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Sample records for events appraise trial

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

    Science.gov (United States)

    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).

  2. Preliminary ethical appraisal of a trial - what's it all about?

    Science.gov (United States)

    Siipi, Helena

    Preliminary ethical appraisal of medical trials is often based on the following four principles: respect for autonomy, beneficence, non-maleficence, and justice. Preliminary ethical appraisal should, however, not be understood solely as application of these four principles to practice. Ethical committees will inevitably interpret the principles and make decisions about their reciprocal importance in connection with each trial. Reasoning does not always proceed from above towards practical recommendations of action, but can instead also be based on a moral rule or practice relating to a certain action. A good preliminary ethical appraisal will also take into account everyday standards of morality, law and shared moral values of the society.

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

    African Journals Online (AJOL)

    Admissibility of hearsay evidence in criminal trials: an appraisal of the Ethiopian legal framework. ... Haramaya Law Review ... 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 ...

  4. Effects of appraisal training on responses to a distressing autobiographical event.

    Science.gov (United States)

    Woud, Marcella L; Zlomuzica, Armin; Cwik, Jan C; Margraf, Jürgen; Shkreli, Lorika; Blackwell, Simon E; Gladwin, Thomas E; Ehring, Thomas

    2018-04-14

    Dysfunctional appraisals are a key factor suggested to be involved in the development and maintenance of PTSD. Research has shown that experimental induction of a positive or negative appraisal style following a laboratory stressor affects analogue posttraumatic stress symptoms. This supports a causal role of appraisal in the development of traumatic stress symptoms and the therapeutic promise of modifying appraisals to reduce PTSD symptoms. The present study aimed to extend previous findings by investigating the effects of experimentally induced appraisals on reactions to a naturally occurring analogue trauma and by examining effects on both explicit and implicit appraisals. Participants who had experienced a distressing life event were asked to imagine themselves in the most distressing moment of that event and then received either a positive or negative Cognitive Bias Modification training targeting appraisals (CBM-App). The CBM-App training induced training-congruent appraisals, but group differences in changes in appraisal over training were only seen for explicit and not implicit appraisals. However, participants trained positively reported less intrusion distress over the subsequent week than those trained negatively, and lower levels of overall posttraumatic stress symptoms. These data support the causal relationship between appraisals and trauma distress, and further illuminate the mechanisms linking the two. Copyright © 2018 Elsevier Ltd. All rights reserved.

  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. 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:

  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. Longitudinal study of appraisal at Three Mile Island: implications for life event research.

    Science.gov (United States)

    Goldsteen, R; Schorr, J K; Goldsteen, K S

    1989-01-01

    This study tests a path model which indicates the occurrence of appraisal following the accident at Three Mile Island (TMI). The model posits a causal relationship between trust in TMI-related authorities, perceived danger, perceived harm to health, and psychological distress. The implications of the findings for life event research are discussed in terms of the etiological significance of meaning, event consequences, and control.

  9. Critical appraisal skills training for health care professionals: a randomized controlled trial [ISRCTN46272378

    Directory of Open Access Journals (Sweden)

    Ewings Paul E

    2004-12-01

    Full Text Available Abstract Introduction Critical appraisal skills are believed to play a central role in an evidence-based approach to health practice. The aim of this study was to evaluate the effectiveness and costs of a critical appraisal skills educational intervention aimed at health care professionals. Methods This prospective controlled trial randomized 145 self-selected general practitioners, hospital physicians, professions allied to medicine, and healthcare managers/administrators from the South West of England to a half-day critical appraisal skills training workshop (based on the model of problem-based small group learning or waiting list control. The following outcomes were assessed at 6-months follow up: knowledge of the principles necessary for appraising evidence; attitudes towards the use of evidence about healthcare; evidence seeking behaviour; perceived confidence in appraising evidence; and ability to critically appraise a systematic review article. Results At follow up overall knowledge score [mean difference: 2.6 (95% CI: 0.6 to 4.6] and ability to appraise the results of a systematic review [mean difference: 1.2 (95% CI: 0.01 to 2.4] were higher in the critical skills training group compared to control. No statistical significant differences in overall attitude towards evidence, evidence seeking behaviour, perceived confidence, and other areas of critical appraisal skills ability (methodology or generalizability were observed between groups. Taking into account the workshop provision costs and costs of participants time and expenses of participants, the average cost of providing the critical appraisal workshops was approximately £250 per person. Conclusions The findings of this study challenge the policy of funding 'one-off' educational interventions aimed at enhancing the evidence-based practice of health care professionals. Future evaluations of evidence-based practice interventions need to take in account this trial's negative findings

  10. Three Mile Island accident: a case study of life event appraisal

    International Nuclear Information System (INIS)

    Goldsteen, R.L.

    1983-01-01

    This research investigates community reactions to the accident at the Three Mile Island (TMI) nuclear powered electric generating plant in March, 1979. The investigation is placed in the context of life event research and chooses an appraisal orientation. Three innovations are argued: 1) perceived consequences of the event best predict reactions to it, 2) the attitudes of significant others toward the event influence reactions to the accident under certain circumstances, and 3) sense of well-being is a good outcome measure for a general population. The hypotheses posit that the attitudes of others will affect sense of well-being only when individual attitudes concerning the consequences of the accident are moderate; when individual attitudes are extreme, the attitudes of others will have no demonstrable effect on outcomes. The findings did not support all the prediction of the hypotheses. However, they indicate that perceived consequences are the best predictors of sense of well-being and that an individual's attitudinal position, his strength of attitude, and the nature of the stimulus are highly related to whether or not an individual will be influenced by the views of others

  11. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial.

    Science.gov (United States)

    Rost, Kathryn M; Marshall, Donna; Xu, Stanley

    2014-09-24

    Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Twenty nine organizations recruited senior health benefit professional members representing public or private employers who had not yet purchased a depression product for all 100+ workers in their company. The research team used randomization blocked by company size to assign eligible employers to: (1) a presentation encouraging employers to purchase a high quality depression product accompanied by a scientifically-derived return on investment estimate, or (2) a presentation encouraging employers to work with their most subscribed health plan to improve depression treatment quality indicators. Two hundred ninety three employers (82.3% of 356) completed baseline data immediately before learning that 140 employers had been randomized to the evidence-based (EB) depression product presentation and 153 had been randomized to the usual care (UC) depression treatment quality indicator presentation. Analysis of 250 (85.3% of 293) employers who completed web-based interviews at 12 and/or 24 months was conducted to determine presentation impact on depression product appraisal and purchasing behavior. The intervention had no impact on depression product appraisal in 232 subjects (F = 2.36, p = .07) or depression product purchasing (chisquare = 1.82, p = .44) in 250 subjects. Depression product appraisal increased in companies with greater health benefit generosity whose benefit professionals were male. Depression product purchasing behavior increased in small companies compared to large companies, companies who knew a vendor that sold depression products at baseline, companies with

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

    Science.gov (United States)

    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.

  13. 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.

  14. 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.

  15. Rivaroxaban for Preventing Atherothrombotic Events in People with Acute Coronary Syndrome and Elevated Cardiac Biomarkers: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

    Science.gov (United States)

    Pandor, Abdullah; Pollard, Daniel; Chico, Tim; Henderson, Robert; Stevenson, Matt

    2016-05-01

    As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures rivaroxaban (Xarelto, Bayer) to submit evidence of the clinical and cost effectiveness of rivaroxaban for the prevention of adverse outcomes in patients after the acute management of acute coronary syndrome (ACS). The School of Health and Related Research Technology Appraisal Group 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 company's submission to NICE. The evidence was derived mainly from a randomised, double-blind, phase III, placebo-controlled trial of rivaroxaban (either 2.5 or 5 mg twice daily) in patients with recent ACS [unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI)]. In addition, all patients received antiplatelet therapy [aspirin alone or aspirin and a thienopyridine either as clopidogrel (approximately 99 %) or ticlopidine (approximately 1 %) according to national or local guidelines]. The higher dose of rivaroxaban (5 mg twice daily) did not form part of the marketing authorisation. A post hoc subgroup analysis of the licensed patients who had ACS with elevated cardiac biomarkers (that is, patients with STEMI and NSTEMI) without prior stroke or transient ischaemic stroke showed that compared with standard care, the addition of rivaroxaban (2.5 mg twice daily) to existing antiplatelet therapy reduced the composite endpoint of cardiovascular mortality, myocardial infarction or stroke, but increased the risk of major bleeding and intracranial haemorrhage. However, there were a number of limitations in the evidence base that warrant caution in its interpretation. In particular, the evidence may be confounded because of the post hoc subgroup

  16. 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

  17. 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…

  18. 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.

  19. Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study

    Science.gov (United States)

    2012-01-01

    Background A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Methods Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. Results The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Conclusion Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity. PMID:22510227

  20. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  1. 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

  2. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Zakeri, Kaveh; Rose, Brent S.; D’Amico, Anthony V.; Jeong, Jong-Hyeon; Mell, Loren K.

    2015-01-01

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  3. A critical appraisal of the reporting quality of published randomized controlled trials in the fall injuries.

    Science.gov (United States)

    Asghari Jafarabadi, Mohammad; Sadeghi-Bazrgani, Homayoun; Dianat, Iman

    2018-06-01

    To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved.

  4. 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....

  5. An appraisal profile of nostalgia.

    Science.gov (United States)

    van Tilburg, Wijnand A P; Bruder, Martin; Wildschut, Tim; Sedikides, Constantine; Göritz, Anja S

    2018-03-05

    The authors aimed to (a) identify the cognitive appraisals underlying nostalgia and (b) compare nostalgia with other emotions in terms of its appraisal profile. In Study 1, participants (N = 1,125) generated narratives. Next, they reported the level of nostalgia and 31 other emotions that these narratives elicited. Subsequently, participants evaluated the narrative events on several cognitive appraisals. Events that elicited nostalgia were pleasant, involved an irretrievable loss, felt psychologically distant, and were unique-an appraisal profile that differed from all other emotions. In Study 2 (N = 1,261), the authors experimentally varied these appraisals in a vignette paradigm and measured anticipated nostalgia and 10 other emotions. Participants anticipated most nostalgia when events were pleasant, involved irretrievable loss, were distant, and were unique-a profile shared only with longing. In Study 3 (N = 994), the authors used a guided autobiographical recall procedure in which they manipulated appraisals and measured the resultant emotions. Corroborating Studies 1-2, nostalgia was most intense for events that were pleasant, irretrievably lost, temporally distant, and unique. This appraisal profile was not shared by other emotions. The findings delineate the distinguishing cognitive appraisal profile of nostalgia. Nostalgia occupies a special place in the pantheon of emotions. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  6. Daily diary study of personality disorder traits: Momentary affect and cognitive appraisals in response to stressful events.

    Science.gov (United States)

    Jarnecke, Amber M; Miller, Michelle L; South, Susan C

    2017-01-01

    Difficulties in emotional expression and emotion regulation are core features of many personality disorders (PDs); yet, we know relatively little about how individuals with PDs affectively respond to stressful situations. The present study seeks to fill this gap in the literature by examining how PD traits are associated with emotional responses to subjective daily stressors, while accounting for cognition and type of stressor experienced (interpersonal vs. noninterpersonal). PD features were measured with the Schedule for Nonadaptive and Adaptive Personality-2 (SNAP-2) diagnostic scores. Participants (N = 77) completed a 1-week experience sampling procedure that measured affect and cognition related to a current stressor 5 times per day. Hierarchical linear modeling (HLM) was used to examine whether and how baseline PD features, momentary cognitions, and type of stressor predicted level of affect. Results demonstrated that paranoid, borderline, and avoidant PD traits predicted negative affect beyond what could be accounted for by cognitions and type of stressor. No PD traits predicted positive affect after accounting for the effects of cognitive appraisals and type of stressor. Findings have implications for validating the role of affect in PDs and understanding how individuals with PDs react in the presence of daily hassles. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  7. 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.

  8. 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 experi...

  9. 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.

  10. Single-trial event-related potentials to significant stimuli.

    Science.gov (United States)

    Rushby, Jacqueline A; Barry, Robert J

    2009-11-01

    The stimulus-response pattern of the skin conductance response (SCR) was used as a model of the Orienting Reflex (OR) to assess the P1, N1, P2, N2 and late positive complex (LPC/P300) components of the ERP in a simple habituation paradigm, in which a single series of 12 innocuous tones were presented at a very long interstimulus interval (2 min). To maintain their waking state during this boring task, participants were instructed to alternately close or open their eyes to each stimulus. None of the baseline-to-peak ERP measures showed trials effects comparable with the marked habituation over trials shown by the SCRs. Principal Components Analysis was used to decompose the ERP, yielding factors identified as the N1, N2, P3a, P3b and Novelty P3 components. An additional factor represented later eye-movement activity. No trial effects were apparent for the N1, N2, P3a or P3b components. The Novelty P3 showed marked response decrement over trials. These results are discussed in relation to current conceptualisations of the OR.

  11. The Eichmann Trial on East German Television : On (not) Reporting about a Transnational Media Event

    NARCIS (Netherlands)

    Keilbach, Judith|info:eu-repo/dai/nl/289029635

    2014-01-01

    This paper discusses the Eichmann trial (1961) as a transnational media event. It describes on the one hand the co-operation of different institutions that facilitated the trial's filming as well as the worldwide distribution of the footage. On the other hand it draws on East and West German

  12. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

    2015-01-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the

  13. 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 and t...

  14. 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

    BACKGROUND: 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......Med 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...

  15. 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

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

    Science.gov (United States)

    Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

    2013-01-01

    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. 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. 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. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). 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 larger study. Potential strengths and limitations of this design are

  17. 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

  18. Predictive event modelling in multicenter clinical trials with waiting time to response.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    A new analytic statistical technique for predictive event modeling in ongoing multicenter clinical trials with waiting time to response is developed. It allows for the predictive mean and predictive bounds for the number of events to be constructed over time, accounting for the newly recruited patients and patients already at risk in the trial, and for different recruitment scenarios. For modeling patient recruitment, an advanced Poisson-gamma model is used, which accounts for the variation in recruitment over time, the variation in recruitment rates between different centers and the opening or closing of some centers in the future. A few models for event appearance allowing for 'recurrence', 'death' and 'lost-to-follow-up' events and using finite Markov chains in continuous time are considered. To predict the number of future events over time for an ongoing trial at some interim time, the parameters of the recruitment and event models are estimated using current data and then the predictive recruitment rates in each center are adjusted using individual data and Bayesian re-estimation. For a typical scenario (continue to recruit during some time interval, then stop recruitment and wait until a particular number of events happens), the closed-form expressions for the predictive mean and predictive bounds of the number of events at any future time point are derived under the assumptions of Markovian behavior of the event progression. The technique is efficiently applied to modeling different scenarios for some ongoing oncology trials. Case studies are considered. Copyright © 2011 John Wiley & Sons, Ltd.

  19. 167: CRITICALLY APPRAISE OF THE REPORTING QUALITY OF RANDOMIZED CONTROLLED TRIALS ARTICLES IN THE FIELD OF DIABETES IN MEDICAL GUIDELINES IN IRAN

    Science.gov (United States)

    Aletaha, Azadeh; Baradaran, Hamid Reza; Soltani, Akbar; Ramezani, Amir

    2017-01-01

    Background and aims To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether randomized controlled trial articles in the field of diabetes are of good quality or not with respect to their high level of received citations, quality and credibility. Method We included RCTs conducted on Diabetes mellitus in Iran. Animal studies, educational, interventions, and non-randomized trials were excluded. This was a bibliographic study examining published journal articles involving RCTs in diabetes research from Iranian authors. A systematic search of ten databases(ISI Web of science, Scopus, PubMed, Science Direct, The Cochrane Library, Taylor & Francis Online, Biomed Central, EBSCO, ProQuest and OVID)were undertaken from July 2004–2014. We excluded duplicated publications reporting the same groups of participants and intervention two independent reviewers identify all eligible articles specifically designed data extraction form. Two reviewers assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statement and also evaluate each article with Scientometry tools in 260 valid English diabetes guidelines. Result Overall, we included 185 RCTs on diabetes mellitus, One hundred and eight five (185) studies were included and appraised. Half of them (55.7%) were published in Iranian journals. Most (89.7%) were parallel RCTs, and being performed on type2 diabetic patients (77.8%). Less than half of the CONSORT items (43.2%) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1% mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8% of trials report how blinding was applied. From 185 articles, twelve articles (10%) are presented in 260 Guidelines. Conclusion The reporting quality of abstracts of RCTs

  20. Clinical trials and late-stage drug development for Alzheimer’s disease: an appraisal from 1984 to 2014

    Science.gov (United States)

    Schneider, Lon S.; Mangialasche, Francesca; Andreasen, Niels; Feldman, Howard; Giacobini, Ezio; Jones, Roy; Mantua, Valentina; Mecocci, Patrizia; Pani, Luca; Winblad, Bengt; Kivipelto, Miia

    2014-01-01

    The modern era of drug development for Alzheimer’s disease began with the proposal of the cholinergic hypothesis of memory impairment and the 1984 research criteria for Alzheimer’s disease. Since then, despite the evaluation of numerous potential treatments in clinical trials, only four cholinesterase inhibitors and memantine have shown sufficient safety and efficacy to allow marketing approval at an international level. Although this is probably because the other drugs tested were ineffective, inadequate clinical development methods have also been blamed for the failures. Here we review the development of treatments for Alzheimer’s disease during the past 30 years, considering the drugs, potential targets, late-stage clinical trials, development methods, emerging use of biomarkers and evolution of regulatory considerations in order to summarize advances and anticipate future developments. We have considered late-stage Alzheimer’s disease drug development from 1984 to 2013, including individual clinical trials, systematic and qualitative reviews, meta-analyses, methods, commentaries, position papers and guidelines. We then review the evolution of drugs in late clinical development, methods, biomarkers and regulatory issues. Although a range of small molecules and biological products against many targets have been investigated in clinical trials, the predominant drug targets have been the cholinergic system and the amyloid cascade. Trial methods have evolved incrementally: inclusion criteria have largely remained focused on mild to moderate Alzheimer’s disease criteria, recently extending to early or prodromal Alzheimer disease or ‘mild cognitive impairment due to Alzheimer’s disease’, for drugs considered to be disease modifying. The duration of trials has remained at 6 to 12 months for drugs intended to improve symptoms; 18- to 24-month trials have been established for drugs expected to attenuate clinical course. Cognitive performance, activities

  1. 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

    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......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...... methods are identified for meta-analysis with zero-event trials, leading to numerous data analyses. We used the binary outcomes from our Cochrane review of randomized trials of laparoscopic vs. small-incision cholecystectomy for patients with symptomatic cholecystolithiasis to illustrate the influence...

  2. 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

  3. Trial latencies estimation of event-related potentials in EEG by means of genetic algorithms

    Science.gov (United States)

    Da Pelo, P.; De Tommaso, M.; Monaco, A.; Stramaglia, S.; Bellotti, R.; Tangaro, S.

    2018-04-01

    Objective. Event-related potentials (ERPs) are usually obtained by averaging thus neglecting the trial-to-trial latency variability in cognitive electroencephalography (EEG) responses. As a consequence the shape and the peak amplitude of the averaged ERP are smeared and reduced, respectively, when the single-trial latencies show a relevant variability. To date, the majority of the methodologies for single-trial latencies inference are iterative schemes providing suboptimal solutions, the most commonly used being the Woody’s algorithm. Approach. In this study, a global approach is developed by introducing a fitness function whose global maximum corresponds to the set of latencies which renders the trial signals most aligned as possible. A suitable genetic algorithm has been implemented to solve the optimization problem, characterized by new genetic operators tailored to the present problem. Main results. The results, on simulated trials, showed that the proposed algorithm performs better than Woody’s algorithm in all conditions, at the cost of an increased computational complexity (justified by the improved quality of the solution). Application of the proposed approach on real data trials, resulted in an increased correlation between latencies and reaction times w.r.t. the output from RIDE method. Significance. The above mentioned results on simulated and real data indicate that the proposed method, providing a better estimate of single-trial latencies, will open the way to more accurate study of neural responses as well as to the issue of relating the variability of latencies to the proper cognitive and behavioural correlates.

  4. Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

    DEFF Research Database (Denmark)

    Lifson, Alan R; Belloso, Waldo H; Davey, Richard T

    2010-01-01

    PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were...... was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication......., peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision...

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

    Science.gov (United States)

    Zhao, Ling; Zhang, Fu-wen; Li, Ying; Wu, Xi; Zheng, Hui; Cheng, Lin-hao; Liang, Fan-rong

    2011-03-24

    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. 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. 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. 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 anatomical structure of the acupoints. AEs could be reduced and

  6. 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.

  7. Many multicenter trials had few events per center, requiring analysis via random-effects models or GEEs.

    Science.gov (United States)

    Kahan, Brennan C; Harhay, Michael O

    2015-12-01

    Adjustment for center in multicenter trials is recommended when there are between-center differences or when randomization has been stratified by center. However, common methods of analysis (such as fixed-effects, Mantel-Haenszel, or stratified Cox models) often require a large number of patients or events per center to perform well. We reviewed 206 multicenter randomized trials published in four general medical journals to assess the average number of patients and events per center and determine whether appropriate methods of analysis were used in trials with few patients or events per center. The median number of events per center/treatment arm combination for trials using a binary or survival outcome was 3 (interquartile range, 1-10). Sixteen percent of trials had less than 1 event per center/treatment combination, 50% fewer than 3, and 63% fewer than 5. Of the trials which adjusted for center using a method of analysis which requires a large number of events per center, 6% had less than 1 event per center-treatment combination, 25% fewer than 3, and 50% fewer than 5. Methods of analysis that allow for few events per center, such as random-effects models or generalized estimating equations (GEEs), were rarely used. Many multicenter trials contain few events per center. Adjustment for center using random-effects models or GEE with model-based (non-robust) standard errors may be beneficial in these scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Social appraisal influences recognition of emotions.

    Science.gov (United States)

    Mumenthaler, Christian; Sander, David

    2012-06-01

    The notion of social appraisal emphasizes the importance of a social dimension in appraisal theories of emotion by proposing that the way an individual appraises an event is influenced by the way other individuals appraise and feel about the same event. This study directly tested this proposal by asking participants to recognize dynamic facial expressions of emotion (fear, happiness, or anger in Experiment 1; fear, happiness, anger, or neutral in Experiment 2) in a target face presented at the center of a screen while a contextual face, which appeared simultaneously in the periphery of the screen, expressed an emotion (fear, happiness, anger) or not (neutral) and either looked at the target face or not. We manipulated gaze direction to be able to distinguish between a mere contextual effect (gaze away from both the target face and the participant) and a specific social appraisal effect (gaze toward the target face). Results of both experiments provided evidence for a social appraisal effect in emotion recognition, which differed from the mere effect of contextual information: Whereas facial expressions were identical in both conditions, the direction of the gaze of the contextual face influenced emotion recognition. Social appraisal facilitated the recognition of anger, happiness, and fear when the contextual face expressed the same emotion. This facilitation was stronger than the mere contextual effect. Social appraisal also allowed better recognition of fear when the contextual face expressed anger and better recognition of anger when the contextual face expressed fear. 2012 APA, 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

    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.

  11. [Application of Chinese Medical Syndrome Scores in Effectiveness Evaluation: a Critical Appraisal of 240 Randomized Controlled Trials].

    Science.gov (United States)

    Luo, Hui; Liao, Xing; Wang, Qian

    2015-10-01

    To explore the role of traditional Chinese medicine (TCM) syndrome scores in effectiveness evaluation of clinical studies. Randomized controlled trials (RCTs) of TCM published in five journals in 2013 were retrieved, including Journal of Traditional Chinese Medicine (JTCM), Chinese Journal of Integrated Traditional and Western Medicine (CJITWM), Chinese Journal of Integrative Medicine (CJIM), Evidence-Based Complementary and Alternative Medicine (ECAM), and American Journal of Chinese Medicine (AJCM). The details of TCM syndrome scores and other relevant factors reported in articles were extracted and analyzed. Descriptive statistics and Chi-square test were used to describe general features of inclusive studies, ratios of reports on CM syndrome scores in each journal, formulated evidence, adopted evaluation rules, important degrees. The difference in the application rate of CM syndrome scores were compared in various diseases, diseases with or without CM syndrome typing, places where clinical studies were implemented, and different journals. A total of 240 RCTs were included, involving 178 published in Chinese version and 62 in English version. CM syndrome scores were used for effectiveness evaluation in 27.1% (65/240) of RCTs, of which, the highest application percentage was 35.3% (18/51) in RCTs published in CJITWM, and the lowest was 0 (0/7) in RCTs published in AJCM. There were 17 methods for grading TCM syndrome scores, of which Guideline for Clinical Research of New Chinese Herbal Medicine was most commonly used. Detailed grading standards for CM syndrome scores were reported in 46 RCTs, and CM syndrome scores were taken as primary or secondary outcomes in 6 RCTs. When describing the percentages of RCTs adopting TCM syndrome score by diseases classification, the lowest was 9.5% (2/21) in mental and behavioral disorders, and the highest was 39.1% (9/23) in endocrine, nutritional, and metabolic diseases. RCTs with TCM syndrome differentiation had a higher

  12. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  13. Challenges in coding adverse events in clinical trials: a systematic review.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    Full Text Available BACKGROUND: 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. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding. METHODS: Systematic review using PRISMA. We searched PubMed, EMBASE and The Cochrane Library. All studies were screened for eligibility by two authors. RESULTS: Our search returned 520 unique studies of which 12 were included. Only one study investigated interobserver variation. It reported that 12% of the codes were evaluated differently by two coders. Independent physicians found that 8% of all the codes deviated from the original description. Other studies found that product summaries could be greatly affected by the choice of dictionary. With the introduction of MedDRA, it seems to have become harder to identify adverse events statistically because each code is divided in subgroups. To account for this, lumping techniques have been developed but are rarely used, and guidance on when to use them is vague. An additional challenge is that adverse events are censored if they already occurred in the run-in period of a trial. As there are more than 26 ways of determining whether an event has already occurred, this can lead to bias, particularly because data analysis is rarely performed blindly. CONCLUSION: There is a lack of evidence that coding of adverse events is a reliable, unbiased and reproducible process. The increase in categories has made detecting adverse events harder, potentially compromising safety. It is crucial that readers of medical publications are aware of these challenges. Comprehensive interobserver

  14. 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

    2017-01-01

    Objective 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. Design 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. Setting Occupational health care in the Netherlands. Participants 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. Interventions 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. Outcomes Measures Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. Results 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. Conclusions 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

  15. Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials.

    Science.gov (United States)

    Hesse, Kerrick; Fulton, Rachael L; Abdul-Rahim, Azmil H; Lees, Kennedy R

    2014-09-01

    Adverse events (AE) in trial populations present a major burden to researchers and patients, yet most events are unrelated to investigational treatment. We aimed to develop a coherent list of expected AEs, whose incidence can be predicted by patient characteristics that will inform future trials and perhaps general poststroke care. We analyzed raw AE data from patients participating in acute ischemic stroke trials. We identified events that occurred with a lower 99% confidence bound greater than nil. Among these, we applied receiver operating characteristic principles to select the fewest types of events that together represented the greatest number of reports. Using ordinal logistic regression, we modeled the incidence of these events as a function of patient age, sex, baseline National Institutes of Health Stroke Scale, and multimorbidity status, defining Ppatients, reporting 21 217 AEs. Among 756 types of AEs, 132 accounted for 82.7%, of which 80% began within 10 days after stroke. Right hemisphere (odds ratio [OR], 1.67), increasing baseline National Institutes of Health Stroke Scale (OR, 1.11), multimorbidity status (OR, 1.09 per disease), patient age (OR, 1.01 per year), height (OR, 1.01 per centimeter), diastolic blood pressure (OR, 0.99 per mm Hg), and smoking (OR, 0.82) were independently associated with developing more AEs but together explained only 13% of the variation. A list of 132 expected AEs after acute ischemic stroke may be used to simplify interpretation and reporting of complications. AEs can be modestly predicted by patient characteristics, facilitating stratification of patients by risk for poststroke complications. © 2014 American Heart Association, Inc.

  16. Data Science Solution to Event Prediction in Outsourced Clinical Trial Models.

    Science.gov (United States)

    Dalevi, Daniel; Lovick, Susan; Mann, Helen; Metcalfe, Paul D; Spencer, Stuart; Hollis, Sally; Ruau, David

    2015-01-01

    Late phase clinical trials are regularly outsourced to a Contract Research Organisation (CRO) while the risk and accountability remain within the sponsor company. Many statistical tasks are delivered by the CRO and later revalidated by the sponsor. Here, we report a technological approach to standardised event prediction. We have built a dynamic web application around an R-package with the aim of delivering reliable event predictions, simplifying communication and increasing trust between the CRO and the in-house statisticians via transparency. Short learning curve, interactivity, reproducibility and data diagnostics are key here. The current implementation is motivated by time-to-event prediction in oncology. We demonstrate a clear benefit of standardisation for both parties. The tool can be used for exploration, communication, sensitivity analysis and generating standard reports. At this point we wish to present this tool and share some of the insights we have gained during the development.

  17. Kernel PLS Estimation of Single-trial Event-related Potentials

    Science.gov (United States)

    Rosipal, Roman; Trejo, Leonard J.

    2004-01-01

    Nonlinear kernel partial least squaes (KPLS) regressior, is a novel smoothing approach to nonparametric regression curve fitting. We have developed a KPLS approach to the estimation of single-trial event related potentials (ERPs). For improved accuracy of estimation, we also developed a local KPLS method for situations in which there exists prior knowledge about the approximate latency of individual ERP components. To assess the utility of the KPLS approach, we compared non-local KPLS and local KPLS smoothing with other nonparametric signal processing and smoothing methods. In particular, we examined wavelet denoising, smoothing splines, and localized smoothing splines. We applied these methods to the estimation of simulated mixtures of human ERPs and ongoing electroencephalogram (EEG) activity using a dipole simulator (BESA). In this scenario we considered ongoing EEG to represent spatially and temporally correlated noise added to the ERPs. This simulation provided a reasonable but simplified model of real-world ERP measurements. For estimation of the simulated single-trial ERPs, local KPLS provided a level of accuracy that was comparable with or better than the other methods. We also applied the local KPLS method to the estimation of human ERPs recorded in an experiment on co,onitive fatigue. For these data, the local KPLS method provided a clear improvement in visualization of single-trial ERPs as well as their averages. The local KPLS method may serve as a new alternative to the estimation of single-trial ERPs and improvement of ERP averages.

  18. Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint.

    Science.gov (United States)

    Jung, Sin-Ho

    2017-07-01

    In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

  19. 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

  20. Use and misuse of common terminology criteria for adverse events in cancer clinical trials

    International Nuclear Information System (INIS)

    Zhang, Sheng; Liang, Fei; Tannock, Ian

    2016-01-01

    Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) were released in 2003 and have been used widely to report toxicity in publications or presentations describing cancer clinical trials. Here we evaluate whether guidelines for reporting toxicity are followed in publications reporting randomized clinical trials (RCTs) for cancer. Phase III RCTs evaluating systemic cancer therapy published between 2011 and 2013, were reviewed to identify eligible studies, which stated explicitly that CTCAE v3.0 was used to report toxicity. Each AE term and its grade were located in CTCAE v3.0 to determine if they fell within the guidelines provided in the explanatory file. A total of 166 publications were included in this analysis. Criteria from CTCAE v3.0 were frequently used incorrectly. For example, CATEGORY names such as Metabolic were misreported as AEs in 19 trials, and inappropriate grades for AEs assigned frequently. For example, febrile neutropenia was graded 1 or 2 in 35 of 91 studies (38 %), but the minimum grade for this toxicity is 3. Alopecia was graded 3 or more in 19 of 77 studies (25 %), but the maximum is only grade 2. The present study provides evidence of poor reporting of toxicity in clinical trials. The study provides a lower estimate for the misuse of AE terms and grades, and implies that other AE terms and grades that conform to CTCAE v3.0 guidelines may have been assigned incorrectly. Inaccurate reporting of toxicity in clinical trials can lead clinicians to make inappropriate treatment decisions

  1. 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.

  2. Impact of hydroxyurea on clinical events in the BABY HUG trial

    Science.gov (United States)

    Files, Beatrice A.; Luo, Zhaoyu; Miller, Scott T.; Kalpatthi, Ram; Iyer, Rathi; Seaman, Phillip; Lebensburger, Jeffrey; Alvarez, Ofelia; Thompson, Bruce; Ware, Russell E.; Wang, Winfred C.

    2012-01-01

    The Pediatric Hydroxyurea Phase 3 Clinical Trial (BABY HUG) was a phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial of hydroxyurea in infants (beginning at 9-18 months of age) with sickle cell anemia. An important secondary objective of this study was to compare clinical events between the hydroxyurea and placebo groups. One hundred and ninety-three subjects were randomized to hydroxyurea (20 mg/kg/d) or placebo; there were 374 patient-years of on-study observation. Hydroxyurea was associated with statistically significantly lower rates of initial and recurrent episodes of pain, dactylitis, acute chest syndrome, and hospitalization; even infants who were asymptomatic at enrollment had less dactylitis as well as fewer hospitalizations and transfusions if treated with hydroxyurea. Despite expected mild myelosuppression, hydroxyurea was not associated with an increased risk of bacteremia or serious infection. These data provide important safety and efficacy information for clinicians considering hydroxyurea therapy for very young children with sickle cell anemia. This clinical trial is registered with the National Institutes of Health (NCT00006400, www.clinicaltrials.gov). PMID:22915643

  3. 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

  4. 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) [DOSAGE ERROR CORRECTED] . 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.

  5. 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.

  6. Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP.

    Science.gov (United States)

    Lazar, Ann A; Bonetti, Marco; Cole, Bernard F; Yip, Wai-Ki; Gelber, Richard D

    2016-04-01

    Investigators conducting randomized clinical trials often explore treatment effect heterogeneity to assess whether treatment efficacy varies according to patient characteristics. Identifying heterogeneity is central to making informed personalized healthcare decisions. Treatment effect heterogeneity can be investigated using subpopulation treatment effect pattern plot (STEPP), a non-parametric graphical approach that constructs overlapping patient subpopulations with varying values of a characteristic. Procedures for statistical testing using subpopulation treatment effect pattern plot when the endpoint of interest is survival remain an area of active investigation. A STEPP analysis was used to explore patterns of absolute and relative treatment effects for varying levels of a breast cancer biomarker, Ki-67, in the phase III Breast International Group 1-98 randomized clinical trial, comparing letrozole to tamoxifen as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer. Absolute treatment effects were measured by differences in 4-year cumulative incidence of breast cancer recurrence, while relative effects were measured by the subdistribution hazard ratio in the presence of competing risks using O-E (observed-minus-expected) methodology, an intuitive non-parametric method. While estimation of hazard ratio values based on O-E methodology has been shown, a similar development for the subdistribution hazard ratio has not. Furthermore, we observed that the subpopulation treatment effect pattern plot analysis may not produce results, even with 100 patients within each subpopulation. After further investigation through simulation studies, we observed inflation of the type I error rate of the traditional test statistic and sometimes singular variance-covariance matrix estimates that may lead to results not being produced. This is due to the lack of sufficient number of events within the subpopulations, which we refer to as instability of

  7. Study design of ASPirin in Reducing Events in the Elderly (ASPREE): a randomized, controlled trial.

    Science.gov (United States)

    2013-11-01

    Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100 mg enteric-coated aspirin will extend a composite primary endpoint termed 'disability-free life' including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65 years and above ('US minorities') and 70 years and above (non-'US minorities'). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14,383 participants have been recruited. Recruitment and study completion are anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia. © 2013. Published by Elsevier Inc. All rights reserved.

  8. 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.

  9. Appraisal of Meconium at Delivery

    Science.gov (United States)

    Paes, Bosco A.; Thompson, Penelope

    1992-01-01

    A critical appraisal of the scientific literature on managing mesconium in labor identified 15 studies which were used to evaluate intervention strategies. Only four were randomized trials: two on the use of amnioinfusion in labor, one on the technique of bulb versus DeLee catheter suction of the newborn, and one on the need for endotracheal intubation and suction in meconium-stained neonates. Current practice is dictated by the most favorable tradeoff between benefit and risk because of limited scientific evidence. PMID:21221284

  10. 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

  11. Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

    Science.gov (United States)

    Gourgou-Bourgade, S; Cameron, D; Poortmans, P; Asselain, B; Azria, D; Cardoso, F; A'Hern, R; Bliss, J; Bogaerts, J; Bonnefoi, H; Brain, E; Cardoso, M J; Chibaudel, B; Coleman, R; Cufer, T; Dal Lago, L; Dalenc, F; De Azambuja, E; Debled, M; Delaloge, S; Filleron, T; Gligorov, J; Gutowski, M; Jacot, W; Kirkove, C; MacGrogan, G; Michiels, S; Negreiros, I; Offersen, B V; Penault Llorca, F; Pruneri, G; Roche, H; Russell, N S; Schmitt, F; Servent, V; Thürlimann, B; Untch, M; van der Hage, J A; van Tienhoven, G; Wildiers, H; Yarnold, J; Bonnetain, F; Mathoulin-Pélissier, S; Bellera, C; Dabakuyo-Yonli, T S

    2015-05-01

    Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT. © 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.

  12. Aspirin Does Not Increase Heart Failure Events in Heart Failure Patients: From the WARCEF Trial.

    Science.gov (United States)

    Teerlink, John R; Qian, Min; Bello, Natalie A; Freudenberger, Ronald S; Levin, Bruce; Di Tullio, Marco R; Graham, Susan; Mann, Douglas L; Sacco, Ralph L; Mohr, J P; Lip, Gregory Y H; Labovitz, Arthur J; Lee, Seitetz C; Ponikowski, Piotr; Lok, Dirk J; Anker, Stefan D; Thompson, John L P; Homma, Shunichi

    2017-08-01

    The aim of this study was to determine whether aspirin increases heart failure (HF) hospitalization or death in patients with HF with reduced ejection fraction receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Because of its cyclooxygenase inhibiting properties, aspirin has been postulated to increase HF events in patients treated with ACE inhibitors or ARBs. However, no large randomized trial has addressed the clinical relevance of this issue. We compared aspirin and warfarin for HF events (hospitalization, death, or both) in the 2,305 patients enrolled in the WARCEF (Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction) trial (98.6% on ACE inhibitor or ARB treatment), using conventional Cox models for time to first event (489 events). In addition, to examine multiple HF hospitalizations, we used 2 extended Cox models, a conditional model and a total time marginal model, in time to recurrent event analyses (1,078 events). After adjustment for baseline covariates, aspirin- and warfarin-treated patients did not differ in time to first HF event (adjusted hazard ratio: 0.87; 95% confidence interval: 0.72 to 1.04; p = 0.117) or first hospitalization alone (adjusted hazard ratio: 0.88; 95% confidence interval: 0.73 to 1.06; p = 0.168). The extended Cox models also found no significant differences in all HF events or in HF hospitalizations alone after adjustment for covariates. Among patients with HF with reduced ejection fraction in the WARCEF trial, there was no significant difference in risk of HF events between the aspirin and warfarin-treated patients. (Warfarin Versus Aspirin in Reduced Cardiac Ejection Fraction trial [WARCEF]; NCT00041938). Copyright © 2017 American College of Cardiology Foundation. All rights reserved.

  13. 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.

  14. 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

  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...... 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...

  16. 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.

  17. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

    Science.gov (United States)

    Bonnetain, Franck; Bonsing, Bert; Conroy, Thierry; Dousseau, Adelaide; Glimelius, Bengt; Haustermans, Karin; Lacaine, François; Van Laethem, Jean Luc; Aparicio, Thomas; Aust, Daniela; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, Laeticia; De Gramont, Aimery; Delpero, Jean Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurelien; Lutz, Manfred; Macarulla, Teresa; Malka, David; Mauer, Muriel; Mitry, Emmanuel; Neoptolemos, John; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taieb, Julien; van Tienhoven, Geertjan; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin-Pélissier, Simone; Collette, Laurence

    2014-11-01

    Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. An audit strategy for time-to-event outcomes measured with error: application to five randomized controlled trials in oncology.

    Science.gov (United States)

    Dodd, Lori E; Korn, Edward L; Freidlin, Boris; Gu, Wenjuan; Abrams, Jeffrey S; Bushnell, William D; Canetta, Renzo; Doroshow, James H; Gray, Robert J; Sridhara, Rajeshwari

    2013-10-01

    Measurement error in time-to-event end points complicates interpretation of treatment effects in clinical trials. Non-differential measurement error is unlikely to produce large bias [1]. When error depends on treatment arm, bias is of greater concern. Blinded-independent central review (BICR) of all images from a trial is commonly undertaken to mitigate differential measurement-error bias that may be present in hazard ratios (HRs) based on local evaluations. Similar BICR and local evaluation HRs may provide reassurance about the treatment effect, but BICR adds considerable time and expense to trials. We describe a BICR audit strategy [2] and apply it to five randomized controlled trials to evaluate its use and to provide practical guidelines. The strategy requires BICR on a subset of study subjects, rather than a complete-case BICR, and makes use of an auxiliary-variable estimator. When the effect size is relatively large, the method provides a substantial reduction in the size of the BICRs. In a trial with 722 participants and a HR of 0.48, an average audit of 28% of the data was needed and always confirmed the treatment effect as assessed by local evaluations. More moderate effect sizes and/or smaller trial sizes required larger proportions of audited images, ranging from 57% to 100% for HRs ranging from 0.55 to 0.77 and sample sizes between 209 and 737. The method is developed for a simple random sample of study subjects. In studies with low event rates, more efficient estimation may result from sampling individuals with events at a higher rate. The proposed strategy can greatly decrease the costs and time associated with BICR, by reducing the number of images undergoing review. The savings will depend on the underlying treatment effect and trial size, with larger treatment effects and larger trials requiring smaller proportions of audited data.

  19. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials.

    Science.gov (United States)

    Brown, Jennifer R; Moslehi, Javid; O'Brien, Susan; Ghia, Paolo; Hillmen, Peter; Cymbalista, Florence; Shanafelt, Tait D; Fraser, Graeme; Rule, Simon; Kipps, Thomas J; Coutre, Steven; Dilhuydy, Marie-Sarah; Cramer, Paula; Tedeschi, Alessandra; Jaeger, Ulrich; Dreyling, Martin; Byrd, John C; Howes, Angela; Todd, Michael; Vermeulen, Jessica; James, Danelle F; Clow, Fong; Styles, Lori; Valentino, Rudy; Wildgust, Mark; Mahler, Michelle; Burger, Jan A

    2017-10-01

    The first-in-class Bruton's tyrosine kinase inhibitor ibrutinib has proven clinical benefit in B-cell malignancies; however, atrial fibrillation (AF) has been reported in 6-16% of ibrutinib patients. We pooled data from 1505 chronic lymphocytic leukemia and mantle cell lymphoma patients enrolled in four large, randomized, controlled studies to characterize AF with ibrutinib and its management. AF incidence was 6.5% [95% Confidence Interval (CI): 4.8, 8.5] for ibrutinib at 16.6-months versus 1.6% (95%CI: 0.8, 2.8) for comparator and 10.4% (95%CI: 8.4, 12.9) at the 36-month follow up; estimated cumulative incidence: 13.8% (95%CI: 11.2, 16.8). Ibrutinib treatment, prior history of AF and age 65 years or over were independent risk factors for AF. Multiple AF events were more common with ibrutinib (44.9%; comparator, 16.7%) among patients with AF. Most (85.7%) patients with AF did not discontinue ibrutinib, and more than half received common anticoagulant/antiplatelet medications on study. Low-grade bleeds were more frequent with ibrutinib, but serious bleeds were uncommon (ibrutinib, 2.9%; comparator, 2.0%). Although the AF rate among older non-trial patients with comorbidities is likely underestimated by this dataset, these results suggest that AF among clinical trial patients is generally manageable without ibrutinib discontinuation ( clinicaltrials.gov identifier: 01578707, 01722487, 01611090, 01646021 ). Copyright© 2017 Ferrata Storti Foundation.

  20. Negative Trauma Appraisals and PTSD Symptoms in Sri Lankan Adolescents.

    Science.gov (United States)

    Ponnamperuma, Thyagi; Nicolson, Nancy A

    2016-02-01

    The cognitive model posits that negative appraisals play an important role in posttraumatic stress disorder, in children as well as in adults. This study examined correlates of negative appraisals in relation to trauma exposure and their relationship to posttraumatic stress symptoms (PTSS) in 414 Sri Lankan adolescents, aged 12 to 16, living in areas impacted in varying degrees by the 2004 tsunami. In 2008, participants completed measures of negative appraisals, lifetime traumatic events, posttraumatic stress symptoms, internalizing symptoms, ongoing adversity, and social support. The majority (70 %) of the participants reported multiple traumatic events; 25 % met DSM-IV criteria for full or partial PTSD. Adolescents who had experienced more severe events, abusive events, greater cumulative trauma, or greater current adversity reported more negative appraisals. In regression analyses controlling for known risk factors such as female gender, cumulative trauma, ongoing adversity, and low social support, negative appraisals were the best predictor of PTSS, explaining 22 % of the variance. This relationship appeared specific to PTSS, as negative appraisals did not predict internalizing symptoms. Findings confirm the link between negative cognitions concerning traumatic events and persistent PTSS in adolescents, but longitudinal studies are needed to determine whether appraisals contribute to symptom maintenance over time.

  1. 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.

  2. The application of particle filters in single trial event-related potential estimation

    International Nuclear Information System (INIS)

    Mohseni, Hamid R; Nazarpour, Kianoush; Sanei, Saeid; Wilding, Edward L

    2009-01-01

    In this paper, an approach for the estimation of single trial event-related potentials (ST-ERPs) using particle filters (PFs) is presented. The method is based on recursive Bayesian mean square estimation of ERP wavelet coefficients using their previous estimates as prior information. To enable a performance evaluation of the approach in the Gaussian and non-Gaussian distributed noise conditions, we added Gaussian white noise (GWN) and real electroencephalogram (EEG) signals recorded during rest to the simulated ERPs. The results were compared to that of the Kalman filtering (KF) approach demonstrating the robustness of the PF over the KF to the added GWN noise. The proposed method also outperforms the KF when the assumption about the Gaussianity of the noise is violated. We also applied this technique to real EEG potentials recorded in an odd-ball paradigm and investigated the correlation between the amplitude and the latency of the estimated ERP components. Unlike the KF method, for the PF there was a statistically significant negative correlation between amplitude and latency of the estimated ERPs, matching previous neurophysiological findings

  3. 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.

  4. 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.

  5. 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.

  6. Dialysis dose in acute kidney injury: no time for therapeutic nihilism – a critical appraisal of the Acute Renal Failure Trial Network study

    Science.gov (United States)

    Ronco, Claudio; Cruz, Dinna; van Straaten, Helen Oudemans; Honore, Patrick; House, Andrew; Bin, Du; Gibney, Noel

    2008-01-01

    The optimal dialysis dose for acute kidney injury is a matter of great controversy. Clinical trials, predominantly single-center studies, have shown conflicting results. The Acute Renal Failure Trial Network (ATN) Study was designed to compare clinical outcomes between patients allocated to an intensive dose versus a less-intensive dose of renal replacement therapy. Recently, the results of this large randomized controlled multicenter study were published. The present article will discuss certain aspects of this trial: the overall design, the baseline patient characteristics, and comparison of the results with earlier studies. Finally, the article will address the implications of the ATN Study results for clinical practice. PMID:18983695

  7. Dialysis dose in acute kidney injury: no time for therapeutic nihilism--a critical appraisal of the Acute Renal Failure Trial Network study.

    Science.gov (United States)

    Ronco, Claudio; Cruz, Dinna; Oudemans van Straaten, Helen; Honore, Patrick; House, Andrew; Bin, Du; Gibney, Noel

    2008-01-01

    The optimal dialysis dose for acute kidney injury is a matter of great controversy. Clinical trials, predominantly single-center studies, have shown conflicting results. The Acute Renal Failure Trial Network (ATN) Study was designed to compare clinical outcomes between patients allocated to an intensive dose versus a less-intensive dose of renal replacement therapy. Recently, the results of this large randomized controlled multicenter study were published. The present article will discuss certain aspects of this trial: the overall design, the baseline patient characteristics, and comparison of the results with earlier studies. Finally, the article will address the implications of the ATN Study results for clinical practice.

  8. 12 CFR 564.5 - Appraiser independence.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Appraiser independence. 564.5 Section 564.5 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPRAISALS § 564.5 Appraiser independence. (a) Staff appraisers. If an appraisal is prepared by a staff appraiser, that appraiser must be...

  9. Prevention of Contrast-Induced AKI: A Review of Published Trials and the Design of the Prevention of Serious Adverse Events following Angiography (PRESERVE) Trial

    Science.gov (United States)

    Gallagher, Martin; Kaufman, James; Cass, Alan; Parikh, Chirag R.; Chertow, Glenn M.; Shunk, Kendrick A.; McCullough, Peter A.; Fine, Michael J.; Mor, Maria K.; Lew, Robert A.; Huang, Grant D.; Conner, Todd A.; Brophy, Mary T.; Lee, Joanne; Soliva, Susan; Palevsky, Paul M.

    2013-01-01

    Summary Contrast-induced AKI (CI-AKI) is a common condition associated with serious, adverse outcomes. CI-AKI may be preventable because its risk factors are well characterized and the timing of renal insult is commonly known in advance. Intravenous (IV) fluids and N-acetylcysteine (NAC) are two of the most widely studied preventive measures for CI-AKI. Despite a multitude of clinical trials and meta-analyses, the most effective type of IV fluid (sodium bicarbonate versus sodium chloride) and the benefit of NAC remain unclear. Careful review of published trials of these interventions reveals design limitations that contributed to their inconclusive findings. Such design limitations include the enrollment of small numbers of patients, increasing the risk for type I and type II statistical errors; the use of surrogate primary endpoints defined by small increments in serum creatinine, which are associated with, but not necessarily causally related to serious, adverse, patient-centered outcomes; and the inclusion of low-risk patients with intact baseline kidney function, yielding low event rates and reduced generalizability to a higher-risk population. The Prevention of Serious Adverse Events following Angiography (PRESERVE) trial is a randomized, double-blind, multicenter trial that will enroll 8680 high-risk patients undergoing coronary or noncoronary angiography to compare the effectiveness of IV isotonic sodium bicarbonate versus IV isotonic sodium chloride and oral NAC versus oral placebo for the prevention of serious, adverse outcomes associated with CI-AKI. This article discusses key methodological issues of past trials investigating IV fluids and NAC and how they informed the design of the PRESERVE trial. PMID:23660180

  10. Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†.

    Science.gov (United States)

    Bellera, C A; Penel, N; Ouali, M; Bonvalot, S; Casali, P G; Nielsen, O S; Delannes, M; Litière, S; Bonnetain, F; Dabakuyo, T S; Benjamin, R S; Blay, J-Y; Bui, B N; Collin, F; Delaney, T F; Duffaud, F; Filleron, T; Fiore, M; Gelderblom, H; George, S; Grimer, R; Grosclaude, P; Gronchi, A; Haas, R; Hohenberger, P; Issels, R; Italiano, A; Jooste, V; Krarup-Hansen, A; Le Péchoux, C; Mussi, C; Oberlin, O; Patel, S; Piperno-Neumann, S; Raut, C; Ray-Coquard, I; Rutkowski, P; Schuetze, S; Sleijfer, S; Stoeckle, E; Van Glabbeke, M; Woll, P; Gourgou-Bourgade, S; Mathoulin-Pélissier, S

    2015-05-01

    The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities. © The Author 2014. 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.

  11. Conducting effective performance appraisals.

    Science.gov (United States)

    2001-01-01

    According to experts, performance appraisals rate just below firing someone as the least favorite thing managers do. Many factors contribute to this view--one is that current systems do a poor job of evaluating performance and in fact often impede both evaluation and performance. When used as part of an ongoing supportive process of goal setting and feedback, performance appraisals can enhance performance and morale. One alternative to traditional employee evaluation methods is full-circle or 360-degree feedback. Contained in this issue are practical suggestions for preparing employees for performance appraisals which, when followed daily, encourage employees to put their best feet forward as part of their regular routine. Also included is a template specific to assessing the performance of clinical laboratory technologists . Additionally, numerous resources are provided to help you refine appraisal systems to fit your needs. Full-circle feedback is proving to be a boon to managers. It relieves them from being the exclusive "heavies" in evaluating performance, integrates appraisal input from several sources, and incorporates increasing employee skills, competencies, and satisfaction, thus improving productivity of people and processes. And aren't integration and continuous improvement what the laboratory is all about?

  12. An Exponential Tilt Mixture Model for Time-to-Event Data to Evaluate Treatment Effect Heterogeneity in Randomized Clinical Trials.

    Science.gov (United States)

    Wang, Chi; Tan, Zhiqiang; Louis, Thomas A

    2014-01-01

    Evaluating the effect of a treatment on a time-to-event outcome is the focus of many randomized clinical trials. It is often observed that the treatment effect is heterogeneous, where only a subgroup of the patients may respond to the treatment due to some unknown mechanism such as genetic polymorphism. In this paper, we propose a semiparametric exponential tilt mixture model to estimate the proportion of patients who respond to the treatment and to assess the treatment effect. Our model is a natural extension of parametric mixture models to a semiparametric setting with a time-to-event outcome. We propose a nonparametric maximum likelihood estimation approach for inference and establish related asymptotic properties. Our method is illustrated by a randomized clinical trial on biodegradable polymer-delivered chemotherapy for malignant gliomas patients.

  13. 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.

  14. 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.

  15. 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

  16. Critical appraisal of published literature

    Science.gov (United States)

    Umesh, Goneppanavar; Karippacheril, John George; Magazine, Rahul

    2016-01-01

    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. PMID:27729695

  17. 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.

  18. Appraisal of Transport Projects

    DEFF Research Database (Denmark)

    Jensen, Anders Vestergaard

    and robustness measures have been elaborated, which examine the subjective part of the MCDA (in form of criteria weights) and its role in decision support making. For this purpose both deterministic and stochastic sensitivity analyses have been developed. In addition, the focus has been formulating a framework...... into account the interests and preferences of different stakeholders. These various interests and preferences have been revealed by the use of decision conferencing, which engage the stakeholders and provide a common platform for understanding the decision problem. Leading up to this framework, this thesis has......, as robustness of a recommended solution is major concern in the final steps of decision making. As mentioned, the appraisal of transport projects is a complex issues involving conflict of various interests and this calls for new approaches to the practice of appraisal. The presented appraisal framework...

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

    NARCIS (Netherlands)

    Lokman, S.; Volker, D.; Zijlstra-Vlasveld, M.C.; Brouwers, E.P.M.; Boon, B.; Beekman, A.T.; Smit, F.; van der Feltz-Cornelis, C.M.

    2017-01-01

    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),

  20. Economic evidence for the clinical management of major depressive disorder: a systematic review and quality appraisal of economic evaluations alongside randomised controlled trials.

    Science.gov (United States)

    Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P

    2017-10-01

    The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions

  1. Workflow in clinical trial sites & its association with near miss events for data quality: ethnographic, workflow & systems simulation.

    Science.gov (United States)

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

    2012-01-01

    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. 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. 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 professionals to reduce near miss events and save time/cost. Clinical trial

  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. Addressing social issues in a universal HIV test and treat intervention trial (ANRS 12249 TasP) in South Africa: methods for appraisal.

    Science.gov (United States)

    Orne-Gliemann, Joanna; Larmarange, Joseph; Boyer, Sylvie; Iwuji, Collins; McGrath, Nuala; Bärnighausen, Till; Zuma, Thembelile; Dray-Spira, Rosemary; Spire, Bruno; Rochat, Tamsen; Lert, France; Imrie, John

    2015-03-01

    The Universal HIV Test and Treat (UTT) strategy represents a challenge for science, but is also a challenge for individuals and societies. Are repeated offers of provider-initiated HIV testing and immediate antiretroviral therapy (ART) socially-acceptable and can these become normalized over time? Can UTT be implemented without potentially adding to individual and community stigma, or threatening individual rights? What are the social, cultural and economic implications of UTT for households and communities? And can UTT be implemented within capacity constraints and other threats to the overall provision of HIV services? The answers to these research questions will be critical for routine implementation of UTT strategies. A social science research programme is nested within the ANRS 12249 Treatment-as-Prevention (TasP) cluster-randomised trial in rural South Africa. The programme aims to inform understanding of the (i) social, economic and environmental factors affecting uptake of services at each step of the continuum of HIV prevention, treatment and care and (ii) the causal impacts of the TasP intervention package on social and economic factors at the individual, household, community and health system level. We describe a multidisciplinary, multi-level, mixed-method research protocol that includes individual, household, community and clinic surveys, and combines quantitative and qualitative methods. The UTT strategy is changing the overall approach to HIV prevention, treatment and care, and substantial social consequences may be anticipated, such as changes in social representations of HIV transmission, prevention, HIV testing and ART use, as well as changes in individual perceptions and behaviours in terms of uptake and frequency of HIV testing and ART initiation at high CD4. Triangulation of social science studies within the ANRS 12249 TasP trial will provide comprehensive insights into the acceptability and feasibility of the TasP intervention package at

  4. 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.

  5. 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 M; Jadhav, Shantanu P; Redish, A David

    2016-12-07

    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. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials.

    Science.gov (United States)

    Mahr, Alfred; Golmard, Clara; Pham, Emilie; Iordache, Laura; Deville, Laure; Faure, Pierre

    2017-07-01

    Scarce studies analyzing adverse event (AE) data from randomized placebo-controlled clinical trials (RPCCTs) of selected illnesses suggested that a substantial proportion of collected AEs are unrelated to the drug taken. This study analyzed the nonspecific AEs occurring with active-drug exposure in RPCCTs for a large range of medical conditions. Randomized placebo-controlled clinical trials published in five prominent medical journals during 2006-2012 were searched. Only trials that evaluated orally or parenterally administered active drugs versus placebo in a head-to-head setting were selected. For AEs reported from ≥10 RPCCTs, Pearson's correlation coefficients (r) were calculated to determine the relationship between AE rates in placebo and active-drug recipients. Random-effects meta-analyses were used to compute proportions of nonspecific AEs, which were truncated at a maximum of 100%, in active-drug recipients. We included 231 trials addressing various medical domains or healthy participants. For the 88 analyzed AE variables, AE rates for placebo and active-drug recipients were in general strongly correlated (r > 0.50) or very strongly correlated (r > 0.80). The pooled proportions of nonspecific AEs for the active-drug recipients were 96.8% (95%CI: 95.5-98.1) for any AEs, 100% (97.9-100) for serious AEs, and 77.7% (72.7-83.2) for drug-related AEs. Results were similar for individual medical domains and healthy participants. The pooled proportion of nonspecificity of 82 system organ class and individual AE types ranged from 38% to 100%. The large proportion of nonspecific AEs reported in active-drug recipients of RPCCTs, including serious and drug-related AEs, highlights the limitations of clinical trial data to determine the tolerability of drugs. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  7. 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.

  8. Self-focused attention affects subsequent processing of positive (but not negative) performance appraisals.

    Science.gov (United States)

    Holzman, Jacob B; Valentiner, David P

    2016-03-01

    Cognitive-behavioral models highlight the conjoint roles of self-focused attention (SFA), post-event processing (PEP), and performance appraisals in the maintenance of social anxiety. SFA, PEP, and biased performance appraisals are related to social anxiety; however, limited research has examined how SFA affects information-processing following social events. The current study examined whether SFA affects the relationships between performance appraisals and PEP following a social event.. 137 participants with high (n = 72) or low (n = 65) social anxiety were randomly assigned to conditions of high SFA or low SFA while engaging in a standardized social performance. Subsequent performance appraisals and PEP were measured. Immediate performance appraisals were not affected by SFA. High levels of SFA led to a stronger, inverse relationship between immediate positive performance appraisals and subsequent negative PEP. High levels of SFA also led to a stronger, inverse relationship between negative PEP and changes in positive performance appraisals.. Future research should examine whether the current findings, which involved a standardized social performance event, extend to interaction events as well as in a clinical sample. These findings suggest that SFA affects the processing of positive information following a social performance event. SFA is particularly important for understanding how negative PEP undermines positive performance appraisals.. Published by Elsevier Ltd.

  9. 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

  10. [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

  11. 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.

  12. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.

    Science.gov (United States)

    Karpefors, Martin; Weatherall, James

    2018-03-21

    In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. We introduce a new means of visualizing the adverse event data across an entire clinical trial. The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.

  13. 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.

  14. 32 CFR 644.44 - Fee appraisals.

    Science.gov (United States)

    2010-07-01

    ... HANDBOOK Appraisal § 644.44 Fee appraisals. (a) Definitions and procedures. (1) The complete and.... The keynote of this approach lies in the sound development of a proper rate. The appraiser must have a...

  15. 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.

  16. 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

  17. Role of multisensory stimuli in vigilance enhancement- a single trial event related potential study.

    Science.gov (United States)

    Abbasi, Nida Itrat; Bodala, Indu Prasad; Bezerianos, Anastasios; Yu Sun; Al-Nashash, Hasan; Thakor, Nitish V

    2017-07-01

    Development of interventions to prevent vigilance decrement has important applications in sensitive areas like transportation and defence. The objective of this work is to use multisensory (visual and haptic) stimuli for cognitive enhancement during mundane tasks. Two different epoch intervals representing sensory perception and motor response were analysed using minimum variance distortionless response (MVDR) based single trial ERP estimation to understand the performance dependency on both factors. Bereitschaftspotential (BP) latency L3 (r=0.6 in phase 1 (visual) and r=0.71 in phase 2 (visual and haptic)) was significantly correlated with reaction time as compared to that of sensory ERP latency L2 (r=0.1 in both phase 1 and phase 2). This implies that low performance in monotonous tasks is predominantly dependent on the prolonged neural interaction with the muscles to initiate movement. Further, negative relationship was found between the ERP latencies related to sensory perception and Bereitschaftspotential (BP) and occurrence of epochs when multisensory cues are provided. This means that vigilance decrement is reduced with the help of multisensory stimulus presentation in prolonged monotonous tasks.

  18. 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.

  19. 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

  20. Are there individual and sibling differences in appraisals of interparental conflict?

    Science.gov (United States)

    Lucas-Thompson, Rachel G; George, Melissa W

    2017-10-01

    Despite decades of empirical literature documenting the harmful effects of frequent, intense, violent, and unresolved interparental conflict on children's adjustment, there is considerable variability in the extent to which marital conflict contributes to the development of children's emotional and behavioral problems. Past research has documented links between properties of interparental conflict itself (e.g., intensity, frequency), children's appraisals of conflict, and children's outcomes, yet less is known about the role of individual and family characteristics in predicting children's conflict appraisals. Sibling studies may be especially helpful in understanding these individual differences yet are notably lacking in marital conflict research. The current study examines individual- and family-characteristic predictors of adolescents' appraisals of conflict in a study of 153 adolescents as well as sibling similarities in conflict appraisals in a subsample of 50 pairs of siblings. Controlling for parent reports of the frequency, intensity, and resolution of interparental conflict, parent-child relationship quality and stressful life events predicted conflict appraisals. In addition, there was nonindependence of sibling appraisals of conflict properties, but self-blame and threat appraisals appeared independent across siblings. Greater discrepancies in siblings' conflict appraisals were related to more negative marital conflict and discrepancies in parent-child relationship quality, and were found in mixed-sex sibling dyads. Implications for future studies on factors that impact children's appraisals of conflict and in particular making use of sibling studies to examine shared environmental and individual influences on appraisals is highlighted. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  1. Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

    Directory of Open Access Journals (Sweden)

    Mathilde Holmskov

    Full Text Available To study in more depth the relationship between type, dose, or duration of methylphenidate offered to children and adolescents with attention deficit hyperactivity disorder and their risks of gastrointestinal adverse events based on our Cochrane systematic review.We use data from our review including 185 randomised clinical trials. Randomised parallel-group trials and cross-over trials reporting gastrointestinal adverse events associated with methylphenidate were included. Data were extracted and quality assessed according to Cochrane guidelines. Data were summarised as risk ratios (RR with 95% confidence intervals (CI using the inverse variance method. Bias risks were assessed according to domains. Trial Sequential Analysis (TSA was used to control random errors. Eighteen parallel group trials and 43 cross-over trials reported gastrointestinal adverse events. All trials were at high risk of bias. In parallel group trials, methylphenidate decreased appetite (RR 3.66, 95% CI 2.56 to 5.23 and weight (RR 3.89, 95% CI 1.43 to 10.59. In cross-over trials, methylphenidate increased abdominal pain (RR 1.61, 95% CI 1.27 to 2.04. We found no significant differences in the risk according to type, dose, or duration of administration. The required information size was achieved in three out of four outcomes.Methylphenidate increases the risks of decreased appetite, weight loss, and abdominal pain in children and adolescents with attention deficit hyperactivity disorder. No differences in the risks of gastrointestinal adverse events according to type, dose, or duration of administration were found.

  2. MAPS Appraisal Report Form

    CERN Multimedia

    HR Department

    2005-01-01

    As announced in Weekly Bulletin 48/2004, from now onwards, the paper MAPS appraisal report form has been replaced by an electronic form, which is available via EDH (on the EDH desktop under Other Tasks / HR & Training) No changes have been made to the contents of the form. Practical information will be available on the web page http://cern.ch/ais/projs/forms/maps/info.htm, and information meetings will be held on the following dates: 18 January 2005: MAIN AUDITORIUM (500-1-001) from 14:00 to 15:30. 20 January 2005: AB AUDITORIUM II (864-1-D02) from14:00 to 15:30. 24 January 2005: AT AUDITORIUM (30-7-018) from 10:00 to 11:30. Human Resources Department Tel. 73566

  3. 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.

  4. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  5. 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...

  6. Relationships of different types of event to cardiovascular death in trials of antihypertensive treatment: an aid to definition of total cardiovascular disease risk in hypertension.

    Science.gov (United States)

    Zambon, Antonella; Arfè, Andrea; Corrao, Giovanni; Zanchetti, Alberto

    2014-03-01

    Guidelines for management of cardiovascular diseases stratify absolute cardiovascular risk into categories with a high-risk threshold defined at a 20% cardiovascular events risk in 10 years, but it is unclear whether only major events or the Framingham-extended definition should be considered. The 2013 ESH-ESC hypertension guidelines, instead, define cardiovascular risk as a risk of cardiovascular death in 10 years, as in the SCORE model, setting the threshold for high risk at the 5% level. It would be therefore convenient to know the quantitative relationship between the risks of the different outcomes adopted by the different guidelines, especially because some outcome definitions include serious nonfatal cardiovascular events relevant in cardiovascular prevention. We have therefore analysed these relationships in trials of antihypertensive therapy as an aid to defining total cardiovascular risk in hypertensive patients. Sixty-one trials were identified, and 51 retained for analysis of the relationship of cardiovascular death to the incidence of all-cause death, major cardiovascular events and inclusive (Framingham) cardiovascular events. The relationship between cardiovascular death rates and each type of event rates was explored by fitting flexible regression models. The included trials provided 15164 cardiovascular deaths and 1674427 patient-years. The relation of each event rate to cardiovascular death rate was best explained by a model considering the logarithm of each event rate as a dependent variable and the logarithm of cardiovascular death rate as a predictor. Mean patients' age and treatment were also predictors, but to a minor extent. The increase of the incidence rates of all types of events was less steep the higher the CV death rate: the rate ratios of all-cause death to cardiovascular death were 2.2, 1.9 and 1.8 at low-moderate (cardiovascular death hypertensive patients whose cardiovascular death risk is calculated by the SCORE model.

  7. Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

    International Nuclear Information System (INIS)

    Hakeem, Abdul; Marmagkiolis, Konstantinos; Hacioglu, Yalcin; Uretsky, Barry F.; Gundogdu, Betul; Leesar, Massoud; Bailey, Steven R.; Cilingiroglu, Mehmet

    2013-01-01

    Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48–1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35–1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group

  8. Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Hakeem, Abdul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Marmagkiolis, Konstantinos [Citizens Memorial Hospital Heart and Vascular Institute, Bolivar, MO (United States); Hacioglu, Yalcin; Uretsky, Barry F.; Gundogdu, Betul [University of Arkansas for Medical Sciences, Little Rock, AR (United States); Leesar, Massoud [University of Alabama at Birmingham, Birmingham, AL (United States); Bailey, Steven R. [University of Texas Health Sciences Center at San Antonio, San Antonio, TX (United States); Cilingiroglu, Mehmet, E-mail: mcilingiroglu@yahoo.com [Arkansas Heart Hospital, Little Rock, AR (United States)

    2013-11-15

    Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48–1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35–1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.

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

    NARCIS (Netherlands)

    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 Jp

    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

  10. Uranium-mill appraisal program

    International Nuclear Information System (INIS)

    Everett, R.J.; Cain, C.L.

    1982-08-01

    The results of special team appraisals at NRC-licensed uranium mills in the period May to November 1981 are reported. Since the Three Mile Island accident, NRC management has instituted a program of special team appraisals of radiation protection programs at certain NRC-licensed facilities. These appraisals were designed to identify weaknesses and strengths in NRC-licensed programs, including those areas not covered by explicit regulatory requirements. The regulatory requirements related to occupational radiation protection and environmental monitoring at uranium mills have been extensively upgraded in the past few years. In addition, there was some NRC staff concern with respect to the effectiveness of NRC licensing and inspection programs. In response to this concern and to changes in mill requirements, the NRC staff recommended that team appraisals be conducted at mills to determine the adequacy of mill programs, the effectiveness of the new requirements, and mill management implementation of programs and requirements. This report describes the appraisal scope and methodology as well as summary findings and conclusions. Significant weaknesses identified during the mill appraisals are discussed as well as recommendations for improvements in uranium mill programs and mill licensing and inspection

  11. 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.

  12. 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

    failure, most treated with an ACE inhibitor). One of the main active controlled trials was confounded by a blood pressure difference between treatments. METHODS: We compared the effects of captopril, valsartan, and their combination on atherosclerotic events in 14,703 patients randomized in the Valsartan...... in Acute Myocardial Infarction Trial (VALIANT). RESULTS: The number of individuals adjudicated as having a fatal or non-fatal MI in the captopril group was 559 (total investigator reported events 798), 587 (796) in the valsartan group, and 554 (756) in the combination group; valsartan versus captopril, p...... = 0.651 (0.965); combination versus captopril, p = 0.187 (0.350). Overall, all atherosclerotic events examined occurred at a similar frequency in the captopril and valsartan groups. CONCLUSIONS: Angiotensin receptor blockers appear to be as effective as ACE inhibitors in reducing atherosclerotic...

  13. Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis.

    Science.gov (United States)

    Pradhan, Richeek; Singh, Sonal

    2018-04-11

    Inconsistencies in data on serious adverse events (SAEs) and mortality in ClinicalTrials.gov and corresponding journal articles pose a challenge to research transparency. The objective of this study was to compare data on SAEs and mortality from clinical trials reported in ClinicalTrials.gov and corresponding journal articles with US Food and Drug Administration (FDA) medical reviews. We conducted a cross-sectional study of a randomly selected sample of new molecular entities approved during the study period 1 January 2013 to 31 December 2015. We extracted data on SAEs and mortality from 15 pivotal trials from ClinicalTrials.gov and corresponding journal articles (the two index resources), and FDA medical reviews (reference standard). We estimated the magnitude of deviations in rates of SAEs and mortality between the index resources and the reference standard. We found deviations in rates of SAEs (30% in ClinicalTrials.gov and 30% in corresponding journal articles) and mortality (72% in ClinicalTrials.gov and 53% in corresponding journal articles) when compared with the reference standard. The intra-class correlation coefficient between the three resources was 0.99 (95% confidence interval [CI] 0.98-0.99) for SAE rates and 0.99 (95% CI 0.97-0.99) for mortality rates. There are differences in data on rates of SAEs and mortality in randomized clinical trials in both ClinicalTrials.gov and journal articles compared with FDA reviews. Further efforts should focus on decreasing existing discrepancies to enhance the transparency and reproducibility of data reporting in clinical trials.

  14. 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

  15. 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

  16. Plasma triglycerides and cardiovascular events in the Treating to New Targets and Incremental Decrease in End-Points through Aggressive Lipid Lowering trials of statins in patients with coronary artery disease

    DEFF Research Database (Denmark)

    Faergeman, Ole; Holme, Ingar; Fayyad, Rana

    2009-01-01

    We determined the ability of in-trial measurements of triglycerides (TGs) to predict new cardiovascular events (CVEs) using data from the Incremental Decrease in End Points through Aggressive Lipid Lowering (IDEAL) and Treating to New Targets (TNT) trials. The trials compared atorvastatin 80 mg...

  17. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial.

    Science.gov (United States)

    Lamas, Gervasio A; Goertz, Christine; Boineau, Robin; Mark, Daniel B; Rozema, Theodore; Nahin, Richard L; Lindblad, Lauren; Lewis, Eldrin F; Drisko, Jeanne; Lee, Kerry L

    2013-03-27

    Chelation therapy with disodium EDTA has been used for more than 50 years to treat atherosclerosis without proof of efficacy. To determine if an EDTA-based chelation regimen reduces cardiovascular events. Double-blind, placebo-controlled, 2 × 2 factorial randomized trial enrolling 1708 patients aged 50 years or older who had experienced a myocardial infarction (MI) at least 6 weeks prior and had serum creatinine levels of 2.0 mg/dL or less. Participants were recruited at 134 US and Canadian sites. Enrollment began in September 2003 and follow-up took place until October 2011 (median, 55 months). Two hundred eighty-nine patients (17% of total; n=115 in the EDTA group and n=174 in the placebo group) withdrew consent during the trial. Patients were randomized to receive 40 infusions of a 500-mL chelation solution (3 g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine, and heparin) (n=839) vs placebo (n=869) and an oral vitamin-mineral regimen vs an oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart. Fifteen percent discontinued infusions (n=38 [16%] in the chelation group and n=41 [15%] in the placebo group) because of adverse events. The prespecified primary end point was a composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. This report describes the intention-to-treat comparison of EDTA chelation vs placebo. To account for multiple interim analyses, the significance threshold required at the final analysis was P = .036. Qualifying previous MIs occurred a median of 4.6 years before enrollment. Median age was 65 years, 18% were female, 9% were nonwhite, and 31% were diabetic. The primary end point occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.99]; P = .035). There was no effect on total mortality (chelation: 87 deaths [10%]; placebo, 93 deaths [11%]; HR, 0

  18. 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.

  19. 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 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.

  20. 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...... Uppsala, Sweden 10 Cardiology, Uppsala Clinical Rsch center, 75185 Uppsala, Sweden Background: Patients with peripheral artery disease (PAD) and acute coronary syndrome (ACS) are at high risk for clinical events and are often difficult to manage. We evaluated cardiovascular outcomes of ACS patients...

  1. 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

  2. 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

  3. Risk-appraisal, outcome and self-efficacy expectancies: Cognitive factors in preventive behaviour related to cancer

    NARCIS (Netherlands)

    Seydel, E.R.; Taal, Erik; Wiegman, O.

    1990-01-01

    Health education often attempts to influence or persuade through risk-appraisal of impending danger or harm. Risk: appraisal implies cognitive processes concerning the severity of the threatening event and the probability of its occurrence. In two studies we investigated whether risk factors could

  4. How "Does" the Comforting Process Work? An Empirical Test of an Appraisal-Based Model of Comforting

    Science.gov (United States)

    Jones, Susanne M.; Wirtz, John G.

    2006-01-01

    Burleson and Goldsmith's (1998) comforting model suggests an appraisal-based mechanism through which comforting messages can bring about a positive change in emotional states. This study is a first empirical test of three causal linkages implied by the appraisal-based comforting model. Participants (N=258) talked about an upsetting event with a…

  5. 9 CFR 50.9 - Appraisals.

    Science.gov (United States)

    2010-01-01

    ... part must be appraised at their fair market value by an appraiser selected by APHIS. APHIS may decline... veterinarian in charge may grant a reasonable time for the presentation of their registration papers. [67 FR...

  6. Using Expectancy Theory to Explain Performance Appraisal ...

    African Journals Online (AJOL)

    pc

    2018-03-05

    Mar 5, 2018 ... appraisal conducting style, the relation between the performance appraisal system and task ... the article first explains the theory model which is based expectancy theory. II. ... which in return lead to rewards. According to [12],.

  7. 12 CFR 564.3 - Appraisals required; transactions requiring a State certified or licensed appraiser.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Appraisals required; transactions requiring a State certified or licensed appraiser. 564.3 Section 564.3 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPRAISALS § 564.3 Appraisals required; transactions requiring a State...

  8. The functional organization of trial-related activity in lexical processing after early left hemispheric brain lesions: An event-related fMRI study.

    Science.gov (United States)

    Fair, Damien A; Choi, Alexander H; Dosenbach, Yannic B L; Coalson, Rebecca S; Miezin, Francis M; Petersen, Steven E; Schlaggar, Bradley L

    2010-08-01

    Children with congenital left hemisphere damage due to perinatal stroke are capable of acquiring relatively normal language functions despite experiencing a cortical insult that in adults often leads to devastating lifetime disabilities. Although this observed phenomenon is accepted, its neurobiological mechanisms are not well characterized. In this paper we examined the functional neuroanatomy of lexical processing in 13 children/adolescents with perinatal left hemispheric damage. In contrast to many previous perinatal infarct fMRI studies, we used an event-related design, which allowed us to isolate trial-related activity and examine correct and error trials separately. Using both group and single subject analysis techniques we attempt to address several methodological factors that may contribute to some discrepancies in the perinatal lesion literature. These methodological factors include making direct statistical comparisons, using common stereotactic space, using both single subject and group analyses, and accounting for performance differences. Our group analysis, investigating correct trial-related activity (separately from error trials), showed very few statistical differences in the non-involved right hemisphere between patients and performance matched controls. The single subject analysis revealed atypical regional activation patterns in several patients; however, the location of these regions identified in individual patients often varied across subjects. These results are consistent with the idea that alternative functional organization of trial-related activity after left hemisphere lesions is in large part unique to the individual. In addition, reported differences between results obtained with event-related designs and blocked designs may suggest diverging organizing principles for sustained and trial-related activity after early childhood brain injuries. 2009 Elsevier Inc. All rights reserved.

  9. Appraisal of family doctors: an evaluation study.

    NARCIS (Netherlands)

    Lewis, M.I.; Elwyn, G.; Wood, F.

    2003-01-01

    BACKGROUND: Appraisal has evolved to become a key component of workforce management. However, it is not clear from existing proposals for appraisal of doctors whether employers, health authorities or primary care organisations should take responsibility for appraisal processes. AIMS: To evaluate the

  10. 7 CFR 4279.144 - Appraisals.

    Science.gov (United States)

    2010-01-01

    ... value of the collateral. All real property appraisals associated with Agency guaranteed loanmaking and... appraise the property in question. All appraisals will include consideration of the potential effects from... value of the collateral. For additional guidance and information concerning the completion of real...

  11. Appraisal Psychology, Neurobiology, and Language.

    Science.gov (United States)

    Schumann, John H.

    2001-01-01

    Proposes that the confluence of stimulus appraisal and social cognition that is effected by the neural system in the brain has important implications for language and learning theories. Describes the anatomy and functions of this neural system and discusses how it may operate in motivation for second language acquisition and how in conjunction…

  12. 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.

  13. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project†.

    Science.gov (United States)

    Kramar, A; Negrier, S; Sylvester, R; Joniau, S; Mulders, P; Powles, T; Bex, A; Bonnetain, F; Bossi, A; Bracarda, S; Bukowski, R; Catto, J; Choueiri, T K; Crabb, S; Eisen, T; El Demery, M; Fitzpatrick, J; Flamand, V; Goebell, P J; Gravis, G; Houédé, N; Jacqmin, D; Kaplan, R; Malavaud, B; Massard, C; Melichar, B; Mourey, L; Nathan, P; Pasquier, D; Porta, C; Pouessel, D; Quinn, D; Ravaud, A; Rolland, F; Schmidinger, M; Tombal, B; Tosi, D; Vauleon, E; Volpe, A; Wolter, P; Escudier, B; Filleron, T

    2015-12-01

    In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in

  14. 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

  15. 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....

  16. Usefulness of proteinuria as a prognostic marker of mortality and cardiovascular events among patients undergoing percutaneous coronary intervention (data from the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events [EXCITE] trial).

    Science.gov (United States)

    Mercado, Nestor; Brugts, Jasper J; Ix, Joachim H; Shlipak, Michael G; Dixon, Simon R; Gersh, Bernard J; Lemos, Pedro A; Guarneri, Mimi; Teirstein, Paul S; Wijns, William; Serruys, Patrick W; Boersma, Eric; O'Neill, William W

    2008-11-01

    Proteinuria was associated with cardiovascular events and mortality in community-based cohorts. The association of proteinuria with mortality and cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) was unknown. The association of urinary dipstick proteinuria with mortality and cardiovascular events (composite of death, myocardial infarction, or nonhemorrhagic stroke) in 5,835 subjects of the EXCITE trial was evaluated. Dipstick urinalysis was performed before PCI, and proteinuria was defined as trace or greater. Subjects were followed up for 210 days/7 months after enrollment for the occurrence of events. Multivariate Cox regression analysis evaluated the independent association of proteinuria with each outcome. Mean age was 59 years, 21% were women, 18% had diabetes mellitus, and mean estimated glomerular filtration rate was 90 ml/min/1.73 m(2). Proteinuria was present in 750 patients (13%). During follow-up, 22 subjects (2.9%) with proteinuria and 54 subjects (1.1%) without proteinuria died (adjusted hazard ratio 2.83, 95% confidence interval [CI] 1.65 to 4.84, p use tool as urinary dipstick may be useful to identify and treat patients at high risk of mortality at the time of PCI.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  18. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial).

    Science.gov (United States)

    Weber, Bernardete; Bersch-Ferreira, Ângela Cristine; Torreglosa, Camila Ragne; Ross-Fernandes, Maria Beatriz; da Silva, Jacqueline Tereza; Galante, Andrea Polo; Lara, Enilda de Sousa; Costa, Rosana Perim; Soares, Rafael Marques; Cavalcanti, Alexandre Biasi; Moriguchi, Emilio H; Bruscato, Neide M; Kesties; Vivian, Lilian; Schumacher, Marina; de Carli, Waldemar; Backes, Luciano M; Reolão, Bruna R; Rodrigues, Milena P; Baldissera, Dúnnia M B; Tres, Glaucia S; Lisbôa, Hugo R K; Bem, João B J; Reolão, Jose B C; Deucher, Keyla L A L; Cantarelli, Maiara; Lucion, Aline; Rampazzo, Daniela; Bertoni, Vanessa; Torres, Rosileide S; Verríssimo, Adriana O L; Guterres, Aldair S; Cardos, Andrea F R; Coutinho, Dalva B S; Negrão, Mayara G; Alencar, Mônica F A; Pinho, Priscila M; Barbosa, Socorro N A A; Carvalho, Ana P P F; Taboada, Maria I S; Pereira, Sheila A; Heyde, Raul V; Nagano, Francisca E Z; Baumgartner, Rebecca; Resende, Fernanda P; Tabalipa, Ranata; Zanini, Ana C; Machado, Michael J R; Araujo, Hevila; Teixeira, Maria L V; Souza, Gabriela C; Zuchinali, Priccila; Fracasso, Bianca M; Ulliam, Karen; Schumacher, Marina; Pierotto, Moara; Hilário, Thamires; Carlos, Daniele M O; Cordeiro, Cintia G N C; Carvalho, Daniele A; Gonçalves, Marília S; Vasconcelos, Valdiana B; Bosquetti, Rosa; Pagano, Raira; Romano, Marcelo L P; Jardim, César A; de Abreu, Bernardo N A; Marcadenti, Aline; Schmitt, Alessandra R; Tavares, Angela M V; Faria, Christiane C; Silva, Flávia M; Fink, Jaqueline S; El Kik, Raquel M; Prates, Clarice F; Vieira, Cristiane S; Adorne, Elaine F; Magedanz, Ellen H; Chieza, Fernanda L; Silva, Ingrid S; Teixeira, Joise M; Trescastro, Eduardo P; Pellegrini, Lívia A; Pinto, Jéssika C; Telles, Cristina T; Sousa, Antonio C S; Almeida, Andreza S; Costa, Ariane A; Carmo, José A C; Silva, Juliana T; Alves, Luciana V S; Sales, Saulo O C; Ramos, Maria E M; Lucas, Marilia C S; Damiani, Monica; Cardoso, Patricia C; Ramos, Salvador S; Dantas, Clenise F; Lopes, Amanda G; Cabral, Ana M P; Lucena, Ana C A; Medeiros, Auriene L; Terceiro, Bernardino B; Leda, Neuma M F S; Baía, Sandra R D; Pinheiro, Josilene M F; Cassiano, Alexandra N; Melo, Andressa N L; Cavalcanti, Anny K O; Souza, Camila V S; Queiroz, Dayanna J M; Farias, Hercilla N C F; Souza, Larissa C F; Santos, Letícia S; Lima, Luana R M; Hoffmann, Meg S; Ribeiro, Átala S Silva; Vasconcelos, Daniel F; Dutra, Eliane S; Ito, Marina K; Neto, José A F; Santos, Alexsandro F; Sousa, Rosângela M L; Dias, Luciana Pereira P; Lima, Maria T M A; Modanesi, Victor G; Teixeira, Adriana F; Estrada, Luciana C N C D; Modanesi, Paulo V G; Gomes, Adriana B L; Rocha, Bárbara R S; Teti, Cristina; David, Marta M; Palácio, Bruna M; Junior, Délcio G S; Faria, Érica H S; Oliveira, Michelle C F; Uehara, Rose M; Sasso, Sandramara; Moreira, Annie S B; Cadinha, Ana C A H; Pinto, Carla W M; Castilhos, Mariana P; Costa, Mariana; Kovacs, Cristiane; Magnoni, Daniel; Silva, Quênia; Germini, Michele F C A; da Silva, Renata A; Monteiro, Aline S; dos Santos, Karina G; Moreira, Priscila; Amparo, Fernanda C; Paiva, Catharina C J; Poloni, Soraia; Russo, Diana S; Silveira, Izabele V; Moraes, Maria A; Boklis, Mirena; Cardoso, Quinto I; Moreira, Annie S B; Damaceno, Aline M S; Santos, Elisa M; Dias, Glauber M; Pinho, Cláudia P S; Cavalcanti, Adrilene C; Bezerra, Amanda S; Queiroga, Andrey V; Rodrigues, Isa G; Leal, Tallita V; Sahade, Viviane; Amaral, Daniele A; Souza, Diana S; Araújo, Givaldo A; Curvello, Karine; Heine, Manuella; Barretto, Marília M S; Reis, Nailson A; Vasconcelos, Sandra M L; Vieira, Danielly C; Costa, Francisco A; Fontes, Jessica M S; Neto, Juvenal G C; Navarro, Laís N P; Ferreira, Raphaela C; Marinho, Patrícia M; Abib, Renata Torres; Longo, Aline; Bertoldi, Eduardo G; Ferreira, Lauren S; Borges, Lúcia R; Azevedo, Norlai A; Martins, Celma M; Kato, Juliana T; Izar, Maria C O; Asoo, Marina T; de Capitani, Mariana D; Machado, Valéria A; Fonzar, Waléria T; Pinto, Sônia L; Silva, Kellen C; Gratão, Lúcia H A; Machado, Sheila D; de Oliveira, Susane R U; Bressan, Josefina; Caldas, Ana P S; Lima, Hatanne C F M; Hermsdorff, Helen H M; Saldanha, Tânia M; Priore, Sílvia E; Feres, Naoel H; Neves, Adila de Queiroz; Cheim, Loanda M G; Silva, Nilma F; Reis, Silvia R L; Penafort, Andreza M; de Queirós, Ana Paula O; Farias, Geysa M N; de los Santos, Mônica L P; Ambrozio, Cíntia L; Camejo, Cirília N; dos Santos, Cristiano P; Schirmann, Gabriela S; Boemo, Jorge L; Oliveira, Rosane E C; Lima, Súsi M B; Bortolini, Vera M S; Matos, Cristina H; Barretta, Claiza; Specht, Clarice M; de Souza, Simone R; Arruda, Cristina S; Rodrigues, Priscila A; Berwanger, Otávio

    2016-01-01

    This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

    NARCIS (Netherlands)

    Bonnetain, Franck; Bonsing, Bert; Conroy, Thierry; Dousseau, Adelaide; Glimelius, Bengt; Haustermans, Karin; Lacaine, François; van Laethem, Jean Luc; Aparicio, Thomas; Aust, Daniela; Bassi, Claudio; Berger, Virginie; Chamorey, Emmanuel; Chibaudel, Benoist; Dahan, Laeticia; de Gramont, Aimery; Delpero, Jean Robert; Dervenis, Christos; Ducreux, Michel; Gal, Jocelyn; Gerber, Erich; Ghaneh, Paula; Hammel, Pascal; Hendlisz, Alain; Jooste, Valérie; Labianca, Roberto; Latouche, Aurelien; Lutz, Manfred; Macarulla, Teresa; Malka, David; Mauer, Muriel; Mitry, Emmanuel; Neoptolemos, John; Pessaux, Patrick; Sauvanet, Alain; Tabernero, Josep; Taieb, Julien; van Tienhoven, Geertjan; Gourgou-Bourgade, Sophie; Bellera, Carine; Mathoulin-Pélissier, Simone; Collette, Laurence

    2014-01-01

    Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across

  20. Modulation of cognitive control levels via manipulation of saccade trial-type probability assessed with event-related BOLD fMRI.

    Science.gov (United States)

    Pierce, Jordan E; McDowell, Jennifer E

    2016-02-01

    Cognitive control supports flexible behavior adapted to meet current goals and can be modeled through investigation of saccade tasks with varying cognitive demands. Basic prosaccades (rapid glances toward a newly appearing stimulus) are supported by neural circuitry, including occipital and posterior parietal cortex, frontal and supplementary eye fields, and basal ganglia. These trials can be contrasted with complex antisaccades (glances toward the mirror image location of a stimulus), which are characterized by greater functional magnetic resonance imaging (MRI) blood oxygenation level-dependent (BOLD) signal in the aforementioned regions and recruitment of additional regions such as dorsolateral prefrontal cortex. The current study manipulated the cognitive demands of these saccade tasks by presenting three rapid event-related runs of mixed saccades with a varying probability of antisaccade vs. prosaccade trials (25, 50, or 75%). Behavioral results showed an effect of trial-type probability on reaction time, with slower responses in runs with a high antisaccade probability. Imaging results exhibited an effect of probability in bilateral pre- and postcentral gyrus, bilateral superior temporal gyrus, and medial frontal gyrus. Additionally, the interaction between saccade trial type and probability revealed a strong probability effect for prosaccade trials, showing a linear increase in activation parallel to antisaccade probability in bilateral temporal/occipital, posterior parietal, medial frontal, and lateral prefrontal cortex. In contrast, antisaccade trials showed elevated activation across all runs. Overall, this study demonstrated that improbable performance of a typically simple prosaccade task led to augmented BOLD signal to support changing cognitive control demands, resulting in activation levels similar to the more complex antisaccade task. Copyright © 2016 the American Physiological Society.

  1. Treatment-related serious adverse events and fatal adverse events with regorafenib in cancer patients: a meta-analysis of phase 3 randomized controlled trials.

    Science.gov (United States)

    Cao, Meihui; Li, Feifei; Wang, Yue; Zhang, Jingdong

    2017-12-01

    Regorafenib (Stivarga) is an oral small-molecule multikinase inhibitor commonly used against a variety of cancers. We performed a meta-analysis of all phase 3 randomized controlled trials (RCTs) of regorafenib to quantify the increased risk of SAEs and FAEs. We carried out a systematic search of electronic databases for studies published from inception to February 2017 without any restrictions. Eligibility criteria included phase 3 RCTs of tumors comparing regorafenib, alone or in combination with non-targeted chemotherapy (regorafenib arm) versus placebo or non-targeted chemotherapy (control arm). Data on SAEs and FAEs were extracted from each study and pooled to determine the overall incidence, relative risks (RRs) and 95% confidence intervals (CIs). A total of four phase 3 RCTs involving 1736 cancer patients met the eligibility criteria and were included. The overall incidence of SAEs and FAEs with regorafenib were 0.23 (95%CI, 0.05-0.40) and 0.02 (95%CI, 0.01-0.03), respectively. Compared with control, the summary RR of developing a regorafenib-related SAE was 1.60 (95%CI, 0.95-2.68, P=0.07), the summary RR of developing a regorafenib-related FAE was 1.71 (95%CI, 0.69-4.24, P=0.25). No evidence was found for the association between regorafenib and higher risk of SAEs and FAEs. This association varied significantly with cancer types (P=0.02) for SAEs but no evidence of heterogeneity was found for FAEs. This meta-analysis demonstrates no evidence for the association between regorafenib and higher risk of SAEs and FAEs. This analysis will be important when considering the trade-off of regorafenib treatment during clinical decision-making.

  2. Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials.

    Science.gov (United States)

    Mega, J L; Stitziel, N O; Smith, J G; Chasman, D I; Caulfield, M; Devlin, J J; Nordio, F; Hyde, C; Cannon, C P; Sacks, F; Poulter, N; Sever, P; Ridker, P M; Braunwald, E; Melander, O; Kathiresan, S; Sabatine, M S

    2015-06-06

    Genetic variants have been associated with the risk of coronary heart disease. In this study, we tested whether or not a composite of these variants could ascertain the risk of both incident and recurrent coronary heart disease events and identify those individuals who derive greater clinical benefit from statin therapy. A community-based cohort study (the Malmo Diet and Cancer Study) and four randomised controlled trials of both primary prevention (JUPITER and ASCOT) and secondary prevention (CARE and PROVE IT-TIMI 22) with statin therapy, comprising a total of 48,421 individuals and 3477 events, were included in these analyses. We studied the association of a genetic risk score based on 27 genetic variants with incident or recurrent coronary heart disease, adjusting for traditional clinical risk factors. We then investigated the relative and absolute risk reductions in coronary heart disease events with statin therapy stratified by genetic risk. We combined data from the different studies using a meta-analysis. When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient in risk for incident or recurrent coronary heart disease was shown. Compared with the low genetic risk category, the multivariable-adjusted hazard ratio for coronary heart disease for the intermediate genetic risk category was 1·34 (95% CI 1·22-1·47, pgenetic risk category was 1·72 (1·55-1·92, pgenetic risk categories. Similarly, we noted greater absolute risk reductions in those individuals in higher genetic risk categories (p=0·0101), resulting in a roughly threefold decrease in the number needed to treat to prevent one coronary heart disease event in the primary prevention trials. Specifically, in the primary prevention trials, the number needed to treat to prevent one such event in 10 years was 66 in people at low genetic risk, 42 in those at intermediate genetic risk, and 25 in those at high

  3. Analysis of Appraising Agricultural Intangible Asset Value by Cost Method

    OpenAIRE

    Li, Xiao-Juan

    2010-01-01

    On the basis of describing the connotation of agricultural intangible asset and cost method, the technical ideas of appraising by cost method are introduced. The article analyzes the advantages (simple appraisal principle and easy to understand and grasp; overall consideration of various factors related to appraisal result value) and disadvantages (high appraisal cost; difficult to appraise and grasp various appraisal factors) of appraising by cost method. The article also summarizes the prec...

  4. Adverse Events During a Randomized Trial of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department.

    Science.gov (United States)

    Weisz, Keith; Bajaj, Lalit; Deakyne, Sara J; Brou, Lina; Brent, Alison; Wathen, Joseph; Roosevelt, Genie E

    2017-07-01

    The co-administration of ketamine and propofol (CoKP) is thought to maximize the beneficial profile of each medication, while minimizing the respective adverse effects of each medication. Our objective was to compare adverse events between ketamine monotherapy (KM) and CoKP for procedural sedation and analgesia (PSA) in a pediatric emergency department (ED). This was a prospective, randomized, single-blinded, controlled trial of KM vs. CoKP in patients between 3 and 21 years of age. The attending physician administered either ketamine 1 mg/kg i.v. or ketamine 0.5 mg/kg and propofol 0.5 mg/kg i.v. The physician could administer up to three additional doses of ketamine (0.5 mg/kg/dose) or ketamine/propofol (0.25 mg/kg/dose of each). Adverse events (e.g., respiratory events, cardiovascular events, unpleasant emergence reactions) were recorded. Secondary outcomes included efficacy, recovery time, and satisfaction scores. Ninety-six patients were randomized to KM and 87 patients were randomized to CoKP. There was no difference in adverse events or type of adverse event, except nausea was more common in the KM group. Efficacy of PSA was higher in the KM group (99%) compared to the CoKP group (90%). Median recovery time was the same. Satisfaction scores by providers, including nurses, were higher for KM, although parents were equally satisfied with both sedation regimens. We found no significant differences in adverse events between the KM and CoKP groups. While CoKP is a reasonable choice for pediatric PSA, our study did not demonstrate an advantage of this combination over KM. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. 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.

  6. Increased reaction time variability in attention-deficit hyperactivity disorder as a response-related phenomenon: evidence from single-trial event-related potentials.

    Science.gov (United States)

    Saville, Christopher W N; Feige, Bernd; Kluckert, Christian; Bender, Stephan; Biscaldi, Monica; Berger, Andrea; Fleischhaker, Christian; Henighausen, Klaus; Klein, Christoph

    2015-07-01

    Increased intra-subject variability (ISV) in reaction times (RTs) is a promising endophenotype for attention-deficit hyperactivity disorder (ADHD) and among the most robust hallmarks of the disorder. ISV has been assumed to represent an attentional deficit, either reflecting lapses in attention or increased neural noise. Here, we use an innovative single-trial event-related potential approach to assess whether the increased ISV associated with ADHD is indeed attributable to attention, or whether it is related to response-related processing. We measured electroencephalographic responses to working memory oddball tasks in patients with ADHD (N = 20, aged 11.3 ± 1.1) and healthy controls (N = 25, aged 11.7 ± 1.1), and analysed these data with a recently developed method of single-trial event-related potential analysis. Estimates of component latency variability were computed for the stimulus-locked and response-locked forms of the P3b and the lateralised readiness potential (LRP). ADHD patients showed significantly increased ISV in behavioural ISV. This increased ISV was paralleled by an increase in variability in response-locked event-related potential latencies, while variability in stimulus-locked latencies was equivalent between groups. This result held across the P3b and LRP. Latency of all components predicted RTs on a single-trial basis, confirming that all were relevant for speed of processing. These data suggest that the increased ISV found in ADHD could be associated with response-end, rather than stimulus-end processes, in contrast to prevailing conceptions about the endophenotype. This mental chronometric approach may also be useful for exploring whether the existing lack of specificity of ISV to particular psychiatric conditions can be improved upon. © 2014 Association for Child and Adolescent Mental Health.

  7. 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 reg...

  8. 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

  9. 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

    Science.gov (United States)

    Raspini, A.

    2012-08-01

    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 marine domain, the increased nutrient input enhanced the production of organic matter

  10. Clinical presentation and course of bleeding events in patients with venous thromboembolism, treated with apixaban or enoxaparin and warfarin. Results from the AMPLIFY trial.

    Science.gov (United States)

    Bleker, Suzanne M; Cohen, Alexander T; Büller, Harry R; Agnelli, Giancarlo; Gallus, Alexander S; Raskob, Gary E; Weitz, Jeffrey I; Curto, Madelyn; Sisson, Melanie; Middeldorp, Saskia

    2016-11-30

    Apixaban, a direct acting oral anticoagulant (DOAC), was found to be non-inferior to and safer as enoxaparin followed by warfarin for treatment of venous thromboembolism (VTE) in the AMPLIFY trial. Information is needed on how bleeding events with DOACs present and develop. In this post-hoc analysis, the clinical presentation and course of all major and clinically relevant non major (CRNM) bleeding events in the AMPLIFY trial were blindly classified by three investigators, using pre-designed classification schemes containing four categories. Odds ratios (OR) for classifying as category three or four (representing a more severe clinical presentation and course) were calculated between apixaban and enoxaparin/warfarin. In total, 63 major and 311 CRNM bleeding events were classified. Of the major bleeds, a more severe clinical presentation occurred in 28.5 % of apixaban versus 44.9 % of enoxaparin/warfarin related recipients (OR 0.49, 95 % confidence interval [CI] 0.14-1.78). A severe clinical course was observed in 14.3 % and in 12.2 %, respectively (OR 1.19, 95 %CI 0.21-6.69). Of the CRNM bleeding events, a more severe clinical presentation and extent of clinical care was found in 25 % of apixaban recipients compared to 22.7 % in the enoxaparin/warfarin group (OR 1.13, 95 %CI 0.65-1.97). The clinical presentation and course of major and CRNM bleeds were similar in apixaban and enoxaparin/warfarin treated patients. This finding should reassure physicians and patients that even in the absence of a specific reversal agent, apixaban is a convenient and safe choice for VTE.

  11. 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.

  12. Appraisals Generate Specific Configurations of Facial Muscle Movements in a Gambling Task: Evidence for the Component Process Model of Emotion.

    Science.gov (United States)

    Gentsch, Kornelia; Grandjean, Didier; Scherer, Klaus R

    2015-01-01

    Scherer's Component Process Model provides a theoretical framework for research on the production mechanism of emotion and facial emotional expression. The model predicts that appraisal results drive facial expressions, which unfold sequentially and cumulatively over time. In two experiments, we examined facial muscle activity changes (via facial electromyography recordings over the corrugator, cheek, and frontalis regions) in response to events in a gambling task. These events were experimentally manipulated feedback stimuli which presented simultaneous information directly affecting goal conduciveness (gambling outcome: win, loss, or break-even) and power appraisals (Experiment 1 and 2), as well as control appraisal (Experiment 2). We repeatedly found main effects of goal conduciveness (starting ~600 ms), and power appraisals (starting ~800 ms after feedback onset). Control appraisal main effects were inconclusive. Interaction effects of goal conduciveness and power appraisals were obtained in both experiments (Experiment 1: over the corrugator and cheek regions; Experiment 2: over the frontalis region) suggesting amplified goal conduciveness effects when power was high in contrast to invariant goal conduciveness effects when power was low. Also an interaction of goal conduciveness and control appraisals was found over the cheek region, showing differential goal conduciveness effects when control was high and invariant effects when control was low. These interaction effects suggest that the appraisal of having sufficient control or power affects facial responses towards gambling outcomes. The result pattern suggests that corrugator and frontalis regions are primarily related to cognitive operations that process motivational pertinence, whereas the cheek region would be more influenced by coping implications. Our results provide first evidence demonstrating that cognitive-evaluative mechanisms related to goal conduciveness, control, and power appraisals affect

  13. 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 ...

  14. Event-rate and delta inflation when evaluating mortality as a primary outcome from randomized controlled trials of nutritional interventions during critical illness: a systematic review.

    Science.gov (United States)

    Summers, Matthew J; Chapple, Lee-anne S; McClave, Stephen A; Deane, Adam M

    2016-04-01

    There is a lack of high-quality evidence that proves that nutritional interventions during critical illness reduce mortality. We evaluated whether power calculations for randomized controlled trials (RCTs) of nutritional interventions that used mortality as the primary outcome were realistic, and whether overestimation was systematic in the studies identified to determine whether this was due to overestimates of event rate or delta. A systematic review of the literature between 2005 and 2015 was performed to identify RCTs of nutritional interventions administered to critically ill adults that had mortality as the primary outcome. Predicted event rate (predicted mortality during the control), predicted mortality during intervention, predicted delta (predicted difference between mortality during the control and intervention), actual event rate (observed mortality during control), observed mortality during intervention, and actual delta (difference between observed mortality during the control and intervention) were recorded. The event-rate gap (predicted event rate minus observed event rate), the delta gap (predicted delta minus observed delta), and the predicted number needed to treat were calculated. Data are shown as median (range). Fourteen articles were extracted, with power calculations provided for 10 studies. The predicted event rate was 29.9% (20.0–52.4%), and the predicted delta was 7.9% (3.0–20.0%). If the study hypothesis was proven correct then, on the basis of the power calculations, the number needed to treat would have been 12.7 (5.0–33.3) patients. The actual event rate was 25.3% (6.1–50.0%), the observed mortality during the intervention was 24.4% (6.3–39.7%), and the actual delta was 0.5% (−10.2–10.3%), such that the event-rate gap was 2.6% (−3.9–23.7%) and delta gap was 7.5% (3.2–25.2%). Overestimates of delta occur frequently in RCTs of nutritional interventions in the critically ill that are powered to determine a mortality

  15. 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

  16. 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...... artery stenosis, treatment with atorvastatin was associated with a 33% reduction in the risk of any stroke (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.47, 0.94; P=0.02), and a 43% reduction in risk of major coronary events (HR 0.57, 95% CI 0.32, 1.00; P=0.05). Later carotid revascularization...

  17. Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate.

    Science.gov (United States)

    Weng, Yanqiu; Palesch, Yuko Y; DeSantis, Stacia M; Zhao, Wenle

    2016-01-01

    In Phase III clinical trials for life-threatening conditions, some serious but expected adverse events, such as early deaths or congestive heart failure, are often treated as the secondary or co-primary endpoint, and are closely monitored by the Data and Safety Monitoring Committee (DSMC). A naïve group sequential design (GSD) for such a study is to specify univariate statistical boundaries for the efficacy and safety endpoints separately, and then implement the two boundaries during the study, even though the two endpoints are typically correlated. One problem with this naïve design, which has been noted in the statistical literature, is the potential loss of power. In this article, we develop an analytical tool to evaluate this negative impact for trials with non-trivial safety event rates, particularly when the safety monitoring is informal. Using a bivariate binary power function for the GSD with a random-effect component to account for subjective decision-making in safety monitoring, we demonstrate how, under common conditions, the power loss in the naïve design can be substantial. This tool may be helpful to entities such as the DSMCs when they wish to deviate from the prespecified stopping boundaries based on safety measures.

  18. A SAS-based solution to evaluate study design efficiency of phase I pediatric oncology trials via discrete event simulation.

    Science.gov (United States)

    Barrett, Jeffrey S; Jayaraman, Bhuvana; Patel, Dimple; Skolnik, Jeffrey M

    2008-06-01

    Previous exploration of oncology study design efficiency has focused on Markov processes alone (probability-based events) without consideration for time dependencies. Barriers to study completion include time delays associated with patient accrual, inevaluability (IE), time to dose limiting toxicities (DLT) and administrative and review time. Discrete event simulation (DES) can incorporate probability-based assignment of DLT and IE frequency, correlated with cohort in the case of DLT, with time-based events defined by stochastic relationships. A SAS-based solution to examine study efficiency metrics and evaluate design modifications that would improve study efficiency is presented. Virtual patients are simulated with attributes defined from prior distributions of relevant patient characteristics. Study population datasets are read into SAS macros which select patients and enroll them into a study based on the specific design criteria if the study is open to enrollment. Waiting times, arrival times and time to study events are also sampled from prior distributions; post-processing of study simulations is provided within the decision macros and compared across designs in a separate post-processing algorithm. This solution is examined via comparison of the standard 3+3 decision rule relative to the "rolling 6" design, a newly proposed enrollment strategy for the phase I pediatric oncology setting.

  19. Cardiovascular events in a physical activity intervention compared with a successful aging intervention: The LIFE Study randomized trial

    Science.gov (United States)

    IMPORTANCE: Whether sustained physical activity prevents cardiovascular disease (CVD) events in older adults is uncertain. OBJECTIVE: To test the hypothesis that cardiovascular morbidity and mortality would be reduced in participants in a long-term physical activity program. DESIGN, SETTING, AND PAR...

  20. 76 FR 72306 - Federal Housing Administration (FHA) Appraiser Roster: Appraiser Qualifications for Placement on...

    Science.gov (United States)

    2011-11-23

    ... disciplinary action in any state in which the appraiser is certified; * * * * * (c) * * * (1) Appraisers subject to state disciplinary action. An appraiser whose state certification in any state has been revoked, suspended, or surrendered as a result of a state disciplinary action is automatically suspended from the...

  1. 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).

  2. 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…

  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

    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.

  4. 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, pMS diagnosis compared with placebo. The safety profile of cladribine was similar to that noted in a trial in patients with relapsing-remitting MS. Further research could clarify the potential effects of oral cladribine treatment in the early stages of MS. Merck Serono SA Geneva

  5. A flexible and coherent test/estimation procedure based on restricted mean survival times for censored time-to-event data in randomized clinical trials.

    Science.gov (United States)

    Horiguchi, Miki; Cronin, Angel M; Takeuchi, Masahiro; Uno, Hajime

    2018-04-22

    In randomized clinical trials where time-to-event is the primary outcome, almost routinely, the logrank test is prespecified as the primary test and the hazard ratio is used to quantify treatment effect. If the ratio of 2 hazard functions is not constant, the logrank test is not optimal and the interpretation of hazard ratio is not obvious. When such a nonproportional hazards case is expected at the design stage, the conventional practice is to prespecify another member of weighted logrank tests, eg, Peto-Prentice-Wilcoxon test. Alternatively, one may specify a robust test as the primary test, which can capture various patterns of difference between 2 event time distributions. However, most of those tests do not have companion procedures to quantify the treatment difference, and investigators have fallen back on reporting treatment effect estimates not associated with the primary test. Such incoherence in the "test/estimation" procedure may potentially mislead clinicians/patients who have to balance risk-benefit for treatment decision. To address this, we propose a flexible and coherent test/estimation procedure based on restricted mean survival time, where the truncation time τ is selected data dependently. The proposed procedure is composed of a prespecified test and an estimation of corresponding robust and interpretable quantitative treatment effect. The utility of the new procedure is demonstrated by numerical studies based on 2 randomized cancer clinical trials; the test is dramatically more powerful than the logrank, Wilcoxon tests, and the restricted mean survival time-based test with a fixed τ, for the patterns of difference seen in these cancer clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

  6. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  7. Critical appraisal of nonrandomized studies-A review of recommended and commonly used tools.

    Science.gov (United States)

    Quigley, Joan M; Thompson, Juliette C; Halfpenny, Nicholas J; Scott, David A

    2018-02-27

    When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies. Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed. From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined. There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review. © 2018 John Wiley & Sons, Ltd.

  8. 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...... from 1. For example, the odds ratio for suicidality for children and adolescents was 2.39 (95% confidence interval = 1.32–4.33), using the Yusuf-Peto method but increased to 2.64 (1.33–5.26) using conditional logistic regression, to 2.69 (1.19–6.09) using beta-binomial, to 2.73 (1.37–5.42) using...

  9. 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 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY REAL ESTATE LENDING AND... appraiser shall be engaged directly by the regulated institution or its agent, and have no direct or...

  10. 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 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS APPRAISALS... interest, financial or otherwise, in the property. If the only qualified persons available to perform an...

  11. Appraisal patterns of envy and related emotions

    NARCIS (Netherlands)

    van de Ven, N.; Zeelenberg, M.; Pieters, R.

    2012-01-01

    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

  12. Performance appraisal of coaches: Acomparative study | Surujlal ...

    African Journals Online (AJOL)

    Within the sport environment, the performance appraisal of coaches continues to be an issue. The performance appraisal of coaches is critical to sport organizations since major decisions like rewarding or terminating coaches is based on it. The purpose of this study was to examine whether any differences exist with regard ...

  13. 45 CFR 1160.12 - Appraisal procedures.

    Science.gov (United States)

    2010-10-01

    ... the amount of partial loss, or damage to, or any reduction in the fair market value as a result..., any reduction in the fair market value of, the indemnified item(s). The appraisers' agreement with... appropriate, such reduction in the fair market value. Disputes between the appraisers with respect to partial...

  14. Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial.

    Science.gov (United States)

    Muhlestein, Joseph B; Lappé, Donald L; Lima, Joao A C; Rosen, Boaz D; May, Heidi T; Knight, Stacey; Bluemke, David A; Towner, Steven R; Le, Viet; Bair, Tami L; Vavere, Andrea L; Anderson, Jeffrey L

    2014-12-03

    Coronary artery disease (CAD) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus, yet CAD often is asymptomatic prior to myocardial infarction (MI) and coronary death. To assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes. The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system (Intermountain Healthcare, Utah), enrolled at a single-site coordinating center, and randomly assigned to CAD screening with CCTA (n = 452) or to standard national guidelines-based optimal diabetes care (n = 448) (targets: glycated hemoglobin level 50 mg/dL [women] or >40 mg/dL [men], triglycerides level <150 mg/dL, systolic blood pressure <120 mm Hg), or aggressive therapy with invasive coronary angiography, was recommended based on CCTA findings. Enrollment occurred between July 2007 and May 2013, and follow-up extended to August 2014. The primary outcome was a composite of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization; the secondary outcome was ischemic major adverse cardiovascular events (composite of CAD death, nonfatal MI, or unstable angina). At a mean follow-up time of 4.0 (SD, 1.7) years, the primary outcome event rates were not significantly different between the CCTA and the control groups (6.2% [28 events] vs 7.6% [34 events]; hazard ratio, 0.80 [95% CI, 0.49-1.32]; P = .38). The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups (4.4% [20 events] vs 3.8% [17 events]; hazard ratio, 1.15 [95% CI, 0.60-2.19]; P = .68). Among

  15. 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.

  16. 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.

  17. The appraisal of clinical guidelines in dentistry.

    Science.gov (United States)

    Glenny, Anne-Marie; Worthington, Helen V; Clarkson, Jan E; Esposito, Marco

    2009-01-01

    To appraise the reported processes involved in the development of published dental guidelines. Electronic databases were searched to identify guidelines making recommendations for any health professional within dentistry. All included guidelines were appraised using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument. A total of 105 guidelines met the inclusion criteria. The appraised guidelines showed lack of rigour in their development (median score 14.3%; range 0% to 100%). Only 10 (9.5%) were coded as 'strongly recommend' by at least two assessors. If recommendations within clinical guidelines are to be relied upon, the methods used in their development must be explicit and free from bias. When using the AGREE checklist to make decisions on whether or not to implement individual sets of guidelines, the findings of the present assessment reinforce the need for more than two assessors to be included in the appraisal of each set of guidelines.

  18. Dementia-related adverse events in PARADIGM-HF and other trials in heart failure with reduced ejection fraction

    DEFF Research Database (Denmark)

    Cannon, Jane A.; Shen, Li; Jhund, Pardeep S.

    2017-01-01

    Aims: Inhibition of neprilysin, an enzyme degrading natriuretic and other vasoactive peptides, is beneficial in heart failure with reduced ejection fraction (HFrEF), as shown in PARADIGM-HF which compared the angiotensin receptor–neprilysin inhibitor (ARNI) sacubitril/valsartan with enalapril....... As neprilysin is also one of many enzymes clearing amyloid-β peptides from the brain, there is a theoretical concern about the long-term effects of sacubitril/valsartan on cognition. Therefore, we have examined dementia-related adverse effects (AEs) in PARADIGM-HF and placed these findings in the context...... of other recently conducted HFrEF trials. Methods and results: In PARADIGM-HF, patients with symptomatic HFrEF were randomized to sacubitril/valsartan 97/103 mg b.i.d. or enalapril 10 mg b.i.d. in a 1:1 ratio. We systematically searched AE reports, coded using the Medical Dictionary for Regulatory...

  19. Cognitive Appraisals Affect Both Embodiment of Thermal Sensation and Its Mapping to Thermal Evaluation.

    Science.gov (United States)

    Keeling, Trevor P; Roesch, Etienne B; Clements-Croome, Derek

    2016-01-01

    The physical environment leads to a thermal sensation that is perceived and appraised by occupants. The present study focuses on the relationship between sensation and evaluation. We asked 166 people to recall a thermal event from their recent past. They were then asked how they evaluated this experience in terms of 10 different emotions (frustrated, resigned, dislike, indifferent, angry, anxious, liking, joyful, regretful, proud). We tested whether four psychological factors (appraisal dimensions) could be used to predict the ensuing emotions, as well as comfort, acceptability, and sensation. The four dimensions were: the Conduciveness of the event, who/what caused the event (Causality), who had control (Agency), and whether the event was expected (Expectations). These dimensions, except for Expectations, were good predictors of the reported emotions. Expectations, however, predicted the reported thermal sensation, its acceptability, and ensuing comfort. The more expected an event was, the more uncomfortable a person felt, and the less likely they reported a neutral thermal sensation. Together, these results support an embodied view of how subjective appraisals affect thermal experience. Overall, we show that appraisal dimensions mediate occupants' evaluation of their thermal sensation, which suggests an additional method for understanding psychological adaption.

  20. Prevention of cardiovascular events in Asian patients with ischaemic stroke at high risk of cerebral haemorrhage (PICASSO): a multicentre, randomised controlled trial.

    Science.gov (United States)

    Kim, Bum Joon; Lee, Eun-Jae; Kwon, Sun U; Park, Jong-Ho; Kim, Yong-Jae; Hong, Keun-Sik; Wong, Lawrence K S; Yu, Sungwook; Hwang, Yang-Ha; Lee, Ji Sung; Lee, Juneyoung; Rha, Joung-Ho; Heo, Sung Hyuk; Ahn, Sung Hwan; Seo, Woo-Keun; Park, Jong-Moo; Lee, Ju-Hun; Kwon, Jee-Hyun; Sohn, Sung-Il; Jung, Jin-Man; Navarro, Jose C; Kang, Dong-Wha

    2018-06-01

    The optimal treatment for patients with ischaemic stroke with a high risk of cerebral haemorrhage is unclear. We assessed the efficacy and safety of cilostazol versus aspirin, with and without probucol, in these patients. In this randomised, controlled, 2 × 2 factorial trial, we enrolled patients with ischaemic stroke with a history of or imaging findings of intracerebral haemorrhage or two or more microbleeds from 67 centres in three Asian countries. Patients were randomly assigned (1:1:1:1) to receive oral cilostazol (100 mg twice a day), aspirin (100 mg once a day), cilostazol plus probucol (250 mg twice a day), or aspirin plus probucol with centralised blocks stratified by centre. Cilostazol versus aspirin was investigated double-blinded; probucol treatment was open-label, but the outcome assessor was masked to assignment. The co-primary outcomes were incidence of the composite of stroke, myocardial infarction, or vascular death (efficacy) and incidence of haemorrhagic stroke (safety), which were assessed in intention-to-treat and modified intention-to-treat populations. Efficacy was analysed with a non-inferiority test and a superiority test if non-inferiority was satisfied. Safety was assessed with a superiority test only. This trial is registered with ClinicalTrials.gov, NCT01013532. Between Aug 1, 2009, and Aug 31, 2015, we randomly assigned 1534 patients to one of the four study groups, of whom 1512 were assessed for the co-primary endpoints. During a median follow-up of 1·9 years (IQR 1·0-3·0), the incidence of composite vascular events was 4·27 per 100 person-years in patients who received cilostazol and 5·33 per 100 person-years in patients who received aspirin (HR 0·80, 95% CI 0·57-1·11; non-inferiority p=0·0077; superiority p=0·18). Incidence of cerebral haemorrhage was 0·61 per 100 person-years in patients who received cilostazol and 1·20 per 100 person-years in those who received aspirin (HR 0·51, 97·5% CI 0·20-1·27; superiority

  1. 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

  2. Testing the reliability and efficiency of the pilot Mixed Methods Appraisal Tool (MMAT) for systematic mixed studies review.

    Science.gov (United States)

    Pace, Romina; Pluye, Pierre; Bartlett, Gillian; Macaulay, Ann C; Salsberg, Jon; Jagosh, Justin; Seller, Robbyn

    2012-01-01

    Systematic literature reviews identify, select, appraise, and synthesize relevant literature on a particular topic. Typically, these reviews examine primary studies based on similar methods, e.g., experimental trials. In contrast, interest in a new form of review, known as mixed studies review (MSR), which includes qualitative, quantitative, and mixed methods studies, is growing. In MSRs, reviewers appraise studies that use different methods allowing them to obtain in-depth answers to complex research questions. However, appraising the quality of studies with different methods remains challenging. To facilitate systematic MSRs, a pilot Mixed Methods Appraisal Tool (MMAT) has been developed at McGill University (a checklist and a tutorial), which can be used to concurrently appraise the methodological quality of qualitative, quantitative, and mixed methods studies. The purpose of the present study is to test the reliability and efficiency of a pilot version of the MMAT. The Center for Participatory Research at McGill conducted a systematic MSR on the benefits of Participatory Research (PR). Thirty-two PR evaluation studies were appraised by two independent reviewers using the pilot MMAT. Among these, 11 (34%) involved nurses as researchers or research partners. Appraisal time was measured to assess efficiency. Inter-rater reliability was assessed by calculating a kappa statistic based on dichotomized responses for each criterion. An appraisal score was determined for each study, which allowed the calculation of an overall intra-class correlation. On average, it took 14 min to appraise a study (excluding the initial reading of articles). Agreement between reviewers was moderate to perfect with regards to MMAT criteria, and substantial with respect to the overall quality score of appraised studies. The MMAT is unique, thus the reliability of the pilot MMAT is promising, and encourages further development. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. 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.

  4. The preventing recurrent vascular events and neurological worsening through intensive organized case-management (PREVENTION trial protocol [clinicaltrials.gov identifier: NCT00931788

    Directory of Open Access Journals (Sweden)

    Tsuyuki Ross

    2010-04-01

    Full Text Available Abstract Background Survivors of transient ischemic attack (TIA or stroke are at high risk for recurrent vascular events and aggressive treatment of vascular risk factors can reduce this risk. However, vascular risk factors, especially hypertension and high cholesterol, are not managed optimally even in those patients seen in specialized clinics. This gap between the evidence for secondary prevention of stroke and the clinical reality leads to suboptimal patient outcomes. In this study, we will be testing a pharmacist case manager for delivery of stroke prevention services. We hypothesize this new structure will improve processes of care which in turn should lead to improved outcomes. Methods We will conduct a prospective, randomized, controlled open-label with blinded ascertainment of outcomes (PROBE trial. Treatment allocation will be concealed from the study personnel, and all outcomes will be collected in an independent and blinded manner by observers who have not been involved in the patient's clinical care or trial participation and who are masked to baseline measurements. Patients will be randomized to control or a pharmacist case manager treating vascular risk factors to guideline-recommended target levels. Eligible patients will include all adult patients seen at stroke prevention clinics in Edmonton, Alberta after an ischemic stroke or TIA who have uncontrolled hypertension (defined as systolic blood pressure (BP > 140 mm Hg or dyslipidemia (fasting LDL-cholesterol > 2.00 mmol/L and who are not cognitively impaired or institutionalized. The primary outcome will be the proportion of subjects who attain 'optimal BP and lipid control'(defined as systolic BP Conclusions Nearly one-quarter of those who survive a TIA or minor stroke suffer another vascular event within a year. If our intervention improves the provision of secondary prevention therapies in these patients, the clinical (and financial implications will be enormous.

  5. 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.

  6. 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 capacity (OR/SD, 0.89; 95% CI, 0.72-1.10; P =0.28), HDL cholesterol (OR/SD, 0.82; 95% CI, 0.66-1.02; P =0.08), or apolipoprotein A-I (OR/SD, 0.83; 95% CI, 0.67-1.03; P =0.08). Twelve months of rosuvastatin (20 mg/day) did not change cholesterol efflux capacity (average percentage change -1.5%, 95% CI, -13.3 to +10.2; P =0.80), but increased HDL cholesterol (+7.7%), apolipoprotein A-I (+4.3%), and HDL particle number (+5.2%). On-statin cholesterol efflux capacity was inversely associated with incident CVD (OR/SD, 0.62; 95% CI, 0

  7. Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials.

    Science.gov (United States)

    Saad, F; Ivanescu, C; Phung, D; Loriot, Y; Abhyankar, S; Beer, T M; Tombal, B; Holmstrom, S

    2017-03-01

    We investigated the impact of skeletal-related events (SREs) on health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) in phase III trials of enzalutamide versus placebo. Patients with mCRPC experiencing at least one SRE during AFFIRM and PREVAIL were assessed for trajectory-adjusted mean change in HRQoL by first SRE using Functional Assessment of Cancer Therapy-Prostate (FACT-P; AFFIRM, three domains, and PREVAIL, nine domains) and EQ-5D (PREVAIL) instruments. First SREs caused HRQoL deterioration in both trials. Spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine FACT-P domains in PREVAIL and all three in AFFIRM (mean (95% confidence interval (CI)) change in FACT-P total score -16.95 (-26.47, -7.44) and -9.69 (-16.10, -3.27), respectively). In PREVAIL, first SREs caused clinically meaningful declines in EQ-5D utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% CI) change -0.24 (-0.39, -0.08)). In AFFIRM, FACT-P and FACT-General total scores showed clinically meaningful declines after radiation/surgery to bone. SREs were associated with clinically meaningful functional declines in the daily lives of patients with mCRPC. Spinal cord compression had the largest impact on HRQoL.

  8. 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.

  9. 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

    International Nuclear Information System (INIS)

    Basch, Ethan; Pugh, Stephanie L.; Dueck, Amylou C.; Mitchell, Sandra A.; Berk, Lawrence; Fogh, Shannon; Rogak, Lauren J.; Gatewood, Marcha; Reeve, Bryce B.; Mendoza, Tito R.; O'Mara, Ann M.; Denicoff, Andrea M.; Minasian, Lori M.; Bennett, Antonia V.; Setser, Ann; Schrag, Deborah

    2017-01-01

    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 obviated by

  10. 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

  11. Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial.

    Science.gov (United States)

    Freund, Yonathan; Cachanado, Marine; Aubry, Adeline; Orsini, Charlotte; Raynal, Pierre-Alexis; Féral-Pierssens, Anne-Laure; Charpentier, Sandrine; Dumas, Florence; Baarir, Nacera; Truchot, Jennifer; Desmettre, Thibaut; Tazarourte, Karim; Beaune, Sebastien; Leleu, Agathe; Khellaf, Mehdi; Wargon, Mathias; Bloom, Ben; Rousseau, Alexandra; Simon, Tabassome; Riou, Bruno

    2018-02-13

    The safety of the pulmonary embolism rule-out criteria (PERC), an 8-item block of clinical criteria aimed at ruling out pulmonary embolism (PE), has not been assessed in a randomized clinical trial. To prospectively validate the safety of a PERC-based strategy to rule out PE. A crossover cluster-randomized clinical noninferiority trial in 14 emergency departments in France. Patients with a low gestalt clinical probability of PE were included from August 2015 to September 2016, and followed up until December 2016. Each center was randomized for the sequence of intervention periods. In the PERC period, the diagnosis of PE was excluded with no further testing if all 8 items of the PERC rule were negative. The primary end point was the occurrence of a thromboembolic event during the 3-month follow-up period that was not initially diagnosed. The noninferiority margin was set at 1.5%. Secondary end points included the rate of computed tomographic pulmonary angiography (CTPA), median length of stay in the emergency department, and rate of hospital admission. Among 1916 patients who were cluster-randomized (mean age 44 years, 980 [51%] women), 962 were assigned to the PERC group and 954 were assigned to the control group. A total of 1749 patients completed the trial. A PE was diagnosed at initial presentation in 26 patients in the control group (2.7%) vs 14 (1.5%) in the PERC group (difference, 1.3% [95% CI, -0.1% to 2.7%]; P = .052). One PE (0.1%) was diagnosed during follow-up in the PERC group vs none in the control group (difference, 0.1% [95% CI, -∞ to 0.8%]). The proportion of patients undergoing CTPA in the PERC group vs control group was 13% vs 23% (difference, -10% [95% CI, -13% to -6%]; P < .001). In the PERC group, rates were significantly reduced for the median length of emergency department stay (mean reduction, 36 minutes [95% CI, 4 to 68]) and hospital admission (difference, 3.3% [95% CI, 0.1% to 6.6%]). Among very low-risk patients with suspected

  12. 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.

  13. Combination of perindopril/indapamide in secondary prevention of stroke and other vascular events: A combined analysis of ADVANCE, PROGRESS and HYVET trials

    Directory of Open Access Journals (Sweden)

    Sougat Sourendra Sarkar

    2011-03-01

    Full Text Available Perindopril/indapamide combination has been shown to reduce cardiovascular risk in different groups of patients. A total of 18,529 patients (9,272 receiving perindopril/indapamide and 9,257 receiving placebo were included in this meta-analysis involving three large randomized clinical trials-ADVANCE, PROGRESS and HYVET. A non-significant reduction in fatal and non-fatal stroke was seen (Odds ratio 0.73; 95% Confidence Interval 0.49 to 1.09; z=1.52 and p= 0.13. The combination was associated with a significantly reduction of vascular death (Odds ratio 0.79; 95% Confidence Interval 0.69 to 0.90; z=3.48 and p=0.0005 and major cardio-vascular events (Odds ratio 0.72; 95% Confidence Interval 0.53 to 0.97; z=2.15 and p= 0.03. Fixed-combination of Perindopril and indapamide substantially reduced major cardiovascular event and vascular death. However, effect on stroke needs further evaluation.

  14. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial.

    Science.gov (United States)

    Huelsmann, Martin; Neuhold, Stephanie; Resl, Michael; Strunk, Guido; Brath, Helmut; Francesconi, Claudia; Adlbrecht, Christopher; Prager, Rudolf; Luger, Anton; Pacher, Richard; Clodi, Martin

    2013-10-08

    The study sought to assess the primary preventive effect of neurohumoral therapy in high-risk diabetic patients selected by N-terminal pro-B-type natriuretic peptide (NT-proBNP). Few clinical trials have successfully demonstrated the prevention of cardiac events in patients with diabetes. One reason for this might be an inaccurate selection of patients. NT-proBNP has not been assessed in this context. A total of 300 patients with type 2 diabetes, elevated NT-proBNP (>125 pg/ml) but free of cardiac disease were randomized. The "control" group was cared for at 4 diabetes care units; the "intensified" group was additionally treated at a cardiac outpatient clinic for the up-titration of renin-angiotensin system (RAS) antagonists and beta-blockers. The primary endpoint was hospitalization/death due to cardiac disease after 2 years. At baseline, the mean age of the patients was 67.5 ± 9 years, duration of diabetes was 15 ± 12 years, 37% were male, HbA1c was 7 ± 1.1%, blood pressure was 151 ± 22 mm Hg, heart rate was 72 ± 11 beats/min, median NT-proBNP was 265.5 pg/ml (interquartile range: 180.8 to 401.8 pg/ml). After 12 months there was a significant difference between the number of patients treated with a RAS antagonist/beta-blocker and the dosage reached between groups (p titration of RAS antagonists and beta-blockers to maximum tolerated dosages is an effective and safe intervention for the primary prevention of cardiac events for diabetic patients pre-selected using NT-proBNP. (Nt-proBNP Guided Primary Prevention of CV Events in Diabetic Patients [PONTIAC]; NCT00562952). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  15. 12 CFR 564.4 - Minimum appraisal standards.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Minimum appraisal standards. 564.4 Section 564.4 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPRAISALS § 564.4 Minimum appraisal standards. For federally related transactions, all appraisals shall, at a minimum: (a...

  16. 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…

  17. 9 CFR 52.3 - Appraisal of swine.

    Science.gov (United States)

    2010-01-01

    ... an APHIS employee alone. (b) The appraisal of swine will be based on the fair market value as determined by the meat or breeding value of the animals. Animals may be appraised in groups, provided that where appraisal is by the head, each animal in the group is the same value per head, and where appraisal...

  18. 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.

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

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    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.

  20. 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

  1. 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.

  2. 32 CFR 644.42 - Appraisal report.

    Science.gov (United States)

    2010-07-01

    ... appraisal report shall be divided into four parts as outlined below: PART I—INTRODUCTION 1. TITLE PAGE. This... photograph. The use of color film and photographs is encouraged, especially wherein development cost either...

  3. Theoretical foundations of shareholders' right to appraisal

    Directory of Open Access Journals (Sweden)

    Vasiljević Mirko

    2017-01-01

    Full Text Available Shareholders' right to appraisal represents a controversial topic of corporation law, which is why a relatively small number of countries accept it. In this article, the authors analyze the goals that are supposed to be achieved with the introduction of shareholders' appraisal rights. In this respect, traditional and modern explanations for the introduction or maintaining of this right have been presented. In the second part of this article, shareholders' right to appraisal has been critically examined, mostly from corporations' perspective. Afterwards, several potential causes of inefficiency of using this right have been identified. Perceiving pros and cons of shareholders' right to appraisal is of particular importance for Serbia, in order to draw a conclusion about harmonization of our legislative solutions with the theoretical foundations of this right.

  4. 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

  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. 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.

  7. 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.

  8. 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.

  9. 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

    2013-01-01

    Background Nitrous oxide causes an acute increase in plasma homocysteine that is more pronounced in patients with the MTHFR C677T or A1298C gene variant. In this randomized controlled trial we sought to determine if patients carrying the MTHFR C677T or A1298C variant had a higher risk for perioperative cardiac events after nitrous oxide anesthesia and if this risk could be mitigated by B-vitamins. Methods We 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 elevation within the first 72 hours after surgery. Results 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 elevation compared to wild-type and heterozygous patients (11.2% vs. 14.0%; relative risk 0.96, 95% CI 0.85 to 1.07, p=0.48). B-vitamins blunted the rise in homocysteine, but had no effect on cardiac troponin I elevation compared to patients receiving placebo (13.2% vs. 13.6%; relative risk 1.02, 95% CI 0.78 to 1.32, p=0.91). Conclusions Neither MTHFR C677T and A1298C gene variant nor acute homocysteine increase are associated with perioperative cardiac troponin elevation after nitrousoxide anesthesia. B-vitamins blunt nitrous oxide-induced homocysteine increase but have no effect on cardiac troponin elevation. PMID:23856660

  10. 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.

  11. 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

  12. 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).

  13. Hemoglobin stability in patients with anemia, CKD, and type 2 diabetes: an analysis of the TREAT (Trial to Reduce Cardiovascular Events With Aranesp Therapy) placebo arm.

    Science.gov (United States)

    Skali, Hicham; Lin, Julie; Pfeffer, Marc A; Chen, Chao-Yin; Cooper, Mark E; McMurray, John J V; Nissenson, Allen R; Remuzzi, Giuseppe; Rossert, Jerome; Parfrey, Patrick S; Scott-Douglas, Nairne W; Singh, Ajay K; Toto, Robert; Uno, Hajime; Ivanovich, Peter

    2013-02-01

    Sparse data are available about the natural history of hemoglobin (Hb) level trends in contemporary patients with anemia, chronic kidney disease (CKD), and type 2 diabetes mellitus. We intended to describe Hb level trends over time with no or minimal administration of erythropoiesis-stimulating agents. Prospective clinical trial cohort. 2,019 individuals with type 2 diabetes, moderate anemia, and CKD from the placebo arm of the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) followed up for 2.3 years with an average of 32 monthly Hb level determinations per patient. Darbepoetin alfa was administered only if Hb level decreased to protocol-directed doses of darbepoetin alfa received due to an Hb level decrease to protocol-directed darbepoetin alfa. The other patients received 1 (16%), 2-4 (16%), or 5 or more (13%) doses of darbepoetin alfa. Those who received no darbepoetin alfa doses had higher baseline Hb levels, higher estimated glomerular filtration rates (eGFRs), less proteinuria, and lower ferritin and transferrin saturation values. On average, Hb levels were stable or increased in all groups. Compared with individuals who received no darbepoetin alfa, those who received 5 or more doses were more likely to receive intravenous iron therapy and blood transfusions and progress to renal replacement therapy, but were not at higher risk of death. The strongest predictors of requiring 5 or more doses of darbepoetin alfa were lower baseline Hb level, lower eGFR, and higher proteinuria level. Post hoc analysis of a clinical trial of a specific population with diabetes, anemia, and non-dialysis-dependent CKD. In the TREAT placebo arm, Hb levels were stable with no or minimal protocol-directed darbepoetin alfa during 2.3 years of follow-up. Most patients with moderate anemia, non-dialysis-dependent CKD, and type 2 diabetes are able to maintain a stable Hb level without implementing long-term erythropoiesis-stimulating agent therapy. Copyright © 2013

  14. 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...

  15. Chronic obstructive pulmonary disease is an independent predictor of death but not atherosclerotic events in patients with myocardial infarction: analysis of the Valsartan in Acute Myocardial Infarction Trial (VALIANT)

    DEFF Research Database (Denmark)

    Hawkins, Nathaniel M; Huang, Zhen; Pieper, Karen S

    2009-01-01

    ) events associated with chronic obstructive pulmonary disease in 14 703 patients with acute MI enrolled in the Valsartan in Acute Myocardial Infarction (VALIANT) trial. Cox proportional hazards models were used to evaluate the relationship between chronic obstructive pulmonary disease and CV outcomes...

  16. A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study.

    Science.gov (United States)

    Pierce, John P; Faerber, Susan; Wright, Fred A; Rock, Cheryl L; Newman, Vicky; Flatt, Shirley W; Kealey, Sheila; Jones, Vicky E; Caan, Bette J; Gold, Ellen B; Haan, Mary; Hollenbach, Kathryn A; Jones, Lovell; Marshall, James R; Ritenbaugh, Cheryl; Stefanick, Marcia L; Thomson, Cynthia; Wasserman, Linda; Natarajan, Loki; Thomas, Ronald G; Gilpin, Elizabeth A

    2002-12-01

    The Women's Healthy Eating and Living (WHEL) Study is a multisite randomized controlled trial of the effectiveness of a high-vegetable, low-fat diet, aimed at markedly raising circulating carotenoid concentrations from food sources, in reducing additional breast cancer events and early death in women with early-stage invasive breast cancer (within 4 years of diagnosis). The study randomly assigned 3088 such women to an intensive diet intervention or to a comparison group between 1995 and 2000 and is expected to follow them through 2006. Two thirds of these women were under 55 years of age at randomization. This research study has a coordinating center and seven clinical sites. Randomization was stratified by age, stage of tumor and clinical site. A comprehensive intervention program that includes intensive telephone counseling, cooking classes and print materials helps shift the dietary pattern of women in the intervention. Through an innovative telephone counseling program, dietary counselors encourage women in the intervention group to meet the following daily behavioral targets: five vegetable servings, 16 ounces of vegetable juice, three fruit servings, 30 g of fiber and 15-20% energy from fat. Adherence assessments occur at baseline, 6, 12, 24 or 36, 48 and 72 months. These assessments can include dietary intake (repeated 24-hour dietary recalls and food frequency questionnaire), circulating carotenoid concentrations, physical measures and questionnaires about health symptoms, quality of life, personal habits and lifestyle patterns. Outcome assessments are completed by telephone interview every 6 months with medical record verification. We will assess evidence of effectiveness by the length of the breast cancer event-free interval, as well as by overall survival separately in all the women in the study as well as specifically in women under and over the age of 55 years.

  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. Clinical Trials

    Medline Plus

    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

  19. 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,…

  20. Psychiatric and cognitive adverse events: A pooled analysis of three phase III trials of adjunctive eslicarbazepine acetate for partial-onset seizures.

    Science.gov (United States)

    Andermann, Eva; Biton, Victor; Benbadis, Selim R; Shneker, Bassel; Shah, Aashit K; Carreño, Mar; Trinka, Eugen; Ben-Menachem, Elinor; Biraben, Arnaud; Rocha, Francisco; Gama, Helena; Cheng, Hailong; Blum, David

    2018-05-01

    To evaluate the nature and incidence of psychiatric and cognitive adverse events (AEs) reported with eslicarbazepine acetate (ESL) used as adjunctive treatment for refractory partial-onset seizures (POS) in adults. This was a post-hoc analysis of data pooled from three randomized double-blind, placebo-controlled trials (BIA-2093-301, -302, -304). After an 8-week baseline period, patients received placebo or adjunctive ESL 400mg (studies 301 and 302 only), 800mg, or 1200mg once daily (QD) for 14weeks (2-week titration period, 12-week maintenance period). Psychiatric and cognitive AEs were identified from individual patient data. Suicidality was also evaluated using the Columbia-Classification Algorithm of Suicide Assessment (C-CASA), or the Columbia-Suicide Severity Rating Scale (C-SSRS). P-values were obtained using the chi-square test of independence or Fisher's exact test, without correcting for multiplicity. The analysis population included 1447 patients (ESL, n=1021; placebo, n = 426). Psychiatric treatment-emergent AEs (TEAEs) occurred in 10.8% of patients receiving ESL, and in a comparable proportion (10.3%) of patients receiving placebo (p=0.802). The incidence of depression and suicidality-related TEAEs was higher for ESL (7.4%) vs. placebo (3.8%) (p=0.009). The occurrence of these TEAEs differed between treatment groups (p = 0.010), but there was no notable trend between increasing ESL dose and increasing incidence of depression and suicidality-related TEAEs. Aggression/hostility-related TEAEs occurred in ESL vs. 0.9% taking placebo. The incidence of cognitive TEAEs was higher for ESL (7.1%) vs. placebo (4.0%) (p=0.023); incidences of memory impairment, attention disturbance, apathy, and aphasia were higher for ESL 1200mg than for other treatment groups. Incidences of psychiatric and cognitive serious AEs (SAEs) were 0.6% and 0.2% with ESL, and 0.5% and 0% with placebo, respectively. Psychiatric and cognitive TEAEs leading to discontinuation occurred in 1

  1. 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

  2. [Evaluation of Wits appraisal with superimposition method].

    Science.gov (United States)

    Xu, T; Ahn, J; Baumrind, S

    1999-07-01

    To compare the conventional Wits appraisal with superimposed Wits appraisal in evaluation of sagittal jaw relationship change between pre and post orthodontic treatment. The sample consists of 48-case pre and post treatment lateral head films. Computerized digitizing is used to get the cephalometric landmarks and measure conventional Wits value, superimposed Wits value and ANB angle. The correlation analysis among these three measures was done by SAS statistical package. The change of ANB angle has higher correlation with the change of superimposed Wits than that of the conventional Wits. The r-value is as high as 0.849 (P < 0.001). The superimposed Wits appraisal reflects the change of sagittal jaw relationship more objectively than the conventional one.

  3. Clinical Trials

    Medline Plus

    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  4. 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

  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. Ixekizumab for Treating Moderate-to-Severe Plaque Psoriasis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

    Science.gov (United States)

    Ramaekers, Bram L T; Wolff, Robert F; Pouwels, Xavier; Oosterhoff, Marije; Van Giessen, Anoukh; Worthy, Gill; Noake, Caro; Armstrong, Nigel; Kleijnen, Jos; Joore, Manuela A

    2018-02-26

    The National Institute for Health and Care Excellence invited Eli Lilly and Company Ltd, the company manufacturing ixekizumab (tradename Taltz ® ), to submit evidence for the clinical and cost effectiveness of ixekizumab. Ixekizumab was compared with tumour necrosis factor-α inhibitors (etanercept, infliximab, adalimumab), ustekinumab, secukinumab, best supportive care and, if non-biological treatment or phototherapy is suitable, also compared with systemic non-biological therapies and phototherapy with ultraviolet B radiation for adults with moderate-to-severe plaque psoriasis. Kleijnen Systematic Reviews Ltd, in collaboration with Maastricht University Medical Center, was commissioned as the independent Evidence Review Group. This article presents a summary of the company submission, the Evidence Review Group report and the development of the National Institute for Health and Care Excellence guidance for the use of this drug in England and Wales by the Appraisal Committee. The Evidence Review Group produced a critical review of the clinical and cost effectiveness of ixekizumab based on the company submission. The company submission presented three randomised controlled trials identified in a systematic review. All randomised controlled trials were phase III, multicentre placebo-controlled trials including 3866 participants with moderate-to-severe psoriasis. Two trials also included an active comparator (etanercept). All randomised controlled trials showed statistically significant increases in two primary outcomes, static Physician Global Assessment (0,1) and improvement of 75% from baseline in the Psoriasis Area and Severity Index. Ixekizumab was generally well tolerated in the randomised controlled trials, with similar discontinuation rates because of adverse events as placebo or etanercept. The most frequent adverse events of special interest were infections and injection-site reactions. The company submission also included a network meta-analysis of

  7. 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

  8. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

    DEFF Research Database (Denmark)

    Kappos, Ludwig; Freedman, Mark S; Polman, Chris H

    2009-01-01

    with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive interferon...... index (FAMS-TOI) at 5 years. Analysis of the primary endpoints was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00185211. FINDINGS: 235 (80%) patients from the early treatment and 123 (70%) from the delayed treatment group completed the 5-year study. Early treatment...

  9. 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

  10. 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.

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

    African Journals Online (AJOL)

    aware of the purposes of the current teacher performance appraisal. However, the ... building, and expensive equipment (Daniel,. 2009). ... development of teachers, teachers' job ...... Appraisers' tend to rate high a person who is similar.

  12. 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...

  13. 12 CFR 528.2a - Nondiscriminatory appraisal and underwriting.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Nondiscriminatory appraisal and underwriting. 528.2a Section 528.2a Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY NONDISCRIMINATION REQUIREMENTS § 528.2a Nondiscriminatory appraisal and underwriting. (a) Appraisal. No savings...

  14. 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.

  15. 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…

  16. Handbook for Conducting Standard CMMI Appraisal Method for Process Improvement (SCAMPI) B and C Appraisals, Version 1.1

    National Research Council Canada - National Science Library

    Hayes, Will; Miluk, Gene; Ming, Lisa; Glover, Margaret; Bisgrove, Jane; Cort, Corrine; Penn, Lynn; Jacobson, Nils; Beynon, Don; Allgood, Bruce

    2005-01-01

    The Standard CMMI Appraisal Method for Process Improvement (SCAMPI) provides a well-defined, publicly available set of methodologies for providing appraisals relative to Capability Maturity Model (trademark) Integration (CMMI) models...

  17. 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 ...

  18. Evaluating Housing Problems through Participatory Rural Appraisal ...

    African Journals Online (AJOL)

    Nekky Umera

    Whether in research, development or policy analysis, in social, forestry, irrigation ... Action, Participatory Rural Appraisal involves interaction between the planners and the ..... Park, Obasanjo Layout, the Kogi People Consumer Shops as well as the confluence .... The institutional arrangements under which a person gains ...

  19. 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.

  20. 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

  1. Embodied Appraisals and Non-emotional States

    Czech Academy of Sciences Publication Activity Database

    Hvorecký, Juraj

    2010-01-01

    Roč. 20, č. 3 (2010), s. 215-223 ISSN 1210-3055 R&D Projects: GA AV ČR(CZ) KJB900090802 Institutional research plan: CEZ:AV0Z90090514 Keywords : embodied appraisal * non-emotional mental states * valence * emotion Subject RIV: AA - Philosophy ; Religion

  2. Appraisal and financing of electric power projects

    International Nuclear Information System (INIS)

    Sheehan, R.H.

    1975-01-01

    This paper starts with the origin, nature and functions of the World Bank Group, reviews the past lending, describes the criteria used by the Bank in its power project appraisals, discusses the Bank's views on nuclear power, and concludes with a look at the probable future sources of financing of electrical expansion in the less developed countries. (orig./UA) [de

  3. 7 CFR 1955.128 - Appraisers.

    Science.gov (United States)

    2010-01-01

    ... type of properties (such as large farms and business property) requiring valuation. For Farmer Programs... REGULATIONS (CONTINUED) PROPERTY MANAGEMENT Disposal of Inventory Property Use of Contractors to Dispose of Inventory Property § 1955.128 Appraisers. (a) Real property. The State Director may authorize the County...

  4. Intelligence Defined and Undefined: A Relativistic Appraisal

    Science.gov (United States)

    Wechsler, David

    1975-01-01

    Major reasons for the continuing divergency of opinion as regards the nature and meaning of intelligence are examined. An appraisal of intelligence as a relative concept is proposed which advocates the necessity of specifying the reference systems to which a statement about intelligence refers. (EH)

  5. Evaluating Library Staff: A Performance Appraisal System.

    Science.gov (United States)

    Belcastro, Patricia

    This manual provides librarians and library managers with a performance appraisal system that measures staff fairly and objectively and links performance to the goals of the library. The following topics are addressed: (1) identifying expectations for quality service or standards of performance; (2) the importance of a library's code of service,…

  6. Elective abdominal hysterectomy: Appraisal of indications and ...

    African Journals Online (AJOL)

    of hysterectomy did not occur until the 19th century, earlier attempts are known. Some references to hysterectomy date back to 5th century BC, in the time of Hippocrates. In. 1600, Schenck of Grabenberg cataloged 26 cases of vaginal hysterectomy in Europe.[2]. Elective abdominal hysterectomy: Appraisal of indications and.

  7. Persistent Ratee Contaminants in Performance Appraisal.

    Science.gov (United States)

    Van Fleet, David D.; Chamberlain, Howard

    The hypothesis that conventional approaches to evaluating contaminants in performance appraisal overlook important individual ratee effects was examined. A rating form was developed that consisted of the following dimensions and behaviors: warmth; guided discourse or indirect teaching methods; control of subject matter; enthusiasm and reinforcing;…

  8. Understanding cohort differences in appraisals of reconstruction ...

    African Journals Online (AJOL)

    Understanding cohort differences in appraisals of reconstruction priorities of mental health systems in postconflict Liberia. ... Conclusion: This study provides additional support for the premise that the utilization of ... of Liberians and that there are differences in preferences across groups. ... AJOL African Journals Online.

  9. 78 FR 31924 - Appraisal Subcommittee; Policy Statements

    Science.gov (United States)

    2013-05-28

    ... financial institutions regulatory agency engages in, contracts for, or regulates; and b) requires the... officer, director, employee or agent of a federally regulated financial institution would not be permitted... FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL [Docket No. AS13-13] Appraisal Subcommittee...

  10. 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 ...

  11. 36 CFR 254.9 - Appraisals.

    Science.gov (United States)

    2010-07-01

    ....9 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE LANDOWNERSHIP... contributory value of any interest in land such as water rights, minerals, or timber, to the extent they are... the physical characteristics of the land being appraised; a statement of all encumbrances; title...

  12. 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...... 0.86 and 0.77, respectively). Our aim was to assess to what extent these differences were due to significant differences in blood pressures and in other variables noted after randomisation....

  13. Post-event processing in social anxiety.

    Science.gov (United States)

    Dannahy, Laura; Stopa, Lusia

    2007-06-01

    Clark and Wells' [1995. A cognitive model of social phobia. In: R. Heimberg, M. Liebowitz, D.A. Hope, & F.R. Schneier (Eds.) Social phobia: Diagnosis, assessment and treatment (pp. 69-93). New York: Guildford Press.] cognitive model of social phobia proposes that following a social event, individuals with social phobia will engage in post-event processing, during which they conduct a detailed review of the event. This study investigated the relationship between self-appraisals of performance and post-event processing in individuals high and low in social anxiety. Participants appraised their performance immediately after a conversation with an unknown individual and prior to an anticipated second conversation task 1 week later. The frequency and valence of post-event processing during the week following the conversation was also assessed. The study also explored differences in the metacognitive processes of high and low socially anxious participants. The high socially anxious group experienced more anxiety, predicted worse performance, underestimated their actual performance, and engaged in more post-event processing than low socially anxious participants. The degree of negative post-event processing was linked to the extent of social anxiety and negative appraisals of performance, both immediately after the conversation task and 1 week later. Differences were also observed in some metacognitive processes. The results are discussed in relation to current theory and previous research.

  14. 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...

  15. Lymphadenectomy extent and survival of patients with gastric carcinoma: a systematic review and meta-analysis of time-to-event data from randomized trials.

    Science.gov (United States)

    Mocellin, Simone; Nitti, Donato

    2015-05-01

    The extent of lymph node dissection in patients with resectable non-metastatic primary carcinoma of the stomach is still a controversial matter of debate, with special regard to its effect on survival. We conducted a systematic review and meta-analysis of time-to-event data from randomized controlled trials (RCTs) comparing the three main types of lymphadenectomy (D1, D2, and D3) for gastric cancer. Hazard ratio (HR) was considered the effect measure for both overall (OS), disease-specific (DSS) and disease-free survival (DFS). The quality of the available evidence was assessed using the GRADE system. Eight RCTs enrolling 2515 patients were eligible. The meta-analysis of four RCTs (n=1599) showed a significant impact of D2 versus D1 lymphadenectomy on DSS (summary HR=0.807, CI: 0.705-0.924, P=0.002), the corresponding number-to-treat being equal to ten. This effect remained clinically valuable even after adjustment for postoperative mortality. However, the quality of evidence was graded as moderate due to inconsistency issues. When OS and DFS were considered, the meta-analysis of respectively five (n=1653) and three RCTs (n=1332) found no significant difference between D2 and D1 lymph node dissection (summary HR=0.911, CI: 0.708-1.172, P=0.471, and summary HR=0.946, CI: 0.840-1.066, P=0.366, respectively). However, at subgroup analysis D2 type resulted superior to D1 type lymphadenectomy in terms of OS considering the two RCTs carried out in Eastern countries (summary HR=0.627, CI: 0.396-0.994, P=0.047). As regards the D3 vs D2 comparison, the meta-analysis of the three available RCTs (n=862) showed no significant impact of more extended lymphadenectomy on OS (summary HR=0.990, CI: 0.814-1.205, P=0.924). Our findings support the superiority of D2 versus D1 lymphadenectomy in terms of survival benefit. However, this advantage is mainly limited to DSS, the level of evidence is moderate, and the interaction with other factors affecting patient survival (such as

  16. Incidence of seizure exacerbation and seizures reported as adverse events during adjunctive treatment with eslicarbazepine acetate: A pooled analysis of three Phase III controlled trials.

    Science.gov (United States)

    Carreño, Mar; Benbadis, Selim; Rocha, Francisco; Blum, David; Cheng, Hailong

    2017-12-01

    To investigate whether adjunctive eslicarbazepine acetate (ESL) could lead to exacerbation of seizures in some patients. Post-hoc analysis of data pooled from three Phase III trials of adjunctive ESL (studies 301, 302, and 304) for refractory partial-onset seizures (POS). Following an 8-week baseline period, patients were randomized to receive placebo or ESL 400, 800, or 1,200 mg once daily (2-week titration, 12-week maintenance, 2-4 week tapering-off periods). Patient seizure diary data and seizure treatment-emergent adverse event (TEAE) reports were pooled for analysis. The modified intent-to-treat and safety populations comprised 1,410 patients and 1,447 patients, respectively. Titration period : Compared with placebo (32/21%), significantly smaller proportions of patients taking ESL 800 mg (20/15%) and 1,200 mg (22/12%) had a ≥25/≥50% increase in standardized seizure frequency (SSF) from baseline; there was no significant difference between placebo and ESL 400 mg. Maintenance period : Compared with placebo (20%), significantly smaller proportions of patients taking ESL (400 mg, 12%; 800 mg, 12%; 1,200 mg, 14%) had an increase in SSF ≥25%. When evaluating ≥50% increases in SSF, only ESL 800 mg (7%) was significantly different from placebo (12%). Some patients had no secondarily generalized tonic-clonic (sGTC) seizures during baseline but had ≥1 sGTC seizure during maintenance treatment (placebo, 11%; ESL 400 mg, 5%; 800 mg, 10%; 1,200 mg, 5%). Fewer patients had a ≥25% increase in sGTC seizure frequency with ESL (400 mg, 11%; 800 mg, 9%; 1,200 mg, 14%) versus placebo (19%). The incidence of seizures reported as TEAEs was low in all treatment groups; incidences were generally lower with ESL versus placebo. Tapering-off period : Similar proportions of patients taking ESL and placebo had a ≥25/≥50% increase in SSF. Seizure TEAE incidence was numerically higher with ESL versus placebo. Treatment with adjunctive ESL does not appear to

  17. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

    Science.gov (United States)

    Berwanger, Otavio; Santucci, Eliana Vieira; de Barros E Silva, Pedro Gabriel Melo; Jesuíno, Isabella de Andrade; Damiani, Lucas Petri; Barbosa, Lilian Mazza; Santos, Renato Hideo Nakagawa; Laranjeira, Ligia Nasi; Egydio, Flávia de Mattos; Borges de Oliveira, Juliana Aparecida; Dall Orto, Frederico Toledo Campo; Beraldo de Andrade, Pedro; Bienert, Igor Ribeiro de Castro; Bosso, Carlos Eduardo; Mangione, José Armando; Polanczyk, Carisi Anne; Sousa, Amanda Guerra de Moraes Rego; Kalil, Renato Abdala Karam; Santos, Luciano de Moura; Sposito, Andrei Carvalho; Rech, Rafael Luiz; Sousa, Antônio Carlos Sobral; Baldissera, Felipe; Nascimento, Bruno Ramos; Giraldez, Roberto Rocha Corrêa Veiga; Cavalcanti, Alexandre Biasi; Pereira, Sabrina Bernardez; Mattos, Luiz Alberto; Armaganijan, Luciana Vidal; Guimarães, Hélio Penna; Sousa, José Eduardo Moraes Rego; Alexander, John Hunter; Granger, Christopher Bull; Lopes, Renato Delascio

    2018-04-03

    The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use

  18. 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.

  19. Response inhibition and cognitive appraisal in clients with acute stress disorder and posttraumatic stress disorder.

    Science.gov (United States)

    Abolghasemi, Abass; Bakhshian, Fereshteh; Narimani, Mohammad

    2013-08-01

    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. 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 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. 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.

  20. 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

  1. 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...

  2. Effect of lowering blood pressure on cardiovascular events and mortality in patients on dialysis : a systematic review and meta-analysis of randomised controlled trials

    NARCIS (Netherlands)

    Heerspink, HiddoJ Lambers; Ninomiya, Toshiharu; Zoungas, Sophia; de Zeeuw, Dick; Grobbee, Diederick E.; Jardine, Meg J.; Gallagher, Martin; Roberts, Matthew A.; Cass, Alan; Neal, Bruce; Perkovic, Vlado

    2009-01-01

    Background Patients undergoing dialysis have a substantially increased risk of cardiovascular mortality and morbidity. Although several trials have shown the cardiovascular benefits of lowering blood pressure in the general population, there is uncertainty about the efficacy and tolerability of

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

    OpenAIRE

    Xie, Manling; Shan, Zhilei; 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 ...

  4. 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.

  5. 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

  6. 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

  7. Naturalizing language: human appraisal and (quasi) technology

    DEFF Research Database (Denmark)

    Cowley, Stephen

    2013-01-01

    Using contemporary science, the paper builds on Wittgenstein’s views of human language. Rather than ascribing reality to inscription-like entities, it links embodiment with distributed cognition. The verbal or (quasi) technological aspect of language is traced to not action, but human specific...... 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...

  8. 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 

  9. Appraising and comparing pressure ulcer guidelines.

    Science.gov (United States)

    Wimpenny, Peter; van Zelm, Ruben

    2007-01-01

    Whilst considerable activity has been related to guideline development for nurses regarding pressure ulcer prevention and management, no attempt has been made to comparatively evaluate these guidelines against some form of quality indicators. To compare and contrast four national pressure ulcer guidelines, and identify similarities and differences in their quality and content. An international comparative appraisal method, using the AGREE (Appraisal of Guidelines Research and Evaluation) instrument, was undertaken to appraise four published pressure ulcer guidelines. Two further domains were added to the AGREE instrument to assess comparability of the guidelines and their perceived contribution to practice. An international group undertook the comparative appraisal. The domain scores for each guideline show some but not total agreement among reviewers. One particular set of guidelines was identified as scoring highest in a majority of AGREE domains. Overall, evidence of variability exists between pressure ulcer guidelines and common areas of development to consider for all guidelines. The results raise many questions concerning the "best" pressure ulcer guideline to use, particularly related to the AGREE scoring. Some notable shortcomings exist in all the pressure ulcer guidelines reviewed and these shortcomings need to be addressed from a quality perspective. However, other issues such as style of reporting and potential contribution to practice might more fully affect choice by practitioners as opposed to guideline developers. Notable differences exist among the four guidelines that are possibly explained by different approaches to development and also because of different cultural factors and intentions for use. Whilst the AGREE tool identifies the quality of the guideline development process it still requires local engagement with practitioners to determine which guideline should be implemented.

  10. Appraisal of emotions in media use

    OpenAIRE

    Bartsch, Anne; Vorderer, Peter; Mangold, Roland; Reinhold, Viehoff

    2008-01-01

    Over the past 20 years, research on meta-emotion and related concepts such as meta-mood and need for affect has become fruitful and prominent across a variety of disciplines, including media psychology. This paper reviews the literature on meta-emotion and considers problems regarding the definition and operationalization of this construct. We propose a process model of meta-emotion and emotion regulation to integrate and extend existing work. Drawing on appraisal theories of emotion, we unde...

  11. The problem of appraising qualitative research

    OpenAIRE

    Dixon-Woods, M; Shaw, R; Agarwal, S; Smith, J

    2004-01-01

    

 Qualitative research can make a valuable contribution to the study of quality and safety in health care. Sound ways of appraising qualitative research are needed, but currently there are many different proposals with few signs of an emerging consensus. One problem has been the tendency to treat qualitative research as a unified field. We distinguish universal features of quality from those specific to methodology and offer a set of minimally prescriptive prompts to assist with the assessme...

  12. Bristol cylinder. Vol. 3A - technical appraisal

    Energy Technology Data Exchange (ETDEWEB)

    1983-06-01

    A consultants' report is presented on a UK funded wave energy device known as the Bristol Cylinder. A detailed engineering appraisal is given for each component and aspects of the device including installation, power generation and maintenance. Finally the discounted cost of energy from the device is assessed. For all topics the views of the consultants are compared with those of the team developing the Bristol Cylinder and where discrepancies occur, these are explained and discussed.

  13. Sustainability appraisal and flood risk management

    International Nuclear Information System (INIS)

    Carter, Jeremy G.; White, Iain; Richards, Juliet

    2009-01-01

    This research establishes that sustainability appraisal (SA) has a role to play in strengthening spatial plans in the context of flooding issues. Indeed, evidence has been gathered to indicate that tentative steps are being taken in this direction during the SA of English regional spatial plans, which are used as an illustrative case study. In England as in many other countries, appraisal procedures including SA and strategic environmental assessment (SEA) are enshrined in planning law. An opportunity therefore exists to utilise existing and familiar planning tools to embed flooding considerations within spatial plans at an early stage in the planning process. SA (and similar appraisal tools such as SEA) can therefore usefully aid in the implementation of decision making principles and government policy relating to flooding. Moreover, with the threats associated with climate change becoming increasingly apparent, of which increased flood risk is a particular concern in many countries, there is a need develop appropriate adaptation responses. This article emphasizes the role that SA can play in managing future flood risk in this context

  14. 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...

  15. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available 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

  16. 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

  17. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

    Science.gov (United States)

    Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

    2015-03-01

    Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. 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.

  19. The SU.FOL.OM3 Study: a secondary prevention trial testing the impact of supplementation with folate and B-vitamins and/or Omega-3 PUFA on fatal and non fatal cardiovascular events, design, methods and participants characteristics

    Directory of Open Access Journals (Sweden)

    Czernichow Sébastien

    2008-06-01

    Full Text Available Abstract Background During the last decades, many basic and clinical research have pointed to the role of B vitamins (folate, vitamins B6 and B12 and n-3 fatty acids as nutritional factors that might have a protective effect on the development of cardiovascular diseases (CVD. Methods/design The SU.FOL.OM3 (SUpplementation with FOlate, vitamin B6 and B12 and/or OMega-3 fatty acids trial is a randomized double-blind, placebo-controlled, secondary-prevention trial designed to test the efficacy of 5-methyl tetra-hydro-folates (5-MTHF supplementation, in combination with vitamin B6 and B12 and/or n-3 fatty acids, at nutritional doses, on fatal and non fatal ischemic CVD in a 2 × 2 factorial design. A total of 2501 patients aged between 45 and 80 years who had a past history, in the previous year, of myocardial infarction (n = 1151 or instable angina pectoris (n = 711 or an ischemic stroke (n = 639 were included. Subjects have to be supplemented and followed up for five years. Daily supplementation comprised nutritional doses of 5-MTHF (560 μg, vitamin B6 (3 mg and B12 (20 μg and/or n-3 fatty acids (600 mg with an EPA:DHA ratio of 2:1. A factorial design 2 × 2 has been applied to investigate the separate effects of the B-vitamins, and the n-3 fatty acids, as well as their interaction as compared to the placebo. The primary endpoint is a combination of myocardial infarction, ischemic stroke and cardiovascular death. Secondary endpoints are events of the composite endpoint taken separately, total mortality, and other cardiovascular events such as acute coronary syndromes, coronary revascularization, cardiac failure, arrhythmia... Conclusion Baseline socio-demographic and medical characteristics of participants are totally comparable in the four randomized groups. Trial registration Current Controlled Trials ISRCTN41926726

  20. Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal.

    Science.gov (United States)

    Simpson, E L; Fitzgerald, P; Evans, P; Tappenden, P; Kalita, N; Reckless, J P D; Bakhai, A

    2013-04-01

    The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer (The Medicines Company) of bivalirudin to submit evidence for its clinical and cost effectiveness within its licensed indication for the treatment of adults with ST-segment elevation myocardial infarction (STEMI) intended for primary percutaneous coronary intervention (PPCI), as part of NICE's single technology appraisal (STA) process. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG), which produced a review of the evidence within the manufacturer's submission to NICE. This article describes the manufacturer's submission, the ERG review and NICE's subsequent decisions. The main evidence was derived from one randomized controlled trial (RCT) of STEMI patients intended for PPCI, comparing bivalirudin with unfractionated heparin plus glycoprotein IIb/IIIa inhibitors (GPIs). Bivalirudin was associated with a significant reduction in cardiac mortality at 30 days (p = 0.03) and at 1-year follow-up (p = 0.005), and a significant reduction in major bleeding at 30 days (p plus GPI. Stent thrombosis up to 24 hours following PPCI was significantly (p target vessel for ischaemia (p = 0.18 and p = 0.12, respectively). There were two decision-analytic models: the base-case scenario used 1-year follow-up data from the RCT; and a sensitivity analysis used 3-year follow-up data. Resource use was primarily drawn from this RCT. Health-related quality-of-life (HR-QOL) estimates were drawn from a UK cohort study. Both models evaluated the incremental costs and outcomes of bivalirudin compared with heparin plus GPI for patients with STEMI intended for PPCI. The analysis adopted a UK NHS perspective over a lifetime horizon. Unit costs were based on year 2009-2010 prices. The model adopted a decision-tree structure to reflect initial events for the initial period (stroke, repeat MI, minor

  1. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    Science.gov (United States)

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

  2. Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies Proposal of a Multidisciplinary Research Group

    NARCIS (Netherlands)

    Vergouwen, Mervyn D. I.; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J. E.; Wijdicks, Eelco F.; Muizelaar, J. Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B. W. E. M.

    2010-01-01

    Background and Purpose-In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of

  3. The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial.

    Science.gov (United States)

    Brenner, Amy; Shakur-Still, Haleema; Chaudhri, Rizwana; Fawole, Bukola; Arulkumaran, Sabaratnam; Roberts, Ian

    2018-06-07

    In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19-0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33-1.86). Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after

  4. 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. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  5. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  6. Bleeding and infection with external ventricular drainage: a systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial.

    Science.gov (United States)

    Dey, Mahua; Stadnik, Agnieszka; Riad, Fady; Zhang, Lingjiao; McBee, Nichol; Kase, Carlos; Carhuapoma, J Ricardo; Ram, Malathi; Lane, Karen; Ostapkovich, Noeleen; Aldrich, Francois; Aldrich, Charlene; Jallo, Jack; Butcher, Ken; Snider, Ryan; Hanley, Daniel; Ziai, Wendy; Awad, Issam A

    2015-03-01

    Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

  7. 76 FR 41441 - Federal Housing Administration (FHA) Appraiser Roster: Appraiser Qualifications for Placement on...

    Science.gov (United States)

    2011-07-14

    ... verifiable education in the appraisal requirements established by FHA. Under amended section 202(g) of the... areas and hinder use of FHA single-family programs at a time when use of those programs has increased... higher education and experience standards that HERA sought to be used for FHA-insured transactions (all...

  8. 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.

  9. Performance appraisal and advancement exercise 2005

    CERN Multimedia

    Human Resources Department

    2004-01-01

    The 2005 performance appraisal and advancement exercise will start in the usual way with annual interviews between staff and their supervisors. These interviews should be held in the period from 15 November 2004 to 15 February 2005 [see Administrative Circular No 26 (Rev. 5) Annex II, § 3. For this exercise, the paper MAPS form has been replaced by an electronic form in the EDH system, which is available via EDH (on the EDH desktop under Other Tasks / HR & Training) No changes have been made to the contents of the form. HR Department will shortly provide further information on this subject. Human Resources Department Tel. 73566

  10. 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, Mette; Stengaard-Pedersen, Kristian; Hørslev-Petersen, Kim

    2017-01-01

    event in the follow-up period, evaluated using systematic journal audits. Logistic regression models will test the hypothesis that there are more cardiovascular events in enrolled patients with a low level of vitamin D (models, based on survival analysis......INTRODUCTION: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypovitaminosis D is high. Moreover, low vitamin D levels have been associated with increased cardiovascular risk in healthy subjects. OBJECTIVE......: To evaluate the long-term risk of cardiovascular events in patients having low total 25-hydroxyvitamin D levels at baseline compared with patients with normal levels, in an efficiently treated, closed cohort of patients with an early diagnosis of RA. METHODS AND ANALYSIS: This study is a prospective, closed...

  11. 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, Mette; Stengaard-Pedersen, Kristian; Hørslev-Petersen, Kim

    2017-01-01

    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......INTRODUCTION: Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypovitaminosis D is high. Moreover, low vitamin D levels have been associated with increased cardiovascular risk in healthy subjects. OBJECTIVE...... event in the follow-up period, evaluated using systematic journal audits. Logistic regression models will test the hypothesis that there are more cardiovascular events in enrolled patients with a low level of vitamin D (

  12. Relation of Gemfibrozil Treatment and High Density Lipoprotein (HDL) Subpopulation Profile with Cardiovascular Events in the Veterans Affairs HDL Intervention Trial (VA-HIT)

    Science.gov (United States)

    Asztalos, Bela F.; Collins, Dorothea; Horvath, Katalin V.; Bloomfield, Hanna E.; Robins, Sander J.; Schaefer, Ernst J.

    2007-01-01

    Objective The significant cardiovascular disease (CVD) event reduction in VA-HIT could not be fully explained by the 6% increase in HDL-C with the fibrate, gemfibrozil. We examined whether measurement of HDL subpopulations provided additional information relative to CVD-risk reduction. Methods and Results HDL subpopulations were characterized by 2-dimensional gel-electrophoresis in subjects who were treated with gemfibrozil (n=754) or placebo (n=741). In this study, samples obtained at the 3-month visit were used and data were analyzed prospectively using CVD events (CHD death, MI, or stroke) during the 5.1 years follow up. Analyses in the gemfibrozil arm showed that subjects with recurrent CVD events had significantly higher preβ-1 and had significantly lower α-1 and α-2 HDL levels than those without such events. Preβ-1 level was a significant positive predictor; α-1 and α-2 levels were significant negative risk factors for future CVD events. α-2 level was superior to HDL-C level in CVD-risk assessment after adjustment for established risk factors. Gemfibrozil treatment was associated with 3%-6% decreases in the small, lipid-poor preβ-1 HDL and in the large, lipid-rich α-1 and α-2 HDL and with increases in the small α-3 (3%) and preα-3 (16%) HDLs. Conclusions While the use of gemfibrozil has been associated with reduction in CVD events in VA-HIT, HDL subpopulation analysis indicates that gemfibrozil-mediated improvement in CVD risk might not be the result of its effects on HDL. It is quite possible that much of the cardiovascular benefits of gemfibrozil are due to a much wider spectrum of effects on metabolic processes that is not reflected by changes in blood lipids and HDL subpopulations. PMID:18078862

  13. The impact of critical appraisal workshops on residents' evidence based medicine skills and knowledge

    Directory of Open Access Journals (Sweden)

    Nasr JA

    2018-04-01

    Full Text Available Justine A Nasr,1,2 John Falatko,1 Alexandra Halalau1,2 1Internal Medicine Department, Beaumont Hospital, Royal Oak, MI, USA; 2Internal Medicine Department, Oakland University William Beaumont School of Medicine, Rochester, MI, USA Objective: To assess the impact of four evidence based medicine (EBM critical appraisal education workshops in improving residents’ EBM knowledge and skills. Methods: The eligible participants in the workshops were 88 residents-in-training, postgraduate years one through four, rotating through the outpatient internal medicine clinic. Four EBM workshops, consisting of 3 days each (30 minutes daily, were taught by our faculty. Topics covered included critical appraisal of randomized controlled trials, case-control and cohort studies, diagnosis studies, and systematic reviews. Results: As a program evaluation, anonymous pre-workshop and post-workshop tests were administered. Each of the four sets of tests showed improvement in scores: therapy from 58% to 77% (42% response rate, harm from 65% to 73% (38% response rate, diagnosis from 49% to 68% (49% response rate, and systematic review from 57% to 72% (30% response rate. Conclusion: We found that teaching EBM in four short workshops improved EBM knowledge and critical appraisal skills related to the four topics. Keywords: evidence based medicine, medical education, assessment methods, graduate, instructional design, curriculum development, curriculum evaluation

  14. 76 FR 49787 - Rural Water Supply Program Approved Appraisal Reports; Availability

    Science.gov (United States)

    2011-08-11

    ... DEPARTMENT OF THE INTERIOR Bureau of Reclamation Rural Water Supply Program Approved Appraisal...: Reclamation provides assistance for appraisal investigations and feasibility studies for rural water supply... the findings and conclusions of the appraisal investigations that identified the water supply problems...

  15. The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

    Science.gov (United States)

    Borgerson, Dawn; Dino, Jennifer

    2012-01-01

    Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

  16. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital: design and development of a randomised controlled trial.

    NARCIS (Netherlands)

    Kasteleyn, M.J.; Gorter, K.J.; Stellato, R.K.; Rijken, M.; Nijpels, G.; Rutten, G.E.H.M.

    2014-01-01

    Background: Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to

  17. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial

    NARCIS (Netherlands)

    Kasteleyn, M.J.; Gorter, K.J.; Stellato, R.K.; Rijken, M.; Nijpels, G.; Rutten, G.E.H.M.

    2014-01-01

    Background: Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to

  18. Adverse Events Associated with Flumazenil Treatment for the Management of Suspected Benzodiazepine Intoxication--A Systematic Review with Meta-Analyses of Randomised Trials

    DEFF Research Database (Denmark)

    Penninga, Elisabeth I; Graudal, Niels; Ladekarl, Morten Baekbo

    2016-01-01

    Flumazenil is used for the reversal of benzodiazepine overdose. Serious adverse events (SAEs) including seizures and cardiac arrhythmias have been reported in patients treated with flumazenil, and the clinical advantage of flumazenil treatment has been questioned. The objective was to assess...

  19. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial

    DEFF Research Database (Denmark)

    NN, NN; Yusuf, S; Teo, K

    2008-01-01

    BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors reduce major cardiovascular events, but are not tolerated by about 20% of patients. We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular...

  20. How to appraise a diagnostic test

    Directory of Open Access Journals (Sweden)

    Ramanitharan Manikandan

    2011-01-01

    Full Text Available Urologists frequently encounter problems in making a clinical diagnosis whose resolution requires the use of diagnostic tests. With an ever increasing choice of investigations being available, the urologist often has to decide which diagnostic test(s will best resolve the patient′s diagnostic problem. In this article, we aim to help the urologist understand how to critically appraise studies on diagnostic tests and make a rational choice. This article presents the guiding principles in scientifically assessing studies on diagnostic tests by proposing a clinical scenario. The authors describe a standardized protocol to assess the validity of the test and its relevance to the clinical problem that can help the urologist in decision making. The three important issues to be considered when evaluating the validity of the study are to identify how the study population was chosen, how the test was performed and whether there is a comparison to the gold standard test so as to confirm or refute the diagnosis. Then, the urologist would need to know the probability of the test in providing the correct diagnosis in an individual patient in order to decide about its utility in solving the diagnostic dilemma. By performing the steps described in this article, the urologist would be able to critically appraise diagnostic studies and draw meaningful conclusions about the investigations in terms of validity, results and its applicability to the patient′s problem. This would provide a scientific basis for using diagnostic tests for improving patient care.

  1. Teaching critical appraisal skills for nursing research.

    Science.gov (United States)

    Jones, Sandra C; Crookes, Patrick A; Johnson, Keryn M

    2011-09-01

    Evidence-based practice is a major focus in nursing, yet the literature continues to document a research-practice gap. Reasons for this gap stem partly from a lack of skills to critique and synthesize the literature, a lack of search skills and difficulty in understanding research articles, and limited knowledge of research by nursing professionals. An innovative and quality driven subject to improve critical appraisal and critical thinking skills was developed for the School of Nursing, Midwifery and Indigenous Health at the University of Wollongong, based on formative research with postgraduate students and supervisors. Through face-to-face and online teaching modules students worked through a structured process of analysing the key aspects of published papers using structured analysis tools for each study design. Pre and post surveys of students found improvements in perceived knowledge of all key skills of critical appraisal. External independent evaluation determined that it was a high quality subject showing many hallmarks of good assessment practice and good practice in use of information and communication technology (ICT) in support of the learning outcomes. Copyright © 2011 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Appointment and duties of appraiser. 11.706 Section 11... OFFENSES AND LAW AND ORDER CODE Probate Proceedings § 11.706 Appointment and duties of appraiser. (a) Upon ordering an estate to be probated, the court shall appoint a disinterested and competent person as an...

  3. 107 an appraisal of the scope of provisions under

    African Journals Online (AJOL)

    Fr. Ikenga

    EZE & EZE: An Appraisal of the Scope of Provisions Under The 1999 Nigerian Constitution for the Control of Pollution. Arising from the Oil and Gas Industry. AN APPRAISAL OF THE .... However, in a historic judgment, a Federal High Court sitting in Benin-City and presided over by Nwokorie J, held that continued gas flaring ...

  4. 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 ...

  5. Appraisal patterns of emotions in human-product interaction

    NARCIS (Netherlands)

    Demir, E.; Desmet, P.M.A.; Hekkert, P.

    2009-01-01

    Emotional design, i.e., designing with an intention to evoke or to prevent a particular emotion, can be facilitated by understanding the processes underlying emotions. A promising approach to understanding these processes in the current psychological literature is appraisal theory. Appraisal theory

  6. 12 CFR 950.10 - Collateral valuation; appraisals.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Collateral valuation; appraisals. 950.10...-BALANCE SHEET ITEMS ADVANCES Advances to Members § 950.10 Collateral valuation; appraisals. (a) Collateral valuation. Each Bank shall determine the value of collateral securing the Bank's advances in accordance with...

  7. Linking the Teacher Appraisal Process to the School Improvement Plan

    Science.gov (United States)

    Reddekopp, Therese

    2007-01-01

    If a school improvement plan includes input from all stakeholders and focuses on data-driven processes that are linked to teacher appraisal, it can be powerful in leading the school toward the common mission of achieving student success. Linking the school improvement plan to the teacher appraisal process creates a system whereby all individuals…

  8. Evaluating School Health Appraisal scheme in Primary Schools ...

    African Journals Online (AJOL)

    Objectives: This study assessed school health appraisal implementation in primary schools within Abakaliki Metropolis. Materials and Methods: This was a cross sectional descriptive study of the forms of health appraisal in all 31 primary schools in Abakaliki metropolis. Relevant information was obtained from the head ...

  9. A Composite Model for Employees' Performance Appraisal and Improvement

    Science.gov (United States)

    Manoharan, T. R.; Muralidharan, C.; Deshmukh, S. G.

    2012-01-01

    Purpose: The purpose of this paper is to develop an innovative method of performance appraisal that will be useful for designing a structured training programme. Design/methodology/approach: Employees' performance appraisals are conducted using new approaches, namely data envelopment analysis and an integrated fuzzy model. Interpretive structural…

  10. 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.

  11. Student feedback on an adapted appraisal model in resource ...

    African Journals Online (AJOL)

    Background. An appraisal model, a type of formal mentorship programme for a cohort of student doctors, is used at the University of Leeds, UK. The University of the Witwatersrand, Johannesburg, South Africa implemented an adapted version of the appraisal process that uses fewer resources. Objective. To explore ...

  12. 50 CFR 34.6 - Schedule of appraisals.

    Science.gov (United States)

    2010-10-01

    ... Secretary shall make fair market value appraisals of areas administered by the Service within five years... reappraised on a schedule of at least once every five years. Until areas are appraised, the fair market value... fee lands added to such areas after that date shall be on the basis of fair market value. ...

  13. Anticoagulant therapy and outcomes in patients with prior or acute heart failure and acute coronary syndromes: Insights from the APixaban for PRevention of Acute ISchemic Events 2 trial.

    Science.gov (United States)

    Cornel, Jan H; Lopes, Renato D; James, Stefan; Stevens, Susanna R; Neely, Megan L; Liaw, Danny; Miller, Julie; Mohan, Puneet; Amerena, John; Raev, Dimitar; Huo, Yong; Urina-Triana, Miguel; Gallegos Cazorla, Alex; Vinereanu, Dragos; Fridrich, Viliam; Harrington, Robert A; Wallentin, Lars; Alexander, John H

    2015-04-01

    Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome (ACS) and either a history of or acute heart failure (HF) are largely unknown. We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations. High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily. Median follow-up was 8 (4-12) months. The primary outcome was cardiovascular death, myocardial infarction, or stroke. The main safety outcome was thrombolysis in myocardial infarction major bleeding. Heart failure was reported in 2,995 patients (41%), either as prior HF (2,076 [28%]) or acute HF (2,028 [27%]). Patients with HF had a very high baseline risk and were more often managed medically. Heart failure was associated with a higher rate of the primary outcome (prior HF: adjusted hazard ratio [HR] 1.73, 95% CI 1.42-2.10, P acute HF: adjusted HR 1.65, 95% CI 1.35-2.01, P acute HF: adjusted HR 2.52, 95% CI 1.82-3.50). Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding (prior HF: adjusted HR 1.22, 95% CI 0.65-2.27, P = .54, acute HF: adjusted HR 1.78, 95% CI 1.03-3.08, P = .04). There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF; however, among patients with acute HF, there were numerically fewer events with apixaban than placebo (14.8 vs 19.3, HR 0.76, 95% CI 0.57-1.01, interaction P = .13), a trend that was not seen in patients with prior HF or no HF. In high-risk patients post-ACS, both prior and acute HFs are associated with an increased risk of subsequent clinical events. Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF; however, there was a tendency toward fewer clinical

  14. Precompetitive achievement goals, stress appraisals, emotions, and coping among athletes.

    Science.gov (United States)

    Nicholls, Adam R; Perry, John L; Calmeiro, Luis

    2014-10-01

    Grounded in Lazarus's (1991, 1999, 2000) cognitive-motivational-relational theory of emotions, we tested a model of achievement goals, stress appraisals, emotions, and coping. We predicted that precompetitive achievement goals would be associated with appraisals, appraisals with emotions, and emotions with coping in our model. The mediating effects of emotions among the overall sample of 827 athletes and two stratified random subsamples were also explored. The results of this study support our proposed model in the overall sample and the stratified subsamples. Further, emotion mediated the relationship between appraisal and coping. Mediation analyses revealed that there were indirect effects of pleasant and unpleasant emotions, which indicates the importance of examining multiple emotions to reveal a more accurate representation of the overall stress process. Our findings indicate that both appraisals and emotions are just as important in shaping coping.

  15. 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

    , 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...... background EEG in various input signal to noise ratios. While both methods can be applied to track dynamical changes, the simplified Kalman filter has an advantage over the Sliding Window Averaging, most notable in a better noise suppression when both are optimized for faster changing latency and amplitude...

  16. Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial.

    Science.gov (United States)

    Lambers Heerspink, Hiddo J; Chertow, Glenn M; Akizawa, Tadao; Audhya, Paul; Bakris, George L; Goldsberry, Angie; Krauth, Melissa; Linde, Peter; McMurray, John J; Meyer, Colin J; Parving, Hans-Henrik; Remuzzi, Giuseppe; Christ-Schmidt, Heidi; Toto, Robert D; Vaziri, Nosratola D; Wanner, Christoph; Wittes, Janet; Wrolstad, Danielle; de Zeeuw, Dick

    2013-11-01

    Type 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population. BEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo. Baseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients. The BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.

  17. Bayesian enhancement two-stage design for single-arm phase II clinical trials with binary and time-to-event endpoints.

    Science.gov (United States)

    Shi, Haolun; Yin, Guosheng

    2018-02-21

    Simon's two-stage design is one of the most commonly used methods in phase II clinical trials with binary endpoints. The design tests the null hypothesis that the response rate is less than an uninteresting level, versus the alternative hypothesis that the response rate is greater than a desirable target level. From a Bayesian perspective, we compute the posterior probabilities of the null and alternative hypotheses given that a promising result is declared in Simon's design. Our study reveals that because the frequentist hypothesis testing framework places its focus on the null hypothesis, a potentially efficacious treatment identified by rejecting the null under Simon's design could have only less than 10% posterior probability of attaining the desirable target level. Due to the indifference region between the null and alternative, rejecting the null does not necessarily mean that the drug achieves the desirable response level. To clarify such ambiguity, we propose a Bayesian enhancement two-stage (BET) design, which guarantees a high posterior probability of the response rate reaching the target level, while allowing for early termination and sample size saving in case that the drug's response rate is smaller than the clinically uninteresting level. Moreover, the BET design can be naturally adapted to accommodate survival endpoints. We conduct extensive simulation studies to examine the empirical performance of our design and present two trial examples as applications. © 2018, The International Biometric Society.

  18. Report of ad hoc committee for appraisal of ABCC Program

    Energy Technology Data Exchange (ETDEWEB)

    Francis, T Jr; Jablon, S; Moore, F E

    1955-11-06

    The function of the Committee, according to its understanding, is to make an objective, scientific appraisal of the ABCC program as to its organization, plan of study, pattern of procedure, adequacy of data, caliber of performance, future outlook, and to report thereon with recommendations. It is apparent that the ABCC program had bogged down because of deficiencies in understanding of purpose, in ideas, in initiative, and in outlook. There has been a lack of investigative leadership and stimulating support. Significant observations have been made and, while gross evidence of radiation effects are not being detected at present, the data not yet analyzed may contain valuable information. If intimations of a shortening in life span should be substantiated, an impetus to investigations of underlying mechanisms will be provided. In any event, the continued imaginative investigation of the study population should yield knowledge of great value to medicine, to human biology, and to peaceful uses of atomic energy. It is believed that the program should be strengthened and given increased support. A unified plan of study is proposed. It should furnish more adequate data by coordination of effort, integration of information, and by maintaining analyses of data at a current level. It offers advantages to the stimulation and carrying out of research. Suggestions as to future plans of maintenance are briefly discussed.

  19. Event Investigation

    International Nuclear Information System (INIS)

    Korosec, D.

    2000-01-01

    The events in the nuclear industry are investigated from the license point of view and from the regulatory side too. It is well known the importance of the event investigation. One of the main goals of such investigation is to prevent the circumstances leading to the event and the consequences of the event. The protection of the nuclear workers against nuclear hazard, and the protection of general public against dangerous effects of an event could be achieved by systematic approach to the event investigation. Both, the nuclear safety regulatory body and the licensee shall ensure that operational significant events are investigated in a systematic and technically sound manner to gather information pertaining to the probable causes of the event. One of the results should be appropriate feedback regarding the lessons of the experience to the regulatory body, nuclear industry and general public. In the present paper a general description of systematic approach to the event investigation is presented. The systematic approach to the event investigation works best where cooperation is present among the different divisions of the nuclear facility or regulatory body. By involving management and supervisors the safety office can usually improve their efforts in the whole process. The end result shall be a program which serves to prevent events and reduce the time and efforts solving the root cause which initiated each event. Selection of the proper method for the investigation and an adequate review of the findings and conclusions lead to the higher level of the overall nuclear safety. (author)

  20. The effectiveness of health appraisal processes currently in addressing health and wellbeing during spatial plan appraisal: a systematic review.

    Science.gov (United States)

    Gray, Selena; Carmichael, Laurence; Barton, Hugh; Mytton, Julie; Lease, Helen; Joynt, Jennifer

    2011-11-24

    Spatial planning affects the built environment, which in turn has the potential to have a significant impact on health, for good or ill. One way of ensuring that spatial plans take due account of health is through the inclusion of health considerations in the statutory and non statutory appraisal processes linked to plan-making processes. A systematic review to identify evaluation studies of appraisals or assessments of plans where health issues were considered from 1987 to 2010. A total of 6161 citations were identified: 6069 from electronic databases, 57 fromwebsite searches, with a further 35 citations from grey literature, of which 20 met the inclusion criteria. These 20 citations reported on a total of 135 different case studies: 11 UK HIA; 11 non UK high income countries HIA, 5 UK SEA or other integrated appraisal; 108 non UK high income SEA or other integrated appraisal. All studies were in English. No relevant studies were identified reporting on low or middle income countries.The studies were limited by potential bias (no independent evaluation, with those undertaking the appraisal also responsible for reporting outcomes), lack of detail and a lack of triangulation of results. Health impact assessments generally covered the four specified health domains (physical activity, mental health and wellbeing, environmental health issues such as pollution and noise, injury) more comprehensively than SEA or other integrated appraisals, although mental health and wellbeing was an underdeveloped area. There was no evidence available on the incorporation of health in Sustainability Appraisal, limited evidence that the recommendations from any type of appraisal were implemented, and almost no evidence that the recommendations had led to the anticipated outcomes or improvements in health postulated. Research is needed to assess (i) the degree to which statutory plan appraisal processes (SA in the UK) incorporate health; (ii) whether recommendations arising from health

  1. The effectiveness of health appraisal processes currently in addressing health and wellbeing during spatial plan appraisal: a systematic review

    Directory of Open Access Journals (Sweden)

    Gray Selena

    2011-11-01

    Full Text Available Abstract Background Spatial planning affects the built environment, which in turn has the potential to have a significant impact on health, for good or ill. One way of ensuring that spatial plans take due account of health is through the inclusion of health considerations in the statutory and non statutory appraisal processes linked to plan-making processes. Methods A systematic review to identify evaluation studies of appraisals or assessments of plans where health issues were considered from 1987 to 2010. Results A total of 6161 citations were identified: 6069 from electronic databases, 57 fromwebsite searches, with a further 35 citations from grey literature, of which 20 met the inclusion criteria. These 20 citations reported on a total of 135 different case studies: 11 UK HIA; 11 non UK high income countries HIA, 5 UK SEA or other integrated appraisal; 108 non UK high income SEA or other integrated appraisal. All studies were in English. No relevant studies were identified reporting on low or middle income countries. The studies were limited by potential bias (no independent evaluation, with those undertaking the appraisal also responsible for reporting outcomes, lack of detail and a lack of triangulation of results. Health impact assessments generally covered the four specified health domains (physical activity, mental health and wellbeing, environmental health issues such as pollution and noise, injury more comprehensively than SEA or other integrated appraisals, although mental health and wellbeing was an underdeveloped area. There was no evidence available on the incorporation of health in Sustainability Appraisal, limited evidence that the recommendations from any type of appraisal were implemented, and almost no evidence that the recommendations had led to the anticipated outcomes or improvements in health postulated. Conclusion Research is needed to assess (i the degree to which statutory plan appraisal processes (SA in the UK

  2. Effects of appraisal purpose and rating format on performance appraisal accuracy

    OpenAIRE

    Carter, Marta L.

    1989-01-01

    The principle of encoding specificity states that effective information retrieval relies upon consistency of encoding and retrieval cues. The present study generalized this principle to a complex social interaction in order to investigate the relation between certain combinations of pre- and post-observational cues and their effects on information categorization, recognition accuracy, and judgment accuracy. It was hypothesized that two experimental factors, appraisal pur...

  3. Nailfold capillaroscopy microscopy - an interdisciplinary appraisal.

    Science.gov (United States)

    Klein-Weigel, Peter Franz; Sunderkötter, Cord; Sander, Oliver

    2016-09-01

    Nailfold capillaroscopy is a method of great diagnostic value in the differential diagnosis of primary versus secondary Raynaud´s phenomenon, of systemic sclerosis versus other so called connective tissue diseases and of additional diagnostic value in other entities. Rheumatologists, dermatologists, and angiologists in Germany have convened in an interdisciplinary working group in which they synergistically combined their expertise to develop a common nomenclature and standards for the technical performance of nailfold capillary microscopy. The article gives an overview of historical and technical aspects of capillaroscopy, morphologic findings, and disease-specific patterns. It also provides a critical appraisal of its significance in the diagnosis and sequelae of these interdisciplinarily-managed diseases including its performance in children and gives an excursion in the potential perspectives of capillaroscopy in less common indications.

  4. Employees' perceptions of justice in performance appraisals.

    Science.gov (United States)

    Vasset, Frøydis; Marnburg, Einar; Furunes, Trude

    2010-05-01

    Of all the tasks undertaken by human resource managers, performance appraisals (PAs) are one of the most unpopular among employees (Meyer 1991, Murphy and Cleveland 1995, Holbrook 2002, Jackman and Strober 2003). As PA guides and plans show (Fletcher 2004, CatalystOne 2010), PAs can be implemented in similar ways in organisations throughout Europe and developed countries elsewhere. But, if employees perceive PA processes as unfair, they may reject the usefulness and validity of the information they receive and so may not be motivated to change behaviour. This article concerns perceptions of organisational justice and explains the results of a study of perceived fairness in PAs among nurses and auxiliary nurses in Norway's municipal health service.

  5. Photographic appraisal of crystal lattice growth technique

    Directory of Open Access Journals (Sweden)

    Kapoor D

    2005-01-01

    Full Text Available Concept of creating mechanical retention for bonding through crystal growth has been successfully achieved in the present study. By using polyacrylic acid, sulphated with sulphuric acid as etchant, abundant crystal growth was demonstrated. Keeping in view the obvious benefits of crystal growth technique, the present SEM study was aimed to observe and compare the changes brought about by different etching agents (phosphoric acid, polyacrylic acid and polyacrylic acid sulphated and to evaluate their advantages and disadvantages in an attempt to reduce iatrogenic trauma caused due to surface enamel alteration. Control and experimental groups were made of 24 and 30 premolars, respectively, for scanning electron microscopic appraisal of normal unetched and etched enamel surface and fracture site and finished surface evaluation. When compared with conventional phosphoric acid and weaker polyacrylic acid, investigations indicated that crystal growth treatment on enamel surface caused minimal iatrogenic trauma and surface alteration were restored to the original untreated condition to a large extent.

  6. Investment appraisal using quantitative risk analysis.

    Science.gov (United States)

    Johansson, Henrik

    2002-07-01

    Investment appraisal concerned with investments in fire safety systems is discussed. Particular attention is directed at evaluating, in terms of the Bayesian decision theory, the risk reduction that investment in a fire safety system involves. It is shown how the monetary value of the change from a building design without any specific fire protection system to one including such a system can be estimated by use of quantitative risk analysis, the results of which are expressed in terms of a Risk-adjusted net present value. This represents the intrinsic monetary value of investing in the fire safety system. The method suggested is exemplified by a case study performed in an Avesta Sheffield factory.

  7. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial

    DEFF Research Database (Denmark)

    Ridker, Paul M; Danielson, Eleanor; Fonseca, Francisco Ah

    2009-01-01

    BACKGROUND: Statins lower high-sensitivity C-reactive protein (hsCRP) and cholesterol concentrations, and hypothesis generating analyses suggest that clinical outcomes improve in patients given statins who achieve hsCRP concentrations less than 2 mg/L in addition to LDL cholesterol less than 1.......8 mmol/L (LDL cholesterol and hsCRP after the start of statin therapy is controversial. We prospectively tested this hypothesis. METHODS: In an analysis of 15 548 initially healthy men and women participating in the JUPITER trial (87% of full cohort), we...... to on-treatment concentrations of LDL cholesterol (>/=1.8 mmol/L or /=2 mg/L or

  8. A psychometric appraisal of the DREEM

    Directory of Open Access Journals (Sweden)

    Hammond Sean M

    2012-01-01

    Full Text Available Abstract Background The quality of the Educational environment is a key determinant of a student centred curriculum. Evaluation of the educational environment is an important component of programme appraisal. In order to conduct such evaluation use of a comprehensive, valid and reliable instrument is essential. One of most widely used contemporary tools for evaluation of the learning environment is the Dundee Ready Education Environment Measure (DREEM. Apart from the initial psychometric evaluation of the DREEM, few published studies report its psychometric properties in detail. The aim of this study was to examine the psychometric quality of the DREEM measure in the context of medical education in Ireland and to explore the construct validity of the device. Methods 239 final year medical students were asked to complete the DREEM inventory. Anonymised responses were entered into a database. Data analysis was performed using PASW 18 and confirmatory factor analysis performed. Results Whilst the total DREEM score had an acceptable level of internal consistency (alpha 0.89, subscale analysis shows that two subscales had sub-optimal internal consistency. Multiple group confirmatory factor analysis (using Fleming's indices shows an overall fit of 0.76, representing a weak but acceptable level of fit. 17 of the 50 items manifest fit indices less than 0.70. We sought the best fitting oblique solution to the 5-subscale structure, which showed large correlations, suggesting that the independence of the separate scales is open to question. Conclusions There has perhaps been an inadequate focus on establishing and maintaining the psychometric credentials of the DREEM. The present study highlights two concerns. Firstly, the internal consistency of the 5 scales is quite variable and, in our sample, appears rather low. Secondly, the construct validity is not well supported. We suggest that users of the DREEM will provide basic psychometric appraisal of the

  9. Evidence from epidemic appraisals in Nigeria

    Directory of Open Access Journals (Sweden)

    Idoteyin O. Ezirim

    2015-10-01

    Full Text Available Although HIV prevalence has increased in most-at-risk populations (MARPs across Nigeria, effective programming was difficult because Nigeria lacked information for prevention programmes to target interventions that maximise coverage and cost effectiveness. Epidemic appraisals (EA were conducted in eight states to provide evidence for the planning, implementation and co-ordination of prevention interventions. Component 1: Mapping determined the size, typology and locations of MARPs. Component 2: Venue profiling identified and profiled venues where general populations engaged in high-risk behaviours. Component 3: Rural appraisals provided insights into risk behaviours and sexual networking in villages. States used mapping results to prioritise areas with a MARP coverage of 70% – 80% and then scale up interventions for non-brothel-based female sex workers (FSWs instead of focusing on brothel-based FSWs. The eight states prioritisedf unding for the high-coverage areas to ensure a minimum coverage level of 70% – 80% of MARPs was reached. The refocused resources led to cost efficiencies. Applying venue profiling results, six states implemented interventions at bars and night clubs – previously not covered. States also maximised intervention coverage for high-risk general populations; this led to the use of resources for general population interventions in a focused way rather than across an entire state. States focused on condom programmes in rural areas. EA results provided the evidence for focusing interventions for high MARP coverage as well as forhigh-risk general populations. The states applied the results and rapidly refocused their interventions, increasing the likelihood of having an impact on HIV transmission in those states. Nigeria is now implementing EAs in the remaining 29 states to effect national-level impact.

  10. A psychometric appraisal of the DREEM

    LENUS (Irish Health Repository)

    Hammond, Sean M

    2012-01-12

    Abstract Background The quality of the Educational environment is a key determinant of a student centred curriculum. Evaluation of the educational environment is an important component of programme appraisal. In order to conduct such evaluation use of a comprehensive, valid and reliable instrument is essential. One of most widely used contemporary tools for evaluation of the learning environment is the Dundee Ready Education Environment Measure (DREEM). Apart from the initial psychometric evaluation of the DREEM, few published studies report its psychometric properties in detail. The aim of this study was to examine the psychometric quality of the DREEM measure in the context of medical education in Ireland and to explore the construct validity of the device. Methods 239 final year medical students were asked to complete the DREEM inventory. Anonymised responses were entered into a database. Data analysis was performed using PASW 18 and confirmatory factor analysis performed. Results Whilst the total DREEM score had an acceptable level of internal consistency (alpha 0.89), subscale analysis shows that two subscales had sub-optimal internal consistency. Multiple group confirmatory factor analysis (using Fleming\\'s indices) shows an overall fit of 0.76, representing a weak but acceptable level of fit. 17 of the 50 items manifest fit indices less than 0.70. We sought the best fitting oblique solution to the 5-subscale structure, which showed large correlations, suggesting that the independence of the separate scales is open to question. Conclusions There has perhaps been an inadequate focus on establishing and maintaining the psychometric credentials of the DREEM. The present study highlights two concerns. Firstly, the internal consistency of the 5 scales is quite variable and, in our sample, appears rather low. Secondly, the construct validity is not well supported. We suggest that users of the DREEM will provide basic psychometric appraisal of the device in future

  11. Effect of vorapaxar on myocardial infarction in the thrombin receptor antagonist for clinical event reduction in acute coronary syndrome (TRA·CER) trial.

    Science.gov (United States)

    Leonardi, Sergio; Tricoci, Pierluigi; White, Harvey D; Armstrong, Paul W; Huang, Zhen; Wallentin, Lars; Aylward, Philip E; Moliterno, David J; Van de Werf, Frans; Chen, Edmond; Providencia, Luis; Nordrehaug, Jan E; Held, Claes; Strony, John; Rorick, Tyrus L; Harrington, Robert A; Mahaffey, Kenneth W

    2013-06-01

    The TRA·CER trial compared vorapaxar, a novel platelet protease-activated receptor (PAR)-1 antagonist, with placebo in 12 944 patients with high-risk non-ST-segment elevation acute coronary syndromes (NSTE ACS). In this analysis, we explored the effect of vorapaxar on myocardial infarction (MI). A blinded, independent central endpoint adjudication committee prospectively defined and classified MI according to the universal MI definition, including peak cardiac marker value (creatine kinase-MB [CK-MB] and/or troponin). Because the trial failed to meet its primary endpoint, these analyses are considered exploratory. During a median follow-up of 502 days, 1580 MIs occurred in 1319 patients. The majority (n = 1025, 64.9%) were type 1 (spontaneous) MI, followed by type 4a [percutaneous coronary intervention (PCI)-related] MI (n = 352; 22.3%). Compared with placebo, vorapaxar reduced the hazard of a first MI of any type by 12% [hazard ratio (HR), 0.88; 95% confidence interval (CI), 0.79-0.98; P = 0.021] and the hazard of total number of MIs (first and subsequent) by 14% (HR, 0.86; 95% CI, 0.77-0.97; P = 0.014), an effect that was sustained over time. Vorapaxar reduced type 1 MI by 17% (HR, 0.83; 95% CI, 0.73-0.95; P = 0.007). Type 4a MIs were not significantly reduced by vorapaxar (HR, 0.90; 95% CI, 0.73-1.12; P = 0.35). Vorapaxar effect was consistent across MI sizes defined by peak cardiac marker elevations and across key clinical subgroups; however, in patients not treated with thienopyridine at baseline (HR, 0.65; 95% CI, 0.46-0.92) compared with patients who received thienopyridine (HR, 0.91; 95% CI, 0.81-1.02), there was a trend towards a higher effect (Pint = 0.077). The PAR-1 antagonist vorapaxar was associated with a reduction of MI, including total number of infarctions. This reduction was sustained over time and was mostly evident in type 1 MI, the most common type of MI observed.

  12. Pain Flare Is a Common Adverse Event in Steroid-Naïve Patients After Spine Stereotactic Body Radiation Therapy: A Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Chiang, Andrew [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada); Zeng, Liang; Zhang, Liying; Lochray, Fiona; Korol, Renee; Loblaw, Andrew; Chow, Edward [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Sahgal, Arjun, E-mail: arjun.sahgal@sunnybrook.ca [Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON (Canada); Department of Radiation Oncology, Princess Margaret Hospital, University of Toronto, Toronto, ON (Canada)

    2013-07-15

    Purpose: To determine the incidence of pain flare after spine stereotactic body radiation therapy (SBRT) in steroid-naïve patients and identify predictive factors. Methods and Materials: Forty-one patients were treated with spine SBRT between February 2010 and April 2012. All patients had their pain assessed at baseline, during, and for 10 days after SBRT using the Brief Pain Inventory. All pain medications were recorded daily and narcotics converted to an oral morphine equivalent dose. Pain flare was defined as a 2-point increase in worst pain score as compared with baseline with no decrease in analgesic intake, a 25% increase in analgesic intake as compared with baseline with no decrease in worst pain score, or if corticosteroids were initiated at any point during or after SBRT because of pain. Results: The median age and Karnofsky performance status were 57.5 years (range, 27-80 years) and 80 (range, 50-100), respectively. Eighteen patients were treated with 20-24 Gy in a single fraction, whereas 23 patients were treated with 24-35 Gy in 2-5 fractions. Pain flare was observed in 68.3% of patients (28 of 41), most commonly on day 1 after SBRT (29%, 8 of 28). Multivariate analysis identified a higher Karnofsky performance status (P=.02) and cervical (P=.049) or lumbar (P=.02) locations as significant predictors of pain flare. In those rescued with dexamethasone, a significant decrease in pain scores over time was subsequently observed (P<.0001). Conclusions: Pain flare is a common adverse event after spine SBRT and occurs most commonly the day after treatment completion. Patients should be appropriately consented for this adverse event.

  13. SENTINEL EVENTS

    Directory of Open Access Journals (Sweden)

    Andrej Robida

    2004-09-01

    Full Text Available Background. The Objective of the article is a two year statistics on sentinel events in hospitals. Results of a survey on sentinel events and the attitude of hospital leaders and staff are also included. Some recommendations regarding patient safety and the handling of sentinel events are given.Methods. In March 2002 the Ministry of Health introduce a voluntary reporting system on sentinel events in Slovenian hospitals. Sentinel events were analyzed according to the place the event, its content, and root causes. To show results of the first year, a conference for hospital directors and medical directors was organized. A survey was conducted among the participants with the purpose of gathering information about their view on sentinel events. One hundred questionnaires were distributed.Results. Sentinel events. There were 14 reports of sentinel events in the first year and 7 in the second. In 4 cases reports were received only after written reminders were sent to the responsible persons, in one case no reports were obtained. There were 14 deaths, 5 of these were in-hospital suicides, 6 were due to an adverse event, 3 were unexplained. Events not leading to death were a suicide attempt, a wrong side surgery, a paraplegia after spinal anaesthesia, a fall with a femoral neck fracture, a damage of the spleen in the event of pleural space drainage, inadvertent embolization with absolute alcohol into a femoral artery and a physical attack on a physician by a patient. Analysis of root causes of sentinel events showed that in most cases processes were inadequate.Survey. One quarter of those surveyed did not know about the sentinel events reporting system. 16% were having actual problems when reporting events and 47% beleived that there was an attempt to blame individuals. Obstacles in reporting events openly were fear of consequences, moral shame, fear of public disclosure of names of participants in the event and exposure in mass media. The majority of

  14. Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: a randomized, placebo-controlled, double-blind clinical trial.

    Science.gov (United States)

    Valadares, Fabiana; Garbi Novaes, Maria Rita Carvalho; Cañete, Roberto

    2013-01-01

    Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day) or placebo. Patients were evaluated during treatment period. Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%), nausea and vomiting (80%). Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy.

  15. 7 CFR 1980.444 - Appraisal of property serving as collateral.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 14 2010-01-01 2009-01-01 true Appraisal of property serving as collateral. 1980.444... Program § 1980.444 Appraisal of property serving as collateral. (a) Appraisal reports prepared by independent qualified fee appraisers will be required on all property that will serve as collateral. In the...

  16. 41 CFR 102-42.40 - When is an appraisal necessary?

    Science.gov (United States)

    2010-07-01

    ... DISPOSAL OF FOREIGN GIFTS AND DECORATIONS General Provisions Appraisals § 102-42.40 When is an appraisal necessary? An appraisal is necessary when— (a) An employee indicates an interest in purchasing a gift or decoration. In this situation, the appraisal must be obtained before the gift or decoration is reported to...

  17. An Investigation into Appraisal Bias: The Role of Decision Support Tools in Debiasing Valuation Judgments

    Science.gov (United States)

    Tidwell, Owen Alan

    2011-01-01

    Given the nature of the valuation task environment appraisers are often made aware of previous value opinions rendered by appraisers, commonly in the form of an historic appraisal. And, because an appraisal task involves the rendering of market value, a hypothetical, unobservable construct based on probabilities, direct feedback against this…

  18. Small Steps Forward Through Critical Appraisal (Editorial

    Directory of Open Access Journals (Sweden)

    Denise Koufogiannakis

    2006-03-01

    Full Text Available As a vocal proponent of evidence based information practice, I have actively encouraged my co‐workers and anyone else who might listen, to take small steps in order to move towards incorporating research evidence into their decision making. I prompt colleagues to search in databases for research articles that may be useful, gather these articles and incorporate research results as part of their decision making process. I am often told of the difficulties faced despite one’s best attempts to make their practice more evidence‐based. A major difficulty is access to the research itself since librarians and information professionals often lack access to databases and journals in our field, particularly those of us working outside of academic libraries. An even more daunting question is how to critically read the existing research to determine whether it is valuable in a specific situation. Not all research is good, and how do we sort out the good from the bad? This inaugural issue of Evidence Based Library and Information Practice brings us one small step closer to addressing some of these concerns by equipping practitioners with information to help in their decision making process. Every issue of Evidence Based Library and Information Practice will incorporate approximately 10 evidence summaries to help readers sort through recently published research and determine if that research was done well. Evidence summaries provide a critical appraisal synthesis for a specific research article, so that practitioners may more readily determine if the evidence in that research study is valid and reliable, and whether they can apply it to their own practice. Evidence summaries are indeed a small step, but an important one. Published in an open‐access forum, these summaries will address three barriers to evidence based practice that we have faced in the past. First of all, they will bring awareness of previously published research to readers who may

  19. Event Modeling

    DEFF Research Database (Denmark)

    Bækgaard, Lars

    2001-01-01

    The purpose of this chapter is to discuss conceptual event modeling within a context of information modeling. Traditionally, information modeling has been concerned with the modeling of a universe of discourse in terms of information structures. However, most interesting universes of discourse...... are dynamic and we present a modeling approach that can be used to model such dynamics.We characterize events as both information objects and change agents (Bækgaard 1997). When viewed as information objects events are phenomena that can be observed and described. For example, borrow events in a library can...

  20. Statistical power in parallel group point exposure studies with time-to-event outcomes: an empirical comparison of the performance of randomized controlled trials and the inverse probability of treatment weighting (IPTW) approach.

    Science.gov (United States)

    Austin, Peter C; Schuster, Tibor; Platt, Robert W

    2015-10-15

    Estimating statistical power is an important component of the design of both randomized controlled trials (RCTs) and observational studies. Methods for estimating statistical power in RCTs have been well described and can be implemented simply. In observational studies, statistical methods must be used to remove the effects of confounding that can occur due to non-random treatment assignment. Inverse probability of treatment weighting (IPTW) using the propensity score is an attractive method for estimating the effects of treatment using observational data. However, sample size and power calculations have not been adequately described for these methods. We used an extensive series of Monte Carlo simulations to compare the statistical power of an IPTW analysis of an observational study with time-to-event outcomes with that of an analysis of a similarly-structured RCT. We examined the impact of four factors on the statistical power function: number of observed events, prevalence of treatment, the marginal hazard ratio, and the strength of the treatment-selection process. We found that, on average, an IPTW analysis had lower statistical power compared to an analysis of a similarly-structured RCT. The difference in statistical power increased as the magnitude of the treatment-selection model increased. The statistical power of an IPTW analysis tended to be lower than the statistical power of a similarly-structured RCT.

  1. Facing the truth: An appraisal of the potential contributions ...

    African Journals Online (AJOL)

    Facing the truth: An appraisal of the potential contributions, paradoxes and challenges of implementing the United Nations conventions on Contracts for the International Sale of Goods (CISG) in Nigeria.

  2. Managerial Competencies and the Managerial Performance Appraisal Process.

    Science.gov (United States)

    Abraham, Steven E.; Karns, Lanny A.; Shaw, Kenneth; Mena, Manuel A.

    2001-01-01

    Human resource managers (n=277) identified six management competencies as critical: leadership, customer focus, results orientation, problem solving, communication skills, and teamwork. However, many companies do not assess these competencies in the management performance appraisal process. (Contains 22 references.) (SK)

  3. Enhancing Positive Reactions to Breast Cancer Risk Appraisal

    National Research Council Canada - National Science Library

    Cochrane, Barbara

    1996-01-01

    .... Thus, this study seeks to: (1) assess the psychological distress of 350 women ages 50 to 85 who receive breast cancer risk appraisal and randomization to immediate or delayed group psychosocial counseling (2...

  4. Enhancing Positive Reactions to Breast Cancer Risk Appraisal

    National Research Council Canada - National Science Library

    Cochrane, Barbara

    1997-01-01

    .... Thus, this study seeks to: (1) assess the psychological distress of 350 women ages 50 to 85 who receive breast cancer risk appraisal and randomization to immediate or delayed group psychosocial counseling; (2...

  5. 77 FR 40051 - Appraisal Subcommittee; Notice of Meeting

    Science.gov (United States)

    2012-07-06

    ... Foundation March 2012 Grant Reimbursement Request. ASC Appraisal Foundation Grant Policy. How To Attend and... requests, the ASC may refuse attendance on that reasonable basis. The use of any video or audio tape...

  6. Appraisal of seven critical reading strategies employed by teachers ...

    African Journals Online (AJOL)

    Appraisal of seven critical reading strategies employed by teachers in Ogun State senior secondary schools to teach reading comprehension. ... as a result of the teachers' ability to engage the students in skilful and well- framed questions.

  7. 7 CFR 1781.14 - Planning, options, and appraisals.

    Science.gov (United States)

    2010-01-01

    ... designated agent when a WS loan, WS advance or RCD loan is made. (d) Options and appraisals related to the purchase of real estate for which a WS loan, WS advance, or RCD loan is made must be developed in...

  8. "The nature of morality‟ in Gilbert Harman: As appraisal | Oyedola ...

    African Journals Online (AJOL)

    "The nature of morality‟ in Gilbert Harman: As appraisal. ... characteristic of scientific beliefs, as espoused by Harman has not undermined the nature of ... Nevertheless, the study concedes that the fact that liar man's grounds are appealing, his ...

  9. An appraisal of the state fund and empowerment programme in ...

    African Journals Online (AJOL)

    An appraisal of the state fund and empowerment programme in Nigeria. ... Distributive politics is one of the most important and controversial aspects of the policy ... all stakeholders in the federal polity should thread softly, be objective, rational, ...

  10. 38 CFR 36.4347 - Lender Appraisal Processing Program.

    Science.gov (United States)

    2010-07-01

    ... appropriate corrective action(s) in the appraisal review process when discrepancies or problems are identified...) Fees. The Secretary may require mortgagees to pay an application fee and/or annual fees, including...

  11. 38 CFR 36.4348 - Servicer Appraisal Processing Program.

    Science.gov (United States)

    2010-07-01

    ... prescribe appropriate corrective action(s) in the appraisal review process when discrepancies or problems... of SAPP authority. (g) Fees. The Secretary will require servicers to pay a $100.00 application fee...

  12. Methodical features of appraisal of partial rights on land

    OpenAIRE

    Makarova, V. V.; Semenenko, B. A.

    2015-01-01

    The theoretical and practical questions of appraisal of right for the permanent using lot lands, and rights for their lease, are examined. The methods of decision of the indicated tasks are offered in evaluation practice.

  13. 41 Appraisal of the Performance of Contingency Cost Provision for ...

    African Journals Online (AJOL)

    Arc. Usman A. Jalam

    ATBU Journal of Environmental Technology, 4, (1), December 2011. 41. Appraisal of the ... quantitative risks analysis in the determination of contingency fund. Therefore, to improve the ... the financial performance of constructed facilities ...

  14. 36 CFR 228.48 - Appraisal and measurement.

    Science.gov (United States)

    2010-07-01

    ... based on knowledge of the extent of the deposit, quality of material, and economic value. A sale must not be made at less than the appraised value which may be expressed as either price per cubic yard or...

  15. Appraisal of biochemical and genetic diversity of mango cultivars ...

    African Journals Online (AJOL)

    Appraisal of biochemical and genetic diversity of mango cultivars using molecular markers. ... Mango (Mangifera indica L.) is one of the oldest fruit crops and is broadly cultivated worldwide. To determine the level of ... HOW TO USE AJOL.

  16. An Appraisal Of The Operation And Management Of Unit Trust ...

    African Journals Online (AJOL)

    An Appraisal Of The Operation And Management Of Unit Trust Schemes In Nigeria. ... Open Access DOWNLOAD FULL TEXT ... instead of being invested in shares or in money market instruments as a result of widespread financial illiteracy.

  17. Naturalizing aesthetics: brain areas for aesthetic appraisal across sensory modalities.

    Science.gov (United States)

    Brown, Steven; Gao, Xiaoqing; Tisdelle, Loren; Eickhoff, Simon B; Liotti, Mario

    2011-09-01

    We present here the most comprehensive analysis to date of neuroaesthetic processing by reporting the results of voxel-based meta-analyses of 93 neuroimaging studies of positive-valence aesthetic appraisal across four sensory modalities. The results demonstrate that the most concordant area of activation across all four modalities is the right anterior insula, an area typically associated with visceral perception, especially of negative valence (disgust, pain, etc.). We argue that aesthetic processing is, at its core, the appraisal of the valence of perceived objects. This appraisal is in no way limited to artworks but is instead applicable to all types of perceived objects. Therefore, one way to naturalize aesthetics is to argue that such a system evolved first for the appraisal of objects of survival advantage, such as food sources, and was later co-opted in humans for the experience of artworks for the satisfaction of social needs. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. An appraisal of construction management practice in Nigeria | Ugwu ...

    African Journals Online (AJOL)

    An appraisal of construction management practice in Nigeria. ... 108 questionnaires were distributed to the key construction actors as follows: 45 to ... conflicting design information, effective co-ordination of resources, critical path method, ...

  19. Evaluation of iopentol (Imagopaque trademark 350) in CT enhancement. A multi-centre monitoring trial assessing adverse events and diagnostic information - results from 1823 patients in France

    International Nuclear Information System (INIS)

    Oxaal, M.; Lambrechts, M.; Bunouf, P.; Menuet, J.F.

    1997-01-01

    Objectives: To evaluate the safety and efficacy of iopentol 350 mg I/ml (Imagopaque trademark /Ivepaque trademark , Nycomed Imaging As, Oslo, Norway), a monomeric non-ionic contrast medium for computed tomography, in a large population. To identify predictive factors for patient safety. Materials and methods: One thousand eight hundred and twenty-three (1,823) patients form 48 centres in France were included during a 5-month period. Safety was evaluated by registering adverse events (AEs) reported by the patients, and data were analysed using a multiple factor model. Results: Only 2.6% of the patients experienced AEs other than discomfort. There were no serious AEs. Overall, AEs were more frequent in patients under 50 years of age, in women, and in patients who received contrast medium as a single bolus. Contrast enhancement was considered adequate or better in 98.9% of the patients. A large variation in discomfort (local warmth/chill or pain) frequency was seen between centres, ranging from 0% to 81%. This result implies that factors other than the CM influence the incidence of discomfort. Conclusions: This first study in a large population shows that iopentol 350 mg I/ml is well tolerated and provides CT images of excellent, good or adequate quality in the vast majority of patients. Age, sex and injection procedure were shown to be independent predictors in the AE survey. (orig.)

  20. Appraisal tools for clinical practice guidelines: a systematic review.

    Directory of Open Access Journals (Sweden)

    Ulrich Siering

    Full Text Available Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools.Among others we searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from 1995 to May 2011 for relevant primary and secondary publications. We also handsearched the reference lists of relevant publications. On the basis of the available literature we firstly generated 34 items to be used in the comparison of appraisal tools and grouped them into thirteen quality dimensions. We then extracted formal characteristics as well as questions and statements of the appraisal tools and assigned them to the items.We identified 40 different appraisal tools. They covered between three and thirteen of the thirteen possible quality dimensions and between three and 29 of the possible 34 items. The main focus of the appraisal tools were the quality dimensions "evaluation of evidence" (mentioned in 35 tools; 88%, "presentation of guideline content" (34 tools; 85%, "transferability" (33 tools; 83%, "independence" (32 tools; 80%, "scope" (30 tools; 75%, and "information retrieval" (29 tools; 73%. The quality dimensions "consideration of different perspectives" and "dissemination, implementation and evaluation of the guideline" were covered by only twenty (50% and eighteen tools (45% respectively.Most guideline appraisal tools assess whether the literature search and the evaluation, synthesis and presentation of the evidence in guidelines follow the principles of evidence-based medicine. Although conflicts of interest and norms and values of guideline developers, as well as patient involvement, affect the trustworthiness of guidelines, they are currently insufficiently considered. Greater focus should be

  1. SCAMPI Lead Appraiser (Service Mark) Body of Knowledge (SLA BOK)

    Science.gov (United States)

    2007-10-01

    University. 34 | CMU/SEI-2007-TR-019 CC 3 Project Planning and Management Moeller, Robert R. COSO Enterprise Risk Management : Understanding the...appraisal participants) to specific amounts of time when the sponsor agrees to having the appraisal. CMP 3.1.2 Employing risk management techniques...contingency and management reserves appropriately • Ensuring the risk management strategy accounts for the OU’s process improvement history • Assessing

  2. The IAEA Transport Safety Appraisal Service (TranSAS)

    International Nuclear Information System (INIS)

    Dicke, G.J.

    2004-01-01

    Representatives of all Member States of the IAEA meet once a year in September at the General Conference in Vienna, Austria, to consider and approve the Agency's programme and budget and to address matters brought before it by the Board of Governors, the Director General, or Member States. In September 1998 the General Conference adopted resolution GC(42)/RES/13 on the Safety of Transport of Radioactive Materials. In adopting that resolution the General Conference recognized that compliance with regulations that take account of the IAEA Regulations for the Safe Transport of Radioactive Material (the IAEA Transport Regulations) is providing a high level of safety during the transport of radioactive material. Good compliance requires that the regulations are implemented effectively. The General Conference therefore requested the IAEA Secretariat to provide a service for carrying out, at the request of any State, an appraisal of the implementation of the Transport Regulations by that State. In response to this request the Director General of the IAEA offered such an appraisal service to all States in letter J1.01.Circ, dated 10 December 1998. The first Transport Safety Appraisal Service (TranSAS) was undertaken and completed at the request of Slovenia in 1999. A report on the results of that appraisal was published and released for general distribution in the early fall of 1999. In each of the General Conferences since 1998, resolutions focused on transport safety have commended the Secretariat for establishing the TranSAS, commended those States that have requested the appraisal service and encouraged other States to avail themselves of this service see GC(43)/RES/11, GC(44)/RES/17, GC(45)/RES/10, GC(46)/RES/9 and GC(47)/RES/7. Six appraisals have been carried out to date as follows: Slovenia, Brazil, United Kingdom, Turkey, Panama and France. This presentation provides an overview of the Transport Safety Appraisal Service and summarizes the major findings from the

  3. The IAEA Transport Safety Appraisal Service (TranSAS)

    Energy Technology Data Exchange (ETDEWEB)

    Dicke, G.J. [International Atomic Energy Agency, Vienna (Austria)

    2004-07-01

    Representatives of all Member States of the IAEA meet once a year in September at the General Conference in Vienna, Austria, to consider and approve the Agency's programme and budget and to address matters brought before it by the Board of Governors, the Director General, or Member States. In September 1998 the General Conference adopted resolution GC(42)/RES/13 on the Safety of Transport of Radioactive Materials. In adopting that resolution the General Conference recognized that compliance with regulations that take account of the IAEA Regulations for the Safe Transport of Radioactive Material (the IAEA Transport Regulations) is providing a high level of safety during the transport of radioactive material. Good compliance requires that the regulations are implemented effectively. The General Conference therefore requested the IAEA Secretariat to provide a service for carrying out, at the request of any State, an appraisal of the implementation of the Transport Regulations by that State. In response to this request the Director General of the IAEA offered such an appraisal service to all States in letter J1.01.Circ, dated 10 December 1998. The first Transport Safety Appraisal Service (TranSAS) was undertaken and completed at the request of Slovenia in 1999. A report on the results of that appraisal was published and released for general distribution in the early fall of 1999. In each of the General Conferences since 1998, resolutions focused on transport safety have commended the Secretariat for establishing the TranSAS, commended those States that have requested the appraisal service and encouraged other States to avail themselves of this service see GC(43)/RES/11, GC(44)/RES/17, GC(45)/RES/10, GC(46)/RES/9 and GC(47)/RES/7. Six appraisals have been carried out to date as follows: Slovenia, Brazil, United Kingdom, Turkey, Panama and France. This presentation provides an overview of the Transport Safety Appraisal Service and summarizes the major findings from

  4. The design of the SAFE or SORRY? study: a cluster randomised trial on the development and testing of an evidence based inpatient safety program for the prevention of adverse events

    Directory of Open Access Journals (Sweden)

    Koopmans Raymond TCM

    2009-04-01

    Full Text Available Abstract Background Patients in hospitals and nursing homes are at risk of the development of, often preventable, adverse events (AEs, which threaten patient safety. Guidelines for prevention of many types of AEs are available, however, compliance with these guidelines appears to be lacking. Besides general barriers that inhibit implementation, this non-compliance is associated with the large number of guidelines competing for attention. As implementation of a guideline is time-consuming, it is difficult for organisations to implement all available guidelines. Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable, unambiguous system for implementation. A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety. The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes. This paper reports the design of this study. Methods and design The patient safety program addresses three AEs: pressure ulcers, falls and urinary tract infections. It consists of bundles and outcome and process indicators based on the existing evidence based guidelines. In addition it includes a multifaceted tailored implementation strategy: education, patient involvement, and a computerized registration and feedback system. The patient safety program was tested in a cluster randomised trial on ten hospital wards and ten nursing home wards. The baseline period was three months followed by the implementation of the patient safety program for fourteen months. Subsequently the follow-up period was nine months. Primary outcome measure was the incidence of AEs on every ward. Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics. Randomisation took

  5. The effects of conscientiousness on the appraisals of daily stressors.

    Science.gov (United States)

    Gartland, Nicola; O'Connor, Daryl B; Lawton, Rebecca

    2012-02-01

    Conscientiousness (C) is positively associated with health and longevity although the mechanisms underlying this relationship are not fully understood. Stress may play a role in explaining the C-longevity relationship. This study investigated whether C predicted the cognitive appraisals of daily stressors/hassles. Participants (N=102) completed measures of C and cognitive appraisal in relation to the most stressful hassle they had experienced in the last 7 days. Correlational analysis revealed that Total C, Order and Industriousness were positively correlated with primary appraisals, and Responsibility was positively correlated with secondary appraisals. The facets of C were then entered into hierarchical regression models, controlling for age and gender. This demonstrated that Order (β=0.27, paccounting for 15.8% of the variance. Responsibility significantly predicted secondary appraisals (β=0.44, paccounting for 16.3% of the variance. These findings indicate that higher Order and Industriousness are related to having a greater stake in daily stressors, whereas higher Responsibility is related to greater confidence in one's ability to deal with daily stressors. These results are the first demonstration that C is related to the appraisals of daily hassles and suggest that C may moderate the experience of stress in daily life. Copyright © 2011 John Wiley & Sons, Ltd.

  6. Alienation appraisals distinguish adults diagnosed with DID from PTSD.

    Science.gov (United States)

    DePrince, Anne P; Huntjens, Rafaële J C; Dorahy, Martin J

    2015-11-01

    Studies are beginning to show the importance of appraisals to different types and severities of psychiatric disorders. Yet, little work in this area has assessed whether trauma-related appraisals can differentiate complex trauma-related disorders, such as posttraumatic stress disorder (PTSD) and dissociative identity disorder (DID). The current study evaluated whether any of 6 trauma-related appraisals distinguished adults diagnosed with DID from those diagnosed with PTSD. To accomplish this, we first examined the basic psychometric properties of a Dutch-translated short-form of the Trauma Appraisals Questionnaire (TAQ) in healthy control (n = 57), PTSD (n = 27) and DID (n = 12) samples. The short-form Dutch translation of the TAQ showed good internal reliability and criterion-related validity for all 6 subscales (betrayal, self-blame, fear, alienation, shame, anger). Of the 6 subscales, the alienation appraisal subscale specifically differentiated DID from PTSD, with the former group reporting more alienation. Abuse-related appraisals that emphasize disconnection from self and others may contribute to reported problems of memory and identity common in DID. The current findings suggest that addressing experiences of alienation may be particularly important in treatment for clients diagnosed with DID. (c) 2015 APA, all rights reserved).

  7. The Good Appraisal Toolkit for Primary Care Chambers Ruth et al The Good Appraisal Toolkit for Primary Care 189pp Radcliffe Publishing 9781857756029 1857756029.

    Science.gov (United States)

    2005-03-02

    The principles and frameworks demonstrated in this book could be used in many other healthcare settings. The text is divided neatly into nine chapters and addresses practical issues such as being an effective appraiser, developing and demonstrating competence, linking appraisal with career development, and evaluation of the appraisal process. The comprehensive approach to all aspects of appraisal makes this a must-have book for all health professionals and managers undertaking appraisals. It should also appeal to clinical governance leads and individuals being appraised. There are excellent tips on how to prepare for appraisals and how to link this with reflection, lifelong learning, career direction, and so on. The book is well referenced and contains an appendix with useful examples for the appraiser.

  8. Unexpected and just missed: the separate influence of the appraisals of expectancy and proximity on negative emotions.

    Science.gov (United States)

    Bossuyt, Evelien; Moors, Agnes; De Houwer, Jan

    2014-04-01

    Previous research has suggested that a goal-incongruent outcome leads to more intense negative emotions when it is unexpected and close to a goal-congruent outcome. Until now, however, no studies have disentangled the influence of the appraisals of expectancy and proximity on emotions. We experimentally manipulated each of these variables in 3 slot machine experiments and measured emotions via differences in motivation (i.e., the tendency to repair the goal incongruence) and feelings (i.e., disappointment, frustration, and anger). The experiments consisted of a series of trials that each started with the sequential presentation of 3 symbols. In case of a win trial, all symbols were equal (e.g., AAA) and the participant gained 10 cents; in case of a loss trial, one or more of the symbols differed and the participant gained 0 cents. Three different loss trials were compared: unexpected proximal ones (e.g., AAB), expected proximal ones (e.g., ABA), and expected distal ones (e.g., ABC). The tendency to repair was measured online via behavior as well as retrospectively via self-reports; feelings were measured retrospectively (Experiments 1 and 2) or online (Experiment 3). Unexpected losses seemed to increase the tendency to repair as well as feelings of disappointment (in all experiments) and feelings of frustration and anger (in Experiments 1 and 3). Proximal losses increased only the tendency to repair (in all experiments). This suggests that the appraisals of expectancy and proximity have a distinct influence on emotions.

  9. Technical Safety Appraisal of the Pinellas Plant

    International Nuclear Information System (INIS)

    1991-01-01

    This report presents the Technical Safety Appraisal (TSA) of the Pinellas Plant in Pinellas County, Florida. The plant is owned and controlled by the US Department of Energy and operated by General Electric Neutron Devices (GEND). The TSA was performed during the period January 15--31, 1989, in support of a Tiger Team Assessment which occurred during the period January 15 to February 2, 1989. The TSA provided the Safety and Health Subteam input to the Tiger Team Assessment. The completion of the assessment process includes: (1) submission of the Team's preliminary findings and concerns, in a Draft Report, to the Manager, Albuquerque Operations Office and to the site contractors at the conclusion of the onsite assessment; (2) review of the Draft Report for technical and factual accuracy; incorporation of the appropriate review comments, suggested changes, and modifications, as well as input from all interested Program Secretarial Offices; preparation of a draft Action Plan by the Albuquerque Operations Office to address the Concerns, and submittal of that Action Plan through the Program Office to ES ampersand H for their review and comment. The Secretary approved the final Action Plan on December 16, 1990, and directed its implementation. The comments and suggestions of the Program Secretarial Offices, the Operations Office, and the site contractor have been incorporated, as appropriate, in this report prior to its publication

  10. Spent fuel storage options: a critical appraisal

    International Nuclear Information System (INIS)

    Singh, K.P.; Bale, M.G.

    1990-01-01

    The delayed decisions on nuclear fuel reprocessing strategies in the USA and other countries have forced the development of new long-term irradiated fuel storage techniques, to allow a larger volume of fuel to be held on the nuclear station site after removal from the reactor. The nuclear power industry has responded to the challenge by developing several viable options for long-term onsite storage, which can be employed individually or in tandem. They are: densification of storage in the existing spent fuel pool; building another fuel pool facility at the plant site; onsite cask park, and on site vault clusters. Desirable attributes of a storage option are: Safety: minimise the number of fuel handling steps; Economy: minimise total installed, and O and M cost; Security: protection from anti-nuclear protesters; Site adaptability: available site space, earthquake characteristics of the region and so on; Non-intrusiveness: minimise required modifications to existing plant systems; Modularisation: afford the option to adapt a modular approach for staged capital outlays; and Maturity: extent of industry experience with the technology. A critical appraisal is made of each of the four aforementioned storage options in the light of these criteria. (2 figures, 1 table, 4 references) (Author)

  11. An annual performance appraisal for CERN

    CERN Multimedia

    2012-01-01

    The March Council session is the occasion for CERN’s annual performance appraisal, but instead of the MARS form familiar to CERN staff, the lab’s working document is an Annual Progress Report, linked to the Medium-Term Plan, matching achievements to objectives. This year, I think it’s fair to say, we were firmly able to tick the ‘achieved’ box.   Top of the list of objectives was the LHC, which exceeded expectations in 2011 by delivering over five times the anticipated luminosity for protons while improving the lead-ion integrated luminosity by an order of magnitude compared to 2010.  As a result, the experiments published over 190 papers and made a staggering 1900 conference presentations. Underpinning this was the Worldwide LHC Computing Grid, which routinely performs so well that we hardly notice it's there. Non-LHC physics also had its day in the sun in 2011, with experiments at the PS, SPS, AD, n_TOF and ISOLDE, as well ...

  12. How to transform economics? A philosophical appraisal

    Directory of Open Access Journals (Sweden)

    Deniz Kellecioglu

    2017-11-01

    Full Text Available Ten years after the global financial crisis there is hardly any evidence that the theories, teaching and policies of mainstream economics have changed. This paper is an attempt to contribute to the greater understanding of this persistence, but also to the discussion on what the requirements are to materialise a transformation in economics, given the dismal outcomes in the world economy. The analytical approach of the paper is to utilise relevant philosophical accounts that point out attributes of dominant discourses, and methodological requirements to supersede an already dominant discourse. The objective is to contribute to an improved understanding of factors that obstruct or construct transformations in a knowledge field such as economics; and thereby contribute to transformation efforts, preferably for a more pluralist and emancipatory economics. Given the complexities and the tensions between different philosophical positions, the conclusions of this appraisal are summarised into five criteria that appear essential to realise a successful transformation in economics: critical juncture; dissimilarity; scholar validation; sensibility; and external power. It is suggested to revise efforts to fulfil these criteria as much, and as soon as possible, given the importance and urgency of changing the trajectory of our economies and societies.

  13. CEO performance appraisal: review and recommendations.

    Science.gov (United States)

    Newman, J F; Tyler, L; Dunbar, D M

    2001-01-01

    CEO performance appraisal (PA) is very valuable to an organization, but the chances of obtaining a PA of high quality decrease as executive responsibility increases. The realities of CEO PA are that it: (1) is inevitable; (2) is creative and complex; (3) involves politics; and (4) has a significant effect on the organization and the executive. PA is conducted for legal and social requirements, to enhance communication, to provide opportunities for improvement, and to relate performance to compensation. This article discusses several problems with chief executive officer (CEO) PA and the contemporary approaches that seek to improve it. Three fundamental areas for evaluation are identified: (1) organizational success; (2) areawide health status; and (3) professional role fulfillment. These provide an outline for successful healthcare PA. In addition to a discussion of the strategic considerations behind a successful CEO PA system, several recommendations are offered for the implementation of the annual evaluation process. The final goal of CEO PA is to link its results to CEO incentive compensation. It is strongly recommended that some portion of the CEO's salary directly hinge on his performance in two critical areas: organizational effectiveness and community health status.

  14. Face Recognition, Musical Appraisal, and Emotional Crossmodal Bias.

    Science.gov (United States)

    Invitto, Sara; Calcagnì, Antonio; Mignozzi, Arianna; Scardino, Rosanna; Piraino, Giulia; Turchi, Daniele; De Feudis, Irio; Brunetti, Antonio; Bevilacqua, Vitoantonio; de Tommaso, Marina

    2017-01-01

    Recent research on the crossmodal integration of visual and auditory perception suggests that evaluations of emotional information in one sensory modality may tend toward the emotional value generated in another sensory modality. This implies that the emotions elicited by musical stimuli can influence the perception of emotional stimuli presented in other sensory modalities, through a top-down process. The aim of this work was to investigate how crossmodal perceptual processing influences emotional face recognition and how potential modulation of this processing induced by music could be influenced by the subject's musical competence. We investigated how emotional face recognition processing could be modulated by listening to music and how this modulation varies according to the subjective emotional salience of the music and the listener's musical competence. The sample consisted of 24 participants: 12 professional musicians and 12 university students (non-musicians). Participants performed an emotional go/no-go task whilst listening to music by Albeniz, Chopin, or Mozart. The target stimuli were emotionally neutral facial expressions. We examined the N170 Event-Related Potential (ERP) and behavioral responses (i.e., motor reaction time to target recognition and musical emotional judgment). A linear mixed-effects model and a decision-tree learning technique were applied to N170 amplitudes and latencies. The main findings of the study were that musicians' behavioral responses and N170 is more affected by the emotional value of music administered in the emotional go/no-go task and this bias is also apparent in responses to the non-target emotional face. This suggests that emotional information, coming from multiple sensory channels, activates a crossmodal integration process that depends upon the stimuli emotional salience and the listener's appraisal.

  15. Face Recognition, Musical Appraisal, and Emotional Crossmodal Bias

    Directory of Open Access Journals (Sweden)

    Sara Invitto

    2017-08-01

    Full Text Available Recent research on the crossmodal integration of visual and auditory perception suggests that evaluations of emotional information in one sensory modality may tend toward the emotional value generated in another sensory modality. This implies that the emotions elicited by musical stimuli can influence the perception of emotional stimuli presented in other sensory modalities, through a top-down process. The aim of this work was to investigate how crossmodal perceptual processing influences emotional face recognition and how potential modulation of this processing induced by music could be influenced by the subject's musical competence. We investigated how emotional face recognition processing could be modulated by listening to music and how this modulation varies according to the subjective emotional salience of the music and the listener's musical competence. The sample consisted of 24 participants: 12 professional musicians and 12 university students (non-musicians. Participants performed an emotional go/no-go task whilst listening to music by Albeniz, Chopin, or Mozart. The target stimuli were emotionally neutral facial expressions. We examined the N170 Event-Related Potential (ERP and behavioral responses (i.e., motor reaction time to target recognition and musical emotional judgment. A linear mixed-effects model and a decision-tree learning technique were applied to N170 amplitudes and latencies. The main findings of the study were that musicians' behavioral responses and N170 is more affected by the emotional value of music administered in the emotional go/no-go task and this bias is also apparent in responses to the non-target emotional face. This suggests that emotional information, coming from multiple sensory channels, activates a crossmodal integration process that depends upon the stimuli emotional salience and the listener's appraisal.

  16. Cognitive and emotional reactions to daily events: the effects of self-esteem and self-complexity.

    Science.gov (United States)

    Campbell, J D; Chew, B; Scratchley, L S

    1991-09-01

    In this article we examine the effects of self-esteem and self-complexity on cognitive appraisals of daily events and emotional lability. Subjects (n = 67) participated in a 2-week diary study; each day they made five mood ratings, described the most positive and negative events of the day, and rated these two events on six appraisal measures. Neither self-esteem nor self-complexity was related to an extremity measure of mood variability. Both traits were negatively related to measures assessing the frequency of mood change, although the effect of self-complexity dissipated when self-esteem was taken into account. Self-esteem (but not self-complexity) was also related to event appraisals: Subjects with low self-esteem rated their daily events as less positive and as having more impact on their moods. Subjects with high self-esteem made more internal, stable, global attributions for positive events than for negative events, whereas subjects low in self-esteem made similar attributions for both types of events and viewed their negative events as being more personally important than did subjects high in self-esteem. Despite these self-esteem differences in subjects' views of their daily events, naive judges (n = 63) who read the event descriptions and role-played their appraisals of them generally did not distinguish between the events that had been experienced by low self-esteem versus high self-esteem diary subjects.

  17. A framework for assessing Health Economic Evaluation (HEE) quality appraisal instruments.

    Science.gov (United States)

    Langer, Astrid

    2012-08-16

    Health economic evaluations support the health care decision-making process by providing information on costs and consequences of health interventions. The quality of such studies is assessed by health economic evaluation (HEE) quality appraisal instruments. At present, there is no instrument for measuring and improving the quality of such HEE quality appraisal instruments. Therefore, the objectives of this study are to establish a framework for assessing the quality of HEE quality appraisal instruments to support and improve their quality, and to apply this framework to those HEE quality appraisal instruments which have been subject to more scrutiny than others, in order to test the framework and to demonstrate the shortcomings of existing HEE quality appraisal instruments. To develop the quality assessment framework for HEE quality appraisal instruments, the experiences of using appraisal tools for clinical guidelines are used. Based on a deductive iterative process, clinical guideline appraisal instruments identified through literature search are reviewed, consolidated, and adapted to produce the final quality assessment framework for HEE quality appraisal instruments. The final quality assessment framework for HEE quality appraisal instruments consists of 36 items organized within 7 dimensions, each of which captures a specific domain of quality. Applying the quality assessment framework to four existing HEE quality appraisal instruments, it is found that these four quality appraisal instruments are of variable quality. The framework described in this study should be regarded as a starting point for appraising the quality of HEE quality appraisal instruments. This framework can be used by HEE quality appraisal instrument producers to support and improve the quality and acceptance of existing and future HEE quality appraisal instruments. By applying this framework, users of HEE quality appraisal instruments can become aware of methodological deficiencies

  18. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial.

    Science.gov (United States)

    Loriot, Yohann; Miller, Kurt; Sternberg, Cora N; Fizazi, Karim; De Bono, Johann S; Chowdhury, Simon; Higano, Celestia S; Noonberg, Sarah; Holmstrom, Stefan; Mansbach, Harry; Perabo, Frank G; Phung, De; Ivanescu, Cristina; Skaltsa, Konstantina; Beer, Tomasz M; Tombal, Bertrand

    2015-05-01

    Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. Median treatment duration was 16·6 months (IQR 10·1-21·1) in the enzalutamide group and 4·6 months (2·8-9·7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11·3 months (95% CI 11·1-13·9) in the enzalutamide group and 5·6 months (5·5-5·6) in the placebo groups (hazard ratio [HR] 0·62 [95% CI 0·54-0·72]; p<0·0001). A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful

  19. Attentional Bias to Beauty with Evolutionary Benefits: Evidence from Aesthetic Appraisal of Landscape Architecture

    Science.gov (United States)

    Zhang, Wei; Tang, Xiaoxiang; He, Xianyou; Lai, Shuxian

    2018-01-01

    Substantial evidence suggests that beauty is associated with the survival and reproduction of organisms. Landscape architecture is composed of a series of natural elements that have significant evolutionary implications. The present study used one pilot material ratings and three experiments to examine the mechanisms of aesthetic appraisals of landscape architecture. The results confirmed that landscape architecture elicited a sense of beauty and captured visual attention more easily than other types of architecture during explicit aesthetic rating task (Experiment 1) and implicit aesthetic perception task (dot-probe paradigm, Experiment 2). Furthermore, the spatial cueing paradigm revealed that response latencies were significantly faster for landscape architecture than non-landscape architecture on valid trials, but there was no significant difference in this contrast on invalid trials at 150-ms stimulus onset asynchrony (SOA, Experiment 3a). At 500-ms SOA (Experiment 3b), participants responded significantly faster for landscape architecture on valid trials, but reacted significantly slower for landscape architecture on invalid trials. The findings indicated that the beauty of landscape architecture can be perceived implicitly, and only faster orienting of attention, but not delayed disengagement of attention was generated at early stages of the processing of landscape architecture. However, the attentional bias at later stages of attentional processes may be resulted from both faster orienting of attention and delayed disengagement of attention from landscape architecture photographs. PMID:29467696

  20. Attentional Bias to Beauty with Evolutionary Benefits: Evidence from Aesthetic Appraisal of Landscape Architecture.

    Science.gov (United States)

    Zhang, Wei; Tang, Xiaoxiang; He, Xianyou; Lai, Shuxian

    2018-01-01

    Substantial evidence suggests that beauty is associated with the survival and reproduction of organisms. Landscape architecture is composed of a series of natural elements that have significant evolutionary implications. The present study used one pilot material ratings and three experiments to examine the mechanisms of aesthetic appraisals of landscape architecture. The results confirmed that landscape architecture elicited a sense of beauty and captured visual attention more easily than other types of architecture during explicit aesthetic rating task (Experiment 1) and implicit aesthetic perception task (dot-probe paradigm, Experiment 2). Furthermore, the spatial cueing paradigm revealed that response latencies were significantly faster for landscape architecture than non-landscape architecture on valid trials, but there was no significant difference in this contrast on invalid trials at 150-ms stimulus onset asynchrony (SOA, Experiment 3a). At 500-ms SOA (Experiment 3b), participants responded significantly faster for landscape architecture on valid trials, but reacted significantly slower for landscape architecture on invalid trials. The findings indicated that the beauty of landscape architecture can be perceived implicitly, and only faster orienting of attention, but not delayed disengagement of attention was generated at early stages of the processing of landscape architecture. However, the attentional bias at later stages of attentional processes may be resulted from both faster orienting of attention and delayed disengagement of attention from landscape architecture photographs.

  1. An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial.

    Science.gov (United States)

    Massicotte, Patricia; Julian, Jim A; Gent, Michael; Shields, Karen; Marzinotto, Velma; Szechtman, Barbara; Andrew, Maureen

    2003-01-25

    Venous thromboembolic events (VTE) are serious complications in children and for which the standard of care, unfractionated heparin followed by oral anticoagulation (UFH/OA), is problematic. The objective of REVIVE was to compare the efficacy and safety of a low molecular weight heparin (reviparin-sodium) to UFH/OA for the treatment of VTE in children. This multicenter, open-label study, with blinded central outcome adjudication, randomized patients with objectively confirmed VTE to receive either reviparin-sodium or UFH/OA. Dose adjustments were made using nomograms. The efficacy outcome was based on recurrent VTE and death due to VTE during the 3-month treatment period. The safety outcomes were major bleeding, minor bleeding and death. Due to slow patient accrual, REVIVE was closed prematurely. At 3 months, with reviparin-sodium, 2/36 patients (5.6%) had recurrent VTE or death compared to 4/40 patients (10.0%) receiving UFH/OA (odds ratio=0.53; 95% CI=(0.05, 4.00); Fisher's exact test: 2P=0.677). There were 7 major bleeds, 2/36 (5.6%) in the reviparin-sodium group and 5/40 (12.5%) in UFH/OA group (odds ratio=0.41; 95% confidence interval 0.04, 2.76); Fisher's exact test: P=0.435). There were 5 deaths during the study period, 1 (2.8%) in the reviparin-sodium group and 4 (10.0%) in the UFH/OA group. All five deaths were unrelated to VTE but one was due to an intracranial hemorrhage in the UFH/OA group. Although limited by small sample size, REVIVE provides valuable information on the incidence of recurrent VTE, major bleeding and problematic issues associated with therapy of VTE in children.

  2. Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.

    Science.gov (United States)

    Schadendorf, Dirk; Wolchok, Jedd D; Hodi, F Stephen; Chiarion-Sileni, Vanna; Gonzalez, Rene; Rutkowski, Piotr; Grob, Jean-Jacques; Cowey, C Lance; Lao, Christopher D; Chesney, Jason; Robert, Caroline; Grossmann, Kenneth; McDermott, David; Walker, Dana; Bhore, Rafia; Larkin, James; Postow, Michael A

    2017-12-01

    Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.

  3. HLA-DPβ1 Asp84-Lys69 antigen-binding signature predicts event-free survival in childhood B-cell precursor acute lymphoblastic leukaemia: results from the MRC UKALL XI childhood ALL trial.

    Science.gov (United States)

    Taylor, G M; Wade, R; Hussain, A; Thompson, P; Hann, I; Gibson, B; Eden, T; Richards, S

    2012-07-01

    We previously reported that children in the UKALL XI ALL trial with HLA-DP 1 and -DP 3 supertypes had significantly worse event-free survival (EFS) than children with other DP supertypes. As DP 1 and DP 3 share two of four key antigen-binding amino-acid polymorphisms (aspartic acid84-lysine69), we asked whether Asp84-Lys69 or Asp84 alone were independent prognostic indicators in childhood acute lymphoblastic leukemia (ALL). We analysed EFS in 798 UKALL XI patients, stratified by Asp84-Lys69 vs non-Asp84-Lys69, for a median follow-up of 12.5 years. Asp84-Lys69 was associated with a significantly worse EFS than non-Asp84-Lys69 (5-year EFS: Asp84-Lys69: 58.8% (95% CI (confidence of interval): 52.7-64.9%); non-Asp84-Lys69: 67.3% (63.4-71.2%); 2P=0.007). Post-relapse EFS was 10% less in Asp84-Lys69 than non-Asp84-Lys69 patients. EFS was significantly worse (P=0.03) and post-relapse EFS marginally worse (P=0.06) in patients with Asp84 compared with Gly84. These results suggest that Asp84-Lys69 predicted adverse EFS in the context of UKALL XI because of Asp84, and may have influenced post-relapse EFS. We speculate that this may be due to the recruitment of Asp84-Lys69-restricted regulatory T cells in the context of this regimen, leading to the re-emergence of residual disease. However, functional and molecular studies of the prognostic value of this and other HLA molecular signatures in other childhood ALL trials are needed.

  4. A Critical Appraisal of the "Day" Diagram

    Science.gov (United States)

    Roberts, Andrew P.; Tauxe, Lisa; Heslop, David; Zhao, Xiang; Jiang, Zhaoxia

    2018-04-01

    The "Day" diagram (Day et al., 1977, https://doi.org/10.1016/0031-9201(77)90108-X) is used widely to make inferences about the domain state of magnetic mineral assemblages. Based on theoretical and empirical arguments, the Day diagram is demarcated into stable "single domain" (SD), "pseudo single domain" ("PSD"), and "multidomain" (MD) zones. It is straightforward to make the necessary measurements for a sample and to plot results within the "domain state" framework based on the boundaries defined by Day et al. (1977, https://doi.org/10.1016/0031-9201(77)90108-X). We discuss 10 issues that limit Day diagram interpretation, including (1) magnetic mineralogy, (2) the associated magnetocrystalline anisotropy type, (3) mineral stoichiometry, (4) stress state, (5) surface oxidation, (6) magnetostatic interactions, (7) particle shape, (8) thermal relaxation, (9) magnetic particle mixtures, and (10) definitional/measurement issues. In most studies, these variables are unknowns and cannot be controlled for, so that hysteresis parameters for single bulk samples are nonunique and any data point in a Day diagram could result from infinite combinations of relevant variables. From this critical appraisal, we argue that the Day diagram is fundamentally ambiguous for domain state diagnosis. Widespread use of the Day diagram has also contributed significantly to prevalent but questionable views, including underrecognition of the importance of stable SD particles in the geological record and reinforcement of the unhelpful PSD concept and of its geological importance. Adoption of approaches that enable correct domain state diagnosis should be an urgent priority for component-specific understanding of magnetic mineral assemblages and for quantitative rock magnetic interpretation.

  5. Protective Factors, Coping Appraisals, and Social Barriers Predict Mental Health Following Community Violence: A Prospective Test of Social Cognitive Theory.

    Science.gov (United States)

    Smith, Andrew J; Felix, Erika D; Benight, Charles C; Jones, Russell T

    2017-06-01

    This study tested social cognitive theory of posttraumatic adaptation in the context of mass violence, hypothesizing that pre-event protective factors (general self-efficacy and perceived social support) would reduce posttraumatic stress symptoms (PTSS) and depression severity through boosting post-event coping self-efficacy appraisals (mediator). We qualified hypotheses by predicting that post-event social support barriers would disrupt (moderate) the health-promoting indirect effects of pre-event protective factors. With a prospective longitudinal sample, we employed path models with bootstrapping resampling to test hypotheses. Participants included 70 university students (71.4% female; 40.0% White; 34.3% Asian; 14.3% Hispanic) enrolled during a mass violence event who completed surveys one year pre-event and 5-6 months post-event. Results revealed significant large effects in predicting coping self-efficacy (mastery model, R 2 = .34; enabling model, R 2 = .36), PTSS (mastery model, R 2 = .35; enabling model, R 2 = .41), and depression severity (mastery model, R 2 = .43; enabling model, R 2 = .46). Overall findings supported study hypotheses, showing that at low levels of post-event social support barriers, pre-event protective factors reduced distress severity through boosting coping self-efficacy. However, as post-event social support barriers increased, the indirect, distress-reducing effects of pre-event protective factors were reduced to nonsignificance. Study implications focus on preventative and responsive intervention. Copyright © 2017 International Society for Traumatic Stress Studies.

  6. Event-free survival of infants and toddlers enrolled in the HR-NBL-1/SIOPEN trial is associated with the level of neuroblastoma mRNAs at diagnosis.

    Science.gov (United States)

    Corrias, Maria V; Parodi, Stefano; Tchirkov, Andrei; Lammens, Tim; Vicha, Ales; Pasqualini, Claudia; Träger, Catarina; Yáñez, Yania; Dallorso, Sandro; Varesio, Luigi; Luksch, Roberto; Laureys, Genevieve; Valteau-Couanet, Dominique; Canete, Adela; Pöetschger, Ulrike; Ladenstein, Ruth; Burchill, Susan A

    2018-07-01

    The purpose of this study was to evaluate whether levels of neuroblastoma mRNAs in bone marrow and peripheral blood from stage M infants (≤12 months of age at diagnosis, MYCN amplified) and toddlers (between 12 and 18 months, any MYCN status) predict event-free survival (EFS). Bone marrow aspirates and peripheral blood samples from 97 infants/toddlers enrolled in the European High-Risk Neuroblastoma trial were collected at diagnosis in PAXgene ™ blood RNA tubes. Samples were analyzed by reverse transcription quantitative polymerase chain reaction according to standardized procedures. Bone marrow tyrosine hydroxylase (TH) or paired-like homeobox 2b (PHOX2B) levels in the highest tertile were associated with worse EFS; hazard ratios, adjusted for age and MYCN status, were 1.5 and 1.8 respectively. Expression of both TH and PHOX2B in the highest tertile predicted worse outcome (p = 0.015), and identified 20 (23%) infants/toddlers with 5-year EFS of 20% (95%CI: 4%-44%). Prognostic significance was maintained after adjusting for over-fitting bias (p = 0.038), age and MYCN status. In peripheral blood, PHOX2B levels in the highest tertile predicted a two-fold increased risk of an event (p = 0.032), and identified 23 (34%) infants/toddlers with 5-year EFS of 29% (95%CI: 12%-48%). Time-dependent receiver operating characteristic analysis confirmed the prognostic value of combined TH and PHOX2B in bone marrow and of PHOX2B in peripheral blood during the first year of follow-up. High levels of bone marrow TH and PHOX2B and of peripheral blood PHOX2B at diagnosis allow early identification of a group of high-risk infant and toddlers with neuroblastoma who may be candidates for alternative treatments. Integration with additional biomarkers, as well as validation in additional international trials is warranted. © 2018 Wiley Periodicals, Inc.

  7. Major bleeding in patients with atrial fibrillation receiving apixaban or warfarin: The ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation): Predictors, Characteristics, and Clinical Outcomes.

    Science.gov (United States)

    Hylek, Elaine M; Held, Claes; Alexander, John H; Lopes, Renato D; De Caterina, Raffaele; Wojdyla, Daniel M; Huber, Kurt; Jansky, Petr; Steg, Philippe Gabriel; Hanna, Michael; Thomas, Laine; Wallentin, Lars; Granger, Christopher B

    2014-05-27

    This study sought to characterize major bleeding on the basis of the components of the major bleeding definition, to explore major bleeding by location, to define 30-day mortality after a major bleeding event, and to identify factors associated with major bleeding. Apixaban was shown to reduce the risk of major hemorrhage among patients with atrial fibrillation in the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial. All patients who received at least 1 dose of a study drug were included. Major bleeding was defined according to the criteria of the International Society on Thrombosis and Haemostasis. Factors associated with major hemorrhage were identified using a multivariable Cox model. The on-treatment safety population included 18,140 patients. The rate of major hemorrhage among patients in the apixaban group was 2.13% per year compared with 3.09% per year in the warfarin group (hazard ratio [HR] 0.69, 95% confidence interval [CI]: 0.60 to 0.80; p < 0.001). Compared with warfarin, major extracranial hemorrhage associated with apixaban led to reduced hospitalization, medical or surgical intervention, transfusion, or change in antithrombotic therapy. Major hemorrhage followed by mortality within 30 days occurred half as often in apixaban-treated patients than in those receiving warfarin (HR 0.50, 95% CI: 0.33 to 0.74; p < 0.001). Older age, prior hemorrhage, prior stroke or transient ischemic attack, diabetes, lower creatinine clearance, decreased hematocrit, aspirin therapy, and nonsteroidal anti-inflammatory drugs were independently associated with an increased risk. Apixaban, compared with warfarin, was associated with fewer intracranial hemorrhages, less adverse consequences following extracranial hemorrhage, and a 50% reduction in fatal consequences at 30 days in cases of major hemorrhage. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

    Science.gov (United States)

    Campos, Carlos M; Caixeta, Adriano; Franken, Marcelo; Bartorelli, Antonio L; Whitbourn, Robert J; Wu, Chiung-Jen; Li Paul Kao, Hsien; Rosli, Mohd Ali; Carrie, Didier; De Bruyne, Bernard; Stone, Gregg W; Serruys, Patrick W; Abizaid, Alexandre

    2018-02-15

    to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon. The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR). After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups. In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  9. Venetoclax for Treating Chronic Lymphocytic Leukaemia: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

    Science.gov (United States)

    Mistry, Hema; Nduka, Chidozie; Connock, Martin; Colquitt, Jill; Mantopoulos, Theodoros; Loveman, Emma; Walewska, Renata; Mason, James

    2018-04-01

    Venetoclax is licensed to treat relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL). As part of the Single Technology Appraisal (STA) ID944, the National Institute for Health and Care Excellence (NICE) invited AbbVie, the manufacturer, to submit evidence on the use of venetoclax, within its licensed indication. The Evidence Review Group (ERG), Warwick Evidence, was asked to provide an independent and critical review of the submitted evidence. Evidence came from three single-arm trials in CLL patients with or without 17p deletion [del(17p])/TP53 chromosomal abnormalities. The anticipated licensed indication specified that venetoclax-eligible del(17p)/TP53 patients should have not responded to, or be deemed unsuitable for, B-cell receptor inhibitor (BCRi) therapy, and that non-del(17p)/TP53 patients should have not responded to both chemoimmunotherapy and BCRi therapy. The three trials were heterogeneous in terms of both del(17p)/TP53 status and previous exposure to BCRi therapy. The M13-982 study investigated 158 R/R CLL patients with the 17p deletion, but only a small number had received previous BCRi therapy; the M12-175 study investigated 67 patients with CLL or small lymphocytic lymphoma, some with the 17p deletion, but very few previously treated with BCRi therapy; and the M14-032 study included 105 patients previously treated with BCRi therapy (either idelalisib or ibrutinib), some of whom had unknown mutation status. The ERG concluded that the study populations did not directly conform to those specified in the licensed indication or in the NICE scope. Outcomes reported included overall response rate (ORR), duration of response, progression-free survival (PFS) and overall survival (OS); adverse events were reported for the pooled population of all three studies, as well as separately for each study. The median PFS was 41.4 and 27.2 months among patients in the M12-175 and M13-982 trials, respectively, whereas the median PFS was not reached in

  10. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  11. An appraisal of the quality of published qualitative dental research.

    Science.gov (United States)

    Masood, Mohd; Thaliath, Ebin T; Bower, Elizabeth J; Newton, J Timothy

    2011-06-01

    To appraise the quality of published qualitative research in dentistry and identify aspects of quality, which require attention in future research. Qualitative research studies on dental topics were appraised using the critical appraisal skills programme (CASP) appraisal framework for qualitative research. The percentage of CASP criteria fully met during the assessment was used as an indication of the quality of each paper. Individual criteria were not weighted. Forty-three qualitative studies were identified for appraisal of which 48% had a dental public health focus. Deficiencies in detail of reporting, research design, methodological rigour, presentation of findings, reflexivity, credibility of findings and relevance of study were identified. Problems with quality were apparent irrespective of journal impact factor, although papers from low impact factor journals exhibited the most deficiencies. Journals with the highest impact factors published the least qualitative research. The quality of much of the qualitative research published on dental topics is mediocre. Qualitative methods are underutilized in oral health research. If quality guidelines such as the CASP framework are used in the context of a thorough understanding of qualitative research design and data analysis, they can promote good practice and the systematic assessment of qualitative research. © 2010 John Wiley & Sons A/S.

  12. Technical Safety Appraisal of the Rocky Flats Plant

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Blake P.

    1989-01-01

    This report provides the results of a Technical Safety Appraisal (TSA) of the Rocky Flats Plant (RFP) conducted November 14 to 18 and November 28 to December 9, 1988. This appraisal covered the effectiveness and improvements in the RFP safety program across the site, evaluating progress to date against standards of accepted practice. The appraisal included coverage of the timeliness and effectiveness of actions taken in response to the recommendations/concerns in three previous Technical Safety Appraisals (TSAs) of RFP Bldg. 707 conducted in July 1986, Bldgs. 771/774 conducted in October/November 1986, and Bldgs. 776/777 conducted in January/February 1988. Results of this appraisal are given in Section IV for each of 14 technical safety areas at RFP. These results include a discussion, conclusions and any new safety concerns for each technical safety area. Appendix A contains a description of the system for categorizing concerns, and the concerns are tabulated in Appendix B. Appendix C reports on the evaluation of the contractor's actions and the current status of each of the 230 recommendations and concerns contained in the three previous TSA reports.

  13. Dancing in pain: pain appraisal and coping in dancers.

    Science.gov (United States)

    Anderson, Ruth; Hanrahan, Stephanie J

    2008-01-01

    This study investigated the relationships between the type of pain experienced (performance pain and injury pain), the cognitive appraisal of pain and pain coping styles in dancers. Fifty-one professional ballet and contemporary dancers (17 males and 34 females), with the mean age of 25.9 years, completed a general pain questionnaire, the Pain Appraisal Inventory, the Survey of Pain Attitudes Control Subscale, and the Sports Inventory for Pain. Multivariate analyses of variance indicated that both the cognitive appraisal of the pain and pain coping styles did not differ according to the type of pain experienced or the pain severity. However, it was found that dancers with performance pain of either low or high severity were more likely to dance in pain than dancers experiencing injury pain. Multiple regression analyses indicated that the appraisal of pain as threatening was predictive of the use of avoidance and catastrophizing pain coping styles. Overall, results indicated that dancers may not differentiate between performance pain and injury pain, or modify their appraisal and coping strategies according to the characteristics of the pain experienced. The study highlighted an opportunity for increased education for dancers in recognizing the difference between pain considered to be a routine aspect of training and pain which is a signal of serious injury.

  14. Fusion events

    International Nuclear Information System (INIS)

    Aboufirassi, M; Angelique, J.C.; Bizard, G.; Bougault, R.; Brou, R.; Buta, A.; Colin, J.; Cussol, D.; Durand, D.; Genoux-Lubain, A.; Horn, D.; Kerambrun, A.; Laville, J.L.; Le Brun, C.; Lecolley, J.F.; Lefebvres, F.; Lopez, O.; Louvel, M.; Meslin, C.; Metivier, V.; Nakagawa, T.; Peter, J.; Popescu, R.; Regimbart, R.; Steckmeyer, J.C.; Tamain, B.; Vient, E.; Wieloch, A.; Yuasa-Nakagawa, K.

    1998-01-01

    The fusion reactions between low energy heavy ions have a very high cross section. First measurements at energies around 30-40 MeV/nucleon indicated no residue of either complete or incomplete fusion, thus demonstrating the disappearance of this process. This is explained as being due to the high amount o energies transferred to the nucleus, what leads to its total dislocation in light fragments and particles. Exclusive analyses have permitted to mark clearly the presence of fusion processes in heavy systems at energies above 30-40 MeV/nucleon. Among the complete events of the Kr + Au reaction at 60 MeV/nucleon the majority correspond to binary collisions. Nevertheless, for the most considerable energy losses, a class of events do occur for which the detected fragments appears to be emitted from a unique source. These events correspond to an incomplete projectile-target fusion followed by a multifragmentation. Such events were singled out also in the reaction Xe + Sn at 50 MeV/nucleon. For the events in which the energy dissipation was maximal it was possible to isolate an isotropic group of events showing all the characteristics of fusion nuclei. The fusion is said to be incomplete as pre-equilibrium Z = 1 and Z = 2 particles are emitted. The cross section is of the order of 25 mb. Similar conclusions were drown for the systems 36 Ar + 27 Al and 64 Zn + nat Ti. A cross section value of ∼ 20 mb was determined at 55 MeV/nucleon in the first case, while the measurement of evaporation light residues in the last system gave an upper limit of 20-30 mb for the cross section at 50 MeV/nucleon

  15. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  16. Coherence explored between emotion components: evidence from event-related potentials and facial electromyography.

    Science.gov (United States)

    Gentsch, Kornelia; Grandjean, Didier; Scherer, Klaus R

    2014-04-01

    Componential theories assume that emotion episodes consist of emergent and dynamic response changes to relevant events in different components, such as appraisal, physiology, motivation, expression, and subjective feeling. In particular, Scherer's Component Process Model hypothesizes that subjective feeling emerges when the synchronization (or coherence) of appraisal-driven changes between emotion components has reached a critical threshold. We examined the prerequisite of this synchronization hypothesis for appraisal-driven response changes in facial expression. The appraisal process was manipulated by using feedback stimuli, presented in a gambling task. Participants' responses to the feedback were investigated in concurrently recorded brain activity related to appraisal (event-related potentials, ERP) and facial muscle activity (electromyography, EMG). Using principal component analysis, the prediction of appraisal-driven response changes in facial EMG was examined. Results support this prediction: early cognitive processes (related to the feedback-related negativity) seem to primarily affect the upper face, whereas processes that modulate P300 amplitudes tend to predominantly drive cheek region responses. Copyright © 2013 Elsevier B.V. All rights reserved.

  17. A critical appraisal of atomoxetine in the management of ADHD

    Directory of Open Access Journals (Sweden)

    Childress AC

    2015-12-01

    Full Text Available Ann C ChildressCenter for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USAAbstract: Attention-deficit/hyperactivity disorder (ADHD is a common neurobehavioral disorder beginning in childhood and often continuing into adulthood. A wealth of data shows that ADHD symptoms respond well to pharmacological treatment. Stimulant medications, including amphetamine and methylphenidate, are most commonly used to treat ADHD. However, with the approval of atomoxetine (Strattera®, [ATX] by the US Food and Drug Administration in late 2002, an effective non-stimulant option became available. The US Food and Drug Administration approved ATX for the treatment of ADHD in children, adolescents, and adults. Although the effect size of ATX is generally lower than that of stimulants, the American Academy of Child and Adolescent Psychiatry Practice Parameter for the treatment of ADHD lists ATX as a first-line treatment option. ATX is widely prescribed and accounted for 6% of the prescriptions of ADHD visits in the US in 2010. Numerous trials have found that ATX improves quality of life and emotional lability in addition to core ADHD symptoms. Although some improvement may be seen in a patient as early as one week after the initiation of treatment, ATX generally takes longer to have a full effect. The median time to response using 25% improvement in ADHD symptoms in pooled trials was 3.7 weeks. Data from these trials indicate that the probability of symptom improvement may continue to increase up to 52 weeks after treatment is initiated. ATX has been shown to be safe and effective in combination with stimulants. It has also been studied systematically in subjects with ADHD and comorbid oppositional defiant disorder, anxiety, depression, and substance use disorders. The mechanism of action of ATX, its efficacy, and adverse events reported in trials is reviewed.Keywords: attention-deficit/hyperactivity disorder, Strattera, non-stimulants, pharmacotherapy

  18. A Critical Appraisal of the `Day' Diagram

    Science.gov (United States)

    Roberts, A. P.; Tauxe, L.; Heslop, D.

    2017-12-01

    The `Day' diagram [Day et al., 1977; doi:10.1016/0031-9201(77)90108-X] is used widely to infer the mean domain state of magnetic mineral assemblages. The Day plot coordinates are the ratios of the saturation remanent magnetization to saturation magnetization (Mrs/Ms) and the coercivity of remanence to coercivity (Bcr/Bc), as determined from a major hysteresis loop and a backfield demagnetization curve. Based on theoretical and empirical arguments, Day plots are typically demarcated into stable single domain (SD), `pseudosingle domain' (`PSD'), and multidomain (MD) zones. It is a simple task to determine Mrs/Ms and Bcr/Bc for a sample and to assign a mean domain state based on the boundaries defined by Day et al. [1977]. Many other parameters contribute to variability in a Day diagram, including surface oxidation, mineral stoichiometry, stress state, magnetostatic interactions, and mixtures of magnetic particles with different sizes and shapes. Bulk magnetic measurements usually lack detailed independent evidence to constrain each free parameter, which makes the Day diagram fundamentally ambiguous. This raises questions about its usefulness for diagnosing magnetic particle size variations. The Day diagram is also used to make inferences about binary mixing of magnetic particles, where, for example, mixtures of SD and MD particles give rise to a bulk `PSD' response even though the concentration of `PSD' grains could be zero. In our assessment of thousands of hysteresis measurements of geological samples, binary mixing occurs in a tiny number of cases. Ternary, quaternary, and higher order mixing are usually observed. Also, uniaxial SD and MD end-members are nearly always inappropriate for considering mixing because uniaxial SD particles are virtually non-existent in igneous rocks. Thus, use of mixing lines in Day diagrams routinely provides unsatisfactory representations of particle size variations. We critically appraise the Day diagram and argue that its many

  19. Certolizumab Pegol for Treating Rheumatoid Arthritis Following Inadequate Response to a TNF-α Inhibitor: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

    Science.gov (United States)

    Bermejo, Iñigo; Stevenson, Matt; Archer, Rachel; Stevens, John W; Goka, Edward; Clowes, Mark; Scott, David L; Young, Adam

    2017-11-01

    As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia ® ) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a detailed review of the evidence for the clinical and cost effectiveness of the technology, based upon the company's submission to NICE. The clinical effectiveness evidence in the company's submission for CZP was based predominantly on six randomised controlled trials (RCTs) comparing the efficacy of CZP against placebo. The clinical effectiveness review identified no head-to-head evidence on the efficacy of CZP against the comparators within the scope; therefore, the company performed a network meta-analysis (NMA). The company's NMA concluded that CZP had a similar efficacy to that of its comparators. The company submitted a Markov model that assessed the incremental cost effectiveness of CZP versus comparator biologic disease-modifying antirheumatic drugs (bDMARDs) for the treatment of RA from the perspective of the National Health Service for three decision problems, each of which followed an inadequate response to a TNFi. These were (1) a comparison against rituximab (RTX) in combination with methotrexate (MTX); (2) a comparison against bDMARDs when RTX was contraindicated or withdrawn due to an adverse event; and (3) a comparison against bDMARDs when MTX was contraindicated or withdrawn due to an adverse event. Results from the company's economic evaluation showed that CZP resulted in a similar number of quality-adjusted life years (QALYs) produced at similar or lower costs compared with comparator b

  20. Effects of School-Based Educational Interventions for Enhancing Adolescents Abilities in Critical Appraisal of Health Claims: A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Lena V Nordheim

    Full Text Available Adolescents are frequent media users who access health claims from various sources. The plethora of conflicting, pseudo-scientific, and often misleading health claims in popular media makes critical appraisal of health claims an essential ability. Schools play an important role in educating youth to critically appraise health claims. The objective of this systematic review was to evaluate the effects of school-based educational interventions for enhancing adolescents' abilities in critically appraising health claims.We searched MEDLINE, Embase, PsycINFO, AMED, Cinahl, Teachers Reference Centre, LISTA, ERIC, Sociological Abstracts, Social Services Abstracts, The Cochrane Library, Science Citation Index Expanded, Social Sciences Citation Index, and sources of grey literature. Studies that evaluated school-based educational interventions to improve adolescents' critical appraisal ability for health claims through advancing the students' knowledge about science were included. Eligible study designs were randomised and non-randomised controlled trials, and interrupted time series. Two authors independently selected studies, extracted data, and assessed risk of bias in included studies. Due to heterogeneity in interventions and inadequate reporting of results, we performed a descriptive synthesis of studies. We used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation to assess the certainty of the evidence.Eight studies were included: two compared different teaching modalities, while the others compared educational interventions to instruction as usual. Studies mostly reported positive short-term effects on critical appraisal-related knowledge and skills in favour of the educational interventions. However, the certainty of the evidence for all comparisons and outcomes was very low.Educational interventions in schools may have beneficial short-term effects on knowledge and skills relevant to the critical appraisal of health

  1. Effects of School-Based Educational Interventions for Enhancing Adolescents Abilities in Critical Appraisal of Health Claims: A Systematic Review.

    Science.gov (United States)

    Nordheim, Lena V; Gundersen, Malene W; Espehaug, Birgitte; Guttersrud, Øystein; Flottorp, Signe

    2016-01-01

    Adolescents are frequent media users who access health claims from various sources. The plethora of conflicting, pseudo-scientific, and often misleading health claims in popular media makes critical appraisal of health claims an essential ability. Schools play an important role in educating youth to critically appraise health claims. The objective of this systematic review was to evaluate the effects of school-based educational interventions for enhancing adolescents' abilities in critically appraising health claims. We searched MEDLINE, Embase, PsycINFO, AMED, Cinahl, Teachers Reference Centre, LISTA, ERIC, Sociological Abstracts, Social Services Abstracts, The Cochrane Library, Science Citation Index Expanded, Social Sciences Citation Index, and sources of grey literature. Studies that evaluated school-based educational interventions to improve adolescents' critical appraisal ability for health claims through advancing the students' knowledge about science were included. Eligible study designs were randomised and non-randomised controlled trials, and interrupted time series. Two authors independently selected studies, extracted data, and assessed risk of bias in included studies. Due to heterogeneity in interventions and inadequate reporting of results, we performed a descriptive synthesis of studies. We used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) to assess the certainty of the evidence. Eight studies were included: two compared different teaching modalities, while the others compared educational interventions to instruction as usual. Studies mostly reported positive short-term effects on critical appraisal-related knowledge and skills in favour of the educational interventions. However, the certainty of the evidence for all comparisons and outcomes was very low. Educational interventions in schools may have beneficial short-term effects on knowledge and skills relevant to the critical appraisal of health claims. The small

  2. Fluctuating confidence: the dynamic consequences of true/false affirmatives and denials on how a listener appraises their personal past.

    Science.gov (United States)

    Davis, Jolee; Bayantemur, Sharon Y; Seecharan, Sasha; Unger, Leslie D; Hellgren, Johanna; Stone, Charles B

    2018-08-01

    The present study examined the mnemonic consequences of true/false denials and affirmatives on how a listener appraises their personal past. To this end, participants (listeners) rated the extent to which they were confident certain events occurred during their childhood. They rated these events both before and after a confederate (speaker) denied or affirmed the occurrence of four different childhood events each, for a total of eight "rehearsed" events. For each set (denials and affirmatives) of events, half were true and half were false. In turn, this created four types of events (two each): true denials, true affirmatives, false denials, and false affirmatives. Additionally, half of the participants were told that the speaker was provided independent information about the veracity of the event's occurrence ("expert" condition). Overall, listeners were less confident in the occurrence of false denial events, but more so when they believed the speaker to be more knowledgeable of the listeners memories, more confident in false affirmative events and, counter intuitively, more confident in the occurrence of true denial events. These results underscore the importance of a nuanced approach to the mnemonic consequences of true and false denials and affirmations in the course of social interactions.

  3. The Efficacy of Performance Appraisal to Increase Employees’ Job Satisfaction

    Directory of Open Access Journals (Sweden)

    Iranita Hervi Mahardayani

    2016-08-01

    Full Text Available This research aims to find out the effectiveness of implementation performance appraisal toward job satisfaction of employees UMKM Bordir Dahlia in Kabupaten Kudus. Sampling was done by using population studies to 16 employees of UMKM embroidery Dahlia Kudus. The type of this research is quantitative with pra experiment approached by One group pre and posttest design method. Data analysis on this research using non parametric with different test techniques Wilcoxon t-tes. The analysis result of different test scale job satisfaction before and after handling obtained Z = - 1,268, with p = 0,205 (p>0,05, so that there is no differences on job satisfaction on employees of embroidery Dahlia before and after treatment by giving performance appraisal. It means treatment by giving performance appraisal unable to increase employees job satisfaction. Therefore, the hypothesis on this research is rejected.

  4. Why is discrimination stressful? The mediating role of cognitive appraisal.

    Science.gov (United States)

    King, Kimberly R

    2005-08-01

    This study attempts to shed light on past findings that experiences of racial and gender discrimination are associated with poor psychological and physical health outcomes by investigating the role of cognitive appraisal as a mediator of the relationship between experiences of discrimination and affective stress reactions. African American female college students (N = 115) imagined themselves in an audiotaped scenario in which they overheard 2 European American male classmates make negative evaluations of them. Participants then completed measures of causal attributions, cognitive appraisal, and affective stress reactions. Multiple regression analyses supported the hypotheses that attributions to racism and to discrimination that combines racism and sexism were associated with increased stress reactions. This relationship was mediated by cognitive appraisals of centrality. (c) 2005 APA

  5. COMMUNICATION OPENNESS IN PERFORMANCE APPRAISAL SYSTEMS ENHANCING JOB SATISFACTION

    Directory of Open Access Journals (Sweden)

    ISMAIL Azman

    2014-06-01

    Full Text Available The aim of this paper is to investigate the relationship between communication openness in performance appraisal systems and job satisfaction. A survey method was employed to gather data from employees who have worked in a privatized postal company in Sarawak, Malaysia. SmartPLS version 2.0 was used to determine the validity and reliability of instrument and test the research hypotheses. The outcomes of SmartPLS path model showed that explanation and feedback were positively and significantly related to job satisfaction. This result confirms that the ability of appraisers to clearly explain the performance appraisal practices and adequately provide feedback in determining performance scores have been important predictors of appraises’ job satisfaction in the studied organization. Further, this study provides discussion, implications and conclusion.

  6. Artificial Neural Networks and the Mass Appraisal of Real Estate

    Directory of Open Access Journals (Sweden)

    Gang Zhou

    2018-03-01

    Full Text Available With the rapid development of computer, artificial intelligence and big data technology, artificial neural networks have become one of the most powerful machine learning algorithms. In the practice, most of the applications of artificial neural networks use back propagation neural network and its variation. Besides the back propagation neural network, various neural networks have been developing in order to improve the performance of standard models. Though neural networks are well known method in the research of real estate, there is enormous space for future research in order to enhance their function. Some scholars combine genetic algorithm, geospatial information, support vector machine model, particle swarm optimization with artificial neural networks to appraise the real estate, which is helpful for the existing appraisal technology. The mass appraisal of real estate in this paper includes the real estate valuation in the transaction and the tax base valuation in the real estate holding. In this study we focus on the theoretical development of artificial neural networks and mass appraisal of real estate, artificial neural networks model evolution and algorithm improvement, artificial neural networks practice and application, and review the existing literature about artificial neural networks and mass appraisal of real estate. Finally, we provide some suggestions for the mass appraisal of China's real estate.

  7. The Role of Cumulative Trauma, Betrayal, and Appraisals in Understanding Trauma Symptomatology.

    Science.gov (United States)

    Martin, Christina Gamache; Cromer, Lisa Demarni; Deprince, Anne P; Freyd, Jennifer J

    2013-03-01

    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 constructed to assess the number of different types of traumas experienced that were low (LBTs), moderate (MBTs), or high in betrayal (HBTs). Greater trauma exposure was related to more symptoms of depression, dissociation, and PTSD, with exposure to HBTs contributing the most. Women were more likely to experience HBTs than men, but there were no gender differences in trauma-related symptoms. Appraisals of trauma were predictive of trauma-related symptoms over and above the effects explained by cumulative trauma at each level of betrayal. The survivor's relationship with the perpetrator, the effect of cumulative trauma, and their combined impact on trauma symptomatology are discussed.

  8. Procedures for the systematic appraisal of operational radiation protection programmes

    International Nuclear Information System (INIS)

    1987-09-01

    The purpose of this document is to give guidance to management and regulators of organisations using ionizing radiations on a technique for systematically appraising their operational radiation protection programme in order that its adequacy and effectiveness can be objectively determined. The appraisal technique is based on analytical trees and can be used to examine either a whole programme, to determine its completion and adequacy or to examine one component of a programme in considerable detail. This document will not develop technical recommendations on particular radiation protection programmes. These will be found in the appropriate Safety Series document on operational radiation protection. 8 refs, figs

  9. FASP, an analytic resource appraisal program for petroleum play analysis

    Science.gov (United States)

    Crovelli, R.A.; Balay, R.H.

    1986-01-01

    An analytic probabilistic methodology for resource appraisal of undiscovered oil and gas resources in play analysis is presented in a FORTRAN program termed FASP. This play-analysis methodology is a geostochastic system for petroleum resource appraisal in explored as well as frontier areas. An established geologic model considers both the uncertainty of the presence of the assessed hydrocarbon and its amount if present. The program FASP produces resource estimates of crude oil, nonassociated gas, dissolved gas, and gas for a geologic play in terms of probability distributions. The analytic method is based upon conditional probability theory and many laws of expectation and variance. ?? 1986.

  10. DMPD: Toll like receptors and autoimmunity: a critical appraisal. [Dynamic Macrophage Pathway CSML Database

    Lifescience Database Archive (English)

    Full Text Available 17959357 Toll like receptors and autoimmunity: a critical appraisal. Papadimitraki ...ml) Show Toll like receptors and autoimmunity: a critical appraisal. PubmedID 17959357 Title Toll like receptors and auto

  11. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  12. Stepped-wedge cluster randomised controlled trial to assess the effectiveness of an electronic medication management system to reduce medication errors, adverse drug events and average length of stay at two paediatric hospitals: a study protocol.

    Science.gov (United States)

    Westbrook, J I; Li, L; Raban, M Z; Baysari, M T; Mumford, V; Prgomet, M; Georgiou, A; Kim, T; Lake, R; McCullagh, C; Dalla-Pozza, L; Karnon, J; O'Brien, T A; Ambler, G; Day, R; Cowell, C T; Gazarian, M; Worthington, R; Lehmann, C U; White, L; Barbaric, D; Gardo, A; Kelly, M; Kennedy, P

    2016-10-21

    Medication errors are the most frequent cause of preventable harm in hospitals. Medication management in paediatric patients is particularly complex and consequently potential for harms are greater than in adults. Electronic medication management (eMM) systems are heralded as a highly effective intervention to reduce adverse drug events (ADEs), yet internationally evidence of their effectiveness in paediatric populations is limited. This study will assess the effectiveness of an eMM system to reduce medication errors, ADEs and length of stay (LOS). The study will also investigate system impact on clinical work processes. A stepped-wedge cluster randomised controlled trial (SWCRCT) will measure changes pre-eMM and post-eMM system implementation in prescribing and medication administration error (MAE) rates, potential and actual ADEs, and average LOS. In stage 1, 8 wards within the first paediatric hospital will be randomised to receive the eMM system 1 week apart. In stage 2, the second paediatric hospital will randomise implementation of a modified eMM and outcomes will be assessed. Prescribing errors will be identified through record reviews, and MAEs through direct observation of nurses and record reviews. Actual and potential severity will be assigned. Outcomes will be assessed at the patient-level using mixed models, taking into account correlation of admissions within wards and multiple admissions for the same patient, with adjustment for potential confounders. Interviews and direct observation of clinicians will investigate the effects of the system on workflow. Data from site 1 will be used to develop improvements in the eMM and implemented at site 2, where the SWCRCT design will be repeated (stage 2). The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospitals Network and Macquarie University. Results will be reported through academic journals and seminar and conference presentations. Australian New Zealand

  13. Nonlinear Appraisal Modeling: An Application of Machine Learning to the Study of Emotion Production

    OpenAIRE

    Meuleman, Ben; Scherer, Klaus R.

    2013-01-01

    Appraisal theory of emotion claims that emotions are not caused by "raw" stimuli, as such, but by the subjective evaluation (appraisal) of those stimuli. Studies that analyzed this relation have been dominated by linear models of analysis. These methods are not ideally suited to examine a basic assumption of many appraisal theories, which is that appraisal criteria interact to differentiate emotions, and hence show nonlinear effects. Studies that did model interactions were either l...

  14. Influenza vaccination for healthcare workers in the UK: appraisal of systematic reviews and policy options

    Science.gov (United States)

    Kliner, Merav; Keenan, Alex; Sinclair, David; Ghebrehewet, Sam; Garner, Paul

    2016-01-01

    Background The UK Department of Health recommends annual influenza vaccination for healthcare workers, but uptake remains low. For staff, there is uncertainty about the rationale for vaccination and evidence underpinning the recommendation. Objectives To clarify the rationale, and evidence base, for influenza vaccination of healthcare workers from the occupational health, employer and patient safety perspectives. Design Systematic appraisal of published systematic reviews. Results The quality of the 11 included reviews was variable; some included exactly the same trials but made conflicting recommendations. 3 reviews assessed vaccine effects in healthcare workers and found 1 trial reporting a vaccine efficacy (VE) of 88%. 6 reviews assessed vaccine effects in healthy adults, and VE was consistent with a median of 62% (95% CI 56 to 67). 2 reviews assessed effects on working days lost in healthcare workers (3 trials), and 3 reported effects in healthy adults (4 trials). The meta-analyses presented by the most recent reviews do not reach standard levels of statistical significance, but may be misleading as individual trials suggest benefit with wide variation in size of effect. The 2013 Cochrane review reported absolute effects close to 0 for laboratory-confirmed influenza, and hospitalisation for patients, but excluded data on clinically suspected influenza and all-cause mortality, which had shown potentially important effects in previous editions. A more recent systematic review reports these effects as a 42% reduction in clinically suspected influenza (95% CI 27 to 54) and a 29% reduction in all-cause mortality (95% CI 15 to 41). Conclusions The evidence for employer and patient safety benefits of influenza vaccination is not straightforward and has been interpreted differently by different systematic review authors. Future uptake of influenza vaccination among healthcare workers may benefit from a fully transparent guideline process by a panel representing all

  15. Learning to Appraise the Quality of Qualitative Research Articles: A Contextualized Learning Object for Constructing Knowledge

    Science.gov (United States)

    Chenail, Ronald J.

    2011-01-01

    Helping beginning qualitative researchers critically appraise qualitative research articles is a common learning objective for introductory methodology courses. To aid students in achieving competency in appraising the quality of qualitative research articles, a multi-part activity incorporating the Critical Appraisal Skills Programme's (CASP)…

  16. 12 CFR 564.8 - Appraisal policies and practices of savings associations and subsidiaries.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Appraisal policies and practices of savings associations and subsidiaries. 564.8 Section 564.8 Banks and Banking OFFICE OF THRIFT SUPERVISION, DEPARTMENT OF THE TREASURY APPRAISALS § 564.8 Appraisal policies and practices of savings associations and...

  17. A Field Study of Discrete Emotions: Athletes' Cognitive Appraisals during Competition

    Science.gov (United States)

    Martinent, Guillaume; Ferrand, Claude

    2015-01-01

    Purpose: Cognitive-motivational-relational theory (CMRT) emphasizes that cognitive appraisal components and core relational themes (in which the 6 separate appraisal judgments are brought together as 1) are the proximal determinants of athletes' emotions. This study aimed to explore appraisals associated with discrete emotions experienced by…

  18. (Un)ethical behavior and performance appraisal: the role of affect, support, and organizational justice

    NARCIS (Netherlands)

    Jacobs, G.; Belschak, F.D.; den Hartog, D.N.

    2014-01-01

    Performance appraisals are widely used as an HR instrument. This study among 332 police officers examines the effects of performance appraisals from a behavioral ethics perspective. A mediation model relating justice perceptions of police officers’ last performance appraisal to their work affect,

  19. 5 CFR 430.405 - Procedures for certifying agency appraisal systems.

    Science.gov (United States)

    2010-01-01

    ... SERVICE REGULATIONS PERFORMANCE MANAGEMENT Performance Appraisal Certification for Pay Purposes § 430.405... appraisals of their relative performance against performance expectations in any given appraisal period..., requirements, or expectations for the employees they supervise to ensure that they clearly link to...

  20. Individual Differences in Children's Risk Perception and Appraisals in Outdoor Play Environments

    Science.gov (United States)

    Little, Helen; Wyver, Shirley

    2010-01-01

    Child characteristics including age, gender, risk-taking behaviour and sensation seeking are thought to influence children's ability to appraise risks. The present study investigated children's risk perceptions and appraisals in the context of common outdoor physical play activities. Risk perceptions and appraisal of four- and five-year olds were…

  1. Automatic Affective Appraisal of Sexual Penetration Stimuli in Women with Vaginismus or Dyspareunia

    NARCIS (Netherlands)

    Huijding, Jorg; Borg, Charmaine; Weijmar-Schultz, Willibrord; de Jong, Peter J.

    Introduction. Current psychological views are that negative appraisals of sexual stimuli lie at the core of sexual dysfunctions. It is important to differentiate between deliberate appraisals and more automatic appraisals, as research has shown that the former are most relevant to controllable

  2. Methods of blinding in reports of randomized controlled trials assessing pharmacologic treatments: a systematic review.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2006-10-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments. METHODS AND FINDINGS: We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1 established blinding of patients or health care providers, (2 maintained the blinding of patients or health care providers, and (3 obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58% describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage, or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or

  3. An Appraisal of the DEXA Wave Energy Converter

    DEFF Research Database (Denmark)

    Pecher, Arthur; Kofoed, Jens Peter

    This report has been requested by VækstFonden and aims at giving an overview of the experimental tests and a general appraisal of the DEXA wave energy converter (WEC). The reported results and findings were obtained during previously performed experimental tests by the Wave Energy Research Group...

  4. 9 CFR 53.3 - Appraisal of animals or materials.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Appraisal of animals or materials. 53.3 Section 53.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... animals or materials. (a) Animals affected by or exposed to disease, and materials required to be...

  5. An appraisal of undergraduate curriculum of technical education in ...

    African Journals Online (AJOL)

    The purpose of this study was to appraise the curriculum of technical teacher education in terms of its compatibility to the goals of the programme. A sample of three Universities offering technical teacher programme was used for the study. Components of the technical teacher education curriculum in each institution were ...

  6. 49 CFR 24.103 - Criteria for appraisals.

    Science.gov (United States)

    2010-10-01

    ...-year sales history of the property. (See appendix A, § 24.103(a)(1).) (ii) All relevant and reliable..., § 24.103(a).) (iii) A description of comparable sales, including a description of all relevant physical..., signature, and certification of the appraiser. (b) Influence of the project on just compensation. The...

  7. Quantum theories of the early universe - a critical appraisal

    International Nuclear Information System (INIS)

    Hu, B.L.

    1988-01-01

    A critical appraisal of certain general problems in the study of quantum processes in curved space as applied to the construction of theories of the early universe is presented. Outstanding issues in different cosmological models and the degree of success of different quantum processes in addressing these issues are summarized. (author)

  8. MAPS evaluation report and procedures governing interviews and performance appraisals

    CERN Multimedia

    HR Department

    2006-01-01

    Following various improvements to the MAPS report and to the procedures governing interviews and performance appraisals (announced in the CERN Bulletin 48-49/2005), a third information session has been organized for all staff members on Tuesday, 31 January at 10 a.m.: AB Auditorium P (864-1-D02), Human Resources Department Tel. 73566

  9. Dimensions in Appraising Fatigue in Relation to Performance

    NARCIS (Netherlands)

    Dam, A. van; Keijsers, G.P.J.; Eling, P.A.T.M.

    2011-01-01

    Studies on the relation between fatigue and performance often fail to find a strong and direct link, implying that multiple factors may be involved. A literature search on the fatigue-performance relationship suggests that two different conceptual frameworks are employed concerning the appraisal of

  10. Performance appraisal: carrot or stick? | Quinn | South African ...

    African Journals Online (AJOL)

    To be critically reflective, practitioners need to gather feedback about their performance so that they can reflect on it and develop themselves in those areas in which weaknesses are recognised. The Academic Development Centre staff agreed to participate in a departmental Performance Appraisal process in order to ...

  11. Investment Appraisal Process in the Banking & Finance Industry

    NARCIS (Netherlands)

    M.M. Akalu; J.R. Turner (Rodney)

    2002-01-01

    textabstractWe have studied how the banking and finance industry performs investment appraisal, measures subsequent follow-up and designates project success or failure. Furthermore, the authors looked into the extent of use of the new generation value management models. The result shows that firms

  12. An Appraisal of the Axiological Dimension of Sexual Relationships ...

    African Journals Online (AJOL)

    In other words, one could say that the attitudes of adolescents towards dating, masturbation or even sexual intercourse are rather negative. Significantly, however, the crux of this article is to establish and appraise the axiological dimension of the permissive sexual relationship with affection, thereafter, suggests ways of ...

  13. Internet Use for Prediagnosis Symptom Appraisal by Colorectal Cancer Patients

    Science.gov (United States)

    Thomson, Maria D.; Siminoff, Laura A.; Longo, Daniel R.

    2012-01-01

    Background: This study explored the characteristics of colorectal cancer (CRC) patients who accessed Internet-based health information as part of their symptom appraisal process prior to consulting a health care provider. Method: Newly diagnosed CRC patients who experienced symptoms prior to diagnosis were interviewed. Brief COPE was used to…

  14. Taking a Second Look at Economic Stabilization Policy: Appraisal ...

    African Journals Online (AJOL)

    Taking a Second Look at Economic Stabilization Policy: Appraisal and issues. ... International Journal of Development and Management Review ... It draws from a background of arguments of different schools of thought on which of the two approaches is better suited for controlling the economy of nations in order to achieve ...

  15. Appraisal and acquisition innovative practices for archives and special collections

    CERN Document Server

    Theimer, Kate

    2015-01-01

    Appraisal and Acquisition: Innovative Practices for Archives and Special Collections explores how archivists and special collections librarians in organizations of different sizes and types have approached the challenges of collection, as well as exploring opportunities to acquire new kinds of materials and conduct thoughtful reappraisal.

  16. Productivity Implications of Employee Performance Appraisal System : A Critical Survey.

    OpenAIRE

    Dr. VSR Subramaniam

    2004-01-01

    The Productivity of any organisation is directly correlated to the Effectiveness of the Employee Performance Appraisal System, subject to the Effectiveness of the Support Systems, depending upon the type of organizational business. INFERENCE : Technology, Systems and Manpower are linked in an inter- related circle focusing towards Productivity =============================================================== DOCTORAL (Ph.D) RESEARCH WORK OF DR.VSR.SUBRAMANIAM IN JAMNALAL BAJAJ INSTITUTE OF MANA...

  17. An APPRAISAL analysis of the language of real estate advertisements

    African Journals Online (AJOL)

    This article focuses on the linguistic choices made by estate agencies in their advertisements of houses, and how these choices compare across two competing agencies in Grahamstown, South Africa – Remax Frontier and Pam Golding Properties. Using Martin and White's (2005) APPRAISAL system, it investigates the ...

  18. Level and Appraisal of Fatigue are Not Specific in Burnout

    NARCIS (Netherlands)

    Dam, A. van; Keijsers, G.P.J.; Verbraak, M.J.P.M.; Eling, P.A.T.M.; Becker, E.S.

    2015-01-01

    Fatigue is a main feature of the burnout syndrome but also very common in other psychiatric disorders such as major depression and anxiety disorders. This raises the question of whether the level and appraisal of fatigue is experienced differently by individuals suffering from burnout than by those

  19. Appraisal of in-service trainee teachers' competency on applications ...

    African Journals Online (AJOL)

    Most procedures used to obtain information about student learning are subsumed under assessment. This study appraised in-service trainee teachers' competency on applications of principles of test items writing. One Study Centre was purposively drawn from the National Teachers' Institute for the study. A sample of 33 ...

  20. 116 Appraisal as a Determinant for Adequate Compensation in ...

    African Journals Online (AJOL)

    User

    2012-01-24

    Jan 24, 2012 ... The fundamental question this work seeks to answer. Appraisal as a Determinant for ..... Organizations should invest richly on people and strive to ... Human Resource Management, New York, McGraw. Hill/Irwin. Drucker P. E. ...

  1. The early evolution of the Archegoniatae: a re-appraisal

    NARCIS (Netherlands)

    Meeuse, A.D.J.

    1966-01-01

    After a re-appraisal of the alternative hypotheses concerning the origin and the early evolution of the archegoniate land plants, the postulation of a thalassiophytic group of precursors with free isomorphic alternating generations by Church, Zimmermann, and several others is rejected. Several

  2. An appraisal of information and communication technologies as new ...

    African Journals Online (AJOL)

    An appraisal of information and communication technologies as new media tools for language teaching and learning in tertiary institutions in Nigeria. ... ICTs, the teacher-student interaction in the learning process is situated within a dynamic pedagogical context that could go beyond the four walls of a traditional classroom.

  3. Integrated performance appraisal of Daylight-Europe case study buildings

    NARCIS (Netherlands)

    Hensen, J.L.M.; Clarke, J.A.; Hand, J.W.; Johnson, K.; Wittchen, K.; Madsen, C.; Compagnon, R.

    1996-01-01

    This paper describes the approach taken within the EC’s Daylight-Europe project to apply combined thermal/daylight simulations to existing building designs which are representative of European types and climate contexts. The outputs from the performance appraisals are then incorporated within design

  4. Caregiving Appraisal in Family Caregivers of Older Adults

    Directory of Open Access Journals (Sweden)

    Akram Farhadi

    2016-04-01

    Conclusion: Caregiving appraisal is a multidimensional concept, which has positive and negative aspects. By taking into account all aspects of this concept, one can better understand and ultimately has a more comprehensive assessment of the status of caregivers, and implement effective interventions towards improving the health of this group.

  5. Job Analysis, Job Descriptions, and Performance Appraisal Systems.

    Science.gov (United States)

    Sims, Johnnie M.; Foxley, Cecelia H.

    1980-01-01

    Job analysis, job descriptions, and performance appraisal can benefit student services administration in many ways. Involving staff members in the development and implementation of these techniques can increase commitment to and understanding of the overall objectives of the office, as well as communication and cooperation among colleagues.…

  6. Technical safety appraisal of the West Valley Demonstration Project

    International Nuclear Information System (INIS)

    1989-09-01

    This report presents the results of one in a series of Technical Safety Appraisals (TSAs) being conducted of DOE nuclear operations by the Assistant Secretary for Environment, Safety, and Health Office of Safety Appraisals TSAs are one of the ititiatives announced by the Secretary of Energy on September 18, 1985, to enhance the DOE environment, safety and health program. This report presents the results of a TSA of the West Valley Demonstration Project (WVDP). The appraisal was conducted by a team of exerts assembled by the DOE Office of Safety Appraisal and was conducted during onsite visits of June 26-30 and July 10-21, 1989. West Valley, about 30 miles south of Buffalo, New York is the location of the only commercial nuclear fuel reprocessing facility operated in the United States. Nuclear Fuels Services, Inc. (NFS) operated the plant from 1966 to 1972 and processed about 640 metric tons of spent reactor fuel. The reprocessing operation generated about 560,000 gallons of high-level radioactive waste, which was transferred into underground tanks for storage. In 1972 NFS closed the plant and subsequently decided not to reopen it

  7. The appraisal of mathematics teachers in Ghana | Fletcher | African ...

    African Journals Online (AJOL)

    This study examined the nature and existing methods of teacher appraisal in Ghana. 441 secondary mathematics teachers participated, of whom 193 teach the subject at the junior secondary level and 248 teach it at the senior secondary level. In addition, 44 Ghana Education Service Officials and 6 Heads of secondary ...

  8. Appraisal of the Performance of Contingency Cost Provision for ...

    African Journals Online (AJOL)

    The paper appraised performance of contingency allowance in addressing projects' cost risk. To achieve this aim, impact of contingency provision in some selected building projects were evaluated. Data for the study was collected by means of checklist from 40 completed projects' files. Furthermore, 100 questionnaires on ...

  9. A Preliminary Appraisal Of The Composition And Industrial ...

    African Journals Online (AJOL)

    A preliminary appraisal of the composition and geotechnical properties of clay deposits at Tumfure, Rukwu and Tashar Garba in Udubo area, northeastern Nigeria has been undertaken and results related to their industrial suitability. Mineralogical studies indicate that the clay is mainly kaolinitic while quartz and feldspar are ...

  10. 32 CFR 644.47 - Appraisal of other interests.

    Science.gov (United States)

    2010-07-01

    ... improvements will include, in addition to complete coverage of all factors influencing the use of the property... construction. (ii) Complete cost data as to original purchase price and Government construction. (iii) Detailed... inspected, it will be so noted in the appraisal report. The decision concerning the necessity for a physical...

  11. Book appraisal: history of dentistry in Nigeria | Michael ... - Ibadan

    African Journals Online (AJOL)

    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 ...

  12. an appraisal of Yemoja among the Yoruba in Nigeria

    African Journals Online (AJOL)

    MR. SUNNY

    This work therefore aims at giving an appraisal of the influence of Yemoja on the socio- ... the advent of both Islam and Christianity in the land. .... a rattle will be sounded so as to attract the attention of the goddess. .... During the festival, prayers are offered for the increase of the farm products (both cash and food crops) that ...

  13. Investigating the appraisal patterns of regret and disappointment

    NARCIS (Netherlands)

    van Dijk, W.W.; Zeelenberg, M.

    2002-01-01

    Regret and disappointment are the two emotions that are most closely linked to decision making. This study compares the appraisal patterns of the two emotions. This is done in the context of the related negative emotions anger and sadness. The results show clear differences between regret and

  14. Evaluating the Capacity of Standard Investment Appraisal Methods

    NARCIS (Netherlands)

    M.M. Akalu

    2002-01-01

    textabstractThe survey findings indicate the existence of gap between theory and practice of capital budgeting. Standard appraisal methods have shown a wider project value discrepancy, which is beyond and above the contingency limit. In addition, the research has found the growing trend in the use

  15. Organizational Justice and Employee Satisfaction in Performance Appraisal

    Science.gov (United States)

    Palaiologos, Anastasios; Papazekos, Panagiotis; Panayotopoulou, Leda

    2011-01-01

    Purpose: This paper aims to explore the performance appraisal (PA) aspects that are connected with organizational justice, and more specifically three kinds of justice, namely distributive, procedural and interactional justice. Design/methodology/approach: The research is based on a sample of 170 respondents who answered a questionnaire giving…

  16. Appraisal of the European Commission's Energy Roadmap 2050

    International Nuclear Information System (INIS)

    Meeus, L.

    2012-01-01

    What is the European energy strategy for 2050? How different is it from the 2020 energy strategy? What are the technology options? What are the policy options? The European Commission provided a first answer to these questions in its Energy Roadmap 2050. This article gives an appraisal of that answer based on the recommendations we made during the preparation of the roadmap.

  17. The effect of sound sources on soundscape appraisal

    NARCIS (Netherlands)

    van den Bosch, Kirsten; Andringa, Tjeerd

    2014-01-01

    In this paper we explore how the perception of sound sources (like traffic, birds, and the presence of distant people) influences the appraisal of soundscapes (as calm, lively, chaotic, or boring). We have used 60 one-minute recordings, selected from 21 days (502 hours) in March and July 2010.

  18. Appraising coach performance: A qualitative analysis of coaches ...

    African Journals Online (AJOL)

    The current study examines the perceptions of sport coaches regarding their performance appraisal. A qualitative approach using in depth interviews was adopted for the study. The sample comprised eleven sport coaches who were selected through a purposive sampling technique. Five themes, namely criteria, feedback, ...

  19. 242-A Evaporator crystallizer facility integrated annual safety appraisal

    International Nuclear Information System (INIS)

    1991-01-01

    This report provides the results of the Fiscal Year (FY) 1991 Annual Integrated Safety Appraisal of the 242-A Evaporator Crystallizer Facility in the Hanford 200 East Area. The appraisal was conducted in December 1990 and January 1991, by the Waste Tank Safety Assurance (WTSA) organizations in conjunction with Radiological Engineering, Criticality Safety, Packaging and Shipping Safety, Emergency Preparedness, Environmental Compliance, and Quality Assurance. Reports of these eight organizations are presented as Sections 2 through 7 of this report. The purpose of the appraisal was to verify that the 242-A Evaporator meets US Department of Energy (DOE) and Westinghouse Hanford Company (WHC) requirements and current industry standards of good practice for the areas being appraised. A further purpose was to identify areas in which program effectiveness could be improved. In accordance with the guidance of WHC Management Requirements and Procedures (MRP)5.6, previously identified deficiencies which are being resolved by line management were not repeated as Findings or Observations unless progress or intended disposition was considered to be unsatisfactory

  20. Performance Appraisal at Four and Five Star Hotels: Ankara Case

    Directory of Open Access Journals (Sweden)

    Yalçın Arslantürk

    2009-12-01

    Full Text Available Nowadays, tourism establishments developing human resources and motivating will make it easier to reach their goals and those who cannot mange to do this will be obsolete in the ever-changing nature of the tourism business. The most important feature of the tourism sector is that it is based on human element and it s labor-intensive. Hence, human element is of great importance. This being the case, the customer satisfaction in accommodation establishments will be greatly dependent on the success of the personnel. Performance appraisal in this regard is a tool used to measure the performance of the employees in establishing job satisfaction and enhancing success. Performance appraisal indicates the performance of the individuals and gives insights as to what should be done to improve the performance. As well as promoting the communication between the employees and the establishment. From the perspectives of the managers, it paves the way for an efficient information flow about the performance of the personnel and makes job planning more rationally. This study first examines performance and performance appraisal. Then, through a field study, deficiencies in the application of performance appraisal were determined in the four and five star hotel establishments. According to the results obtained, some suggestions were put forward.

  1. Asset Management Plans, Appraisal Guidance for 2003-04.

    Science.gov (United States)

    Department for Education and Skills, London (England).

    This document is one in a series which aims to assist Local Authorities in Britain with asset management planning (AMPs) for schools. AMPs set out the information needed, and the criteria used, to make decisions about spending on school premises. The document provides guidance on the appraisal of school AMPs in 2002 to inform 3-year formulaic…

  2. Decision-Making Styles and Problem-Solving Appraisal.

    Science.gov (United States)

    Phillips, Susan D.; And Others

    1984-01-01

    Compared decision-making style and problem-solving appraisal in 243 undergraduates. Results suggested that individuals who employ rational decision-making strategies approach problematic situations, while individuals who endorse dependent decisional strategies approach problematic situations without confidence in their problem-solving abilities.…

  3. Adolescent sexuality education: An appraisal of some scalable ...

    African Journals Online (AJOL)

    Adolescent sexuality education: An appraisal of some scalable interventions for the Nigerian context. VC Pam. Abstract. Most issues around sexual intercourse are highly sensitive topics in Nigeria. Despite the disturbingly high adolescent HIV prevalence and teenage pregnancy rate in Nigeria, sexuality education is ...

  4. Appraisal Distortions and Intimate Partner Violence: Gender, Power, and Interaction

    Science.gov (United States)

    Whiting, Jason B.; Oka, Megan; Fife, Stephen T.

    2012-01-01

    In relationships characterized by control, abuse, or violence, many appraisal distortions occur including denial and minimization. However, the nature of the distortion varies depending on the individual's role in the relationship (i.e., abuser or victim). Reducing these distortions is an important component in treatment success and involves…

  5. 75 FR 77449 - Interagency Appraisal and Evaluation Guidelines

    Science.gov (United States)

    2010-12-10

    ... regulations \\1\\ implementing Title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of... Guidelines) to provide further guidance to regulated financial institutions on prudent appraisal and... Proposal, changes in market conditions underscore the importance of institutions following sound collateral...

  6. A Critical Appraisal of Circumferential Resection Margins in Esophageal Carcinoma

    NARCIS (Netherlands)

    Pultrum, Bareld B.; Honing, Judith; Smit, Justin K.; van Dullemen, Hendrik M.; van Dam, Gooitzen M.; Groen, Henk; Hollema, Harry; Plukker, John Th. M.

    In esophageal cancer, circumferential resection margins (CRMs) are considered to be of relevant prognostic value, but a reliable definition of tumor-free CRM is still unclear. The aim of this study was to appraise the clinical prognostic value of microscopic CRM involvement and to determine the

  7. 50 CFR 34.7 - Fair market value appraisals.

    Science.gov (United States)

    2010-10-01

    ... 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... procedures in order to estimate the fair market value of each area as a whole. The evaluation will be...

  8. 7 CFR 3015.56 - Appraisal of real property.

    Science.gov (United States)

    2010-01-01

    ... of real property. In some cases, it will be necessary to establish the market value of land or a building or the fair rental rate of land or of space in a building. In these cases, the awarding agency must require that the market value or fair rental rate be set by an independent appraiser (or by a...

  9. 78 FR 10367 - Appraisals for Higher-Priced Mortgage Loans

    Science.gov (United States)

    2013-02-13

    ... the current sale. A creditor of a ``higher-risk mortgage'' must also: Provide the applicant, at the... addition, the final rule implements the Act's requirement that the creditor of a ``higher-risk mortgage... provision requiring appraisals for ``higher-risk mortgages'' that was added to TILA by the Dodd-Frank Wall...

  10. An investigation of self-appraised cognition versus measured ...

    African Journals Online (AJOL)

    The implications of this investigation are far-reaching in terms of the necessity to regard a student holistically, to realise the importance of how students appraise themselves cognitively, and the need to pay special attention to building a healthy self-concept. South African Journal of Higher Education Vol. 21 (4) 2007: pp.

  11. Investment appraisal of technology innovations on dairy farm electricity consumption

    NARCIS (Netherlands)

    Upton, J.; Murphy, M.; Boer, de I.J.M.; Groot Koerkamp, P.W.G.; Berentsen, P.B.M.; Shalloo, L.

    2015-01-01

    The aim of this study was to conduct an investment appraisal for milk-cooling, water-heating, and milk-harvesting technologies on a range of farm sizes in 2 different electricity-pricing environments. This was achieved by using a model for electricity consumption on dairy farms. The model simulated

  12. An Appraisal of Equal Educational Opportunities and its Implications ...

    African Journals Online (AJOL)

    The paper appraised the concept of equal educational opportunities and its implications for peace and development in Nigeria. In the age of Plato, education was meant to make each person contribute his best in the stratum that he belonged. In consequence, all children were educated together at the nursery, kindergarten ...

  13. Appraisal of Student-Teacher's Attitude Toward Teaching Profession ...

    African Journals Online (AJOL)

    The disposition of teachers within and outside the school will in no little amount positively affect the academic achievement of students. Thus, this paper is a descriptive survey which sought to appraise the attitude of student-teacher's relationship across teacher training institutes in Lagos State, Nigeria. This study was ...

  14. Texas Teacher Evaluation & Support System (T-TESS) Appraiser Handbook

    Science.gov (United States)

    Texas Education Agency, 2016

    2016-01-01

    The Texas Education Agency's (TEA) approved instrument for evaluating teachers, the Professional Development and Appraisal System (PDAS), was the primary instrument used by 86 percent of local education agencies (LEAs) in the state and has been in place since 1997. In acknowledging the vital roles teachers play in student achievement, and based on…

  15. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma.

    Science.gov (United States)

    Weber, Jeffrey S; Dummer, Reinhard; de Pril, Veerle; Lebbé, Celeste; Hodi, F Stephen

    2013-05-01

    Ipilimumab 3 mg/kg was the first agent to demonstrate improved survival in previously treated patients with metastatic melanoma in a phase 3 trial (MDX010-20). Ipilimumab produced a characteristic spectrum of immune-related adverse events (irAEs) of special interest, consistent with its immune-based mechanism of action. In MDX010-20, 676 previously treated patients were randomized 3:1:1 to receive ipilimumab 3 mg/kg plus the glycoprotein 100 melanoma antigen vaccine (gp100), ipilimumab 3 mg/kg + placebo, or gp100 vaccine + placebo. For the current report, the authors conducted a detailed analysis of the time to onset and resolution of irAEs associated with ipilimumab therapy. Grade 2 through 5 irAEs generally developed during the induction phase of treatment (0-12 weeks). Most, including grade 3/4 irAEs, were reversible when managed with treatment guidelines using vigilant monitoring and corticosteroids. The median time to resolution (to grade 1 or 0 or to the grade at baseline) of irAEs that had an onset during the induction phase was approximately 6 weeks for grade 2 through 4 irAEs and 8 weeks for grade 3 and 4 irAEs. Across the entire study duration, most grade 2 through 4 irAEs resolved within 12 weeks. Most ipilimumab-associated irAEs, including grade 3/4 symptoms, developed within 12 weeks of initial dosing and resolved within 12 weeks of onset. IrAEs were well characterized in their evolution and could be managed using published algorithms. Copyright © 2013 American Cancer Society.

  16. Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial.

    Science.gov (United States)

    Avezum, Alvaro; Lopes, Renato D; Schulte, Phillip J; Lanas, Fernando; Gersh, Bernard J; Hanna, Michael; Pais, Prem; Erol, Cetin; Diaz, Rafael; Bahit, M Cecilia; Bartunek, Jozef; De Caterina, Raffaele; Goto, Shinya; Ruzyllo, Witold; Zhu, Jun; Granger, Christopher B; Alexander, John H

    2015-08-25

    Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. However, the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves. We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism, major bleeding, and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling. Of the 18 201 patients enrolled in ARISTOTLE, 4808 (26.4%) had a history of moderate or severe valvular heart disease or previous valve surgery. Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.97 and HR, 0.84; 95%, CI 0.67-1.04; interaction P=0.38), causing less major bleeding (HR, 0.79; 95% CI, 0.61-1.04 and HR, 0.65; 95% CI, 0.55-0.77; interaction P=0.23), and reducing mortality (HR, 1.01; 95% CI, 0.84-1.22 and HR, 0.84; 95% CI, 0.73-0.96; interaction P=0.10). More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease. There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism, causing less bleeding, and reducing death in patients with and without valvular heart disease. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00412984. © 2015 American Heart Association, Inc.

  17. Detection of Respiratory Adverse Events in Pediatric Dental Patients Sedated With 0.75mg/Kg of Midazolam and Oxygen by Continuous Pretracheal Auscultation: A Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Somri, Mostafa; Matter, Ibrahim; Hadjittofi, Christopher; Hoash, Naser; Moaddi, Bian; Kharouba, Johnny; Parisinos, Constantinos A; Peretz, Benjamin

    Sedation is becoming more commonplace for pediatric patients undergoing minor procedures. Fortunately, electronic monitors have contributed to a reduction in the associated respiratory adverse events (RAEs). To test the hypothesis that adding the pretracheal stethoscope (PTS) to standard monitoring methods (SMMs) may improve RAE detection in sedated pediatric dental patients, the frequency of RAEs detected by SMMs (i.e. visual observation, capnography, and pulse oximetry) was compared to that detected by SMMs alongside continuous PTS auscultation. A prospective, randomised, controlled trial was performed with 100 pediatric patient participants of ASA≤2, who were scheduled to receive dental treatment under 0.75 mg/kg and oxygen. Patients were randomised into Groups A (n=50; SMMs) and B (n=50; SMMs+PTS). Inclusion criteria were behavioral management problems and intolerance to dental treatment despite behavioral management techniques or nitrous oxide administration. Exclusion criteria were high-risk conditions for RAEs, altered mental status, gastrointestinal disorders, parental refusal of conscious sedation and failure of previous conscious sedation. An anesthesist was present throughout the dental treatments. RAEs were detected in 10 (20%) and 22(44%) Group A and B patients respectively (p=0.01). The majority of RAEs within Group B were detected by PTS auscultation (n=19). Capnography produced 13 and 15 false-positive results in Groups A and B respectively, whereas the PTS produced 4(8%) false-positive results in Group B (p=0.009). PTS was found to be useful for detecting RAEs during pediatric dental sedation with 0.75mg/kg midazolam and oxygen, in the presence of an anesthesist.

  18. Experimental appraisal of personal beliefs in science: constraints on performance in the 9 to 14 age group.

    Science.gov (United States)

    Howe, C; Tolmie, A; Sofroniou, N

    1999-06-01

    Recent curricula initiatives have promoted experimentation as a means by which relatively young children can appraise their personal beliefs and thereby modify these beliefs towards received scientific ideas. However, key psychological theories signal problems, and the enterprise is not in any event securely grounded in empirical research. As a consequence, the study reported here aimed to provide comprehensive information about children's abilities to use experimentation to appraise their beliefs, while allowing full exploration of theorized constraints. The study involved 24 children at each of three age levels within the 9 to 14 range. The children were first interviewed to establish their beliefs about influences on outcome in four educationally significant topic areas: flotation, pressure, motion and shadows. Subsequently, they were asked to conduct investigations to determine whether selected beliefs were correct. The results showed that, regardless of age or topic, very few children appreciated that to explore whether some variable is influencing outcome it is necessary to manipulate that variable experimentally and that variable only. There was a strong tendency to manipulate other variables, a tendency attributed to the intrusion of everyday reasoning practices into the experimental context. Once extraneous variables had been introduced, the children experienced great difficulties with subsequent stages in the experimental process, e.g., predicting, observing and drawing conclusions. It is concluded that experimentation as a means of appraising beliefs is not straightforward in the 9 to 14 age group, and that the pattern of difficulties has psychological significance given the background theories. Nevertheless, while not straightforward, experimental appraisal remains possible given appropriate teacher support, and proposals are made as to the form which the support should take.

  19. Health system guidance appraisal--concept evaluation and usability testing.

    Science.gov (United States)

    Ako-Arrey, Denis E; Brouwers, Melissa C; Lavis, John N; Giacomini, Mita K

    2016-01-05

    Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. The final

  20. B plant/WESF integrated annual safety appraisal

    International Nuclear Information System (INIS)

    Anderson, J.K.

    1990-12-01

    This report provides the results of the Fiscal Year 1990 Annual Integrated Safety Appraisal of the B Plant and Waste Encapsulation and Storage Facility in the Hanford Site 200 East Area. The appraisal was conducted in August and September 1990, by the Defense Waste Disposal Safety group, in conjunction with Health Physics and Emergency Preparedness. Reports of these three organizations for their areas of responsibility are presented. The purpose of the appraisal was to determine if the areas being appraised meet US Department of Energy (DOE) and Westinghouse Hanford Company (WHC) requirements and current industry standards of good practice. A further purpose was to identify areas in which program effectiveness could be improved. In accordance with the guidance of WHC Management Requirements and Procedures 5.6, previously identified deficiencies which are being resolved by line management were not repeated as Findings or Observations unless progress or intended disposition was considered to be unsatisfactory. The overall assessment is that there are no major safety problems associated with current operations. Programs are in place to provide the necessary safety controls, evaluations, overviews, and support. In most respects these programs are being implemented effectively. However, there are a number of deficiencies in details of program design and implementation. The appraisal identified a total of 23 Findings and 27 Observations of deficiencies. All Observations are Seriousness Category 3. Fifteen Findings were Category 2 and 8 were Category 3. Most of the Category 2 Findings were so categorized on the basis of noncompliance with mandatory DOE Orders or WHC policies and procedures, rather than potential risk to personnel