, after which adequate pain relief was seen. Group D exhibited inadequate pain relief. No adverse reactions were noted after applying the film in any of the groups. Conclusion: Transmucosal delivery of meloxicam was found to be effective and safe in postsurgical pain control of periodontal flap surgery. The minimum effective dosage via this route for meloxicam was found to be with 30 mg mucoadhesive films.

  13. Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov.

    Science.gov (United States)

    Su, Eric Wen; Sanger, Todd M

    2017-01-01

    Drug repositioning (i.e., drug repurposing) is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics) and PolyAnalyst (Megaputer) were utilized. An I2E query extracts "Serious Adverse Events" (SAE) data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer).

  14. Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review.

    Science.gov (United States)

    Williams, Mark R; McKeown, Andrew; Pressman, Zachary; Hunsinger, Matthew; Lee, Kendrick; Coplan, Paul; Gilron, Ian; Katz, Nathaniel P; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Turk, Dennis C; Dworkin, Robert H; Smith, Shannon M

    2016-11-01

    Thorough assessment and reporting of adverse events (AEs) facilitates a detailed understanding of a treatment's risk-benefit profile. Although the Consolidated Standards of Reporting Trials (CONSORT) 2004 statement provides recommendations regarding AE reporting, adherence to these standards is often inadequate. We investigated AE reporting in clinical trials of intravenous and invasive pain treatments published in 6 major anesthesiology and pain journals between 2000 to 2003 and 2006 to 2012. We examined whether AE reporting improved after publication of the 2004 CONSORT recommendations and also comprehensively reviewed AE assessment using the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting recommendations. No improvement was found overall in CONSORT harms reporting scores from pre- to postpublication of the CONSORT recommendations, with only 5 of 10 fulfilled on average. AE reporting assessed using the ACTTION coding manual was generally inadequate, and 8% of articles failed to report any AE information at all. Anesthesiology and pain journals were similar in AE reporting quality, although industry-sponsored trials reported more AE information than nonindustry sponsored trials. Improvement is needed in AE reporting in analgesic clinical trials. The CONSORT checklist and ACTTION AE recommendations can assist investigators and editors in improving clinical trial transparency and quality. This systematic review of AE reporting in intravenous and invasive pain treatment trials shows that little improvement has been made since the 2004 CONSORT harms reporting guidelines. Better assessment and reporting of treatment AEs is necessary to understand the full clinical effect of intravenous and invasive treatments. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  15. Frequency of cancer events with saxagliptin in the SAVOR-TIMI 53 trial.

    Science.gov (United States)

    Leiter, L A; Teoh, H; Mosenzon, O; Cahn, A; Hirshberg, B; Stahre, C A M; Hoekstra, J B L; Alvarsson, M; Im, K; Scirica, B M; Bhatt, D L; Raz, I

    2016-02-01

    The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-Thrombolysis in Myocardial Infarction (TIMI) 53 trial randomized trial of 16,492 patients (placebo, n = 8212; saxagliptin, n = 8280) treated and followed for a median of 2.1 years afforded an opportunity to explore whether there was any association with cancer reported as a serious adverse event. At least one cancer event was reported by 688 patients (4.1%): 362 (4.3%) and 326 (3.8%) in the placebo and saxagliptin arms, respectively (p = 0.13). There were 59 (0.6%) deaths adjudicated as malignancy deaths with placebo and 53 (0.6%) with saxagliptin. Stratification by gender, age, race and ethnicity, diabetes duration, baseline glycated haemoglobin and pharmacotherapy did not show any clinically meaningful differences between the two study arms. The overall number of cancer events and malignancy-associated mortality rates were generally balanced between the placebo and saxagliptin groups, suggesting a null relationship with saxagliptin use over the median follow-up of 2.1 years. Multivariable modelling showed that male gender, dyslipidaemia and current smoking were independent predictors of cancer. These randomized data with adequate numbers of cancer cases are reassuring but limited, by the short follow-up in a trial not designed to test this hypothesis. © 2015 John Wiley & Sons Ltd.

  16. A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials.

    Science.gov (United States)

    Mukherjee, Som D; Coombes, Megan E; Levine, Mitch; Cosby, Jarold; Kowaleski, Brenda; Arnold, Andrew

    2011-10-01

    In early phase oncology trials, novel targeted therapies are increasingly being tested in combination with traditional agents creating greater potential for enhanced and new toxicities. When a patient experiences a serious adverse event (SAE), investigators must determine whether the event is attributable to the investigational drug or not. This study seeks to understand the clinical reasoning, tools used and challenges faced by the researchers who assign causality to SAE's. Thirty-two semi-structured interviews were conducted with medical oncologists and trial coordinators at six Canadian academic cancer centres. Interviews were recorded and transcribed verbatim. Individual interview content analysis was followed by thematic analysis across the interview set. Our study found that causality assessment tends to be a rather complex process, often without complete clinical and investigational data at hand. Researchers described using a common processing strategy whereby they gather pertinent information, eliminate alternative explanations, and consider whether or not the study drug resulted in the SAE. Many of the interviewed participants voiced concern that causality assessments are often conducted quickly and tend to be highly subjective. Many participants were unable to identify any useful tools to help in assigning causality and welcomed more objectivity in the overall process. Attributing causality to SAE's is a complex process. Clinical trial researchers apply a logical system of reasoning, but feel that the current method of assigning causality could be improved. Based on these findings, future research involving the development of a new causality assessment tool specifically for use in early phase oncology clinical trials may be useful.

  17. A systematic review of adverse event reporting in companion animal clinical trials evaluating cancer treatment.

    Science.gov (United States)

    Giuffrida, Michelle A

    2016-11-01

    OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized. Data for AE reporting were collected with a 14-item checklist adapted from the 2004 CONSORT extension for reporting harms. Study characteristics associated with the AE reporting checklist score were identified by means of linear regression analysis. RESULTS 168 articles with data for 6,132 animals were included. Standardized terminology was significantly more likely to be used to describe AEs for trials that included chemotherapy (92/115 [80.0%]) than for trials that did not (16/53 [30.2%]). Median AE reporting checklist score was 5 out of 14 (range, 0 to 12). Poorly reported items included methods and time frame of AE ascertainment, AE data analysis, and reasons for treatment discontinuation and death. Trials with industry funding, a single-arm design, and treatment with chemotherapy were associated with a significantly higher quality of AE reporting. CONCLUSIONS AND CLINICAL RELEVANCE Reporting of adverse events in veterinary clinical trials evaluating cancer treatment was selective and heterogeneous. Harms associated with cancer treatments could be underestimated because of suboptimal collection and reporting of AE data. Findings supported the adoption of a higher standard for AE surveillance and reporting in veterinary patients.

  18. Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis: the EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial.

    Science.gov (United States)

    Wheeler, David C; London, Gerard M; Parfrey, Patrick S; Block, Geoffrey A; Correa-Rotter, Ricardo; Dehmel, Bastian; Drüeke, Tilman B; Floege, Jürgen; Kubo, Yumi; Mahaffey, Kenneth W; Goodman, William G; Moe, Sharon M; Trotman, Marie-Louise; Abdalla, Safa; Chertow, Glenn M; Herzog, Charles A

    2014-11-17

    Premature cardiovascular disease limits the duration and quality of life on long-term hemodialysis. The objective of this study was to define the frequency of fatal and nonfatal cardiovascular events attributable to atherosclerotic and nonatherosclerotic mechanisms, risk factors for these events, and the effects of cinacalcet, using adjudicated data collected during the EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial. EVOLVE was a randomized, double-blind, placebo-controlled clinical trial that randomized 3883 hemodialysis patients with moderate to severe secondary hyperparathyroidism to cinacalcet or matched placebo for up to 64 months. For this post hoc analysis, the outcome measure was fatal and nonfatal cardiovascular events reflecting atherosclerotic and nonatherosclerotic cardiovascular diseases. During the trial, 1518 patients experienced an adjudicated cardiovascular event, including 958 attributable to nonatherosclerotic disease. Of 1421 deaths during the trial, 768 (54%) were due to cardiovascular disease. Sudden death was the most frequent fatal cardiovascular event, accounting for 24.5% of overall mortality. Combining fatal and nonfatal cardiovascular events, randomization to cinacalcet reduced the rates of sudden death and heart failure. Patients randomized to cinacalcet experienced fewer nonatherosclerotic cardiovascular events (adjusted relative hazard 0.84, 95% CI 0.74 to 0.96), while the effect of cinacalcet on atherosclerotic events did not reach statistical significance. Accepting the limitations of post hoc analysis, any benefits of cinacalcet on cardiovascular disease in the context of hemodialysis may result from attenuation of nonatherosclerotic processes. Unique identifier: NCT00345839. URL: ClinicalTrials.gov. © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  19. Reporting adverse events in randomized controlled trials in periodontology: a systematic review.

    Science.gov (United States)

    Faggion, Clovis M; Tu, Yu-Kang; Giannakopoulos, Nikolaos N

    2013-09-01

    Reporting of adverse events is of paramount importance in randomized controlled trials (RCTs) to guide the implementation of new therapeutic approaches in clinical practice. The aim of this study was to assess the quality of adverse events reporting in RCTs published in the periodontal literature. Two authors (CMF and NNG) searched the PubMed and LILACS electronic databases independently and in duplicate to identify RCTs published in periodontology from 2002 to 2003 and from 2011 to 2012. Reporting quality in RCTs was assessed with reference to the 2004 CONSORT Extension for Harms checklist. Differences in adverse events reporting between industry- and non-industry-funded RCTs were also determined. Cohen's kappa statistic was used to determine the extent of inter-reviewer agreement. Fischer's exact test was used to assess differences in reporting between the two samples. The analysis included 246 publications. One hundred twenty-four of 990 (13%) items and 223 of 1460 (15%) items were adequately reported in publications from 2002 to 2003 and from 2011 to 2012 respectively. Three checklist topics were significantly better reported in the 2011-2012 sample; two recommendations were better reported in non-industry-funded trials in publications from both periods. Improvement and standardization of adverse events reporting in periodontology are needed. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP. AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise...... at home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans....

  1. Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial.

    Science.gov (United States)

    Lokman, Suzanne; Volker, Danielle; Zijlstra-Vlasveld, Moniek C; Brouwers, Evelien Pm; Boon, Brigitte; Beekman, Aartjan Tf; Smit, Filip; Van der Feltz-Cornelis, Christina M

    2017-10-05

    To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. Occupational health care in the Netherlands. Employees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very

  2. Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: an ACTTION systematic review

    OpenAIRE

    Shannon M Smith; Paillard, Florence; McKeown, Andrew; Burke, Laurie B.; Edwards, Robert R.; Katz, Nathaniel P; Papadopoulos, Elektra J.; Rappaport, Bob A.; Slagle, Ashley; Strain, Eric C.; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

    2015-01-01

    Measurement of inappropriate medication use events (e.g., abuse, misuse) in clinical trials is important in characterizing a medication���s abuse potential. However, no ���gold standard��� assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (i.e., content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) o...

  3. Longer-Term Assessment of Trastuzumab-Related Cardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial

    NARCIS (Netherlands)

    Procter, Marion; Suter, Thomas M.; de Azambuja, Evandro; Dafni, Urania; van Dooren, Veerle; Muehlbauer, Susanne; Climent, Miguel Angel; Rechberger, Ernst; Liu, Walter Tsang-Wu; Toi, Mazakasu; Coombes, R. Charles; Dodwell, David; Pagani, Olivia; Madrid, Jorge; Hall, Marcia; Chen, Shin-Cheh; Focan, Christian; Muschol, Michael; van Veldhuisen, Dirk J.; Piccart-Gebhart, Martine J.

    2010-01-01

    Purpose We investigated the incidence of cardiac adverse events in patients with early breast cancer in the Herceptin Adjuvant (HERA) trial who were treated with 1 year of trastuzumab after completion of (neo)adjuvant chemotherapy. Patients and Methods The HERA trial is a three-group, randomized

  4. Interplay between hippocampal sharp wave ripple events and vicarious trial and error behaviors in decision making

    Science.gov (United States)

    Papale, Andrew E.; Zielinski, Mark C.; Frank, Loren; Jadhav, Shantanu P.; Redish, A. David

    2016-01-01

    Summary Current theories posit that memories encoded during experiences are subsequently consolidated into longer-term storage. Hippocampal sharp-wave ripple (SWR) events have been linked to this consolidation process during sleep, but SWRs also occur during awake immobility, where their role remains unclear. We report that awake SWR rates at the reward site are inversely related to the prevalence of vicarious trial and error (VTE) behaviors, thought to be involved in deliberation processes. SWR rates were diminished immediately after VTE behaviors and an increase in the rate of SWR events at the reward site predicted a decrease in subsequent VTE behaviors at the choice point. Furthermore, SWR disruptions increased VTE behaviors. These results suggest an inverse relationship between SWRs and VTE behaviors, and suggest that awake SWRs and associated planning and memory consolidation mechanisms are engaged specifically in the context of higher levels of behavioral certainty. PMID:27866796

  5. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies

  6. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review.

    Science.gov (United States)

    Chowers, Michal Y; Gottesman, Bat Sheva; Leibovici, Leonard; Pielmeier, Ulrike; Andreassen, Steen; Paul, Mical

    2009-08-01

    Our objectives were to systematically assess the quality of reporting of adverse events (AEs) in publications of randomized trials of highly active antiretroviral therapy (HAART), and to examine whether reporting quality affects the effect estimates reported for AEs. We searched the PubMed, Cochrane library and EMBASE electronic databases up to December 2008. We included all published randomized controlled trials assessing HAART for treatment-naive adult HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting was extracted according to CONSORT guidelines. We pooled the relative risks for AEs and compared results by sponsorship and different reporting methods. Forty-nine trials, including 19 882 patients, published between 2000 and 2008, met the inclusion criteria. Only one of the trials reported on AE collection methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did not refer to the attribution methods. AE reporting was nearly always selective and selection criteria were highly variable, based on severity grading or occurrence threshold. Presentation of AEs above an occurrence threshold was more common in studies sponsored by industry (30/31) than in studies sponsored by non-profit organizations (3/18). Moreover, we showed that differences in the methods of reporting AEs may affect the results reported for AEs. No significant improvement in AE reporting was seen over this period. We found substantial variability in AE reporting. Variability was influenced by sponsor identity and affected outcomes. These facts obstruct our ability to choose HAART based on currently published data.

  7. Predictive factors for reporting adverse events following spinal manipulation in randomized clinical trials - secondary analysis of a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Brown, Benjamin; Lystad, Reidar P; Engel, Roger M

    2017-08-01

    While spinal manipulative therapy (SMT) is recommended for the treatment of spinal disorders, concerns exist about adverse events associated with the intervention. Adequate reporting of adverse events in clinical trials would allow for more accurate estimations of incidence statistics through meta-analysis. However, it is not currently known if there are factors influencing adverse events reporting following SMT in randomized clinical trials (RCTs). Thus our objective was to investigate predictive factors for the reporting of adverse events in published RCTs involving SMT. The Physiotherapy Evidence Database (PEDro) and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included: sample size; publication date relative to the 2010 CONSORT statement; risk of bias; the region treated; and number of intervention sessions. 7398 records were identified, of which 368 articles were eligible for inclusion. A total of 140 (38.0%) articles reported on adverse events. Articles were more likely to report on adverse events if they possessed larger sample sizes, were published after the 2010 CONSORT statement, had a low risk of bias and involved multiple intervention sessions. The region treated was not a significant predictor for reporting on adverse events. Predictors for reporting on adverse events included larger sample size, publication after the 2010 CONSORT statement, low risk of bias and trials involving multiple intervention sessions. We recommend that researchers focus on developing robust methodologies and participant follow-up regimens for RCTs involving SMT. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Relation between P300 and event-related theta-band synchronization: a single-trial analysis.

    Science.gov (United States)

    Wang, Xue; Ding, Mingzhou

    2011-05-01

    Recent reports show that theta-band (4-7 Hz) power is enhanced by target detection in the standard oddball paradigm, which, together with increased P300, is considered as providing complementary neural mechanisms supporting memory and attention processes. We hypothesize that the increased theta event-related synchronization (ERS) may stem largely from not accounting for the trial-to-trial variability of the P300 evoked component and may not reflect a separate mechanism for target detection and related cognitive processing. EEG was recorded from healthy volunteers performing visual and auditory odd-ball tasks. Ongoing-activity was obtained using two methods: (a) subtracting the ASEO-estimated (analysis of single-trial event-related potentials and ongoing-activity) single-trial ERP from corresponding single-trial EEG time series and (b) subtracting the average event-related potential (AERP) from single-trial EEG time series. Event-related oscillatory activities obtained from the two methods were compared. The amount of power increase in the theta-band was greatly attenuated for the single-trial based method relative to the traditional AERP method. Our results suggest that the theta-ERS arises largely from not modeling the trial-to-trial variability of the P300. ERP components such as the P300 vary from trial-to-trial in both amplitude and latency. The traditional AERP method leaves traces of evoked responses in the residual data which can negatively impact the inference of ongoing oscillatory dynamics. Thus, caution should be exercised in interpreting such phenomena in basic and clinical contexts. Copyright © 2010 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  9. Spatial-Temporal Feature Analysis on Single-Trial Event Related Potential for Rapid Face Identification.

    Science.gov (United States)

    Jiang, Lei; Wang, Yun; Cai, Bangyu; Wang, Yueming; Wang, Yiwen

    2017-01-01

    The event-related potential (ERP) is the brain response measured in electroencephalography (EEG), which reflects the process of human cognitive activity. ERP has been introduced into brain computer interfaces (BCIs) to communicate the computer with the subject's intention. Due to the low signal-to-noise ratio of EEG, most ERP studies are based on grand-averaging over many trials. Recently single-trial ERP detection attracts more attention, which enables real time processing tasks as rapid face identification. All the targets needed to be retrieved may appear only once, and there is no knowledge of target label for averaging. More interestingly, how the features contribute temporally and spatially to single-trial ERP detection has not been fully investigated. In this paper, we propose to implement a local-learning-based (LLB) feature extraction method to investigate the importance of spatial-temporal components of ERP in a task of rapid face identification using single-trial detection. Comparing to previous methods, LLB method preserves the nonlinear structure of EEG signal distribution, and analyze the importance of original spatial-temporal components via optimization in feature space. As a data-driven methods, the weighting of the spatial-temporal component does not depend on the ERP detection method. The importance weights are optimized by making the targets more different from non-targets in feature space, and regularization penalty is introduced in optimization for sparse weights. This spatial-temporal feature extraction method is evaluated on the EEG data of 15 participants in performing a face identification task using rapid serial visual presentation paradigm. Comparing with other methods, the proposed spatial-temporal analysis method uses sparser (only 10% of the total) features, and could achieve comparable performance (98%) of single-trial ERP detection as the whole features across different detection methods. The interesting finding is that the N250 is

  10. Surrogate marker analysis in cancer clinical trials through time-to-event mediation techniques.

    Science.gov (United States)

    Vandenberghe, Sjouke; Duchateau, Luc; Slaets, Leen; Bogaerts, Jan; Vansteelandt, Stijn

    2017-01-01

    The meta-analytic approach is the gold standard for validation of surrogate markers, but has the drawback of requiring data from several trials. We refine modern mediation analysis techniques for time-to-event endpoints and apply them to investigate whether pathological complete response can be used as a surrogate marker for disease-free survival in the EORTC 10994/BIG 1-00 randomised phase 3 trial in which locally advanced breast cancer patients were randomised to either taxane or anthracycline based neoadjuvant chemotherapy. In the mediation analysis, the treatment effect is decomposed into an indirect effect via pathological complete response and the remaining direct effect. It shows that only 4.2% of the treatment effect on disease-free survival after five years is mediated by the treatment effect on pathological complete response. There is thus no evidence from our analysis that pathological complete response is a valuable surrogate marker to evaluate the effect of taxane versus anthracycline based chemotherapies on progression free survival of locally advanced breast cancer patients. The proposed analysis strategy is broadly applicable to mediation analyses of time-to-event endpoints, is easy to apply and outperforms existing strategies in terms of precision as well as robustness against model misspecification.

  11. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  12. Events

    Directory of Open Access Journals (Sweden)

    Igor V. Karyakin

    2016-02-01

    Full Text Available The 9th ARRCN Symposium 2015 was held during 21st–25th October 2015 at the Novotel Hotel, Chumphon, Thailand, one of the most favored travel destinations in Asia. The 10th ARRCN Symposium 2017 will be held during October 2017 in the Davao, Philippines. International Symposium on the Montagu's Harrier (Circus pygargus «The Montagu's Harrier in Europe. Status. Threats. Protection», organized by the environmental organization «Landesbund für Vogelschutz in Bayern e.V.» (LBV was held on November 20-22, 2015 in Germany. The location of this event was the city of Wurzburg in Bavaria.

  13. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79-653). The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  14. Effects of Steroids on Quality of Recovery and Adverse Events after General Anesthesia: Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Mihara, Takahiro; Ishii, Tomoko; Ka, Koui; Goto, Takahisa

    2016-01-01

    Quality of recovery (QoR) after surgery is a relevant outcome. The early postoperative quality of recovery of a patient can be determined using the QoR-40 questionnaire. The aim of this meta-analysis and Trial Sequential Analysis was to determine if perioperative administration of glucocorticosteroids improved patients' quality of recovery after general anesthesia and if adverse events occurred. We searched six databases, including trial registration sites. Randomized clinical trials reporting the efficacy of glucocorticosteroids on quality of recovery evaluated using the QoR-40 after general anesthesia were eligible. The QoR-40 data were combined as the mean difference with confidence intervals using a random-effects model. The I2 statistic was used to assess heterogeneity. The quality of the trials was evaluated using the Cochrane methodology. Moreover, Trial Sequential Analysis was carried out to prevent the inflation of type 1 errors caused by multiple testing and sparse data. We also assessed adverse events. Three randomized clinical trials (totaling 301 patients) were analyzed. The results from one published and four unpublished randomized clinical trials were unavailable. Dexamethasone was investigated in all three trials, and the results suggested that it significantly improved QoR-40 at postoperative day one scores compared with placebo (mean difference [95% confidence interval]: 14.2 points [10.4 to 18.1]; P analysis because of the absence of trials with low risk of bias. The Trial Sequential Analysis-adjusted confidence interval was -1.6 to 30.0, indicating that further trials are required. The reporting of adverse events was insufficient. These findings indicate that perioperative dexamethasone administration may improve short-term (i.e., one day) quality of recovery after general anesthesia and surgery. We need more randomized clinical trials with low risk of bias assessing the effects of glucocorticosteroids on quality of life, other outcomes, and

  15. Protocol of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project: formal consensus method for the development of guidelines for standardised time-to-event endpoints' definitions in cancer clinical trials.

    Science.gov (United States)

    Bellera, Carine A; Pulido, Marina; Gourgou, Sophie; Collette, Laurence; Doussau, Adélaïde; Kramar, Andrew; Dabakuyo, Tienhan Sandrine; Ouali, Monia; Auperin, Anne; Filleron, Thomas; Fortpied, Catherine; Le Tourneau, Christophe; Paoletti, Xavier; Mauer, Murielle; Mathoulin-Pélissier, Simone; Bonnetain, Franck

    2013-03-01

    In randomised phase III cancer clinical trials, the most objectively defined and only validated time-to-event endpoint is overall survival (OS). The appearance of new types of treatments and the multiplication of lines of treatment have resulted in the use of surrogate endpoints for overall survival such as progression-free survival (PFS), or time-to-treatment failure. Their development is strongly influenced by the necessity of reducing clinical trial duration, cost and number of patients. However, while these endpoints are frequently used, they are often poorly defined and definitions can differ between trials which may limit their use as primary endpoints. Moreover, this variability of definitions can impact on the trial's results by affecting estimation of treatments' effects. The aim of the Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN) project is to provide recommendations for standardised definitions of time-to-event endpoints in randomised cancer clinical trials. We will use a formal consensus methodology based on experts' opinions which will be obtained in a systematic manner. Definitions will be independently developed for several cancer sites, including pancreatic, breast, head and neck and colon cancer, as well as sarcomas and gastrointestinal stromal tumours (GISTs). The DATECAN project should lead to the elaboration of recommendations that can then be used as guidelines by researchers participating in clinical trials. This process should lead to a standardisation of the definitions of commonly used time-to-event endpoints, enabling appropriate comparisons of future trials' results. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Neurofeedback in children with ADHD: specific event-related potential findings of a randomized controlled trial.

    Science.gov (United States)

    Wangler, Susanne; Gevensleben, Holger; Albrecht, Björn; Studer, Petra; Rothenberger, Aribert; Moll, Gunther H; Heinrich, Hartmut

    2011-05-01

    In a randomized controlled trial, we could demonstrate clinical efficacy of neurofeedback (NF) training for children with ADHD (Gevensleben et al., 2009a). The present investigation aimed at learning more about the neuronal mechanisms of NF training. Children with ADHD either completed a NF training or a computerized attention skills training (ratio 3:2). NF training consisted of one block of theta/beta training and one block of slow cortical potential (SCP) training, each comprising 18 training units. At three times (pre-training, between the two training blocks and at post-training), event-related potentials (ERP) were recorded during the Attention Network Test. ERP analysis focused on the P3, reflecting inter alia attentional resources for stimulus evaluation, and the contingent negative variation (CNV), primarily related to cognitive preparation. After NF training, an increase of the CNV in cue trials could be observed, which was specific for the SCP training. A larger pre-training CNV was associated with a larger reduction of ADHD symptomatology for SCP training. CNV effects reflect neuronal circuits underlying resource allocation during cognitive preparation. These distinct ERP effects are closely related to a successful NF training in children with ADHD. In future studies, neurophysiological recordings could help to optimize and individualize NF training. The findings contribute to a better understanding of the mechanisms underlying NF training in children with ADHD. Copyright © 2010 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

  17. Single-Trial Event-Related Potential Based Rapid Image Triage System

    Directory of Open Access Journals (Sweden)

    Ke Yu

    2011-06-01

    Full Text Available Searching for points of interest (POI in large-volume imagery is a challenging problem with few good solutions. In this work, a neural engineering approach called rapid image triage (RIT which could offer about a ten-fold speed up in POI searching is developed. It is essentially a cortically-coupled computer vision technique, whereby the user is presented bursts of images at a speed of 6–15 images per second and then neural signals called event-related potential (ERP is used as the ‘cue’ for user seeing images of high relevance likelihood. Compared to past efforts, the implemented system has several unique features: (1 it applies overlapping frames in image chip preparation, to ensure rapid image triage performance; (2 a novel common spatial-temporal pattern (CSTP algorithm that makes use of both spatial and temporal patterns of ERP topography is proposed for high-accuracy single-trial ERP detection; (3 a weighted version of probabilistic support-vector-machine (SVM is used to address the inherent unbalanced nature of single-trial ERP detection for RIT. High accuracy, fast learning, and real-time capability of the developed system shown on 20 subjects demonstrate the feasibility of a brainmachine integrated rapid image triage system for fast detection of POI from large-volume imagery.

  18. 12 CFR 34.45 - Appraiser independence.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Appraiser independence. 34.45 Section 34.45... APPRAISALS Appraisals § 34.45 Appraiser independence. (a) Staff appraisers. If an appraisal is prepared by a staff appraiser, that appraiser must be independent of the lending, investment, and collection functions...

  19. Effective Appraisal Systems.

    Science.gov (United States)

    Winsor, Jerry L.

    An examination of the goals of an effective employee appraisal system of an effective employee evaluation procedure is the focus of this paper.The paper discusses the purposes of the appraisal system and its objectivity (or lack of it), the selection of items to be judged, the standards for judging the performance of an employee, and the person…

  20. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  1. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Directory of Open Access Journals (Sweden)

    Thomas J Hwang

    Full Text Available For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results.Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns.We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67% positive and 8 (33% negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%, and for oncologic (N = 7, 29% and neurologic (N = 6, 24% indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02 for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04 for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33. For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03, and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms.The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer

  2. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  3. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial.

    NARCIS (Netherlands)

    Farkouh, M.E.; Kirshner, H.; Harrington, R.A.; Ruland, S.; Verheugt, F.W.A.; Schnitzer, T.J.; Burmester, G.R.; Mysler, E.; Hochberg, M.C.; Doherty, M.; Ehrsam, E.; Gitton, X.; Krammer, G.; Mellein, B.; Gimona, A.; Matchaba, P.; Hawkey, C.J.; Chesebro, J.H.

    2004-01-01

    BACKGROUND: The potential for cyclo-oxygenase 2 (COX2)-selective inhibitors to increase the risk for myocardial infarction is controversial. The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) aimed to assess gastrointestinal and cardiovascular safety of the COX2 inhibitor

  4. Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial.

    Science.gov (United States)

    Paanalahti, Kari; Holm, Lena W; Nordin, Margareta; Asker, Martin; Lyander, Jessica; Skillgate, Eva

    2014-03-12

    The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy. The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain. In addition women and men were compared regarding the occurrence of adverse events. Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 767) were randomized to one of three treatment arms 1) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249), 2) manual therapy excluding spinal manipulation (n = 258) and 3) manual therapy excluding stretching (n = 260). Treatments were provided by students in the seventh semester of total eight. Adverse events were measured with a questionnaire after each return visit and categorized in to five levels; 1) short minor, 2) long minor, 3) short moderate, 4) long moderate and 5) serious adverse events, based on the duration and/or severity of the event. Generalized estimating equations were used to examine the association between adverse event and treatments arms. The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events (OR = 2.19 (95% CI: 1.52-3.15)), and long moderate adverse events (OR = 2.49 (95% CI: 1.77-3.52)) compared to men. Adverse

  5. Program Facilitates CMMI Appraisals

    Science.gov (United States)

    Sweetser, Wesley

    2005-01-01

    A computer program has been written to facilitate appraisals according to the methodology of Capability Maturity Model Integration (CMMI). [CMMI is a government/industry standard, maintained by the Software Engineering Institute at Carnegie Mellon University, for objectively assessing the engineering capability and maturity of an organization (especially, an organization that produces software)]. The program assists in preparation for a CMMI appraisal by providing drop-down lists suggesting required artifacts or evidence. It identifies process areas for which similar evidence is required and includes a copy feature that reduces or eliminates repetitive data entry. It generates reports to show the entire framework for reference, the appraisal artifacts to determine readiness for an appraisal, and lists of interviewees and questions to ask them during the appraisal. During an appraisal, the program provides screens for entering observations and ratings, and reviewing evidence provided thus far. Findings concerning strengths and weaknesses can be exported for use in a report or a graphical presentation. The program generates a chart showing capability level ratings of the organization. A context-sensitive Windows help system enables a novice to use the program and learn about the CMMI appraisal process.

  6. Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

    Science.gov (United States)

    Smith, Shannon M; Paillard, Florence; McKeown, Andrew; Burke, Laurie B; Edwards, Robert R; Katz, Nathaniel P; Papadopoulos, Elektra J; Rappaport, Bob A; Slagle, Ashley; Strain, Eric C; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

    2015-05-01

    Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory

  7. Politicisation of performance appraisals

    Directory of Open Access Journals (Sweden)

    Sonia Swanepoel

    2014-02-01

    Full Text Available Orientation: Employees are a source of competitive advantage for organisations and human resource management seek to promote employee efficiency. One of the tools organisations utilise to achieve this goal is performance appraisals.Research purpose: The purpose of this study was to investigate the weaknesses in performance appraisal and to determine whether it is politicised in the North West Department of Health and Social Development in South Africa.Motivation for study: Many organisations either ignore the existence of politics in the appraisal process or assume that its impact can be minimised if they refine their appraisal instruments. Executives admit that, in appraising others, they often intentionally avoid meeting the goal of accuracy in favour of achieving goals that have more to do with exercising discretion and maintaining departmental effectiveness. Ironically, these same executives lament that the appraisals they receive often do not accurately represent their abilities and performance (Gioia & Longenecker, 1994.Research approach, design and method: Self-administered questionnaires were used as a means of collecting data and analysis was done through the use of the Statistical Package for the Social Sciences (SPSS.Main findings: The results of the study showed that respondents believe that performance appraisals are highly politicised.Practical/managerial implications: If used effectively, performance appraisals may improve employee productivity and efficiency as well as motivation and performance. However, if performance appraisal is perceived as unfair and political, it can diminish rather than enhance employee attitudes and performance.Contribution: Amongst others, it is recommended that managers should consider separating assessment for development and assessment for rewards.

  8. Stress appraisals and training performance on a complex laboratory task.

    Science.gov (United States)

    Gildea, Kevin M; Schneider, Tamara R; Shebilske, Wayne L

    2007-08-01

    We investigated whether training performance on a complex laboratory task differs for trainees whose stress appraisals denote challenge or threat. Past research outside a training context found better performance on tasks when stress appraisals denoted challenge (in which perceived situational demands are commensurate with perceived resources) as opposed to threat (in which perceived coping resources fall short of the demands of the stressor). College students performed Space Fortress during 80 3-min practice trials, 20 tests, and posttests (retention, transfer, secondary task interference). Stress appraisals were measured with a two-item scale (Experiments 1-3) or an eight-item scale (Experiment 3) with (Study 1) or without (Experiments 2 and 3) brief hands-on experience. In all experiments, training improved performance and challenged trainees outperformed threatened trainees throughout training as well as on some baseline and posttraining tests. These studies are the first to document that stress appraisals predict training performance. They suggest that little information about a task is needed for appraisals to account for a significant amount of variance (11%) in training performance. Investigating the dynamic interplay of stress appraisals and training will increase the understanding of stress appraisals and of training. Stress appraisals may improve training if used as a screening tool and/or by implementing interventions aimed at changing appraisals from threat to challenge.

  9. Reporting of loss to follow-up information in randomised controlled trials with time-to-event outcomes: a literature survey

    Directory of Open Access Journals (Sweden)

    Bender Ralf

    2011-09-01

    Full Text Available Abstract Background To assess the reporting of loss to follow-up (LTFU information in articles on randomised controlled trials (RCTs with time-to-event outcomes, and to assess whether discrepancies affect the validity of study results. Methods Literature survey of all issues of the BMJ, Lancet, JAMA, and New England Journal of Medicine published between 2003 and 2005. Eligible articles were reports of RCTs including at least one Kaplan-Meier plot. Articles were classified as "assessable" if sufficient information was available to assess LTFU. In these articles, LTFU information was derived from Kaplan-Meier plots, extracted from the text, and compared. Articles were then classified as "consistent" or "not consistent". Sensitivity analyses were performed to assess the validity of study results. Results 319 eligible articles were identified. 187 (59% were classified as "assessable", as they included sufficient information for evaluation; 140 of 319 (44% presented consistent LTFU information between the Kaplan-Meier plot and text. 47 of 319 (15% were classified as "not consistent". These 47 articles were included in sensitivity analyses. When various imputation methods were used, the results of a chi2-test applied to the corresponding 2 × 2 table changed and hence were not robust in about half of the studies. Conclusions Less than half of the articles on RCTs using Kaplan-Meier plots provide assessable and consistent LTFU information, thus questioning the validity of the results and conclusions of many studies presenting survival analyses. Authors should improve the presentation of both Kaplan-Meier plots and LTFU information, and reviewers of study publications and journal editors should critically appraise the validity of the information provided.

  10. Event-level relationship between methamphetamine use significantly associated with non-adherence to pharmacologic trial medications in event-level analyses.

    Science.gov (United States)

    Hermanstyne, Keith A; Santos, Glenn-Milo; Vittinghoff, Eric; Santos, Deirdre; Colfax, Grant; Coffin, Phillip

    2014-10-01

    Methamphetamine use has been previously associated with poor medication adherence, but, to date, there have been no studies that have conducted event-level analyses on correlates of medication adherence in studies of pharmacologic agents for methamphetamine dependence. We pooled data from two previous, randomized controlled trials (using bupropion and mirtazapine, respectively) for methamphetamine dependence and used a mixed effects logistic model to examine correlates of daily opening of the medication event monitoring system (MEMS) cap as a repeated measure. We explored whether periods of observed methamphetamine use via urine testing were associated with study medication adherence based on MEMS cap openings. We found a significant negative association between methamphetamine-urine positivity and event-level study medication adherence as measured by MEMS cap openings (AOR: 0.69; 95% CI: 0.49-0.98). In addition, age (AOR: 1.07; 95% CI: 1.02-1.11) and depressive symptoms (AOR: 0.78; 95% CI: 0.64-0.90) were significantly associated with adherence. Finally, participants were more likely to open their study medication bottles on days when they presented for in-person urine testing. Our event-level analysis shows that methamphetamine use can be associated with reduced medication adherence as measured by MEMS cap openings in pharmacologic trials, which corroborates prior research. These findings may suggest that medication adherence support in pharmacologic trials among methamphetamine users may be needed to improve study compliance and could be targeted towards periods of time when there are more likely to not open their study medication pill bottles. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. Assessing the spatiotemporal evolution of neuronal activation with single-trial event-related potentials and functional MRI

    NARCIS (Netherlands)

    Eichele, T.; Specht, K.; Moosmann, M.; Jongsma, M.L.A.; Quian Quiroga, R.; Nordby, H.; Hugdahl, K.

    2005-01-01

    The brain acts as an integrated information processing system, which methods in cognitive neuroscience have so far depicted in a fragmented fashion. Here, we propose a simple and robust way to integrate functional MRI (fMRI) with single trial event-related potentials (ERP) to provide a more complete

  12. Under-reporting of venous and arterial thrombotic events in randomized clinical trials: a meta-analysis

    NARCIS (Netherlands)

    Stuijver, Danka J. F.; Romualdi, Erica; van Zaane, Bregje; Bax, Leon; Büller, Harry R.; Gerdes, Victor E. A.; Squizzato, Alessandro

    2015-01-01

    For the detection of unwanted outcomes of new interventions, physicians rely on adverse event reporting. We attempt to quantify the reported incidence of venous thromboembolism (VTE) and arterial thrombosis (AT) in randomized clinical trials (RCTs), and evaluate the extent of under-reporting. We

  13. The Treatment of Adolescent Suicide Attempters Study (TASA): Predictors of Suicidal Events in an Open Treatment Trial

    Science.gov (United States)

    Brent, David A.; Greenhill, Laurence L.; Compton, Scott; Emslie, Graham; Wells, Karen; Walkup, John T.; Vitiello, Benedetto; Bukstein, Oscar; Stanley, Barbara; Posner, Kelly; Kennard, Betsy D.; Cwik, Mary F.; Wagner, Ann; Coffey, Barbara; March, John S.; Riddle, Mark; Goldstein, Tina; Curry, John; Barnett, Shannon; Capasso, Lisa; Zelazny, Jamie; Hughes, Jennifer; Shen, Sa; Gugga, S. Sonia; Turner, J. Blake

    2009-01-01

    Objective: To identify the predictors of suicidal events and attempts in adolescent suicide attempters with depression treated in an open treatment trial. Method: Adolescents who had made a recent suicide attempt and had unipolar depression (n =124) were either randomized (n = 22) or given a choice (n = 102) among three conditions. Two…

  14. Baseline plasma fatty acids profile and incident cardiovascular events in the SU.FOL.OM3 trial: the evidence revisited.

    Science.gov (United States)

    Fezeu, Léopold K; Laporte, François; Kesse-Guyot, Emmanuelle; Andreeva, Valentina A; Blacher, Jacques; Hercberg, Serge; Galan, Pilar

    2014-01-01

    We aimed to investigate the association between baseline plasma fatty acids profile and the risk of future major cardiovascular events in patients with a history of ischaemic heart disease or ischemic stroke. Baseline plasma fatty acids as well as established cardiovascular risk factors were measured in 2,263 patients enrolled in the SUpplementation with FOLate, vitamins B-6 and B-12 and/or OMega-3 fatty acids randomized controlled trial. Incident major cardiovascular, cardiac and cerebrovascular events were ascertained during the 4.7 years of follow up. Hazard ratios were obtained from Cox proportional hazards models after adjustment for cardiovascular risk factors. During the follow-up, 154, 379 and 84 patients had major cardiovascular, cardiac and cerebrovascular events respectively. Upon adjustment for gender, initial event, baseline age and BMI, the risk of developing a major cardiovascular event decreased significantly in successive quartiles of arachidonic acid (P trendomega 3 polyunsaturated fatty acids (P trendacid (P trendacid (P trendacid + docosahexaenoic acid (P trendacid + docosapentaenoic acid + docosahexaenoic acid (P trendacid (P trendacid remained inversely associated with the risk of developing a major cardiovascular event (P trendacid was inversely associated with the risk a cerebrovascular event (P trendomega 3 polyunsaturated fatty acids with recurrence of Cardiovascular diseases was mainly driven by well-known cardiovascular risk factors. Controlled-Trials.com ISRCTN41926726.

  15. Physician Appraisals: Key Challenges

    Directory of Open Access Journals (Sweden)

    Klich Jacek

    2017-06-01

    Full Text Available The main purpose of the article is to identify key criteria being used for physician appraisals and to find how communication skills of physicians are valued in those appraisals. ScienceDirect and EBSCOhost databases were used for this search. The results show that a physician appraisal is underestimated both theoretically and empirically. The particular gap exists with respect to the communication skills of physicians, which are rarely present in medical training syllabi and physician assessments. The article contributes to the theoretical discourse on physician appraisals and points out at the inconsistency between the high status of physicians as a key hospital resource on the one hand and, on the other hand, at inadequate and poorly researched assessment of their performance with a special emphasis on communication skills. The article may inspire health managers to develop and implement up-to-date assessment forms for physicians and good managerial practices in this respect in hospitals and other health care units.

  16. Employee Satisfaction with Performance Appraisals and Appraisers: The Role of Perceived Appraisal Use.

    Science.gov (United States)

    Boswell, Wendy R.; Boudreau, John W.

    2000-01-01

    In a survey of 128 manufacturing employees, the perception that performance appraisal had developmental uses was associated with satisfaction with appraisals and appraisers. Reaction to the evaluation did not depend on the outcome of the appraisal or its perceived fairness. (SK)

  17. Single-trial event-related potential extraction through one-unit ICA-with-reference

    Science.gov (United States)

    Lih Lee, Wee; Tan, Tele; Falkmer, Torbjörn; Leung, Yee Hong

    2016-12-01

    Objective. In recent years, ICA has been one of the more popular methods for extracting event-related potential (ERP) at the single-trial level. It is a blind source separation technique that allows the extraction of an ERP without making strong assumptions on the temporal and spatial characteristics of an ERP. However, the problem with traditional ICA is that the extraction is not direct and is time-consuming due to the need for source selection processing. In this paper, the application of an one-unit ICA-with-Reference (ICA-R), a constrained ICA method, is proposed. Approach. In cases where the time-region of the desired ERP is known a priori, this time information is utilized to generate a reference signal, which is then used for guiding the one-unit ICA-R to extract the source signal of the desired ERP directly. Main results. Our results showed that, as compared to traditional ICA, ICA-R is a more effective method for analysing ERP because it avoids manual source selection and it requires less computation thus resulting in faster ERP extraction. Significance. In addition to that, since the method is automated, it reduces the risks of any subjective bias in the ERP analysis. It is also a potential tool for extracting the ERP in online application.

  18. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting.

    Science.gov (United States)

    Bruland, Philipp; McGilchrist, Mark; Zapletal, Eric; Acosta, Dionisio; Proeve, Johann; Askin, Scott; Ganslandt, Thomas; Doods, Justin; Dugas, Martin

    2016-11-22

    Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  19. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

    Directory of Open Access Journals (Sweden)

    Philipp Bruland

    2016-11-01

    Full Text Available Abstract Background Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems. Methods Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project. Results The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records. Conclusions Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list.

  20. 12 CFR 323.5 - Appraiser independence.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Appraiser independence. 323.5 Section 323.5... APPRAISALS § 323.5 Appraiser independence. (a) Staff appraisers. If an appraisal is prepared by a staff appraiser, that appraiser must be independent of the lending, investment, and collection functions and not...

  1. Parents' appraisals, reflected appraisals, and children's self-appraisals of sport competence: A yearlong study

    OpenAIRE

    Bois, Julien; Sarrazin, Philippe; Brustad, Robert; Chanal, Julien; Trouilloud, David

    2005-01-01

    International audience; This study investigated the contribution of the reflected appraisal process to the ontogeny of children's self-perceptions of physical competence. Emanating from symbolic interactionist thought, reflected appraisals refer to individuals' perceptions of others' evaluations of their abilities. The influence of parents' appraisals of their child's competence on the child's self-appraisals was hypothesized to be mediated by parents' reflected appraisals. Data were collecte...

  2. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review

    Science.gov (United States)

    Muturi-Kioi, Vincent; Lewis, David; Launay, Odile; Leroux-Roels, Geert; Anemona, Alessandra; Loulergue, Pierre; Bodinham, Caroline L.; Aerssens, Annelies; Groth, Nicola; Saul, Allan; Podda, Audino

    2016-01-01

    Background In the context of early vaccine trials aimed at evaluating the safety profile of novel vaccines, abnormal haematological values, such as neutropenia, are often reported. It is therefore important to evaluate how these trials should be planned not to miss potentially important safety signals, but also to understand the implications and the clinical relevance. Methodology We report and discuss the results from five clinical trials (two with a new Shigella vaccine in the early stage of clinical development and three with licensed vaccines) where the absolute neutrophil counts (ANC) were evaluated before and after vaccination. Additionally, we have performed a systematic review of the literature on cases of neutropenia reported during vaccine trials to discuss our results in a more general context. Principal Findings Both in our clinical trials and in the literature review, several cases of neutropenia have been reported, in the first two weeks after vaccination. However, neutropenia was generally transient and had a benign clinical outcome, after vaccination with either multiple novel candidates or well-known licensed vaccines. Additionally, the vaccine recipients with neutropenia frequently had lower baseline ANC than non-neutropenic vaccinees. In many instances neutropenia occurred in subjects of African descent, known to have lower ANC compared to western populations. Conclusions It is important to include ANC and other haematological tests in early vaccine trials to identify potential safety signals. Post-vaccination neutropenia is not uncommon, generally transient and clinically benign, but many vaccine trials do not have a sampling schedule that allows its detection. Given ethnic variability in the level of circulating neutrophils, normal ranges taking into account ethnicity should be used for determination of trial inclusion/exclusion criteria and classification of neutropenia related adverse events. Trial registration ClinicalTrials.gov NCT02017899

  3. Multivariate Bayesian decoding of single-trial event-related fMRI responses for memory retrieval of voluntary actions.

    Science.gov (United States)

    Lee, Dongha; Yun, Sungjae; Jang, Changwon; Park, Hae-Jeong

    2017-01-01

    This study proposes a method for classifying event-related fMRI responses in a specialized setting of many known but few unknown stimuli presented in a rapid event-related design. Compared to block design fMRI signals, classification of the response to a single or a few stimulus trial(s) is not a trivial problem due to contamination by preceding events as well as the low signal-to-noise ratio. To overcome such problems, we proposed a single trial-based classification method of rapid event-related fMRI signals utilizing sparse multivariate Bayesian decoding of spatio-temporal fMRI responses. We applied the proposed method to classification of memory retrieval processes for two different classes of episodic memories: a voluntarily conducted experience and a passive experience induced by watching a video of others' actions. A cross-validation showed higher classification performance of the proposed method compared to that of a support vector machine or of a classifier based on the general linear model. Evaluation of classification performances for one, two, and three stimuli from the same class and a correlation analysis between classification accuracy and target stimulus positions among trials suggest that presenting two target stimuli at longer inter-stimulus intervals is optimal in the design of classification experiments to identify the target stimuli. The proposed method for decoding subject-specific memory retrieval of voluntary behavior using fMRI would be useful in forensic applications in a natural environment, where many known trials can be extracted from a simulation of everyday tasks and few target stimuli from a crime scene.

  4. Multivariate Bayesian decoding of single-trial event-related fMRI responses for memory retrieval of voluntary actions.

    Directory of Open Access Journals (Sweden)

    Dongha Lee

    Full Text Available This study proposes a method for classifying event-related fMRI responses in a specialized setting of many known but few unknown stimuli presented in a rapid event-related design. Compared to block design fMRI signals, classification of the response to a single or a few stimulus trial(s is not a trivial problem due to contamination by preceding events as well as the low signal-to-noise ratio. To overcome such problems, we proposed a single trial-based classification method of rapid event-related fMRI signals utilizing sparse multivariate Bayesian decoding of spatio-temporal fMRI responses. We applied the proposed method to classification of memory retrieval processes for two different classes of episodic memories: a voluntarily conducted experience and a passive experience induced by watching a video of others' actions. A cross-validation showed higher classification performance of the proposed method compared to that of a support vector machine or of a classifier based on the general linear model. Evaluation of classification performances for one, two, and three stimuli from the same class and a correlation analysis between classification accuracy and target stimulus positions among trials suggest that presenting two target stimuli at longer inter-stimulus intervals is optimal in the design of classification experiments to identify the target stimuli. The proposed method for decoding subject-specific memory retrieval of voluntary behavior using fMRI would be useful in forensic applications in a natural environment, where many known trials can be extracted from a simulation of everyday tasks and few target stimuli from a crime scene.

  5. Improving the capture of adverse event data in clinical trials: the role of the International Atomic Energy Agency.

    Science.gov (United States)

    Davidson, Susan E; Trotti, Andy; Ataman, Ozlem U; Seong, Jinsil; Lau, Fen Nee; da Motta, Neiro W; Jeremic, Branislav

    2007-11-15

    To report meetings of the Applied Radiation Biology and Radiotherapy section of the International Atomic Energy Agency (IAEA), organized to discuss issues surrounding, and develop initiatives to improve, the recording of adverse events (AE) in clinical trials. A first meeting was held in Atlanta, GA (October 2004). A second meeting was held in Denver, CO (October 2005) and focused on AE data capture. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (CTCAE) was suggested during the first meeting as the preferred common platform for the collection and reporting of AE data in its clinical trials. The second meeting identified and reviewed the current weaknesses and variations in the capture of AE data, and proposals to improve the quality and consistency of data capture were discussed. There is heterogeneity in the collection of AE data between both institutions and individual clinicians. The use of multiple scoring systems hampers comparisons of treatment outcomes between centers and trials. There is often insufficient detail on normal tissue treatment effects, which leads to an underestimate of toxicity. Implementation of improved data capture was suggested for one of the ongoing IAEA clinical trials. There is a need to compare the quality and completeness of data between institutions and the efficacy of structured/directed vs. traditional passive data collection. Data collection using the CTCAE (with or without a questionnaire) will be investigated in an IAEA multinational trial of radiochemotherapy and high-dose-rate brachytherapy in cervical cancer.

  6. The dynamic interplay between appraisal and core affect in daily life

    Directory of Open Access Journals (Sweden)

    Peter eKuppens

    2012-10-01

    Full Text Available Appraisals and core affect are both considered central to the experience of emotion. In this study we examine the bidirectional relationships between these two components of emotional experience by examining how core affect changes following how people appraise events and how appraisals in turn change following how they feel in daily life. In an experience sampling study, participants recorded their core affect and appraisals of ongoing events; data were analyzed using cross-lagged multilevel modeling. Valence-appraisal relationships were found to be characterized by congruency: The same appraisals that were associated with a change in pleasure-displeasure (motivational congruency, other-agency, coping potential, and future expectancy, changed themselves as a function of pleasure-displeasure. In turn, mainly secondary appraisals of who is responsible and how one is able to cope with events were associated with changes in arousal, which itself is followed by changes in the future appraised relevance of events. These results integrate core affect and appraisal approaches to emotion by demonstrating the dynamic interplay of how appraisals are followed by changes in core affect which in turn change our basis for judging future events.

  7. Methods for implementing patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials

    Science.gov (United States)

    Basch, Ethan; Rogak, Lauren J.; Dueck, Amylou C.

    2016-01-01

    Purpose There is increasing interest to use patient-reported outcome (PRO) measures to evaluate symptomatic adverse events (AEs) in cancer treatment trials. However, there are currently no standard recommended approaches for integrating patient-reported AE measures into trials. Methods Approaches are identified from prior trials for selecting AEs for solicited patient-reporting; administering patient-reported AE measures; and analyzing and reporting results. Findings Approaches for integrating patient-reported AE measures into cancer trials generally combine current standard methods for clinician-reported AEs as well as established best practices for employing PRO measures. Specific AEs can be selected for a PRO questionnaire based on common and expected reactions in a given trial context, derived from literature review and qualitative/mixed methods evaluations and should be the same set administered across all arms of a trial. A mechanism for collecting unsolicited patient-reported AEs will also ideally be included. Patients will preferably report at baseline and end of active treatment as well as on a frequent standardized schedule during active treatment, such as weekly from home, with a recall period corresponding to the frequency of reporting (e.g., past 7 days). Less frequent reporting may be considered after an initial intensive monitoring period for trials of prolonged treatments and during long-term follow up. Electronic PRO data collection is preferred. Backup data collection for missed PRO reports is advisable to boost response rates. Analysis can employ a combination of approaches to AE and PRO data. If a high proportion of patients is experiencing baseline symptoms, systematic subtraction of these from on-study AEs should be considered to improve reporting of symptoms related to treatment. More granular longitudinal analyses of individual symptoms can also be useful. Implications Methods are evolving for integrating patient-reported symptomatic AEs

  8. Coping and negative appraisal as mediators between control beliefs and psychological symptoms in children of divorce.

    Science.gov (United States)

    Sandler, I N; Kim-Bae, L S; MacKinnon, D

    2000-09-01

    Examined control beliefs of children of divorce as predictors of their coping, negative appraisals for stressful events, and mental health problems. We tested whether coping and negative appraisal for stressful events mediated the relations between multiple dimensions of control beliefs and mental health problems. Different dimensions of control beliefs were related to different aspects of coping and negative stress appraisal. Internal control beliefs for positive events were related to both active and avoidant coping. Unknown control beliefs for positive events were related to higher active coping and higher negative appraisal. Unknown control beliefs for negative events were related to higher avoidant coping. In addition, evidence for mediation was found such that the effect of unknown control beliefs for positive events on mental health problems was mediated by negative appraisal. Implications and directions for further research are discussed.

  9. Real estate surfaces appraisal

    Directory of Open Access Journals (Sweden)

    Marina Ciuna

    2014-07-01

    Full Text Available In the appraisal of the market value of the properties are applied two important surface indexes: the market surface ratio of the secondary surfaces and the ratio of the site value to total value (allocation method. The measure of both these indexes can be revealed difficult: the data collection of the surface trade ratio in the market can get different results and in practice often the valuer refolds on the fixed coefficients brought in the handbooks and in the circulars of the public administration; the appraisal of the ratio of the site, especially in the central zones and for ancient buildings, where besides the incidence is higher, is developed extrapolating the ratios from the peripheral zones for new building or falling back on the publications of real estate sector.For the market comparison methods are proposed a series of test of surface trade ratio and land value ratio to foresee the effect on the appraisal result.

  10. Appraisal of Transport Projects

    DEFF Research Database (Denmark)

    Jensen, Anders Vestergaard

    The evaluation of transport projects has traditionally been based on quantitative descriptions of selected impacts by the use of cost-benefit analysis (CBA). However, environmental impacts are now taking into consideration when decisions have to be made, regarding which large transport projects...... complexity. Optimisation has been replaced with satisficing, where satisficing is defined as finding an acceptable or satisfactory solution to a problem instead of a socio-economical optimal solution. This calls for new approaches of appraising transport projects that goes beyond what the classical CBA...... projects: • How to reconcile socio-economic and public acceptance to obtain decisions that are both rational and legitimate • How to involve stakeholders in the appraisal • How to apply robustness as mean to improve the appraisal The examination of these main focuses has been two-folded: For each question...

  11. Critical appraisal of published literature

    Directory of Open Access Journals (Sweden)

    Goneppanavar Umesh

    2016-01-01

    Full Text Available With a large output of medical literature coming out every year, it is impossible for readers to read every article. Critical appraisal of scientific literature is an important skill to be mastered not only by academic medical professionals but also by those involved in clinical practice. Before incorporating changes into the management of their patients, a thorough evaluation of the current or published literature is an important step in clinical practice. It is necessary for assessing the published literature for its scientific validity and generalizability to the specific patient community and reader′s work environment. Simple steps have been provided by Consolidated Standard for Reporting Trial statements, Scottish Intercollegiate Guidelines Network and several other resources which if implemented may help the reader to avoid reading flawed literature and prevent the incorporation of biased or untrustworthy information into our practice.

  12. Teaching critical appraisal skills in healthcare settings.

    Science.gov (United States)

    Horsley, Tanya; Hyde, Chris; Santesso, Nancy; Parkes, Julie; Milne, Ruairidh; Stewart, Ruth

    2011-11-09

    Critical appraisal is the process of assessing and interpreting evidence by systematically considering its validity, results and relevance to an individual's work. Within the last decade critical appraisal has been added as a topic to many medical school and UK Royal College curricula, and several continuing professional development ventures have been funded to provide further training. This is an update of a Cochrane review first published in 2001. To assess the effects of teaching critical appraisal skills to health professionals on the process of care, patient outcomes and knowledge of health professionals. SEARCH METHODS. We updated the search (see Appendix 1 for search strategies by database) and used those search strategies to search the Cochrane Central Register of Controlled Trials (1997 to June 2011) and MEDLINE (from 1997 to June 2011). We also searched EMBASE, CINAHL and PsycINFO (up to January 2010). We searched LISA (up to January 2010), ERIC (up to January 2010), SIGLE (up to January 2010) and Web of Knowledge (up to January 2010). We also searched the Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE) and the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register up to January 2010. Randomised trials, controlled clinical trials, controlled before and after studies and interrupted time series analyses that examined the effectiveness of educational interventions teaching critical appraisal to health professionals. The outcomes included process of care, patient mortality, morbidity, quality of life and satisfaction. We included studies reporting on health professional knowledge/awareness only when based upon objective, standardised, validated instruments. We did not consider studies involving students. Two review authors independently extracted data and assessed risk of bias. We contacted authors of included studies to obtain missing data. In total, we reviewed a total of 11

  13. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  14. Effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events : A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhu, Y; Shen, X; Jiang, Q; Wang, Z; Wang, Z; Dong, X; Li, J; Han, Q; Zhao, J; Wang, B; Liu, L

    2017-11-07

    The present meta-analysis was designed to improve statistical power and review the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events. PubMed, Embase, Web of Science, and the Cochrane Library were searched from inception to May 2017. Studies considered to be eligible were randomized controlled trials about the effects of monoclonal antibodies against PCSK9 on clinical cardiovascular events. The primary endpoint was positively adjudicated cardiovascular events; the secondary endpoint comprised cardiac mortality, myocardial infarction (MI), coronary revascularization, stroke, and hospitalization for unstable angina. We included 20 randomized controlled trials involving 67,934 patients. Monoclonal antibodies against PCSK9 were associated with a significant reduction in positively adjudicated cardiovascular events (relative risk [RR] = 0.87; 95% confidence interval [CI] = 0.81-0.93; z = 4.03; p = 0.000), MI (RR = 0.78; 95% CI = 0.71-0.86; z = 4.96; p = 0.000), coronary revascularization (RR = 0.81, 95% CI = 0.75-0.88; z = 4.93; p = 0.000), and stroke (RR = 0.76, 95% CI = 0.65-0.89; z = 3.47; p = 0.001). Monoclonal antibodies against PCSK9 did not reduce hospitalization rates due to unstable angina. The results of subgroup analysis showed that evolocumab was associated with a lower risk of positively adjudicated cardiovascular events, MI, coronary revascularization, and stroke without reducing cardiac mortality. Alirocumab reduced the incidence of cardiac mortality but not of other cardiovascular events, while bococizumab was associated with a reduced risk of stroke. Monoclonal antibodies against PCSK9 were associated with a lower risk of positively adjudicated cardiovascular events, MI, coronary revascularization, and stroke.

  15. The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.

    Science.gov (United States)

    Chou, Victoria B; Omer, Saad B; Hussain, Hamidah; Mugasha, Christine; Musisi, Maria; Mmiro, Francis; Musoke, Philippa; Jackson, J Brooks; Guay, Laura A

    2007-12-01

    To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting. The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification. In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery. Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.

  16. 12 CFR 722.5 - Appraiser independence.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Appraiser independence. 722.5 Section 722.5... § 722.5 Appraiser independence. (a) Staff appraiser. If an appraisal is prepared by a staff appraiser, that appraiser must be independent of the lending, investment, and collection functions and not...

  17. 12 CFR 225.65 - Appraiser independence.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Appraiser independence. 225.65 Section 225.65... Federally Related Transactions § 225.65 Appraiser independence. (a) Staff appraisers. If an appraisal is prepared by a staff appraiser, that appraiser must be independent of the lending, investment, and...

  18. Amiodarone, anticoagulation, and clinical events in patients with atrial fibrillation: insights from the ARISTOTLE trial.

    Science.gov (United States)

    Flaker, Greg; Lopes, Renato D; Hylek, Elaine; Wojdyla, Daniel M; Thomas, Laine; Al-Khatib, Sana M; Sullivan, Renee M; Hohnloser, Stefan H; Garcia, David; Hanna, Michael; Amerena, John; Harjola, Veli-Pekka; Dorian, Paul; Avezum, Alvaro; Keltai, Matyas; Wallentin, Lars; Granger, Christopher B

    2014-10-14

    Amiodarone is an effective medication in preventing atrial fibrillation (AF), but it interferes with the metabolism of warfarin. This study sought to examine the association of major thrombotic clinical events and bleeding with the use of amiodarone in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. Baseline characteristics of patients who received amiodarone at randomization were compared with those who did not receive amiodarone. The interaction between randomized treatment and amiodarone was tested using a Cox model, with main effects for randomized treatment and amiodarone and their interaction. Matching on the basis of a propensity score was used to compare patients who received and who did not receive amiodarone at the time of randomization. In ARISTOTLE, 2,051 (11.4%) patients received amiodarone at randomization. Patients on warfarin and amiodarone had time in the therapeutic range that was lower than patients not on amiodarone (56.5% vs. 63.0%; p amiodarone-treated patients had a stroke or a systemic embolism (1.58%/year vs. 1.19%/year; adjusted hazard ratio [HR]: 1.47, 95% confidence interval [CI]: 1.03 to 2.10; p = 0.0322). Overall mortality and major bleeding rates were elevated, but were not significantly different in amiodarone-treated patients and patients not on amiodarone. When comparing apixaban with warfarin, patients who received amiodarone had a stroke or a systemic embolism rate of 1.24%/year versus 1.85%/year (HR: 0.68, 95% CI: 0.40 to 1.15), death of 4.15%/year versus 5.65%/year (HR: 0.74, 95% CI: 0.55 to 0.98), and major bleeding of 1.86%/year versus 3.06%/year (HR: 0.61, 95% CI: 0.39 to 0.96). In patients who did not receive amiodarone, the stroke or systemic embolism rate was 1.29%/year versus 1.57%/year (HR: 0.82, 95% CI: 0.68 to 1.00), death was 3.43%/year versus 3.68%/year (HR: 0.93, 95% CI: 0.83 to 1.05), and major bleeding was 2.18%/year versus 3.03%/year (HR: 0.72, 95

  19. Detecting potential safety issues in large clinical or observational trials by Bayesian screening when event counts arise from poisson distributions.

    Science.gov (United States)

    Gould, A Lawrence

    2013-01-01

    Patients in large clinical trials and in studies employing large observational databases report many different adverse events, most of which will not have been anticipated at the outset. Conventional hypothesis testing of between group differences for each adverse event can be problematic: Lack of significance does not mean lack of risk, the tests usually are not adjusted for multiplicity, and the data determine which hypotheses are tested. This article describes a Bayesian screening approach that does not test hypotheses, is self-adjusting for multiplicity, provides a direct assessment of the likelihood of no material drug-event association, and quantifies the strength of the observed association. The criteria for assessing drug-event associations can be determined by clinical or regulatory considerations. In contrast to conventional approaches, the diagnostic properties of this new approach can be evaluated analytically. Application of the method to findings from a vaccine trial yields results similar to those found by methods using a false discovery rate argument or a hierarchical Bayes approach. [Supplemental materials are available for this article. Go to the publisher's online edition of Journal of Biopharmaceutical Statistics for the following free supplemental resource: Appendix R: Code for calculations.].

  20. Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian National Monitoring Centre for Clinical Trials

    Directory of Open Access Journals (Sweden)

    De Rosa Marisa

    2008-07-01

    Full Text Available Abstract Background Although interim analysis approaches in clinical trials are widely known, information on current practice of planned monitoring is still scarce. Reports of studies rarely include details on the strategies for both data monitoring and interim analysis. The aim of this project is to investigate the forms of monitoring used in cancer clinical trials and in particular to gather information on the role of interim analyses in the data monitoring process of a clinical trial. This study focused on the prevalence of different types of interim analyses and data monitoring in cancer clinical trials. Methods Source of investigation were the protocols of cancer clinical trials included in the Italian registry of clinical trials from 2000 to 2005. Evaluation was restricted to protocols of randomised studies with a time to event endpoint, such as overall survival (OS or progression free survival (PFS. A template data extraction form was developed and tested in a pilot phase. Selection of relevant protocols and data extraction were performed independently by two evaluators, with differences in the data assessment resolved by consensus with a third reviewer, referring back to the original protocol. Information was obtained on a general characteristics of the protocol b disease localization and patient setting; c study design d interim analyses; e DSMC. Results The analysis of the collected protocols reveals that 70.7% of the protocols incorporate statistical interim analysis plans, but only 56% have also a DSMC and be considered adequately planned. The most concerning cases are related to lack of any form of monitoring (20.0% of the protocols, and the planning of interim analysis, without DSMC (14.7%. Conclusion The results indicate that there is still insufficient attention paid to the implementation of interim analysis.

  1. Workflow in Clinical Trial Sites & Its Association with Near Miss Events for Data Quality: Ethnographic, Workflow & Systems Simulation

    Science.gov (United States)

    Araujo de Carvalho, Elias Cesar; Batilana, Adelia Portero; Claudino, Wederson; Lima Reis, Luiz Fernando; Schmerling, Rafael A.; Shah, Jatin; Pietrobon, Ricardo

    2012-01-01

    Background With the exponential expansion of clinical trials conducted in (Brazil, Russia, India, and China) and VISTA (Vietnam, Indonesia, South Africa, Turkey, and Argentina) countries, corresponding gains in cost and enrolment efficiency quickly outpace the consonant metrics in traditional countries in North America and European Union. However, questions still remain regarding the quality of data being collected in these countries. We used ethnographic, mapping and computer simulation studies to identify/address areas of threat to near miss events for data quality in two cancer trial sites in Brazil. Methodology/Principal Findings Two sites in Sao Paolo and Rio Janeiro were evaluated using ethnographic observations of workflow during subject enrolment and data collection. Emerging themes related to threats to near miss events for data quality were derived from observations. They were then transformed into workflows using UML-AD and modeled using System Dynamics. 139 tasks were observed and mapped through the ethnographic study. The UML-AD detected four major activities in the workflow evaluation of potential research subjects prior to signature of informed consent, visit to obtain subject́s informed consent, regular data collection sessions following study protocol and closure of study protocol for a given project. Field observations pointed to three major emerging themes: (a) lack of standardized process for data registration at source document, (b) multiplicity of data repositories and (c) scarcity of decision support systems at the point of research intervention. Simulation with policy model demonstrates a reduction of the rework problem. Conclusions/Significance Patterns of threats to data quality at the two sites were similar to the threats reported in the literature for American sites. The clinical trial site managers need to reorganize staff workflow by using information technology more efficiently, establish new standard procedures and manage

  2. Statins but not aspirin reduce thrombotic risk assessed by thrombin generation in diabetic patients without cardiovascular events: the RATIONAL trial.

    Directory of Open Access Journals (Sweden)

    Alejandro Macchia

    Full Text Available The systematic use of aspirin and statins in patients with diabetes and no previous cardiovascular events is controversial. We sought to assess the effects of aspirin and statins on the thrombotic risk assessed by thrombin generation (TG among patients with type II diabetes mellitus and no previous cardiovascular events.Prospective, randomized, open, blinded to events evaluation, controlled, 2×2 factorial clinical trial including 30 patients randomly allocated to aspirin 100 mg/d, atorvastatin 40 mg/d, both or none. Outcome measurements included changes in TG levels after treatment (8 to 10 weeks, assessed by a calibrated automated thrombogram. At baseline all groups had similar clinical and biochemical profiles, including TG levels. There was no interaction between aspirin and atorvastatin. Atorvastatin significantly reduced TG measured as peak TG with saline (85.09±55.34 nmol vs 153.26±75.55 nmol for atorvastatin and control groups, respectively; p = 0.018. On the other hand, aspirin had no effect on TG (121.51±81.83 nmol vs 116.85±67.66 nmol, for aspirin and control groups, respectively; p = 0.716. The effects of treatments on measurements of TG using other agonists were consistent.While waiting for data from ongoing large clinical randomized trials to definitively outline the role of aspirin in primary prevention, our study shows that among diabetic patients without previous vascular events, statins but not aspirin reduce thrombotic risk assessed by TG.ClinicalTrials.gov NCT00793754.

  3. Modeling dropout from adverse event data: impact of dosing regimens across pregabalin trials in the treatment of generalized anxiety disorder.

    Science.gov (United States)

    Lalovic, Bojan; Hutmacher, Matt; Frame, Bill; Miller, Raymond

    2011-05-01

    Dizziness represents a major determinant of dropout in the treatment of generalized anxiety disorder with pregabalin. Titration (dose escalation) regimens based on clinical judgment were implemented to mitigate this adverse event and reduce patient dropout across clinical trials. Dropout is an important treatment failure endpoint, which can be analyzed using time-to-event models that incorporate daily dosing or other time-varying information. A parametric discrete-time dropout model with daily dizziness severity score as a covariate afforded a systematic, model-based assessment of titration dosing strategies, with model predictions evaluated against corresponding nonparametric estimates. A Gompertz hazard function adequately described the decreasing dropout hazard over time for individuals with severe or moderate dizziness and a lower, constant hazard for individuals reporting no dizziness or mild dizziness. Predictive performance of the model was adequate based on external validation with an independent trial and other goodness-of-fit criteria. Prospective simulations highlight the utility of this approach in reducing dropout based on examination of untested titration scenarios for future generalized anxiety disorder or other trials.

  4. Assurance calculations for planning clinical trials with time-to-event outcomes.

    Science.gov (United States)

    Ren, Shijie; Oakley, Jeremy E

    2014-01-15

    We consider the use of the assurance method in clinical trial planning. In the assurance method, which is an alternative to a power calculation, we calculate the probability of a clinical trial resulting in a successful outcome, via eliciting a prior probability distribution about the relevant treatment effect. This is typically a hybrid Bayesian-frequentist procedure, in that it is usually assumed that the trial data will be analysed using a frequentist hypothesis test, so that the prior distribution is only used to calculate the probability of observing the desired outcome in the frequentist test. We argue that assessing the probability of a successful clinical trial is a useful part of the trial planning process. We develop assurance methods to accommodate survival outcome measures, assuming both parametric and nonparametric models. We also develop prior elicitation procedures for each survival model so that the assurance calculations can be performed more easily and reliably. We have made free software available for implementing our methods. Copyright © 2013 John Wiley & Sons, Ltd.

  5. The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the Microbicides Development Programme 301 Trial (MDP301).

    Science.gov (United States)

    Jentsch, Ute; Lunga, Precious; Lacey, Charles; Weber, Jonathan; Cairns, Janet; Pinheiro, Gisela; Joseph, Sarah; Stevens, Wendy; McCormack, Sheena

    2012-01-01

    We describe the application of a novel HIV confirmatory testing algorithm to determine the primary efficacy endpoint in a large Phase III microbicide trial. 9385 women were enrolled between 2005 and 2009. Of these women, 537 (6%) had at least one positive HIV rapid test after enrolment. This triggered the use of the algorithm which made use of archived serum and Buffy Coat samples. The overall sample set was >95% complete. 419 (78%) of the rapid test positive samples were confirmed as primary endpoints using a combination of assays for the detection of HIV-specific antibodies (EIA's and Western Blot), and for components of the virus itself (PCR for the detection of nucleic acids and EIA for p24 antigen). 63 (12%) cases were confirmed as being HIV-positive at screening or enrolment and 55 (10%) were confirmed as HIV negative. The testing algorithm confirmed the endpoint at the same visit as that of the first positive rapid test in 90% of cases and at the time of the preceding visit in 10% of cases. Of the 63 cases which were subsequently confirmed to be HIV-1 positive at or before enrolment, 54 specimens contained no detectable HIV antibodies at screening or enrolment. However, 43 were positive using an EIA which detects both HIV antigen and antibody and also had a positive p24 antigen or HIV PCR test, which was highly suggestive of acute infection. There were 6 unusual cases which had undetectable HIV-1 DNA or RNA. In 4 of the 6 cases the presence of HIV-1-specific antibodies was confirmed by Western Blot. One of these cases with an indeterminate Western Blot was a previous vaccine trial participant. The algorithm served the objectives of the study well and can be recommended for use in determining HIV as an endpoint in clinical trials. ISRCTN.org ISRCTN 64716212.

  6. The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the Microbicides Development Programme 301 Trial (MDP301.

    Directory of Open Access Journals (Sweden)

    Ute Jentsch

    Full Text Available We describe the application of a novel HIV confirmatory testing algorithm to determine the primary efficacy endpoint in a large Phase III microbicide trial. 9385 women were enrolled between 2005 and 2009. Of these women, 537 (6% had at least one positive HIV rapid test after enrolment. This triggered the use of the algorithm which made use of archived serum and Buffy Coat samples. The overall sample set was >95% complete. 419 (78% of the rapid test positive samples were confirmed as primary endpoints using a combination of assays for the detection of HIV-specific antibodies (EIA's and Western Blot, and for components of the virus itself (PCR for the detection of nucleic acids and EIA for p24 antigen. 63 (12% cases were confirmed as being HIV-positive at screening or enrolment and 55 (10% were confirmed as HIV negative. The testing algorithm confirmed the endpoint at the same visit as that of the first positive rapid test in 90% of cases and at the time of the preceding visit in 10% of cases. Of the 63 cases which were subsequently confirmed to be HIV-1 positive at or before enrolment, 54 specimens contained no detectable HIV antibodies at screening or enrolment. However, 43 were positive using an EIA which detects both HIV antigen and antibody and also had a positive p24 antigen or HIV PCR test, which was highly suggestive of acute infection. There were 6 unusual cases which had undetectable HIV-1 DNA or RNA. In 4 of the 6 cases the presence of HIV-1-specific antibodies was confirmed by Western Blot. One of these cases with an indeterminate Western Blot was a previous vaccine trial participant. The algorithm served the objectives of the study well and can be recommended for use in determining HIV as an endpoint in clinical trials.ISRCTN.org ISRCTN 64716212.

  7. The effects of reward magnitude on reward processing: An averaged and single trial event-related potential study.

    Science.gov (United States)

    Meadows, Caroline C; Gable, Philip A; Lohse, Keith R; Miller, Matthew W

    2016-07-01

    From a neurobiological and motivational perspective, the feedback-related negativity (FRN) and reward positivity (RewP) event-related potential (ERP) components should increase with reward magnitude (reward associated with valence (success/failure) feedback). To test this hypothesis, we recorded participants' electroencephalograms while presenting them with potential monetary rewards ($0.00-$4.96) pre-trial for each trial of a reaction time task and presenting them with valence feedback post-trial. Averaged ERPs time-locked to valence feedback were extracted, and results revealed a valence by magnitude interaction for neural activity in the FRN/RewP time window. This interaction was driven by magnitude affecting RewP, but not FRN, amplitude. Moreover, single trial ERP analyses revealed a reliable correlation between magnitude and RewP, but not FRN, amplitude. Finally, P3b and late positive potential (LPP) amplitudes were affected by magnitude. Results partly support the neurobiological (dopamine) account of the FRN/RewP and suggest motivation affects feedback processing, as indicated by multiple ERP components. Copyright © 2016 Elsevier B.V. All rights reserved.

  8. Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF)

    Science.gov (United States)

    McMurray, John J.V.; Anand, Inder S.; Diaz, Rafael; Maggioni, Aldo P.; O'Connor, Christopher; Pfeffer, Marc A.; Solomon, Scott D.; Tendera, Michal; van Veldhuisen, Dirk J.; Albizem, Moetaz; Cheng, Sunfa; Scarlata, Debra; Swedberg, Karl; Young, James B.; Amuchastegui, M.; Belziti, C.; Bluguermann, J.; Caccavo, M.; Cartasegna, L.; Colque, R.; Cuneo, C.; Fernandez, A.; Gabito, A.; Goicochea, R.; Gonzalez, M.; Gorosito, V.; Grinfeld, L.; Hominal, M.; Kevorkian, R.; Litvak Bruno, M.; Llanos, J.; Mackinnon, I.; Manuale, O.; Marzetti, E.; Nul, D.; Perna, E.; Riccitelli, M.; Sanchez, A.; Santos, D.; Schygiel, P.; Toblli, J.; Vogel, D.; Aggarwal, A.; Amerena, J.; De Looze, F.; Fletcher, P.; Hare, D.; Ireland, M.; Krum, H.; Lattimore, J.; Marwick, T.; Sindone, A.; Thompson, P.; Waites, J.; Altenberger, J.; Ebner, C.; Lenz, K.; Pacher, R.; Poelzl, G.; Charlier, F.; de Ceuninck, M.; De Keulenaer, G.; Dendale, P.; Maréchal, P.; Mullens, W.; Thoeng, J.; Vanderheyden, M.; Vanhaecke, J.; Weytjens, C.; Wollaert, B.; Albuquerque, D.; Almeida, D.; Aspe y Rosas, J.; Bocchi, E.; Bordignon, S.; Clausell, N.; Kaiser, S.; Leaes, P.; Martins Alves, S.; Montera, M.; Moura, L.; Pereira de Castro, R.; Rassi, S.; Reis, A.; Saraiva, J.; Simões, M.; Souza Neto, J.; Teixeira, M.; Benov, H.; Chompalova, B.; Donova, T.; Georgiev, P.; Gotchev, D.; Goudev, A.; Grigorov, M.; Guenova, D.; Hergeldjieva, V.; Ivanov, D.; Kostova, E.; Manolova, A.; Marchev, S.; Nikolov, F.; Popov, A.; Raev, D.; Tzekova, M.; Czarnecki, W.; Giannetti, N.; Haddad, H.; Heath, J.; Huynh, T.; Lepage, S.; Liu, P.; Lonn, E.; Ma, P.; Manyari, D.; Moe, G.; Parker, J.; Pesant, Y.; Rajda, M.; Ricci, J.; Roth, S.; Sestier, F.; Sluzar, V.; Sussex, B.; Vizel, S.; Antezana, G.; Bugueno, C.; Castro, P.; Conejeros, C.; Manriquez, L.; Martinez, D.; Potthoff, S.; Stockins, B.; Vukasovic, J.; Gregor, P.; Herold, M.; Jerabek, O.; Jirmar, R.; Kuchar, R.; Linhart, A.; Podzemska, B.; Soucek, M.; Spac, J.; Spacek, R.; Vodnansky, P.; Bronnum-Schou, J.; Clemmensen, K.; Egstrup, K.; Jensen, G.; Kjoller-Hansen, L.; Kober, L.; Markenvard, J.; Rokkedal, J.; Skagen, K.; Torp-Pedersen, C.; Tuxen, C.; Videbak, L.; Laks, T.; Vahula, V.; Harjola, V.; Kettunen, R.; Kotila, M.; Bauer, F.; Cohen Solal, A.; Coisne, D.; Davy, J.; De Groote, P.; Dos Santos, P.; Funck, F.; Galinier, M.; Gibelin, P.; Isnard, R.; Neuder, Y.; Roul, G.; Sabatier, R.; Trochu, J.; Anker, S.; Denny, S.; Dreykluft, T.; Flesch, M.; Genth-Zotz, S.; Hambrecht, R.; Hein, J.; Jeserich, M.; John, M.; Kreider-Stempfle, H.; Laufs, U.; Muellerleile, K.; Natour, M.; Sandri, M.; Schäufele, T.; von Hodenberg, E.; Weyland, K.; Winkelmann, B.; Tse, H.; Yan, B.; Barsi, B.; Csikasz, J.; Dezsi, C.; Edes, I.; Forster, T.; Karpati, P.; Kerekes, C.; Kis, E.; Kosa, I.; Lupkovics, G.; Nagy, A.; Preda, I.; Ronaszeki, A.; Tomcsanyi, J.; Zamolyi, K.; Agarwal, D.; Bahl, V.; Bordoloi, A.; Chockalingam, K.; Chopda, M.; Chopra, V.; Dugal, J.; Ghaisas, N.; Ghosh, S.; Grant, P.; Hiremath, S.; Iyengar, S.; Jagadeesa Subramania, B.; Jain, P.; Joshi, A.; Khan, A.; Mullasari, A.; Naik, S.; Oomman, A.; Pai, V.; Pareppally Gopal, R.; Parikh, K.; Patel, T.; Prakash, V.; Sastry, B.; Sathe, S.; Sinha, N.; Srikanthan, V.; Subburamakrishnan, P.; Thacker, H.; Wander, G.; Admon, D.; Katz, A.; Klainman, E.; Lewis, B.; Marmor, A.; Moriel, M.; Mosseri, M.; Shotan, A.; Weinstein, J.; Zimlichman, R.; Agostoni, P.; Albanese, M.; Alunni, G.; Bini, R.; Boccanelli, A.; Bolognese, L.; Campana, C.; Carbonieri, E.; Carpino, C.; Checco, L.; Cosmi, F.; D'Angelo, G.; De Cristofaro, M.; Floresta, A.; Fucili, A.; Galvani, M.; Ivleva, A.; Marra, S.; Musca, G.; Peccerillo, N.; Perrone Filardi, P.; Picchio, E.; Russo, T.; Scelsi, L.; Senni, M.; Tavazzi, L.; Erglis, A.; Jasinkevica, I.; Kakurina, N.; Veze, I.; Volans, E.; Bagdonas, A.; Berukstis, E.; Celutkiene, J.; Dambrauskaite, A.; Jarasuniene, D.; Luksiene, D.; Rudys, A.; Sakalyte, G.; Sliaziene, S.; Aguilar-Romero, R.; Cardona-Muñoz, E.; Castro-Jimenez, J.; Chavez-Herrera, J.; Chuquiure Valenzuela, E.; De la Pena, G.; Herrera, E.; Leiva-Pons, J.; Lopez Alvarado, A.; Mendez Machado, G.; Ramos-Lopez, G.; Basart, D.; Buijs, E.; Cornel, J.; de Leeuw, M.; Dijkgraaf, R.; Dunselman, P.; Freericks, M.; Hamraoui, K.; Lenderlink, T.; Linssen, G.; Lodewick, P.; Lodewijks, C.; Lok, D.; Nierop, P.; Ronner, E.; Somsen, A.; van Dantzig, J.; van der Burgh, P.; van Kempen, L.; van Vlies, B.; Voors, A.; Wardeh, A.; Willems, F.; Dickstein, K.; Gundersen, T.; Hole, T.; Thalamus, J.; Westheim, A.; Dabrowski, M.; Gorski, J.; Korewicki, J.; Kuc, K.; Miekus, P.; Musial, W.; Niegowska, J.; Piotrowski, W.; Podolec, P.; Polonski, L.; Ponikowski, P.; Rynkiewicz, A.; Szelemej, R.; Trusz-Gluza, M.; Ujda, M.; Wojciechowski, D; Wysokinski, A.; Camacho, A.; Fonseca, C.; Monteiro, P.; Apetrei, E.; Bruckner, I.; Carasca, E.; Coman, I.; Datcu, M.; Dragulescu, S.; Ionescu, P.; Iordachescu-Petica, D.; Manitiu, I.; Popa, V.; Pop-Moldovan, A.; Radoi, M.; Stamate, S.; Tomescu, M.; Vita, I.; Aroutiounov, G.; Ballyuzek, M.; Bart, B.; Churina, S.; Glezer, M.; Goloshchekin, B.; Ivleva, A.; Kobalava, Z.; Kostenko, V.; Lopatin, Y.; Martynov, A.; Orlov, V.; Semernin, E.; Shogenov, Z.; Sidorenko, B.; Skvortsov, A.; Storzhakov, G.; Sulimov, V.; Talibov, O.; Tereshenko, S.; Tsyrline, V.; Zadionchenko, V.; Zateyshchikov, D.; Dzupina, A.; Hranai, M.; Kmec, J.; Micko, K.; Murin, J.; Pella, D.; Sojka, G.; Spisak, V.; Vahala, P.; Vinanska, D.; Badat, A.; Bayat, J.; Dawood, S.; Delport, E.; Ellis, G.; Garda, R.; Klug, E.; Mabin, T.; Naidoo, D.; Pretorius, M.; Ranjith, N.; Van Zyl, L.; Weich, H.; Anguita, M.; Berrazueta, J.; Bruguera i Cortada, J.; de Teresa, E.; Gómez Sánchez, M.; González Juanatey, J.; Gonzalez-Maqueda, I.; Jordana, R.; Lupon, J.; Manzano, L.; Pascual Figal, D.; Pulpón, L.; Recio, J.; Ridocci Soriano, F.; Rodríguez Lambert, J.; Roig Minguell, E.; Roig Minguell, E.; Romero, J.; Valdovinos, P.; Klintberg, L.; Kronvall, T.; Lycksell, M.; Morner, S.; Rydberg, E.; Swedberg, K.; Timberg, I.; Wikstrom, G.; Moccetti, T.4; Ashok, J.; Banerjee, P.; Carr-White, G.; Cleland, J.; Connolly, E.; Francis, M.; Greenbaum, R.; Kadr, H.; Lindsay, S.; McMurray, J.; Megarry, S.; Memon, A.; Murdoch, D.; Senior, R.; Squire, I.; Tan, L.; Witte, K.; Adams, K.; Adamson, P.; Adler, A.; Altschul, L.; Altschuller, A.; Amirani, H.; Anand, I.; Andreou, C.; Ansari, M.; Antonishen, M.; Banchs, H.; Banerjee, S.; Banish, D.; Bank, A.; Barbagelata, A.; Barnard, D.; Bellinger, R.; Benn, A.; Berk, M.; Berry, B.; Bethala, V.; Bilazarian, S.; Bisognano, J.; Bleyer, F.; Blum, M.; Boehmer, J.; Bouchard, A.; Boyle, A.; Bozkurt, B.; Brown, C.; Burlew, B.; Burnham, K.; Butler, J.; Call, J.; Cambier, P.; Cappola, T.; Carlson, R.; Chandler, B.; Chandra, R.; Chandraratna, P.; Chernick, R.; Colan, D.; Colfer, H.; Colucci, W.; Connelly, T.; Costantini, O.; Dadkhah, S.; Dauber, I.; Davis, J.; Davis, S.; Denning, S.; Drazner, M.; Dunlap, S.; Egbujiobi, L.; Elkayam, U.; Elliott, J.; El-Shahawy, M.; Essandoh, L.; Ewald, G.; Fang, J.; Farhoud, H.; Felker, G.; Fernandez, J.; Festin, R.; Fishbein, G.; Florea, V.; Flores, E.; Floro, J.; Gabris, M.; Garg, M.; Gatewood, R.; Geller, M.; Ghali, J.; Ghumman, W.; Gibbs, G.; Gillespie, E.; Gilmore, R.; Gogia, H.; Goldberg, L.; Gradus-Pizlo, I.; Grainger, T.; Gudmundsson, G.; Gunawardena, D.; Gupta, D.; Hack, T.; Hall, S.; Hamroff, G.; Hankins, S.; Hanna, M.; Hargrove, J.; Haught, W.; Hauptman, P.; Hazelrigg, M.; Herzog, C.; Heywood, J.; Hill, T.; Hilton, T.; Hirsch, H.; Hunter, J.; Ibrahim, H.; Imburgia, M.; Iteld, B.; Jackson, B.; Jaffrani, N.; Jain, D.; Jain, A.; James, M.; Jimenez, J.; Johnson, E.; Kale, P.; Kaneshige, A.; Kapadia, S.; Karia, D.; Karlsberg, R.; Katholi, R.; Kerut, E.; Khoury, W.; Kipperman, R.; Klapholz, M.; Kosinski, E.; Kozinn, M.; Kraus, D.; Krueger, S.; Krum, H.; Kumar, S.; Lader, E.; Lee, C.; Levy, W.; Lewis, E.; Light-McGroary, K.; Loh, I.; Lombardi, W.; Machado, C.; Maislos, F.; Mancini, D.; Markus, T.; Mather, P.; McCants, K.; McGrew, F.; McLaurin, B.; McMillan, E.; McNamara, D.; Meyer, T.; Meymandi, S.; Miller, A.; Minami, E.; Modi, M.; Mody, F.; Mohanty, P.; Moscoso, R.; Moskowitz, R.; Moustafa, M.; Mullen, M.; Naz, T.; Noonan, T.; O'Brien, T.; Oellerich, W.; Oren, R.; Pamboukian, S.; Pereira, N.; Pitt, W.; Porter, C.; Prabhu, S.; Promisloff, S.; Ratkovec, R.; Richardson, R.; Ross, A.; Saleh, N.; Saltzberg, M.; Sarkar, S.; Schmedtje, J.; Schneider, R.; Schuyler, G.; Shanes, J.; Sharma, A.; Siegel, C.; Siegel, R.; Silber, D.; Singh, V.; Singh, N.; Singh, J.; Sklar, J.; Small, R.; Smith, A.; Smith, E.; Smith, E.; Smull, D.; Sotolongo, R.; Staniloae, C.; Stapleton, D.; Steele, P.; Stehlik, J.; Stein, M.; Tang, W.; Thadani, U.; Torre-Amoine, G.; Trichon, B.; Tsai, C.; Tummala, R.; Van Bakel, A.; Vicari, R.; Vijay, N.; Vijayaraghavan, K.; Vittorio, T.; Vossler, M.; Wagoner, L.; Wallis, D.; Ward, N.; Widmer, M.; Wight, J.; Wilkins, C.; Williams, C.; Williams, G.; Winchester, M.; Winkel, E.; Wittmer, B.; Wood, D.; Wormer, D.; Wright, R.; Xu, Z.; Yasin, M.; Zolty, R.

    2013-01-01

    Aims This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes. Methods and results Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L. Conclusion The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity. PMID:23329651

  9. Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov

    Directory of Open Access Journals (Sweden)

    Eric Wen Su

    2017-03-01

    Full Text Available Drug repositioning (i.e., drug repurposing is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics and PolyAnalyst (Megaputer were utilized. An I2E query extracts “Serious Adverse Events” (SAE data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer.

  10. Exams? Why worry? Interpreting anxiety as facilitative and stress appraisals.

    Science.gov (United States)

    Strack, Juliane; Esteves, Francisco

    2015-01-01

    The present study examined why people differ in how they appraise the same stressful situation (an approaching exam). We explored whether interpreting anxiety as a facilitative emotion can affect the type of stress appraisal people make. One hundred and three undergraduate students took part in this study, which lasted for 10 days (leading up to an exam). The students completed a daily self-reported evaluation of anxiety, emotional exhaustion, and stress experienced. The findings suggest a process by which a stressful time can be experienced as motivating rather than threatening or emotionally exhausting. For example, interpreting anxiety as facilitative moderated the relationship between anxiety and stress appraisals. When interpreting their anxiety as facilitative, individuals showed a higher tendency to make challenge stress appraisals and a lower tendency to appraising the stressor as a threat. These differences were especially visible with high levels of anxiety. Furthermore, interpreting anxiety as facilitative was negatively associated with emotional exhaustion, but positively associated with the academic performance. These findings suggest an explanation why people differ in how they appraise the same stressor: how people interpret their anxiety may to a large part affect how they appraise difficult events and situations.

  11. Biopsy-proven acute cellular rejection as an efficacy endpoint of randomized trials in liver transplantation: a systematic review and critical appraisal.

    Science.gov (United States)

    Rodríguez-Perálvarez, Manuel; Rico-Juri, Jose M; Tsochatzis, Emmanuel; Burra, Patrizia; De la Mata, Manuel; Lerut, Jan

    2016-09-01

    Biopsy-proven acute cellular rejection (ACR) is the primary efficacy endpoint in most randomized trials evaluating immunosuppression in liver transplantation. However, ACR is not a major cause of graft loss, and a certain grade of immune activation may be even beneficial for long-term graft acceptance. Validated criteria to select candidates for liver biopsy are lacking, and routine clinical practice relies on liver tests, which are inaccurate markers of ACR. Indeed, both the agreement among clinicians to select candidates for liver biopsy and the correlation between the clinical suspicion of ACR and histological findings are poor. In randomized trials evaluating immunosuppression protocols, this concern grows exponentially due to the open-label and multicenter nature of most studies. Therefore, biopsy-proven ACR is a suboptimal efficacy endpoint given its limited impact on prognosis and the heterogeneous diagnosis, which may increase the risk of bias. Chronic rejection and/or graft loss would be more appropriate endpoints, but would certainly require larger studies with prolonged surveillances. An objective method to select candidates for liver biopsy is therefore urgently needed, and only severe episodes of histological ACR should be considered as potentially harmful. Emerging surrogate markers of ACR and antibody-mediated rejection require further investigation to determine their clinical role. © 2015 Steunstichting ESOT.

  12. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials

    OpenAIRE

    Boussageon, Rémy; Bejan-Angoulvant, Theodora; Saadatian-Elahi, Mitra; Lafont, Sandrine; Bergeonneau, Claire; Kassaï, Behrouz; Erpeldinger, Sylvie; Wright, James M; Gueyffier, François; Cornu, Catherine

    2011-01-01

    Objective To determine all cause mortality and deaths from cardiovascular events related to intensive glucose lowering treatment in people with type 2 diabetes. Design Meta-analysis of randomised controlled trials. Data sources Medline, Embase, and the Cochrane database of systematic reviews. Study selection Randomised controlled trials that assessed the effect of intensive glucose lowering treatment on cardiovascular events and microvascular complications in adults (≥18 years) with type 2 di...

  13. Comparison of Fatal or Irreversible Events With Extended?Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy

    OpenAIRE

    Gibson, C. Michael; Korjian, Serge; Chi, Gerald; Daaboul, Yazan; Jain, Purva; Arbetter, Douglas; Goldhaber, Samuel Z; Hull, Russel; Hernandez, Adrian F.; Lopes, Renato D.; Gold, Alex; Cohen, Alexander T.; Harrington, Robert A.

    2017-01-01

    Background Extended?duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial?a multicenter, double?blind, rando...

  14. A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors.

    Science.gov (United States)

    Chen, T W; Razak, A R; Bedard, P L; Siu, L L; Hansen, A R

    2015-09-01

    There are limited data about the quality of immune-related adverse event (irAE) reporting in immune checkpoint inhibitor (ICI) clinical trial publications. A systematic search of citations from Medline, EMBASE and Cochrane databases identified prospective clinical trials involving ICIs in advanced solid tumors from 2003 to 2013. A 21-point quality score (QS) was adapted from the CONSORT harms extension statement. Linear regression was used to identify factors associated with quality reporting. After a review of 2628 articles, 50 trial reports were included, with ICIs as either monotherapy (54%) or part of a combination regimen (46%). The mean QS was 11.21 points (range 3.50-17.50 points). The median grade 3/4 AE rate reported was 21% (range 0%-66%) and 29/50 (58%) trials concluded that irAEs were tolerable. Multivariate regression analysis revealed that year of publication (within last 5 years, P = 0.01) and journal impact factor >15 (P = 0.004) were associated with higher QS. Complete reporting of specific characteristics of irAEs including onset, management and reversibility were reported by 14%, 8% and 6% of studies, respectively. The incidence of grade 3/4 adverse events was higher for inhibitors against CTLA-4 compared with other immune checkpoints (P reporting of irAEs is suboptimal. A standardized reporting method of irAEs that accounts for tolerability, management and reversibility is needed and would enable a more precise evaluation of the therapeutic risk benefit ratio of ICIs. © The Author 2015. 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.

  15. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe

    2010-01-01

    In the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, combined ezetimibe (10 mg) and simvastatin (40 mg) decreased low-density lipoprotein cholesterol levels by 50% and ischemic cardiovascular event (ICE) risk by 22% compared to placebo. A larger decrease in ICE risk might have been...... with baseline aortic jet velocity (JV) data, baseline and 1-year low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B, and no ICEs during the first year were included in the analysis. Relations between on-treatment measurements of 1-year LCs and time-to-ICE occurrence...

  16. [Autism spectrum disorder and evaluation of perceived stress parents and professionals: Study of the psychometric properties of a French adaptation of the Appraisal of Life Event Scale (ALES-vf)].

    Science.gov (United States)

    Cappe, É; Poirier, N; Boujut, É; Nader-Grosbois, N; Dionne, C; Boulard, A

    2017-08-01

    Autism and related disorders are grouped into the category of « Autism Spectrum Disorder » (ASD) in the DSM-5. This appellation reflects the idea of a dimensional representation of autism that combines symptoms and characteristics that vary in severity and intensity. Despite common characteristics, there are varying degrees in intensity and in the onset of symptoms, ranging from a disability that can be very heavy with a total lack of communication and major disorders associated with the existence of a relative autonomy associated, sometimes, with extraordinary intellectual abilities. Parents are faced with several difficult situations, such as sleep disturbances, agitation, shouting, hetero violence, self-harm, learning difficulties, stereotyping, lack of social and emotional reciprocity, inappropriate behavior, etc. They can feel helpless and may experience stress related to these developmental and behavioral difficulties. The heterogeneity of symptoms, the presence of behavioral problems, the lack of reciprocity and autonomy also represent a challenge for practitioners in institutions and teachers at school. The objective of this research is to present the validation of a French translation of the Appraisal of Life Events Scale (ALES-vf) from Ferguson, Matthex and Cox, specifically adapted to the context of ASD. ALES was originally developed to operationalize the three dimensions of perceived stress (threat, loss and challenge) described by Lazarus and Folkman. ALES-vf was initially translated into French and adapted to the situation of parents of children with ASD. It was subsequently administered to 343 parents, 150 paramedical professionals involved with people with ASD, and 155 teachers from an ordinary school environment and from specialized schools, welcoming in their classroom at least one child with ASD. An exploratory factor analysis performed on data from 170 parents highlighted two exploratory models with four and three factors, slightly different

  17. Appraisal of the quality of public lighting based on road surface luminance and glare.

    NARCIS (Netherlands)

    Boer, J.B. Burghout, F. & Heemskerck Veeckens, J.F.T. van

    1959-01-01

    Conclusions from earlier investigations indicating an average luminance of 2 cd/m 2 as necessary for dense traffic were confirmed by appraisals of luminance level and visibility trials. The colour of the light influences the visibility as well as the appraisal of luminance level, pattern and

  18. Ticagrelor effects on myocardial infarction and the impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial.

    Science.gov (United States)

    Mahaffey, Kenneth W; Held, Claes; Wojdyla, Daniel M; James, Stefan K; Katus, Hugo A; Husted, Steen; Steg, Philippe Gabriel; Cannon, Christopher P; Becker, Richard C; Storey, Robert F; Khurmi, Nardev S; Nicolau, José C; Yu, Cheuk-Man; Ardissino, Diego; Budaj, Andrzej; Morais, Joao; Montgomery, Debra; Himmelmann, Anders; Harrington, Robert A; Wallentin, Lars

    2014-04-22

    This study sought to report the treatment effect of ticagrelor on myocardial infarction (MI) and the strategy for and impact of event adjudication in the PLATO (Platelet Inhibition and Patient Outcomes) trial. In PLATO, ticagrelor reduced cardiovascular death, MI, or stroke in patients with acute coronary syndromes (ACS). A clinical events committee (CEC) prospectively defined and adjudicated all suspected MI events, on the basis of events reported by investigators and by triggers on biomarkers. Treatment comparisons used CEC-adjudicated data, and per protocol, excluded silent MI. Overall, 1,299 (610 ticagrelor, 689 clopidogrel) MIs reported by the CEC occurred during the trial. Of these, 1,097 (504 ticagrelor, 593 clopidogrel) contributed to the primary composite endpoint. Site investigators reported 1,198 (580 ticagrelor, 618 clopidogrel) MIs. Ticagrelor significantly reduced overall MI rates (12-month CEC-adjudicated Kaplan-Meier rates: 5.8% ticagrelor, 6.9% clopidogrel; hazard ratio [HR]: 0.84; 95% confidence interval [CI]: 0.75 to 0.95). Nonprocedural MI (HR: 0.86; 95% CI: 0.74 to 1.01) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor. MIs related to coronary artery bypass graft surgery were few, but numerical excess was observed in patients assigned ticagrelor. Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance (HR: 0.88; 95% CI: 0.78 to 1.00). In patients with ACS, ticagrelor significantly reduced the incidence of MI compared with clopidogrel, with consistent results across most MI subtypes. CEC procedures identified more MI endpoints compared with site investigators. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Appraisal and coping styles account for the effects of temperament on preadolescent adjustment

    OpenAIRE

    Thompson, Stephanie F.; Zalewski, Maureen; Lengua, Liliana J.

    2014-01-01

    Temperament, appraisal, and coping are known to underlie emotion regulation, yet less is known about how these processes relate to each other across time. We examined temperamental fear, frustration, effortful control, and impulsivity, positive and threat appraisals, and active and avoidant coping as processes underpinning the emotion regulation of pre-adolescent children managing stressful events. Appraisal and coping styles were tested as mediators of the longitudinal effects of temperament...

  20. Planning and evaluating clinical trials with composite time-to-first-event endpoints in a competing risk framework.

    Science.gov (United States)

    Rauch, G; Beyersmann, J

    2013-09-20

    Composite endpoints combine several events of interest within a single variable. These are often time-to-first-event data, which are analyzed via survival analysis techniques. To demonstrate the significance of an overall clinical benefit, it is sufficient to assess the test problem formulated for the composite. However, the effect observed for the composite does not necessarily reflect the effects for the components. Therefore, it would be desirable that the sample size for clinical trials using composite endpoints provides enough power not only to detect a clinically relevant superiority for the composite but also to address the components in an adequate way. The single components of a composite endpoint assessed as time-to-first-event define competing risks. We consider multiple test problems based on the cause-specific hazards of competing events to address the problem of analyzing both a composite endpoint and its components. Thereby, we use sequentially rejective test procedures to reduce the power loss to a minimum. We show how to calculate the sample size for the given multiple test problem by using a simply applicable simulation tool in SAS. Our ideas are illustrated by two clinical study examples. Copyright © 2013 John Wiley & Sons, Ltd.

  1. Anemia predicts thromboembolic events, bleeding complications and mortality in patients with atrial fibrillation: insights from the RE-LY trial.

    Science.gov (United States)

    Westenbrink, B D; Alings, M; Connolly, S J; Eikelboom, J; Ezekowitz, M D; Oldgren, J; Yang, S; Pongue, J; Yusuf, S; Wallentin, L; van Gilst, W H

    2015-05-01

    Anemia may predispose to thromboembolic events or bleeding in anticoagulated patients with atrial fibrillation (AF). To investigate whether anemia is associated with thromboembolic events and bleeding in patients with AF. We retrospectively analyzed the RE-LY trial database, which randomized 18 113 patients with AF and a risk of stroke to receive dabigatran or warfarin for a median follow-up of 2 years. Cox regression analysis was used to determine whether anemia predicted cardiovascular events and bleeding complications in these patients. Anemia was present in 12% of the population at baseline, and the presence of anemia was associated with a higher risk of thromboembolic cardiovascular events, including the composite endpoint of all-cause mortality or myocardial infarction (adjusted hazard ratio [HR] 1.50, 95% confidence interval [CI] 1.32-1.71) and the primary RE-LY outcome of stroke or systemic embolism (adjusted HR 1.41, 95% CI 1.12-1.78). Anemia was also associated with a higher risk of major bleeding complications (adjusted HR 2.14, 95% CI 1.87-2.46) and discontinuation of anticoagulants (adjusted HR 1.40, 95% CI 1.28-1.79). The association between anemia and outcome was similar irrespective of cardiovascular comorbidities, randomized treatment allocation, or prior use of warfarin. The incidence of events was lower in patients with transient anemia than in patients in whom anemia was sustained (adjusted HR 0.66, 95% CI 0.49-0.91). Anemia is associated with an increased risk of thromboembolic events, bleeding complications and mortality in anticoagulated patients with AF. These findings suggest that patients with anemia should be monitored closely during all types of anticoagulant treatment. © 2015 International Society on Thrombosis and Haemostasis.

  2. [Critically appraised article].

    Science.gov (United States)

    Neumann, Ignacio; Grassi, Bruno

    2012-01-01

    Angiotensin receptor blockers (ARB) and angiotensin converting enzyme (ACE) inhibitors are known to reduce proteinuria. Their combination might be more effective than either treatment alone, but long-term data for comparative changes in renal function are not available. We investigated the renal effects of ramipril (an ACE inhibitor), telmisartan (an ARB), and their combination in patients aged 55 years or older with established atherosclerotic vascular disease or with diabetes with end-organ damage. The trial ran from 2001 to 2007. After a 3-week run-in period, 25,620 participants were randomly assigned to ramipril 10 mg a day (n = 8,576), telmisartan 80 mg a day (n = 8,542), or to a combination of both drugs (n = 8,502; median follow-up was 56 months), and renal function and proteinuria were measured. The primary renal outcome was a composite of dialysis, doubling of serum creatinine, and death. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00153101. 784 patients permanently discontinued randomised therapy during the trial because of hypotensive symptoms (406 on combination therapy, 149 on ramipril, and 229 on telmisartan). The number of events for the composite primary outcome was similar for telmisartan (n = 1,147 [13.4%]) and ramipril (1,150 [13.5%]; hazard ratio [HR] 1.00, 95% CI 0.92-1.09), but was increased with combination therapy (1,233 [14.5%]; HR 1.09, 1.01-1.18, p = 0.037). The secondary renal outcome, dialysis or doubling of serum creatinine, was similar with telmisartan (189 [2.21%]) and ramipril (174 [2.03%];HR 1.09, 0.89-1.34) and more frequent with combination therapy (212 [2.49%]: HR 1.24,1.01-1.51, p = 0.038). Estimated glomerular filtration rate (eGFR) declined least with ramipril compared with telmisartan (-2.82 [SD 17.2] mL/min/1.73 m² vs -4.12 [17.4], p proteinuria to a greater extent than monotherapy, overall it worsens major renal outcomes.

  3. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction end- points in an international clinical trial: Review of the PURSUIT study

    NARCIS (Netherlands)

    K.W. Mahaffey (Kenneth); R.A. Harrington (Robert Alex); K.M. Akkerhuis (Martijn); N.S. Kleiman (Neal); L.G. Berdan (Lisa); B.S. Crenshaw (Brian); B.E. Tardiff (Barbara); C.B. Granger (Christopher); I. DeJong (Ingrid); M. Bhapkar (Manju); P. Widimsky (Petr); R. Corbalon (Ramón); K.L. Lee (Kerry); J.W. Deckers (Jaap); M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert)

    2001-01-01

    textabstractBackground. Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs) reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable

  4. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction end-points in an international clinical trial: review of the PURSUIT study

    NARCIS (Netherlands)

    K.W. Mahaffey (Kenneth); R.A. Harrington (Robert Alex); N.S. Kleiman (Neal); L.G. Berdan (Lisa); B.S. Crenshaw (Brian); B.E. Tardiff (Barbara); C.B. Granger (Christopher); I. DeJong (Ingrid); M. Bhapkar (Manju); P. Widimsky (Petr); R. Corbalon (Ramón); K.L. Lee (Kerry); J.W. Deckers (Jaap); M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); K.M. Akkerhuis (Martijn)

    2001-01-01

    textabstractAbstract: Background Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs) reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in

  5. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial: a multi-centred, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thompson Kara

    2010-12-01

    Full Text Available Abstract Background Despite lack of outward signs, most individuals after non-disabling stroke (NDS and transient ischemic attack (TIA have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress. In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity. Methods/Design A single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE. Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be

  6. The FDA outlook of events reporting after ticagrelor or clopidogrel in the PLATO Trial: impact of sponsor censoring dates, drug discontinuation, and withdrawal of consent.

    Science.gov (United States)

    Serebruany, Victor L

    2011-01-01

    Censoring by the study sponsor of clinical endpoint events in indication-seeking randomized trials represents a controversial approach since the reported data may be biased in favor of experimental agents due to the obvious conflict of interest. The frequency of drug discontinuation and rates of consent withdrawal may also impact the trial outcomes. To assess patterns of event reporting dependent on sponsor censoring dates, drug discontinuation and consent withdrawal in the PLATO trial. Analysis of the Food and Drug Administration Complete Response Review for ticagrelor. Excluding adjudicated deaths, the distribution for clopidogrel appears more uniform while that for ticagrelor was skewed to the right, suggesting more events were reported after the sponsor censoring end date. PLATO investigators reported 16 unmatched primary endpoint events for ticagrelor immediately following the sponsor censoring date. Twenty-six out of 30 unreported events following early drug discontinuation occurred amongst patients using ticagrelor. More ticagrelor patients withdrew consent (Δ = 47), or were 'not willing' to complete the study (Δ = 87) when compared to clopidogrel. Site-reported primary endpoints were unequally distributed for clopidogrel and ticagrelor in the PLATO trial. This pattern suggests the importance of questioning the impact of sponsor-mediated censoring on event reporting by investigators in indication-seeking trials. In PLATO, this pattern seems to have favored the experimental drug and may require further assessment. Copyright © 2012 S. Karger AG, Basel.

  7. Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

    Science.gov (United States)

    Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

    2017-08-17

    A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

  8. Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal.

    Science.gov (United States)

    Lecluse, L L A; Spuls, Ph I

    2015-01-01

    Arits et al. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior to methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma. This single-blind, noninferiority, randomized controlled trial was conducted at one coordinating academic hospital and six peripheral dermatological departments in the Netherlands between March 2008 and August 2010. Patients with a superficial basal cell carcinoma were randomly assigned to be treated with PDT (two treatments); or imiquimod 5% cream, once daily five times a week for 6 weeks; or fluorouracil 5% cream twice daily for 4 weeks. Follow-up visits were planned after 3 months and 1 year. The primary outcome was defined as the probability that a patient was free of tumour reoccurrence at both 3 and 12 months' follow-up. Secondary outcomes were aesthetic outcome of the treated area, compliance and adverse reactions. In total 911 patients were assessed for eligibility, of whom 601 were randomized: 202 to receive MAL-PDT, 198 to receive imiquimod cream and 201 to receive fluorouracil cream. The proportions (95% confidence intervals) of patients tumour free at both 3 and 12 months were 72·8% (66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream and 80·1% (74·7-85·9) for fluorouracil cream. For patients treated with MAL-PDT, moderate-to-severe pain and burning sensation were reported most often during the treatment itself. For the creams, moderate-to-severe local swelling, erosion, crust formation and itching of the skin were mentioned most often. Arits et al. conclude that topical fluorouracil was noninferior and imiquimod was superior to MAL-PDT for treatment of superficial basal cell carcinoma. Imiquimod cream is suggested as the preferred treatment. © 2015 British Association of Dermatologists.

  9. Measuring appraisal during advanced cancer: psychometric testing of the appraisal of caregiving scale.

    Science.gov (United States)

    Lambert, Sylvie D; Yoon, Hyojin; Ellis, Katrina R; Northouse, Laurel

    2015-05-01

    Examine the psychometric properties of the Appraisal of Caregiving Scale (ACS). Data were collected as part of the FOCUS Program trial in Michigan (N = 484 caregivers). Exploratory factor analysis found the ACS measured Threat, General Stress, and Benefit appraisals. Cronbach's alphas for all subscales exceeded 0.70. Construct validity analyses indicated the Threat subscale correlated significantly with concepts of avoidant coping, burden, and dyadic support (r > 0.30). General Stress correlated significantly with burden (r = 0.348) and dyadic support (r = -0.373), and the Benefit subscale correlated significantly with active coping (r = 0.444). Known group analyses indicated that depressed caregivers had higher Threat and General Stress scores than non-depressed caregivers. Also, younger caregivers reported significantly higher scores on the General Stress subscale than older caregivers. Predictive validity analyses found appraisal scores at baseline accounted for 33.3% of the variance in hopelessness and 27.8% of the variance in depression at Time 2. The ACS is a reliable measure of Threat, General Stress, and Benefit appraisals, with some support for its validity. Health professionals may find the ACS useful for guiding intervention development. Future research should continue to examine the ACS' validity. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Classification of single-trial auditory events using dry-wireless EEG during real and motion simulated flight.

    Science.gov (United States)

    Callan, Daniel E; Durantin, Gautier; Terzibas, Cengiz

    2015-01-01

    Application of neuro-augmentation technology based on dry-wireless EEG may be considerably beneficial for aviation and space operations because of the inherent dangers involved. In this study we evaluate classification performance of perceptual events using a dry-wireless EEG system during motion platform based flight simulation and actual flight in an open cockpit biplane to determine if the system can be used in the presence of considerable environmental and physiological artifacts. A passive task involving 200 random auditory presentations of a chirp sound was used for evaluation. The advantage of this auditory task is that it does not interfere with the perceptual motor processes involved with piloting the plane. Classification was based on identifying the presentation of a chirp sound vs. silent periods. Evaluation of Independent component analysis (ICA) and Kalman filtering to enhance classification performance by extracting brain activity related to the auditory event from other non-task related brain activity and artifacts was assessed. The results of permutation testing revealed that single trial classification of presence or absence of an auditory event was significantly above chance for all conditions on a novel test set. The best performance could be achieved with both ICA and Kalman filtering relative to no processing: Platform Off (83.4% vs. 78.3%), Platform On (73.1% vs. 71.6%), Biplane Engine Off (81.1% vs. 77.4%), and Biplane Engine On (79.2% vs. 66.1%). This experiment demonstrates that dry-wireless EEG can be used in environments with considerable vibration, wind, acoustic noise, and physiological artifacts and achieve good single trial classification performance that is necessary for future successful application of neuro-augmentation technology based on brain-machine interfaces.

  11. Characterization and multiparameter analysis of visual adverse events in irofulven single-agent phase I and II trials.

    Science.gov (United States)

    Raymond, Eric; Kahatt, Carmen; Rigolet, Marie Hélène; Sutherland, William; Lokiec, François; Alexandre, Jérôme; Tombal, Bertrand; Elman, Michael; Lee, Michael S; MacDonald, John R; Cullen, Michael; Misset, Jean-Louis; Cvitkovic, Esteban

    2004-11-15

    Irofulven (6-hydroxymethylacylfulvene) is a novel agent, derived from illudin S, with potent apoptotic effects in preclinical models. In the Phase I trial evaluating intermittent weekly schedules, visual symptoms were dose limiting. The aim of this analysis was to better characterize the visual adverse events of irofulven and provide treatment guidelines. Clinical data from 277 patients entered in single-agent Phase I to II clinical trials who received irofulven on days 1 and 15 every 4 weeks; days 1, 8, and 15 every 4 weeks; or days 1 and 8 every 3 weeks were included in this multiparameter analysis. Overall, 74 patients (27%) experienced visual symptoms. The most frequently reported symptoms were flashing lights (12% of patients), blurred vision (9%), and photosensitivity (8%). Grade 3 toxicity was observed in 12 patients (4%). The incidence and severity of visual events were dose dependent, with no grade 3 visual events occurring at doses 0.50 mg/kg. Clinical examination and visual field assessment were found to be better correlated with symptoms and appear to be more appropriate for surveillance of irofulven retinal symptoms than electroretinograms. On the basis of retained antitumor activity and reversibility of grade 1 and 2 visual symptoms at lower doses, it appears that an irofulven dose of < or =0.50 mg/kg or < or =20 mg/m2, not to exceed 50 mg in a single dose, given as a 30-minute infusion on days 1 and 8 every 3 weeks or days 1 and 15 every 4 weeks minimizes the frequency and severity of visual symptoms.

  12. Classification of Single-Trial Auditory Events Using Dry-Wireless EEG During Real and Motion Simulated Flight

    Directory of Open Access Journals (Sweden)

    Daniel eCallan

    2015-02-01

    Full Text Available Application of neuro-augmentation technology based on dry-wireless EEG may be considerably beneficial for aviation and space operations because of the inherent dangers involved. In this study we evaluate classification performance of perceptual events using a dry-wireless EEG system during motion platform based flight simulation and actual flight in an open cockpit biplane to determine if the system can be used in the presence of considerable environmental and physiological artifacts. A passive task involving 200 random auditory presentations of a chirp sound was used for evaluation. The advantage of this auditory task is that it does not interfere with the perceptual motor processes involved with piloting the plane. Classification was based on identifying the presentation of a chirp sound versus silent periods. Evaluation of Independent component analysis and Kalman filtering to enhance classification performance by extracting brain activity related to the auditory event from other non-task related brain activity and artifacts was assessed. The results of permutation testing revealed that single trial classification of presence or absence of an auditory event was significantly above chance for all conditions on a novel test set. The best performance could be achieved with both ICA and Kalman filtering relative to no processing: Platform Off (83.4% vs 78.3%, Platform On (73.1% vs 71.6%, Biplane Engine Off (81.1% vs 77.4%, and Biplane Engine On (79.2% vs 66.1%. This experiment demonstrates that dry-wireless EEG can be used in environments with considerable vibration, wind, acoustic noise, and physiological artifacts and achieve good single trial classification performance that is necessary for future successful application of neuro-augmentation technology based on brain-machine interfaces.

  13. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared to clopidogrel: Data from the PLATO trials

    DEFF Research Database (Denmark)

    Patel, Manesh R.; Becker, Richard C.; Wojdyla, Daniel M.

    Abstract 14299: Cardiovascular Events in Acute Coronary Syndrome Patients With Peripheral Arterial Disease Treated With Ticagrelor Compared to Clopidogrel: Data From the PLATO Trial Manesh R Patel1; Richard C Becker1; Daniel M Wojdyla2; Håkan Emanuelsson3; William Hiatt4; Jay Horrow5; Steen Husted6...... with PAD treated with ticagrelor compared with clopidogrel in the PLATO Trial. Methods: The PLATO trial was a multicenter, double-blind, randomized trial, comparing ticagrelor (180-mg loading dose, 90 mg twice daily thereafter) and clopidogrel (300-to-600-mg loading dose, 75 mg daily thereafter...

  14. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial.

    Science.gov (United States)

    Procter, Marion; Suter, Thomas M; de Azambuja, Evandro; Dafni, Urania; van Dooren, Veerle; Muehlbauer, Susanne; Climent, Miguel Angel; Rechberger, Ernst; Liu, Walter Tsang-Wu; Toi, Mazakasu; Coombes, R Charles; Dodwell, David; Pagani, Olivia; Madrid, Jorge; Hall, Marcia; Chen, Shin-Cheh; Focan, Christian; Muschol, Michael; van Veldhuisen, Dirk J; Piccart-Gebhart, Martine J

    2010-07-20

    We investigated the incidence of cardiac adverse events in patients with early breast cancer in the Herceptin Adjuvant (HERA) trial who were treated with 1 year of trastuzumab after completion of (neo)adjuvant chemotherapy. The HERA trial is a three-group, randomized trial that compared 1 year or 2 years of trastuzumab with observation in women with human epidermal growth factor receptor-2 (HER2) -positive early breast cancer. Eligible patients had normal left ventricular ejection fraction (LVEF; >or= 55%) after completion of (neo)adjuvant chemotherapy with or without radiotherapy. Cardiac function was monitored throughout the trial. This analysis considers patients randomly assigned to 1 year of trastuzumab treatment or observation. There were 1,698 patients randomly assigned to observation and 1,703 randomly assigned to 1 year of trastuzumab treatment; 94.1% of patients had been treated with anthracyclines. The incidence of discontinuation of trastuzumab because of cardiac disorders was low (5.1%). At a median follow-up of 3.6 years, the incidence of cardiac end points remained low, though it was higher in the trastuzumab group than in the observation group (severe CHF, 0.8% v 0.0%; confirmed significant LVEF decreases, 3.6% v 0.6%) In the trastuzumab group, 59 of 73 patients with a cardiac end point reached acute recovery; of these 59 patients, 52 were considered by the cardiac advisory board (CAB) to have a favorable outcome from the cardiac end point. The incidence of cardiac end points remains low even after longer-term follow-up. The cumulative incidence of any type of cardiac end point increases during the scheduled treatment period of 1 year, but it remains relatively constant thereafter.

  15. Changes in body weight and pulse: outcome events in overweight and obese subjects with cardiovascular disease in the SCOUT trial.

    Science.gov (United States)

    Seimon, R V; Espinoza, D; Finer, N; James, W P T; Legler, U F; Coutinho, W; Sharma, A M; Van Gaal, L; Maggioni, A P; Sweeting, A; Torp-Pedersen, C; Gebski, V; Caterson, I D

    2015-05-01

    The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in pulse rate, and the impact of these changes on subsequent cardiovascular outcome events in both the placebo and sibutramine groups. 9804 males and females, aged ⩾55 years, with a body mass index of 27-45 kg m(-)(2) were included in this current subanalysis of the SCOUT trial. Subjects were required to have a history of cardiovascular disease and/or type 2 diabetes mellitus with at least one cardiovascular risk factor, to assess cardiovascular outcomes. The primary outcome event (POE) was a composite of nonfatal myocardial infarction, nonfatal stroke, resuscitated cardiac arrest or cardiovascular death. Time-to-event analyses of the POE were performed using Cox regression models. During the initial 6-week sibutramine treatment period, the induced pulse rate increase was related to weight change (1.9±7.7 beats per minute (bpm)  with weight increase; 1.4±7.3 bpm, 0-5 kg weight loss; 0.6±7.4 bpm, ⩾5 kg weight loss). Throughout the subsequent treatment period, those continuing on sibutramine showed a consistently higher mean pulse rate than the placebo group. There was no difference in POE rates with either an increase or decrease in pulse rate over the lead-in period, or during lead-in baseline to 12 months post randomization. There was also no relationship between pulse rate at lead-in baseline and subsequent cardiovascular events in subjects with or without a cardiac arrhythmia. Baseline pulse rate and changes in pulse rate may not be an important modifier nor a clinically useful predictor of outcome in an individual elderly cardiovascular obese subject exposed to weight management.

  16. 4 CFR 4.2 - Performance appraisal.

    Science.gov (United States)

    2010-01-01

    ... appraisals of job performance of employees; encourages employee participation in establishing performance..., promoting, reducing in grade, retaining, and removing employees. (b) Each performance appraisal system shall... of each following appraisal period, communicating to reach GAO employee the performance standards and...

  17. How to appraise the effectiveness of treatment.

    Science.gov (United States)

    Stewart, Suzanne B; Dahm, Phillip; Scales, Charles D

    2011-10-01

    Advances in treatment and disease prevention occur frequently in urology. Urologists must identify a framework within which to evaluate these therapeutic innovations. The evidence-based approach to critical appraisal is described using an example from the urological literature. A three-part assessment of the trial validity, treatment effect, and applicability of results will permit the urologist to critically incorporate medical and surgical advances into practice. Validity of clinical trials hinges upon balancing patient prognosis at the initiation, execution, and conclusion of the trial. Readers should be aware of not only the magnitude of the estimated treatment effect, but also its precision. Finally, urologists should consider all patient-important outcomes as well as the balance of potential benefits, harms, and costs, and patient values and preferences when making treatment decisions. Use of this framework for critical appraisal will lead to a more evidence-based application of new therapies for patients. Incorporation of a more evidence-based practice within urology will lead to an increase in the quality of patient care.

  18. How to appraise the effectiveness of treatment

    Directory of Open Access Journals (Sweden)

    Suzanne B Stewart

    2011-01-01

    Full Text Available Introduction: Advances in treatment and disease prevention occur frequently in urology. Urologists must identify a framework within which to evaluate these therapeutic innovations. Materials and Methods: The evidence-based approach to critical appraisal is described using an example from the urological literature. A three-part assessment of the trial validity, treatment effect, and applicability of results will permit the urologist to critically incorporate medical and surgical advances into practice. Results: Validity of clinical trials hinges upon balancing patient prognosis at the initiation, execution, and conclusion of the trial. Readers should be aware of not only the magnitude of the estimated treatment effect, but also its precision. Finally, urologists should consider all patient-important outcomes as well as the balance of potential benefits, harms, and costs, and patient values and preferences when making treatment decisions. Conclusion: Use of this framework for critical appraisal will lead to a more evidence-based application of new therapies for patients. Incorporation of a more evidence-based practice within urology will lead to an increase in the quality of patient care.

  19. Social Anxiety and Depression in Adolescents in Relation to Perceived Competence and Situational Appraisal.

    Science.gov (United States)

    Smari, Jakob; Petursdottir, Guolaug; Porsteindottir, Vin

    2001-01-01

    Questionnaires, as well as an inventory of cost and likelihood appraisal of negative social and non-social events, were filled in by 184 adolescents. It was expected, and supported by the results, that social anxiety would be related to low perceived social competence and threat appraisal, whereas depression would be related to more general…

  20. Very low levels of atherogenic lipoproteins and the risk for cardiovascular events: a meta-analysis of statin trials.

    Science.gov (United States)

    Boekholdt, S Matthijs; Hovingh, G Kees; Mora, Samia; Arsenault, Benoit J; Amarenco, Pierre; Pedersen, Terje R; LaRosa, John C; Waters, David D; DeMicco, David A; Simes, R John; Keech, Antony C; Colquhoun, David; Hitman, Graham A; Betteridge, D John; Clearfield, Michael B; Downs, John R; Colhoun, Helen M; Gotto, Antonio M; Ridker, Paul M; Grundy, Scott M; Kastelein, John J P

    2014-08-05

    Levels of atherogenic lipoproteins achieved with statin therapy are highly variable, but the consequence of this variability for cardiovascular disease risk is not well-documented. The aim of this meta-analysis was to evaluate: 1) the interindividual variability of reductions in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), or apolipoprotein B (apoB) levels achieved with statin therapy; 2) the proportion of patients not reaching guideline-recommended lipid levels on high-dose statin therapy; and 3) the association between very low levels of atherogenic lipoproteins achieved with statin therapy and cardiovascular disease risk. This meta-analysis used individual patient data from 8 randomized controlled statin trials, in which conventional lipids and apolipoproteins were determined in all study participants at baseline and at 1-year follow-up. Among 38,153 patients allocated to statin therapy, a total of 6,286 major cardiovascular events occurred in 5,387 study participants during follow-up. There was large interindividual variability in the reductions of LDL-C, non-HDL-C, and apoB achieved with a fixed statin dose. More than 40% of trial participants assigned to high-dose statin therapy did not reach an LDL-C target LDL-C >175 mg/dl, those who reached an LDL-C 75 to cardiovascular events of 0.56 (95% confidence interval [CI]: 0.46 to 0.67), 0.51 (95% CI: 0.42 to 0.62), and 0.44 (95% CI: 0.35 to 0.55), respectively. Similar associations were observed for non-HDL-C and apoB. The reductions of LDL-C, non-HDL-C, and apoB levels achieved with statin therapy displayed large interindividual variation. Among trial participants treated with high-dose statin therapy, >40% did not reach an LDL-C target LDL-C levels have a lower risk for major cardiovascular events than do those achieving moderately low levels. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. Current practices in economic appraisal

    NARCIS (Netherlands)

    Mossink, J.C.M.

    2000-01-01

    By means of economic appraisal, the costs and the benefits of health, environment and safety management can be made clear, both at the national level and at the company level. As such it is a tool in advocating good practices. This paper explores the possibilities of economic appraisal for policy

  2. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study

    Directory of Open Access Journals (Sweden)

    Lee Kerry L

    2001-07-01

    Full Text Available Abstract Background Limited information has been published regarding how specific processes for event adjudication can affect event rates in trials. We reviewed nonfatal myocardial infarctions (MIs reported by site investigators in the international Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide Therapy (PURSUIT trial and those adjudicated by a central clinical events committee (CEC to determine the reasons for differences in event rates. Methods The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. The primary end-point was death or post-enrolment MI at 30 days as assessed by the CEC; this end-point was also constructed using site-reported events. The CEC identified suspected MIs by systematic review of clinical, cardiac enzyme, and electrocardiographic data. Results The CEC identified 5005 (46% suspected events, of which 1415 (28% were adjudicated as MI. The site investigator and CEC assessments of whether a MI had occurred disagreed in 983 (20% of the 5005 patients with suspected MI, mostly reflecting site misclassification of post-enrolment MIs (as enrolment MIs or underreported periprocedural MIs. Patients for whom the CEC and site investigator agreed that no end-point MI had occurred had the lowest mortality at 30 days and between 30 days and 6 months, and those with agreement that a MI had occurred had the highest mortality. Conclusion CEC adjudication provides a standard, systematic, independent, and unbiased assessment of end-points, particularly for trials that span geographic regions and clinical practice settings. Understanding the review process and reasons for disagreement between CEC and site investigator assessments of MI is important to design future trials and interpret event rates between trials.

  3. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial.

    Science.gov (United States)

    Lemoel, Fabien; Contenti, Julie; Giolito, Didier; Boiffier, Mathieu; Rapp, Jocelyn; Istria, Jacques; Fournier, Marc; Ageron, François-Xavier; Levraut, Jacques

    2017-12-01

    The goal of our study was to compare the frequency and severity of recovery reactions between ketamine and ketamine-propofol 1:1 admixture ("ketofol"). We performed a multicentric, randomized, double-blind trial in which adult patients received emergency procedural sedations with ketamine or ketofol. Our primary outcome was the proportion of unpleasant recovery reactions. Other outcomes were frequency of interventions required by these recovery reactions, rates of respiratory or hemodynamic events, emesis, and satisfaction of patients as well as providers. A total of 152 patients completed the study, 76 in each arm. Compared with ketamine, ketofol determined a 22% reduction in recovery reactions incidence (p ketamine. We found a significant reduction in recovery reactions and emesis frequencies among adult patients receiving emergency procedural sedations with ketofol, compared with ketamine. © 2017 by the Society for Academic Emergency Medicine.

  4. An expectation-maximization algorithm based Kalman smoother approach for single-trial estimation of event-related potentials.

    Science.gov (United States)

    Ting, Chee-Ming; Samdin, S Balqis; Salleh, Sh-Hussain; Omar, M Hafizi; Kamarulafizam, I

    2012-01-01

    This paper applies an expectation-maximization (EM) based Kalman smoother (KS) approach for single-trial event-related potential (ERP) estimation. Existing studies assume a Markov diffusion process for the dynamics of ERP parameters which is recursively estimated by optimal filtering approaches such as Kalman filter (KF). However, these studies only consider estimation of ERP state parameters while the model parameters are pre-specified using manual tuning, which is time-consuming for practical usage besides giving suboptimal estimates. We extend the KF approach by adding EM based maximum likelihood estimation of the model parameters to obtain more accurate ERP estimates automatically. We also introduce different model variants by allowing flexibility in the covariance structure of model noises. Optimal model selection is performed based on Akaike Information Criterion (AIC). The method is applied to estimation of chirp-evoked auditory brainstem responses (ABRs) for detection of wave V critical for assessment of hearing loss. Results shows that use of more complex covariances are better estimating inter-trial variability.

  5. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.

    Science.gov (United States)

    2009-09-01

    The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least 1 year. The TRA*CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. TRA*CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.

  6. Varied Search Protocols Lead to Clinically Relevant Results. A review of: Patel, Manesh R., Connie M. Schardt, Linda L. Sanders, and Sheri A. Keitz. “Randomized Trial for Answers to Clinical Questions: Evaluating a Pre‐Appraised Versus a MEDLINE Search Protocol.” Journal of the Medical Library Association 94.4 (2006: 382‐6.

    Directory of Open Access Journals (Sweden)

    Marcy L. Brown

    2008-03-01

    Full Text Available Objective – To determine the success rate of electronic resources for answering clinical questions by comparing speed, validity, and applicability of two different protocols for searching the medical literature.Design – Randomized trial with results judged by blinded panel.Setting – Duke University Medical Center in Durham, North Carolina, United States ofAmerica.Subjects – Thirty‐two 2nd and 3rd year internal medicine residents on an eight week general medicine rotation at the Duke University Medical Center.Methods – Two search protocols were developed:Protocol A: Participants searched MEDLINE first, and then searched pre‐appraised resources if needed.Protocol B: Participants searched pre‐appraised resources first, which included UpToDate, ACP JournalClub, Cochrane Database of Systematic Reviews, and DARE. The residents then searched MEDLINE if an answer could not be found in the 66 initial group of pre‐appraised resources. Residents were randomised by computer-assisted block order into four blocks of eight residents each. Two blocks were assigned to Protocol A, and two to Protocol B. Each day, residents developed at least one clinical question related to caring for patients. The questions were transcribed onto pocket-sized cards, with the answer sought later using the assigned protocol. If answers weren’t found using either protocol, searches were permitted in other available resources. When an article that answered a question was found, the resident recorded basic information about the question and the answer as well as the time required to find the answer (less than five minutes; between five and ten minutes; or more than ten minutes. Residents were to select answers that were “methodologically sound and clinically important” (384. Ten faculty members formally trained in evidence‐based medicine (EBM reviewed a subset of therapy‐related questions and answers. The reviewers, who were blinded to the search protocols

  7. Development of a Report Card for Identifying Local Sublingual Immunotherapy Events in Clinical Trials.

    Science.gov (United States)

    Norquist, Josephine; Flood, Emuella; Tanzosh, Tiffany; Li, Haojie; Iskold, Beata; Ganser, Thelma Rose; Marson-Smith, Helen

    2017-08-01

    The sublingual immunotherapy (SLIT) Report Card was developed to capture patient-reported local reactions from the administration of SLIT, based on the World Allergy Organization side-effect grading system. The objective was to evaluate understandability, usability, and translatability of the paper and electronic versions of the SLIT Report Card. Adults (aged 18+ years), adolescents (aged 12-17 years), and parents/caregivers and their children (aged 5-11 years) participated in two rounds of interviews, testing the paper version in Round 1, and both the paper and electronic versions in Round 2. Interviews assessed comprehension and usability by subjects. Translatability identified potential issues related to translation or cultural relevance. Ten adults, ten adolescents, and ten parent/child dyads were interviewed. In general, subjects demonstrated a clear understanding of the instrument's content. However, some subjects were uncertain of or suggested clarifying the meaning of certain terms, including tablet, ulcer, taste alteration, uvula, nausea, and itching in the ear. The translatability assessment also identified uvula and nausea as potentially problematic for translation. Subjects could use the electronic device and found navigation 'easy', with only a few minor suggestions made to improve usability. Some wording and formatting changes were made based on subjects' feedback and the translatability assessment. The SLIT Report Card was refined following best practices for instrument development, including cognitive interviewing, usability, and translatability assessment. The refined SLIT Report Card is appropriate for comprehensively and systematically collecting SLIT-related local reactions directly from subjects in a clinical trial setting, taking into account the World Allergy Organization grading system.

  8. Adverse Event Recording and Reporting in Clinical Trials Comparing Lumbar Disk Replacement with Lumbar Fusion: A Systematic Review.

    Science.gov (United States)

    Hiratzka, Jayme; Rastegar, Farbod; Contag, Alec G; Norvell, Daniel C; Anderson, Paul A; Hart, Robert A

    2015-12-01

    Study Design Systematic review. Objectives (1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive information when making treatment decisions. Methods A systematic search of PubMed, the Cochrane collaboration database, and the National Guideline Clearinghouse through May 2015 was conducted. Randomized controlled trials with at least 2 years of follow-up comparing lumbar artificial disk replacement with lumbar fusion were included. Patients were required to have axial or mechanical low back pain of ≥3 months' duration due to degenerative joint disease defined as degenerative disk disease, facet joint disease, or spondylosis. Outcomes included the quality of AE acquisition methodology and results reporting, and AEs were defined as those secondary to the procedure and reoperations. Individual and pooled relative risks and their 95% confidence intervals comparing lumbar TDR with fusion were calculated. Results RCTs demonstrated a generally poor description of methods for assessing AEs. There was a consistent lack of clear definition or grading for these events. Furthermore, there was a high degree of variation in reporting of surgery-related AEs. Most studies lacked adequate reporting of the timing of AEs, and there were no clear distinctions between acute or chronic AEs. Meta-analysis of the pooled data demonstrated a twofold increased risk of AEs in patients having lumbar fusion compared with patients having lumbar TDR at 2-year follow-up, and this relative risk was maintained at 5 years. Furthermore, the pooled data demonstrated a 1.7 times greater relative risk of

  9. Appraising Adaptive Management

    Directory of Open Access Journals (Sweden)

    Kai N. Lee

    1999-12-01

    Full Text Available Adaptive management is appraised as a policy implementation approach by examining its conceptual, technical, equity, and practical strengths and limitations. Three conclusions are drawn: (1 Adaptive management has been more influential, so far, as an idea than as a practical means of gaining insight into the behavior of ecosystems utilized and inhabited by humans. (2 Adaptive management should be used only after disputing parties have agreed to an agenda of questions to be answered using the adaptive approach; this is not how the approach has been used. (3 Efficient, effective social learning, of the kind facilitated by adaptive management, is likely to be of strategic importance in governing ecosystems as humanity searches for a sustainable economy.

  10. Quantifying learning-dependent changes in the brain: Single-trial multivoxel pattern analysis requires slow event-related fMRI.

    Science.gov (United States)

    Visser, Renée M; de Haan, Michelle I C; Beemsterboer, Tinka; Haver, Pia; Kindt, Merel; Scholte, H Steven

    2016-08-01

    Single-trial analysis is particularly useful for assessing cognitive processes that are intrinsically dynamic, such as learning. Studying these processes with fMRI is problematic, as the low signal-to-noise ratio of fMRI requires the averaging over multiple trials, obscuring trial-by-trial changes in neural activation. The superior sensitivity of multivoxel pattern analysis over univariate analyses has opened up new possibilities for single-trial analysis, but this may require different fMRI designs. Here, we measured fMRI and pupil dilation responses during discriminant aversive conditioning, to assess associative learning in a trial-by-trial manner. The impact of design choices was examined by varying trial spacing and trial order in a series of five experiments (total n = 66), while keeping stimulus duration constant (4.5 s). Our outcome measure was the change in similarity between neural response patterns related to two consecutive presentations of the same stimulus (within-stimulus) and between patterns related to pairs of different stimuli (between-stimulus) that shared a specific outcome (electric stimulation vs. no consequence). This trial-by-trial similarity analysis revealed clear single-trial learning curves in conditions with intermediate (8.1-12.6 s) and long (16.5-18.4 s) intervals, with effects being strongest in designs with long intervals and counterbalanced stimulus presentation. No learning curves were observed in designs with shorter intervals (1.6-6.1 s), indicating that rapid event-related designs-at present, the most common designs in fMRI research-are not suited for single-trial pattern analysis. These findings emphasize the importance of deciding on the type of analysis prior to data collection. © 2016 Society for Psychophysiological Research.

  11. 9 CFR 50.9 - Appraisals.

    Science.gov (United States)

    2010-01-01

    ... appraised within 15 days after being classified as infected with tuberculosis, except that the veterinarian... part must be appraised at their fair market value by an appraiser selected by APHIS. APHIS may decline... animals should be appraised at a higher value. The decision by the Administrator regarding the value of...

  12. 36 CFR 223.222 - Appraisal.

    Science.gov (United States)

    2010-07-01

    .... The Chief of the Forest Service shall determine the appraised value of special forest products. Valid methods to determine appraised value include, but are not limited to, transaction evidence appraisals... forest products must be sold at minimum rates or appraised value, whichever is higher. Contract and...

  13. Training Supervisors in Employee Performance Appraisals.

    Science.gov (United States)

    Sims, Ronald R.

    1988-01-01

    The author presents a training program for supervisors designed to improve an organization's performance appraisal system. Legal issues surrounding performance appraisal are discussed. Course topics include (1) definition and purpose of performance appraisal, (2) how appraisals can improve performance, (3) negative reactions and how to overcome…

  14. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial): a multi-centred, randomised controlled trial.

    Science.gov (United States)

    MacKay-Lyons, Marilyn; Gubitz, Gordon; Giacomantonio, Nicholas; Wightman, Howard; Marsters, David; Thompson, Kara; Blanchard, Chris; Eskes, Gail; Thornton, Marianne

    2010-12-08

    Despite lack of outward signs, most individuals after non-disabling stroke (NDS) and transient ischemic attack (TIA) have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress). In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity. A single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT) or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE). Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be compared. Ethical approval for the trial has been

  15. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...... Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated...... these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infarction or stroke, hospitalisation for unstable angina, arterial revascularisation, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT00239681. Findings For 17802 patients in the JUPITER trial...

  16. Establishing a Records Appraisal Workflow

    National Research Council Canada - National Science Library

    Maik Schmerbauch

    2016-01-01

      RIM conducted several records appraisal projects for such departments as human resources and the procurement unit as part of the general administrative program, which for two decades had secured...

  17. Examining the relationships between challenge and threat cognitive appraisals and coaching behaviours in football coaches.

    Science.gov (United States)

    Dixon, Martin; Turner, Martin J; Gillman, Jamie

    2017-12-01

    Previous research demonstrates that sports coaching is a stressful activity. This article investigates coaches' challenge and threat cognitive appraisals of stressful situations and their impact on coaching behaviour, using Blascovich and Mendes' (2000) biopsychosocial model as a theoretical framework. A cross-sectional correlational design was utilised to examine the relationships between irrational beliefs (Shortened general attitude and belief scale), challenge and threat appraisals (Appraisal of life events scale), and coaching behaviours (Leadership scale for sports) of 105 professional football academy coaches. Findings reveal significant positive associations between challenge appraisals and social support, and between threat appraisals and autocratic behaviour, and a significant negative association between threat appraisals and positive feedback. Results also show that higher irrational beliefs are associated with greater threat, and lesser challenge cognitive appraisals. However, no associations were revealed between irrational beliefs and challenge cognitive appraisals. Additionally, findings demonstrate a positive relationship between age and training and instruction. Results suggest that practitioners should help coaches to appraise stressful situations as a challenge to promote positive coaching behaviours.

  18. Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.

    Science.gov (United States)

    Ivers, Noah; Schwalm, J-D; Witteman, Holly O; Presseau, Justin; Taljaard, Monica; McCready, Tara; Bosiak, Beth; Cunningham, Jennifer; Smarz, Shelley; Desveaux, Laura; Tu, Jack V; Atzema, Clare; Oakes, Garth; Isaranuwatchai, Wanrudee; Grace, Sherry L; Bhatia, R Sacha; Natarajan, Madhu; Grimshaw, Jeremy M

    2017-08-01

    Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, P.M.; Genest, J.; Boekholdt, S.M.

    2010-01-01

    Background HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Methods...

  20. Early blood pressure lowering treatment in acute stroke. Ordinal analysis of vascular events in the Scandinavian Candesartan Acute Stroke Trial (SCAST)

    DEFF Research Database (Denmark)

    Jusufovic, Mirza; Sandset, Else Charlotte; Bath, Philip M

    2016-01-01

    OBJECTIVE: Early blood pressure-lowering treatment appears to be beneficial in patients with acute intracerebral haemorrhage and potentially in ischaemic stroke. We used a new method for analysis of vascular events in the Scandinavian Candesartan Acute Stroke Trial to see if the effect was depend......OBJECTIVE: Early blood pressure-lowering treatment appears to be beneficial in patients with acute intracerebral haemorrhage and potentially in ischaemic stroke. We used a new method for analysis of vascular events in the Scandinavian Candesartan Acute Stroke Trial to see if the effect...... was dependent on the timing of treatment. METHODS: Scandinavian Candesartan Acute Stroke Trial was a randomized controlled and placebo-controlled trial of candesartan within 30 h of ischaemic or haemorrhagic stroke. Of 2029 patients, 231 (11.4%) had a vascular event (vascular death, nonfatal stroke or nonfatal...... logistic regression for analysis and adjusted for predefined prognostic variables. RESULTS: Candesartan had no overall effect on vascular events (adjusted common odds ratio 1.11, 95% confidence interval 0.84-1.47, P = 0.48), and the effects were the same in ischaemic and haemorrhagic stroke. Among...

  1. Influence of nitrous oxide anesthesia, B-vitamins, and MTHFR gene polymorphisms on perioperative cardiac events: the vitamins in nitrous oxide (VINO) randomized trial

    National Research Council Canada - National Science Library

    Nagele, Peter; Brown, Frank; Francis, Amber; Scott, Mitchell G; Gage, Brian F; Miller, J Philip

    2013-01-01

    ...) C677T or A1298C gene variant. In this randomized controlled trial, the authors sought to determine whether patients carrying the MTHFR C677T or A1298C variant had a higher risk for perioperative cardiac events after nitrous oxide...

  2. Physicians' knowledge and attitude towards adverse event reporting system and result to intervention--randomized nested trial among Bulgarian physicians.

    Science.gov (United States)

    Stoynova, Veselina; Getov, Ilko N; Naseva, Emilia K; Lebanova, Hristina V; Grigorov, Evgeni E

    2013-08-01

    To identify the factors that influence physicians' under-reporting in Bulgaria and their attitude towards adverse event reporting system and to estimate the role of self-education by providing educational materials. A randomized nested trial among physicians-general practitioners and specialists in Bulgaria was conducted by a validated questionnaire in order to evaluate their knowledge and attitude towards adverse event reporting system. One month after the intervention the participants were re-visited and were asked to answer the same questions again in order to estimate the change in their knowledge and attitude towards pharmacovigilance system and to obtain their evaluation for the materials provided. The response rate was 91. Fifty seven (46.3%) physicians were not familiar with the pharmacovigilance system. The most common reason for non-reporting adverse drug reactions (ADRs) was uncertainty concerning the relationship between the suspected drug and ADRs, the ADRs were already known and the fact that the physician was not aware where they should report. Although 103 (83.7%) respondents in the entry survey and by 102 (82.9%) of those participating in the exit survey consider ADRs reporting as their obligation (p more than 0.05), only 50 (40.7%) and 31 (25.2%), respectively answered that they had ever reported ADRs; 109 (88.6%) of the surveyed physicians assessed the provided educational materials as useful for them. The physicians in Bulgaria have poor knowledge for the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude towards ADRs reporting system. National drug regulatory authority should play a more active role in improving physicians' adherence to the ADRs reporting systems and the developed educational pack can be used in nationwide campaign.

  3. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST).

    Science.gov (United States)

    Abraham, William T; Compton, Steven; Haas, Garrie; Foreman, Blair; Canby, Robert C; Fishel, Robert; McRae, Scott; Toledo, Gloria B; Sarkar, Shantanu; Hettrick, Douglas A

    2011-01-01

    The relative sensitivity and unexplained detection rate of changes in intrathoracic impedance has not been compared with standard heart failure (HF) monitoring using daily weight changes. The Fluid Accumulation Status Trial (FAST) prospectively followed 156 HF patients with implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator devices modified to record daily changes in intrathoracic impedance in a blinded fashion for 537±312 days. Daily impedance changes were used to calculate a fluid index that could be compared with a prespecified threshold. True positives were defined as adjudicated episodes of worsening HF occurring within 30 days of a fluid index above threshold or an acute weight gain. Unexplained detections were defined as threshold crossings or acute weight gains not associated with worsening HF. Impedance measurements were performed on >99% of follow-up days, compared with only 76% of days for weight measurements. Sixty-five HF events occurred during follow-up (0.32/patient-year). Forty HF events were detected by impedance but not weight, whereas 5 were detected by weight but not impedance. Sensitivity was greater (76% vs 23%; P<.0001) and unexplained detection rate was lower (1.9 vs 4.3/patient-year; P<.0001) for intrathoracic impedance monitoring at the threshold of 60Ω days compared with acute weight increases of 3 lbs in 1 day or 5 lbs in 3 days and also over a wide range of fluid index and weight thresholds. The sensitivity and unexplained detection rate of intrathoracic impedance monitoring was superior to that seen for acute weight changes. Intrathoracic impedance monitoring represents a useful adjunctive clinical tool for managing HF in patients with implanted devices. © 2011 Wiley Periodicals, Inc.

  4. The Yusuf-Peto method was not a robust method for meta-analyses of rare events data from antidepressant trials

    DEFF Research Database (Denmark)

    Sharma, Tarang; Gøtzsche, Peter C.; Kuss, Oliver

    2017-01-01

    Objectives The aim of the study was to identify the validity of effect estimates for serious rare adverse events in clinical study reports of antidepressants trials, across different meta-analysis methods. Study Design and Setting Four serious rare adverse events (all-cause mortality, suicidality......, aggressive behavior, and akathisia) were meta-analyzed using different methods. The Yusuf-Peto odds ratio ignores studies with no events and was compared with the alternative approaches of generalized linear mixed models (GLMMs), conditional logistic regression, a Bayesian approach using Markov Chain Monte...... the GLMM, and finally to 2.87 (1.42–5.98) using the MCMC approach. Conclusion The method used for meta-analysis of rare events data influences the estimates obtained, and the exclusion of double-zero event studies can give misleading results. To ensure reduction of bias and erroneous inferences...

  5. Compliance with and short-term adverse events from clarithromycin versus placebo in patients with stable coronary heart disease: the CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, C M; Kolmos, H J; Frydendall, N

    2009-01-01

    mg of clarithromycin daily versus 2200 patients to matching placebo for 14 days. This paper presents protocol-specified analysis of the patient-reported information regarding their compliance and non-serious adverse events during the 14 days of treatment as well as serious adverse events (mortality...... and hospitalizations) during the first 30 days after randomization. METHODS: Randomized clinical trial focusing on patient-reported information regarding their compliance and adverse events. RESULTS: Of the randomized patients, 99% reported information regarding their compliance and adverse events. A 100% tablet...... intake was reported by 90% of the clarithromycin group and by 93.7% of the placebo group. Of the clarithromycin patients, 39.5% reported at least one non-serious adverse event versus 25.1% of the placebo patients (P adverse reactions were reported 950 times by 697 patients (32...

  6. Teacher Professional Development and Appraisal

    Directory of Open Access Journals (Sweden)

    Kushtarbek Kimshanov

    2016-06-01

    Full Text Available Abstract The paper is based on analysis of international literature on school teacher appraisal and professional development.  Teacher appraisal is a very important area of study, and traditionally it has been quite a contested field as well.  Teachers used to feel tension and anxiety due to unfair teacher appraisal, and they often reacted to teacher appraisal with resentment and nervousness.  Historically, teacher teacher appraisal was aimed to inform the issues and training considerations in education during the decades of the seventies and was establish to exercise greater accountability to maintain a high standard in education. However, eventually the developmental purpose had been emphasized. This paper presents rich literature on teacher appraisal and teacher development concepts. Abstrak Artikel ini berdasarkan analisis literatur internasional pada penilaian guru sekolah dan pengembangan profesional. Penilaian guru merupakan bidang kajian yang sangat penting, dan sudah menjadi bidang kajian yang cukup sering diperdebatkan. Guru kerap merasa tegang dan cemas dikarenakan penilaian guru yang tidak adil, dan mereka sering bereaksi terhadap penilaian guru dengan kekesalan dan gugup. Dalam sejarahnya, penilaian guru bertujuan untuk memberitahukan isu-isu dan pertimbangan pelatihan dalam pendidikan selama dekade tujuh puluhan dan telah dibentuk untuk melatih akuntabilitas yang lebih baik untuk mengatasi standar pendidikan yang tinggi. Namun, akhirnya tujuan pengembangan telah ditekankan. Artikel ini memberikan beragam informasi tentang penilaian guru dan konsep pengembangan guru. How to Cite : Kimshanov, K. Dyikanbaeva, T. (2015. Teacher Professional Development and Appraisal. TARBIYA: Journal Of Education In Muslim Society, 2(2, 146-152. doi:10.15408/tjems.v2i2.2802. Permalink/DOI: http://dx.doi.org/10.15408/tjems.v2i2.2802

  7. Intensity and duration of negative emotions: comparing the role of appraisals and regulation strategies.

    Science.gov (United States)

    Brans, Karen; Verduyn, Philippe

    2014-01-01

    Intensity and duration are two central characteristics of an emotional response. Appraisals and regulation strategies are among the most important determinants of these emotion features. However, as intensity and duration are only moderately correlated, appraisals and regulation strategies may be differently related to these characteristics. A systematic empirical study comparing predictors of emotion intensity and duration is missing. The goal of the present study is to fill this gap. Participants were asked to recall recently experienced episodes of anger, fear, disgust, guilt, sadness, and shame. Subsequently, they were asked to answer a number of questions regarding (a) the intensity and duration of these emotions, (b) their appraisal of the emotion-eliciting event, and (c) their use of a wide range of regulation strategies. Emotion intensity was found to be mainly predicted by appraisals whereas emotion duration was equally well predicted by appraisals and regulation strategies.

  8. Intensity and duration of negative emotions: comparing the role of appraisals and regulation strategies.

    Directory of Open Access Journals (Sweden)

    Karen Brans

    Full Text Available Intensity and duration are two central characteristics of an emotional response. Appraisals and regulation strategies are among the most important determinants of these emotion features. However, as intensity and duration are only moderately correlated, appraisals and regulation strategies may be differently related to these characteristics. A systematic empirical study comparing predictors of emotion intensity and duration is missing. The goal of the present study is to fill this gap. Participants were asked to recall recently experienced episodes of anger, fear, disgust, guilt, sadness, and shame. Subsequently, they were asked to answer a number of questions regarding (a the intensity and duration of these emotions, (b their appraisal of the emotion-eliciting event, and (c their use of a wide range of regulation strategies. Emotion intensity was found to be mainly predicted by appraisals whereas emotion duration was equally well predicted by appraisals and regulation strategies.

  9. Intensity and Duration of Negative Emotions: Comparing the Role of Appraisals and Regulation Strategies

    Science.gov (United States)

    Brans, Karen; Verduyn, Philippe

    2014-01-01

    Intensity and duration are two central characteristics of an emotional response. Appraisals and regulation strategies are among the most important determinants of these emotion features. However, as intensity and duration are only moderately correlated, appraisals and regulation strategies may be differently related to these characteristics. A systematic empirical study comparing predictors of emotion intensity and duration is missing. The goal of the present study is to fill this gap. Participants were asked to recall recently experienced episodes of anger, fear, disgust, guilt, sadness, and shame. Subsequently, they were asked to answer a number of questions regarding (a) the intensity and duration of these emotions, (b) their appraisal of the emotion-eliciting event, and (c) their use of a wide range of regulation strategies. Emotion intensity was found to be mainly predicted by appraisals whereas emotion duration was equally well predicted by appraisals and regulation strategies. PMID:24670979

  10. Risk of adverse events with bevacizumab addition to therapy in advanced non-small-cell lung cancer: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Lai XX

    2016-04-01

    Full Text Available Xi-Xi Lai, Ren-Ai Xu, Yu-Ping Li, Han Yang Department of Respiratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China Background: Bevacizumab, a monoclonal antibody against vascular endothelial growth factor ligand, has shown survival benefits in the treatment of many types of malignant tumors, including non-small-cell lung cancer (NSCLC. We conducted this systematic review and meta-analysis to investigate the risk of the most clinically relevant adverse events related to bevacizumab in advanced NSCLC.Methods: Databases from PubMed, Web of Science, and Cochrane Library up to August 2015, were searched to identify relevant studies. We included prospective randomized controlled Phase II/III clinical trials that compared therapy with or without bevacizumab for advanced NSCLC. Summary relative risk (RR and 95% confidence intervals were calculated using random effects or fixed effects according to the heterogeneity among included trials.Results: A total of 3,745 patients from nine clinical trials were included in the meta-analysis. Summary RRs showed a statistically significant bevacizumab-associated increased risk in three of the adverse outcomes studied: proteinuria (RR =7.55, hypertension (RR =5.34, and hemorrhagic events (RR =2.61. No statistically significant differences were found for gastrointestinal perforation (P=0.60, arterial and venous thromboembolic events (P=0.35 and P=0.92, respectively, or fatal events (P=0.29.Conclusion: The addition of bevacizumab to therapy in advanced NSCLC did significantly increase the risk of proteinuria, hypertension, and hemorrhagic events but not arterial/venous thromboembolic events, gastrointestinal perforation, or fatal adverse events. Keywords: toxicities, angiogenesis inhibitors, non-small-cell lung carcinoma, meta-analysis, safety

  11. Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial.

    Science.gov (United States)

    Sakamoto, Tomohiro; Ogawa, Hisao; Nakao, Koichi; Hokimoto, Seiji; Tsujita, Kenichi; Koide, Shunichi; Yamamoto, Nobuyasu; Shimomura, Hideki; Matsumura, Toshiyuki; Oshima, Shuichi; Kikuta, Koichi; Oka, Hideki; Kimura, Kazuo; Matsui, Kunihiko

    2016-04-01

    The purpose of this study was to examine the cardiovascular protective effects of candesartan in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs). Candesartan has been reported to reduce cardiovascular events when therapy was started 6 months after PCI with bare-metal stents in patients who survived restenosis. Candesartan started immediately after PCI with DESs was also effective in preventing cardiovascular events. The 4C trial was a multicenter, prospective, randomized, open-label study. A total of 1145 patients at 39 centers in Japan were randomly assigned to receive candesartan plus standard medical treatment or standard medical treatment alone. The primary endpoints were all-cause death, and a composite of non-fatal myocardial infarction (MI), unstable angina pectoris (uAP), congestive heart failure (CHF), and non-fatal cerebrovascular events. The follow-up period was up to 3 years after the index PCI (ClinicalTrials.gov NCT00139386). The incidence of total death, one of the primary endpoints, was comparable between the two treatment groups (3.8% each, p=0.9702). Another primary endpoint, non-fatal major cardiovascular events, tended to occur more often in the control group than in the candesartan group (9.2% vs. 12.5%, p=0.0985). In contrast, candesartan significantly reduced one of the pre-specified secondary endpoints: cardiovascular events that included non-fatal MI, uAP, and CHF (4.4% vs. 6.7%, p=0.0136). Furthermore, candesartan significantly reduced another secondary endpoint that included cardiovascular events and cardiovascular death (5.0% vs. 7.7%, p=0.0493). The 4C trial showed that candesartan administered immediately after PCI with DESs did not improve the prognosis after the index procedure, but did reduce some cardiac-related events for 3 years. Copyright © 2015. Published by Elsevier Ltd.

  12. Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial.

    Science.gov (United States)

    Lopez-Villegas, Antonio; Catalan-Matamoros, Daniel; Robles-Musso, Emilio; Peiro, Salvador

    2016-11-01

    The purpose of the present study was to assess the effectiveness of the remote monitoring (RM) of older adults with pacemakers on health-related quality of life, functional capacity, feasibility, reliability and safety. The PONIENTE study is a controlled, non-randomized, non-blinded clinical trial, with data collection carried out during the pre-implant stage and after 12 months. Between October of 2012 and November of 2013, 82 patients were assigned to either a remote monitoring group (n = 30) or a conventional hospital monitoring (HM) group (n = 52). The EuroQol-5D (EQ-5D) and the Duke Activity Status Index were used to measure health-related quality of life and functional capacity, respectively. Baseline characteristics and number of hospital visits were also analyzed. The baseline characteristics of the two study groups were similar for both the EQ-5D (RM 0.74, HM 0.67; P = 0.404) and the Duke Activity Status Index (RM 21.42, HM 19.95; P = 0.272). At the 12-month follow up, the EQ-5D utility score was improved for both groups (RM 0.91, HM 0.81; P = 0.154), unlike the EQ-5D Visual Analog Scale (P = 0.043). The Duke Activity Status Index score was similar to the baseline score. The number of in-hospital visits was 27% lower (3 vs 4; P < 0.001) in the remote group as compared with the hospital group. The PONIENTE trial suggests that the remote monitoring of pacemakers in older adults is an equivalent option to hospital monitoring, in terms of health-related quality of life and functional capacity. Furthermore, it allows for the early detection of clinical and pacemaker-related adverse events, and significantly reduces the number of in-hospital visits. Geriatr Gerontol Int 2016; 16: 1188-1195. © 2015 Japan Geriatrics Society.

  13. HOW APPRAISERS DEVELOP FAIR VALUE

    Directory of Open Access Journals (Sweden)

    MIROSLAV ŠKODA

    2012-01-01

    Full Text Available Management is responsible for its own financial decisions. If we take into account, that fair value concept was shown in financial crisis as something that does not work anymore in this way; there is a big need to develop it for the future. Non-professional readers of financial statements believe, however, that company financials are the work of the public accounting firm that had signed the audit certificate. The main reason for bringing this point up is that when companies disclose Fair Value (FV information in their financial statements, they are taking responsibility for the values disclosed. Management may often be encouraged to utilize the services of an outside professional, but at the end of the day, the outside appraiser is a hired gun. Although the appraiser has to take responsibility for his own work, hiring the appraiser does not absolve management of its ultimate responsibility. The obverse of this is also true. Management does not have to hire the appraiser to develop any fair value disclosures made in the financial statements. Developing FV information is not recommended as a do-it yourself undertaking, there is nothing in Generally Accepted Accounting Principles (GAAP or Securities Exchange Commission (SEC regulations, however, that requires an outside appraiser.

  14. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Lystad, Reidar P; Brown, Benjamin T

    2017-03-14

    Reporting of adverse events in randomized clinical trials (RCTs) is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT) statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT). During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1) they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2) they mentioned adverse events (or any related terms) in the title or abstract. Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078). Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of allocation of adverse event indexing terms in both databases. We

  15. Assignment of adverse event indexing terms in randomized clinical trials involving spinal manipulative therapy: an audit of records in MEDLINE and EMBASE databases

    Directory of Open Access Journals (Sweden)

    Lindsay M. Gorrell

    2017-03-01

    Full Text Available Abstract Background Reporting of adverse events in randomized clinical trials (RCTs is encouraged by the authors of The Consolidated Standards of Reporting Trials (CONSORT statement. With robust methodological design and adequate reporting, RCTs have the potential to provide useful evidence on the incidence of adverse events associated with spinal manipulative therapy (SMT. During a previous investigation, it became apparent that comprehensive search strategies combining text words with indexing terms was not sufficiently sensitive for retrieving records that were known to contain reports on adverse events. The aim of this analysis was to compare the proportion of articles containing data on adverse events associated with SMT that were indexed in MEDLINE and/or EMBASE and the proportion of those that included adverse event-related words in their title or abstract. Methods A sample of 140 RCT articles previously identified as containing data on adverse events associated with SMT was used. Articles were checked to determine if: (1 they had been indexed with relevant terms describing adverse events in the MEDLINE and EMBASE databases; and (2 they mentioned adverse events (or any related terms in the title or abstract. Results Of the 140 papers, 91% were MEDLINE records, 85% were EMBASE records, 81% were found in both MEDLINE and EMBASE records, and 4% were not in either database. Only 19% mentioned adverse event-related text words in the title or abstract. There was no significant difference between MEDLINE and EMBASE records in the proportion of available papers (p = 0.078. Of the 113 papers that were found in both MEDLINE and EMBASE records, only 3% had adverse event-related indexing terms assigned to them in both databases, while 81% were not assigned an adverse event-related indexing term in either database. Conclusions While there was effective indexing of RCTs involving SMT in the MEDLINE and EMBASE databases, there was a failure of

  16. First Contact: the intersection of demographics, knowledge, and appraisal of treatment at the initial infertility visit

    Science.gov (United States)

    CHILDRESS, Krista J.; LAWSON, Angela K.; GHANT, Marissa S.; MENDOZA, Gricelda; CARDOZO, Eden R.; CONFINO, Edmond; MARSH, Erica E.

    2015-01-01

    Objective To determine the impact of the initial infertility visit on treatment-related knowledge, patient anxiety, and appraisals of treatment. Study Design Prospective survey. Setting Academic medical center. Patients 234 English-speaking women, ages 18-50, attending their first infertility visit Intervention(s) Participants completed a survey assessing health literacy, knowledge, anxiety, and appraisals of the treatment process before and after their infertility visit. Main Outcome Measure(s) 1) Knowledge of infertility and treatment and, 2) Anxiety and appraisal scores. Results Most participants were white and earned >$100,000/year and had at least a college education. Baseline knowledge of reproductive anatomy, ART, and fertility factors was modest, but improved after the initial visit. Factors associated with higher knowledge included higher education and income, White or Asian ethnicity, and English as their primary language. Patient appraisals of treatment represented by the positive (Challenge) and negative (Threat and Loss) subscale scores on the Appraisal of Life Events (ALE) scale, changed from the pre-visit survey to the post-visit survey. Negative appraisals of treatment and anxiety scores decreased and positive appraisals of treatment increased after the initial visit. Lower knowledge was associated with higher positive appraisal scores lower health literacy was associated with higher anxiety and appraisal scores (positive and negative) post-visit. Black women had higher Challenge scores compared to White and Asian women. Hispanic women had higher anxiety scores than non-Hispanic women. Conclusions Infertility patients have modest baseline knowledge of fertility and infertility treatment. The initial infertility visit can improve this knowledge and decrease both negative appraisals of treatment and anxiety levels. Differences in knowledge and appraisal were seen across ethnic groups and other demographic variables. Physicians should individualize

  17. First contact: the intersection of demographics, knowledge, and appraisal of treatment at the initial infertility visit.

    Science.gov (United States)

    Childress, Krista J; Lawson, Angela K; Ghant, Marissa S; Mendoza, Gricelda; Cardozo, Eden R; Confino, Edmond; Marsh, Erica E

    2015-07-01

    To determine the impact of the initial infertility visit on treatment-related knowledge, patient anxiety, and appraisals of treatment. Prospective survey. Academic medical center. Two hundred thirty-four English-speaking women aged 18-50 years attending their first infertility visit. Participants completed a survey assessing health literacy, knowledge, anxiety, and appraisals of the treatment process before and after their infertility visit. Knowledge of infertility and treatment and anxiety and appraisal scores. Most participants were white and earned >$100,000/year and had at least a college education. Baseline knowledge of reproductive anatomy, assisted reproductive technology (ART), and fertility factors was modest but improved after the initial visit. Factors associated with higher knowledge included higher education and income, white or Asian ethnicity, and English as a primary language. Patient appraisals of treatment represented by the positive (Challenge) and negative (Threat and Loss) subscale scores on the Appraisal of Life Events (ALE) scale changed over time Negative appraisals of treatment and anxiety scores decreased and positive appraisals of treatment increased after the initial visit. Lower knowledge was associated with higher positive appraisal scores; lower health literacy was associated with higher anxiety and appraisal scores (positive and negative) after the visit. Black women had higher Challenge scores compared with white and Asian women. Hispanic women had higher anxiety scores than non-Hispanic women. Infertility patients have modest baseline knowledge of fertility and infertility treatment. The initial infertility visit can improve this knowledge and decrease both negative appraisals of treatment and anxiety levels. Differences in knowledge and appraisal were seen across ethnic groups and other demographic variables. Physicians should individualize patient counseling to improve patients' knowledge and provide realistic treatment

  18. Intensified secondary prevention intending a reduction of recurrent events in TIA and minor stroke patients (INSPiRE-TMS: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leistner Stefanie

    2013-01-01

    Full Text Available Abstract Background Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. Support programs with multifactorial risk factor modifications after stroke or TIA have not been investigated in large-scale prospective controlled trials so far. INSPiRE-TMS is a prospective, multi-center, randomized open intervention trial for intensified secondary prevention after minor stroke and TIA. Methods/design Patients with acute TIA or minor stroke admitted to the participating stroke centers are screened and recruited during in-hospital stay. Patients are randomised in a 1:1 ratio to intervention (support program and control (usual care arms. Inclusion of 2.082 patients is planned. The support program includes cardiovascular risk factor measurement and feedback, monitoring of medication adherence, coaching in lifestyle modifications, and active involvement of relatives. Standardized motivational interviewing is used to assess and enhance patients’ motivation. Primary objective is a reduction of new major vascular events defined as nonfatal stroke and myocardial infarction or vascular death. Recruitment time is planned for 3.5 years, follow up time is at least 2 years for every patient resulting in a total study time of 5 years (first patient in to last patient out. Discussion Given the high risk for vascular re-events in acute stroke and the available effective strategies in secondary prevention, the INSPIRE-TMS support program has the potential to lead to a relevant reduction of recurrent events and a prolongation of the event-free survival time. The trial will provide the basis for the decision whether an intensified secondary prevention program after stroke should be implemented into regular care. A cost-effectiveness evaluation will be performed. Trial registration clinicaltrials.gov: 01586702

  19. Atorvastatin reduces the risk of cardiovascular events in patients with carotid atherosclerosis: a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Sillesen, H.; Amarenco, P.; Hennerici, M.G.

    2008-01-01

    BACKGROUND AND PURPOSE: The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found that treatment with atorvastatin 80 mg per day reduced the risk of stroke and cardiovascular events in patients with a recent transient ischemic attack (TIA) or stroke. We hypothesized...... this benefit would be greatest in the subgroup of patients with carotid stenosis. METHODS: The SPARCL trial randomized patients with TIA or stroke within 1 to 6 months without known coronary heart disease (CHD) and low-density lipoprotein cholesterol 100 to 190 mg/dL to treatment with atorvastatin 80 mg per...

  20. Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs.

    Science.gov (United States)

    Chaibi, Aleksander; Benth, J Rat Šaltyt; Tuchin, Peter J; Russell, Michael Bjørn

    2017-06-01

    Unlike pharmacological randomized controlled trials (RCTs), manual-therapy RCTs do not always report adverse events (AEs). The few manual-therapy RCTs that provide information on AEs are frequently without details, such as the type and-, severity of the AE and reason for withdrawal. To prospectively report all AEs in a chiropractic spinal manipulative therapy (CSMT) RCT. A prospective 3-armed, single-blinded, placebo, RCT. Seventy migraineurs were randomized to the CSMT or a placebo, with 12 intervention sessions over three months. The recommendations by CONSORT and the International Headache Society's Task Force on AEs in migraine RCTs were followed. A standardized reporting scheme designed for pharmacological RCTs was used, and the AEs were described as frequencies and percentages within each group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of AEs in each group were calculated when possible. Attributable risk (%) and relative risk were calculated with the corresponding 95% CIs. AEs were assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the CSMT group and the placebo group, respectively, and tiredness on the intervention day was reported by 8.5% and 1.4% of CSMT group and the placebo group, respectively. The highest attributable risk was for tiredness on the treatment day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0). AEs were mild and transient, and severe or serious AEs were not observed. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials.

    Science.gov (United States)

    Sheffet, Alice J; Howard, George; Sam, Albert; Jamil, Zafar; Weaver, Fred; Chiu, David; Voeks, Jenifer H; Howard, Virginia J; Hughes, Susan E; Flaxman, Linda; Longbottom, Mary E; Brott, Thomas G

    2018-01-01

    We report patient enrollment and retention by race and ethnicity in the CREST (Carotid Revascularization Endarterectomy Versus Stent Trial) and assess potential effect modification by race/ethnicity. In addition, we discuss the challenge of detecting differences in study outcomes when subgroups are small and the event rate is low. We compared 2502 patients by race, ethnicity, baseline characteristics, and primary outcome (any periprocedural stroke, death, or myocardial infarction and subsequent ipsilateral stroke up to 10 years). Two hundred forty (9.7%) patients were minority by race (6.1%) or ethnicity (3.6%); 109 patients (4.4%) were black, 32 (1.3%) Asian, 2332 (93.4%) white, 11 (0.4%) other, and 18 (0.7%) unknown. Ninety (3.6%) were Hispanic, 2377 (95%) non-Hispanic, and 35 (1.4%) unknown. The rate of the primary end point for all patients was 10.9%±0.9% at 10 years and did not differ by race or ethnicity (Pinter>0.24). The proportion of minorities recruited to CREST was below their representation in the general population, and retention of minority patients was lower than for whites. Primary outcomes did not differ by race or ethnicity. However, in CREST (like other studies), the lack of evidence of a racial/ethnic difference in the treatment effect should be interpreted with caution because of low statistical power to detect such a difference. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732. © 2017 American Heart Association, Inc.

  2. Minimizing adverse events while maintaining clinical improvement in a pediatric attention-deficit/hyperactivity disorder crossover trial with dextroamphetamine and methylphenidate.

    Science.gov (United States)

    Ramtvedt, Bjørn E; Aabech, Henning S; Sundet, Kjetil

    2014-04-01

    The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial. Thirty-six medication-naïve children 9-14 years of age, diagnosed with ADHD, were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and a placebo in a randomly assigned, counterbalanced sequence. Barkley's Side-Effect Rating Scale (SERS), rated by parents, was used to assess adverse events. SERS were available for 34 children, and data were analyzed both at the group and the single-subject level. The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level. Overall, insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo. No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms. Furthermore, dextroamphetamine and methylphenidate did not differ from each other on any SERS item, except that dextroamphetamine was associated with higher severity of "insomnia" and a higher prevalence of "unusually happy." Single-subject analyses showed that one or more adverse events were reported in 14 children (41%), and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ("best drug") and those with methylphenidate as their best drug. Among children in whom both stimulants were associated with a decrease in ADHD symptoms, a clinically valid difference between the two stimulants in total adverse events score was found in 7 (39%) of the 18 cases. In these children, the availability of both stimulants provided an opportunity to minimize adverse events, while maintaining a reduction in ADHD symptoms. The availability of both dextroamphetamine and methylphenidate

  3. 30 CFR 882.12 - Appraisals.

    Science.gov (United States)

    2010-07-01

    ...)(2) of this section shall be made to determine if the increase in value as originally appraised has... unreclaimed. If the updated appraised value results in lower increase in value, such increase shall be used as...

  4. Introducing the event related fixed interval area (ERFIA) multilevel technique: a method to analyze the complete epoch of event-related potentials at single trial level

    NARCIS (Netherlands)

    Vossen, C.J.; Vossen, H.G.M.; Marcus, M.A.E.; van Os, J.; Lousberg, R.

    2013-01-01

    In analyzing time-locked event-related potentials (ERPs), many studies have focused on specific peaks and their differences between experimental conditions. In theory, each latency point after a stimulus contains potentially meaningful information, regardless of whether it is peak-related. Based on

  5. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Saito, Yoshihiko; Okada, Sadanori; Ogawa, Hisao; Soejima, Hirofumi; Sakuma, Mio; Nakayama, Masafumi; Doi, Naofumi; Jinnouchi, Hideaki; Waki, Masako; Masuda, Izuru; Morimoto, Takeshi

    2017-02-14

    The long-term efficacy and safety of low-dose aspirin for primary prevention of cardiovascular events in patients with type 2 diabetes mellitus are still inconclusive. The JPAD trial (Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes) was a randomized, open-label, standard care-controlled trial examining whether low-dose aspirin affected cardiovascular events in 2539 Japanese patients with type 2 diabetes mellitus and without preexisting cardiovascular disease. Patients were randomly allocated to receive aspirin (81 or 100 mg daily; aspirin group) or no aspirin (no-aspirin group) in the JPAD trial. After that trial ended in 2008, we followed up with the patients until 2015, with no attempt to change the previously assigned therapy. Primary end points were cardiovascular events, including sudden death, fatal or nonfatal coronary artery disease, fatal or nonfatal stroke, and peripheral vascular disease. For the safety analysis, hemorrhagic events, consisting of gastrointestinal bleeding, hemorrhagic stroke, and bleeding from any other sites, were also analyzed. The primary analysis was conducted for cardiovascular events among patients who retained their original allocation (a per-protocol cohort). Analyses on an intention-to-treat cohort were conducted for hemorrhagic events and statistical sensitivity. The median follow-up period was 10.3 years; 1621 patients (64%) were followed up throughout the study; and 2160 patients (85%) retained their original allocation. Low-dose aspirin did not reduce cardiovascular events in the per-protocol cohort (hazard ratio, 1.14; 95% confidence interval, 0.91-1.42). Multivariable Cox proportional hazard model adjusted for age, sex, glycemic control, kidney function, smoking status, hypertension, and dyslipidemia showed similar results (hazard ratio, 1.04; 95% confidence interval, 0.83-1.30), with no heterogeneity of efficacy in subgroup analyses stratified by each of these factors (all interaction P>0

  6. Exploiting the intra-subject latency variability from single-trial event-related potentials in the P3 time range: A review and comparative evaluation of methods.

    Science.gov (United States)

    Ouyang, Guang; Hildebrandt, Andrea; Sommer, Werner; Zhou, Changsong

    2017-04-01

    The intra-subject variability (ISV) in brain responses during cognitive processing across experimental trials has been recognised as an important facet of neural functionality reflecting an intrinsic neurophysiological characteristic of the brain. In recent decades, ISV in behaviour has been found to be significantly associated with cognitive functioning varying across individuals, development, ages, and pathological conditions. Event-related potentials (ERPs) measured in single trials are important tools for characterizing ISV at the neural level. However, due to the overlapping spectra of noise and signals, the retrieval of information from single-trial ERPs related to cognitive processing has been a challenge. We review the major problems that researchers face in the estimation of ISV in single-trial ERPs. Then, we present an extensive evaluation of several methods of single-trial latency estimation based on both simulated and real data. The relationships of ISV in ERPs and reaction times are compared between the different single-trial methods to assess their relative efficiency in predicting task performance from neural signals. The pros and cons of the methods are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Evaluation Of Performance Appraisal In PT. Xyz

    OpenAIRE

    Tenges, Yuan Y.N

    2013-01-01

    Managing employee's performance is imperative and it cannot be done if the employee's potential and their ability to perform are not measured. Performance appraisal is a management tool that tries to count the employee's performance. The term performance appraisal refers to the process by which an individual's work performance is assessed. Research objective is to evaluate the performance appraisal in PT. XYZ. Performance appraisal is a process in which organizations evaluate or assess employ...

  8. Competitive Strategy, Performance Appraisal and Firm Results

    OpenAIRE

    Bayo-Moriones, Alberto; Galdon-Sanchez, Jose Enrique; Martinez-de-Morentin, Sara

    2016-01-01

    In this study, we address the relationship between performance appraisal and competitive strategy, as well as the impact of this relationship on firm performance. The results indicate that the adoption of developmental performance appraisal and the use of administrative performance appraisal are higher among firms that pursue differentiation strategies compared to those competing on costs. Regarding firm performance, the interaction between a developmental appraisal system and a quality strat...

  9. Theoretical approaches to employee appraisal methods

    OpenAIRE

    Šalková, Andrea

    2013-01-01

    Performance appraisal is the most important process of HR management in an organization. Regular employee appraisal can reveal the status of their performance and it also provides information necessary for any further operation of the organization, eventually its development. To have this information correct, it is important to choose the appropriate procedure used for employee appraisal. There are many performance appraisal methods available for various situations. However, none of them appr...

  10. How to perform a critically appraised topic: part 2, appraise, evaluate, generate, and recommend.

    Science.gov (United States)

    Kelly, Aine Marie; Cronin, Paul

    2011-11-01

    This article continues the discussion of a critically appraised topic started in Part 1. A critically appraised topic is a practical tool for learning and applying critical appraisal skills. This article outlines steps 4-7 involved in performing a critically appraised topic for studies of diagnostic tests: Appraise, Appraise the literature; Evaluate, evaluate the strength of the evidence from the literature; Generate, generate graphs of conditional probability; and Recommend, draw conclusions and make recommendations. For steps 4-7 of performing a critically appraised topic, the main study results are summarized and translated into clinically useful measures of accuracy, efficacy, or risk.

  11. 36 CFR 254.9 - Appraisals.

    Science.gov (United States)

    2010-07-01

    ... Acquisition Conference 1992 (Washington, DC, 1992), ISBN 0-16-038050-2 when appraising the values of the..., impartial, and has training and experience in appraising property similar to the property involved in the...: (i) Determine the highest and best use of the property to be appraised; (ii) Estimate the value of...

  12. Appraisal and Selection for Digital Curation

    Directory of Open Access Journals (Sweden)

    Jinfang Niu

    2014-10-01

    Full Text Available Based on existing appraisal/selection policies in libraries, archives, museum, social science and science data centers, this paper presents a generic appraisal/selection framework for digital curation. In presenting this framework, the author discusses how archival appraisal theories, methods, and criteria adapt to the general digital curation context.

  13. 5 CFR 9901.411 - Appraisal period.

    Science.gov (United States)

    2010-01-01

    ... period, an employee has not met the minimum period of performance, management may extend the appraisal... PERSONNEL SYSTEM (NSPS) Performance Management § 9901.411 Appraisal period. (a) Except as provided in... groups of employees; (2) The appraisal period may begin after October 1 for employees who move to an NSPS...

  14. Effects of candesartan in acute stroke on vascular events during long-term follow-up: results from the Scandinavian Candesartan Acute Stroke Trial (SCAST).

    Science.gov (United States)

    Hornslien, Astrid G; Sandset, Else C; Igland, Jannicke; Terént, Andreas; Boysen, Gudrun; Bath, Philip M W; Murray, Gordon D; Berge, Eivind

    2015-08-01

    Randomized-controlled trials have shown no beneficial short-term effects of blood pressure lowering treatment in the acute phase of stroke. We aimed to see whether blood pressure lowering treatment with candesartan in the acute phase can lead to benefits that become apparent over a longer period of follow-up. The Scandinavian Candesartan Acute Stoke Trial was a randomized- and placebo-controlled trial of candesartan in 2,029 patients with acute stroke and systolic blood pressure ≥140 mmHg. Trial treatment was given for seven-days, and the primary follow-up period was six-months. We have used the national patient registries and the cause of death registries in the Scandinavian countries to collect data on vascular events and deaths up to three-years from randomization. The primary end-point was the composite of stroke, myocardial infarction, or vascular death, and we used Cox proportional hazards regression model for analysis. Long-term data were available for 1,256 of the 1,286 patients (98%) from Scandinavia. The risk of the primary composite end-point did not differ significantly between the groups (candesartan 178/632 events, placebo 203/624 events, hazard ratio = 0·87, 95% confidence interval 0·71-1·07). There were also no statistically significant differences for the secondary end-points stroke and all-cause death, or in any of the pre-specified subgroups. Treatment with candesartan in the acute phase of stroke was not associated with clear long-term clinical benefits. This result supports the conclusion from trials with short-term follow-up, that blood pressure lowering treatment with candesartan should not be given routinely to patients with acute stroke and raised blood pressure. © 2015 World Stroke Organization.

  15. Prolonged dual antiplatelet therapy after percutaneous coronary intervention reduces ischemic events without affecting the need for repeat revascularization: insights from the CREDO trial.

    Science.gov (United States)

    Brener, Sorin J; Steinhubl, Steven R; Berger, Peter B; Brennan, Danielle M; Topol, Eric J

    2007-07-01

    Dual antiplatelet therapy reduces ischemic events after percutaneous coronary intervention (PCI) and in patients with acute coronary syndromes. The relationship between target vessel revascularization (TVR) and ischemic events in patients treated with aspirin and clopidogrel or aspirin alone from 1 month to 1 year after PCI has not been studied. Patients enrolled in the CREDO trial were treated with aspirin and clopidogrel or aspirin and placebo for up to 1 year. We compared the rates of TVR and ischemic events (cardiac death, myocardial infarction or stroke) in the two groups, and modeled the effect of clopidogrel treatment on ischemic events after adjusting for relevant parameters. RESULTS One month after PCI, 1,955 patients have remained asymptomatic. By 1 year, ischemic events occurred in 5.3% of placebo- and 3.1% of clopidogrel-treated patients; p = 0.02. The rate of TVR was 11.9% and 12.2%, respectively; p = 0.82. Only 7 patients (clopidogrel: 3 and placebo: 4) experienced TVR within 7 days of an ischemic event. After adjustment, long-term dual antiplatelet therapy was associated with a 48% reduction in events; p = 0.01. Patients who experienced TVR had a significantly higher rate of ischemic events than those without TVR, regardless of treatment assignment: 12.3% vs. 3.1%, respectively; p < 0.001. Thus, after successful PCI, prolonged dual antiplatelet therapy reduces ischemic events without affecting TVR. Overall, patients with TVR experienced an ischemic event much more often that was not related to the PCI vessel. This suggests that the benefit of antiplatelet therapy after coronary revascularization is indexed to the patient's underlying atherothrombotic process, rather than the artery that underwent intervention.

  16. Exercise and Motor Training in People with Parkinson's Disease: A Systematic Review of Participant Characteristics, Intervention Delivery, Retention Rates, Adherence, and Adverse Events in Clinical Trials

    Directory of Open Access Journals (Sweden)

    Natalie E. Allen

    2012-01-01

    Full Text Available There is research evidence that exercise and motor training are beneficial for people with Parkinson's disease (PD, and clinicians seek to implement optimal programs. This paper summarizes important factors about the nature and reporting of randomized controlled trials of exercise and/or motor training for people with PD which are likely to influence the translation of research into clinical practice. Searches identified 53 relevant trials with 90 interventions conducted for an average duration of 8.3 (SD 4.2 weeks. Most interventions were fully supervised (74% and conducted at a facility (79%. Retention rates were high with 69% of interventions retaining ≥85% of their participants; however adherence was infrequently reported, and 72% of trials did not report adverse events. Overall, the labor-intensive nature of most interventions tested in these trials and the sparse reporting of adherence and adverse events are likely to pose difficulties for therapists attempting to balance benefits and costs when selecting protocols that translate to sustainable clinical practice for people with PD.

  17. Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial.

    Science.gov (United States)

    Nissen, Steven E; Wolski, Kathy E; Prcela, Lisa; Wadden, Thomas; Buse, John B; Bakris, George; Perez, Alfonso; Smith, Steven R

    2016-03-08

    Few cardiovascular outcomes trials have been conducted for obesity treatments. Withdrawal of 2 marketed drugs has resulted in controversy about the cardiovascular safety of obesity agents. To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction) compared with placebo in overweight and obese patients. Randomized, multicenter, placebo-controlled, double-blind noninferiority trial enrolling 8910 overweight or obese patients at increased cardiovascular risk from June 13, 2012, to January 21, 2013, at 266 US centers. After public release of confidential interim data by the sponsor, the academic leadership of the study recommended termination of the trial and the sponsor agreed. An Internet-based weight management program was provided to all participants. Participants were randomized to receive placebo (n=4454) or naltrexone, 32 mg/d, and bupropion, 360 mg/d (n=4456). Time from randomization to first confirmed occurrence of a MACE. The primary analysis planned to assess a noninferiority hazard ratio (HR) of 1.4 after 378 expected events, with a confidential interim analysis after approximately 87 events (25% interim analysis) to assess a noninferiority HR of 2.0 for consideration of regulatory approval. Among the 8910 participants randomized, mean age was 61.0 years (SD, 7.3 years), 54.5% were female, 32.1% had a history of cardiovascular disease, and 85.2% had diabetes, with a median body mass index of 36.6 (interquartile range, 33.1-40.9). For the 25% interim analysis, MACE occurred in 59 placebo-treated patients (1.3%) and 35 naltrexone-bupropion-treated patients (0.8%; HR, 0.59; 95% CI, 0.39-0.90). After 50% of planned events, MACE occurred in 102 patients (2.3%) in the placebo group and 90 patients (2.0%) in the naltrexone-bupropion group (HR, 0.88; adjusted 99.7% CI, 0.57-1.34). Adverse effects were more common in the

  18. Exploring trauma associated appraisals in trauma survivors from collectivistic cultures.

    Science.gov (United States)

    Engelbrecht, Alberta; Jobson, Laura

    2016-01-01

    Appraisals are a key feature in understanding an individual's experience; this is especially important when the experience is a traumatic one. However, research is diminutive when looking at the interaction between trauma appraisals and culture in relation to posttraumatic stress disorder using qualitative methodologies. This study explored cultural differences in perceptions and appraisals of trauma using three qualitative focus groups with community members (n = 11) from collectivistic cultures who had experienced a traumatic event and three qualitative individual key informant interviews with mental health practitioners (n = 3) routinely working with trauma survivors. Using template analysis, eight emergent themes were highlighted from the data sets [(1) trauma and adjustment; (2) cultural and social roles; (3) traumatised self; (4) relationships; (5) external attribution; (6) future; (7) education; (8) language] that potentially have significant consequences for posttrauma psychological adjustment and recovery. Cumulatively, while a number of themes are similar to that which is emphasised in current literature (e.g. damaged self, negative appraisals of the world, others, future) a number of themes were also resonant and warrant further scrutiny. For instance, the importance and interconnectedness of the group to the individual and the impact trauma has on this; the importance of social roles, cultural appropriateness and violations of cultural values and norms; findings and implications are discussed.

  19. How to critically appraise the clinical literature.

    Science.gov (United States)

    Cronin, Paul; Rawson, James V; Heilbrun, Marta E; Lee, Janie M; Kelly, Aine M; Sanelli, Pina C; Bresnahan, Brian W; Paladin, Angelisa M

    2014-09-01

    Recent efforts have been made to standardize the critical appraisal of clinical health care research. In this article, critical appraisal of diagnostic test accuracy studies, screening studies, therapeutic studies, systematic reviews and meta-analyses, cost-effectiveness studies, recommendations and/or guidelines, and medical education studies is discussed as are the available instruments to appraise the literature. By having standard appraisal instruments, these studies can be appraised more easily for completeness, bias, and applicability for implementation. Appraisal requires a different set of instruments, each designed for the individual type of research. We also hope that this article can be used in academic programs to educate the faculty and trainees of the available resources to improve critical appraisal of health research. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

  20. Psychological impact of health risk appraisal of Korean women at different levels of breast cancer risk: neglected aspect of the web-based cancer risk assessment tool.

    Science.gov (United States)

    Kye, Su Yeon; Park, Keeho; Park, Hyeong Geun; Kim, Myung-hyun

    2012-01-01

    Health risk appraisal is often utilized to modify individual's health behavior, especially concerning disease prevention, and web-based health risk appraisal services are being provided to the general public in Korea. However, little is known about the psychological effect of the health risk appraisal even though poorly communicated information by the web-based service may result in unintended adverse health outcomes. This study was conducted to explore the psychological effect of health risk appraisal using epidemiological risk factor profile. We conducted a randomized trial comparing risk factor list type health risk appraisal and risk score type health risk appraisal. We studied 60 women aged 30 years and older who had no cancer. Anxiety level was assessed using the Spielberger State-Trait Anxiety Inventory YZ. The results of multivariate analysis showed that risk status was the independent predictors of increase of state anxiety after health risk appraisal intervention when age, education, health risk appraisal type, numeracy, state anxiety, trait anxiety, and health risk appraisal type by risk status interaction was adjusted. Women who had higher risk status had an odd of having increased anxiety that was about 5 times greater than women who had lower risk status. Our findings indicate that communicating the risk status by individual health risk appraisal service can induce psychological sequelae, especially in women having higher risk status. Hospitals, institutes, or medical schools that are operating or planning to operate the online health risk appraisal service should take side effects such as psychological sequelae into consideration.

  1. Baseline characteristics and event rates among anticoagulated patients with atrial fibrillation in practice and pivotal NOAC trials

    Directory of Open Access Journals (Sweden)

    Peter A. Noseworthy

    2017-10-01

    Full Text Available The data report details the baseline characteristics and observed outcomes among patients included in a large US administrative claims database (Optum Labs Data Warehouse and those enrolled in the pivotal phase III clinical trials examining apixaban, dabigratan, edoxaban and rivaroxaban versus warfarin for the prevention of cardio embolism (Granger et al., 2011; Cannolly et al., 2009; Patel et al., 2011; Giugliano et al., 2013 [1–4]. These data are to be interpreted in the context of the linked publication (Noseworthy et al., 2017 [5]. These data illustrate baseline characteristics in patients treated in routine practice and those enrolled in clinical trials. For instance, patients treated with apixaban in practice tended to be slightly older and we more likely to be female than those enrolled in the apixaban clinical trial. Patient treated with rivaroxaban in practice tended to have lower CHADS2 scores than those included in the rivaroxaban clinical trial. Overall, and stratified by baseline CHADS2 scores, patients treated with NOACs in routine practice had comparable or slightly lower stroke risks than those in the clinical trials. Patients treated with NOACs in routine practice had slightly higher bleeding risk in practice, particularly in high-risk patients with CHADS2 ≥ 3, compared to those in the clinical trials. These data may serve as a benchmark for realized outcomes among anticoagulated patients with atrial fibrillation in the United States and may serve as a useful comparison to other datasets or countries.

  2. Anemia predicts thromboembolic events, bleeding complications and mortality in patients with atrial fibrillation : insights from the RE-LY trial

    NARCIS (Netherlands)

    Westenbrink, B. D.; Alings, M.; Connolly, S. J.; Eikelboom, J.; Ezekowitz, M. D.; Oldgren, J.; Yang, S.; Pongue, J.; Yusuf, S.; Wallentin, L.; van Gilst, W. H.

    BackgroundAnemia may predispose to thromboembolic events or bleeding in anticoagulated patients with atrial fibrillation (AF). ObjectivesTo investigate whether anemia is associated with thromboembolic events and bleeding in patients with AF. Patients and methodsWe retrospectively analyzed the RE-LY

  3. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Tepel, Martin; van der Giet, Markus; Statz, Mario

    2003-01-01

    Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown.......Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown....

  4. Effects of blood-pressure-lowering treatment in hypertension: 9. Discontinuations for adverse events attributed to different classes of antihypertensive drugs: meta-analyses of randomized trials.

    Science.gov (United States)

    Thomopoulos, Costas; Parati, Gianfranco; Zanchetti, Alberto

    2016-10-01

    Choice of antihypertensive drugs is also based on the expected burden of adverse events associated with each class of agents, and we have recently identified treatment discontinuation for adverse events as a measure of treatment tolerability frequently reported in randomized controlled trials (RCTs). To investigate whether all classes of blood pressure (BP) lowering drugs increase discontinuations for adverse events when compared with placebo and whether risk of discontinuation is similar for all classes when compared in head-to-head RCTs. RCTs of BP-lowering treatment were subdivided in groups according to class of drug compared with placebo or with other classes. Risk ratios and 95% confidence intervals of major cardiovascular events and of treatment discontinuations for adverse events were calculated (random-effects model). Thirty-eight placebo-controlled RCTs (147 788 patients) and 37 head-to-head RCTs (242 481 patients) provided comparative information on discontinuations for adverse events. All classes of drugs significantly increased discontinuations for adverse events over those occurring on placebo: risk ratio diuretics 2.23 (1.32-3.76), beta-blockers 2.88 (1.58-5.28), calcium antagonists 2.03 (1.17-3.56), angiotensin-converting enzyme inhibitors 2.78 (1.37-5.47), central agents 1.74 (1.24-2.45), with the single exception of angiotensin receptor blockers, which did not significantly increase adverse events over placebo [risk ratio 1.13 (0.78-1.62)]. Similarly, in head-to-head comparison RCTs with other classes, angiotensin receptor blockers were the only class associated with a significantly lower risk of adverse events [risk ratio 0.71 (0.58-0.87)] when head-to-head compared with other classes. Regression analysis also shows that incidence of discontinuations for adverse events is proportional to the number of antihypertensive and other cardiovascular drugs, which accounts for the high incidence of this outcome often found in groups randomized to

  5. Adverse events analysis as an educational tool to improve patient safety culture in primary care: A randomized trial

    Directory of Open Access Journals (Sweden)

    Ramil-Hermida Luis

    2011-06-01

    Full Text Available Abstract Background Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following: - Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia. - Find and analyze educational tools to improve patient safety culture in primary care. - Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Design and methods Design Experimental unifactorial study of two groups, control and intervention. Study population Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. Sample From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Intervention Residents and their respective tutor (tutor-resident pair in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group-either intervention or control-through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent

  6. Effect of verapamil on mortality and major events after acute myocardial infarction (the Danish Verapamil Infarction Trial II--DAVIT II)

    DEFF Research Database (Denmark)

    1990-01-01

    The effect of verapamil on death and major events (i.e., death or reinfarction) after an acute myocardial infarction was studied in a double-blind, randomized, placebo-controlled multicenter trial. Eight hundred seventy-eight patients started treatment with verapamil, 360 mg/day, and 897 patients.......79, hazard ratio, 1.05; 95% confidence limits, 0.72 to 1.54), and major event rates 24.9 and 24.9% (p = 1.0, hazard ratio 0.98; 95% confidence limits 0.72 to 1.39). Long-term treatment with verapamil after an acute myocardial infarction caused a significant reduction in major events, and the positive effect...... with placebo. Treatment started in the second week after admission and continued for up to 18 months (mean 16 months). Ninety-five deaths and 146 major events occurred in the verapamil group and 119 deaths and 180 major events in the placebo group. The 18-month mortality rates were 11.1 and 13.8% (p = 0...

  7. Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution.

    Science.gov (United States)

    Oquendo, Maria A; Feldman, Sarah; Silverman, Emily; Currier, Dianne; Brown, Gregory K; Chen, Donna; Chiapella, Page; Fischbach, Ruth; Gould, Madelyn; Stanley, Barbara; Strauss, David; Zelazny, Jamie; Pearson, Jane

    2011-01-01

    Adverse events (AEs) and serious adverse events (SAEs) are important outcomes of any intervention study yet are under-researched. Vague and variable definitions and substantial underreporting make comparisons of risk between studies difficult and evaluation of the safety of a particular intervention almost impossible. These realities may deter researchers from studying at-risk populations. Suicidal behavior is an adverse event in any study, and potentially a very serious one. Thus the issues of reporting and definition are particularly salient for researchers who work with populations at risk for suicidal behavior, especially when the suicidal behavior is the outcome of interest. We conducted a qualitative study with experienced suicide researchers and intervention experts to delineate the issues related to reporting serious adverse events faced by investigators conducting trials in suicide prevention. Participants from multiple sites were interviewed by phone, interviews transcribed and coded for definition and reporting issues and suggested solutions. A narrative synthesis was prepared and validated by all participants. Participants highlighted the difficulties in defining AEs and SAEs and stressed the importance and complexity of ensuring the AE was related to the study and reported properly, and were in agreement about the consequences of AEs to both institutions and individuals. Participants identified the need for the development of clear and consistent AE definitions and reporting requirements. Clear and consistently applied definitions of adverse and serious adverse events and reporting requirements would enhance the comparability of intervention studies in suicidal populations.

  8. Comparative Safety and Neuropsychiatric Adverse Events Associated With Efavirenz Use in First-Line Antiretroviral Therapy: A Systematic Review and Meta-Analysis of Randomized Trials.

    Science.gov (United States)

    Ford, Nathan; Shubber, Zara; Pozniak, Anton; Vitoria, Marco; Doherty, Meg; Kirby, Catherine; Calmy, Alexandra

    2015-08-01

    Efavirenz (EFV) is widely used for the treatment of antiretroviral-naive HIV-positive individuals, but there are concerns about the risk of adverse neuropsychiatric events. We systematically reviewed the safety of EFV in first-line therapy. Four databases were searched until October 2014 for randomized trials comparing EFV against non-EFV-based regimens for the treatment of antiretroviral-naive HIV-positive adults and children. The primary outcome was drug discontinuation as a result of any adverse event. Relative risks and proportions were pooled using random-effects meta-analysis. Forty-two trials were included for review. A lower relative and absolute risk of discontinuations due to adverse drug reactions was seen with EFV compared to nevirapine. The relative and absolute risk of discontinuation was greater for EFV compared with low-dose EFV, rilpivirine, tenofovir, atazanavir, and maraviroc. The relative risk of discontinuation was greater for EFV compared with dolutegravir and raltegravir, but absolute risks were not significantly different. There was no difference in the risk of any severe clinical adverse events for any comparison. With the exception of dizziness, fewer than 10% of patients exposed to EFV experienced any other specific type of neuropsychiatric event. No suicides were reported. This review found that over 90% of patients remained on an EFV-based first-line regimen after an average follow-up time of 78 weeks. The relative risk of discontinuations due to adverse events was higher for EFV compared with most other first-line options, but absolute differences were less than 5% for all comparisons.

  9. Secondary prevention of new vascular events with lifestyle intervention in patients with noncardioembolic mild ischemic stroke: a single-center randomized controlled trial.

    Science.gov (United States)

    Kono, Yuji; Yamada, Sumio; Yamaguchi, Junko; Hagiwara, Yuta; Iritani, Naoki; Ishida, Shimpei; Araki, Amane; Hasegawa, Yasuhiro; Sakakibara, Hisataka; Koike, Yasuo

    2013-01-01

    Lifestyle modification is associated with a substantially decreased risk of cardiovascular events. However, the role of lifestyle intervention for secondary prevention in patients with noncardioembolic ischemic stroke is inadequately defined. We assessed the hypothesis that lifestyle intervention can reduce the onset of new vascular events in patients with noncardioembolic mild ischemic stroke. We conducted an observer-blind randomized controlled trial that enrolled 70 patients (48 men, mean age 63.5 years) with acute noncardioembolic mild ischemic stroke. The patients were allocated in equal numbers to a lifestyle intervention group or a control group. We performed lifestyle interventions, which comprised exercise training, salt restriction and nutrition advice for 24 weeks. Then all patients were prospectively followed up for occurrence of the primary endpoints, including hospitalization due to stroke recurrence and the onset of other vascular events. We also evaluated systolic blood pressure (SBP) at the clinic and at home, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), hemoglobin A1c (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) to compare the efficacy of the lifestyle interventions. This trial was terminated earlier than expected because of the prespecified early stopping rule for efficacy. After the 24-week intervention period, the intervention group showed a significant increase in daily physical activity and a significant decrease in salt intake (physical activity, p = 0.012; salt intake, p lifestyle intervention group experienced at least 1 vascular event. A sequential plans analysis indicated the superiority of the lifestyle intervention in interim analysis. Kaplan-Meier survival curves after the log-rank test showed a significant prognostic difference between the randomized groups (p = 0.005). Lifestyle intervention with appropriate medication is beneficial for reducing the incidence of new vascular

  10. Risk Analysis in Investment Appraisal

    OpenAIRE

    Savvides, Savvakis C.

    1994-01-01

    This paper was prepared for the purpose of presenting the methodology and uses of the Monte Carlo simulation technique as applied in the evaluation of investment projects to analyse and assess risk. The first part of the paper highlights the importance of risk analysis in investment appraisal. The second part presents the various stages in the application of the risk analysis process. The third part examines the interpretation of the results generated by a risk analysis application including ...

  11. Performance Management and Performance Appraisal

    OpenAIRE

    Mudříková, Zuzana

    2008-01-01

    The main objective of the bachelor's labour is to search and judge the rules and processes in the area of performance management and performance appraisal used in the company NOVACS, then to confront applied theory with used practise, to identify and to clear up advantages and disadvantages of apllied system of management performance and evaluation of employees, finally try to propose some right alternations and renewals.

  12. Factors influencing managers’ attitudes towards performance appraisal

    Directory of Open Access Journals (Sweden)

    Tanya du Plessis

    2017-01-01

    Full Text Available Orientation: Managers often have negative attitudes towards performance appraisal because of its problematic nature, which is influenced by political and social contextual factors. These negative attitudes lead to reduced employee support, inaccurate performance appraisal ratings and, consequently, negative employee perceptions of the performance appraisal process. This state of affairs necessitates a deeper understanding of the factors influencing managers’ attitudes towards performance appraisal.Research purpose: The purpose of this research was to gain a deeper understanding of the factors that influence managers’ attitudes towards performance appraisal.Motivation for the study: Previous research has confirmed the importance of performance appraisals in organisations. However, managers’ dislike of and aversion to performance appraisal impact negatively on the effectiveness of performance appraisal systems and ultimately the development and performance of employees.Research design, approach and method: An interpretivist qualitative study was adopted, utilising naïve sketches and in-depth interviews to collect data from eight managers, purposively selected. The data were analysed by using Tesch’s descriptive data analysis technique.Main findings: This study revealed that performance appraisal is fundamentally an uncomfortable and emotional process for managers, which results in their adopting defensive attitudes. Because of many uncertainties, managers do not always display the ability or readiness to conduct performance appraisals. The organisational context might place the individual manager in a position to distort employee ratings, which in turn negatively influences that manager’s attitude.Practical and managerial implications: This study provides insight into the present-day experience of managers in respect of performance appraisal and highlights the factors that influence their attitudes.Contribution: The insight gained from

  13. Aspirin for primary prevention of cardiovascular and all-cause mortality events in diabetes: updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Kunutsor, S K; Seidu, S; Khunti, K

    2017-03-01

    To evaluate the benefits and harms of aspirin for the primary prevention of cardiovascular disease and all-cause mortality events in people with diabetes by conducting a systematic review and meta-analysis. Randomized controlled trials of aspirin compared with placebo (or no treatment) in people with diabetes with no history of cardiovascular disease were identified from MEDLINE, EMBASE, Web of Science, the Cochrane Library and a manual search of bibliographies to November 2015. Study-specific relative risks with 95% CIs were aggregated using random effects models. A total of 10 randomized trials were included in the review. There was a significant reduction in risk of major adverse cardiovascular events: relative risk of 0.90 (95% CI 0.81-0.99) in groups taking aspirin compared with placebo or no treatment. Limited subgroup analyses suggested that the effect of aspirin on major adverse cardiovascular events differed by baseline cardiovascular disease risk, medication compliance and sex (P for interaction for all > 0.05).There was no significant reduction in the risk of myocardial infarction, coronary heart disease, stroke, cardiovascular mortality or all-cause mortality. Aspirin significantly reduced the risk of myocardial infarction for a treatment duration of ≤ 5 years. There were differences in the effect of aspirin by dosage and treatment duration on overall stroke outcomes (P for interaction for all diabetes who are at increased cardiovascular disease risk. © 2016 Diabetes UK.

  14. A Complex Systems Model Approach to Quantified Mineral Resource Appraisal

    Science.gov (United States)

    Gettings, M.E.; Bultman, M.W.; Fisher, F.S.

    2004-01-01

    For federal and state land management agencies, mineral resource appraisal has evolved from value-based to outcome-based procedures wherein the consequences of resource development are compared with those of other management options. Complex systems modeling is proposed as a general framework in which to build models that can evaluate outcomes. Three frequently used methods of mineral resource appraisal (subjective probabilistic estimates, weights of evidence modeling, and fuzzy logic modeling) are discussed to obtain insight into methods of incorporating complexity into mineral resource appraisal models. Fuzzy logic and weights of evidence are most easily utilized in complex systems models. A fundamental product of new appraisals is the production of reusable, accessible databases and methodologies so that appraisals can easily be repeated with new or refined data. The data are representations of complex systems and must be so regarded if all of their information content is to be utilized. The proposed generalized model framework is applicable to mineral assessment and other geoscience problems. We begin with a (fuzzy) cognitive map using (+1,0,-1) values for the links and evaluate the map for various scenarios to obtain a ranking of the importance of various links. Fieldwork and modeling studies identify important links and help identify unanticipated links. Next, the links are given membership functions in accordance with the data. Finally, processes are associated with the links; ideally, the controlling physical and chemical events and equations are found for each link. After calibration and testing, this complex systems model is used for predictions under various scenarios.

  15. Observed and predicted reduction of ischemic cardiovascular events in the Simvastatin and Ezetimibe in Aortic Stenosis trial

    DEFF Research Database (Denmark)

    Holme, Ingar; Boman, Kurt; Brudi, Philippe

    2010-01-01

    expected for the degree of lipid-lowering observed. This analysis investigated relations between changes in lipoprotein components (LCs), and ICE risk decrease in the SEAS trial in all patients, by severity of aortic stenosis (AS), and compared to results of other clinical trials. A total of 1,570 patients...... were assessed in all patients and in JV tertiles (3.3 m/s). Observed and predicted ICE risk decreases were compared by Cox model. Decreases in LCs after 1 year of ezetimibe plus simvastatin were associated with decreased ICE risk in all patients and in the 2 lower JV tertiles (p...

  16. Shallow water carbonate platforms (Late Aptian–Early Albian, Southern Apennines in the context of supraregional to global changes: re-appraisal of palaeoecological events as reflectors of carbonate factory response

    Directory of Open Access Journals (Sweden)

    A. Raspini

    2012-08-01

    Full Text Available This paper discusses the palaeoenvironmental significance of the "Orbitolina Level", the microbial carbonates and the Salpingoporella dinarica-rich deposits encased in the Aptian/Albian shallow water carbonate platform strata of Monte Tobenna and Monte Faito (Southern Italy. These facies show a peculiar field appearance due to their color and/or fossil content. In the shallow water carbonate strata, the Late Aptian "Orbitolina Level" was formed during a period of decreasing accommodation space. Microbial carbonates occur in different levels in the composite section. They reach their maximum thickness around the sequence boundaries just above the "Orbitolina Level" and close to the Aptian–Albian transition, and were not deposited during maximum flooding. S. dinarica-rich deposits occur in the lower part of the Monte Tobenna-Monte Faito composite section, in both restricted and more open lagoonal sediments. S. dinarica has its maximum abundance below the "Orbitolina Level" and disappears 11 m above this layer.

    On the basis of δ13C and δ18O values recorded at Tobenna-Faito, the succession has been correlated to global sea-level changes and to the main volcanic and climatic events during the Aptian. Deterioration of the inner lagoon environmental conditions was related to high trophic levels triggered by volcano-tectonic activity. Microbial carbonates were deposited especially in periods of third-order sea level lowering. In such a scenario, periods of increased precipitation during the Gargasian induced the mobilization of clay during flooding of the exposed platform due to high-frequency sea-level changes, with consequent terrigenous input to the lagoon. This and the high nutrient levels made the conditions unsuitable for the principle carbonate producers, and an opportunistic biota rich in orbitolinids (Mesorbitolina texana and M. parva populated the platform. In the more open

  17. Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative.

    Science.gov (United States)

    Reeve, Bryce B; McFatrich, Molly; Pinheiro, Laura C; Weaver, Meaghann S; Sung, Lillian; Withycombe, Janice S; Baker, Justin N; Mack, Jennifer W; Waldron, Mia K; Gibson, Deborah; Tomlinson, Deborah; Freyer, David R; Mowbray, Catriona; Jacobs, Shana; Palma, Diana; Martens, Christa E; Gold, Stuart H; Jackson, Kathryn D; Hinds, Pamela S

    2017-03-01

    Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. From seven pediatric research hospitals, children/adolescents ages 7-15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive interviews with retrospective probing were completed with children in the age groups of 7-8, 9-12, and 13-15 years. The children/adolescents and proxies were interviewed independently. Two rounds of interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as "very easy" or "somewhat easy" and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive. © 2016 Wiley Periodicals, Inc.

  18. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review.

    Science.gov (United States)

    Melloni, Chiara; Washam, Jeffrey B; Jones, W Schuyler; Halim, Sharif A; Hasselblad, Victor; Mayer, Stephanie B; Heidenfelder, Brooke L; Dolor, Rowena J

    2015-01-01

    Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety of concomitant use of PPIs and DAPT in the postdischarge treatment of unstable angina/non-ST-segment-elevation myocardial infarction patients. We searched for clinical studies in MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews, from 1995 to 2012. Reviewers screened and extracted data, assessed applicability and quality, and graded the strength of evidence. We performed meta-analyses of direct comparisons when outcomes and follow-up periods were comparable. Thirty-five studies were eligible. Five (4 randomized controlled trials and 1 observational) assessed the effect of omeprazole when added to DAPT; the other 30 (observational) assessed the effect of PPIs as a class when compared with no PPIs. Random-effects meta-analyses of the studies assessing PPIs as a class consistently reported higher event rates in patients receiving PPIs for various clinical outcomes at 1 year (composite ischemic end points, all-cause mortality, nonfatal MI, stroke, revascularization, and stent thrombosis). However, the results from randomized controlled trials evaluating omeprazole compared with placebo showed no difference in ischemic outcomes, despite a reduction in upper gastrointestinal bleeding with omeprazole. Large, well-conducted observational studies of PPIs and randomized controlled trials of omeprazole seem to provide conflicting results for the effect of PPIs on cardiovascular outcomes when coadministered with DAPT. Prospective trials that directly compare pharmacodynamic parameters and clinical events among specific PPI agents in patients with unstable angina/non-ST-segment-elevation myocardial infarction treated with DAPT are warranted. © 2015 American Heart Association, Inc.

  19. The Power of Developmental Performance Appraisal

    Directory of Open Access Journals (Sweden)

    Nasser Salim Alghanabousi

    2013-02-01

    Full Text Available Development of employee performance is a must that any organization should take into account to be a successful in achieving its goals. However, the tools of developing that performance are varying based on the type of the organization and the nature of the work performed. Performance appraisal is one of the effective tools that help the organization to measure the accomplishment of its goals, if implemented effectively. In education, it became evident that performance appraisal of educators is an essential element of the development of any educational institution. To make the performance appraisal fruitful, the development element should be dominant in the sense that other elements of the appraisal should serve the broad aim of the appraisal process. Therefore, a well-designed and comprehensive system is needed to cover all the aspects of appraisal process that include of the goals, criteria, instruments, and continuous support.

  20. Challenging the One-Dose-Fits-All Model for Insulin in the Acute Treatment of Pediatric Diabetic Ketoacidosis. A Critical Appraisal of "Low-Dose Versus Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial" by Nallasamy et al (JAMA Pediatrics 2014; 168:999-1005).

    Science.gov (United States)

    Orwoll, Benjamin Edward

    2016-10-01

    To review the findings and discuss the implications of the use of low-dose insulin infusions in pediatric diabetic ketoacidosis compared with standard-dose insulin. A search of the electronic PubMed database was used to perform the clinical query as well as to search for additional relevant literature. The article by Nallasamy K et al "Low-Dose vs Standard-Dose Insulin in Pediatric Diabetic Ketoacidosis: A Randomized Clinical Trial. JAMA Pediatrics 2014; 17:e477-e480" was selected for critical appraisal and literature review. The authors performed a randomized controlled trial among 50 consecutive patients of 0-12 years old presenting to the emergency department in diabetic ketoacidosis. They found that low-dose (0.05 U/kg/hr) insulin infusion was noninferior to standard-dose (0.1 U/kg/hr) insulin in terms of resolution of hyperglycemia and acidosis with a trend toward lower rates of therapy-related complications in the low-dose group. Low-dose insulin infusion is noninferior to standard-dose insulin in the treatment of younger pediatric patients with diabetic ketoacidosis and may lead to fewer therapy-related complications.

  1. 32 CFR 644.47 - Appraisal of other interests.

    Science.gov (United States)

    2010-07-01

    ... statement to this effect should be included and the plan for appraising the mineral estate identified. Unless the person who is appraising the surface has had training and experience in appraising minerals... furnishing gross or tract appraisals. (b) Timber. (1) Where the land being appraised has only young trees or...

  2. 25 CFR 11.706 - Appointment and duties of appraiser.

    Science.gov (United States)

    2010-04-01

    ... appraiser to appraise all of the decedent's real and personal property within the estate. (b) It shall be the duty of the appraiser to appraise separately the true cash value of each article or item of property within the estate, including debts due the decedent, and to indicate the appraised value of each...

  3. The effect of real-time CPR feedback and post event debriefing on patient and processes focused outcomes: A cohort study: trial protocol

    Science.gov (United States)

    2011-01-01

    Background Cardiac arrest affects 30-35, 000 hospitalised patients in the UK every year. For these patients to be given the best chance of survival, high quality cardiopulmonary resuscitation (CPR) must be delivered, however the quality of CPR in real-life is often suboptimal. CPR feedback devices have been shown to improve CPR quality in the pre-hospital setting and post-event debriefing can improve adherence to guidelines and CPR quality. However, the evidence for use of these improvement methods in hospital remains unclear. The CPR quality improvement initiative is a prospective cohort study of the Q-CPR real-time feedback device combined with post-event debriefing in hospitalised adult patients who sustain a cardiac arrest. Methods/design The primary objective of this trial is to assess whether a CPR quality improvement initiative will improve rate of return of sustained spontaneous circulation in in-hospital-cardiac-arrest patients. The study is set in one NHS trust operating three hospital sites. Secondary objectives will evaluate: any return of spontaneous circulation; survival to hospital discharge and patient cerebral performance category at discharge; quality of CPR variables and cardiac arrest team factors. Methods: All three sites will have an initial control phase before any improvements are implemented; site 1 will implement audiovisual feedback combined with post event debriefing, site 2 will implement audiovisual feedback only and site 3 will remain as a control site to measure any changes in outcome due to any other trust-wide changes in resuscitation practice. All adult patients sustaining a cardiac arrest and receiving resuscitation from the hospital cardiac arrest team will be included. Patients will be excluded if; they have a Do-not-attempt resuscitation order written and documented in their medical records, the cardiac arrest is not attended by a resuscitation team, the arrest occurs out-of-hospital or the patient has previously participated

  4. Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review.

    Science.gov (United States)

    Clarkson, Carl E; O'mahony, Deborah; Jones, Diana E

    2015-05-01

    Acupuncture within pregnancy has frequently been investigated, often finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear. To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups. MEDLINE, CINAHL, Allied and Complementary Medicine Database, and Physiotherapy Evidence Database (PEDro) were searched for relevant studies between 2000 and 2014. Seventeen studies using penetrating acupuncture and making comment on adverse events experienced were included. Quality appraisal of the selected publications was performed using either the PEDro scale or the Downs and Black checklist. Quality of reporting was evaluated against STRICTA and CONSORT guidelines, with data on adverse events extracted in accordance with CONSORT and Good Clinical Practice adverse event guidelines. Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14 and 17% in the acupuncture groups and between 15 and 19% in non-acupuncture groups. Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture-related interventions. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  5. Late thrombotic events after bioresorbable scaffold implantation: a systematic review andmeta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Collet, Carlos; Asano, Taku; Miyazaki, Yosuke; Tenekecioglu, Erhan; Katagiri, Yuki; Sotomi, Yohei; Cavalcante, Rafael; de Winter, Robbert J.; Kimura, Takeshi; Gao, Runlin; Puricel, Serban; Cook, Stéphane; Capodanno, Davide; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients

  6. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial.

    Science.gov (United States)

    Pol, Tymon; Held, Claes; Westerbergh, Johan; Lindbäck, Johan; Alexander, John H; Alings, Marco; Erol, Cetin; Goto, Shinya; Halvorsen, Sigrun; Huber, Kurt; Hanna, Michael; Lopes, Renato D; Ruzyllo, Witold; Granger, Christopher B; Hijazi, Ziad

    2018-02-01

    Dyslipidemia is a major risk factor for cardiovascular events. The prognostic importance of lipoproteins in patients with atrial fibrillation is not well understood. We aimed to explore the association between apolipoprotein A1 (ApoA1) and B (ApoB) and cardiovascular events in patients with atrial fibrillation receiving oral anticoagulation. Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, ApoA1 and ApoB plasma levels were measured at baseline in 14 884 atrial fibrillation patients. Median length of follow-up was 1.9 years. Relationships between continuous levels of ApoA1 and ApoB and clinical outcomes were evaluated using Cox models adjusted for cardiovascular risk factors, medication including statins, and cardiovascular biomarkers. A composite ischemic outcome (ischemic stroke, systemic embolism, myocardial infarction, and cardiovascular death) was used as the primary end point. Median (25th, 75th) ApoA1 and ApoB levels were 1.10 (0.93, 1.30) and 0.70 g/L (0.55, 0.85), respectively. In adjusted analyses, higher levels of ApoA1 were independently associated with a lower risk of the composite ischemic outcome (hazard ratio, 0.81; PURL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984. © 2018 The Authors and Bristol‐Myers Squibb. Published on behalf of the American Heart Association, Inc., by Wiley.

  7. Appraisal patterns of envy and related emotions

    OpenAIRE

    van de Ven, Niels; Zeelenberg, Marcel; Pieters, Rik

    2011-01-01

    Envy is a frustrating emotion that arises from upward social comparison. Two studies investigated the appraisals that distinguish benign envy (aimed at improving one’s own situation) from malicious envy (aimed at pulling down the superior other). Study 1 found that appraisals of deservingness and control potential differentiated both types of envy. We manipulated these appraisals in Study 2 and found that while both did not influence the intensity of envy, they did determine the type of envy ...

  8. Crizotinib for Untreated Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

    Science.gov (United States)

    Morgan, Philip; Woolacott, Nerys; Biswas, Mousumi; Mebrahtu, Teumzghi; Harden, Melissa; Hodgson, Robert

    2017-09-01

    As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal process, the manufacturer of crizotinib submitted evidence on the clinical and cost effectiveness of crizotinib in untreated anaplastic lymphoma kinase-positive (ALK-positive) non-small-cell lung cancer (NSCLC). Crizotinib has previously been assessed by NICE for patients with previously treated ALK-positive NSCLC (TA 296). It was not approved in this previous appraisal, but had been made available through the cancer drugs fund. As part of this new appraisal, the company included a price discount patient access scheme (PAS). The Centre for Reviews and Dissemination and Centre for Health Economics Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company's submission and the ERG's review and summarises the resulting NICE guidance issued in August 2016. The main clinical-effectiveness data were derived from a multicentre randomised controlled trial-PROFILE 1014-that compared crizotinib with pemetrexed chemotherapy in combination with carboplatin or cisplatin in patients with untreated non-squamous ALK-positive NSCLC. In the trial, crizotinib demonstrated improvements in progression-free survival (PFS) and overall survival (OS). The company's economic model was a three-state 'area under the curve' Markov model. The base-case incremental cost-effectiveness ratio (ICER) was estimated to be greater than £50,000 per quality-adjusted life-year (QALY) gained (excluding the PAS discount). The ERG assessment of the evidence submitted by the company raised a number of concerns. In terms of the clinical evidence, the OS benefit was highly uncertain due to the cross-over permitted in the trial and the immaturity of the data; only 26% of events had occurred by the data cut-off point. In the economic modelling, the most significant concerns related to the analysis

  9. Excess pressure integral predicts cardiovascular events independent of other risk factors in the conduit artery functional evaluation substudy of Anglo-Scandinavian Cardiac Outcomes Trial.

    Science.gov (United States)

    Davies, Justin E; Lacy, Peter; Tillin, Therese; Collier, David; Cruickshank, J Kennedy; Francis, Darrel P; Malaweera, Anura; Mayet, Jamil; Stanton, Alice; Williams, Bryan; Parker, Kim H; McG Thom, Simon A; Hughes, Alun D

    2014-07-01

    Excess pressure integral (XSPI), a new index of surplus work performed by the left ventricle, can be calculated from blood pressure waveforms and may indicate circulatory dysfunction. We investigated whether XSPI predicted future cardiovascular events and target organ damage in treated hypertensive individuals. Radial blood pressure waveforms were acquired by tonometry in 2069 individuals (aged, 63±8 years) in the Conduit Artery Functional Evaluation (CAFE) substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT). Measurements of left ventricular mass index (n=862) and common carotid artery intima media thickness (n=923) were also performed. XSPI and the integral of reservoir pressure were lower in people treated with amlodipine±perindopril than in those treated with atenolol±bendroflumethiazide, although brachial systolic blood pressure was similar. A total of 134 cardiovascular events accrued during a median 3.4 years of follow-up; XSPI was a significant predictor of cardiovascular events after adjustment for age and sex, and this relationship was unaffected by adjustment for conventional cardiovascular risk factors or Framingham risk score. XSPI, central systolic blood pressure, central augmentation pressure, central pulse pressure, and integral of reservoir pressure were correlated with left ventricular mass index, but only XSPI, augmentation pressure, and central pulse pressure were associated positively with carotid artery intima media thickness. Associations between left ventricular mass index, XSPI, and integral of reservoir pressure and carotid artery intima media thickness and XSPI were unaffected by multivariable adjustment for other covariates. XSPI is a novel indicator of cardiovascular dysfunction and independently predicts cardiovascular events and targets organ damage in a prospective clinical trial. © 2014 American Heart Association, Inc.

  10. Vorapaxar for secondary prevention of thrombotic events for patients with previous myocardial infarction: a prespecified subgroup analysis of the TRA 2°P-TIMI 50 trial.

    Science.gov (United States)

    Scirica, Benjamin M; Bonaca, Marc P; Braunwald, Eugene; De Ferrari, Gaetano M; Isaza, Daniel; Lewis, Basil S; Mehrhof, Felix; Merlini, Piera A; Murphy, Sabina A; Sabatine, Marc S; Tendera, Michal; Van de Werf, Frans; Wilcox, Robert; Morrow, David A

    2012-10-13

    Vorapaxar inhibits platelet activation by antagonising thrombin-mediated activation of the protease-activated receptor 1 on human platelets. The effect of adding other antiplatelet drugs to aspirin for long-term secondary prevention of thrombotic events in stable patients with previous myocardial infarction is uncertain. We tested this effect in a subgroup of patients from the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P)-TIMI 50 trial. In TRA 2°P-TIMI 50--a randomised, placebo-controlled, parallel trial--we randomly assigned patients with a history of atherothrombosis to receive vorapaxar (2·5 mg daily) or matching placebo in a 1:1 ratio. Patients, and those giving treatment, assessing outcomes, and analysing results were masked to treatment allocation. Patients with a qualifying myocardial infarction within the previous 2 weeks to 12 months were analysed as a pre-defined subgroup. The primary efficacy endpoint was cardiovascular death, myocardial infarction, or stroke, analysed by intention to treat. We analysed events by Kaplan-Meier analysis and compared groups with a Cox proportional hazard model. TRA 2°P-TIMI 50 is registered at ClinicalTrials.gov (NCT00526474). 17,779 of 26,449 patients had a qualifying myocardial infarction and were assigned treatment (8898 to vorapaxar and 8881 to placebo). Median follow-up was 2·5 years (IQR 2·0-2·9). Cardiovascular death, myocardial infarction, or stroke occurred in 610 of 8898 patients in the vorapaxar group and 750 of 8881 in the placebo group (3-year Kaplan-Meier estimates 8·1%vs 9·7%, HR 0·80, 95% CI 0·72-0·89; p<0·0001). Moderate or severe bleeding was more common in the vorapaxar group versus the placebo group (241/8880 [3·4%, 3-year Kaplan-Meier estimate] vs 151/8849 [2·1%, 3-year Kaplan-Meier estimate], HR 1·61, 95% CI 1·31-1·97; p<0·0001). Intracranial haemorrhage occurred in 43 of 8880 patients (0·6%, 3-year Kaplan-Meier estimate) with

  11. Potential modification of the UKPDS risk engine and evaluation of macrovascular event rates in controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Yang F

    2013-07-01

    Full Text Available Fred Yang,1 June Ye,2 Kenneth Pomerantz,3 Murray Stewart1 1Alternative Development Program, GlaxoSmithKline, King of Prussia, PA, 2Discovery Biometrics, GlaxoSmithKline, Research Triangle Park, NC, 3Clinical Development and Medical Affairs, Boehringer-Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA Background: The aim of this study was to evaluate a modified UKPDS risk engine in order to establish a risk prediction benchmark for the general diabetes population. Methods: Data sources were summary demographic and risk factor data from the major type 2 diabetes mellitus outcomes studies, including ACCORD, ADVANCE, VADT, RECORD, PROactive, ADOPT, and BARI 2D. Patients in these studies spanned a wide spectrum of disease, from drug-naïve to insulin-dependent. Cardiovascular events/major adverse coronary events (CVE/MACE were primary or safety end points. Overall observed rates for cardiovascular events/MACE were summarized, and the observed annualized event rates were calculated using linear approximation. Simulation studies were then conducted using original (cardiovascular history excluded and modified (cardiovascular history included United Kingdom Prospective Diabetes Study (UKPDS models; the predicted event rates were then compared with the observed event rates for all studies. The consistency of the predicted rates derived from each model was then evaluated using descriptive statistics and linear regression. Results: The original UKPDS model tended to overestimate event rates across studies. The ratio of predicted events versus observed MACE ranged from 0.9 to 2.0, with mean of 1.5 ± 0.4 and a coefficient of variation of 26% (R2 = 0.80. However, cardiovascular risk predictions were more precise using a modified UKPDS model; the ratio of predicted versus observed MACE events ranged from 1.8 to 2.4, with a mean of 2.1 ± 0.25 and a coefficient of variation of 13% (R2 = 0.94. Conclusion: A modified UKPDS model which includes adjustments for

  12. Chronic Lyme Disease: An appraisal

    Science.gov (United States)

    Marques, Adriana

    2008-01-01

    Synopsis “Chronic Lyme disease” is a confusing term that has been used to describe very different patient populations. Studies have shown that most patients diagnosed with “chronic Lyme disease” either have no objective evidence of previous or current infection with B. burgdorferi or are patients that should be classified as having post-Lyme disease syndrome, which is defined as continuing or relapsing non-specific symptoms (such as fatigue, musculoskeletal pain, and cognitive complaints) in a patient previously treated for Lyme disease. Despite extensive study, there is currently no clear evidence that post-Lyme disease syndrome is due to persistent infection with B. burgdorferi. Four randomized placebo-controlled studies have shown that antibiotic therapy offers no sustained benefit to patients with post-Lyme disease syndrome. These studies also showed a substantial placebo effect and a significant risk of treatment-related adverse events. Further research to elucidate the mechanisms underlying persistent symptoms after Lyme disease and controlled trials of new approaches to the treatment and management of these patients are needed. PMID:18452806

  13. A practical approach to evidence-based dentistry: III: how to appraise and use an article about therapy.

    Science.gov (United States)

    Brignardello-Petersen, Romina; Carrasco-Labra, Alonso; Glick, Michael; Guyatt, Gordon H; Azarpazhooh, Amir

    2015-01-01

    Dental practitioners spend most of their time administering treatments. To ensure that their clinical decisions are informed by the best available evidence, dental practitioners need to be skilled in critically appraising studies addressing therapy issues. Randomized controlled trials offer the optimal study design to inform decisions regarding therapy. The critical appraisal of randomized controlled trials involves assessing the risk of bias, results, and applicability. In this article, the authors present these concepts and provide guidance for this type of appraisal. Dentists who wish to inform their clinical decisions regarding therapy and prevention questions can use these guidelines to decide what type of studies to search, define the specific question of interest to search efficiently for these studies, and critically appraise an article about therapy or prevention. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

  14. Test Takers' Performance Appraisals, Appraisal Calibration, and Cognitive and Metacognitive Strategy Use

    Science.gov (United States)

    Phakiti, Aek

    2016-01-01

    The current study explores the nature and relationships among test takers' performance appraisals, appraisal calibration, and reported cognitive and metacognitive strategy use in a language test situation. Performance appraisals are executive processes of strategic competence for judging test performance (e.g., evaluating the correctness or…

  15. Positive emotion, appraisal, and the role of appraisal overlap in positive emotion co-occurrence.

    Science.gov (United States)

    Tong, Eddie M W; Jia, Lile

    2017-02-01

    Appraisal research has traditionally focused on negative emotions but has not addressed issues concerning the relationships between several positive emotions and appraisals in daily life and the extent to which co-occurrence of positive emotions can be explained by overlap in appraisals. Driven by a priori hypotheses on appraisal-emotion relationships, this study investigated 12 positive emotions and 13 appraisal dimensions using Ecological Momentary Assessment. The results provide strong evidence that positive emotions and appraisals correlate significantly in daily life. Importantly, we found that the positive emotions' overlap on theoretically relevant, as compared to irrelevant, appraisals was stronger and more predictive of their co-occurrence. Furthermore, appraisal overlap on theoretically relevant appraisals predicted the co-occurrence of positive emotions even when the appraisal of pleasantness was excluded, indicating that positive emotions do not co-occur just by virtue of their shared valence. Our findings affirmed and refined the appraisal profiles of positive emotions and underscore the importance of appraisals in accounting for the commonality and differences among positive emotions. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  16. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial

    OpenAIRE

    Berg, Astrid T; Stafne, Signe N; Aud Hiller; Slørdahl, Stig A.; Inger-Lise Aamot

    2015-01-01

    Objectives: To assess the effect of two different physical therapy interventions in patients with stable coronary heart disease and non-cardiac chest pain. Methods: A randomized controlled trial was carried out at a university hospital in Norway. A total of 30 patients with known and stable coronary heart disease and self-reported persistent chest pain reproduced by palpation of intercostal trigger points were participating in the study. The intervention was deep friction massage and heat pac...

  17. Cholesterol Efflux Capacity, High-Density Lipoprotein Particle Number, and Incident Cardiovascular Events: An Analysis From the JUPITER Trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin).

    Science.gov (United States)

    Khera, Amit V; Demler, Olga V; Adelman, Steven J; Collins, Heidi L; Glynn, Robert J; Ridker, Paul M; Rader, Daniel J; Mora, Samia

    2017-06-20

    Recent failures of drugs that raised high-density lipoprotein (HDL) cholesterol levels to reduce cardiovascular events in clinical trials have led to increased interest in alternative indices of HDL quality, such as cholesterol efflux capacity, and HDL quantity, such as HDL particle number. However, no studies have directly compared these metrics in a contemporary population that includes potent statin therapy and low low-density lipoprotein cholesterol. HDL cholesterol levels, apolipoprotein A-I, cholesterol efflux capacity, and HDL particle number were assessed at baseline and 12 months in a nested case-control study of the JUPITER trial (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin), a randomized primary prevention trial that compared rosuvastatin treatment to placebo in individuals with normal low-density lipoprotein cholesterol but increased C-reactive protein levels. In total, 314 cases of incident cardiovascular disease (CVD) (myocardial infarction, unstable angina, arterial revascularization, stroke, or cardiovascular death) were compared to age- and gender-matched controls. Conditional logistic regression models adjusting for risk factors evaluated associations between HDL-related biomarkers and incident CVD. Cholesterol efflux capacity was moderately correlated with HDL cholesterol, apolipoprotein A-I, and HDL particle number (Spearman r = 0.39, 0.48, and 0.39 respectively; P JUPITER, cholesterol efflux capacity was associated with incident CVD in individuals on potent statin therapy but not at baseline. For both baseline and on-statin analyses, HDL particle number was the strongest of 4 HDL-related biomarkers as an inverse predictor of incident events and biomarker of residual risk. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00239681. © 2017 American Heart Association, Inc.

  18. Blended Learning zur hausärztlichen Demenz-Fortbildung: Einschätzung durch Nutzer einer cluster-randomisierten Studie / Blended learning for dementia related professional development: appraisal of participating general practitioners in a cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Vollmar, Horst Christian

    2010-01-01

    Full Text Available Blended learning may offer an effective and efficient educational intervention to reduce the knowledge-to-practice gap in healthcare. The aim of this study was to compare knowledge acquisition about dementia management between a blended learning approach using online modules in addition to quality circles (QC and QC alone. Primary outcome was the knowledge gain before and after the interventions. A questionnaire about the appraisal of the interventions respectively the usage of the e-learning modules was analysed. A subgroup analysis of the actual users of the e-learning modules was performed. 166 GPs were available for analysis and filled out a knowledge test at least two times (three times for further analyses. A significant increase of knowledge was found in both groups that indicated positive learning effects of both approaches. However, there was no significant difference between the groups. A subgroup analysis of the GPs who self-reported that they had actually used the online modules showed that they had a significant increase in their knowledge scores and found it useful. Nevertheless they rated also the blended learning approach suboptimal compared with the classical approach. A blended learning approach was not superior to a QC approach for improving knowledge about dementia management. However, a subgroup of GPs who were motivated to actually use the online modules had a gain in knowledge.

  19. Cardiovascular events in acute coronary syndrome patients with peripheral arterial disease treated with ticagrelor compared with clopidogrel: Data from the PLATO Trial.

    Science.gov (United States)

    Patel, Manesh R; Becker, Richard C; Wojdyla, Daniel M; Emanuelsson, Hakan; Hiatt, William R; Horrow, Jay; Husted, Steen; Mahaffey, Kenneth W; Steg, P Gabriel; Storey, Robert F; Wallentin, Lars; James, Stefan K

    2015-06-01

    To determine the effect of ticagrelor compared to clopidogrel in patients with peripheral artery disease (PAD) and acute coronary syndromes (ACS). PLATO (n = 18,624) was a multicentre, double-blind, randomized trial in ACS, that showed a 16% reduction in cardiovascular death (CV-death), myocardial infarction (MI) and stroke with ticagrelor compared with clopidogrel, without significant increase in overall major bleeding. We performed a post-hoc analysis of cardiovascular and bleeding outcomes in PLATO according to reported PAD status at baseline. At one year, CV death, MI or stroke occurred in 19.3% of patients with PAD (n = 1144) compared to 10.2% in patients without PAD (p PLATO-defined major bleeding event rates at one year were 14.8% for ticagrelor compared to 17.9% for clopidogrel, (HR: 0.81 95% CI 0.59-1.10; interaction p = 0.09). PAD patients have a high rate of ischaemic and bleeding events post ACS. The reduction of CV death, MI or stroke with ticagrelor compared with clopidogrel in PAD patients was consistent with the overall trial result although it did not reach statistical significance. Overall major bleeding was similar between the therapies. © The European Society of Cardiology 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  20. 50 CFR 34.6 - Schedule of appraisals.

    Science.gov (United States)

    2010-10-01

    ...) shall be included in the areas appraised during the first fiscal year. Once appraised, areas shall be reappraised on a schedule of at least once every five years. Until areas are appraised, the fair market value...

  1. 36 CFR 228.48 - Appraisal and measurement.

    Science.gov (United States)

    2010-07-01

    .... All mineral materials for sale must be appraised to determine fair market value. Appraisals must be... not be made at less than the appraised value which may be expressed as either price per cubic yard or...

  2. An Appraisal of Practices of Adult Evening Programs of Community Colleges in Washington State.

    Science.gov (United States)

    Kahn, Louis

    This study assessed the practices of the adult evening programs of community colleges in Washington State. From a survey of the literature, a list was made of practices recommended by writers in the field of adult education and was used in developing an appraisal instrument, which was then refined by a trial group of respondents. The refined…

  3. Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

    Science.gov (United States)

    Tan, Wei; Hong, Chi-Chen; Admane, Sonal; Dozier, Askia; Siedlecki, Francine; Whitworth, Amy; DiRaddo, Ann Marie; DePaolo, Dawn; Jacob, Sandra M.; Ma, Wen Wee; Miller, Austin; Adjei, Alex A.; Dy, Grace K.

    2017-01-01

    Background: Serious adverse events (SAEs) and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL) or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011–2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G), Medical Outcomes Study Social Support Survey (MOSSSS), Charlson comorbidity scores (CCS) and Royal Marsden scores (RMS) were obtained at baseline. Frequency of dose limiting toxicities (DLTs), subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher’s exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04). Conclusions: Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials. PMID:28672850

  4. Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events.

    Science.gov (United States)

    Anwar, Sidra; Tan, Wei; Hong, Chi-Chen; Admane, Sonal; Dozier, Askia; Siedlecki, Francine; Whitworth, Amy; DiRaddo, Ann Marie; DePaolo, Dawn; Jacob, Sandra M; Ma, Wen Wee; Miller, Austin; Adjei, Alex A; Dy, Grace K

    2017-06-26

    Background: Serious adverse events (SAEs) and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL) or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011-2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G), Medical Outcomes Study Social Support Survey (MOSSSS), Charlson comorbidity scores (CCS) and Royal Marsden scores (RMS) were obtained at baseline. Frequency of dose limiting toxicities (DLTs), subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher's exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04). Conclusions: Lower (worse) EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.

  5. Quality-of-Life (QOL during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

    Directory of Open Access Journals (Sweden)

    Sidra Anwar

    2017-06-01

    Full Text Available Background: Serious adverse events (SAEs and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011–2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G, Medical Outcomes Study Social Support Survey (MOSSSS, Charlson comorbidity scores (CCS and Royal Marsden scores (RMS were obtained at baseline. Frequency of dose limiting toxicities (DLTs, subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher’s exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04. Conclusions: Lower (worse EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.

  6. Tirofiban use with clopidogrel and aspirin decreases adverse cardiovascular events after percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials.

    Science.gov (United States)

    Sethi, Ankur; Bahekar, Amol; Doshi, Hardik; Bhuriya, Rohit; Bedi, Updesh; Singh, Sarabjeet; Khosla, Sandeep

    2011-01-01

    Current guidelines deemed usefulness of routine early glycoprotein IIb/IIIa inhibitor (GPI) administration in ST-elevation myocardial infarction (STEMI) before primary percutaneous coronary intervention (PCI) with dual antiplatelet therapy as uncertain. We aimed to examine the current evidence for the use of tirofiban, a nonpeptide glycoprotein IIb/IIIa inhibitor, in STEMI patients treated with dual antiplatelet therapy. We performed systematic searches of MEDLINE, EMBASE, and CENTRAL databases for randomized controlled trials (RCTs) of tirofiban use in STEMI patients treated with aspirin and clopidogrel which reported clinical and/or angiographic outcomes after primary PCI. Data were combined using random effect and fixed effect models for heterogeneous and homogeneous outcomes respectively using Review Manager 5 (The Nordic Cochrane Centre, The Cochrane Collaboration, 2008). Six randomized controlled trials were eligible for the inclusion; involving 708 patients in tirofiban group and 721 control subjects. Routine tirofiban use decreased the major adverse cardiovascular events (odds ratio [OR] 0.50; 95% confidence interval [CI], 0.26-0.94). Corrected thrombolysis in myocardial infarction (TIMI) frame count was also reduced with tirofiban (mean difference -8.48 [95% CI, -12.62 to -4.34]). There were no significant differences in the rates of postprocedure TIMI flow grade 3 and TIMI myocardial perfusion/blush grade 3, major bleeding by TIMI criteria, or mortality in the 2 groups. Current analysis of available studies suggests that routine and early tirofiban use before primary PCI may decrease the major cardiovascular events in STEMI patients treated with aspirin and clopidogrel without any significant increase in major bleeding. An adequately powered randomized trial is urgently needed to confirm the above findings and estimate the effect size. Copyright © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  7. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial.

    Science.gov (United States)

    van Gaal, Betsie G I; Schoonhoven, Lisette; Mintjes, Joke A J; Borm, George F; Hulscher, Marlies E J L; Defloor, Tom; Habets, Herbert; Voss, Andreas; Vloet, Lilian C M; Koopmans, Raymond T C M; van Achterberg, Theo

    2011-09-01

    Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously. This study aimed to test the effect of the SAFE or SORRY? programme on the incidence of three adverse events (pressure ulcers, urinary tract infections and falls). This paper describes Part I of the study: the effect on the incidence of adverse events. A cluster randomised trial was conducted between September 2006 and November 2008. After a three-month baseline period the intervention was implemented followed by a nine-month follow-up period. Ten wards from four hospitals and ten wards from six nursing homes were stratified for institute and ward type and then randomised to intervention or usual care group. During baseline and follow-up, patients (≥18 years) with an expected length of stay of at least five days, were asked to participate. The SAFE or SORRY? programme consisted of the essential recommendations of guidelines for the three adverse events. A multifaceted implementation strategy was used for the implementation: education, patient involvement and feedback on process and outcome indicators. The usual care group continued care as usual. Data were collected on the incidence of adverse events and a Poisson regression model was used to estimate the rate ratio of the adverse events between the intervention and the usual care group at follow-up. At follow-up, 2201 hospital patients with 3358 patient weeks and 392 nursing home patients with 5799 patient weeks were observed. Poisson regression analyses showed a rate ratio for the development of an adverse event in favour of the intervention group of 0.57 (95% CI: 0.34-0.95) and 0.67 (95% CI: 0.48-0.99) for hospital patients and nursing home patients respectively. This study showed that implementing multiple guidelines simultaneously is possible, which is promising. Patients in the intervention groups developed 43% and 33% fewer adverse events compared to the

  8. Sleep and Neurodegeneration: A Critical Appraisal.

    Science.gov (United States)

    Pillai, Jagan A; Leverenz, James B

    2017-06-01

    Sleep abnormalities are clearly recognized as a distinct clinical symptom of concern in neurodegenerative disorders. Appropriate management of sleep-related symptoms has a positive impact on quality of life in patients with neurodegenerative disorders. This review provides an overview of mechanisms that are currently being considered that tie sleep with neurodegeneration. It appraises the literature regarding specific sleep changes seen in common neurodegenerative diseases, with a focus on Alzheimer disease and synucleinopathies (ie, Parkinson disease, dementia with Lewy bodies, multiple system atrophy), that have been better studied. Sleep changes may also serve as markers to identify patients in the preclinical stage of some neurodegenerative disorders. A hypothetical model is postulated founded on the conjecture that specific sleep abnormalities, when noted to increase in severity beyond that expected for age, could be a surrogate marker reflecting pathophysiological processes related to neurodegenerative disorders. This provides a clinical strategy for screening patients in the preclinical stages of neurodegenerative disorders to enable therapeutic trials to establish the efficacy of neuroprotective agents to prevent or delay the development of symptoms and functional decline. It is unclear if sleep disturbance directly impacts neurodegenerative processes or is a secondary outcome of neurodegeneration; this is an active area of research. The clinical importance of recognizing and managing sleep changes in neurodegenerative disorders is beyond doubt. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  9. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01).

    Science.gov (United States)

    de Azambuja, Evandro; Procter, Marion J; van Veldhuisen, Dirk J; Agbor-Tarh, Dominique; Metzger-Filho, Otto; Steinseifer, Jutta; Untch, Michael; Smith, Ian E; Gianni, Luca; Baselga, Jose; Jackisch, Christian; Cameron, David A; Bell, Richard; Leyland-Jones, Brian; Dowsett, Mitch; Gelber, Richard D; Piccart-Gebhart, Martine J; Suter, Thomas M

    2014-07-10

    To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy. The Herceptin Adjuvant (HERA) trial is a three-arm, randomized trial comparing 2 years or 1 year of trastuzumab with observation in 5,102 patients with human epidermal growth factor receptor 2 (HER2) -positive early-stage breast cancer. Cardiac function was closely monitored. Eligible patients had left ventricular ejection fraction (LVEF) ≥ 55% at study entry following neoadjuvant chemotherapy with or without radiotherapy. This 8-year median follow-up analysis considered patients randomly assigned to 2 years or 1 year of trastuzumab or observation. The as-treated safety population for 2 years of trastuzumab (n = 1,673), 1 year of trastuzumab (n = 1,682), and observation (n = 1,744) is reported. Cardiac adverse events leading to discontinuation of trastuzumab occurred in 9.4% of patients in the 2-year arm and 5.2% of patients in the 1-year arm. Cardiac death, severe congestive heart failure (CHF), and confirmed significant LVEF decrease remained low in all three arms. The incidence of severe CHF (0.8%, 0.8%, and 0.0%, respectively) and confirmed significant LVEF decrease (7.2%, 4.1%, and 0.9%, respectively) was significantly higher in the 2-year and 1-year trastuzumab arms compared with the observation arm. Severe CHF was the same for 2-year and 1-year trastuzumab. Of patients with confirmed LVEF decrease receiving 2-year trastuzumab, 87.5% reached acute recovery. Of patients with confirmed LVEF decrease receiving 1-year trastuzumab, 81.2% reached acute recovery. Long-term assessment at 8-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy, and cardiac events were reversible in the vast majority of patients. © 2014 by American Society of Clinical Oncology.

  10. Emerging consumers' appraisals, emotions and complaint ...

    African Journals Online (AJOL)

    This article deals with the interplay between emerging collectivistic consumers' blame attributions, emotions experienced and coping strategies employed following appraisals of product performance failures. The general aim was to explore and describe emerging African consumers' appraisals, emotions and complaint ...

  11. Performance Appraisals Systems in the Middle Eeast

    DEFF Research Database (Denmark)

    Giangreco, Antonio; Carugati, Andrea; Pilati, Massimo

    2010-01-01

    This paper critically examines the logics behind performance appraisal systems in Western contexts in an effort to better understand their applicability in the Middle East (ME). We present a literature review that investigates the major justifications and uses of Performance appraisal systems (PASs...

  12. Performance Appraisal Knowledge: An Implication on Workplace ...

    African Journals Online (AJOL)

    Performance appraisal is a central component of any performance management system that serves as a tool for measuring and achieving performance expectation. This study therefore explored the impact of performance appraisal knowledge on employees' commitment to their workplace. Data for this study were obtained ...

  13. Performance Appraisals Can Yield Tangible Results.

    Science.gov (United States)

    Blai, Boris, Jr.

    An objective, measure-oriented job performance appraisal plan permits management to evaluate worker performance more accurately and precisely, and provides a means for assessing the degree-of-match between employee qualifications and job skills requirements for hiring, advancement, and dismissal decisions. Deficient appraisals may be costly,…

  14. 5 CFR 301.303 - Performance appraisal.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Performance appraisal. 301.303 Section....303 Performance appraisal. As soon as practicable, but beginning not later than January 1, 1984, overseas agencies are required to evaluate the performance of employees who serve under overseas local hire...

  15. Employee Appraisal System: A Supervisor's Manual.

    Science.gov (United States)

    Minnesota State Dept. of Personnel, St. Paul.

    The manual provides supervisors with both a reference as they assist employees in writing descriptions and developing performance indicators and with a guide for conducting performance appraisal interviews with employees. It contains the basic guidelines for the operation of the performance appraisal system, discussing such matters as how often…

  16. AN APPRAISAL OF PSYCHOTROPIC DRUGS AND THEIR ...

    African Journals Online (AJOL)

    This paper appraises the psychotropic drugs and its consequences, reactions on construction workers, responses to a given performance, which can be behavioral, perceptional, physiological, emotional and cognitive. This study was basically an appraisal of psychotropic drugs on construction workers, identification of types ...

  17. 5 CFR 430.307 - Appraising performance.

    Science.gov (United States)

    2010-01-01

    ... MANAGEMENT Managing Senior Executive Performance § 430.307 Appraising performance. (a) Annual appraisals... must be based on both individual and organizational performance, taking into account such factors as... principles set forth under section 2301 of title 5, United States Code. (b) Details and job changes. (1) When...

  18. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

    Science.gov (United States)

    Piccini, Jonathan P; Garg, Jyotsna; Patel, Manesh R; Lokhnygina, Yuliya; Goodman, Shaun G; Becker, Richard C; Berkowitz, Scott D; Breithardt, Günter; Hacke, Werner; Halperin, Jonathan L; Hankey, Graeme J; Nessel, Christopher C; Mahaffey, Kenneth W; Singer, Daniel E; Califf, Robert M; Fox, Keith A A

    2014-07-21

    There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors. Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and according to the randomized treatment. During a median follow-up of 1.9 years, 779 (5.5%) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm (n = 395 rivaroxaban vs. n = 384 warfarin). The median number of transfused packed red blood cells (PRBC) per episode was similar in both arms [2 (25th, 75th: 2, 4) units]. Overall, few transfusions of whole blood (n = 14), platelets (n = 10), or cryoprecipitate (n = 2) were used. Transfusion of fresh frozen plasma (FFP) was significantly less in the rivaroxaban arm (n = 45 vs. n = 81 units) after adjustment for covariates [odds ratio (OR) 0.43 (95% CI 0.29-0.66); P ROCKET AF, the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin. However, use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  19. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial.

    Science.gov (United States)

    Bonaca, Marc P; Bhatt, Deepak L; Oude Ophuis, Ton; Steg, P Gabriel; Storey, Robert; Cohen, Marc; Kuder, Julia; Im, Kyungah; Magnani, Giulia; Budaj, Andrzej; Theroux, Pierre; Hamm, Christian; Špinar, Jindrich; Kiss, Robert G; Dalby, Anthony J; Medina, Felix A; Kontny, Frederic; Aylward, Philip E; Jensen, Eva C; Held, Peter; Braunwald, Eugene; Sabatine, Marc S

    2016-07-01

    In the PEGASUS-TIMI 54 trial, treatment with ticagrelor reduced the incidence of cardiovascular death, myocardial infarction, or stroke by 15% to 16% among stable patients compared with placebo. However, more patients prematurely discontinued treatment with ticagrelor than with placebo. To investigate the reasons and timing of discontinuation of treatment with ticagrelor among stable patients prior myocardial infarction. In the PEGASUS-TIMI 54 trial, 21 162 stable outpatients with prior myocardial infarction were randomly assigned to 90 mg of ticagrelor twice daily, 60 mg of ticagrelor twice daily, or placebo, with all of the patients receiving a low dose of aspirin. These participants were followed up for a median of 33 months (study start date: October 2010; completion date: December 2014). Discontinuation of treatment was evaluated by treatment arm, cause, and timing. This analysis was initiated in May 2015. Discontinuation of treatment. Over 33 months, 32%, 29%, and 21% of patients receiving 90 mg of ticagrelor, 60 mg of ticagrelor, and placebo, respectively, discontinued treatment (P < .001). Discontinuation of treatment due to an adverse event occurred in 19%, 16%, and 9% of patients, respectively (P < .001). The most frequent adverse events leading to discontinuation of treatment were bleeding (with Kaplan-Meier event rates of 7.8%, 6.2%, and 1.5% of patients, respectively; P < .001) and dyspnea (6.5%, 4.6%, and 0.8% of patients, respectively; P < .001). Eighty-six percent of bleeding events that led to the discontinuation of treatment with ticagrelor were nonmajor, and 86% of adverse events due to dyspnea that led to discontinuation of treatment with ticagrelor were mild or moderate in severity. The discontinuation rates are annualized for patients who received 90 mg of ticagrelor twice daily (hazard ratio [HR], 2.00 [95% CI, 1.84-2.16] for the first year; HR, 1.12 [95% CI, 1.00-1.26] for the second and third years) and patients who

  20. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial.

    Science.gov (United States)

    Leist, Thomas P; Comi, Giancarlo; Cree, Bruce A C; Coyle, Patricia K; Freedman, Mark S; Hartung, Hans-Peter; Vermersch, Patrick; Casset-Semanaz, Florence; Scaramozza, Matthew

    2014-03-01

    Patients who develop relapsing-remitting multiple sclerosis (MS) present with a first clinical demyelinating event. In this double-blind, multicentre, randomised, phase 3 study we investigated the effect of oral cladribine on conversion to clinically definite MS in patients with a first clinical demyelinating event, when given at the same doses shown to be effective in relapsing-remitting MS. Between Oct 21, 2008, and Oct 11, 2010, we recruited patients aged 18-55 years, inclusive, from 160 hospitals, private clinics, or treatment centres in 34 countries. Eligible patients had a first clinical demyelinating event within 75 days before screening, at least two clinically silent lesions of at least 3 mm on a T2-weighted brain MRI scan, and an Expanded Disability Status Scale score of 5.0 or lower. Patients with a first clinical demyelinating event ≤75 days before screening were randomly assigned (1:1:1) to receive cladribine tablets at cumulative doses of 5.25 mg/kg or 3.5 mg/kg or placebo. Randomisation was done with a central web-based randomisation system and was stratified by geographic region. Masking was maintained using a two-physician model. The primary endpoint of this 96-week study was time to conversion to clinically definite MS according to the Poser criteria. This study is registered with ClinicalTrials.gov, number NCT00725985. Of 903 participants assessed for eligibility, 616 patients received cladribine 5.25 mg/kg (n=204), cladribine 3.5 mg/kg (n=206), or placebo (n=206). At trial termination on Oct 25, 2011, cladribine was associated with a risk reduction versus placebo for time to conversion to clinically definite MS (hazard ratio [HR] for 5.25 mg/kg=0.38, 95% CI 0.25-0.58, p<0.0001; HR for 3.5 mg/kg=0.33, 0.21-0.51, p<0.0001). Adverse events were reported in 165 (81%) patients in the cladribine 5.25 mg/kg group, 168 (82%) patients in the cladribine 3.5 mg/kg group, and 162 (79%) patients in the placebo group. We noted no increase in risk of adverse

  1. Increased water intake to reduce headache: Learning from a critical appraisal

    OpenAIRE

    Price, A.; Burls, A

    2015-01-01

    Clinical Bottom Line\\ud Water intake is a cost effective, non-invasive and low-risk intervention to reduce or prevent headache pain. Rationale: Chronic mild dehydration may trigger headache. Increased water intake could help. A small trial shows modest benefit; however, a larger methodologically sound randomized controlled trial is needed to confirm efficacy.\\ud \\ud Critically Appraised Paper\\ud Spigt, M., Weerkamp, N., Troost, J., van Schayck, C. P., & Knottnerus, J. A. (2012). ‘A randomized...

  2. Appraisal patterns of envy and related emotions.

    Science.gov (United States)

    van de Ven, Niels; Zeelenberg, Marcel; Pieters, Rik

    2012-06-01

    Envy is a frustrating emotion that arises from upward social comparison. Two studies investigated the appraisals that distinguish benign envy (aimed at improving one's own situation) from malicious envy (aimed at pulling down the superior other). Study 1 found that appraisals of deservingness and control potential differentiated both types of envy. We manipulated these appraisals in Study 2 and found that while both did not influence the intensity of envy, they did determine the type of envy that resulted. The more a situation was appraised as undeserved, the more participants experienced malicious envy. Benign envy was experienced more when the situation was not undeserved, and the most when the situation was appraised as both deserved and controllable. The current research also clarifies how the types of envy differ from the related emotions admiration and resentment.

  3. International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction

    DEFF Research Database (Denmark)

    Kristensen, Søren L; Køber, Lars; Jhund, Pardeep S

    2015-01-01

    BACKGROUND: International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction (HF-REF), but there are few data for those with preserved ejection fraction (HF-PEF). METHODS AND RESULTS: We analyzed outcomes by international geographic...... Trial in HF-REF (CORONA). Crude rates of heart failure hospitalization varied by geographic region, and more so for HF-PEF than for HF-REF. Rates in patients with HF-PEF were highest in the United States/Canada (HF hospitalization rate 7.6 per 100 patient-years in I-Preserve; 8.8 in CHARM.......01-1.74; P=0.04) in I-Preserve and 1.85 (95% confidence interval, 1.17-2.91; P=0.01) in CHARM-Preserved. In HF-REF, rates of HF hospitalization were slightly lower in Western Europe compared with other regions. For both HF-REF and HF-PEF, there were few regional differences in rates of all...

  4. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Andrew M. Busch

    2017-04-01

    Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  5. The clinical relevance of embolic events detected by transesophageal echocardiography during cemented total hip arthroplasty: a randomized clinical trial.

    Science.gov (United States)

    Koessler, M J; Fabiani, R; Hamer, H; Pitto, R P

    2001-01-01

    The first aim of this prospective clinical study was to characterize the relationship between embolic events observed during cemented total hip arthroplasty using transesophageal echocardiography (TEE), and changes in cardiopulmonary function. The second aim was to assess the efficiency of a modified cementing technique that was developed to reduce the risk of embolism. The modification consists in a vacuum drainage placed in the proximal femur to reduce the increase of intramedullary pressure during insertion of the prosthesis. One hundred twenty patients were randomized into two groups. Group 1 received a total hip arthroplasty cemented conventionally, whereas Group 2 was cemented with the modified technique. Continuous TEE, hemodynamic monitoring, and blood gas analysis were done during the perioperative period. Severe embolic events were imaged during the insertion of the femoral component and the reduction of the hip joint. Embolism occurred in 93.3% of patients operated on with the conventional cementing technique, compared with 13.3% of patients operated on with the modified technique (P syndrome in any study patient. The results of the study indicate that embolic events observed using TEE can cause increased pulmonary shunt values during hip arthroplasty, especially in patients with systemic disease (ASA physical status III). The modified surgical technique effectively reduced the incidence of embolization during cemented hip arthroplasty. Use of conventional cementing techniques is associated with echocardiographic evidence of embolism in 93% of patients and with a significant increase in pulmonary shunting. The incidence of embolism and change in shunting are reduced with a modified cementing technique that limits increases in intramedullary pressure.

  6. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial.

    Science.gov (United States)

    Busch, Andrew M; Tooley, Erin M; Dunsiger, Shira; Chattillion, Elizabeth A; Srour, John Fani; Pagoto, Sherry L; Kahler, Christopher W; Borrelli, Belinda

    2017-04-17

    Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC). Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from η(2)partial of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress. The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  7. Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: Rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials.

    Science.gov (United States)

    Ridker, Paul M; Amarenco, Pierre; Brunell, Robert; Glynn, Robert J; Jukema, J Wouter; Kastelein, John J P; Koenig, Wolfgang; Nissen, Steven; Revkin, James; Santos, Raul D; Schwartz, Pamela F; Yunis, Carla; Tardif, Jean-Claude

    2016-08-01

    Although statins significantly reduce vascular event rates, residual cholesterol risk remains high in many patient groups, including those with known vascular disease as well as in the setting of high-risk primary prevention. Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9), prolongs the half-life of hepatic low-density lipoprotein (LDL) receptors, and reduces circulating atherogenic cholesterol levels. The SPIRE program comprises 6 lipid-lowering studies and 2 cardiovascular outcomes trials, each comparing bococizumab (150 mg subcutaneously every 2 weeks) to matching placebo. The 6 SPIRE lipid-lowering studies include 3 parallel 12-month assessments of bococizumab on atherogenic lipids among statin-treated individuals at high residual risk (SPIRE-HR, SPIRE-LDL, SPIRE-LL), one 12-month study of bococizumab among individuals with familial hypercholesterolemia (SPIRE-FH), one 6-month study of bococizumab among those with statin intolerance (SPIRE-SI), and one 3-month study of bococizumab delivery using an auto-injector device (SPIRE-AI). The SPIRE-1 and SPIRE-2 event-driven cardiovascular outcome trials will assess the efficacy and safety of bococizumab in the prevention of incident vascular events in high-risk populations with and without clinically evident cardiovascular disease who have directly measured entry LDL cholesterol levels ≥70 mg/dL (SPIRE-1, n = 17,000) or ≥100 mg/dL (SPIRE-2, n = 11,000). The SPIRE trials, inclusive of more than 30,000 participants worldwide, will ascertain the magnitude of reduction in atherogenic lipids that accrue with bococizumab and determine whether the addition of this PCSK9 inhibitor to standard treatment significantly reduces cardiovascular morbidity and mortality in high-risk patients, including those without a history of clinical cardiovascular events. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Relationship of baseline HDL subclasses, small dense LDL and LDL triglyceride to cardiovascular events in the AIM-HIGH clinical trial.

    Science.gov (United States)

    Albers, John J; Slee, April; Fleg, Jerome L; O'Brien, Kevin D; Marcovina, Santica M

    2016-08-01

    Previous results of the AIM-HIGH trial showed that baseline levels of the conventional lipid parameters were not predictive of future cardiovascular (CV) outcomes. The aims of this secondary analysis were to examine the levels of cholesterol in high density lipoprotein (HDL) subclasses (HDL2-C and HDL3-C), small dense low density lipoprotein (sdLDL-C), and LDL triglyceride (LDL-TG) at baseline, as well as the relationship between these levels and CV outcomes. Individuals with CV disease and low baseline HDL-C levels were randomized to simvastatin plus placebo or simvastatin plus extended release niacin (ERN), 1500 to 2000 mg/day, with ezetimibe added as needed in both groups to maintain an on-treatment LDL-C in the range of 40-80 mg/dL. The primary composite endpoint was death from coronary disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome, or symptom-driven coronary or cerebrovascular revascularization. HDL-C, HDL3-C, sdLDL-C and LDL-TG were measured at baseline by detergent-based homogeneous assays. HDL2-C was computed by the difference between HDL-C and HDL3-C. Analyses were performed on 3094 study participants who were already on statin therapy prior to enrollment in the trial. Independent contributions of lipoprotein fractions to CV events were determined by Cox proportional hazards modeling. Baseline HDL3-C was protective against CV events (HR: 0.84, p = 0.043) while HDL-C, HDL2-C, sdLDL-C and LDL-TG were not event-related (HR: 0.96, p = 0.369; HR: 1.07, p = 0.373; HR: 1.05, p = 0.492; HR: 1.03, p = 0.554, respectively). The results of this secondary analysis of the AIM-HIGH Study indicate that levels of HDL3-C, but not other lipoprotein fractions, are predictive of CV events, suggesting that the HDL3 subclass may be primarily responsible for the inverse association of HDL-C and CV disease. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial.

    Science.gov (United States)

    Ridker, Paul M; Genest, Jacques; Boekholdt, S Matthijs; Libby, Peter; Gotto, Antonio M; Nordestgaard, Børge G; Mora, Samia; MacFadyen, Jean G; Glynn, Robert J; Kastelein, John J P

    2010-07-31

    HDL-cholesterol concentrations are inversely associated with occurrence of cardiovascular events. We addressed, using the JUPITER trial cohort, whether this association remains when LDL-cholesterol concentrations are reduced to the very low ranges with high-dose statin treatment. Participants in the randomised placebo-controlled JUPITER trial were adults without diabetes or previous cardiovascular disease, and had baseline concentrations of LDL cholesterol of less than 3.37 mmol/L and high-sensitivity C-reactive protein of 2 mg/L or more. Participants were randomly allocated by a computer-generated sequence to receive rosuvastatin 20 mg per day or placebo, with participants and adjudicators masked to treatment assignment. In the present analysis, we divided the participants into quartiles of HDL-cholesterol or apolipoprotein A1 and sought evidence of association between these quartiles and the JUPITER primary endpoint of first non-fatal myocardial infarction or stroke, hospitalisation for unstable angina, arterial revascularisation, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT00239681. For 17,802 patients in the JUPITER trial, rosuvastatin 20 mg per day reduced the incidence of the primary endpoint by 44% (p<0.0001). In 8901 (50%) patients given placebo (who had a median on-treatment LDL-cholesterol concentration of 2.80 mmol/L [IQR 2.43-3.24]), HDL-cholesterol concentrations were inversely related to vascular risk both at baseline (top quartile vs bottom quartile hazard ratio [HR] 0.54, 95% CI 0.35-0.83, p=0.0039) and on-treatment (0.55, 0.35-0.87, p=0.0047). By contrast, among the 8900 (50%) patients given rosuvastatin 20 mg (who had a median on-treatment LDL-cholesterol concentration of 1.42 mmol/L [IQR 1.14-1.86]), no significant relationships were noted between quartiles of HDL-cholesterol concentration and vascular risk either at baseline (1.12, 0.62-2.03, p=0.82) or on-treatment (1.03, 0.57-1.87, p=0.97). Our analyses

  10. International ring trial for the validation of an event-specific Golden Rice 2 quantitative real-time polymerase chain reaction method.

    Science.gov (United States)

    Jacchia, Sara; Nardini, Elena; Bassani, Niccolò; Savini, Christian; Shim, Jung-Hyun; Trijatmiko, Kurniawan; Kreysa, Joachim; Mazzara, Marco

    2015-05-27

    This article describes the international validation of the quantitative real-time polymerase chain reaction (PCR) detection method for Golden Rice 2. The method consists of a taxon-specific assay amplifying a fragment of rice Phospholipase D α2 gene, and an event-specific assay designed on the 3' junction between transgenic insert and plant DNA. We validated the two assays independently, with absolute quantification, and in combination, with relative quantification, on DNA samples prepared in haploid genome equivalents. We assessed trueness, precision, efficiency, and linearity of the two assays, and the results demonstrate that both the assays independently assessed and the entire method fulfill European and international requirements for methods for genetically modified organism (GMO) testing, within the dynamic range tested. The homogeneity of the results of the collaborative trial between Europe and Asia is a good indicator of the robustness of the method.

  11. A comparative study between a simplified Kalman filter and Sliding Window Averaging for single trial dynamical estimation of event-related potentials

    DEFF Research Database (Denmark)

    Vedel-Larsen, Esben; Fuglø, Jacob; Channir, Fouad

    2010-01-01

    The classical approach for extracting event-related potentials (ERPs) from the brain is ensemble averaging. For long latency ERPs this is not optimal, partly due to the time-delay in obtaining a response and partly because the latency and amplitude for the ERP components, like the P300......, are variable and depend on cognitive function. This study compares the performance of a simplified Kalman filter with Sliding Window Averaging in tracking dynamical changes in single trial P300. The comparison is performed on simulated P300 data with added background noise consisting of both simulated and real...... in the P300 component and in a considerably higher robustness towards suboptimal settings. The latter is of great importance in a clinical setting where the optimal setting cannot be determined....

  12. The appraisal rationalisation of real estate expertise

    Directory of Open Access Journals (Sweden)

    Marina Ciuna

    2013-12-01

    Full Text Available The Italian appraisal practice is characterized by valuations developed in subjective opinions formulated by the valuers, according to the experience and the competence rather than on the survey of the market data of comparable properties. This practice makes up for the lack of information on the real estate market and to the consequent absence of systematic collections of market data. This tradition is in the cadastral appraisal for the rural (1886 and urban properties (1939. The assessed income is appraised for a representative property and wide to all the other properties with arbitrary scores (pure number. The assessed value is derived from the income with fixed multipliers. The reform of the cadastral appraisals (2013 provides the employment of predetermined statistic functions rather than the automated valuation models applied in the mass appraisal. There are therefore ample spaces to rationalize the Italian valuations. For the market appraisal the process of rationalization is based on the comparison between the expertise and the market comparison approach. For the cadastral appraisal the process of rationalization is based on the statistic application to the fixed functions with the survey of a sample of market prices and the ratios study according to the valuation standards.

  13. Appraisal and job performance: A theoretical integration

    Directory of Open Access Journals (Sweden)

    C. Orpen

    1986-04-01

    Full Text Available It has been found that appraisal systems (high vs. low appraisals can be distinguished in terms of the extent to which they link rewards to performance, encourage competition among individuals, and supervise job activities closely. However, the results of research relating high versus low appraisal to employee job performance have been inconsistent. The present paper shows how this inconsistency can be removed by the argument from facilitation theory, that high appraisal will improve performance for tasks that are well-learned, but that low appraisal will do so for poorly- earned tasks; i.e., by the fact that the extent to which tasks have been well learnt moderates the impact of appraisal systems on performance. A contingency view of the appropriateness of performance appraisal systems is advocated.Opsomming "Hoe" vs. "lae" personeelaanslagsisteme verskil in die mate waartoe vergoeding gekoppel word aan prestasie, die mededinging onder individue aanmoeding en aanleiding gee tot streng toesighouding al dan nie. In die literatuur word inkonsekwente resultate met "hoe" en "lae" aanslagsisteme gerapporteer. In hierdie artikel word betoog dat "hoe" aanslagsisteme prestasie sal verhoog wanneer die besondere taak reeds goed baasgeraak is terwyl "lae" aanslagsisteme prestasie sal verhoog in gevalle waar 'n besondere taak nog nie goed bemeester is nie. 'n Kontingente beskouing van die toepaslikheid van prestasie-evalueringsisteme word bepleit.

  14. Effects of Omega-3 fatty acid on major cardiovascular events and mortality in patients with coronary heart disease: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wen, Y T; Dai, J H; Gao, Q

    2014-05-01

    There is considerable discrepancy regarding the protective effects of Omega-3 polyunsaturated fatty acids (Omega-3 PUFAs) in patients with coronary heart disease (CHD) from the early-phase clinical randomized controlled trials (RCTs). We conducted a meta-analysis of RCTs to address this issue. Pubmed, the Cochrane Central Register of Controlled Trials, and EMBASE databases (∼ May 2013) were systematically searched. Odds ratios (OR) and associated 95% CI were retrieved by using random-effect model according to heterogeneity. A total of 14 RCTs involving 16,338 individuals in the Omega-3 PUFAs group and 16,318 in the control group were identified. Patients assigned to Omega-3 PUFAs did not demonstrate satisfactory improvements on major cardiovascular events (OR, 0.93; 95% CI, 0.86 to 1.01; P = 0.08; I(2) = 46%). By contrast, the reduced risks of death from cardiac causes, sudden cardiac death and death from all causes (OR, 0.88; 95% CI, 0.80 to 0.96; P = 0.003; I(2) = 0%; OR, 0.86; 95% CI, 0.76 to 0.98; P = 0.03; I(2) = 29%; and OR, 0.92; 95% CI, 0.85 to 0.99; P = 0.02; I(2) = 6%; respectively) were shown. Supplement of Omega-3 PUFAs in patients with CHD is not associated with a protective effect on major cardiovascular events, while it does exert beneficial effects in reducing death from cardiac causes, sudden cardiac death and death from all causes. However, with currently available cardio-protective therapies, whether dietary supplementation with Omega-3 PUFAs should be still considered in patients with CHD is currently debated. Copyright © 2013 Elsevier B.V. All rights reserved.

  15. Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin.

    Science.gov (United States)

    Navar, Ann Marie; Gallup, Dianne S; Lokhnygina, Yuliya; Green, Jennifer B; McGuire, Darren K; Armstrong, Paul W; Buse, John B; Engel, Samuel S; Lachin, John M; Standl, Eberhard; Van de Werf, Frans; Holman, Rury R; Peterson, Eric D

    2017-11-01

    Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan-Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91-1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02-1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function. © 2017 American Heart Association, Inc.

  16. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Astrid T Berg

    2015-04-01

    Full Text Available Objectives: To assess the effect of two different physical therapy interventions in patients with stable coronary heart disease and non-cardiac chest pain. Methods: A randomized controlled trial was carried out at a university hospital in Norway. A total of 30 patients with known and stable coronary heart disease and self-reported persistent chest pain reproduced by palpation of intercostal trigger points were participating in the study. The intervention was deep friction massage and heat pack versus heat pack only. The primary outcome was pain intensity after the intervention period and 3 months after the last treatment session, measured by Visual Analogue Scale, 0 to 100. Secondary outcome was health-related quality of life. Results: Treatment with deep friction massage and heat pack gave significant pain reduction compared to heat pack only (–17.6, 95% confidence interval: –30.5, –4.7; p < 0.01, and the reduction was persistent at 3 months’ follow-up (–15.2, 95% confidence interval: –28.5, –1.8; p = 0.03. Health-related quality of life improved in all three domains in patients with no significant difference between groups. Conclusion: Deep friction massage combined with heat pack is an efficient treatment of musculoskeletal chest pain in patients with stable coronary heart disease.

  17. The CYTO-PV: A Large-Scale Trial Testing the Intensity of CYTOreductive Therapy to Prevent Cardiovascular Events in Patients with Polycythemia Vera

    Directory of Open Access Journals (Sweden)

    Roberto Marchioli

    2011-01-01

    Full Text Available Polycythemia vera (PV is a chronic myeloproliferative disorder whose major morbidity and mortality are thrombohaemorragic events. Current guidelines advise maintaining hematocrit (HCT level below 45% in males and 42% in females. Such targets lean on pathophysiological reasoning, while evidence from ECLAP and PVSG-01, the two largest prospective studies in this disease, suggests no difference in the rate of thrombosis in patients maintained at different HCT values below 50%–52%. Cytoreductive therapy in PV (CYTO-PV is a multicenter, randomized, and controlled trial assess the benefit/risk profile of cytoreductive therapy with phlebotomy or HU aimed at maintaining HCT < 45% versus maintaining HCT in the range 45%–50%. CYTO-PV is being conducted in the framework of the Gruppo Italiano Malattie Ematologiche nell'Adulto (GIMEMA and is funded by the Italian Drug Agency (AIFA. It is an independent trial with broad recruitment criteria to mimic clinical practice. We describe here the study and its advancement status. Conclusions. Clinical research in rare disease can be carried out with limited funds, provided a research hypothesis is felt as clinically relevant by a scientific community willing to share knowledge on the outcome of clinical practice, thus producing scientific results useful to improve treatment and prognosis of patients.

  18. On the Agreement between Manual and Automated Methods for Single-Trial Detection and Estimation of Features from Event-Related Potentials.

    Science.gov (United States)

    Biurrun Manresa, José A; Arguissain, Federico G; Medina Redondo, David E; Mørch, Carsten D; Andersen, Ole K

    2015-01-01

    The agreement between humans and algorithms on whether an event-related potential (ERP) is present or not and the level of variation in the estimated values of its relevant features are largely unknown. Thus, the aim of this study was to determine the categorical and quantitative agreement between manual and automated methods for single-trial detection and estimation of ERP features. To this end, ERPs were elicited in sixteen healthy volunteers using electrical stimulation at graded intensities below and above the nociceptive withdrawal reflex threshold. Presence/absence of an ERP peak (categorical outcome) and its amplitude and latency (quantitative outcome) in each single-trial were evaluated independently by two human observers and two automated algorithms taken from existing literature. Categorical agreement was assessed using percentage positive and negative agreement and Cohen's κ, whereas quantitative agreement was evaluated using Bland-Altman analysis and the coefficient of variation. Typical values for the categorical agreement between manual and automated methods were derived, as well as reference values for the average and maximum differences that can be expected if one method is used instead of the others. Results showed that the human observers presented the highest categorical and quantitative agreement, and there were significantly large differences between detection and estimation of quantitative features among methods. In conclusion, substantial care should be taken in the selection of the detection/estimation approach, since factors like stimulation intensity and expected number of trials with/without response can play a significant role in the outcome of a study.

  19. Midcourse correction to a clinical trial when the event rate is underestimated: the Look AHEAD (Action for Health in Diabetes) Study.

    Science.gov (United States)

    Brancati, Frederick L; Evans, Mary; Furberg, Curt D; Geller, Nancy; Haffner, Steven; Kahn, Steven E; Kaufmann, Peter G; Lewis, Cora E; Nathan, David M; Pitt, Bertram; Safford, Monika M

    2012-02-01

    The Look AHEAD (Action for Health in Diabetes) Study is a long-term clinical trial that aims to determine the cardiovascular disease (CVD) benefits of an intensive lifestyle intervention (ILI) in obese adults with type 2 diabetes. The study was designed to have 90% statistical power to detect an 18% reduction in the CVD event rate in the ILI Group compared to the Diabetes Support and Education (DSE) Group over 10.5 years of follow-up. The original power calculations were based on an expected CVD rate of 3.125% per year in the DSE group; however, a much lower-than-expected rate in the first 2 years of follow-up prompted the Data and Safety Monitoring Board (DSMB) to recommend that the Steering Committee undertake a formal blinded evaluation of these design considerations. The Steering Committee created an Endpoint Working Group (EPWG) that consisted of individuals masked to study data to examine relevant issues. The EPWG considered two primary options: (1) expanding the definition of the primary endpoint and (2) extending follow-up of participants. Ultimately, the EPWG recommended that the Look AHEAD Steering Committee approve both strategies. The DSMB accepted these modifications, rather than recommending that the trial continue with inadequate statistical power. Trialists sometimes need to modify endpoints after launch. This decision should be well justified and should be made by individuals who are fully masked to interim results that could introduce bias. This article describes this process in the Look AHEAD study and places it in the context of recent articles on endpoint modification and recent trials that reported endpoint modification.

  20. Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Basch, Ethan, E-mail: ebasch@med.unc.edu [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Pugh, Stephanie L. [NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania (United States); Dueck, Amylou C. [Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona (United States); Mitchell, Sandra A. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Berk, Lawrence [Radiation Oncology, University of South Florida, Tampa, Florida (United States); Fogh, Shannon [Department of Radiation Oncology, University of California, San Francisco, San Francisco, California (United States); Rogak, Lauren J. [Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York (United States); Gatewood, Marcha [Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia (United States); Reeve, Bryce B. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Mendoza, Tito R. [Department of Symptom Research, The University of Texas MD. Anderson Cancer Center, Houston, Texas (United States); O' Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M. [Division of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland (United States); Bennett, Antonia V. [Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina (United States); Setser, Ann [Setser Health Consulting, LLC, St. Louis, Missouri (United States); Schrag, Deborah [Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts (United States); and others

    2017-06-01

    Purpose: To assess the feasibility of measuring symptomatic adverse events (AEs) in a multicenter clinical trial using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Methods and Materials: Patients enrolled in NRG Oncology's RTOG 1012 (Prophylactic Manuka Honey for Reduction of Chemoradiation Induced Esophagitis-Related Pain during Treatment of Lung Cancer) were asked to self-report 53 PRO-CTCAE items representing 30 symptomatic AEs at 6 time points (baseline; weekly ×4 during treatment; 12 weeks after treatment). Reporting was conducted via wireless tablet computers in clinic waiting areas. Compliance was defined as the proportion of visits when an expected PRO-CTCAE assessment was completed. Results: Among 226 study sites participating in RTOG 1012, 100% completed 35-minute PRO-CTCAE training for clinical research associates (CRAs); 80 sites enrolled patients, of which 34 (43%) required tablet computers to be provided. All 152 patients in RTOG 1012 agreed to self-report using the PRO-CTCAE (median age 66 years; 47% female; 84% white). Median time for CRAs to learn the system was 60 minutes (range, 30-240 minutes), and median time for CRAs to teach a patient to self-report was 10 minutes (range, 2-60 minutes). Compliance was high, particularly during active treatment, when patients self-reported at 86% of expected time points, although compliance was lower after treatment (72%). Common reasons for noncompliance were institutional errors, such as forgetting to provide computers to participants; patients missing clinic visits; Internet connectivity; and patients feeling “too sick.” Conclusions: Most patients enrolled in a multicenter chemoradiotherapy trial were willing and able to self-report symptomatic AEs at visits using tablet computers. Minimal effort was required by local site staff to support this system. The observed causes of missing data may be

  1. Stigma, Reflected Appraisals, and Recovery Outcomes in Mental Illness

    Science.gov (United States)

    Markowitz, Fred E.; Angell, Beth; Greenberg, Jan S.

    2011-01-01

    Drawing on modified labeling theory and the reflected appraisals process and using longitudinal data from 129 mothers and their adult children with schizophrenia, we estimate models of the effects of mothers' stigmatized identity appraisals of their mentally ill children on reflected and self-appraisals, and how appraisals affect outcomes…

  2. ORIGINAL Is the Role of Teacher Performance Appraisal in Ethiopia ...

    African Journals Online (AJOL)

    were collected through interview from 24 parents who were involved in teacher performance appraisal in the sample schools. ... Thus, it would be possible to say the role of teacher performance appraisal is rhetoric rather than a reality. The processes ... conflict between appraisers and appraises, and a source of inaccurate ...

  3. Performance Appraisal Is Based on Five Major Assumptions.

    Science.gov (United States)

    Silver, Harvey A.

    This review of the performance appraisal process discusses the major assumptions on which performance appraisal is based, the general goals of performance appraisal, and the characteristics of effective performance appraisal programs. The author stresses the dependence of the process on the assumption that human behavior can be changed; he…

  4. Employee Performance Appraisal and the 95/5 Rule

    Science.gov (United States)

    Rasch, Lee

    2004-01-01

    Many colleges use some form of an employee performance appraisal process. Yet, despite prevalent use, the performance appraisal process is facing growing criticism. The author reviews the literature regarding the process of performance appraisal in higher education, focusing on articles supportive of the use of the performance appraisal, and those…

  5. Characterization of Cytomegalovirus Breakthrough Events in a Phase 2 Prophylaxis Trial of Letermovir (AIC246, MK 8228).

    Science.gov (United States)

    Lischka, Peter; Michel, Detlef; Zimmermann, Holger

    2016-01-01

    The efficacy of different letermovir (AIC246, MK8228) doses (60, 120, and 240 mg/day) against human cytomegalovirus (HCMV) was evaluated in a recent phase 2b dose-range-finding prophylaxis study in stem-cell transplant recipients. Here we report the genotypic and phenotypic characterization of 15 viral breakthroughs considered to be virological failures. Direct sequencing of an HCMV open reading frame UL56 region that included amino acids 230-370 and thus encompassed all known letermovir resistance mutations was followed by marker-transfer experiments to assess the impact of the identified sequence polymorphisms on viral fitness and susceptibility to letermovir. UL56 genotyping was successful for 12 of 15 patients. Six amino acid substitutions were detected in 5 patients. In 1 subject from the 60-mg-dose group, the known letermovir resistance mutation V236M was identified subsequent to a wild-type viremic episode. The remaining 5 sequence variants (L134V, S227I, Q228H, R410G, and D414N) were shown to be inert with regard to letermovir susceptibility, thus representing natural polymorphisms. Our findings represent the first case of a letermovir resistance mutation emerging in the clinic, apparently because of a suboptimal prophylactic dose (60 mg/day). This is in agreement with the trial's efficacy analyses, findings of which suggest that letermovir doses of 60 mg/day and 120 mg/day are suboptimal for prophylaxis whereas a dose of 240 mg/day appears to achieve complete suppression of viremia. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  6. Internet-based personalized feedback to reduce 21st-birthday drinking: a randomized controlled trial of an event-specific prevention intervention.

    Science.gov (United States)

    Neighbors, Clayton; Lee, Christine M; Lewis, Melissa A; Fossos, Nicole; Walter, Theresa

    2009-02-01

    This article presents an initial randomized controlled trial of an event-specific prevention intervention. Participants included 295 college students (41.69% male, 58.31% female) who intended to consume 2 or more drinks on their 21st birthday. Participants completed a screening/baseline assessment approximately 1 week before they turned 21 and were randomly assigned to receive Web-based personalized feedback or assessment only. Feedback included normative information, protective behaviors, and personalized blood alcohol concentration information. A follow-up assessment was completed approximately 1 week after a student's birthday. Results indicated a significant intervention effect in reducing estimated blood alcohol concentration (d = 0.33). The intervention effect was moderated by 21st-birthday drinking intentions, and the intervention was primarily effective among those who intended to reach higher levels of intoxication. Results provide some support for normative information as a mediator of intervention efficacy. Overall results provide support for Web-based personalized feedback as an intervention approach for specific events associated with extreme drinking.

  7. Aspirin for primary prevention of cardiovascular events: meta-analysis of randomized controlled trials and subgroup analysis by sex and diabetes status.

    Directory of Open Access Journals (Sweden)

    Manling Xie

    Full Text Available To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status.We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12.Fourteen trials (107,686 participants were eligible. Aspirin was associated with reductions in major cardiovascular events (risk ratio, 0.90; 95% confidence interval, 0.85-0.95, myocardial infarction (0.86; 0.75-0.93, ischemic stroke (0.86; 0.75-0.98 and all-cause mortality (0.94; 0.89-0.99. There were also increases in hemorrhagic stroke (1.34; 1.01-1.79 and major bleeding (1.55; 1.35-1.78 with aspirin. The number needed to treat to prevent 1 major cardiovascular event over a mean follow-up of 6.8 years was 284. By comparison, the numbers needed to harm to cause 1 major bleeding is 299. In subgroup analyses, pooled results demonstrated a reduction in myocardial infarction among men (0.71; 0.59-0.85 and ischemic stroke among women (0.77; 0.63-0.93. Aspirin use was associated with a reduction (0.65; 0.51-0.82 in myocardial infarction among diabetic men. In meta-regression analyses, the results suggested that aspirin therapy might be associated with a decrease in stroke among diabetic women and a decrease in MI among diabetic men and risk reductions achieved with low doses (75 mg/day were as large as those obtained with higher doses (650 mg/day.The use of low-dose aspirin was beneficial for primary prevention of CVD and the decision regarding an aspirin regimen should be made on an individual patient basis. The effects of aspirin therapy varied by sex and diabetes status. A clear benefit of aspirin in the primary prevention of CVD in people with diabetes needs more trials.

  8. Aspirin for Primary Prevention of Cardiovascular Events: Meta-Analysis of Randomized Controlled Trials and Subgroup Analysis by Sex and Diabetes Status

    Science.gov (United States)

    Zhang, Yan; Chen, Sijing; Yang, Wei; Bao, Wei; Rong, Ying; Yu, Xuefeng; Hu, Frank B.; Liu, Liegang

    2014-01-01

    Objective To evaluate the benefits and harms of aspirin for the primary prevention of CVD and determine whether the effects vary by sex and diabetes status. Methods We searched Medline, Embase, and Cochrane databases for randomized controlled trials comparing the effects of aspirin with placebo or control in people with no pre-existing CVD. Two investigators independently extracted data and assessed the study quality. Analyses were performed using Stata version 12. Results Fourteen trials (107,686 participants) were eligible. Aspirin was associated with reductions in major cardiovascular events (risk ratio, 0.90; 95% confidence interval, 0.85–0.95), myocardial infarction (0.86; 0.75–0.93), ischemic stroke (0.86; 0.75–0.98) and all-cause mortality (0.94; 0.89–0.99). There were also increases in hemorrhagic stroke (1.34; 1.01–1.79) and major bleeding (1.55; 1.35–1.78) with aspirin. The number needed to treat to prevent 1 major cardiovascular event over a mean follow-up of 6.8 years was 284. By comparison, the numbers needed to harm to cause 1 major bleeding is 299. In subgroup analyses, pooled results demonstrated a reduction in myocardial infarction among men (0.71; 0.59–0.85) and ischemic stroke among women (0.77; 0.63–0.93). Aspirin use was associated with a reduction (0.65; 0.51–0.82) in myocardial infarction among diabetic men. In meta-regression analyses, the results suggested that aspirin therapy might be associated with a decrease in stroke among diabetic women and a decrease in MI among diabetic men and risk reductions achieved with low doses (75 mg/day) were as large as those obtained with higher doses (650 mg/day). Conclusions The use of low-dose aspirin was beneficial for primary prevention of CVD and the decision regarding an aspirin regimen should be made on an individual patient basis. The effects of aspirin therapy varied by sex and diabetes status. A clear benefit of aspirin in the primary prevention of CVD in people with diabetes

  9. Using functional analysis in archival appraisal a practical and effective alternative to traditional appraisal methodologies

    CERN Document Server

    Robyns, Marcus C

    2014-01-01

    In an age of scarcity and the challenge of electronic records, can archivists and records managers continue to rely upon traditional methodology essentially unchanged since the early 1950s? Using Functional Analysis in Archival Appraisal: A Practical and Effective Alternative to Traditional Appraisal Methodologies shows how archivists in other countries are already using functional analysis, which offers a better, more effective, and imminently more practical alternative to traditional appraisal methodologies that rely upon an analysis of the records themselves.

  10. Maladaptive trauma appraisals mediate the relation between attachment anxiety and PTSD symptom severity.

    Science.gov (United States)

    Ogle, Christin M; Rubin, David C; Siegler, Ilene C

    2016-05-01

    In a large sample of community-dwelling older adults with histories of exposure to a broad range of traumatic events, we examined the extent to which appraisals of traumatic events mediate the relations between insecure attachment styles and posttraumatic stress disorder (PTSD) symptom severity. Participants completed an assessment of adult attachment, in addition to measures of PTSD symptom severity, event centrality, event severity, and ratings of the A1 PTSD diagnostic criterion for the potentially traumatic life event that bothered them most at the time of the study. Consistent with theoretical proposals and empirical studies indicating that individual differences in adult attachment systematically influence how individuals evaluate distressing events, individuals with higher attachment anxiety perceived their traumatic life events to be more central to their identity and more severe. Greater event centrality and event severity were each in turn related to higher PTSD symptom severity. In contrast, the relation between attachment avoidance and PTSD symptoms was not mediated by appraisals of event centrality or event severity. Furthermore, neither attachment anxiety nor attachment avoidance was related to participants' ratings of the A1 PTSD diagnostic criterion. Our findings suggest that attachment anxiety contributes to greater PTSD symptom severity through heightened perceptions of traumatic events as central to identity and severe. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  11. Does the age-related positivity effect in autobiographical recall reflect differences in appraisal or memory?

    Science.gov (United States)

    Schryer, Emily; Ross, Michael

    2014-07-01

    Two studies examined the extent to which the age-related positivity effect in autobiographical recall is the result of age differences in appraisal and memory. In Study 1, older and younger participants reported 1 pleasant and 1 unpleasant event for 5 days. Participants attempted to recall those events a week later. In Study 2, older and younger participants imagined that positive, negative, and neutral hypothetical events had occurred either to themselves or to an acquaintance and were later asked to recall those events. In Study 1, younger adults reported a complete set of positive and negative events. Older adults reported a pleasant event each day, but 38% did not report an unpleasant event on at least 1 day. A week later, older and younger adults were equally likely to recall the events they had reported. In Study 2, older adults who imagined events happened to themselves rated events as more positive in valence than younger adults did. Older and younger adults were equally likely to remember pleasant and unpleasant events at the end of the study. The data suggest that the age-related positivity effect resides in the appraisal rather than the recall of autobiographical events. © The Author 2013. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial.

    Science.gov (United States)

    Wang, Kaijun; Li, Haiyan; Kwong, Winghan J; Antman, Elliott M; Ruff, Christian T; Giugliano, Robert P; Cohen, David J; Magnuson, Elizabeth A

    2017-08-11

    The impact of different types of extracranial bleeding events on health-related quality of life and health-state utility among patients with atrial fibrillation is not well understood. The ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) Trial compared edoxaban with warfarin with respect to the prevention of stroke or systemic embolism in atrial fibrillation. Data from the EuroQol-5D (EQ-5D-3L) questionnaire, prospectively collected at 3-month intervals for up to 48 months, were used to estimate the impact of different categories of bleeding events on health-state utility over 12 months following the event. Longitudinal mixed-effect models revealed that major gastrointestinal bleeds and major nongastrointestinal bleeds were associated with significant immediate decreases in utility scores (-0.029 [-0.044 to -0.014; P<0.001] and -0.029 [-0.046 to -0.012; P=0.001], respectively). These effects decreased in magnitude over time, and were no longer significant for major nongastrointestinal bleeds at 9 months, but remained borderline significant for major gastrointestinal bleeds at 12 months. Clinically relevant nonmajor and minor bleeds were associated with smaller but measurable immediate impacts on utility (-0.010 [-0.016 to -0.005] and -0.016 [-0.024 to -0.008]; P<0.001 for both), which remained relatively constant and statistically significant over the 12 months following the bleeding event. All categories of bleeding events were associated with negative impacts on health-state utility in patients with atrial fibrillation. Major bleeds were associated with relatively large immediate decreases in utility scores that gradually diminished over 12 months; clinically relevant nonmajor and minor bleeds were associated with smaller immediate decreases in utility that persisted over 12 months. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00781391. © 2017 The

  13. Soy Isoflavones for Reducing Bone Loss Study: effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women.

    Science.gov (United States)

    Alekel, D Lee; Genschel, Ulrike; Koehler, Kenneth J; Hofmann, Heike; Van Loan, Marta D; Beer, Bonnie S; Hanson, Laura N; Peterson, Charles T; Kurzer, Mindy S

    2015-02-01

    This study aims to assess the overall safety and potential endometrium-stimulating effects of soy isoflavone tablets consumed (3 y) by postmenopausal women and to determine endometrial thickness response to treatment among compliant women, taking into account hormone concentrations and other hypothesized modifying factors. We randomized healthy postmenopausal women (aged 45.8-65.0 y) to placebo control or two doses (80 or 120 mg/d) of soy isoflavones at two sites. We used intent-to-treat analysis (N = 224) and compliant analysis (>95%; N = 208) to assess circulating hormone concentrations, adverse events, and endometrial thickness (via transvaginal ultrasound). Median values for endometrial thickness (mm) declined from baseline through 36 months. Nonparametric analysis of variance for treatment differences among groups showed no differences in absolute (or percentage of change) endometrial thickness (χ(2) P ranged from 0.12 to 0.69) or in circulating hormones at any time point. A greater number of adverse events in the genitourinary system (P = 0.005) were noted in the 80 mg/day group compared with the 120 mg/day group, whereas other systems showed no treatment effects. The model predicting endometrial thickness response (using natural logarithm) to treatment among compliant women across time points was significant (P ≤ 0.0001), indicating that estrogen exposure (P = 0.0013), plasma 17β-estradiol (P = 0.0086), and alcohol intake (P = 0.023) contributed significantly to the response. Neither the 80 mg/day dose (P = 0.57) nor the 120 mg/day dose (P = 0.43) exerted an effect on endometrial thickness across time. Our randomized controlled trial verifies the long-term overall safety of soy isoflavone tablet intake by postmenopausal women who display excellent compliance. We find no evidence of treatment effects on endometrial thickness, adverse events, or circulating hormone concentrations, most notably thyroid function, across a 3-year period.

  14. Bleeding risk associated with 1 year of dual antiplatelet therapy after percutaneous coronary intervention: Insights from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.

    Science.gov (United States)

    Aronow, Herbert D; Steinhubl, Steven R; Brennan, Danielle M; Berger, Peter B; Topol, Eric J

    2009-02-01

    The optimal duration of dual antiplatelet therapy after percutaneous coronary intervention (PCI) is unknown. Incremental reductions in the risk of major adverse cardiovascular events may be partially offset by an increased incidence of bleeding in the months after a PCI. We examined the incidence, severity, and predictors of bleeding associated with 1 year of dual antiplatelet therapy after PCI among 1,816 patients in the Clopidogrel for the Reduction of Event During Observation (CREDO) trial. We also compared bleeding in patients who received dual antiplatelet therapy for 1 year to those who did so for only 4 weeks. Bleeding was categorized as major or minor using the modified Thrombolysis In Myocardial Infarction (TIMI) Study Group criteria. Major or minor bleeding occurred in 146 patients during 1 year of follow-up. More than 80% of bleeding events were periprocedural. Multivariable predictors of any bleeding included increasing age and coronary artery bypass. Any (major or minor) bleeding occurred in 71 (8.1%) and 77 (8.9%), major bleeding in 34 (3.9%) and 49 (5.6%), and minor bleeding in 37 (4.2%) and 29 (3.3%) of placebo- and clopidogrel-treated patients, respectively; these differences were not significant. However, major gastrointestinal bleeding occurred in significantly more clopidogrel- than placebo-treated patients (13 [1.4%] vs 3 [0.3%] [P = .011]). Adding clopidogrel to aspirin beyond 4 weeks post PCI is not associated with a significant increase in the overall rate of major or minor bleeding, although it is associated with an increase in major gastrointestinal bleeding in the year after a PCI.

  15. Single trial classification for the categories of perceived emotional facial expressions: an event-related fMRI study

    Science.gov (United States)

    Song, Sutao; Huang, Yuxia; Long, Zhiying; Zhang, Jiacai; Chen, Gongxiang; Wang, Shuqing

    2016-03-01

    Recently, several studies have successfully applied multivariate pattern analysis methods to predict the categories of emotions. These studies are mainly focused on self-experienced emotions, such as the emotional states elicited by music or movie. In fact, most of our social interactions involve perception of emotional information from the expressions of other people, and it is an important basic skill for humans to recognize the emotional facial expressions of other people in a short time. In this study, we aimed to determine the discriminability of perceived emotional facial expressions. In a rapid event-related fMRI design, subjects were instructed to classify four categories of facial expressions (happy, disgust, angry and neutral) by pressing different buttons, and each facial expression stimulus lasted for 2s. All participants performed 5 fMRI runs. One multivariate pattern analysis method, support vector machine was trained to predict the categories of facial expressions. For feature selection, ninety masks defined from anatomical automatic labeling (AAL) atlas were firstly generated and each were treated as the input of the classifier; then, the most stable AAL areas were selected according to prediction accuracies, and comprised the final feature sets. Results showed that: for the 6 pair-wise classification conditions, the accuracy, sensitivity and specificity were all above chance prediction, among which, happy vs. neutral , angry vs. disgust achieved the lowest results. These results suggested that specific neural signatures of perceived emotional facial expressions may exist, and happy vs. neutral, angry vs. disgust might be more similar in information representation in the brain.

  16. Using Genetic Algorithms for Real Estate Appraisals

    National Research Council Canada - National Science Library

    Vincenzo Del Giudice; Pierfrancesco De Paola; Fabiana Forte

    2017-01-01

    .... Also, to verify the reliability of genetic algorithms for real estate appraisals and, at the same time, to show the forecasting potentialities of these techniques in the analysis of housing markets...

  17. EMPLOYEE PERFORMANCE APPRAISAL: A CONCEPTUAL FRAMEWORK

    OpenAIRE

    RUSU Gabriela; AVASILCAI Silvia; HUȚU Carmen-Aida

    2016-01-01

    Recent studies highlight the importance of employee performance appraisal in the context of strategic human resources management, outlining the role of organizational context. Accordingly, the paper presents an employee performance appraisal conceptual framework including the role of contextual factors, where strategic human resources management plays a key role. Moreover, the model includes two sets of procedural and representative basic performance criteria, as well as a new category ...

  18. Adverse events analysis as an educational tool to improve patient safety culture in primary care: a randomized trial.

    Science.gov (United States)

    González-Formoso, Clara; Martín-Miguel, María Victoria; Fernández-Domínguez, Ma José; Rial, Antonio; Lago-Deibe, Fernando Isidro; Ramil-Hermida, Luis; Pérez-García, Margarita; Clavería, Ana

    2011-06-14

    Patient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care. Experimental unifactorial study of two groups, control and intervention. Tutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain. From the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned. Residents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After

  19. APPRAISAL ANALYSIS IN FREEDOM WRITERS MOVIE

    Directory of Open Access Journals (Sweden)

    Nani Hidayati

    2017-02-01

    Full Text Available This study attempts to find out conveyed messages in the movie from the realization of the appraisal and narrative structure as well as to describe the use of the Appraisal System to express LaGravenese's (a Attitudes, (bEngagement & (c Graduation towards the main characters in Freedom Writers movie screenplay. Using both quantitative and qualitative descriptive approach for discourse appraisal system analysis, the result of this study reveals several messages of tolerance, earning respect and trust, honor diversity, and striving for success and trust from the realization of Appraisal and Narrative Structure either in the dialogues or monologues of Freedom Writers’ characters. The result from the Appraisal Devices realizing (a Attitudes reveals that LaGravenese likes to express characters’ negative emotion explicitly than implicitly. He likes to express characters’ negative capability than other kinds of Judgments. He appreciates the characters using more Negative Value which denotes that in his opinion, they see each other negatively. (bEngagement used in the screenplay describes that he emphasizes more on characters’ denial towards each other’s opinion and existence with the use of more Disclaim Heterogloss in the screenplay. (cGraduation used in the screenplay describes that the use of more Sharpening Focus indicates he emphasizes on characters’ category boundary more than scaling of intensity. Keywords: Appraisal Devices, Attitude, Engagement, and Graduation.

  20. What happens during annual appraisal interviews? How leader-follower interactions unfold and impact interview outcomes.

    Science.gov (United States)

    Meinecke, Annika L; Lehmann-Willenbrock, Nale; Kauffeld, Simone

    2017-07-01

    Despite a wealth of research on antecedents and outcomes of annual appraisal interviews, the ingredients that make for a successful communication process within the interview itself remain unclear. This study takes a communication approach to highlight leader-follower dynamics in annual appraisal interviews. We integrate relational leadership theory and recent findings on leader-follower interactions to argue (a) how supervisors' task- and relation-oriented statements can elicit employee involvement during the interview process and (b) how these communication patterns affect both supervisors' and employees' perceptions of the interview. Moreover, we explore (c) how supervisor behavior is contingent upon employee contributions to the appraisal interview. We audiotaped 48 actual annual appraisal interviews between supervisors and their employees. Adopting a multimethod approach, we used quantitative interaction coding (N = 32,791 behavioral events) as well as qualitative open-axial coding to explore communication patterns among supervisors and their employees. Lag sequential analysis revealed that supervisors' relation-oriented statements triggered active employee contributions and vice versa. These relation-activation patterns were linked to higher interview success ratings by both supervisors and employees. Moreover, our qualitative findings highlight employee disagreement as a crucial form of active employee contributions during appraisal interviews. We distinguish what employees disagreed about, how the disagreement was enacted, and how supervisors responded to it. Overall employee disagreement was negatively related to ratings of supervisor support. We discuss theoretical implications for performance appraisal and leadership theory and derive practical recommendations for promoting employee involvement during appraisal interviews. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Relative Risk Appraisal, the September 11 Attacks, and Terrorism-Related Fears

    Science.gov (United States)

    Marshall, Randall D.; Bryant, Richard A.; Amsel, Lawrence; Suh, Eun Jung; Cook, Joan M.; Neria, Yuval

    2013-01-01

    There are now replicated findings that posttraumatic stress disorder (PTSD) symptoms related to the September 11, 2001, attacks occurred in large numbers of persons who did not fit the traditional definition of exposure to a traumatic event. These data are not explained by traditional epidemiologic “bull’s eye” disaster models, which assume the psychological effects are narrowly, geographically circumscribed, or by existing models of PTSD onset. In this article, the authors develop a researchable model to explain these and other terrorism-related phenomena by synthesizing research and concepts from the cognitive science, risk appraisal, traumatic stress, and anxiety disorders literatures. They propose the new term relative risk appraisal to capture the psychological function that is the missing link between the event and subjective response in these and other terrorism-related studies to date. Relative risk appraisal highlights the core notion from cognitive science that human perception is an active, multidimensional process, such that for unpredictable societal threats, proximity to the event is only one of several factors that influence behavioral responses. Addressing distortions in relative risk appraisal effectively could reduce individual and societal vulnerability to a wide range of adverse economic and ethnopolitical consequences to terrorist attacks. The authors present ways in which these concepts and related techniques can be helpful in treating persons with September 11– or terrorism-related distress or psychopathology. PMID:17516775

  2. Etiopathogenesis of cataract: An appraisal

    Directory of Open Access Journals (Sweden)

    Varun B Gupta

    2014-01-01

    Full Text Available Natural eye lens is a crystalline substance to produce a clear passage for light. Cataract is opacity within the clear lens of the eye and is the dominant cause of socio-medical problem i.e., blindness worldwide. The only available treatment of cataract is surgery. However, insufficient surgical facilities in poor and developing countries and post-operative complications inspire researchers to find out other modes of treatment for cataract. In this review, an attempt has been made to appraise various etiological factors of cataract to make their perception clear to build up counterpart treatment. Present study is an assortment of various available literatures and electronic information in view of cataract etiopathogenesis. Various risk factors have been identified in development of cataracts. They can be classified in to genetic factors, ageing (systemic diseases, nutritional and trace metals deficiencies, smoking, oxidative stress etc., traumatic, complicated (inflammatory and degenerative diseases of eye, metabolic (diabetes, galactosemia etc., toxic substances including drugs abuses, alcohol etc., radiation (ultraviolet, electromagnetic waves etc. are implicated as significant risk factors in the development of cataract.

  3. Etiopathogenesis of cataract: An appraisal

    Science.gov (United States)

    Gupta, Varun B; Rajagopala, Manjusha; Ravishankar, Basavaiah

    2014-01-01

    Natural eye lens is a crystalline substance to produce a clear passage for light. Cataract is opacity within the clear lens of the eye and is the dominant cause of socio-medical problem i.e., blindness worldwide. The only available treatment of cataract is surgery. However, insufficient surgical facilities in poor and developing countries and post-operative complications inspire researchers to find out other modes of treatment for cataract. In this review, an attempt has been made to appraise various etiological factors of cataract to make their perception clear to build up counterpart treatment. Present study is an assortment of various available literatures and electronic information in view of cataract etiopathogenesis. Various risk factors have been identified in development of cataracts. They can be classified in to genetic factors, ageing (systemic diseases, nutritional and trace metals deficiencies, smoking, oxidative stress etc.), traumatic, complicated (inflammatory and degenerative diseases of eye), metabolic (diabetes, galactosemia etc.), toxic substances including drugs abuses, alcohol etc., radiation (ultraviolet, electromagnetic waves etc.) are implicated as significant risk factors in the development of cataract. PMID:24618482

  4. A randomized trial of a strategy for increasing high-density lipoprotein cholesterol levels: effects on progression of coronary heart disease and clinical events.

    Science.gov (United States)

    Whitney, Edwin J; Krasuski, Richard A; Personius, Bradley E; Michalek, Joel E; Maranian, Ara M; Kolasa, Mark W; Monick, Erik; Brown, B Gregory; Gotto, Antonio M

    2005-01-18

    The high-density lipoprotein (HDL) cholesterol level is a strong predictor of cardiovascular events in epidemiologic studies. Until recently, it has been less extensively studied as a therapeutic target. To assess the angiographic and clinical effects of a pharmacologic strategy to increase HDL cholesterol levels. Randomized, double-blind, placebo-controlled trial conducted from 1993 to 1996. Outpatient specialty clinic of a large U.S. military medical center. 143 military retirees younger than 76 years of age with low HDL cholesterol levels and angiographically evident coronary disease. Gemfibrozil, niacin, and cholestyramine or corresponding placebos, with aggressive dietary and lifestyle intervention at baseline. Change from baseline to 30 months and a composite measure of clinical events that included hospitalization for angina, myocardial infarction, transient ischemic attack and stroke, death, and cardiovascular procedures. At baseline, mean (+/-SD) lipid values were as follows: total cholesterol, 5.1 +/- 0.8 mmol/L (196 +/- 31 mg/dL); low-density lipoprotein (LDL) cholesterol, 3.3 +/- 0.7 mmol/L (128 +/- 27 mg/dL); and HDL cholesterol, 0.9 +/- 0.2 mmol/L (34 +/- 6 mg/dL). Compared with placebo, the pharmacologically treated group experienced a 20% (95% CI, 14.8% to 24.3%) decrease in total cholesterol level, a 36% (CI, 28.4% to 43.5%) increase in HDL cholesterol level, a 26% (CI, 19.1% to 33.7%) decrease in LDL cholesterol level, and a 50% (CI, 40.5% to 59.2%) reduction in triglyceride levels. Focal coronary stenosis increased by 1.4% in the placebo group but decreased by 0.8% in the drug group (difference, -2.2 percentage points [CI, -4.2 to -0.1 percentage points]). A composite cardiovascular event end point was reached in 26% of patients in the placebo group and 13% of those in the drug group (difference, 13.7 percentage points [CI, 0.9 to 26.5 percentage points]). Side effects, particularly flushing and gastrointestinal intolerance, were more common in

  5. Impact of metabolic syndrome and its components on cardiovascular disease event rates in 4900 patients with type 2 diabetes assigned to placebo in the field randomised trial

    Directory of Open Access Journals (Sweden)

    Scott Russell

    2011-11-01

    Full Text Available Abstract Background Patients with the metabolic syndrome are more likely to develop type 2 diabetes and may have an increased risk of cardiovascular disease (CVD events.We aimed to establish whether CVD event rates were influenced by the metabolic syndrome as defined by the World Health Organisation (WHO, the National Cholesterol Education Program (NCEP Adult Treatment Panel III (ATP III and the International Diabetes Federation (IDF and to determine which component(s of the metabolic syndrome (MS conferred the highest cardiovascular risk in in 4900 patients with type 2 diabetes allocated to placebo in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD trial. Research design and methods We determined the influence of MS variables, as defined by NCEP ATPIII, IDF and WHO, on CVD risk over 5 years, after adjustment for CVD, sex, HbA1c, creatinine, and age, and interactions between the MS variables in a Cox proportional-hazards model. Results About 80% had hypertension, and about half had other features of the metabolic syndrome (IDF, ATPIII. There was no difference in the prevalence of metabolic syndrome variables between those with and without CVD at study entry. The WHO definition identified those at higher CVD risk across both sexes, all ages, and in those without prior CVD, while the ATPIII definition predicted risk only in those aged over 65 years and in men but not in women. Patients meeting the IDF definition did not have higher risk than those without IDF MS. CVD risk was strongly influenced by prior CVD, sex, age (particularly in women, baseline HbA1c, renal dysfunction, hypertension, and dyslipidemia (low HDL-c, triglycerides > 1.7 mmol/L. The combination of low HDL-c and marked hypertriglyceridemia (> 2.3 mmol/L increased CVD risk by 41%. Baseline systolic blood pressure increased risk by 16% per 10 mmHg in those with no prior CVD, but had no effect in those with CVD. In those without prior CVD, increasing numbers of

  6. Impact of metabolic syndrome and its components on cardiovascular disease event rates in 4900 patients with type 2 diabetes assigned to placebo in the FIELD randomised trial.

    Science.gov (United States)

    Scott, Russell; Donoghoe, Mark; Watts, Gerald F; O'Brien, Richard; Pardy, Christopher; Taskinen, Marja-Riitta; Davis, Timothy M E; Colman, Peter G; Manning, Patrick; Fulcher, Gregory; Keech, Anthony C

    2011-11-21

    Patients with the metabolic syndrome are more likely to develop type 2 diabetes and may have an increased risk of cardiovascular disease (CVD) events.We aimed to establish whether CVD event rates were influenced by the metabolic syndrome as defined by the World Health Organisation (WHO), the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and the International Diabetes Federation (IDF) and to determine which component(s) of the metabolic syndrome (MS) conferred the highest cardiovascular risk in in 4900 patients with type 2 diabetes allocated to placebo in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. We determined the influence of MS variables, as defined by NCEP ATPIII, IDF and WHO, on CVD risk over 5 years, after adjustment for CVD, sex, HbA1c, creatinine, and age, and interactions between the MS variables in a Cox proportional-hazards model. About 80% had hypertension, and about half had other features of the metabolic syndrome (IDF, ATPIII). There was no difference in the prevalence of metabolic syndrome variables between those with and without CVD at study entry. The WHO definition identified those at higher CVD risk across both sexes, all ages, and in those without prior CVD, while the ATPIII definition predicted risk only in those aged over 65 years and in men but not in women. Patients meeting the IDF definition did not have higher risk than those without IDF MS.CVD risk was strongly influenced by prior CVD, sex, age (particularly in women), baseline HbA1c, renal dysfunction, hypertension, and dyslipidemia (low HDL-c, triglycerides > 1.7 mmol/L). The combination of low HDL-c and marked hypertriglyceridemia (> 2.3 mmol/L) increased CVD risk by 41%. Baseline systolic blood pressure increased risk by 16% per 10 mmHg in those with no prior CVD, but had no effect in those with CVD. In those without prior CVD, increasing numbers of metabolic syndrome variables (excluding waist) escalated risk

  7. Lower preoperative quality of life increases postoperative risk of adverse events in women with endometrial cancer: results from the LACE trial.

    Science.gov (United States)

    Baker, Jannah; Janda, Monika; Gebski, Val; Forder, Peta; Hogg, Russell; Manolitsas, Tom; Obermair, Andreas

    2015-04-01

    To examine the association between preoperative quality of life (QoL) and postoperative adverse events in women treated for endometrial cancer. 760 women with apparent Stage I endometrial cancer were randomised into a clinical trial evaluating laparoscopic versus open surgery. This analysis includes women with preoperative QoL measurements, from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, and who were followed up for at least 6 weeks after surgery (n=684). The outcomes for this study were defined as (1) the occurrence of moderate to severe adverse events within 6 months (Common Toxicology Criteria (CTC) grade≥3); and (2) any serious adverse event (SAE). The association between preoperative QoL and the occurrence of AE was examined, after controlling for baseline comorbidity and other factors. After adjusting for other factors, odds of occurrence of AE of CTC grade≥3 were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.00-1.03, p=0.030), which was driven by physical well-being (PWB) (OR=1.09, 95% CI 1.04-1.13, p=0.0002) and functional well-being subscales (FWB) (OR=1.04, 95% CI 1.00-1.07, p=0.035). Similarly, odds of SAE occurrence were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.01-1.04, p=0.011), baseline PWB (OR=1.11, 95% CI 1.06-1.16, p<0.0001) or baseline FWB subscales (OR=1.05, 95% CI 1.01-1.10, p=0.0077). Women with early endometrial cancer presenting with lower QoL prior to surgery are at higher risk of developing a serious adverse event following surgery. Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council, Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare

  8. Atherogenic Lipoprotein Subfractions Determined by Ion Mobility and First Cardiovascular Events After Random Allocation to High-Intensity Statin or Placebo: The Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) Trial.

    Science.gov (United States)

    Mora, Samia; Caulfield, Michael P; Wohlgemuth, Jay; Chen, Zhihong; Superko, H Robert; Rowland, Charles M; Glynn, Robert J; Ridker, Paul M; Krauss, Ronald M

    2015-12-08

    Cardiovascular disease (CVD) can occur in individuals with low low-density lipoprotein (LDL) cholesterol (LDL-C). We investigated whether detailed measures of LDL subfractions and other lipoproteins can be used to assess CVD risk in a population with both low LDL-C and high C-reactive protein who were randomized to high-intensity statin or placebo. In 11 186 Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) participants, we tested whether lipids, apolipoproteins, and ion mobility-measured particle concentrations at baseline and after random allocation to rosuvastatin 20 mg/d or placebo were associated with first CVD events (n=307) or CVD/all-cause death (n=522). In placebo-allocated participants, baseline LDL-C was not associated with CVD (adjusted hazard ratio [HR] per SD, 1.03; 95% confidence interval [CI], 0.88-1.21). In contrast, associations with CVD events were observed for baseline non-high-density lipoprotein (HDL) cholesterol (HR, 1.18; 95% CI, 1.01-1.38), apolipoprotein B (HR, 1.28; 95% CI, 1.11-1.48), and ion mobility-measured non-HDL particles (HR, 1.19; 95% CI, 1.05-1.35) and LDL particles (HR, 1.21; 95% CI, 1.07-1.37). Association with CVD events was also observed for several LDL and very-low-density lipoprotein subfractions but not for ion mobility-measured HDL subfractions. In statin-allocated participants, CVD events were associated with on-treatment LDL-C, non-HDL cholesterol, and apolipoprotein B; these were also associated with CVD/all-cause death, as were several LDL and very-low-density lipoprotein subfractions, albeit with a pattern of association that differed from the baseline risk. In JUPITER, baseline LDL-C was not associated with CVD events, in contrast with significant associations for non-HDL cholesterol and atherogenic particles: apolipoprotein B and ion mobility-measured non-HDL particles, LDL particles, and select subfractions of very-low-density lipoprotein particles and

  9. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study.

    Science.gov (United States)

    Windecker, Stephan; Tijssen, Jan; Giustino, Gennaro; Guimarães, Ana H C; Mehran, Roxana; Valgimigli, Marco; Vranckx, Pascal; Welsh, Robert C; Baber, Usman; van Es, Gerrit-Anne; Wildgoose, Peter; Volkl, Albert A; Zazula, Ana; Thomitzek, Karen; Hemmrich, Melanie; Dangas, George D

    2017-02-01

    Optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) is unknown and determined empirically. The direct factor Xa inhibitor rivaroxaban may potentially reduce TAVR-related thrombotic complications and premature valve failure. GALILEO is an international, randomized, open-label, event-driven, phase III trial in more than 1,520 patients without an indication for oral anticoagulation who underwent a successful TAVR (ClinicalTrials.govNCT02556203). Patients are randomized (1:1 ratio), 1 to 7days after a successful TAVR, to either a rivaroxaban-based strategy or an antiplatelet-based strategy. In the experimental arm, subjects receive rivaroxaban (10mg once daily [OD]) plus acetylsalicylic acid (ASA, 75-100mg OD) for 90days followed by rivaroxaban alone. In the control arm, subjects receive clopidogrel (75mg OD) plus ASA (as above) for 90days followed by ASA alone. In case new-onset atrial fibrillation occurs after randomization, full oral anticoagulation will be implemented with maintenance of the original treatment assignment. The primary efficacy end point is the composite of all-cause death, stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, and systemic embolism. The primary safety end point is the composite of life-threatening, disabling, and major bleeding, according to the Valve Academic Research Consortium definitions. GALILEO will test the hypothesis that a rivaroxaban-based antithrombotic strategy reduces the risk of thromboembolic complications post-TAVR with an acceptable risk of bleeding compared with the currently recommended antiplatelet therapy-based strategy in subjects without need of chronic oral anticoagulation. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  10. High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: a randomised trial in South Africa.

    Science.gov (United States)

    Lagarde, Emmanuel; Taljaard, Dirk; Puren, Adrian; Auvert, Bertran

    2009-03-01

    The Tara KLamp (TK) device has been claimed to enable circumcisions to be performed safely and easily in medical and non-medical environments. Published evaluation studies have been conducted among young children only. Following a randomised controlled trial (RCT) on 3 274 participants on the impact of male circumcision on HIV transmission, 69 control group members participated in this male circumcision methods trial and were randomised to a forceps-guided (FG) group and a TK group, and circumcised. Of the 166 men asked to participate, 97 declined, most (94) refusing circumcision by the TK technique; 34 men were randomised to the FG group and 35 to the TK group, and 32 and 24 patients were circumcised by the FG and TK methods respectively, of whom 29 and 19 respectively attended the post-circumcision visit. All 12 adverse event sheets corresponded to the TK group (pv. 3%; p=0.004), delayed wound healing (21% v. 3%; p=0.004) and problems with penis appearance (31% v. 3%; p=0.001). Participants randomised to the TK method were significantly more likely to report bleeding (21% v. 0%; p=0.02), injury to the penis (21% v. 0%; p=0.02), infection (32% v. 0%; p=0.002), swelling (83%/ v. 0%; pv. 0%; p=0.056). The mean score of self-estimated pain was 9.5 for participants circumcised by TK compared with 6.1 for other participants (adjusted p=0.003). This study provides compelling evidence that strongly cautions against use of the TK method on young adults.

  11. Metabolites of Glutamate Metabolism Are Associated With Incident Cardiovascular Events in the PREDIMED PREvención con DIeta MEDiterránea (PREDIMED) Trial.

    Science.gov (United States)

    Zheng, Yan; Hu, Frank B; Ruiz-Canela, Miguel; Clish, Clary B; Dennis, Courtney; Salas-Salvado, Jordi; Hruby, Adela; Liang, Liming; Toledo, Estefania; Corella, Dolores; Ros, Emilio; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; Lapetra, José; Serra-Majem, Lluis; Estruch, Ramón; Martínez-González, Miguel A

    2016-09-15

    Glutamate metabolism may play a role in the pathophysiology of cardiometabolic disorders. However, there is limited evidence of an association between glutamate-related metabolites and, moreover, changes in these metabolites, and risk of cardiovascular disease (CVD). Plasma levels of glutamate and glutamine were measured at baseline and 1-year follow-up in a case-cohort study including 980 participants (mean age 68 years; 46% male) from the PREvención con DIeta MEDiterránea (PREDIMED) randomized trial, which assessed a Mediterranean diet intervention in the primary prevention of CVD. During median 4.8 years of follow-up, there were 229 incident CVD events (nonfatal stroke, nonfatal myocardial infarction, or CVD death). In fully adjusted models, per 1-SD, baseline glutamate was associated with 43% (95% CI: 16% to 76%) and 81% (39% to 137%) increased risk of composite CVD and stroke alone, respectively, and baseline glutamine-to-glutamate ratio with 25% (6% to 40%) and 44% (25% to 58%) decreased risk of composite CVD and stroke alone, respectively. Associations appeared linear for stroke (both Plinear trend≤0.005). Among participants with high baseline glutamate, the interventions lowered CVD risk by 37% compared to the control diet; the intervention effects were not significant when baseline glutamate was low (Pinteraction=0.02). No significant effect of the intervention on year-1 changes in metabolites was observed, and no effect of changes themselves on CVD risk was apparent. Baseline glutamate was associated with increased CVD risk, particularly stroke, and glutamine-to-glutamate ratio was associated with decreased risk. Participants with high glutamate levels may obtain greater benefits from the Mediterranean diet than those with low levels. URL: www.controlled-trials.com. Unique identifier: ISRCTN 35739639. © 2016 The Authors and The Broad Institute. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  12. Remote ischemic preconditioning reduces perioperative cardiac and renal events in patients undergoing elective coronary intervention: a meta-analysis of 11 randomized trials.

    Directory of Open Access Journals (Sweden)

    Hanjun Pei

    Full Text Available BACKGROUND: Results from randomized controlled trials (RCT concerning cardiac and renal effect of remote ischemic preconditioning(RIPC in patients with stable coronary artery disease(CAD are inconsistent. The aim of this study was to explore whether RIPC reduce cardiac and renal events after elective percutaneous coronary intervention (PCI. METHODS AND RESULTS: RCTs with data on cardiac or renal effect of RIPC in PCI were searched from Pubmed, EMBase, and Cochrane library (up to July 2014. Meta-regression and subgroup analysis were performed to identify the potential sources of significant heterogeneity(I(2 ≥ 40%. Eleven RCTs enrolling a total of 1713 study subjects with stable CAD were selected. Compared with controls, RIPC significantly reduced perioperative incidence of myocardial infarction (MI [odds ratio(OR = 0.68; 95% CI, 0.51 to 0.91; P = 0.01; I(2 = 41.0%] and contrast-induced acute kidney injury(AKI (OR = 0.61; 95% CI, 0.38 to 0.98; P = 0.04; I(2 = 39.0%. Meta-regression and subgroup analyses confirmed that the major source of heterogeneity for the incidence of MI was male proportion (coefficient  = -0.049; P = 0.047; adjusted R(2 = 0.988; P = 0.02 for subgroup difference. CONCLUSIONS: The present meta-analysis of RCTs suggests that RIPC may offer cardiorenal protection by reducing the incidence of MI and AKI in patients undergoing elective PCI. Moreover, this effect on MI is more pronounced in male subjects. Future high-quality, large-scale clinical trials should focus on the long-term clinical effect of RIPC.

  13. Influence of nitrous oxide anesthesia, B-vitamins, and MTHFR gene polymorphisms on perioperative cardiac events: the vitamins in nitrous oxide (VINO) randomized trial.

    Science.gov (United States)

    Nagele, Peter; Brown, Frank; Francis, Amber; Scott, Mitchell G; Gage, Brian F; Miller, J Philip

    2013-07-01

    Nitrous oxide causes an acute increase in plasma homocysteine that is more pronounced in patients with the methylenetetrahydrofolate reductase (MTHFR) C677T or A1298C gene variant. In this randomized controlled trial, the authors sought to determine whether patients carrying the MTHFR C677T or A1298C variant had a higher risk for perioperative cardiac events after nitrous oxide anesthesia and whether this risk could be mitigated by B-vitamins. The authors randomized adult patients with cardiac risk factors undergoing noncardiac surgery, to receive nitrous oxide plus intravenous B-vitamins before and after surgery, or to nitrous oxide and placebo. Serial cardiac biomarkers and 12-lead electrocardiograms were obtained. The primary study endpoint was the incidence of myocardial injury, as defined by cardiac troponin I increase within the first 72 h after surgery. A total of 500 patients completed the trial. Patients who were homozygous for either MTHFR C677T, or A1298C gene variant (n=98; 19.6%) had no increased rate of postoperative cardiac troponin I increase compared with wild-type and heterozygous patients (11.2 vs. 14.0%; relative risk 0.96; 95% CI, 0.85-1.07; P=0.48). B-vitamins blunted the rise in homocysteine, but had no effect on cardiac troponin I increase compared with patients receiving placebo (13.2 vs. 13.6%; relative risk 1.02; 95% CI 0.78 to 1.32; P=0.91). Neither MTHFR C677T and A1298C gene variant, nor acute homocysteine increase are associated with perioperative cardiac troponin increase after nitrous oxide anesthesia. B-vitamins blunt nitrous oxide-induced homocysteine increase but have no effect on cardiac troponin I increase.

  14. Diagnostic accuracy of point-of-care testing for acute coronary syndromes, heart failure and thromboembolic events in primary care: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Diemand Albert

    2011-03-01

    Full Text Available Abstract Background Evidence of the clinical benefit of 3-in-1 point-of-care testing (POCT for cardiac troponin T (cTnT, N-terminal pro-brain natriuretic peptide (NT-proBNP and D-dimer in cardiovascular risk stratification at primary care level for diagnosing acute coronary syndromes (ACS, heart failure (HF and thromboembolic events (TE is very limited. The aim of this study is to analyse the diagnostic accuracy of POCT in primary care. Methods Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls. Men and women presenting in 68 primary care practices in Zurich County (Switzerland with chest pain or symptoms of dyspnoea or TE were consecutively included after baseline consultation and working diagnosis. A follow-up visit including confirmed diagnosis was performed to determine the accuracy of the working diagnosis, and comparison of working diagnosis accuracy between the two groups. Results The 218 POCT patients and 151 conventional diagnosis controls were mostly similar in characteristics, symptoms and pre-existing diagnoses, but differed in working diagnosis frequencies. However, the follow-up visit showed no statistical intergroup difference in confirmed diagnosis frequencies. Working diagnoses overall were significantly more correct in the POCT group (75.7% vs 59.6%, p = 0.002, as were the working diagnoses of ACS/HF/TE (69.8% vs 45.2%, p = 0.002. All three biomarker tests showed good sensitivity and specificity. Conclusion POCT confers substantial benefit in primary care by correctly diagnosing significantly more patients. Trial registration DRKS: DRKS00000709

  15. Quality Appraisal of Single-Subject Experimental Designs: An Overview and Comparison of Different Appraisal Tools

    Science.gov (United States)

    Wendt, Oliver; Miller, Bridget

    2012-01-01

    Critical appraisal of the research literature is an essential step in informing and implementing evidence-based practice. Quality appraisal tools that assess the methodological quality of experimental studies provide a means to identify the most rigorous research suitable for evidence-based decision-making. In single-subject experimental research,…

  16. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)

    DEFF Research Database (Denmark)

    Poulter, Neil R; Wedel, Hans; Dahlöf, Björn

    2005-01-01

    Results of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA) show significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-based combination drug regimen than in those allocated an atenolol-based combination drug regimen (HR...

  17. Stent parameters predict major adverse clinical events and the response to platelet glycoprotein IIb/IIIa blockade: findings of the ESPRIT trial.

    Science.gov (United States)

    Tcheng, James E; Lim, Ing Haan; Srinivasan, Shankar; Jozic, Joseph; Gibson, C Michael; O'Shea, J Conor; Puma, Joseph A; Simon, Daniel I

    2009-02-01

    Only limited data describe relationships between stent parameters (length and diameter), adverse events after percutaneous coronary intervention, and effects of platelet glycoprotein IIb/IIIa blockade by stent parameters. In this post hoc analysis of the 1983 patients receiving a stent in the Enhanced Suppression of the Platelet Glycoprotein IIb/IIIa Receptor with Integrilin Therapy randomized percutaneous coronary intervention trial of eptifibatide versus placebo, rates of the major adverse cardiac event (MACE) end point (death, myocardial infarction, urgent target-vessel revascularization, or thrombotic bailout) at 48 hours and 1 year were correlated with stent parameters and then analyzed by randomization to eptifibatide versus placebo. In the placebo group, MACE increased with number of stents implanted, total stent length (by quartiles of or=30 mm), and total stented vessel area (by quartiles of area or=292 mm(2)). By stent parameters, MACE at 48 hours was reduced in the eptifibatide group at stent lengths of 18 to or=30 mm (OR, 0.43; 95% CI, 0.25 to 0.75; P=0.003), stent diameters of >2.5 to <3.5 mm (OR, 0.56; 95% CI, 0.39 to 0.82; P=0.002), and with 2 stents implanted (OR, 0.39; 95% CI, 0.22 to 0.69; P=0.001). In the placebo group, near-linear relationships were observed between both increasing stent length and increasing stented vessel area and MACE at 48 hours and 1 year (all, P<0.001); these gradients were flattened in the eptifibatide group (P=0.005 for stent length). Stent parameters predict MACE after percutaneous coronary intervention. Glycoprotein IIb/IIIa blockade mitigates much of the hazard of increasing procedural complexity.

  18. A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

    Directory of Open Access Journals (Sweden)

    Ramya Bhargava

    2015-01-01

    Full Text Available Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial. Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L or higher range group (1.8 to 2.4 mmol/L. Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events. Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result. Trial Registration Number. This trial is registered with ISRCTN registration number ISRCTN24741445.

  19. Management of adverse events in patients with hormone receptor-positive breast cancer treated with everolimus: observations from a phase III clinical trial.

    Science.gov (United States)

    Peterson, Mary E

    2013-08-01

    Everolimus is a mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced renal cell carcinoma, pancreatic neuroendocrine tumors, subependymal giant cell astrocytoma associated with tuberous sclerosis complex, renal angiomyolipoma and tuberous sclerosis complex, and, in combination with exemestane, for hormone receptor-positive HER2-negative advanced breast cancer after failure of treatment with letrozole or anastrozole. Results from the phase III BOLERO-2 trial demonstrated that everolimus in combination with exemestane provided significant clinical benefit to patients with advanced hormone receptor-positive breast cancer. Although everolimus is generally well tolerated, as with most therapies administered in an advanced cancer setting, drug-related adverse events (AEs) inevitably occur. Most common AEs observed in the everolimus studies include stomatitis, rash, infection, noninfectious pneumonitis, and hyperglycemia. Clinical awareness and early identification of such AEs by oncology nurses are essential to dosing (interruptions, reduction, and treatment discontinuation); quality of life; and, ultimately, patient outcomes. Because everolimus has already been shown to significantly improve clinical efficacy in patients with advanced breast cancer, a proactive approach to the practical management of AEs associated with this mTOR inhibitor as well as other most common AEs observed in this patient population has been reviewed and outlined here.

  20. Relationship between Pulmonary Adverse Events and Everolimus Exposure in Japanese and Non-Japanese Patients: A Meta-Analysis of Oncology Trials.

    Science.gov (United States)

    Noguchi, Shinzaburo; Shinohara, Nobuo; Ito, Tetsuhide; Ohtsu, Atsushi; Ravaud, Alain; Jerusalem, Guy; Ohno, Nobutsugu; Gallo, Jorge; Bouillaud, Emmanuel; Fan, Jenna; Nonomura, Norio

    2017-01-01

    This meta-analysis explores the relationship between the everolimus minimum (Cmin) and maximum (Cmax) exposure and the risk for pulmonary adverse events (AEs) in Japanese versus non-Japanese patients. Patient-level data from patients treated with daily everolimus in advanced solid tumor trials were evaluated using a Cox regression model, stratified by cancer type or treatment arm, with log-transformed time-averaged Cmin or Cmax as a time-varying covariate. Kaplan-Meier analysis was used to evaluate the relationship between pulmonary AEs and pharmacokinetic parameters. Thirty studies were identified. In the Cmin population (n = 1,962), all-grade pulmonary AE incidence was significantly higher in Japanese versus non-Japanese patients (19.9 vs. 9.4%). Pharmacokinetic parameters were similar between Japanese and non-Japanese patients. A 2-fold increase in everolimus Cmin significantly increased the risk for the first any-grade pulmonary AE in Japanese (risk ratio: 1.824; 95% CI: 1.141-2.918) and non-Japanese patients (risk ratio: 1.406; 95% CI: 1.156-1.710). The risk for pulmonary AEs is related to everolimus exposure. Local monitoring and reporting differences might account for the significantly higher reported incidence of low-grade everolimus-associated pulmonary AEs in Japanese versus non-Japanese patients. Patients should be carefully monitored for early signs of pulmonary AEs, and appropriate medical management should be implemented. © 2017 S. Karger AG, Basel.

  1. Assessing and appraising nursing students' professional communication

    Science.gov (United States)

    Diers, Jane E.

    The purpose of this research was to define professional communication in nursing and to develop a prototype to assess and appraise communication at a selected college. The research focused on verbal and nonverbal communication between the nurse and the client using a simulated environment. The first objective was to identify the major characteristics of professional communication in nursing. In this study, the characteristics of professional communication emerged from the constant comparison method of the results of research studies in the fields of healthcare and communication. These characteristics became the elements, representative properties, and descriptive dimensions to assess and appraise verbal and nonverbal communication at the college of study. The second objective was to develop a template to assess verbal and nonverbal communication at a selected college. Using a two-fold process, the researcher used the results from the first objective to begin template construction. First, specialists in the fields of communication and nursing established the content validity of the elements, representative properties, and descriptive dimensions. Second, the course educators determined the relevancy and importance of the elements, properties, and descriptive dimensions to the objectives of two courses at the college of study. The third objective was to develop a rubric to appraise nursing students' verbal and nonverbal communication in a videotaped communication review. An appraisal rubric was constructed from an extension of the template. This rubric was then tested by faculty at the selected college to appraise the communication of five students each in the junior and senior years of the nursing program.

  2. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial.

    Science.gov (United States)

    Ikeda, Yasuo; Shimada, Kazuyuki; Teramoto, Tamio; Uchiyama, Shinichiro; Yamazaki, Tsutomu; Oikawa, Shinichi; Sugawara, Masahiro; Ando, Katsuyuki; Murata, Mitsuru; Yokoyama, Kenji; Ishizuka, Naoki

    2014-12-17

    Prevention of atherosclerotic cardiovascular diseases is an important public health priority in Japan due to an aging population. To determine whether daily, low-dose aspirin reduces the incidence of cardiovascular events in older Japanese patients with multiple atherosclerotic risk factors. The Japanese Primary Prevention Project (JPPP) was a multicenter, open-label, randomized, parallel-group trial. Patients (N = 14,464) were aged 60 to 85 years, presenting with hypertension, dyslipidemia, or diabetes mellitus recruited by primary care physicians at 1007 clinics in Japan between March 2005 and June 2007, and were followed up for up to 6.5 years, with last follow-up in May 2012. A multidisciplinary expert panel (blinded to treatment assignments) adjudicated study outcomes. Patients were randomized 1:1 to enteric-coated aspirin 100 mg/d or no aspirin in addition to ongoing medications. Composite primary outcome was death from cardiovascular causes (myocardial infarction, stroke, and other cardiovascular causes), nonfatal stroke (ischemic or hemorrhagic, including undefined cerebrovascular events), and nonfatal myocardial infarction. Secondary outcomes included individual end points. The study was terminated early by the data monitoring committee after a median follow-up of 5.02 years (interquartile range, 4.55-5.33) based on likely futility. In both the aspirin and no aspirin groups, 56 fatal events occurred. Patients with an occurrence of nonfatal stroke totaled 114 in the aspirin group and 108 in the no aspirin group; of nonfatal myocardial infarction, 20 in the aspirin group and 38 in the no aspirin group; of undefined cerebrovascular events, 3 in the aspirin group and 5 in the no aspirin group. The 5-year cumulative primary outcome event rate was not significantly different between the groups (2.77% [95% CI, 2.40%-3.20%] for aspirin vs 2.96% [95% CI, 2.58%-3.40%] for no aspirin; hazard ratio [HR], 0.94 [95% CI, 0.77-1.15]; P = .54). Aspirin

  3. Comparison of African American college students' coping with racially and nonracially stressful events.

    Science.gov (United States)

    Hoggard, Lori S; Byrd, Christy M; Sellers, Robert M

    2012-10-01

    Racial discrimination, a common experience for many African Americans, has been conceptualized within a stress and coping framework. However, few have examined whether racially stressful events are appraised and coped with differently from nonracially stressful events. The present study uses a daily diary method to examine African American college students' appraisals and coping behaviors in racially and nonracially stressful situations. The study examines the following 3 questions: 1) Do African Americans appraise racially stressful events differently from nonracially stressful events? 2) Do they cope with racially stressful events differently from nonracially stressful events? and 3) Do they cope with racially stressful events differently from nonracially stressful events, even after controlling for differences in cognitive appraisals of the events? The present sample consists of 35 participants who reported experiencing at least one racially stressful event and at least one nonracially stressful event during a 20-day diary study. Overall, no differences were found in students' appraisals in the racially stressful versus nonracially stressful events. Participants used less planful problem solving and more confrontive, ruminative, and avoidance coping strategies in the racially stressful events as compared with the nonracially stressful events. These findings suggest a need for race-specific models for coping with racial discrimination. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

  4. How to critically appraise an article.

    Science.gov (United States)

    Young, Jane M; Solomon, Michael J

    2009-02-01

    Critical appraisal is a systematic process used to identify the strengths and weaknesses of a research article in order to assess the usefulness and validity of research findings. The most important components of a critical appraisal are an evaluation of the appropriateness of the study design for the research question and a careful assessment of the key methodological features of this design. Other factors that also should be considered include the suitability of the statistical methods used and their subsequent interpretation, potential conflicts of interest and the relevance of the research to one's own practice. This Review presents a 10-step guide to critical appraisal that aims to assist clinicians to identify the most relevant high-quality studies available to guide their clinical practice.

  5. How to locate and appraise qualitative research in complementary and alternative medicine.

    Science.gov (United States)

    Franzel, Brigitte; Schwiegershausen, Martina; Heusser, Peter; Berger, Bettina

    2013-06-03

    The aim of this publication is to present a case study of how to locate and appraise qualitative studies for the conduct of a meta-ethnography in the field of complementary and alternative medicine (CAM). CAM is commonly associated with individualized medicine. However, one established scientific approach to the individual, qualitative research, thus far has been explicitly used very rarely. This article demonstrates a case example of how qualitative research in the field of CAM studies was identified and critically appraised. Several search terms and techniques were tested for the identification and appraisal of qualitative CAM research in the conduct of a meta-ethnography. Sixty-seven electronic databases were searched for the identification of qualitative CAM trials, including CAM databases, nursing, nutrition, psychological, social, medical databases, the Cochrane Library and DIMDI. 9578 citations were screened, 223 articles met the pre-specified inclusion criteria, 63 full text publications were reviewed, 38 articles were appraised qualitatively and 30 articles were included. The search began with PubMed, yielding 87% of the included publications of all databases with few additional relevant findings in the specific databases. CINHAL and DIMDI also revealed a high number of precise hits. Although CAMbase and CAM-QUEST® focus on CAM research only, almost no hits of qualitative trials were found there. Searching with broad text terms was the most effective search strategy in all databases. This publication presents a case study on how to locate and appraise qualitative studies in the field of CAM. The example shows that the literature search for qualitative studies in the field of CAM is most effective when the search is begun in PubMed followed by CINHAL or DIMDI using broad text terms. Exclusive CAM databases delivered no additional findings to locate qualitative CAM studies.

  6. How to locate and appraise qualitative research in complementary and alternative medicine

    Science.gov (United States)

    2013-01-01

    Background The aim of this publication is to present a case study of how to locate and appraise qualitative studies for the conduct of a meta-ethnography in the field of complementary and alternative medicine (CAM). CAM is commonly associated with individualized medicine. However, one established scientific approach to the individual, qualitative research, thus far has been explicitly used very rarely. This article demonstrates a case example of how qualitative research in the field of CAM studies was identified and critically appraised. Methods Several search terms and techniques were tested for the identification and appraisal of qualitative CAM research in the conduct of a meta-ethnography. Sixty-seven electronic databases were searched for the identification of qualitative CAM trials, including CAM databases, nursing, nutrition, psychological, social, medical databases, the Cochrane Library and DIMDI. Results 9578 citations were screened, 223 articles met the pre-specified inclusion criteria, 63 full text publications were reviewed, 38 articles were appraised qualitatively and 30 articles were included. The search began with PubMed, yielding 87% of the included publications of all databases with few additional relevant findings in the specific databases. CINHAL and DIMDI also revealed a high number of precise hits. Although CAMbase and CAM-QUEST® focus on CAM research only, almost no hits of qualitative trials were found there. Searching with broad text terms was the most effective search strategy in all databases. Conclusions This publication presents a case study on how to locate and appraise qualitative studies in the field of CAM. The example shows that the literature search for qualitative studies in the field of CAM is most effective when the search is begun in PubMed followed by CINHAL or DIMDI using broad text terms. Exclusive CAM databases delivered no additional findings to locate qualitative CAM studies. PMID:23731997

  7. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial.

    Science.gov (United States)

    Huffman, Jeff C; Mastromauro, Carol A; Beach, Scott R; Celano, Christopher M; DuBois, Christina M; Healy, Brian C; Suarez, Laura; Rollman, Bruce L; Januzzi, James L

    2014-06-01

    Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events. There has been minimal study of collaborative care (CC) management models for mental health disorders in high-risk cardiac inpatients, and no prior CC intervention has simultaneously managed depression and anxiety disorders. To determine the impact of a low-intensity CC intervention for depression, generalized anxiety disorder, and panic disorder among patients hospitalized for an acute cardiac illness. Single-blind randomized clinical trial, with study assessors blind to group assignment, from September 2010 through July 2013 of 183 patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome, arrhythmia, or heart failure and found to have clinical depression, generalized anxiety disorder, or panic disorder on structured assessment. Participants were randomized to 24 weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders (n = 92) or to enhanced usual care (serial notification of primary medical providers; n = 91). The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate. Improvement in mental health-related quality of life (Short Form-12 Mental Component Score [SF-12 MCS]) at 24 weeks, compared between groups using a random-effects model in an intent-to-treat analysis. Patients randomized to CC had significantly greater estimated mean improvements in SF-12 MCS at 24 weeks (11.21 points [from 34.21 to 45.42] in the CC group vs 5.53 points [from 36.30 to 41.83] in the control group; estimated mean difference, 5.68 points [95% CI, 2.14-9.22]; P = .002; effect size, 0.61). Patients receiving CC also had significant improvements in depressive symptoms and general functioning, and higher rates of

  8. 19 CFR 152.108 - Unacceptable bases of appraisement.

    Science.gov (United States)

    2010-04-01

    ... merchandise may not be appraised on the basis of: (a) The selling price in the United States of merchandise... merchandise that is identical merchandise, or similar merchandise, to the merchandise being appraised; (e) The...

  9. 9 CFR 52.3 - Appraisal of swine.

    Science.gov (United States)

    2010-01-01

    ... are known to be infected with pseudorabies will be appraised by an APHIS employee and a representative... determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that...

  10. 19 CFR 127.23 - Appraisement of merchandise.

    Science.gov (United States)

    2010-04-01

    ... shall be appraised in accordance with sections 402 and 402a, Tariff Act of 1930, as amended (19 U.S.C. 1401a, 1402). Such merchandise shall also be appraised at its actual domestic value in its condition at...

  11. What is interesting? Exploring the appraisal structure of interest.

    Science.gov (United States)

    Silvia, Paul J

    2005-03-01

    Relative to other emotions, interest is poorly understood. On the basis of theories of appraisal process and structure, it was predicted that interest consists of appraisals of novelty (factors related to unfamiliarity and complexity) and appraisals of coping potential (the ability to understand the new, complex thing). Four experiments, using in vivo rather than retrospective methods, supported this appraisal structure. The findings were general across measured and manipulated appraisals, interesting stimuli (random polygons, visual art, poetry), and measures of interest (self-reports, forced-choice, behavioral measures). Furthermore, the appraisal structure was specific to interest (it did not predict enjoyment, a related positive emotion), and appraisals predicted interest beyond relevant traits (curiosity, openness). The appraisal perspective offers a powerful way of construing the causes of interest. Copyright 2005 APA, all rights reserved.

  12. Performance appraisal and merit recognition exercise 2007

    CERN Multimedia

    HR Department

    2006-01-01

    The 2007 performance appraisal and merit recognition exercise will start in the usual way with annual interviews between staff and their supervisors. This year, these interviews should be held in the period from 8 January 2007 to 16 April 2007. Interconnection with the 5-yearly review, a number of modifications to the procedures relating to the performance appraisal and merit recognition are currently under study. Administrative Circular No. 26 (Procedures governing the Career Development of Staff Members) and the electronic MAPS form in EDH are being reviewed and will be available from January onwards. HR Department will shortly provide further information on this subject. Human Resources Department Tel. 73566

  13. Naturalizing language: human appraisal and (quasi) technology

    DEFF Research Database (Denmark)

    Cowley, Stephen

    2013-01-01

    interactivity. This species-specific form of sense-making sustains, among other things, using texts, making/construing phonetic gestures and thinking. Human action is thus grounded in appraisals or sense-saturated coordination. To illustrate interactivity at work, the paper focuses on a case study. Over 11 s......, a crime scene investigator infers that she is probably dealing with an inside job: she uses not words, but intelligent gaze. This connects professional expertise to circumstances and the feeling of thinking. It is suggested that, as for other species, human appraisal is based in synergies. However, since...

  14. Religion, Psychology and Globalisation Process: Attitudinal Appraisal

    Directory of Open Access Journals (Sweden)

    Emmanuel Orok Duke

    2016-10-01

    Full Text Available A key consequence of globalisation is the integrative approach to reality whereby emphasis is placed on interdependence. Religion being an expression of human culture is equally affected by this cultural revolution. The main objective of this paper is to examine how religious affiliation, among Christians, influences attitudes towards the application of psychological sciences to the assuagement of human suffering. The sociological theory of structural functionalism was deployed to explain attitudinal appraisal. Ethnographic methodology, through quantitative analysis of administered questionnaire, was also used. The study reveals that religious tenets largely shape attitudinal appraisal and redefine the borders of globalisation’s metanarratives.

  15. Sequential unfolding of appraisals: EEG evidence for the interaction of novelty and pleasantness.

    Science.gov (United States)

    van Peer, Jacobien M; Grandjean, Didier; Scherer, Klaus R

    2014-02-01

    An important question in emotion research is what elicits emotions and causes variations in their quality and intensity. Appraisal theories propose a cognitive process through which stimuli are evaluated on a number of different criteria. The combination of results on these criteria determines which specific emotion is elicited. In the present study, we addressed several questions regarding the mechanisms underlying this process, specifically whether appraisal criteria are processed (a) in a fixed sequence, (b) independently of each other, and (c) by different neural structures or circuits. Two appraisal criteria, stimulus novelty and pleasantness, were manipulated with a 3-stimulus oddball paradigm with affective pictures. Electroencephalographic (EEG) markers for the appraisal processes were distinguished using a spatiotemporal clustering analysis. Consistent with theories that assume a fixed sequence of the appraisal process, the analyses revealed early effects of novelty on global field power and the topographical pattern of EEG activity, followed in time by effects involving pleasantness. Moreover, both measures showed significant interactions of novelty and pleasantness in late processing stages (650 ms-800 ms), indicating that the processing of pleasantness depends on the preceding appraisal of novelty. The results of spatiotemporal clustering suggest that the late processing of highly relevant stimuli is not based on a single mechanism, but consists of the initial activation of distinct neural processes to evaluate novel stimuli, followed by activation of different neural mechanisms for the combined evaluation of both novel and highly valenced (i.e., unpleasant or pleasant) stimuli (a distinction that is not apparent in conventional event-related potential measures). PsycINFO Database Record (c) 2014 APA, all rights reserved.

  16. The System of Employee Appraisal in a Company

    OpenAIRE

    Vaverová, Lucie

    2011-01-01

    This bachelor study called "The System of Employee Appraisal in a Company" deals with a general subscription of a personal process "Employee appraisal". It describes the principles of the system of employee appraisal and also covers the conditions necessary for its efficiency and operation. The bachelor study is focused on the system of employee appraisal centrally implemented in company ČEZ, a. s. This system is analyzed and compared with generally stated theoretical principles. The study in...

  17. Effect of Genotype-Guided Warfarin Dosing on Clinical Events and Anticoagulation Control Among Patients Undergoing Hip or Knee Arthroplasty: The GIFT Randomized Clinical Trial.

    Science.gov (United States)

    Gage, Brian F; Bass, Anne R; Lin, Hannah; Woller, Scott C; Stevens, Scott M; Al-Hammadi, Noor; Li, Juan; Rodríguez, Tomás; Miller, J Philip; McMillin, Gwendolyn A; Pendleton, Robert C; Jaffer, Amir K; King, Cristi R; Whipple, Brandi DeVore; Porche-Sorbet, Rhonda; Napoli, Lynnae; Merritt, Kerri; Thompson, Anna M; Hyun, Gina; Anderson, Jeffrey L; Hollomon, Wesley; Barrack, Robert L; Nunley, Ryan M; Moskowitz, Gerard; Dávila-Román, Victor; Eby, Charles S

    2017-09-26

    Warfarin use accounts for more medication-related emergency department visits among older patients than any other drug. Whether genotype-guided warfarin dosing can prevent these adverse events is unknown. To determine whether genotype-guided dosing improves the safety of warfarin initiation. The randomized clinical Genetic Informatics Trial (GIFT) of Warfarin to Prevent Deep Vein Thrombosis included patients aged 65 years or older initiating warfarin for elective hip or knee arthroplasty and was conducted at 6 US medical centers. Enrollment began in April 2011 and follow-up concluded in October 2016. Patients were genotyped for the following polymorphisms: VKORC1-1639G>A, CYP2C9*2, CYP2C9*3, and CYP4F2 V433M. In a 2 × 2 factorial design, patients were randomized to genotype-guided (n = 831) or clinically guided (n = 819) warfarin dosing on days 1 through 11 of therapy and to a target international normalized ratio (INR) of either 1.8 or 2.5. The recommended doses of warfarin were open label, but the patients and clinicians were blinded to study group assignment. The primary end point was the composite of major bleeding, INR of 4 or greater, venous thromboembolism, or death. Patients underwent a screening lower-extremity duplex ultrasound approximately 1 month after arthroplasty. Among 1650 randomized patients (mean age, 72.1 years [SD, 5.4 years]; 63.6% women; 91.0% white), 1597 (96.8%) received at least 1 dose of warfarin therapy and completed the trial (n = 808 in genotype-guided group vs n = 789 in clinically guided group). A total of 87 patients (10.8%) in the genotype-guided group vs 116 patients (14.7%) in the clinically guided warfarin dosing group met at least 1 of the end points (absolute difference, 3.9% [95% CI, 0.7%-7.2%], P = .02; relative rate [RR], 0.73 [95% CI, 0.56-0.95]). The numbers of individual events in the genotype-guided group vs the clinically guided group were 2 vs 8 for major bleeding (RR, 0.24; 95% CI, 0

  18. 41 CFR 102-75.310 - Who must agencies use to appraise the real property?

    Science.gov (United States)

    2010-07-01

    ... appraise the real property? 102-75.310 Section 102-75.310 Public Contracts and Property Management Federal... PROPERTY DISPOSAL Surplus Real Property Disposal Appraisal § 102-75.310 Who must agencies use to appraise... with the types of property to be appraised when conducting the appraisal. When an appraisal is required...

  19. Negative Cognitive Errors and Positive Illusions: Moderators of Relations between Divorce Events and Children's Psychological Adjustment.

    Science.gov (United States)

    Mazur, Elizabeth; Wolchik, Sharlene

    Building on prior literature on adults' and children's appraisals of stressors, this study investigated relations among negative and positive appraisal biases, negative divorce events, and children's post-divorce adjustment. Subjects were 79 custodial nonremarried mothers and their children ages 9 to 13 who had experienced parental divorce within…

  20. Patterns of blood pressure response during intensive BP lowering and clinical events: results from the secondary prevention of small subcortical strokes trial.

    Science.gov (United States)

    Ku, Elaine; Scherzer, Rebecca; Odden, Michelle C; Shlipak, Michael; White, Carole L; Field, Thalia S; Benavente, Oscar; Pergola, Pablo E; Peralta, Carmen A

    2018-04-01

    We applied cluster analysis to identify discrete patterns of concomitant responses of systolic (SBP), diastolic (DBP) and pulse pressure (PP) during intensive BP lowering; and to evaluate their clinical relevance and association with risk of mortality, major vascular events (MVEs), and stroke. We used an unsupervised cluster procedure to identify distinct patterns of BP change during the first 9 months of anti-hypertensive therapy intensification among 1,331 participants in the Secondary Prevention of Small Subcortical Strokes Trial who were previously randomized to lower BP target (SBP < 130 mm Hg) after lacunar stroke. The cluster procedure partitioned participants into three groups in the lower SBP target arm, persons with: 1) mildly elevated baseline SBP and minimal visit-to-visit BP variability (mild reducers); 2) moderately elevated baseline SBP and moderate visit-to-visit BP variability (moderate reducers); and 3) very elevated baseline SBP with very large visit-to-visit BP variability during intensification (large reducers). In the lower SBP target group, moderate reducers had a higher risk of death (adjusted HR 1.6 [95% CI 1.0-2.7]), MVE (adjusted HR 2.1 [95% CI 1.4-3.2]), and stroke (adjusted HR 2.6[95% CI 1.7-4.1]) compared to mild reducers. Large reducers had the highest risk of death (adjusted HR 2.3 [95% CI 1.2-4.4]), but risk of MVE (HR = 1.7 [95%CI 0.9-3.1]) and stroke (HR = 1.6 [95%CI: 0.8-3.5]) were not statistically significantly different compared to mild reducers. Among persons with prior lacunar stroke, baseline BP levels, and BP variability in the setting of intensive BP lowering can identify discrete groups of persons at higher risk of adverse outcomes.

  1. Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular events. A randomized controlled trial.

    Science.gov (United States)

    Vaccaro, O; Masulli, M; Bonora, E; Del Prato, S; Giorda, C B; Maggioni, A P; Mocarelli, P; Nicolucci, A; Rivellese, A A; Squatrito, S; Riccardi, G

    2012-11-01

    Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Multicentre, randomized, open label, parallel group trial of 48 month duration. Type 2 diabetic subjects, 50-75 years, BMI 20-45 Kg/m(2), on secondary failure to metformin monotherapy will be randomized to add-on a sulfonylurea or pioglitazone. The primary efficacy outcome is a composite endpoint of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, and unplanned coronary revascularization. Principal secondary outcome is a composite ischemic endpoint of sudden death, fatal and non-fatal myocardial infarction and stroke, endovascular or surgical intervention on the coronary, leg or carotid arteries, major amputations. Side effects, quality of life and economic costs will also be evaluated. Efficacy, safety, tolerability, and study conduct will be monitored by an independent Data Safety Monitoring Board. End points will be adjudicated by an independent external committee. TOSCA.IT is the first on-going study investigating the head-to-head comparison of adding a sulfonylurea or pioglitazone to existing metformin treatment in terms of hard cardiovascular outcomes. Clinicaltrials.gov ID NCT00700856. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. 77 FR 54721 - Appraisals for Higher-Risk Mortgage Loans

    Science.gov (United States)

    2012-09-05

    ... Part 1222 Appraisals for Higher-Risk Mortgage Loans; Proposed Rule #0;#0;Federal Register / Vol. 77... Part 1222 RIN 2590-AA58 Appraisals for Higher-Risk Mortgage Loans AGENCIES: Board of Governors of the... TILA provision requiring appraisals for ``higher-risk mortgages'' that was added to TILA as part of the...

  3. 78 FR 10367 - Appraisals for Higher-Priced Mortgage Loans

    Science.gov (United States)

    2013-02-13

    ... Part 1222 Appraisals for Higher-Priced Mortgage Loans; Final Rule #0;#0;Federal Register / Vol. 78, No... Part 1222 RIN 2590-AA58 Appraisals for Higher-Priced Mortgage Loans AGENCY: Board of Governors of the... requiring appraisals for ``higher-risk mortgages'' that was added to TILA by the Dodd-Frank Wall Street...

  4. Characteristics of Appraisal Systems That Promote Job Satisfaction of Teachers

    Science.gov (United States)

    Deneire, Alexia; Vanhoof, Jan; Faddar, Jerich; Gijbels, David; Van Petegem, Peter

    2014-01-01

    This article examines if and how characteristics of appraisal systems used for secondary school teachers affect job satisfaction. Using multilevel analyses on data of 3 473 teachers in Flanders (Belgium), we found that appraisals with a developmental purpose and appraisals perceived as being a fair judgement, both have a positive impact on job…

  5. 28 CFR 345.41 - Performance appraisal for inmate workers.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Performance appraisal for inmate workers... FEDERAL PRISON INDUSTRIES (FPI) INMATE WORK PROGRAMS Inmate Worker Standards and Performance Appraisal § 345.41 Performance appraisal for inmate workers. Work supervisors should complete a performance...

  6. Appraising Composing in Secondary-School Music Lessons

    Science.gov (United States)

    Major, Angela E.

    2008-01-01

    The aim of this paper is to define music appraisal and to explore the role that talk plays in the process of helping pupils in secondary school music lessons to develop their appraisal skills. This paper offers a definition of appraisal, and traces its developing role in the National Curriculum in England since the early 1990s. The role of…

  7. Teacher appraisal in Botswana secondary schools: a critical analysis

    African Journals Online (AJOL)

    Teacher appraisal in Botswana secondary schools: a critical analysis. ... It emerged that many teachers viewed the current teacher appraisal system in Botswana as demoralising, even threatening. Our study confirmed the thesis that ... There is hardly a country in the world where teacher appraisal is not a contentious issue.

  8. 19 CFR 152.101 - Basis of appraisement.

    Science.gov (United States)

    2010-04-01

    ..., Trade Agreements Act of 1979. (b) Methods. Imported merchandise will be appraised on the basis, and in... computed value method, the merchandise will be appraised using the deductive value method if it is possible to do so. If the deductive value cannot be determined, the appraised value will be determined as...

  9. Performance Appraisal in UK Universities: A Case of Procedural Compliance?

    Science.gov (United States)

    Bryman, Alan; And Others

    1994-01-01

    Research evidence concerning the introduction of performance appraisal in United Kingdom universities is presented. The notion of "procedural compliance" is introduced to draw attention to the largely externally imposed appraisal of universities and to the nature of institutional response. Findings of a study of appraisal in four…

  10. Problems of Clinical Nurse Performance Appraisal System: A Qualitative Study

    Directory of Open Access Journals (Sweden)

    Nasrin Nikpeyma

    2014-03-01

    Conclusion: The findings of this study reveal that the nurse performance appraisal system confronts with various problems. Some of these problems are related to organizational context while the others concerned structure, process and results of the performance appraisal system. In order to achieve high quality of patient care as the final goal of performance appraisal, changing and revision of this system is necessary.

  11. Teacher Appraisal and Its Outcomes in Singapore Primary Schools

    Science.gov (United States)

    Kelly, Khim Ong; Ang, Shi Yun Angela; Chong, Wei Ling; Hu, Wei Sheng

    2008-01-01

    Purpose: The purpose of this paper is to examine the attributes of the performance appraisal system used for primary school teachers in Singapore, and how those attributes affect satisfaction with the appraisal system, stress experienced with the appraisal system, attitudes towards performance bonus, job satisfaction and motivation, and perceived…

  12. Pain and Other Non-Neurological Adverse Events in Children with Sickle Cell Anemia and Previous Stroke who Received Hydroxyurea and Phlebotomy or Chronic Transfusions and Chelation: Results from the SWiTCH Clinical Trial

    Science.gov (United States)

    Alvarez, Ofelia; Yovetich, Nancy A.; Scott, J. Paul; Owen, William; Miller, Scott T.; Schultz, William; Lockhart, Alexandre; Aygun, Banu; Flanagan, Jonathan; Bonner, Melanie; Mueller, Brigitta U.; Ware, Russell E.

    2014-01-01

    Purpose To compare the non-neurological events in children with sickle cell anemia (SCA) and previous stroke enrolled in SWiTCH. Methods The NHLBI-sponsored Phase III multicenter randomized clinical trial Stroke With Transfusions Changing to Hydroxyurea (SWiTCH) (ClinicalTrials.gov NCT00122980) compared continuation of chronic blood transfusion/iron chelation to switching to hydroxyurea/phlebotomy for secondary stroke prevention and management of iron overload. All randomized children were included in the analysis (intention to treat). The Fisher's Exact test was used to compare the frequency of subjects who experienced at least one SCA-related adverse event (AE) or serious adverse event (SAE) in each arm and to compare event rates. Results 133 subjects, mean age 13 ±3.9 years (range 5.2-19.0 years) and mean time of 7 years on chronic transfusion at study entry, were randomized and treated. Numbers of subjects experiencing non-neurological AEs were similar in the two treatment arms, including SCA-related events, SCA pain events, and low rates of acute chest syndrome and infection. However, fewer children continuing transfusion/chelation experienced SAEs (p=0.012), SCA-related SAEs (p=0.003), and SCA pain SAEs (p=0.016) as compared to children on the hydroxyurea/phlebotomy arm. The timing of phlebotomy did not influence SAEs. Older age at baseline predicted having at least 1 SCA pain event. Patients with recurrent neurological events during SWiTCH were not more likely to experience pain. Conclusions In children with SCA and prior stroke, monthly transfusions and daily iron chelation provided superior protection against acute vaso-occlusive pain SAEs when compared to hydroxyurea and monthly phlebotomy. PMID:23861242

  13. 38 CFR 36.4365 - Appraisal requirements.

    Science.gov (United States)

    2010-07-01

    ... demonstrate a ready market, or (ii) The declarant will provide cash assets or acceptable bonds for payment of... Appraisal requirements. (a) Existing resale condominiums. Upon acceptance by the local office of the...) Low rise and high rise condominiums. Low rise and high rise condominiums shall comply with local...

  14. African Traditional Sculptures: An Appraisal of Classification ...

    African Journals Online (AJOL)

    These are the aesthetic (form and structure) and the ethnological (function) approaches. These approaches, however, seem to be bedeviled by inhering weaknesses. In this paper, both approaches (the aesthetic and the ethnological) are appraised and their hermitic and misleading characters are highlighted. It is then ...

  15. Role of Appraisals in Energy Efficiency Financing

    Energy Technology Data Exchange (ETDEWEB)

    Doyle, V.; Bhargava, A.

    2012-05-01

    This research identifies barriers and challenges and current industry status including several key appraisal industry developments for identifying and valuing energy efficiency, critical obstacles to documenting and assessing the potential added value from energy efficiency improvements, current opportunities to support and standardize reporting on energy efficiency and to ensure proper valuation, and next steps towards enabling energy efficiency financing market transformation.

  16. Validating the Watson Glaser Critical Thinking Appraisal

    Science.gov (United States)

    Hassan, Karma El; Madhum, Ghida

    2007-01-01

    This study validated the Watson Glaser Critical Thinking Appraisal (WGCTA) on a sample of 273 private university students in Lebanon. For that purpose, evidence for construct validation was investigated through identifying the test's factor structure and subscale total correlations, in addition to differences in scores by gender, different levels,…

  17. APPRAISING THE CONDITIONS OF UNIVERSAL MORALITY ...

    African Journals Online (AJOL)

    , both physical and social, the existence of which creates the atmosphere for the evolution of cross-cultural values and by which we can appraise values that will lead to the development of human society. The call for a context-bound ...

  18. Teacher trainees' appraisal of guidance and counselling ...

    African Journals Online (AJOL)

    The study appraised the guidance and counselling services in Colleges of Education in Ghana. Four research questions were posed to direct the study. The evaluation research design was used whilst a multi – stage sampling procedure was employed to select a sample of 185 students. A 40–item questionnaire with ...

  19. United Nations and multilateralism: appraising USA's unilateralism ...

    African Journals Online (AJOL)

    Multilateralism as symbolized by the United Nations Organization, seems to have come under threat today, and nowhere is this more evident than in the United States-United Nations relations particularly in the area of military interventions around the world. The aim of this paper is to appraise the practice of the principle of ...

  20. 32 CFR 644.44 - Fee appraisals.

    Science.gov (United States)

    2010-07-01

    ... and justification must be given for each amount. Adjustments may be shown either by a tabular analysis or by a narrative discussion. (4) The market value of an income-producing property is quite often... to Remainder $20,000 (3) The appraisal of the property before the taking must be a complete narrative...

  1. Evaluating Housing Problems through Participatory Rural Appraisal ...

    African Journals Online (AJOL)

    Lokoja, a medium sized community in the Middle Belt of Nigeria experienced a massive influx of population in the last twelve years. This study examined housing problems that resulted thereafter. Through a participatory appraisal using group discussion and brainstorming, transect walk and matrix ranking, a sampled ...

  2. Employee Perceptions and Value of Performance Appraisals

    Science.gov (United States)

    Bagnell, Rhea

    2012-01-01

    Performance appraisals traditionally have been studied quantitatively, from the manager's point of view, without considering their value or lack of value to workers. The absence of this information indicates that workers' perceptions and feelings have not always been considered. Therefore, the purpose of this phenomenological study was…

  3. Implementing performance appraisal : Exploring the employee experience

    NARCIS (Netherlands)

    Farndale, E.; Kelliher, C.

    2013-01-01

    Line managers play an important role as implementers of performance appraisal, enacting procedures designed by the HR function. However, the actual employee experience of these procedures (which may differ from how they were intended or enacted) in terms of perceptions of justice in the process is

  4. Organisational Justice Theory Perceptions in Performance Appraisal ...

    African Journals Online (AJOL)

    This paper examines employees. perceptions of the performance appraisal system of a Ghanaian tertiary institution in terms of satisfaction and fairness to the system, utilizing a hypothesized four-factor justice model of organizational justice as the theoretical basis. The study was conducted using 119 senior administrative ...

  5. Appraisal in Context: Clashing with Organizational Realities.

    Science.gov (United States)

    McCall, Morgan W., Jr.; DeVries, David L.

    In spite of the efforts of researchers and practitioners, performance appraisal systems remain more of an albatross than an effective organizational tool. The movement toward objective measurement, employee participation, multiple raters, and the like, represents a definite improvement over traditional trait ratings. Still, internal improvements…

  6. Accountability and records appraisal | Tough | ESARBICA Journal ...

    African Journals Online (AJOL)

    This article endeavours to highlight a variety of issues around accountability and appraisal and does so from the perspective of parliamentary systems of government. These include many African countries as well as Australia, Barbados, Canada, India, New Zealand, the United Kingdom (UK). This should be an appropriate ...

  7. Energy considerations in real estate appraising

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-04-01

    Purposes of the seminar on the subject, the basis of this report, include the following: (1) to provide the appraiser an opportunity to learn how to identify and analyze the actual physical consumption of energy as well as the energy-saving improvements in properties under appraisal and in comparable sale and lease properties; (2) to help the appraiser in developing methods to keep meaningful records on the energy consumption of subject and comparable properties so as to observe in an orderly way the behavior of buyers, sellers, tenants, landlords, borrowers, and lenders with respect to energy efficiency; and (3) to assist the appraiser in learning to measure the relative sensitivities of the various segments of the market to energy considerations as indicated by differences in sale prices and rentals. To achieve these goals, the seminar employed two case studies, one for a angle-family residence and one for a multi-family building, both in Topeka, Kansas. The case studies are for illustrative purposes only; in applying the lessons of the seminar to their own daily work, students should be careful to develop information that is pertinent to their subject properties and subject areas and not rely on any of the particulars laid out in the cases.

  8. *Corresponding author Mineralogical Appraisal of Sediments of ...

    African Journals Online (AJOL)

    MICHAEL

    Mineralogical Appraisal of Sediments of Duricrust Suites and Pans around Jwaneng. Area, Botswana. 1*ATLHOPHENG, JULIUS R; 2GEORGES-IVO E. EKOSSE. 1. Department of Environmental Science, University of Botswana, Private Bag UB0704. Gaborone. 2. Geology, Mining and Minerals Programs, University of ...

  9. Performance Appraisal Interview: A Review of Research.

    Science.gov (United States)

    1987-01-01

    found that feedback from patients and co-workers had a greater impact on " nurses’ perceptions of the link between delivering high quality patient care ...Occupational Psycology , 47, 225-230. Fletcher, C. & Williams, R. (1976). The influence of performance feedback in appraisal interviews. Journal of

  10. 7 CFR 762.127 - Appraisal requirements.

    Science.gov (United States)

    2010-01-01

    ... security is generally required on all loans. An appraisal for loans or lines of credit for annual.... On loan transactions of $250,000 or less, the lender must demonstrate to the Agency's satisfaction... agricultural property. On loan transactions greater than $250,000, which includes principal plus accrued...

  11. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation).

    Science.gov (United States)

    Goodman, Shaun G; Wojdyla, Daniel M; Piccini, Jonathan P; White, Harvey D; Paolini, John F; Nessel, Christopher C; Berkowitz, Scott D; Mahaffey, Kenneth W; Patel, Manesh R; Sherwood, Matthew W; Becker, Richard C; Halperin, Jonathan L; Hacke, Werner; Singer, Daniel E; Hankey, Graeme J; Breithardt, Gunter; Fox, Keith A A; Califf, Robert M

    2014-03-11

    This study sought to report additional safety results from the ROCKET AF (Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF trial demonstrated similar risks of stroke/systemic embolism and major/nonmajor clinically relevant bleeding (principal safety endpoint) with rivaroxaban and warfarin. The risk of the principal safety and component bleeding endpoints with rivaroxaban versus warfarin were compared, and factors associated with major bleeding were examined in a multivariable model. The principal safety endpoint was similar in the rivaroxaban and warfarin groups (14.9 vs. 14.5 events/100 patient-years; hazard ratio: 1.03; 95% confidence interval: 0.96 to 1.11). Major bleeding risk increased with age, but there were no differences between treatments in each age category (<65, 65 to 74, ≥75 years; pinteraction = 0.59). Compared with those without (n = 13,455), patients with a major bleed (n = 781) were more likely to be older, current/prior smokers, have prior gastrointestinal (GI) bleeding, mild anemia, and a lower calculated creatinine clearance and less likely to be female or have a prior stroke/transient ischemic attack. Increasing age, baseline diastolic blood pressure (DBP) ≥90 mm Hg, history of chronic obstructive pulmonary disease or GI bleeding, prior acetylsalicylic acid use, and anemia were independently associated with major bleeding risk; female sex and DBP <90 mm Hg were associated with a decreased risk. Rivaroxaban and warfarin had similar risk for major/nonmajor clinically relevant bleeding. Age, sex, DBP, prior GI bleeding, prior acetylsalicylic acid use, and anemia were associated with the risk of major bleeding. (An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: NCT00403767

  12. Retrospective Appraisals Mediate the Effects of Combat Experiences on PTS and Depression Symptoms in U.S. Army Medics.

    Science.gov (United States)

    Pitts, Barbara L; Safer, Martin A

    2016-02-01

    A life-threatening traumatic experience can cause physical and psychological distress, but it can also be remembered with pride from having demonstrated one's courage and abilities under severe circumstances. Characteristics of the event, early response, as well as later personal reflection, together determine the individual's response to a traumatic event. We investigated how traumatic combat experiences and retrospective appraisals of those experiences affected reports of symptoms of posttraumatic stress and depression in 324 U.S. Army medics. Higher levels of combat experiences were associated with both appraisals of threat to life (r = .40) and appraisals of personal benefit of the deployment (r = .15). Threat appraisals were associated with increases (r = .33 and .29), whereas benefit appraisals were associated with decreases (r = -.28 and -.30, respectfully), in symptoms of posttraumatic stress and depression. These opposing mediation pathways led to weak or nonsignificant total effects, which concealed the effects of combat intensity on posttraumatic stress (R(2) = .28) and depression (R(2) = .24). Acknowledging the beneficial effects that a combat experience had on one's life was associated with less intense behavioral health symptoms and offset the detrimental effects of traumatic combat experiences. Copyright © 2016 International Society for Traumatic Stress Studies.

  13. The Role of Cumulative Trauma, Betrayal, and Appraisals in Understanding Trauma Symptomatology

    OpenAIRE

    Martin, Christina Gamache; Cromer, Lisa DeMarni; DePrince, Anne P.; Freyd, Jennifer J.

    2011-01-01

    Poor psychological outcomes are common among trauma survivors, yet not all survivors experience adverse sequelae. The current study examined links between cumulative trauma exposure as a function of the level of betrayal (measured by the relational closeness of the survivor and the perpetrator), trauma appraisals, gender, and trauma symptoms. Participants were 273 college students who reported experiencing at least one traumatic event on a trauma checklist. Three cumulative indices were const...

  14. Response Inhibition and Cognitive Appraisal in Clients with Acute Stress Disorder and Posttraumatic Stress Disorder

    Directory of Open Access Journals (Sweden)

    Abass Abolghasemi

    2013-09-01

    Full Text Available Objective: The purpose of the present study was to compare response inhibition and cognitive appraisal in clients with acute stress disorder, clients with posttraumatic stress disorder, and normal individuals .Method:This was a comparative study. The sample consisted of 40 clients with acute stress disorder, 40 patients with posttraumatic stress disorder, and 40 normal individuals from Mazandaran province selected through convenience sampling method. Data were collected using Composite International Diagnostic Interview, Stroop Color-Word Test, Posttraumatic Cognitions Inventory, and the Impact of Event Scale. Results:Results showed that individuals with acute stress disorder are less able to inhibit inappropriate responses and have more impaired cognitive appraisals compared to those with posttraumatic stress disorder. Moreover, results showed that response inhibition and cognitive appraisal explain 75% of the variance in posttraumatic stress disorder symptoms and 38% of the variance in posttraumatic stress disorder symptoms .Conclusion:The findings suggest that response inhibition and cognitive appraisal are two variables that influence the severity of posttraumatic stress disorder and acute stress disorder symptoms. Also, these results have important implications for pathology, prevention, and treatment of posttraumatic stress disorder and acute stress disorder

  15. How Should an Effective Performance Appraisal Be: EFL Teachers’ Perspective

    Directory of Open Access Journals (Sweden)

    Holi Ibrahim Holi Ali

    2012-11-01

    Full Text Available This study is set to examine EFL teachers’ perceptions, views about what makes an effective performance appraisal system by adopting a quantitative survey design for data collection. A total number of 45 college instructors in the Sultanate of Oman responded to survey on: how is an effective performance appraisal perceived by EFL teachers? How do teachers perceive their participation in developing the appraisal system? And how might the present performance appraisal practices be improved? The result reveals that staff participation in developing performance appraisal system and goals, feedback confidentiality, quality appraiser, quality of place and time of appraisal, appraiser-appraisee relationships, and developmental nature of performance appraisal would help in making effective appraisal and the overall PA effectiveness depends mostly on these factors. The result has a significant implication for improving the process of teacher performance appraisal in Oman and enriches the body knowledge of PA in general. The study puts forwards suggestions and recommendations for improving PA practices and exercises in EFL contexts.

  16. Trastuzumab-Associated Cardiac Events at 8 Years of Median Follow-Up in the Herceptin Adjuvant Trial (BIG 1-01)

    NARCIS (Netherlands)

    de Azambuja, Evandro; Procter, Marion J.; van Veldhuisen, Dirk J.; Agbor-Tarh, Dominique; Metzger-Filho, Otto; Steinseifer, Jutta; Untch, Michael; Smith, Ian E.; Gianni, Luca; Baselga, Jose; Jackisch, Christian; Cameron, David A.; Bell, Richard; Leyland-Jones, Brian; Dowsett, Mitch; Gelber, Richard D.; Piccart-Gebhart, Martine J.; Suter, Thomas M.

    2014-01-01

    Purpose To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following 1 or 2 years of adjuvant therapy. Patients and Methods The Herceptin Adjuvant (HERA) trial is a three-arm, randomized trial comparing 2 years or 1 year of trastuzumab with observation in

  17. A Randomized Controlled Trial Investigating the Effects of Neurofeedback, Methylphenidate, and Physical Activity on Event-Related Potentials in Children with Attention-Deficit/Hyperactivity Disorder.

    Science.gov (United States)

    Janssen, Tieme Willem Pieter; Bink, Marleen; Geladé, Katleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-05-01

    Electroencephalographic (EEG) neurofeedback (NF) is considered a nonpharmacological alternative for medication in attention-deficit/hyperactivity disorder (ADHD). Comparisons of the behavioral efficacy of NF and medication have produced inconsistent results. EEG measures can provide insight into treatment mechanisms, but have received little consideration. In this randomized controlled trial (RCT), effects of NF were compared with methylphenidate (MPH), and physical activity (PA) in children with ADHD on event-related potential (ERP) indices of response inhibition, which are involved in ADHD psychopathology. Using a multicenter three way parallel group RCT design, 112 children with a Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) (American Psychiatric Association 1994 ) diagnosis of ADHD, between 7 and 13 years of age, were initially included. NF training consisted of 30 sessions of theta/beta training at Cz over a 10 week period. PA training was a semiactive control group, matched in frequency and duration. MPH was titrated using a double-blind placebo controlled procedure in 6 weeks, followed by a stable dose for 4 weeks. ERP measures of response inhibition, N2 and P3, were available for 81 children at pre- and postintervention (n = 32 NF, n = 25 MPH, n = 24 PA). Only the medication group showed a specific increase in P3 amplitude compared with NF (partial eta-squared [ηp(2) ] = 0.121) and PA (ηp(2) = 0.283), which was related to improved response inhibition. Source localization of medication effects on P3 amplitude indicated increased activation primarily in thalamic and striatal nuclei. This is the first study that simultaneously compared NF with stimulant treatment and a semiactive control group. Only stimulant treatment demonstrated specific improvements in brain function related to response inhibition. These results are in line with recent doubts on the efficacy and specificity of NF as treatment for ADHD. Train

  18. EXCESS PRESSURE INTEGRAL PREDICTS CARDIOVASCULAR EVENTS INDEPENDENT OF OTHER RISK FACTORS IN THE CONDUIT ARTERY FUNCTIONAL EVALUATION (CAFE) SUB-STUDY OF ANGLO-SCANDINAVIAN CARDIAC OUTCOMES TRIAL (ASCOT)

    Science.gov (United States)

    Davies, Justin E; Lacy, Peter; Tillin, Therese; Collier, David; Cruickshank, J Kennedy; Francis, Darrel P; Malaweera, Anura; Mayet, Jamil; Stanton, Alice; Williams, Bryan; Parker, Kim H; McG Thom, Simon A; Hughes, Alun D

    2014-01-01

    Excess pressure integral (XSPI), a new index of surplus work performed by the left ventricle, can be calculated from blood pressure (BP) waveforms and may indicate circulatory dysfunction. We investigated whether XSPI predicted future cardiovascular (CV) events and target organ damage in treated hypertensive individuals. Radial BP waveforms were acquired by tonometry in 2069 individuals (63±8y) in the Conduit Artery Functional Evaluation sub-study of the Anglo-Scandinavian Cardiac Outcomes trial. Measurements of left ventricular mass index (LVMI; n = 862) and common carotid artery intima media thickness (cIMT; n = 923) were also performed. XSPI and the integral of reservoir pressure (PRI) were lower in people treated with amlodipine ± perindopril than atenolol ± bendroflumethiazide, although brachial systolic BP was similar. A total of 134 CV events accrued over a median 3.4 years of follow-up; XSPI was a significant predictor of CV events after adjustment for age and sex and this relationship was unaffected by adjustment for conventional CV risk factors or Framingham risk score. XSPI, central systolic BP, central augmentation pressure (AP), central pulse pressure (cPP) and PRI were correlated with LVMI, but only XSPI, AP and cPP were positively associated with cIMT. Associations between LVMI and XSPI and PRI, and cIMT and XSPI were unaffected by multivariable adjustment for other covariates. XSPI is a novel indicator of CV dysfunction and independently predicts CV events and target organ damage in a prospective clinical trial. PMID:24821941

  19. A systematic appraisal of the Evidence-Based Dentistry Journal.

    Science.gov (United States)

    Mehta, Nikisha; Marshman, Zoe

    2016-09-01

    BackgroundThis systematic appraisal was conducted to determine if the Evidence-Based Dentistry Journal (EBDJ) acts as a reliable and contemporary source of knowledge for practitioners across all disciplines within dentistry.ObjectivesThe main objectives were to determine i) the year the articles were published and included in the EBDJ; ii) if the articles published covered all fields equally within dentistry; iii) the type of study design of the articles reported in the journal and; iv) the level of expertise of the writers of the commentaries.MethodsThis study used a systematic approach to assess the articles included in the journal. Data were extracted on the difference in the year the article was originally published and the year the article was included in the EBDJ, the number of articles in each dental discipline, the type of study designs included in the journal and the expertise of the commentators of each article. The information provided by the journal was validated by accessing the original articles through electronic databases.ResultsThe appraisal considered the 582 articles that met the inclusion criteria. Overall, 45.3% of the articles were included in the EBDJ in the same year and 44.8% of the articles were included a year after they were originally published. The number of articles varied across disciplines within dentistry: 23.7% from dental public health, 18.4% from periodontology and 11.8% from orthodontics, with only 4.6% from prosthodontics, 1% from oral pathology and 0.5% from dental materials. Most of the articles were systematic reviews and randomised controlled trials at 72% and 22.3% respectively. The writers of the commentaries were mostly academics and hospital consultants (71.2% and 13.6% commentators).ConclusionsOn the whole, it can be concluded that the journal acts as a reliable and contemporary source of knowledge/evidence for dentists, however, not all specialities within dentistry had equal coverage.

  20. A critical appraisal of the phenomenon of aspirin resistance

    DEFF Research Database (Denmark)

    Svenstrup Poulsen, Tina; Risom Kristensen, Søren; Atar, Dan

    2005-01-01

    Aspirin is the mainstay antiplatelet treatment in patients with high risk of cardiovascular atherothrombotic events, and its beneficial effect is documented in several clinical trials. Nevertheless, the effectiveness of aspirin has been questioned by the emergence of the concept of 'aspirin...

  1. Addition of an oral histamine antagonist to reduce adverse events associated with fumaric acid esters in the treatment of psoriasis: a randomized double-blind placebo-controlled trial.

    Science.gov (United States)

    Balak, D M W; Fallah-Arani, S; Venema, C M; Neumann, H A M; Thio, H B

    2015-03-01

    Fumaric acid esters (FAEs) are considered an effective and safe long-term treatment for psoriasis. However, 30-40% of patients need to discontinue FAE treatment due to intolerable adverse events. To assess whether the addition of cetirizine, an oral histamine-1 receptor antagonist, to FAEs would reduce the incidence of adverse events. In a randomized, double-blind, placebo-controlled trial, patients with psoriasis with a Psoriasis Area and Severity Index ≥ 10 starting an FAE up to a dose of dimethylfumarate 720 mg per day were randomized 1 : 1 to receive either additional cetirizine 10 mg once daily (n = 25) or placebo (n = 25) for 12 weeks. Randomization and treatment allocation were done at our hospital trial pharmacy. Primary outcomes were the incidence of adverse events and the proportion of patients discontinuing treatment. Fifty patients (33 male, 17 female; median age 44 years) were enrolled. Addition of cetirizine did not reduce the incidence of adverse events compared with placebo (84% vs. 84%, P = 1·00). The types of adverse events were not different between the cetirizine and placebo groups, the most common being gastrointestinal complaints (68% vs. 64%) and flushes (60% vs. 48%). The proportion of patients discontinuing treatment was not statistically different between the cetirizine and placebo groups (24% vs. 32%, P = 0·53). Addition of oral cetirizine 10 mg once daily to FAE treatment did not reduce adverse events in patients with psoriasis during the first 12 weeks of treatment. The mechanisms underlying FAE-induced gastrointestinal and flushing symptoms likely involve mediators other than histamine. © 2014 British Association of Dermatologists.

  2. An Appraisal of Coupled Climate Model Simulations

    Energy Technology Data Exchange (ETDEWEB)

    Sperber, K; Gleckler, P; Covey, C; Taylor, K; Bader, D; Phillips, T; Fiorino, M; Achutarao, K

    2004-02-24

    In 2002, the Program for Climate Model Diagnosis and Intercomparison (PCMDI) proposed the concept for a state-of-the-science appraisal of climate models to be performed approximately every two years. Motivation for this idea arose from the perceived needs of the international modeling groups and the broader climate research community to document progress more frequently than provided by the Intergovernmental Panel on Climate Change (IPCC) Assessment Reports. A committee of external reviewers, which included senior researchers from four leading international modeling centers, supported the concept by stating in its review: ''The panel enthusiastically endorses the suggestion that PCMDI develop an independent appraisal of coupled model performance every 2-3 years. This would provide a useful 'mid-course' evaluation of modeling progress in the context of larger IPCC and national assessment activities, and should include both coupled and single-component model evaluations.''

  3. Not so critical appraisal of dapagliflozin

    Directory of Open Access Journals (Sweden)

    Doggrell SA

    2014-08-01

    Full Text Available Sheila A Doggrell School of Biomedical Science, Faculty of Health, Queensland University of Technology, Brisbane, QLD, AustraliaA recent review by Salvo et al published in Patient Preference and Adherence concerned dapagliflozin, and was titled “Patient considerations in the management of type 2 diabetes – critical appraisal of dapagliflozin”.1 Having read the article, I do not consider it to be a critical appraisal of dapagliflozin. Thus, after comparing dapagliflozin with other oral antidiabetic medications, the authors concluded that “Dapagliflozin’s noted blood pressure reduction, weight loss, and low potential to cause hypoglycemia are advantageous, when compared with currently available oral medications”.1 This statement is not supported by the content of the review and/or the literature. Read the original article 

  4. Performance appraisal and advancement exercise 2006

    CERN Multimedia

    Human Resources Department

    2005-01-01

    The 2006 performance appraisal and advancement exercise will start in the usual way with annual interviews between staff and their supervisors. This year, these interviews should be held in the period from 1 December 2005 to 31 March 2006. In this connection, a number of improvements to the procedures relating to the interviews and performance appraisal are currently under study. Administrative Circular No 26 (Procedures governing the Career Development of Staff Members) and the electronic MAPS form in EDH are being reviewed and will be available from December onwards. In the meantime supervisors can start the interview procedure. HR Department will shortly provide further information on this subject. The 2005 MAPS report can be retrieved for consultation at any time via EDH. Human Resources Department Tel. 73566

  5. Performance appraisal and advancement exercise 2006 (Rev)

    CERN Multimedia

    Human Resources Department

    2005-01-01

    The 2006 performance appraisal and advancement exercise will start in the usual way with annual interviews between staff and their supervisors. This year, these interviews should be held in the period from 1 December 2005 to 15 March 2006*. In this connection, a number of improvements to the procedures relating to the interviews and performance appraisals are currently under study. Administrative Circular No. 26 (Procedures Governing the Career Development of Staff Members) and the electronic MAPS form in EDH are being reviewed and will be available from December onwards. In the meantime supervisors can start the interview procedure. HR Department will shortly provide further information on this subject. The 2005 MAPS report can be retrieved for consultation at any time via EDH. * Instead of 31 March, as indicated in the electronic Bulletin No. 47 of 21 November 2005 Human Resources Department Tel. 73566

  6. Promotional literature: how do we critically appraise?

    Science.gov (United States)

    Shetty, V V; Karve, A V

    2008-01-01

    There has been a tremendous increase in the number of new and generic drugs coming into the market. The busy practitioner obtains the information from various sources, of which promotional literature forms an important source. The promotional literature provided by the pharmaceutical companies cannot be entirely relied upon; moreover, very few physicians are equipped with the skills of critically appraising it. The new drug should be relevant to the clinician's practice in terms of population studied, the disease and the need for new treatment. The methodology of the study should be carefully judged to determine the authenticity of the evidence. The new drug should be preferred over the existing one if it offers clear advantages in terms of safety, tolerability, efficacy and price. Critical appraisal of promotional literature can provide valuable information to the busy physician to practice evidence-based medicine.

  7. Mood and creativity: an appraisal tendency perspective

    OpenAIRE

    de Rooij, A.; Jones, S.

    2013-01-01

    There is a strong relationship between the mood one is in, and the way one performs creatively. Previous research has shown that this relationship is complex. In this paper we argue that this complexity partly lies in a faulty conceptualization of mood. We will argue that an appraisal tendency perspective on moods will help to further clarify the relationship between mood and creativity. To support this argument we will highlight some inconsistencies in previous research, and use the appraisa...

  8. Identification of Employee Performance Appraisal Methods in Agricultural Organizations

    Directory of Open Access Journals (Sweden)

    Venclova Katerina

    2013-06-01

    Full Text Available A formal employee performance appraisal is regarded as one of the tools of human resources performance management. People, their knowledge and skills are currently considered to be the most valuable resource a company has. The article focuses on methods of employee performance appraisal in agricultural organizations in the Czech Republic. The first part of the article deals with the theoretical background of the term “formal appraisal” and employee performance appraisal methods as defined by Czech and foreign specialists. Further, the article describes, based on a questionnaire survey, employee performance appraisal methods that are considered importantfor the agricultural organizations in the Czech Republic. The aim of the article is to identify the current state of formal employee appraisal in a sample group of agricultural organizationsand to test dependencies between selected qualitative characteristics. The outcomes show that the most commonly used methods of employee performance appraisal in agricultural organizations include predefined goal-based performance appraisal, predefined standard outcome-based performance appraisal and appraisal interviews. Agricultural organizations apply these methodsin particular due to the fact that their findings are further utilized in other areas of human resource management, such as reward system and personnel planning. In statistical terms, dependencybetween the method of employee performance appraisal according to predefined goals applied by agricultural organizations and personnel planning (an area of human resources managementhas been proven (p-value: 0.032, Phi coefficient: 4.578.

  9. Endothelial dysfunction: a comprehensive appraisal

    Directory of Open Access Journals (Sweden)

    Vilariño Jorge O

    2006-02-01

    vasodilatation produced by drugs that are NO donors, such as nitroglycerine, called "endothelium independent". The vasodilatation is quantified by measuring the arterial diameter with high resolution ultrasonography. Laser-Doppler techniques are now starting to be used that also consider tissue perfusion. There is so much proof about endothelial dysfunction that it is reasonable to believe that there is diagnostic and prognostic value in its evaluation for the late outcome. There is no doubt that endothelial dysfunction contributes to the initiation and progression of atherosclerotic disease and could be considered an independent vascular risk factor. Although prolonged randomized clinical trials are needed for unequivocal evidence, the data already obtained allows the methods of evaluation of endothelial dysfunction to be considered useful in clinical practice and have overcome the experimental step, being non-invasive increases its value making it use full for follow-up of the progression of the disease and the effects of different treatments.

  10. Cognitive appraisals and problem-directed coping: a prospective study of stress.

    Science.gov (United States)

    Krantz, S E

    1983-03-01

    Information-seeking and problem-directed coping behaviors following a stressful event were observed as a function of cognitive appraisals of coping resources. Subjectively defined failure on a college exam served as an example of a mild stressor. Prior to the first midterm exam, students generated alternative strategies that could be used in the event of dissatisfaction with performance and rated the feasibility of using these strategies. Academic coping behaviors were measured by self-report and direct observation during the 3 weeks prior to the next exam. Coping cognitions were found to predict academic behaviors but not exam scores.

  11. The effect of valsartan, captopril, or both on atherosclerotic events after acute myocardial infarction: an analysis of the Valsartan in Acute Myocardial Infarction Trial (VALIANT)

    DEFF Research Database (Denmark)

    McMurray, John; Solomon, Scott; Pieper, Karen

    2006-01-01

    . It is not clear whether ARBs reduce atherosclerotic events such as myocardial infarction (MI) like ACE inhibitors. This evidence gap may reflect the nature of the studies conducted, to date. Placebo-controlled studies enrolled cohorts at low risk of atherosclerotic events (e.g., patients with chronic heart...

  12. Fewer adverse events as a result of the SAFE or SORRY? programme in hospitals and nursing homes. part i: primary outcome of a cluster randomised trial

    NARCIS (Netherlands)

    Gaal, B. van; Schoonhoven, L.; Mintjes, J.A.; Borm, G.F.; Hulscher, M.E.J.L.; Defloor, T.; Habets, H.; Voss, A.; Vloet, L.C.M.; Koopmans, R.T.C.M.; Achterberg, T. van

    2011-01-01

    BACKGROUND: Patient care guidelines are usually implemented one at a time, yet patients are at risk for multiple, often preventable, adverse events simultaneously. OBJECTIVE: This study aimed to test the effect of the SAFE or SORRY? programme on the incidence of three adverse events (pressure

  13. Safety reporting and adverse-event profile of mirtazapine described in randomized controlled trials in comparison with other classes of antidepressants in the acute-phase treatment of adults with depression: systematic review and meta-analysis.

    Science.gov (United States)

    Watanabe, Norio; Omori, Ichiro M; Nakagawa, Atsuo; Cipriani, Andrea; Barbui, Corrado; McGuire, Hugh; Churchill, Rachel; Furukawa, Toshi A

    2010-01-01

    Mirtazapine has a unique mechanism of antidepressant action, and thus is thought to have a different profile of adverse events from that of other antidepressants. To present a methodologically rigorous systematic review of the adverse event profile of mirtazapine and point to possible problems with safety reporting in randomized controlled trials (RCTs) of the acute-phase treatment of major depression in adults with mirtazapine in comparison with other types of antidepressant. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register was electronically searched using the following search terms: 'depress*', 'dysthymi*', 'adjustment disorder*', 'mood disorder*', 'affective disorder', 'affective symptoms' and 'mirtazapine'. Pharmaceutical companies and experts in this field were contacted, and the reference lists of the relevant RCTs were checked, for additional data. No language restriction was imposed. Two authors independently assessed the quality of trials for inclusion in the review. Disagreements were resolved by consensus. Two authors independently extracted data on adverse events. Disagreements were resolved by consensus. The adequacy of safety reporting was assessed by one author. Regarding the adequacy of safety reporting, the qualitative and quantitative parameters of safety reporting were determined. Regression analyses were conducted to assess characteristics of trials influencing safety reporting. The primary and secondary outcomes in the systematic review of the adverse events associated with mirtazapine were defined as the proportion of patients having each of 43 adverse events listed in the modified version of the WHO Adverse Reaction Terminology, and the proportion of patients experiencing at least one adverse event, respectively. Meta-analyses were conducted for these outcomes. Twenty-five RCTs involving 4842 patients were identified as meeting our inclusion criteria. With regard to safety reporting, only two trials and

  14. MASS APPRAISAL AND REAL ESTATE TAXATION

    Directory of Open Access Journals (Sweden)

    VORONIN V. О.

    2015-12-01

    Full Text Available Raising of problem. The government at the legislative level fixed the definition of market value for tax purposes as mandatory in the implementation of real estate transactions. In order to meet the requirements of objectivity, uniformity and consistency of the results obtained during the evaluation procedures, as well as minimize the influence of subjective factors, there is a need to develop a methodology for evaluating an automated procedure for determining the estimated value of the property based on its market value. To solve this problem, we use special techniques and methods of mass appraisal that incorporates computer-supported statistical analyses, such as multiple regression analysis and adaptive estimation procedure for use in the field of property valuation and property rights. Purpose. Realization of this goal involves the development of the concept of a computer-assisted mass appraisal. The basis of this concept is an adaptive hybrid models of market pricing in different market segments that incorporates software adaptive algorithms for determining the market value by the three evaluation approaches using the results of a multi-level real estate market analysis. It was proposed the utility automated valuation models which is intended for the implementation of a computerized real estate valuation based on the developed software adaptive algorithms. Con-clusion. To achieve this goal have been developed and used concepts underlying of computerized mass appraisal. The basis of this concept is adaptive hybrid pricing models in various segments of the real estate market of Ukraine. The problem is solved by the application of the developed software-based adaptive algorithms for determining the market value of three evaluation approaches using the results of a multi-level analysis of the real estate market. It was pro-posed the model of automated appraisal, according to it was implemented computerization of appraisal procedures on the

  15. A novel adaptation of a parent-child observational assessment tool for appraisals and coping in children exposed to acute trauma.

    Science.gov (United States)

    Marsac, Meghan L; Kassam-Adams, Nancy

    2016-01-01

    Millions of children worldwide are exposed to acute potentially traumatic events (PTEs) annually. Many children and their families experience significant emotional distress and/or functional impairment following PTEs. While current research has begun to highlight a role for early appraisals and coping in promoting or preventing full recovery from PTEs, the exact nature of the relationships among appraisals, coping, and traumatic stress reactions as well as how appraisals and coping behaviors are influenced by the child's environment (e.g., parents) remains unclear; assessment tools that reach beyond self-report are needed to improve this understanding. The objective of the current study is to describe the newly created Trauma Ambiguous Situations Tool (TAST; i.e., an observational child-parent interview and discussion task that allows assessment of appraisals, coping, and parent-child processes) and to report on initial feasibility and validation of TAST implemented with child-parent dyads in which children were exposed to a PTE. As part of a larger study on the role of biopsychosocial factors in posttraumatic stress reactions, children (aged 8-13) and parents (n=25 child-parent dyads) completed the TAST during the child's hospitalization for injury. Children and parents engaged well with the TAST. The time to administer the TAST was feasible, even in a peri-trauma context. The TAST solicited a wide array of appraisals (threat and neutral) and coping solutions (proactive and avoidant). Forced-choice and open-ended appraisal assessments provided unique information. The parent-child discussion portion of the TAST allowed for direct observation of parent-child processes and demonstrated parental influence on children's appraisals and coping solutions. The TAST is a promising new research tool, which may help to explicate how parents influence their child's developing appraisals and coping solutions following a PTE. More research should examine the relationships of

  16. Research report appraisal: how much understanding is enough?

    Science.gov (United States)

    Lipscomb, Martin

    2014-07-01

    When appraising research papers, how much understanding is enough? More specifically, in deciding whether research results can inform practice, do appraisers need to substantively understand how findings are derived or is it sufficient simply to grasp that suitable analytic techniques were chosen and used by researchers? The degree or depth of understanding that research appraisers need to attain before findings can legitimately/sensibly inform practice is underexplored. In this paper it is argued that, where knowledge/justified beliefs derived from research evidence prompt actions that materially affect patient care, appraisers have an epistemic duty to demand high (maximal) rather than low (minimal) levels of understanding regards finding derivation (i.e. appraisers have a duty to seek a superior epistemic situation). If this argument holds assumptions about appraiser competence/ability and the feasibility of current UK conceptions of evidence based practice are destabilized. © 2014 John Wiley & Sons Ltd.

  17. A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events.

    Science.gov (United States)

    Faillie, Jean-Luc; Ferrer, Pili; Gouverneur, Amandine; Driot, Damien; Berkemeyer, Shoma; Vidal, Xavier; Martínez-Zapata, Maria José; Huerta, Consuelo; Castells, Xavier; Rottenkolber, Marietta; Schmiedl, Sven; Sabaté, Mònica; Ballarín, Elena; Ibáñez, Luisa

    2017-06-01

    The objective of the study was to develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events. We developed a structured risk of bias checklist applicable to randomized trials, cohort, case-control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers. Interrater and intrarater reliability were determined using 20 randomly selected studies, assessed by three other independent reviewers including one performing a 3-week retest. The developed checklist examines eight domains: study design and objectives, selection bias, attrition, adverse events information bias, other information bias, statistical methods to control confounding, other statistical methods, and conflicts of interest. The total number of questions varied from 10 to 32 depending on the study design. Interrater and intrarater agreements were fair with Kendall's W of 0.70 and 0.74, respectively. Median time to complete the checklist was 8.5 minutes. The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events. Hence, it might be considered as a novel useful tool for systematic reviews and meta-analyses focusing on drug safety. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Body-related cognitions, affect and post-event processing in body dysmorphic disorder.

    Science.gov (United States)

    Kollei, Ines; Martin, Alexandra

    2014-03-01

    Cognitive behavioural models postulate that individuals with BDD engage in negative appearance-related appraisals and affect. External representations of one's appearance are thought to activate a specific mode of processing characterized by increased self-focused attention and an activation of negative appraisals and affect. The present study used a think-aloud approach including an in vivo body exposure to examine body-related cognitions and affect in individuals with BDD (n = 30), as compared to individuals with major depression (n = 30) and healthy controls (n = 30). Participants were instructed to think aloud during baseline, exposure and follow-up trials. Individuals with BDD verbalized more body-related and more negative body-related cognitions during all trials and reported higher degrees of negative affect than both control groups. A weaker increase of positive body-related cognitions during exposure, a stronger increase of sadness and anger after exposure and higher levels of post-event processing, were specific processes in individuals with BDD. Individuals with major depression were not excluded from the BDD group. This is associated with a reduction of internal validity, as the two clinical groups are somewhat interwoven. Key findings need to be replicated. The findings indicate that outcomes such as negative appearance-related cognitions and affect are specific to individuals with BDD. An external representation of one's appearance activates a specific mode of processing in BDD, manifesting itself in the absence of positive body-related cognitions, increased anger and sadness, and high levels of post-event processing. These specific processes may contribute toward maintenance of BDD psychopathology. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. Development of the Pain Appraisal Inventory: Psychometric Properties

    OpenAIRE

    Unruh, Anita M; Ritchie, Judith A

    1998-01-01

    OBJECTIVE: To discuss the development, content validity, internal consistency and factor structure of a Pain Appraisal Inventory (PAI).DESIGN: A PAI was constructed with a threat appraisal scale and a challenge appraisal scale. Content validity was demonstrated with a panel of health experts. A sample of 309 individuals participated in a random community survey about troublesome pain in the two weeks preceding the telephone interview.RESULTS: Confirmatory factor analysis produced a two-factor...

  20. The Appraisal of Data Centres: Deconstructing the Cash Flow

    OpenAIRE

    Patrick McAllister; Pavlos Loizou

    2007-01-01

    This paper analyses the appraisal of a specialized form of real estate - data centres - that has a unique blend of locational, physical and technological characteristics that differentiate it from conventional real estate assets. Market immaturity, limited trading and a lack of pricing signals enhance levels of appraisal uncertainty and disagreement relative to conventional real estate assets. Given the problems of applying standard discounted cash flow, an approach to appraisal is proposed t...

  1. The appraisal of data centres: deconstructing the cash flow \\ud

    OpenAIRE

    McAllister, Patrick; Loizou, Pavlos

    2007-01-01

    This paper analyses the appraisal of a specialized form of real estate - data centres - that has a unique blend of locational, physical and technological characteristics that differentiate it from conventional real estate assets. Market immaturity, limited trading and a lack of pricing signals enhance levels of appraisal uncertainty and disagreement relative to conventional real estate assets. Given the problems of applying standard discounted cash flow, an approach to appraisal is proposed t...

  2. SCAMPI Lead Appraiser (Service Mark) Body of Knowledge (SLA BOK)

    Science.gov (United States)

    2007-10-01

    members 2. CMP 5.5.2 Delivering appraisal results 3. CMP 6.1.2 Clarifying the OU’s process improvement history SOFTWARE ENGINEERING INSTITUTE | 9 4...contingency and management reserves appropriately • Ensuring the risk management strategy accounts for the OU’s process improvement history • Assessing...Preparing appraisal team members to perform their roles on the appraisal Examples • The Myers-Briggs Type Indicator ( MBTI ) can be used to help highlight

  3. Identification of Employee Performance Appraisal Methods in Agricultural Organizations

    OpenAIRE

    Venclova Katerina; Salkova Andrea; Kolackova Gabriela

    2013-01-01

    A formal employee performance appraisal is regarded as one of the tools of human resources performance management. People, their knowledge and skills are currently considered to be the most valuable resource a company has. The article focuses on methods of employee performance appraisal in agricultural organizations in the Czech Republic. The first part of the article deals with the theoretical background of the term “formal appraisal” and employee performance appraisal methods as defined by ...

  4. Performance Appraisal Method of Logistic Distribution for Fresh Agricultural Products

    OpenAIRE

    Yu, Hang; Zhang, Kai

    2010-01-01

    Through the initial selection, screening and simplification, a set of performance appraisal system of logistic distribution suited to fresh agricultural products is established. In the process of establishing the appraisal indicator, the representative appraisal indicator of logistic distribution of fresh agricultural products is further obtained by delivering experts’ survey and applying the ABC screening system. The distribution costs, transportation and service level belong to the first ...

  5. Effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on cardiovascular events and residual renal function in dialysis patients: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Liu, Youxia; Ma, Xinxin; Zheng, Jie; Jia, Junya; Yan, Tiekun

    2017-06-30

    The role of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) reducing risk of cardiovascular events (CVEs) and preserving kidney function in patients with chronic kidney disease is well-documented. However, the efficacy and safety of these agents in dialysis patients is still a controversial issue. We systematically searched MEDLINE, Embase, Cochrane Library and Wanfang for randomized trials. The relative risk (RR) reductions were calculated with a random-effects model. Major cardiovascular events, changes in GFR and drug-related adverse events were analyzed. Eleven trials included 1856 participants who were receiving dialysis therapy. Compared with placebo or other active agents groups, ARB therapy reduced the risk of heart failure events by 33% (RR 0.67, 95% CI 0.47 to 0.93) with similar decrement in blood pressure in dialysis patients. Indirect comparison suggested that fewer cardiovascular events happened during treatment with ARB (0.77, 0.63 to 0.94). The results indicated no significant differences between the two treatment regimens with regard to frequency of myocardial infarction (1.0, 0.45 to 2.22), stroke (1.16, 0.69 to 1.96), cardiovascular death (0.89, 0.64 to 1.26) and all-cause mortality (0.94, 0.75 to 1.17). Five studies reported the renoprotective effect and revealed that ACEI/ARB therapy significantly slowed the rate of decline in both residual renal function (MD 0.93 mL/min/1.73 m2, 0.38 to 1.47 mL/min/1.73 m2) and urine volume (MD 167 ml, 95% CI 21 ml to 357 ml). No difference in drug-related adverse events was observed in both treatment groups. This study demonstrates that ACE-Is/ARBs therapy decreases the loss of residual renal function, mainly for patients with peritoneal dialysis. Overall, ACE-Is and ARBs do not reduce cardiovascular events in dialysis patients, however, treatment with ARB seems to reduce cardiovascular events including heart failure. ACE-Is and ARBs do not induce an extra risk

  6. Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Science.gov (United States)

    Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

    2014-01-01

    Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial

  7. Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial.

    Science.gov (United States)

    Vaccaro, Olga; Masulli, Maria; Nicolucci, Antonio; Bonora, Enzo; Del Prato, Stefano; Maggioni, Aldo P; Rivellese, Angela A; Squatrito, Sebastiano; Giorda, Carlo B; Sesti, Giorgio; Mocarelli, Paolo; Lucisano, Giuseppe; Sacco, Michele; Signorini, Stefano; Cappellini, Fabrizio; Perriello, Gabriele; Babini, Anna Carla; Lapolla, Annunziata; Gregori, Giovanna; Giordano, Carla; Corsi, Laura; Buzzetti, Raffaella; Clemente, Gennaro; Di Cianni, Graziano; Iannarelli, Rossella; Cordera, Renzo; La Macchia, Olga; Zamboni, Chiara; Scaranna, Cristiana; Boemi, Massimo; Iovine, Ciro; Lauro, Davide; Leotta, Sergio; Dall'Aglio, Elisabetta; Cannarsa, Emanuela; Tonutti, Laura; Pugliese, Giuseppe; Bossi, Antonio C; Anichini, Roberto; Dotta, Francesco; Di Benedetto, Antonino; Citro, Giuseppe; Antenucci, Daniela; Ricci, Lucia; Giorgino, Francesco; Santini, Costanza; Gnasso, Agostino; De Cosmo, Salvatore; Zavaroni, Donatella; Vedovato, Monica; Consoli, Agostino; Calabrese, Maria; di Bartolo, Paolo; Fornengo, Paolo; Riccardi, Gabriele

    2017-11-01

    The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50-75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2-3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and previous cardiovascular events, to add-on pioglitazone (15-45 mg) or a sulfonylurea (5-15 mg glibenclamide, 2-6 mg glimepiride, or 30-120 mg gliclazide, in accordance with local practice). The trial was unblinded, but event adjudicators were unaware of treatment assignment. The primary outcome, assessed with a Cox proportional-hazards model, was a composite of first occurrence of all-cause death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularisation, assessed in the modified intention-to-treat population (all randomly assigned participants with baseline data available and without any protocol violations in relation to inclusion or exclusion criteria). This study is registered with ClinicalTrials.gov, number NCT00700856. Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-years) who

  8. Evidence appraisal: a scoping review, conceptual framework, and research agenda.

    Science.gov (United States)

    Goldstein, Andrew; Venker, Eric; Weng, Chunhua

    2017-11-01

    Critical appraisal of clinical evidence promises to help prevent, detect, and address flaws related to study importance, ethics, validity, applicability, and reporting. These research issues are of growing concern. The purpose of this scoping review is to survey the current literature on evidence appraisal to develop a conceptual framework and an informatics research agenda. We conducted an iterative literature search of Medline for discussion or research on the critical appraisal of clinical evidence. After title and abstract review, 121 articles were included in the analysis. We performed qualitative thematic analysis to describe the evidence appraisal architecture and its issues and opportunities. From this analysis, we derived a conceptual framework and an informatics research agenda. We identified 68 themes in 10 categories. This analysis revealed that the practice of evidence appraisal is quite common but is rarely subjected to documentation, organization, validation, integration, or uptake. This is related to underdeveloped tools, scant incentives, and insufficient acquisition of appraisal data and transformation of the data into usable knowledge. The gaps in acquiring appraisal data, transforming the data into actionable information and knowledge, and ensuring its dissemination and adoption can be addressed with proven informatics approaches. Evidence appraisal faces several challenges, but implementing an informatics research agenda would likely help realize the potential of evidence appraisal for improving the rigor and value of clinical evidence.

  9. Initial 3-weeks' Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) followed by Clopidogrel alone in high-risk patients with Acute Non-Disabling Cerebrovascular Events (ADANCE): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Yang, Fang; Lei, Hui; Jiang, Wenrui; Jiang, Wen; Han, Junliang; Zhao, Gang

    2014-11-01

    Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial demonstrated that dual-antiplatelet therapy (clopidogrel and aspirin), compared with aspirin monotherapy, reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events. Apixaban, a new oral anticoagulant, has been proven to be as safe and effective as traditional anticoagulants while carrying significantly less risk of intracranial hemorrhage. Patients with transient ischemic attack (TIA)/minor stroke might benefit from apixaban treatment; therefore, an adequately powered randomized study is needed. The ADANCE [Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events] study is a randomized, double-blind clinical trial with a target enrollment of 5,500 patients. A 21-day regimen of apixaban or of clopidogrel with aspirin followed by clopidogrel on days 22 through 90 will be administered to randomized participants with acute TIA or minor ischemic stroke. The primary efficacy endpoint is the percentage of patients with any new stroke (ischemic or hemorrhage), including fatal stroke, at day 21. Study visits will be performed on the day of randomization, and at days 7, 22, and 90. The novel oral anticoagulant apixaban has been widely used with fewer adverse effects than traditional anticoagulants. We designed the ADANCE trial to observe the effects of apixaban on recurrent stroke after TIA or minor stroke. The results should better guide the selection of anticoagulant or dual-antiplatelet therapy for patients with acute TIA or minor ischemic stroke.

  10. Prospective, controlled assessment of the impact of formal evidence-based medicine teaching workshop on ability to appraise the medical literature.

    Science.gov (United States)

    Harewood, G C; Hendrick, L M

    2010-03-01

    The ability to critically appraise the calibre of studies in medical literature is increasingly important for medical professionals. This prospective controlled study evaluated the impact of a 6-h Evidence Based Medicine (EBM) Workshop on the critical appraisal skills of medical trainees. Individuals attended three 2-h workshops over a 3-week period, incorporating didactic lectures in statistics, clinical trial design, appraising research papers and practical examples. Appraisal skills were assessed pre- and post-training based on grading the quality of randomised control studies (level 1 evidence), cohort studies (level 2 evidence) and case-control studies (level 3 evidence) [From Oxford Centre for Evidence Based Medicine Levels of Evidence (2001), http://www.cebm.net/critical_appraisal.asp ]. Overall grading improved from 39% (pre-course) to 74% (post-course), P = 0.002, with grading of levels 1, 2 and 3 studies improving from 42 to 75%, 53 to 61% and 21 to 84%, respectively. We conclude that a 6-h formal EBM workshop is effective in enhancing the critical appraisal skills of medical trainees.

  11. 12 CFR 34.43 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... lending institution, provided that: (i) There has been no obvious and material change in market conditions or physical aspects of the property that threatens the adequacy of the institution's real estate... by a State certified or licensed appraiser is required for all real estate-related financial...

  12. 12 CFR 323.3 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... lending institution, provided that: (i) There has been no obvious and material change in market conditions or physical aspects of the property that threatens the adequacy of the institution's real estate... State certified or licensed appraiser is required for all real estate-related financial transactions...

  13. 76 FR 20822 - Proposed Information Collection (Servicer's Staff Appraisal Reviewer (SAR) Application) Activity...

    Science.gov (United States)

    2011-04-13

    ... needed to nominate servicer appraisal employee as a staff appraisal reviewer. DATES: Written comments and... AFFAIRS Proposed Information Collection (Servicer's Staff Appraisal Reviewer (SAR) Application) Activity... proper performance of VBA's functions, including whether the information will have practical utility; (2...

  14. 5 CFR 1330.405 - Procedures for certifying agency appraisal systems.

    Science.gov (United States)

    2010-01-01

    ... senior employees based on appraisals of their relative performance against performance expectations in any given appraisal period reflecting performance evaluation results that make meaningful distinctions... REGULATIONS WITH THE OFFICE OF PERSONNEL MANAGEMENT HUMAN RESOURCES MANAGEMENT Performance Appraisal...

  15. The 2008 Circum-Arctic Resource Appraisal

    Science.gov (United States)

    Moore, Thomas E.; Gautier, Donald L.

    2017-11-15

    Professional Paper 1824 comprises 30 chapters by various U.S. Geological Survey authors, including introduction and methodology chapters, which together provide documentation of the geological basis and methodology of the 2008 Circum-Arctic Resource Appraisal, results of which were first released in August 2008.  Twenty-eight chapters summarize the petroleum geology and resource potential of individual, geologically defined provinces north of the Arctic Circle, including those of northern Alaska, northern Canada, east and west Greenland, and most of Arctic Russia, as well as certain offshore areas of the north Atlantic Basin and the Polar Sea. Appendixes tabulate the input and output information used during the assessment.

  16. Air Force Senior Executive Appraisal System.

    Science.gov (United States)

    1981-06-01

    II ail . %a iritI Ia I raaa inr iial I ni .N aaa f piaI I i’aa’a reI eI f IlIa, joIaa slial ’. i -aatit aI ita Irl- it IIN tipo tt tIhaI I iadil...intertiening variables . The results are’ soinarized in Table C2. Table (:2. Comparison of Mean Scores of Appraisals by Ethnic G;roup and Sex’ Mean SD

  17. BOOK APPRAISAL: HISTORY OF DENTISTRY IN NIGERIA

    OpenAIRE

    Michael, O.S.

    2016-01-01

    The book appraised in this edition of Chronicles of Medical History, History of Dentistry in Nigeria, is a product of many years of painstaking research. The Author, Professor Eyitope Ogunbodede, has put together an excellent book that is a great work of art. Dentistry is one of the first specialties in medicine with a very long history; evidence of periodontal disease has been traced back to at least 100, 000 years in human remains. However, the book by Professor Ogunbodede is the first comp...

  18. BOOK APPRAISAL: HISTORY OF DENTISTRY IN NIGERIA.

    Science.gov (United States)

    Michael, O S

    2016-06-01

    The book appraised in this edition of Chronicles of Medical History, History of Dentistry in Nigeria, is a product of many years of painstaking research. The Author, Professor Eyitope Ogunbodede, has put together an excellent book that is a great work of art. Dentistry is one of the first specialties in medicine with a very long history; evidence of periodontal disease has been traced back to at least 100, 000 years in human remains. However, the book by Professor Ogunbodede is the first comprehensive record of the History of dentistry in Nigeria. It is a must-read for every medical professional practicing in Nigeria and a worthy addition to every library.

  19. Performance appraisal & promotion process: A measured approach

    Science.gov (United States)

    Kumar, Jitendra

    2012-06-01

    Most of the companies have yearly performance appraisal process for their employees. This process involves rating of employees by their manager. And Companies rely purely on managerís state of thinking and perception. Humans have tendency to become biased, corrupt, give favor to some employees whom they like. This favor is due to some other reasons e.g. personal reason, social reason, political reason, flattering. All these reasons are not related to the work that the employee is doing for the organization.

  20. Rationale and design of the PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage (PICASSO) study: A randomized controlled trial.

    Science.gov (United States)

    Hong, Keun-Sik; Kim, Bum Joon; Lee, Jun-Young; Kwon, Sun U

    2015-10-01

    Prior intracerebral haemorrhage and cerebral microbleeds may increase the risk of haemorrhagic stroke. However, the optimal long-term antiplatelet therapy and lipid management in these patients remain unclear. PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage was designed to compare cilostazol and aspirin and to assess the effect of adding probucol, a lipid-lowering and anti-oxidative agent, in patients at high risk of haemorrhagic stroke. The projected sample size is 1600 patients with at least 12 months of follow-up. PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage is a randomized trial involving 67 institutes from 3 countries. Patients with non-cardioembolic ischemic stroke or transient ischemic attack within 180 days and with prior intracerebral haemorrhage or multiple cerebral microbleeds on gradient echo imaging are eligible. Enrolled patients are simultaneously randomized in a 2 × 2 factorial design: double-blind for cilostazol 200 mg/day vs. aspirin 100 mg/day, and an open-label, blind end-point evaluation for probucol 500 mg/day vs. non-probucol. The co-primary end-points are the safety end-point of haemorrhagic stroke and the efficacy end-point of a composite of stroke, myocardial infarction, or vascular death. Time-to-event will be analyzed separately for each intervention: superiority testing for the safety of cilostazol over aspirin as well as the efficacy of probucol over non-probucol, and non-inferiority testing for the efficacy of cilostazol to aspirin. PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage is the largest secondary stroke prevention trial for informing antiplatelet therapy and lipid management in patients at high risk of haemorrhagic stroke. © 2015 World Stroke Organization.

  1. An appraisal of the literature on teaching physical examination skills.

    Science.gov (United States)

    Easton, Graham; Stratford-Martin, James; Atherton, Helen

    2012-07-01

    To discover which models for teaching physical examination skills have been proposed, and to appraise the evidence for each. We conducted a narrative review of relevant literature from 1990-2010. We searched the databases MEDLINE, PsycINFO, and ERIC (The Education Resource Information Centre) for the terms: 'physical examination' AND 'teaching' as both MESH terms and keyword searches. We excluded web-based or video teaching, non-physical examination skills (e.g. communication skills), and articles about simulated patients or models. We identified five relevant articles. These five studies outlined several approaches to teaching physical examination skills, including Peyton's 4-step model, an adaptation of his model to a 6-step model; the silent run through; and collaborative discovery. There was little evidence to support one method over others. One controlled trial suggested that silent run-through could improve performance of complex motor tasks, and another suggested that collaborative discovery improves students' ability to recognise key findings in cardiac examinations. There are several models for teaching physical examinations, but few are designed specifically for that purpose and there is little evidence to back any one model over another. We propose an approach which adopts several key features of these models. Future research could usefully evaluate the effectiveness of the proposed models, or develop innovative practical models for teaching examination skills.

  2. [The six steps necessary in elaborating critically appraised topics].

    Science.gov (United States)

    García Villar, C

    2014-01-01

    Different types of critically appraised topics (CATs) can be elaborated in diagnostic imaging: comparison of diagnostic tests, evaluation of techniques for early detection (screening), economical analyses, or therapeutic aspects, among others. Their design will vary in function of the question they aim to answer. For example, for treatment evaluation, clinical trials are the best, but if there are secondary studies (systematic reviews or meta-analyses) that synthesize information from several studies, the results will be more important and the scientific conclusions will be more relevant. Regardless of the study design used, the elaboration of a CAT will involve six steps: 1) question; 2) systematic and efficient bibliographic search; 3) levels of evidence (choosing the articles that have the best level); 4) critical reading of the articles chosen; 5) applying conclusions to the context, and 6) recommendations. In this article, we will describe these steps and the nuances for different types of studies in each step. Copyright © 2013 SERAM. Published by Elsevier Espana. All rights reserved.

  3. Cabazitaxel for the second-line treatment of metastatic hormone-refractory prostate cancer: a NICE single technology appraisal.

    Science.gov (United States)

    Kearns, Ben; Lloyd Jones, Myfanwy; Stevenson, Matt; Littlewood, Chris

    2013-06-01

    The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cabazitaxel (Jevtana®, sanofi-aventis, UK) to submit evidence of its clinical and cost effectiveness for the second-line treatment of metastatic hormone-refractory prostate cancer (mHRPC). The School of Health and Related Research Technology Appraisal Group (ScHARR-TAG) at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the manufacturer's submission to NICE. Clinical evidence was derived from a multinational randomized open-label phase III trial of cabazitaxel plus prednisone or prednisolone in men with mHRPC that had progressed during or following treatment with docetaxel. The comparator was mitoxantrone plus prednisone or prednisolone. Use of cabazitaxel was associated with a statistically significant improvement in overall survival, median progression-free survival and time to tumour progression. However, it was also associated with an increased incidence of adverse events such as neutropenia. Utility data were based on interim results from the early access programme for cabazitaxel. Data were only available for a small number of patients with stable disease, resulting in great uncertainty as to the effect of cabazitaxel on quality of life. For their economic evaluation, the manufacturer estimated that the use of cabazitaxel was associated with an incremental cost of £74,908 per QALY gained. However, the ERG disagreed with the manufacturer over two key methodological points. The first concerned modelling and extrapolating survival; the second point was concerned with the choice of patient population. The ERG altered the manufacturer's evaluation to take into account these two points of disagreement. The resulting cost per QALY gained was £82,950. The NICE Appraisal Committee believed the analysis

  4. Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial

    DEFF Research Database (Denmark)

    Herly, M; Stengaard-Pedersen, K.; Hørslev-Petersen, K.

    2017-01-01

    , will determine the extent to which independent variables (including different levels of vitamin D at baseline) predict whether a cardiovascular event will occur, and also when this will be. ETHICS AND DISSEMINATION: All patients have received verbal and written information before enrolment, and have given...... written consent at baseline. To disseminate comprehension of factors of prognostic importance to cardiovascular outcome in RA, we will attempt to have a first draft ready no later than 1 year after the adjudication process has finished. If low vitamin D levels can predict cardiovascular events in RA...

  5. Changes in problem-solving appraisal after cognitive therapy for the prevention of suicide.

    Science.gov (United States)

    Ghahramanlou-Holloway, M; Bhar, S S; Brown, G K; Olsen, C; Beck, A T

    2012-06-01

    Cognitive therapy has been found to be effective in decreasing the recurrence of suicide attempts. A theoretical aim of cognitive therapy is to improve problem-solving skills so that suicide no longer remains the only available option. This study examined the differential rate of change in problem-solving appraisal following suicide attempts among individuals who participated in a randomized controlled trial for the prevention of suicide. Changes in problem-solving appraisal from pre- to 6-months post-treatment in individuals with a recent suicide attempt, randomized to either cognitive therapy (n = 60) or a control condition (n = 60), were assessed by using the Social Problem-Solving Inventory-Revised, Short Form. Improvements in problem-solving appraisal were similarly observed for both groups within the 6-month follow-up. However, during this period, individuals assigned to the cognitive therapy condition demonstrated a significantly faster rate of improvement in negative problem orientation and impulsivity/carelessness. More specifically, individuals receiving cognitive therapy were significantly less likely to report a negative view toward life problems and impulsive/carelessness problem-solving style. Cognitive therapy for the prevention of suicide provides rapid changes within 6 months on negative problem orientation and impulsivity/carelessness problem-solving style. Given that individuals are at the greatest risk for suicide within 6 months of their last suicide attempt, the current study demonstrates that a brief cognitive intervention produces a rapid rate of improvement in two important domains of problem-solving appraisal during this sensitive period.

  6. Patient room lighting influences on sleep, appraisal and mood in hospitalized people.

    Science.gov (United States)

    Giménez, Marina C; Geerdinck, Leonie M; Versteylen, Mathijs; Leffers, Pieter; Meekes, Gaby J B M; Herremans, Hannelore; de Ruyter, Boris; Bikker, Jan Willem; Kuijpers, Petra M J C; Schlangen, Luc J M

    2017-04-01

    Irregular 24 h light/dark cycles with night-time light exposure and a low amplitude are disruptive for sleep, mood and circadian rhythms. Nevertheless such lighting conditions are quite common in medical care facilities. A controlled clinical trial among 196 cardiology ward patients (mean age 66.5 ± 13.1 years SD) investigated how a patient room lighting intervention affects sleep, appraisal and mood across hospitalization. Patients were either assigned to a standardly-lit room or to a room with an interventional lighting system offering a dynamic 24 h light/dark cycle with low nocturnal light exposure and 2 h of bright light (1750 lux) during daytime. Measures included wrist actigraphy and questionnaires assessing alertness, sleep quality, anxiety, depression and lighting appraisal. The median length of hospitalization was 5 days in both study arms. Subjective scores on sleep, alertness, anxiety and depression did not differ between arms. Lighting appraisal in intervention rooms was better as compared to standardly-lit rooms, both in patients (P lighting instead of standard lighting. After 5 days of hospitalization, sleep duration in the lighting intervention rooms increased by 29 min, or a relative 7.3%, as compared to standardly-lit rooms. A 24 h lighting system with enhanced daytime brightness and restricted nocturnal light exposure can improve some aspects of appraisal and objective sleep in hospital patients. More clinical research is needed to establish the best lighting strategy to promote healing and wellbeing within healthcare settings. © 2016 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

  7. The practice of investment viability appraisal in Akure, Nigeria ...

    African Journals Online (AJOL)

    This paper examines the role played by valuers in choosing the right viability appraisal technique for an investment appraisal. Structured questionnaire was administered on Twenty one (21) registered and practicing Estate Surveying and Valuation firms in Akure out of which fourteen (14) were retrieved and found good for ...

  8. 50 CFR 34.7 - Fair market value appraisals.

    Science.gov (United States)

    2010-10-01

    ... market value. The only structures that will be included in the appraisal are those that were present at... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false Fair market value appraisals. 34.7 Section... (CONTINUED) THE NATIONAL WILDLIFE REFUGE SYSTEM REFUGE REVENUE SHARING WITH COUNTIES § 34.7 Fair market value...

  9. Employee performance appraisal and productivity levels in selected ...

    African Journals Online (AJOL)

    The focus of this study was on performance appraisal of academic staff of Universities in Nigeria and their productivity levels. The prime problem that necessitated this study was to examine the effectiveness of the subjective methods used in appraising qualitative work attributes of the employees and to assess the extent to ...

  10. 78 FR 78519 - Appraisals for Higher-Priced Mortgage Loans

    Science.gov (United States)

    2013-12-26

    ... 1026 Appraisals for Higher-Priced Mortgage Loans; Final Rule #0;#0;Federal Register / Vol. 78 , No. 248... Appraisals for Higher-Priced Mortgage Loans AGENCY: Board of Governors of the Federal Reserve System (Board... for ``higher-risk mortgages.'' For certain mortgages with an annual percentage rate that exceeds the...

  11. 7 CFR 1781.14 - Planning, options, and appraisals.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 12 2010-01-01 2010-01-01 false Planning, options, and appraisals. 1781.14 Section 1781.14 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE...) LOANS AND ADVANCES § 1781.14 Planning, options, and appraisals. (a) WS and RCD area plans are developed...

  12. Appraisal Systems in L2 vs. L3 Learning Experiences

    Science.gov (United States)

    Gabrys-Barker, Danuta

    2011-01-01

    This article offers a comment on the ways multilingual language users perceive their L2 and L3 learning experiences at the level of appraisals, that is, variables that "assign value to current stimuli based on past experience". In the theoretical part of the article the concept of appraisals is introduced and briefly outlined from the different…

  13. 116 Appraisal as a Determinant for Adequate Compensation in ...

    African Journals Online (AJOL)

    User

    2012-01-24

    Jan 24, 2012 ... workforce, while taking into account other factors. Finally the paper recommends that private sector organizations should develop an appraisal system base on careful job analysis and establish its reliability and validity. Key Words: Appraisal, Determinant, Adequate Compensation, Private. Sector.

  14. Appraisal of the Hydrological Potential of Ungauged Basin Using ...

    African Journals Online (AJOL)

    Discharge data for most basins in developing countries are lacking or inadequate where available. An alternative is to find other ways of appraising the natural water potential of basins without stream discharge records. This study attempts an appraisal of the water resource potential of the Eze-Aku basin in Ebonyi State of ...

  15. Toward Narrowing the Research-Practice Gap in Performance Appraisal.

    Science.gov (United States)

    Banks, Cristina G.; Murphy, Kevin R.

    1985-01-01

    Coordination between research and practice in performance appraisal is essential. Specifically, researchers should focus on utilization methods while practitioners should focus on appraisal content. Cognitive process research may increase raters' ability to judge accurately but fails to address raters' willingness to provide accurate ratings. (BL)

  16. An Appraisal of the Axiological Dimension of Sexual Relationships ...

    African Journals Online (AJOL)

    An Appraisal of the Axiological Dimension of Sexual Relationships among Adolescents. ... this article is to establish and appraise the axiological dimension of the permissive sexual relationship with affection, thereafter, suggests ways of educating adolescents for more positive disposition towards such sexual relationships.

  17. Women's Appraisals of Sexual-Assault Risk in Dating Situations.

    Science.gov (United States)

    Cue, Kelly L.; And Others

    1996-01-01

    Investigated how 165 female college students appraised their sexual assault risk in hypothetical dating situations, varying male partner characteristics and the consumption of alcohol. Findings suggest that women are partially accurate in making sexual-assault risk appraisals, and thus may benefit from rape prevention education that specifically…

  18. The State of Archival Appraisal Practices in the ESARBICA Region ...

    African Journals Online (AJOL)

    When archivists appraise records, they make a determination as to what to keep and destroy. In other words, they decide who has voice and who remains voiceless. Appraisal involves value prescription to records, and is one of the most important responsibilities of archivists. The future research potential of records is a ...

  19. Teacher Emotion Management in the Classroom: Appraisal, Regulation, and Coping

    Science.gov (United States)

    Chang, Mei-Lin

    2009-01-01

    Compared with other professions, teachers in P-12 schools seem to experience the highest level of emotional exhaustion. The purpose of this study was to examine teacher emotions within the context of teachers' appraisals and the ways they regulate and cope with their emotions. This was done by exploring novice teachers' appraisals of classroom…

  20. The merits of measuring challenge and hindrance appraisals.

    Science.gov (United States)

    Searle, Ben J; Auton, Jaime C

    2015-01-01

    The challenge-hindrance framework has shown that challenge stressors (work characteristics associated with potential personal gain) tend to have positive outcomes, whereas hindrance stressors (those which obstruct goals) have negative outcomes. However, typical research methods assume that stressors allocated to these categories are appraised consistently by different people and across different situations. We validate new measures of challenge and hindrance appraisals and demonstrate their utility in stress research. We used a cross-sectional survey of American employees (Study 1, n = 333), a diary survey of Australian employees (Study 2, n = 241), and a survey of Australian college students whose performance was evaluated independently (Study 3, n = 350). Even after accounting for the effects of stressors, challenge and hindrance appraisals consistently explained unique variance in affective states, with indications that stressors have indirect effects via appraisals. Such effects were seen within- as well as between-participants (Study 2). Appraisals also had expected associations with specific coping behaviors (Study 1), while challenge appraisal was associated with task performance (Study 3). The scales of challenge and hindrance appraisals were psychometrically sound across multiple contexts. RESULTS highlight the merit of considering appraisal in stress research.

  1. Assessment of the Appraisal Practices of Architectural Records at ...

    African Journals Online (AJOL)

    The purpose of the study was to investigate the appraisal practices of architectural records at Gaborone City Council (GCC) in Botswana. The study was guided by the American Taxonomy approach and the ISO 15489; complemented with the Shrock (1996) guidelines to cater for the appraisal of intrinsic values found in ...

  2. Job Performance Appraisal System Training Program. Final Report.

    Science.gov (United States)

    Glasgow, Zita; Simkins, Mary Lou

    The Civil Service Reform Act of 1978 requires each government agency to develop a performance-based employee appraisal system. The purpose of this study was to determine how to train effectively more than 200,000 Air Force civilian employees to use the Job Performance Appraisal System (JPAS) designed by the Air Force. Experimental comparisons were…

  3. Problems of clinical nurse performance appraisal system: a qualitative study.

    Science.gov (United States)

    Nikpeyma, Nasrin; Abed Saeedi, Zhila; Azargashb, Eznollah; Alavi Majd, Hamid

    2014-03-01

    The purpose of this study is to explore problems of clinical nurse performance appraisal system. This study employed a descriptive qualitative approach. The participants were purposively selected from clinical nurses working across all of the hospital units in a large metropolitan teaching hospital in Tehran, Iran in 2012. Data were collected using five focus group interviews, which were audio taped. The number of participants in each group ranged from 7 to 10. The semi-structured interviews were guided by a set of nondirective questions, and continued until the data reached saturation. Data were analyzed using framework analysis. Four major themes regarding the problems of clinical nurse performance appraisal system emerged from the analysis of textual data. These themes were contextual problems, problems related to performance appraisal structure, problems related to performance appraisal process and those related to performance appraisal results. The findings of this study reveal that the nurse performance appraisal system confronts with various problems. Some of these problems are related to organizational context while the others concerned structure, process and results of the performance appraisal system. In order to achieve high quality of patient care as the final goal of performance appraisal, changing and revision of this system is necessary. Copyright © 2013. Published by Elsevier B.V.

  4. Conveying the Performance Appraisal: The Research and Its Implications.

    Science.gov (United States)

    Wilson, Gerald L.

    Results of an examination of research literature on performance-appraisal interviewing and its implications are pr