Sample records for exploratory post hoc

  1. Rotigotine and specific non-motor symptoms of Parkinson's disease: post hoc analysis of RECOVER.

    PubMed

    Ray Chaudhuri, K; Martinez-Martin, Pablo; Antonini, Angelo; Brown, Richard G; Friedman, Joseph H; Onofrj, Marco; Surmann, Erwin; Ghys, Liesbet; Trenkwalder, Claudia

    2013-07-01

    Non-motor symptoms of Parkinson's disease (PD) represent major causes of morbidity. RECOVER, a randomized controlled trial of rotigotine transdermal system, was the first prospective controlled trial to use the Non-Motor Symptoms Scale (NMSS) as an exploratory outcome for assessment of treatment effects on non-motor symptoms in PD. Rotigotine improved NMSS total score compared with placebo, and the "Sleep/fatigue" and "Mood/apathy" domains. This post hoc analysis further characterizes the effects of rotigotine on sleep/fatigue and mood/apathy. Patients with PD and unsatisfactory early-morning motor impairment were randomized to transdermal patches of rotigotine (2-16 mg/24 h) or placebo. Treatment was titrated to optimal dose over 1-8 weeks, maintained for 4 weeks. The NMSS was assessed at baseline and end of treatment. Post hoc analyses are presented for individual items of the "Sleep/fatigue" and "Mood/apathy" domains. The interpretation of p-values is considered exploratory in nature. Of 287 patients randomized, NMSS data were available for 267 patients (178 rotigotine, 89 placebo). Within the "Sleep/fatigue" domain there was a significant difference, in favor of rotigotine, in change from baseline score in 1 of 5 items: "fatigue (tiredness) or lack of energy" (ANCOVA, p < 0.0001). Within the "Mood/apathy" domain, there were significant differences in favor of rotigotine in 4 of 7 items: "lost interest in surroundings" (p < 0.0001), "lost interest in doing things" (p < 0.0001), "seems sad or depressed" (p < 0.01), and "difficulty experiencing pleasure" (p < 0.05). Rotigotine transdermal system may improve non-motor symptoms such as fatigue, symptoms of depression, anhedonia, and apathy in patients with PD; further prospective controlled studies are required to confirm this post hoc analysis. Copyright © 2013 Elsevier Ltd. All rights reserved.

  2. An Exploratory Study in School Counselor Consultation Engagement

    ERIC Educational Resources Information Center

    Perera-Diltz, Dilani M.; Moe, Jeffry L.; Mason, Kimberly L.

    2011-01-01

    Consultation, an indirect school counselor service, is provided by 79% (n = 998) school counselor currently. Most frequently consultation occurs with teachers, parents, and principals. MANOVA and post hoc analysis indicate differences in consultation practices across academic levels. Choosing a consultation model based on the type of service…

  3. The Interaction of Motivation and Therapist Adherence Predicts Outcome in Cognitive Behavioral Therapy for Panic Disorder: Preliminary Findings

    ERIC Educational Resources Information Center

    Huppert, Jonathan D.; Barlow, David H.; Gorman, Jack M.; Shear, M. Katherine; Woods, Scott W.

    2006-01-01

    This report is a post-hoc, exploratory examination of the relationships among patient motivation, therapist protocol adherence, and panic disorder outcome in patients treated with cognitive behavioral therapy within the context of a randomized clinical trial for the treatment of panic disorder (Barlow, Gorman, Shear, & Woods, 2000). Results…

  4. Nurse adoption of continuous patient monitoring on acute post-surgical units: managing technology implementation.

    PubMed

    Jeskey, Mary; Card, Elizabeth; Nelson, Donna; Mercaldo, Nathaniel D; Sanders, Neal; Higgins, Michael S; Shi, Yaping; Michaels, Damon; Miller, Anne

    2011-10-01

    To report an exploratory action-research process used during the implementation of continuous patient monitoring in acute post-surgical nursing units. Substantial US Federal funding has been committed to implementing new health care technology, but failure to manage implementation processes may limit successful adoption and the realisation of proposed benefits. Effective approaches for managing barriers to new technology implementation are needed. Continuous patient monitoring was implemented in three of 13 medical/surgical units. An exploratory action-feedback approach, using time-series nurse surveys, was used to identify barriers and develop and evaluate responses. Post-hoc interviews and document analysis were used to describe the change implementation process. Significant differences were identified in night- and dayshift nurses' perceptions of technology benefits. Research nurses' facilitated the change process by evolving 'clinical nurse implementation specialist' expertise. Health information technology (HIT)-related patient outcomes are mediated through nurses' acting on new information but HIT designed for critical care may not transfer to acute care settings. Exploratory action-feedback approaches can assist nurse managers in assessing and mitigating the real-world effects of HIT implementations. It is strongly recommended that nurse managers identify stakeholders and develop comprehensive plans for monitoring the effects of HIT in their units. © 2011 Blackwell Publishing Ltd.

  5. Investigating the Reliability and Factor Structure of Kalichman's "Survey 2: Research Misconduct" Questionnaire: A Post Hoc Analysis Among Biomedical Doctoral Students in Scandinavia.

    PubMed

    Holm, Søren; Hofmann, Bjørn

    2017-10-01

    A precondition for reducing scientific misconduct is evidence about scientists' attitudes. We need reliable survey instruments, and this study investigates the reliability of Kalichman's "Survey 2: research misconduct" questionnaire. The study is a post hoc analysis of data from three surveys among biomedical doctoral students in Scandinavia (2010-2015). We perform reliability analysis, and exploratory and confirmatory factor analysis using a split-sample design as a partial validation. The results indicate that a reliable 13-item scale can be formed (Cronbach's α = .705), and factor analysis indicates that there are four reliable subscales each tapping a different construct: (a) general attitude to misconduct (α = .768), (b) attitude to personal misconduct (α = .784), (c) attitude to whistleblowing (α = .841), and (d) attitude to blameworthiness/punishment (α = .877). A full validation of the questionnaire requires further research. We, nevertheless, hope that the results will facilitate the increased use of the questionnaire in research.

  6. Migraine and Cardiovascular Disease in Women: the Role of Aspirin – Subgroup Analyses in the Women’s Health Study

    PubMed Central

    Kurth, Tobias; Diener, Hans-Christoph; Buring, Julie E.

    2011-01-01

    Background Migraine with aura (MA) has been associated with increased risk of cardiovascular disease (CVD). The role of aspirin on this association remains unclear. Methods Post-hoc subgroup analyses of the Women’s Health Study, a randomized trial testing 100mg aspirin on alternate days in primary prevention of CVD among 39,876 women aged ≥45. Results During 10 years, 998 major CVD events were confirmed in 39,757 women with complete migraine information. Aspirin reduced risk of ischemic stroke (RR=0.76; 95%CI=0.63–0.93) but not other CVD. Migraine or MA did not modify the effect of aspirin on CVD except for myocardial infarction (MI) (p-interaction=0.01). Women with MA on aspirin had increased risk of MI (RR=3.72, 95%CI=1.39–9.95). Further exploratory analyses indicate this is only apparent among women with MA on aspirin who ever smoked or had history of hypertension (p-interaction<0.01). Conclusion In post-hoc subgroup analyses, aspirin had similar protective effects on ischemic stroke for women with or without migraine. By contrast, our data suggest that women with MA on aspirin had increased risk of MI. The small number of outcome events in subgroups, the exploratory nature of our analyses, and lack of plausible mechanisms raise the possibility of a chance finding, which must caution the interpretation. PMID:21673005

  7. Rotigotine transdermal system and evaluation of pain in patients with Parkinson's disease: a post hoc analysis of the RECOVER study.

    PubMed

    Kassubek, Jan; Chaudhuri, Kallol Ray; Zesiewicz, Theresa; Surmann, Erwin; Boroojerdi, Babak; Moran, Kimberly; Ghys, Liesbet; Trenkwalder, Claudia

    2014-03-06

    Pain is a troublesome non-motor symptom of Parkinson's disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting 'any' pain (pain score ≥1) at baseline, and subgroups reporting 'mild' (score 1-3), and 'moderate-to-severe' pain (score ≥4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a ≥30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported 'any' pain; of these 87 (33%) reported 'mild', and 100 (37%) 'moderate-to-severe' pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with 'any' pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with 'moderate-to-severe' pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders. The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine; this may be partly attributable to benefits in motor function and sleep disturbances. Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings.

  8. Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis.

    PubMed

    Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

    2016-04-02

    Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD). To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. 130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD.

  9. Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson’s Disease: A Post Hoc Analysis

    PubMed Central

    Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

    2016-01-01

    Background: Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson’s disease (PD). Objective: To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. Methods: In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as “Selegiline+Rotigotine” and “Selegiline+Placebo”. Outcome measures included change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. Results: 130 patients were evaluable for efficacy analyses (“Selegiline+Rotigotine”: 84, “Selegiline+Placebo”: 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: –4.89 [–7.87 to –1.91], p = 0.0015; for UPDRS II+III: –5.76 [–9.71 to –1.82], p = 0.0045). Higher proportion of patients in the “Selegiline+Rotigotine” group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. Conclusions: In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD. PMID:27061066

  10. Rotigotine transdermal system and evaluation of pain in patients with Parkinson’s disease: a post hoc analysis of the RECOVER study

    PubMed Central

    2014-01-01

    Background Pain is a troublesome non-motor symptom of Parkinson’s disease (PD). The RECOVER (Randomized Evaluation of the 24-hour Coverage: Efficacy of Rotigotine; Clintrials.gov: NCT00474058) study demonstrated significant improvements in early-morning motor function (UPDRS III) and sleep disturbances (PDSS-2) with rotigotine transdermal system. Improvements were also reported on a Likert pain scale (measuring any type of pain). This post hoc analysis of RECOVER further evaluates the effect of rotigotine on pain, and whether improvements in pain may be attributable to benefits in motor function or sleep disturbance. Methods PD patients with unsatisfactory early-morning motor impairment were randomized to optimal-dose (up to 16 mg/24 h) rotigotine or placebo, maintained for 4 weeks. Pain was assessed in the early-morning using an 11-point Likert pain scale (rated average severity of pain (of any type) over the preceding 12 hours from 0 [no pain] to 10 [worst pain ever experienced]). Post hoc analyses for patients reporting ‘any’ pain (pain score ≥1) at baseline, and subgroups reporting ‘mild’ (score 1–3), and ‘moderate-to-severe’ pain (score ≥4) were performed. Likert pain scale change from baseline in rotigotine-treated patients was further analyzed based on a UPDRS III/PDSS-2 responder analysis (a responder defined as showing a ≥30% reduction in early morning UPDRS III total score or PDSS-2 total score). As post hoc analyses, all p values presented are exploratory. Results Of 267 patients with Likert pain data (178 rotigotine, 89 placebo), 187 (70%) reported ‘any’ pain; of these 87 (33%) reported ‘mild’, and 100 (37%) ‘moderate-to-severe’ pain. Change from baseline pain scores decreased with rotigotine compared with placebo in patients with ‘any’ pain (-0.88 [95% CI: -1.56, -0.19], p = 0.013), and in the subgroup with ‘moderate-to-severe’ pain (-1.38 [-2.44, -0.31], p = 0.012). UPDRS III or PDSS-2 responders showed greater improvement in pain than non-responders. Conclusions The results from this post hoc analysis of the RECOVER study suggest that pain was improved in patients with PD treated with rotigotine; this may be partly attributable to benefits in motor function and sleep disturbances. Prospective studies are warranted to investigate this potential benefit and the clinical relevance of these findings. PMID:24602411

  11. Efficacy of Rotigotine at Different Stages of Parkinson's Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage.

    PubMed

    Giladi, Nir; Nicholas, Anthony P; Asgharnejad, Mahnaz; Dohin, Elisabeth; Woltering, Franz; Bauer, Lars; Poewe, Werner

    2016-10-19

    The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in 'off' state) Parkinson's disease (PD). To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory. Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p < 0.05 for each HY stage), with treatment differences increasing with increasing HY stages. Similar results were observed for UPDRS II and UPDRS III. This post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1-4).

  12. Measuring the Effectiveness of a Genetic Counseling Supervision Training Conference.

    PubMed

    Atzinger, Carrie L; He, Hua; Wusik, Katie

    2016-08-01

    Genetic counselors who receive formal training report increased confidence and competence in their supervisory roles. The effectiveness of specific formal supervision training has not been assessed previously. A day-long GC supervision conference was designed based on published supervision competencies and was attended by 37 genetic counselors. Linear Mixed Model and post-hoc paired t-test was used to compare Psychotherapy Supervisor Development Scale (PSDS) scores among/between individuals pre and post conference. Generalized Estimating Equation (GEE) model and post-hoc McNemar's test was used to determine if the conference had an effect on GC supervision competencies. PSDS scores were significantly increased 1 week (p < 0.001) and 6 months (p < 0.001) following the conference. For three supervision competencies, attendees were more likely to agree they were able to perform them after the conference than before. These effects remained significant 6 months later. For the three remaining competencies, the majority of supervisors agreed they could perform these before the conference; therefore, no change was found. This exploratory study showed this conference increased the perceived confidence and competence of the supervisors who attended and increased their self-reported ability to perform certain supervision competencies. While still preliminary, this supports the idea that a one day conference on supervision has the potential to impact supervisor development.

  13. In Situ Distribution Guided Analysis and Visualization of Transonic Jet Engine Simulations.

    PubMed

    Dutta, Soumya; Chen, Chun-Ming; Heinlein, Gregory; Shen, Han-Wei; Chen, Jen-Ping

    2017-01-01

    Study of flow instability in turbine engine compressors is crucial to understand the inception and evolution of engine stall. Aerodynamics experts have been working on detecting the early signs of stall in order to devise novel stall suppression technologies. A state-of-the-art Navier-Stokes based, time-accurate computational fluid dynamics simulator, TURBO, has been developed in NASA to enhance the understanding of flow phenomena undergoing rotating stall. Despite the proven high modeling accuracy of TURBO, the excessive simulation data prohibits post-hoc analysis in both storage and I/O time. To address these issues and allow the expert to perform scalable stall analysis, we have designed an in situ distribution guided stall analysis technique. Our method summarizes statistics of important properties of the simulation data in situ using a probabilistic data modeling scheme. This data summarization enables statistical anomaly detection for flow instability in post analysis, which reveals the spatiotemporal trends of rotating stall for the expert to conceive new hypotheses. Furthermore, the verification of the hypotheses and exploratory visualization using the summarized data are realized using probabilistic visualization techniques such as uncertain isocontouring. Positive feedback from the domain scientist has indicated the efficacy of our system in exploratory stall analysis.

  14. Factors impacting the efficacy of venlafaxine extended release 75–225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan

    PubMed Central

    Watanabe, Yoshinori; Asami, Yuko; Hirano, Yoko; Kuribayashi, Kazuhiko; Itamura, Rio; Imaeda, Takayuki

    2018-01-01

    Purpose To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75–225 mg/day dose in patients with major depressive disorder (MDD). Methods We performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression–17 items (HAM-D17) total score, Hamilton Rating Scale for Depression–6 items score, and Montgomery–Asberg Depression Rating Scale total score. The following factors were considered in the subgroup analyses: sex, age, HAM-D17 total score at baseline, duration of MDD, duration of current depressive episode, history of previous depressive episodes, history of previous medications for MDD, and CYP2D6 phenotype. For each subgroup, an analysis of covariance model was fitted and the adjusted mean of the treatment effect and corresponding 95% CI were computed. Due to the exploratory nature of the investigation, no statistical hypothesis testing was used. Results Venlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group. Conclusion These results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER. PMID:29844674

  15. Factors impacting the efficacy of venlafaxine extended release 75-225 mg/day in patients with major depressive disorder: exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study in Japan.

    PubMed

    Watanabe, Yoshinori; Asami, Yuko; Hirano, Yoko; Kuribayashi, Kazuhiko; Itamura, Rio; Imaeda, Takayuki

    2018-01-01

    To explore the potential factors impacting the efficacy of venlafaxine extended release (ER) and treatment differences between 75 mg/day and 75-225 mg/day dose in patients with major depressive disorder (MDD). We performed exploratory post hoc subgroup analyses of a randomized, double-blind, placebo-controlled study conducted in Japan. A total of 538 outpatients aged 20 years or older with a primary diagnosis of MDD who experienced single or recurrent episodes were randomized into three groups: fixed-dose, flexible-dose, or placebo. Venlafaxine ER was initiated at 37.5 mg/day and titrated to 75 mg/day for both fixed-dose and flexible-dose group, and to 225 mg/day for flexible-dose group (if well tolerated). Efficacy endpoints were changes from baseline at Week 8 using the Hamilton Rating Scale for Depression-17 items (HAM-D 17 ) total score, Hamilton Rating Scale for Depression-6 items score, and Montgomery-Asberg Depression Rating Scale total score. The following factors were considered in the subgroup analyses: sex, age, HAM-D 17 total score at baseline, duration of MDD, duration of current depressive episode, history of previous depressive episodes, history of previous medications for MDD, and CYP2D6 phenotype. For each subgroup, an analysis of covariance model was fitted and the adjusted mean of the treatment effect and corresponding 95% CI were computed. Due to the exploratory nature of the investigation, no statistical hypothesis testing was used. Venlafaxine ER improved symptoms of MDD compared with placebo in most subgroups. The subgroup with a long duration of MDD (>22 months) consistently showed greater treatment benefits in the flexible-dose group than in the fixed-dose group. These results suggest that a greater treatment response to venlafaxine ER (up to 225 mg/day) can be seen in patients with a longer duration of MDD. Further investigations are needed to identify additional factors impacting the efficacy of venlafaxine ER.

  16. Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis.

    PubMed

    Davis, Lori L; Pilkinton, Patricia; Poddar, Swati; Blansett, Catherine; Toscano, Richard; Parker, Pamela E

    2014-06-01

    To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder (PTSD). A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized, controlled trial of Individual Placement and Support in Veterans with PTSD. When examining groups within each moderator, there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation (number needed to treat [NNT] = 1.5) and inadequate housing (NNT = 1.5) compared with the main finding of the pilot study (NNT = 2.07). Compared with the main finding of the pilot study, there was no greater advantage of IPS for those with adequate transportation (NNT = 2.4) or adequate housing (NNT = 2.4). Compared with the main finding in the pilot study, those without a family care burden had a greater benefit from IPS (NNT = 1.4) and those with family care burden had a reduced treatment effect (NNT = 3.3). These results are exploratory and are not intended to guide clinical decision-making, but rather offer a potentially useful strategy in the design of larger trials of IPS.

  17. Exploring the Use of Individualized, Reflective Guidance In an Educational Multi-User Virtual Environment

    NASA Astrophysics Data System (ADS)

    Nelson, Brian C.

    2007-02-01

    This study examines the patterns of use and potential impact of individualized, reflective guidance in an educational Multi-User Virtual Environment (MUVE). A guidance system embedded within a MUVE-based scientific inquiry curriculum was implemented with a sample of middle school students in an exploratory study investigating (a) whether access to the guidance system was associated with improved learning, (b) whether students viewing more guidance messages saw greater improvement on content tests than those viewing less, and (c) whether there were any differences in guidance use among boys and girls. Initial experimental findings showed that basic access to individualized guidance used with a MUVE had no measurable impact on learning. However, post-hoc exploratory analyses indicated that increased use of the system among those with access to it was positively associated with content test score gains. In addition, differences were found in overall learning outcomes by gender and in patterns of guidance use by boys and girls, with girls outperforming boys across a spectrum of guidance system use. Based on these exploratory findings, the paper suggests design guidelines for the development of guidance systems embedded in MUVEs and outlines directions for further research.

  18. Efficacy of Rotigotine at Different Stages of Parkinson’s Disease Symptom Severity and Disability: A Post Hoc Analysis According to Baseline Hoehn and Yahr Stage

    PubMed Central

    Giladi, Nir; Nicholas, Anthony P.; Asgharnejad, Mahnaz; Dohin, Elisabeth; Woltering, Franz; Bauer, Lars; Poewe, Werner

    2016-01-01

    Background: The efficacy of rotigotine has been demonstrated in studies of patients with early (i.e. not receiving levodopa) and advanced (i.e. not adequately controlled on levodopa; average 2.5 h/day in ‘off’ state) Parkinson’s disease (PD). Objective: To further investigate the efficacy of rotigotine transdermal patch across different stages of PD symptom severity and functional disability, according to baseline Hoehn and Yahr (HY) staging. Methods: Post hoc analysis of six placebo-controlled studies of rotigotine in patients with early PD (SP506, SP512, SP513; rotigotine ≤8 mg/24 h) or advanced-PD (CLEOPATRA-PD, PREFER, SP921; rotigotine ≤16 mg/24 h). Data were pooled and analyzed according to baseline HY stage (1, 2, 3 or 4) for change from baseline to end of maintenance in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), UPDRS III (motor) and UPDRS II+III; statistical tests are exploratory. Results: Data were available for 2057 patients (HY 1 : 262; HY 2 : 1230; HY 3 : 524; HY 4 : 41). Patients at higher HY stages were older, had a longer time since PD diagnosis and higher baseline UPDRS II+III scores vs patients at lower HY stages. Rotigotine improved UPDRS II+III versus placebo for each individual HY stage (p < 0.05 for each HY stage), with treatment differences increasing with increasing HY stages. Similar results were observed for UPDRS II and UPDRS III. Conclusions: This post hoc analysis suggests that rotigotine may be efficacious across a broad range of progressive stages of PD symptom severity and functional disability (HY stages 1–4). PMID:27567886

  19. The Advantages of Using Planned Comparisons over Post Hoc Tests.

    ERIC Educational Resources Information Center

    Kuehne, Carolyn C.

    There are advantages to using a priori or planned comparisons rather than omnibus multivariate analysis of variance (MANOVA) tests followed by post hoc or a posteriori testing. A small heuristic data set is used to illustrate these advantages. An omnibus MANOVA test was performed on the data followed by a post hoc test (discriminant analysis). A…

  20. On the Post Hoc Power in Testing Mean Differences

    ERIC Educational Resources Information Center

    Yuan, Ke-Hai; Maxwell, Scott

    2005-01-01

    Retrospective or post hoc power analysis is recommended by reviewers and editors of many journals. Little literature has been found that gave a serious study of the post hoc power. When the sample size is large, the observed effect size is a good estimator of the true power. This article studies whether such a power estimator provides valuable…

  1. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis

    PubMed Central

    LeWitt, Peter A.; Poewe, Werner; Elmer, Lawrence W.; Asgharnejad, Mahnaz; Boroojerdi, Babak; Grieger, Frank; Bauer, Lars

    2016-01-01

    Objectives Transdermal delivery of rotigotine maintains stable plasma concentrations for 24 hours. Three phase 3 studies of rotigotine as add-on to levodopa in advanced Parkinson's disease showed a significant reduction in “off” time from baseline to end of maintenance (EoM). However, detailed analyses over the range of a day have not yet been performed. The objective was to examine the time course of the efficacy profile of rotigotine throughout the day. Methods Post hoc analysis of diary data from 3 double-blind, placebo-controlled studies of rotigotine in patients with advanced Parkinson's disease inadequately controlled with levodopa, with average “off” time of ≥2.5 h/d (CLEOPATRA-PD [NCT00244387], 16-week maintenance; PREFER, 24-week maintenance; SP921 [NCT00522379], 12-week maintenance). Patients marked 30-minute intervals as “off,” “on without troublesome dyskinesia,” “on with troublesome dyskinesia,” or “sleep.” Diaries completed on the 3 days before EoM were analyzed. A 2-sample t test was performed for comparison of rotigotine + levodopa versus placebo + levodopa for mean percentage of time per status during four 6-hour periods: 12:00am (midnight) to 6:00am, 6:00am to 12:00pm (noon), noon to 6:00pm, and 6:00pm to midnight. Results Data were available for 967 patients (placebo + levodopa, 260; rotigotine + levodopa, 707). During the 24-hour period at EoM, an advantage in mean percentage time spent “off” and “on without troublesome dyskinesia” was observed with rotigotine + levodopa versus placebo + levodopa during the three 6-hour periods from 6:00am to midnight (P < 0.05; exploratory analysis). Conclusions These exploratory analyses of patients with motor fluctuations suggest that the efficacy of rotigotine transdermal patch, as captured by diary data, in reducing “off” time and increasing “on time without troublesome dyskinesia” may cover the full waking day. PMID:26882318

  2. The Efficacy Profile of Rotigotine During the Waking Hours in Patients With Advanced Parkinson's Disease: A Post Hoc Analysis.

    PubMed

    LeWitt, Peter A; Poewe, Werner; Elmer, Lawrence W; Asgharnejad, Mahnaz; Boroojerdi, Babak; Grieger, Frank; Bauer, Lars

    2016-01-01

    Transdermal delivery of rotigotine maintains stable plasma concentrations for 24 hours. Three phase 3 studies of rotigotine as add-on to levodopa in advanced Parkinson's disease showed a significant reduction in "off" time from baseline to end of maintenance (EoM). However, detailed analyses over the range of a day have not yet been performed. The objective was to examine the time course of the efficacy profile of rotigotine throughout the day. Post hoc analysis of diary data from 3 double-blind, placebo-controlled studies of rotigotine in patients with advanced Parkinson's disease inadequately controlled with levodopa, with average "off" time of ≥2.5 h/d (CLEOPATRA-PD [NCT00244387], 16-week maintenance; PREFER, 24-week maintenance; SP921 [NCT00522379], 12-week maintenance). Patients marked 30-minute intervals as "off," "on without troublesome dyskinesia," "on with troublesome dyskinesia," or "sleep." Diaries completed on the 3 days before EoM were analyzed. A 2-sample t test was performed for comparison of rotigotine + levodopa versus placebo + levodopa for mean percentage of time per status during four 6-hour periods: 12:00AM (midnight) to 6:00AM, 6:00AM to 12:00PM (noon), noon to 6:00PM, and 6:00PM to midnight. Data were available for 967 patients (placebo + levodopa, 260; rotigotine + levodopa, 707). During the 24-hour period at EoM, an advantage in mean percentage time spent "off" and "on without troublesome dyskinesia" was observed with rotigotine + levodopa versus placebo + levodopa during the three 6-hour periods from 6:00AM to midnight (P < 0.05; exploratory analysis). These exploratory analyses of patients with motor fluctuations suggest that the efficacy of rotigotine transdermal patch, as captured by diary data, in reducing "off" time and increasing "on time without troublesome dyskinesia" may cover the full waking day.

  3. Fluoxetine-clonazepam cotherapy for anxious depression: an exploratory, post-hoc analysis of a randomized, double blind study.

    PubMed

    Papakostas, George I; Clain, Alisabet; Ameral, Victoria E; Baer, Lee; Brintz, Carrie; Smith, Ward T; Londborg, Peter D; Glaudin, Vincent; Painter, John R; Fava, Maurizio

    2010-01-01

    Anxious depression, defined as major depressive disorder (MDD) accompanied by high levels of anxiety, seems to be both common and difficult to treat, with antidepressant monotherapy often yielding modest results. We sought to examine the relative benefits of antidepressant-anxiolytic cotherapy versus antidepressant monotherapy for patients with anxious depression versus without anxious depression. We conducted a post-hoc analysis of an existing dataset (N=80), from a 3-week, randomized, double-blind trial which demonstrated cotherapy with fluoxetine and clonazepam to result in superior efficacy than fluoxetine monotherapy in MDD. The present analysis involved examining whether anxious depression status served as a predictor and moderator of symptom improvement. Anxious depression status was not found to predict symptom improvement, or serve as a moderator of clinical improvement to cotherapy versus monotherapy. However, the advantage in remission rates in favor of cotherapy versus monotherapy was, numerically, much larger for patients with anxious depression (32.2%) than it was for patients without anxious MDD (9.7%). The respective number needed to treat statistic for these two differences in response rates were, approximately, one in three for patients with anxious depression versus one in 10 for patients without anxious depression. The efficacy of fluoxetine-clonazepam cotherapy compared with fluoxetine monotherapy was numerically but not statistically enhanced for patients with anxious depression than those without anxious depression.

  4. Effects of Visual, Auditory, and Tactile Navigation Cues on Navigation Performance, Situation Awareness, and Mental Workload

    DTIC Science & Technology

    2007-02-01

    Differences (ANOVA post hoc analyses) (Experiment 1) 45 Appendix D. NASA - TLX Subscale Score Mean Differences (ANOVA post hoc analyses) (Experiment 1) 47... NASA - TLX Subscale Score Mean Differences (ANOVA post hoc analyses) (Experiment 2) 55 Distribution List 56 v List of Figures Figure 1...15 Figure 16. Overall NASA - TLX score versus waypoint display modality................................... 16

  5. Muscle dysmorphia, gender role stress, and sociocultural influences: an exploratory study.

    PubMed

    Tucker, Readdy; Watkins, Patti Lou; Cardinal, Bradley J

    2011-06-01

    Our study explored the contribution of gender role stress (GRS) and sociocultural appearance demands to symptoms of muscle dysmorphia (MD) in a college sample of 219 women and 154 men. For women, five GRS subscales, sociocultural appearance demands, age, and frequency of aerobic exercise predicted MD symptoms (model R2 = .33; F(8,210) = 12.81, p < . 001); for men, only one GRS subscale, age, and sociocultural appearance demands predicted MD symptoms (model R2 = .40; F(3,150) = 9.52, p < .001). Post hoc analyses revealed that a small number of items explained a substantial portion of the variation, suggesting that MD may be more related to specific perceptions of pressure to attain an attractive body than to global gender role stress.

  6. Valid randomization-based p-values for partially post hoc subgroup analyses.

    PubMed

    Lee, Joseph J; Rubin, Donald B

    2015-10-30

    By 'partially post-hoc' subgroup analyses, we mean analyses that compare existing data from a randomized experiment-from which a subgroup specification is derived-to new, subgroup-only experimental data. We describe a motivating example in which partially post hoc subgroup analyses instigated statistical debate about a medical device's efficacy. We clarify the source of such analyses' invalidity and then propose a randomization-based approach for generating valid posterior predictive p-values for such partially post hoc subgroups. Lastly, we investigate the approach's operating characteristics in a simple illustrative setting through a series of simulations, showing that it can have desirable properties under both null and alternative hypotheses. Copyright © 2015 John Wiley & Sons, Ltd.

  7. Post Hoc Analyses of ApoE Genotype-Defined Subgroups in Clinical Trials.

    PubMed

    Kennedy, Richard E; Cutter, Gary R; Wang, Guoqiao; Schneider, Lon S

    2016-01-01

    Many post hoc analyses of clinical trials in Alzheimer's disease (AD) and mild cognitive impairment (MCI) are in small Phase 2 trials. Subject heterogeneity may lead to statistically significant post hoc results that cannot be replicated in larger follow-up studies. We investigated the extent of this problem using simulation studies mimicking current trial methods with post hoc analyses based on ApoE4 carrier status. We used a meta-database of 24 studies, including 3,574 subjects with mild AD and 1,171 subjects with MCI/prodromal AD, to simulate clinical trial scenarios. Post hoc analyses examined if rates of progression on the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog) differed between ApoE4 carriers and non-carriers. Across studies, ApoE4 carriers were younger and had lower baseline scores, greater rates of progression, and greater variability on the ADAS-cog. Up to 18% of post hoc analyses for 18-month trials in AD showed greater rates of progression for ApoE4 non-carriers that were statistically significant but unlikely to be confirmed in follow-up studies. The frequency of erroneous conclusions dropped below 3% with trials of 100 subjects per arm. In MCI, rates of statistically significant differences with greater progression in ApoE4 non-carriers remained below 3% unless sample sizes were below 25 subjects per arm. Statistically significant differences for ApoE4 in post hoc analyses often reflect heterogeneity among small samples rather than true differential effect among ApoE4 subtypes. Such analyses must be viewed cautiously. ApoE genotype should be incorporated into the design stage to minimize erroneous conclusions.

  8. Inhibition of Orthopaedic Implant Infections by Immunomodulatory Effects of Host Defense Peptides

    DTIC Science & Technology

    2014-12-01

    significance was determined by t- tests or by one-way analysis of variance (ANOVA) followed by Bonferroni post hoc tests in experiments with multiple...groups. Non- parametric Mann-Whitney tests , Kruskal-Wallis ANOVA followed by Newman-Kuels post hoc tests , or van Elteren’s two-way tests were applied to...in D, and black symbols in A), statistical analysis was by one-way ANOVA followed by Bonferroni versus control, post hoc tests . Otherwise, statistical

  9. Zinc Finger Transcription Factors as Novel Genetic Switches to Modulate Metastatic Progression of Breast Tumors

    DTIC Science & Technology

    2008-05-01

    critical level of significance set up at P < 0.05, and significant differences between groups of treatments were analyzed with post hoc Turkish test ...2008 differences between groups of treatments were analyzed with post hoc Turkish test . As shown in Fig. 2A, particular ATFs synergized with chromatin...using ANOVA test and the post hoc Turkish test ; critical level of significance was set up at P < 0.05. B, real- time expression analysis of maspin mRNA

  10. An exploratory study of death anxiety and trainees' choice of theoretical orientation.

    PubMed

    Belviso, Francesco; Gaubatz, Michael D

    2013-01-01

    This study investigated the association between therapist trainees' death anxiety and their preference for "objective" (i.e., quantitative and rational) over "subjective" (i.e., experiential and symbolic) theoretical orientations. In this correlational investigation, 303 clinical psychology and counseling trainees at a Midwestern school of professional psychology completed instruments assessing their fear of personal death and their endorsement of superordinate dimensions of psychotherapy orientations. As hypothesized, trainees who reported higher levels of death anxiety displayed a stronger preference for objective over subjective orientations, a relationship that was found in post hoc analyses to be particularly salient for male trainees. These findings suggest that trainees' death anxiety, and their attempts to control it, could influence their choice of a theoretical orientation. Potential implications for training institutions are discussed.

  11. An exploratory study of death anxiety and trainees' choice of theoretical orientation.

    PubMed

    Belviso, Francesco; Gaubatz, Michael D

    This study investigated the association between therapist-trainees' death anxiety and their preference for "objective" (i.e., quantitative and rational) over "subjective" (i.e., experiential and symbolic) theoretical orientations. In this correlational investigation, 303 clinical psychology and counseling trainees at a Midwestern school of professional psychology completed instruments assessing their fear of personal death and their endorsement of superordinate dimensions of psychotherapy orientations. As hypothesized, trainees who reported higher levels of death anxiety displayed a stronger preference for objective over subjective orientations, a relationship that was found in post-hoc analyses to be particularly salient for male trainees. These findings suggest that trainees' death anxiety, and their attempts to control it, could influence their choice of a theoretical orientation. Potential implications for training institutions are discussed.

  12. Assessing infertility-related stress: the factor structure of the Fertility Problem Inventory in Italian couples undergoing infertility treatment.

    PubMed

    Donarelli, Zaira; Gullo, Salvatore; Lo Coco, Gianluca; Marino, Angelo; Scaglione, Piero; Volpes, Aldo; Allegra, Adolfo

    2015-01-01

    The factor structure of the Fertility Problem Inventory (FPI) and its invariance across gender were examined in Italian couples undergoing infertility treatment. About 1000 subjects (both partners of 500 couples) completed two questionnaires prior to commencing infertility treatment at a private Clinic in Palermo, Italy. Confirmatory Factor Analysis demonstrated that the original factor structure of the FPI was partially confirmed. Two correlated factors (Infertility Life Domains and Importance of Parenthood) were obtained via a post hoc Exploratory Factor Analysis. Finally, the invariance of this factor structure across gender was confirmed. The study supported the relevance of two interrelated factors specific to infertility stress which could help clinicians to focus on the core infertility-related stress domains of infertile couples.

  13. Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: the case of acute stroke trials.

    PubMed

    Jafari, Nahid; Hearne, John; Churilov, Leonid

    2013-11-10

    A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. Copyright © 2013 John Wiley & Sons, Ltd.

  14. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries.

    PubMed

    Gruber, Joann F; Hille, Darcy A; Liu, G Frank; Kaplan, Susan S; Nelson, Micki; Goveia, Michelle G; Mast, T Christopher

    2017-01-01

    Rotavirus is the leading cause of severe diarrhea worldwide in young children. Although rotavirus vaccine efficacy is high in developed countries, efficacy is lower in developing countries. Here, we investigated heterogeneity of rotavirus vaccine efficacy by infant characteristics in developing countries. An exploratory, post hoc analysis was conducted using randomized controlled trial data of the pentavalent rotavirus vaccine (RV5) conducted in Africa and Asia (NCT00362648). Infants received either 3 doses of vaccine/placebo and were followed for up to 2 years. Within subgroups, vaccine efficacies and 95% confidence intervals (CIs) against rotavirus gastroenteritis (RVGE) were estimated using Poisson regression. We assessed heterogeneity of efficacy by age at first dose, gender, breastfeeding status and nutrition status. African children receiving the first dose at <8 weeks had lower efficacy (23.7%; 95% CI: -8.2%-46.3%) than those vaccinated at ≥8 weeks (59.1%; 95% CI: 34.0%-74.6%). Marginally statistically significant differences were observed by age at first dose, gender and underweight status in Ghana and gender in Asian countries. Heterogeneity of efficacy was observed for age at first dose in African countries. This was an exploratory analysis; additional studies are needed to validate these results.

  15. Sigsearch: a new term for post hoc unplanned search for statistically significant relationships with the intent to create publishable findings.

    PubMed

    Hashim, Muhammad Jawad

    2010-09-01

    Post-hoc secondary data analysis with no prespecified hypotheses has been discouraged by textbook authors and journal editors alike. Unfortunately no single term describes this phenomenon succinctly. I would like to coin the term "sigsearch" to define this practice and bring it within the teaching lexicon of statistics courses. Sigsearch would include any unplanned, post-hoc search for statistical significance using multiple comparisons of subgroups. It would also include data analysis with outcomes other than the prespecified primary outcome measure of a study as well as secondary data analyses of earlier research.

  16. An exploratory thermographic investigation of the effects of connective tissue massage on autonomic function.

    PubMed

    Holey, Liz A; Dixon, John; Selfe, James

    2011-09-01

    The purpose of this study was to measure effects of connective tissue massage (CTM) on the autonomic nervous system using thermography and physiological measurements. A repeated-measures design was used. The setting was a university laboratory. Skin temperature at the site of massage, blood pressure, heart rate, and dorsal foot temperature were measured in 8 healthy participants before CTM, immediately after, and at 15-minute intervals for 1 hour. The effect of CTM on skin temperature was statistically significant, P = .011. Post hoc pairwise comparisons revealed that the 15-, 30-, 45-, and 60-minute data all differed significantly from the pre-CTM data (all P < .05) and also from the immediately post-CTM data (all P < .05). For diastolic blood pressure, the main analysis of variance showed a statistical significance at P = .062. For other variables, there was no evidence for an effect. Evidence was seen of some effects of CTM on autonomic function. This is information that will increase our knowledge of how CTM affects the autonomic nervous system. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  17. Bayesian Exploratory Factor Analysis

    PubMed Central

    Conti, Gabriella; Frühwirth-Schnatter, Sylvia; Heckman, James J.; Piatek, Rémi

    2014-01-01

    This paper develops and applies a Bayesian approach to Exploratory Factor Analysis that improves on ad hoc classical approaches. Our framework relies on dedicated factor models and simultaneously determines the number of factors, the allocation of each measurement to a unique factor, and the corresponding factor loadings. Classical identification criteria are applied and integrated into our Bayesian procedure to generate models that are stable and clearly interpretable. A Monte Carlo study confirms the validity of the approach. The method is used to produce interpretable low dimensional aggregates from a high dimensional set of psychological measurements. PMID:25431517

  18. Effectiveness of complex psycho-educational interventions for smoking relapse prevention: an exploratory meta-analysis.

    PubMed

    Song, Fujian; Huttunen-Lenz, Maija; Holland, Richard

    2010-09-01

    Existing systematic reviews have concluded that psycho-educational interventions for smoking relapse prevention were ineffective. Our objective was to conduct an exploratory meta-analysis, guided by mechanisms of these complex interventions for preventing smoking relapse. Relevant trials were identified from a Cochrane review and by an updated search of MEDLINE and PsycINFO (up to August 2009). We examined theories or mechanisms underlying relapse prevention interventions, and process variables reported in trials. Odds ratios (ORs) for the rate of smoking abstinence at the longest follow-up were pooled in meta-analysis. Forty-nine trials were included, and interventions were at least partly based on the cognitive-behavioural approach to coping skills training in 41 trials. Only a few trials reported data on process variables. Coping skills training for smoking relapse prevention was effective for community quitters (OR 1.27, 95% CI: 1.08-1.49), and particularly for those who stopped smoking for at least 1 week at baseline (OR 1.52, 95% CI: 1.20-1.93). These findings were interpretable with mechanisms of coping skills training for relapse prevention. On the basis of post hoc subgroup analyses, coping skills training for smoking relapse prevention is effective for motivated community quitters. This finding has important public health implications and needs to be confirmed by further trials.

  19. A Randomized Controlled Trial of the Effects of Online Pain Management Education on Primary Care Providers.

    PubMed

    Trudeau, Kimberlee J; Hildebrand, Cristina; Garg, Priyanka; Chiauzzi, Emil; Zacharoff, Kevin L

    2017-04-01

    To improve pain management practices, we developed an online interactive continuing education (CE) program for primary care providers (PCPs). This program follows the flow of clinical decision-making through simulated cases at critical pain treatment points along the pain treatment continuum. A randomized controlled trial was conducted to test the efficacy of this program. Participants were randomized to either the experimental condition or the control condition (online, text-based CE program). A total of 238 primary care providers were recruited through hospitals, professional newsletters, and pain conferences. Participants in both conditions reported significantly improved scores on knowledge (KNOW-PAIN 50), attitudes (CAOS), and pain practice behaviors (PPBS) scales over the four-month study. The experimental condition showed significantly greater change over time on the tamper-resistant formulations (TRFs) of opioids and dosing CAOS subscale compared with the control condition. Post hoc comparisons suggested that participants in the experimental condition were less likely to endorse use of opioid TRFs over time compared with the control condition. Exploratory analyses for potential moderators indicated a significant three-way interaction with time, condition, and discipline (i.e., physician vs other) for the impediments and concerns attitudes subscale and the early refill behaviors subscale. Post hoc comparisons indicated that physicians in the experimental condition exhibited the greatest change in attitudes and the nonphysicians exhibited the greatest change in reported behaviors in response to requests for early refills. Findings suggest online CE programs may positively impact PCPs' knowledge, attitudes, and pain practice behaviors but provide minimal evidence for the value of including interactivity. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  20. Distant Healing Of Surgical Wounds: An Exploratory Study

    PubMed Central

    Schlitz, Marilyn; Hopf, Harriet W.; Eskenazi, Loren; Vieten, Cassandra; Radin, Dean

    2012-01-01

    Distant healing intention (DHI) is one of the most common complementary and alternative medicine (CAM) healing modalities, but clinical trials to date have provided ambivalent support for its efficacy. One possible reason is that DHI effects may involve variables that are sensitive to unknown, uncontrolled, or uncontrollable factors. To examine two of those potential variables – expectation and belief – the effects of DHI were explored on objective and psychosocial measures associated with surgical wounds in 72 women undergoing plastic surgery. Participants were randomly assigned to one of three groups: blinded and receiving DHI (DH), blinded and not receiving DHI (Control), and knowing that they were receiving DHI (Expectancy). Outcome measures included collagen deposition in a surrogate wound and several self-report measures. DHI was provided by experienced distant healers. No differences in the main measures were observed across the three groups. Participants’ prior belief in the efficacy of DHI was negatively correlated with the status of their mental health at the end of the study (p = 0.04, two-tailed), and healers’ perceptions of the quality of their subjective “contact” with the participants were negatively correlated both with change in mood (p = 0.001) and with collagen deposition (p = 0.04). A post-hoc analysis found that among participants assigned to receive DHI under blinded conditions, those undergoing reconstructive surgery after breast cancer treatment reported significantly better change in mood than those who were undergoing purely elective cosmetic surgery (p = 0.004). If future DHI experiments confirm the post-hoc observations, then some of the ambiguity observed in earlier DHI studies may be attributable to interactions among participants’ and healers’ beliefs, their expectations, and their motivations. PMID:22742672

  1. Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.

    PubMed

    Wilhelm, Marcel; Rief, Winfried; Doering, Bettina K

    2018-05-21

    Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects. Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation. Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects. Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

  2. The Effect of Sitagliptin on the Regression of Carotid Intima-Media Thickening in Patients with Type 2 Diabetes Mellitus: A Post Hoc Analysis of the Sitagliptin Preventive Study of Intima-Media Thickness Evaluation.

    PubMed

    Mita, Tomoya; Katakami, Naoto; Shiraiwa, Toshihiko; Yoshii, Hidenori; Gosho, Masahiko; Shimomura, Iichiro; Watada, Hirotaka

    2017-01-01

    Background. The effect of dipeptidyl peptidase-4 (DPP-4) inhibitors on the regression of carotid IMT remains largely unknown. The present study aimed to clarify whether sitagliptin, DPP-4 inhibitor, could regress carotid intima-media thickness (IMT) in insulin-treated patients with type 2 diabetes mellitus (T2DM). Methods . This is an exploratory analysis of a randomized trial in which we investigated the effect of sitagliptin on the progression of carotid IMT in insulin-treated patients with T2DM. Here, we compared the efficacy of sitagliptin treatment on the number of patients who showed regression of carotid IMT of ≥0.10 mm in a post hoc analysis. Results . The percentages of the number of the patients who showed regression of mean-IMT-CCA (28.9% in the sitagliptin group versus 16.4% in the conventional group, P  = 0.022) and left max-IMT-CCA (43.0% in the sitagliptin group versus 26.2% in the conventional group, P  = 0.007), but not right max-IMT-CCA, were higher in the sitagliptin treatment group compared with those in the non-DPP-4 inhibitor treatment group. In multiple logistic regression analysis, sitagliptin treatment significantly achieved higher target attainment of mean-IMT-CCA ≥0.10 mm and right and left max-IMT-CCA ≥0.10 mm compared to conventional treatment. Conclusions . Our data suggested that DPP-4 inhibitors were associated with the regression of carotid atherosclerosis in insulin-treated T2DM patients. This study has been registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000007396).

  3. Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia (the ADvance Trial): A Two Year Follow-up Including Results of Delayed Activation.

    PubMed

    Leoutsakos, Jeannie-Marie S; Yan, Haijuan; Anderson, William S; Asaad, Wael F; Baltuch, Gordon; Burke, Anna; Chakravarty, M Mallar; Drake, Kristen E; Foote, Kelly D; Fosdick, Lisa; Giacobbe, Peter; Mari, Zoltan; McAndrews, Mary Pat; Munro, Cynthia A; Oh, Esther S; Okun, Michael S; Pendergrass, Jo Cara; Ponce, Francisco A; Rosenberg, Paul B; Sabbagh, Marwan N; Salloway, Stephen; Tang-Wai, David F; Targum, Steven D; Wolk, David; Lozano, Andres M; Smith, Gwenn S; Lyketsos, Constantine G

    2018-06-09

    Given recent challenges in developing new treatments for Alzheimer dementia (AD), it is vital to explore alternate treatment targets, such as neuromodulation for circuit dysfunction. We previously reported an exploratory Phase IIb double-blind trial of deep brain stimulation targeting the fornix (DBS-f) in mild AD (the ADvance trial). We reported safety but no clinical benefits of DBS-f versus the delayed-on (sham) treatment in 42 participants after one year. However, secondary post hoc analyses of the one-year data suggested a possible DBS-f benefit for participants≥65 years. To examine the long-term safety and clinical effects of sustained and delayed-on DBS-f treatment of mild AD after two years. 42 participants underwent implantation of DBS-f electrodes, with half randomized to active DBS-f stimulation (early on) for two years and half to delayed-on (sham) stimulation after 1 year to provide 1 year of active DBS-f stimulation (delayed on). We evaluated safety and clinical outcomes over the two years of the trial. DBS-f had a favorable safety profile with similar rates of adverse events across both trial phases (years 1 and 2) and between treatment arms. There were no differences between treatment arms on any primary clinical outcomes. However, post-hoc age group analyses suggested a possible benefit among older (>65) participants. DBS-f was safe. Additional study of mechanisms of action and methods for titrating stimulation parameters will be needed to determine if DBS has potential as an AD treatment. Future efficacy studies should focus on patients over age 65.

  4. Finding benefits from acculturative stress among Asian Americans: Self-reflection moderating the mediating effects of ethnocultural empathy on positive outcomes.

    PubMed

    Wei, Meifen; Li, Chun-I; Wang, Cixin; Ko, Stacy Y

    2016-11-01

    This study examined a moderated mediation model to see whether self-reflection moderated (a) the association between acculturative stress and ethnocultural empathy and (b) the indirect effects of acculturative stress on 2 positive outcomes (i.e., bicultural competence and making positive sense of adversity) through ethnocultural empathy. A total of 330 Asian American college students from a West coast university participated in an online survey. Results from PROCESS supported hypotheses. First, self-reflection significantly moderated the effects of acculturative stress on ethnocultural empathy. Specifically, the effect of acculturative stress on ethnocultural empathy was significantly positive for those with lower self-reflection. Conversely, this effect was not significant for those with higher self-reflection, but ethnocultural empathy was consistently high across all levels of acculturative stress for those with higher self-reflection. Post hoc exploratory analyses examined the moderated mediation model using each of the 5 domains of acculturative stress as predictors; results supported the moderated mediation hypotheses for 2 domains, discrimination and cultural isolation. Second, self-reflection significantly moderated the indirect effects of acculturative stress on 2 positive outcomes through ethnocultural empathy. Results from conditional indirect effects suggested that the indirect effects of acculturative stress on 2 positive outcomes through ethnocultural empathy were significantly positive for those with lower self-reflection. Conversely, the indirect effects were not significant for those with higher self-reflection, but the 2 positive outcomes stayed high at all levels of acculturative stress. Post hoc analyses found that 5 of 6 components of bicultural competence used as outcome variables supported the moderation mediation hypotheses. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  5. Moving beyond Univariate Post-Hoc Testing in Exercise Science: A Primer on Descriptive Discriminate Analysis

    ERIC Educational Resources Information Center

    Barton, Mitch; Yeatts, Paul E.; Henson, Robin K.; Martin, Scott B.

    2016-01-01

    There has been a recent call to improve data reporting in kinesiology journals, including the appropriate use of univariate and multivariate analysis techniques. For example, a multivariate analysis of variance (MANOVA) with univariate post hocs and a Bonferroni correction is frequently used to investigate group differences on multiple dependent…

  6. Benefits of Using Planned Comparisons Rather Than Post Hoc Tests: A Brief Review with Examples.

    ERIC Educational Resources Information Center

    DuRapau, Theresa M.

    The rationale behind analysis of variance (including analysis of covariance and multiple analyses of variance and covariance) methods is reviewed, and unplanned and planned methods of evaluating differences between means are briefly described. Two advantages of using planned or a priori tests over unplanned or post hoc tests are presented. In…

  7. Tri-Center Analysis: Determining Measures of Trichotomous Central Tendency for the Parametric Analysis of Tri-Squared Test Results

    ERIC Educational Resources Information Center

    Osler, James Edward

    2014-01-01

    This monograph provides an epistemological rational for the design of a novel post hoc statistical measure called "Tri-Center Analysis". This new statistic is designed to analyze the post hoc outcomes of the Tri-Squared Test. In Tri-Center Analysis trichotomous parametric inferential parametric statistical measures are calculated from…

  8. The Stability of Post Hoc Model Modifications in Covariance Structure Models.

    ERIC Educational Resources Information Center

    Hutchinson, Susan R.

    The work of R. MacCallum et al. (1992) was extended by examining chance modifications through a Monte Carlo simulation. The stability of post hoc model modifications was examined under varying sample size, model complexity, and severity of misspecification using 2- and 4-factor oblique confirmatory factor analysis (CFA) models with four and eight…

  9. Relationship between Omnibus and Post-hoc Tests: An Investigation of performance of the F test in ANOVA.

    PubMed

    Chen, Tian; Xu, Manfei; Tu, Justin; Wang, Hongyue; Niu, Xiaohui

    2018-02-25

    Comparison of groups is a common statistical test in many biomedical and psychosocial research studies. When there are more than two groups, one first performs an omnibus test for an overall difference across the groups. If this null is rejected, one then proceeds to the next step of post-hoc pairwise group comparisons to determine sources of difference. Otherwise, one stops and declares no group difference. A common belief is that if the omnibus test is significant, there must exist at least two groups that are significantly different and vice versa. Thus, when the omnibus test is significant, but no post-hoc between-group comparison shows significant difference, one is bewildered at what is going on and wondering how to interpret the results. At the end of the spectrum, when the omnibus test is not significant, one wonders if all post-hoc tests will be non-significant as well so that stopping after a nonsignificant omnibus test will not lead to any missed opportunity of finding group difference. In this report, we investigate this perplexing phenomenon and discuss how to interpret such results.

  10. Post hoc analyses: after the facts.

    PubMed

    Srinivas, Titte R; Ho, Bing; Kang, Joseph; Kaplan, Bruce

    2015-01-01

    Prospective clinical trials are constructed with high levels of internal validity. Sample size and power considerations usually address primary endpoints. Primary endpoints have traditionally included events that are becoming increasingly less common and thus have led to growing use of composite endpoints and noninferiority trial designs in transplantation. This approach may mask real clinical benefit in one or the other domain with regard to either clinically relevant secondary endpoints or other unexpected findings. In addition, endpoints solely chosen based on power considerations are prone to misjudgment of actual treatment effect size as well as consistency of that effect. In the instances where treatment effects may have been underestimated, valuable information may be lost if buried within a composite endpoint. In all these cases, analyses and post hoc analyses of data become relevant in informing practitioners about clinical benefits or safety signals that may not be captured by the primary endpoint. On the other hand, there are many pitfalls in using post hoc determined endpoints. This short review is meant to allow readers to appreciate post hoc analysis not as an entity with a single approach, but rather as an analysis with unique limitations and strengths that often raise new questions to be addressed in further inquiries.

  11. Standardizing the intrinsic brain: Towards robust measurement of inter-individual variation in 1000 functional connectomes

    PubMed Central

    Yan, Chao-Gan; Craddock, R. Cameron; Zuo, Xi-Nian; Zang, Yu-Feng; Milham, Michael P.

    2014-01-01

    As researchers increase their efforts to characterize variations in the functional connectome across studies and individuals, concerns about the many sources of nuisance variation present and their impact on resting state fMRI (R-fMRI) measures continue to grow. Although substantial within-site variation can exist, efforts to aggregate data across multiple sites such as the 1000 Functional Connectomes Project (FCP) and International Neuroimaging Data-sharing Initiative (INDI) datasets amplify these concerns. The present work draws upon standardization approaches commonly used in the microarray gene expression literature, and to a lesser extent recent imaging studies, and compares them with respect to their impact on relationships between common R-fMRI measures and nuisance variables (e.g., imaging site, motion), as well as phenotypic variables of interest (age, sex). Standardization approaches differed with regard to whether they were applied post-hoc vs. during pre-processing, and at the individual vs. group level; additionally they varied in whether they addressed additive effects vs. additive + multiplicative effects, and were parametric vs. non-parametric. While all standardization approaches were effective at reducing undesirable relationships with nuisance variables, post-hoc approaches were generally more effective than global signal regression (GSR). Across approaches, correction for additive effects (global mean) appeared to be more important than for multiplicative effects (global SD) for all R-fMRI measures, with the exception of amplitude of low frequency fluctuations (ALFF). Group-level post-hoc standardizations for mean-centering and variance-standardization were found to be advantageous in their ability to avoid the introduction of artifactual relationships with standardization parameters; though results between individual and group-level post-hoc approaches were highly similar overall. While post-hoc standardization procedures drastically increased test–retest (TRT) reliability for ALFF, modest reductions were observed for other measures after post-hoc standardizations—a phenomena likely attributable to the separation of voxel-wise from global differences among subjects (global mean and SD demonstrated moderate TRT reliability for these measures). Finally, the present work calls into question previous observations of increased anatomical specificity for GSR over mean centering, and draws attention to the near equivalence of global and gray matter signal regression. PMID:23631983

  12. The Description and Indexing of Editorial Cartoons: An Exploratory Study

    ERIC Educational Resources Information Center

    Landbeck, Christopher Ryan

    2013-01-01

    While access to images in general has improved in the last 20 years, due to both advances in electronic storage and dissemination and to improvements in the intellectual provisions of them, access to editorial cartoons lags behind access to other types of images. While there have been piecemeal or ad hoc efforts to organize large cartoon…

  13. Brief Classroom Training Sessions for Workplace Readiness: Are They Effective?

    ERIC Educational Resources Information Center

    Palesy, Debra

    2017-01-01

    Classroom training sessions for new home care workers (HCWs) are often brief and ad hoc, varying in format and content. Yet the application of this training may be central to worker and client safety. A qualitative approach was adopted for this inquiry, comprising two separate but related practical studies. In the first, exploratory study,…

  14. Portable Low-Volume Therapy for Severe Blood Loss

    DTIC Science & Technology

    2013-06-01

    with Tukey’s post hoc test were performed to find treatment differences within different time points for total hemoglobin (tHb), pH, pressure of...Tukey’s post hoc test were performed to find treatment differences within time points. No correlation was observed for any of the parameters at any...Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE Form Approved OMB

  15. Genetic testing in combination with preventive donepezil treatment for patients with amnestic mild cognitive impairment: an exploratory economic evaluation of personalized medicine.

    PubMed

    Djalalov, Sandjar; Yong, Jean; Beca, Jaclyn; Black, Sandra; Saposnik, Gustavo; Musa, Zahra; Siminovitch, Katherine; Moretti, Myla; Hoch, Jeffrey S

    2012-12-01

    To evaluate the cost effectiveness of genetic screening for the apolipoprotein (APOE) ε4 allele in combination with preventive donepezil treatment in comparison with the standard of care for amnestic mild cognitive impairment (AMCI) patients in Canada. We performed a cost-effectiveness analysis using a Markov model with a societal perspective and a time horizon of 30 years. For each strategy, we calculated quality-adjusted life-years (QALYs), using utilities from the literature. Costs were also based on the literature and, when appropriate, Ontario sources. One-way and probabilistic sensitivity analyses were performed. Expected value of perfect information (EVPI) analysis was conducted to explore the value of future research. The base case results in our exploratory study suggest that the combination of genetic testing and preventive donepezil treatment resulted in a gain of 0.027 QALYs and an incremental cost of $1,015 (in 2009 Canadian dollars [Can$]), compared with the standard of care. The incremental cost-effectiveness ratio (ICER) for the base case was Can$38,016 per QALY. The ICER was sensitive to the effectiveness of donepezil in slowing the rate of progression to Alzheimer's disease (AD), utility in AMCI patients, and AD and donepezil treatment costs. EVPI analysis showed that additional information on these parameters would be of value. Using presently available clinical evidence, this exploratory study illustrates that genetic testing combined with preventive donepezil treatment for AMCI patients may be economically attractive. Since our results were based on a secondary post hoc analysis, our study alone is insufficient to warrant recommending APOE genotyping in AMCI patients. Future research on the effectiveness of preventive donepezil as a targeted therapy is recommended.

  16. An exploratory study of alternative configurations of governing boards of substance abuse treatment centers

    PubMed Central

    Blum, Terry C.; Roman, Paul M.

    2011-01-01

    Boards of directors are the ultimate governing authorities for most organizations providing substance abuse treatment. A governing board may establish policies, monitor and improve operations, and represent a treatment organization to the public. This paper explores alternative configurations of governing boards in a national sample of 500 substance abuse treatment centers. The study proceeds from the premise that boards may be configured with varying levels of engagement in five aspects of internal management and external connections in treatment center operating environments. Based on interviews with treatment center administrative directors, four clusters emerge, describing boards that are: (1) active and balanced across internal and external domains; (2) active boundary spanners concentrating primarily on external relationships; (3) focused primarily on internal organizational management; and (4) relatively inactive. In post hoc analysis, we found that placement in these clusters is associated with treatment center attributes such as rate of growth and financial results, use of evidence based practices and provision of integrated care. PMID:21489737

  17. A preliminary investigation on the efficacy of N-acetyl cysteine for mania or hypomania.

    PubMed

    Magalhães, Pedro Vieira da Silva; Dean, Olivia M; Bush, Ashley I; Copolov, David L; Malhi, Gin S; Kohlmann, Kristy; Jeavons, Susan; Schapkaitz, Ian; Anderson-Hunt, Murray; Berk, Michael

    2013-06-01

    Oxidative imbalance has emerged as a treatment target in bipolar disorder. As very limited data are available on the clinical use of antioxidants for mania, we report here results from a post hoc and exploratory subgroup analysis of a randomized, placebo-controlled trial of N-acetyl cysteine (NAC). This was a placebo-controlled, randomized, clinical trial assessing the effect of NAC over 24 weeks in mania or hypomania. Symptomatic and functional outcomes were collected over the study period. Fifteen participants were available for this report; two participants in each group failed to complete all assessments. Within-group analyses pointed to an improvement in the NAC group on manic symptoms and worsening in the placebo group on depressive symptoms at endpoint. Although the sample size was small, these results indicated within-group efficacy for this glutathione precursor as compared to placebo. Future trials specifically designed to demonstrate the efficacy of NAC in mania are needed.

  18. Do Brief Alcohol Interventions Reduce Tobacco Use among Adolescents and Young Adults? A Systematic Review and Meta-Analysis

    PubMed Central

    Hennessy, Emily A.; Tanner-Smith, Emily E.; Steinka-Fry, Katarzyna T.

    2015-01-01

    This meta-analysis synthesizes studies of brief interventions (BIs) that targeted alcohol consumption and reported both alcohol and tobacco outcomes. It examines whether BIs reduce alcohol and tobacco use for adolescents and young adults among interventions that (1) directly targeted tobacco and alcohol use, or (2) did not target tobacco use but measured it as a secondary outcome. Multiple databases and grey literature sources were searched (1980–2012) resulting in the identification of 18 randomized or controlled quasi-experimental studies (5949 participants). Analyses were conducted using random effects inverse-variance weighted three-level models. BIs were associated with a significant reduction in alcohol consumption relative to control groups (ḡ = 0.11, 95% CI [0.04, 0.17]) but not with a significant decrease in tobacco use (ḡ = 0.07, 95% CI [−0.01, 0.16]). Directly addressing tobacco was not a significant moderator affecting tobacco use outcomes. Post-hoc exploratory analysis revealed potential questions to address with future research. PMID:26130030

  19. Vibrotactile Sensitivity of the Head

    DTIC Science & Technology

    2009-01-01

    Frequency interaction, F (12, 120) = .82, p = .63. Post hoc comparisons ( LSD ) revealed that PZ (M = –8.04 dB) was significantly more sensitive to...Post hoc comparisons ( LSD ) also revealed that thresholds at 45 and 63 Hz were significantly higher than thresholds at 32 Hz (M = –3.56), p ɘ.05...B.; Shaw , J.; Walsh, N.; Nguyen, V. Effects of Aging on Vibration Detection Thresholds at Various Body Regions. BMC Geriatrics. 3(1). http://www

  20. Neuromathematical Trichotomous Mixed Methods Analysis: Using the Neuroscientific Tri-Squared Test Statistical Metric as a Post Hoc Analytic to Determine North Carolina School of Science and Mathematics Leadership Efficacy

    ERIC Educational Resources Information Center

    Osler, James Edward, II; Mason, Letita R.

    2016-01-01

    This study examines the leadership efficacy amongst graduates of The North Carolina School of Science and Mathematics (NCSSM) for the classes of 2000 through 2007 from a neuroscientific and neuromathematic perspective. NCSSM alumni (as the primary unit of analysis) were examined using a novel neuromathematic post hoc method of analysis. This study…

  1. Level of literacy and dementia: A secondary post-hoc analysis from North-West India.

    PubMed

    Raina, Sunil Kumar; Chander, Vishav; Kumar, Dinesh; Raina, Sujeet; Bhardwaj, Ashok

    2014-10-01

    A relation between literacy and dementia has been studied in past and an association has been documented. This is in spite of some studies pointing to the contrary. The current study was aimed at investigating the influence of level of literacy on dementia in a sample stratified by geography (Migrant, Urban, Rural and Tribal areas of sub-Himalayan state of Himachal Pradesh, India). The study was based on post-hoc analysis of data obtained from a study conducted on elderly population (60 years and above) from selected geographical areas (Migrant, Urban, Rural and Tribal) of Himachal Pradesh state in North-west India. Analysis of variance revealed an effect of education on cognitive scores [F = 2.823, P =0.01], however, post-hoc Tukey's HSD test did not reveal any significant pairwise comparisons. The possibility that education effects dementia needs further evaluation, more so in Indian context.

  2. Regressive research: The pitfalls of post hoc data selection in the study of unconscious mental processes.

    PubMed

    Shanks, David R

    2017-06-01

    Many studies of unconscious processing involve comparing a performance measure (e.g., some assessment of perception or memory) with an awareness measure (such as a verbal report or a forced-choice response) taken either concurrently or separately. Unconscious processing is inferred when above-chance performance is combined with null awareness. Often, however, aggregate awareness is better than chance, and data analysis therefore employs a form of extreme group analysis focusing post hoc on participants, trials, or items where awareness is absent or at chance. The pitfalls of this analytic approach are described with particular reference to recent research on implicit learning and subliminal perception. Because of regression to the mean, the approach can mislead researchers into erroneous conclusions concerning unconscious influences on behavior. Recommendations are made about future use of post hoc selection in research on unconscious cognition.

  3. Iron Activation of Cellular Oxidases: Modulation of NeuronalViability (In Vitro).

    DTIC Science & Technology

    2018-04-06

    Findings related to each specific aim of the study or project, answering each research or study questions, and/or hypothesis: The experimentation ...significant (NS) differences between groups when normalized to GAPDH. All groups were compared using one-way ANOVA with Tukey’s post -hoc test . Western...pɘ.0001. All groups were compared using one-way ANOVA with Tukey’s post -hoc test . All graphs represent n=6. Bars represent mean +/- SEM. It is

  4. Predictors of pneumonia on routine chest radiographs in patients with COPD: a post hoc analysis of two 1-year randomized controlled trials

    PubMed Central

    Rubin, David B; Ahmad, Harris A; O’Neal, Michael; Bennett, Sophie; Lettis, Sally; Galkin, Dmitry V; Crim, Courtney

    2018-01-01

    Background Patients with COPD are at risk for life-threatening pneumonia. Although anatomical abnormalities in the thorax may predispose to pneumonia, those abnormalities identified on routine chest X-rays (CXRs) in patients with COPD have not been studied to better understand pneumonia risk. Methods We conducted a post hoc exploratory analysis of data from two replicate year-long clinical trials assessing the impact of fluticasone furoate–vilanterol versus vilanterol alone on COPD exacerbations (GSK studies: HZC102871/NCT01009463 and HZC102970/NCT01017952). Abnormalities on baseline CXRs from 179 patients who developed pneumonia and 50 randomly selected patients who did not were identified by blinded consensus readings conducted by two radiologists. Positive and negative likelihood ratios and diagnostic odds ratios (ORs) were calculated to evaluate the markers for subsequent pneumonia development during the 1-year study period. Results Baseline characteristics distinguishing the pneumonia and non-pneumonia groups included a lower body mass index (24.9 vs 27.5 kg/m2, P=0.008), more severe airflow obstruction (mean post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity ratio: 42.3% vs 47.6%, P=0.003), and prior pneumonia (36% vs 20%, P=0.030). Baseline CXR findings with the highest diagnostic ORs were: elevated hemi-diaphragm (OR: 6.87; 95% CI: 0.90, 52.26), thick tracheal-esophageal stripe (OR: 4.39 [0.25, 78.22]), narrow cardiac silhouette (OR: 2.91 [0.85, 9.99]), calcified pleural plaque/mid-chest pleural thickening (OR: 2.82 [0.15, 53.76]), and large/prominent pulmonary artery shadow (OR: 1.94 [0.95, 3.97]). The presence of a narrow cardiac silhouette at baseline was associated with a statistically significant lower mean pre-bronchodilator FEV1 (P=0.040). There was also a trend for a lower mean pre-bronchodilator FEV1 in patients with a large/prominent pulmonary artery shadow at baseline (P=0.095). Conclusion Findings on routine CXR that relate to pathophysiological mechanisms of pneumonia could help determine pneumonia risk in patients with COPD. PMID:29386888

  5. Still Far from Personal Learning: Key Aspects and Emergent Topics about How Future Professionals' PLEs Are

    ERIC Educational Resources Information Center

    Prendes Espinosa, María Paz; Castañeda, Linda; Gutierrez, Isabel; Román, Mª del Mar

    2016-01-01

    The CAPPLE project is an exploratory research project that aims to analyse the PLEs of future Spanish professionals. An ad-hoc survey about their habits for learning was conducted using a sample of 2054 university students from the last year of a degree. After data collection, two main processes were carried out: (1) the analysis of some of the…

  6. Commentary on "Prognostic effect of carcinoma in situ in muscle-invasive urothelial carcinoma patients receiving neoadjuvant chemotherapy."

    PubMed

    Thomas, D E; Kaimakliotis, H Z; Rice, K R; Pereira, J A; Johnston, P; Moore, M L; Reed, A; Cregar, D M; Franklin, C; Loman, R L; Koch, M O; Bihrle, R; Foster, R S; Masterson, T A; Gardner, T A; Sundaram, C P; Powell, C R; Beck, Sdw; Grignon, D J; Cheng, L; Albany, C; Hahn, N M

    2018-07-01

    Carcinoma in situ (CIS) is a poor prognostic finding in urothelial carcinoma. However, its significance in muscle-invasive urothelial carcinoma (MIUC) treated with neoadjuvant chemotherapy (NAC) is uncertain. We assessed the effect of CIS found in pretreatment transurethral resection of bladder tumor (TURBT) biopsies on the pathologic and clinical outcomes. Subjects with MIUC treated with NAC before cystectomy were identified. The pathologic complete response (pCR) rates stratified by TURBT CIS status were compared. The secondary analyses included tumor response, progression-free survival (PFS), overall survival (OS), and an exploratory post hoc analysis of patients with pathologic CIS only (pTisN0) at cystectomy. A total of 137 patients with MIUC were identified. TURBT CIS was noted in 30.7% of the patients. The absence of TURBT CIS was associated with a significantly increased pCR rate (23.2% vs. 9.5%; odds ratio = 4.08; 95% CI: 1.19-13.98; P = 0.025). Stage pTisN0 disease was observed in 19.0% of the TURBT CIS patients. TURBT CIS status did not significantly affect the PFS or OS outcomes. Post hoc analysis of the pTisN0 patients revealed prolonged median PFS (104.5 vs. 139.9 months; P = 0.055) and OS (104.5 vs. 152.3 months; P = 0.091) outcomes similar to those for the pCR patients. The absence of CIS on pretreatment TURBT in patients with MIUC undergoing NAC was associated with increased pCR rates, with no observed differences in PFS or OS. Isolated CIS at cystectomy was frequently observed, with lengthy PFS and OS durations similar to those for pCR patients. Further studies aimed at understanding the biology and clinical effect of CIS in MIUC are warranted. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines

    PubMed Central

    van Essen, Gerrit A; Beran, Jiri; Devaster, Jeanne-Marie; Durand, Christelle; Duval, Xavier; Esen, Meral; Falsey, Ann R; Feldman, Gregory; Gervais, Pierre; Innis, Bruce L; Kovac, Martina; Launay, Odile; Leroux-Roels, Geert; McElhaney, Janet E; McNeil, Shelly; Oujaa, Mohammed; Richardus, Jan Hendrik; Ruiz-Palacios, Guillermo; Osborne, Richard H; Oostvogels, Lidia

    2014-01-01

    Background Patient-reported outcomes (PROs) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment. Objectives To evaluate PROs in people aged ≥65 years receiving two different vaccines. Methods This was a phase III, randomised, observer-blind study (NCT00753272) of the AS03-adjuvanted inactivated trivalent split-virion influenza vaccine (AS03-TIV) versus non-adjuvanted vaccine (TIV). Using the FluiiQ questionnaire, symptom (systemic, respiratory, total) and life impact (activities, emotions, relationships) scores were computed as exploratory endpoints, with minimal important difference (MID) in influenza severity between vaccines considered post-hoc as >7%. Vaccine efficacy of AS03-TIV relative to TIV in severe influenza (hospitalisation, complication, most severe one-third of episodes based on the area under the curve for systemic symptom score) was calculated post-hoc. The main analyses (descriptive) were conducted in the according-to-protocol cohort (n = 280 AS03-TIV, n = 315 TIV) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction. Results Mean systemic symptom, total symptom and impact on activities scores were lower with AS03-TIV versus TIV. Mean respiratory symptom, impact on emotions and impact on relationships scores were similar. Influenza tended to be less severe with AS03-TIV, but the MID was reached only for impact on activities (mean 9·0%). Relative vaccine efficacy in severe influenza was 29·38% (95% CI: 7·60–46·02). Conclusions AS03-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people. Higher efficacy of AS03-TIV relative to TIV was shown for prevention of severe illness. PMID:24702710

  8. Prognostic Effect of Carcinoma In Situ in Muscle-invasive Urothelial Carcinoma Patients Receiving Neoadjuvant Chemotherapy.

    PubMed

    Thomas, Derek E; Kaimakliotis, Hristos Z; Rice, Kevin R; Pereira, Jose A; Johnston, Paul; Moore, Marietta L; Reed, Angela; Cregar, Dylan M; Franklin, Cindy; Loman, Rhoda L; Koch, Michael O; Bihrle, Richard; Foster, Richard S; Masterson, Timothy A; Gardner, Thomas A; Sundaram, Chandru P; Powell, Charles R; Beck, Stephen D W; Grignon, David J; Cheng, Liang; Albany, Costantine; Hahn, Noah M

    2017-08-01

    Carcinoma in situ (CIS) is a poor prognostic finding in urothelial carcinoma. However, its significance in muscle-invasive urothelial carcinoma (MIUC) treated with neoadjuvant chemotherapy (NAC) is uncertain. We assessed the effect of CIS found in pretreatment transurethral resection of bladder tumor (TURBT) biopsies on the pathologic and clinical outcomes. Subjects with MIUC treated with NAC before cystectomy were identified. The pathologic complete response (pCR) rates stratified by TURBT CIS status were compared. The secondary analyses included tumor response, progression-free survival (PFS), overall survival (OS), and an exploratory post hoc analysis of patients with pathologic CIS only (pTisN0) at cystectomy. A total of 137 patients with MIUC were identified. TURBT CIS was noted in 30.7% of the patients. The absence of TURBT CIS was associated with a significantly increased pCR rate (23.2% vs. 9.5%; odds ratio, 4.08; 95% confidence interval, 1.19-13.98; P = .025). Stage pTisN0 disease was observed in 19.0% of the TURBT CIS patients. TURBT CIS status did not significantly affect the PFS or OS outcomes. Post hoc analysis of the pTisN0 patients revealed prolonged median PFS (104.5 vs. 139.9 months; P = .055) and OS (104.5 vs. 152.3 months; P = .091) outcomes similar to those for the pCR patients. The absence of CIS on pretreatment TURBT in patients with MIUC undergoing NAC was associated with increased pCR rates, with no observed differences in PFS or OS. Isolated CIS at cystectomy was frequently observed, with lengthy PFS and OS durations similar to those for pCR patients. Further studies aimed at understanding the biology and clinical effect of CIS in MIUC are warranted. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Multiple comparison analysis testing in ANOVA.

    PubMed

    McHugh, Mary L

    2011-01-01

    The Analysis of Variance (ANOVA) test has long been an important tool for researchers conducting studies on multiple experimental groups and one or more control groups. However, ANOVA cannot provide detailed information on differences among the various study groups, or on complex combinations of study groups. To fully understand group differences in an ANOVA, researchers must conduct tests of the differences between particular pairs of experimental and control groups. Tests conducted on subsets of data tested previously in another analysis are called post hoc tests. A class of post hoc tests that provide this type of detailed information for ANOVA results are called "multiple comparison analysis" tests. The most commonly used multiple comparison analysis statistics include the following tests: Tukey, Newman-Keuls, Scheffee, Bonferroni and Dunnett. These statistical tools each have specific uses, advantages and disadvantages. Some are best used for testing theory while others are useful in generating new theory. Selection of the appropriate post hoc test will provide researchers with the most detailed information while limiting Type 1 errors due to alpha inflation.

  10. A randomized, crossover pharmacokinetic study comparing generic tacrolimus vs. the reference formulation in subpopulations of kidney transplant patients.

    PubMed

    Bloom, R D; Trofe-Clark, J; Wiland, A; Alloway, R R

    2013-01-01

    An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Ad hoc posterior tibial vessels perforator propeller flaps for the reconstruction of lower third leg soft- tissue defects.

    PubMed

    Balakrishnan, Thalaivirithan Margabandu; Ramkumar, Jayagosh; Jaganmohan, Janardhanan

    2017-01-01

    Lower third leg soft tissue defects with anatomical and pathological constraints are posing formidable challenges to reconstructive surgeon. This retrospective study was conducted to assess the effectiveness of ad hoc posterior tibial vessels perforator-propeller flaps for the reconstruction of small and medium sized soft tissue defects in the lower third leg. 22 patients (16 were males and 6 were females) were involved in this study between period of January 2012 and December 2016.We followed the protocol of initial non delineating exploratory incision made to find out single best perforator in all patients. All the defects in leg reconstructed with adhoc posterior tibial vessel propeller flaps. All 22 flaps survived well. All in an average of 13 months follow up period, had pain free walking, with minimal scarring and acceptable aesthesis at the reconstruction sites with no need for any secondary procedure. With inability of preoperatively dopplering the perforators in the lower third leg region, the exploratory posterior nondelineating incision was used in all cases to secure the single best perforator for the propeller flaps. Thus adhoc posterior tibial vessel propeller flaps are dependable, easily adoptable for the reconstruction of soft tissue defects of the lower third leg region.

  12. Ad hoc posterior tibial vessels perforator propeller flaps for the reconstruction of lower third leg soft- tissue defects

    PubMed Central

    Balakrishnan, Thalaivirithan Margabandu; Ramkumar, Jayagosh; Jaganmohan, Janardhanan

    2017-01-01

    Introduction: Lower third leg soft tissue defects with anatomical and pathological constraints are posing formidable challenges to reconstructive surgeon. Aim: This retrospective study was conducted to assess the effectiveness of ad hoc posterior tibial vessels perforator-propeller flaps for the reconstruction of small and medium sized soft tissue defects in the lower third leg. Patients and Methods: 22 patients (16 were males and 6 were females) were involved in this study between period of January 2012 and December 2016.We followed the protocol of initial non delineating exploratory incision made to find out single best perforator in all patients. All the defects in leg reconstructed with adhoc posterior tibial vessel propeller flaps. Results: All 22 flaps survived well. All in an average of 13 months follow up period, had pain free walking, with minimal scarring and acceptable aesthesis at the reconstruction sites with no need for any secondary procedure. Conclusion: With inability of preoperatively dopplering the perforators in the lower third leg region, the exploratory posterior nondelineating incision was used in all cases to secure the single best perforator for the propeller flaps. Thus adhoc posterior tibial vessel propeller flaps are dependable, easily adoptable for the reconstruction of soft tissue defects of the lower third leg region. PMID:29618863

  13. Development and Validation of the Subjective Awareness of Neuropsychological Deficits Questionnaire for Children (SAND-C)

    PubMed Central

    HUFFORD, BRADLEY J.; FASTENAU, PHILIP S.

    2009-01-01

    Although lowered awareness of abilities has been associated with poorer outcome in adults with neurological compromise, a dearth of research exists examining whether lowered awareness exists in younger populations. Using findings from recent literature and expert opinion, a 47-item Subjective Awareness of Neuropsychological Deficits Questionnaire for Children (SAND-C) was created to assess awareness of cognitive functioning in 6 domains (attention, psychomotor, visual-spatial, language, memory, and executive functioning). Confirmatory factor analysis (CFA) of the SAND-C was conducted on a sample consisting of 365 healthy children and 48 children with epilepsy. The SAND-C was found to have strong reliability. Factor analysis confirmed the a priori 6 factor model, but the 6-factor model was only marginally better than a more parsimonious 1-factor solution. Post-hoc exploratory factor analyses indicate that the SAND-C may measure more constructs for adolescents than for younger children. The difference between younger and older children may reflect developmental changes in metacognitive awareness and abstraction about their own abilities. PMID:15969352

  14. Evaluation of Early Ground Control Station Configurations for Interacting with a UAS Traffic Management (UTM) System

    NASA Technical Reports Server (NTRS)

    Dao, Arik-Quang V.; Martin, Lynne; Mohlenbrink, Christoph; Bienert, Nancy; Wolte, Cynthia; Gomez, Ashley; Claudatos, Lauren; Mercer, Joey

    2017-01-01

    The purpose of this paper is to report on a human factors evaluation of ground control station design concepts for interacting with an unmanned traffic management system. The data collected for this paper comes from recent field tests for NASA's Unmanned Traffic Management (UTM) project, and covers the following topics; workload, situation awareness, as well as flight crew communication, coordination, and procedures. The goal of this evaluation was to determine if the various software implementations for interacting with the UTM system can be described and classified into design concepts to provide guidance for the development of future UTM interfaces. We begin with a brief description of NASA's UTM project, followed by a description of the test range configuration related to a second development phase. We identified (post hoc) two classes in which the ground control stations could be grouped. This grouping was based on level of display integration. The analysis was exploratory and informal. It was conducted to compare ground stations across those two classes and against the aforementioned topics. Herein, we discuss the results.

  15. Changes in Corneal Deformation Parameters after Lenticule Creation and Extraction during Small Incision Lenticule Extraction (SMILE) Procedure

    PubMed Central

    Shen, Yang; Zhao, Jing; Yao, Peijun; Miao, Huamao; Niu, Lingling

    2014-01-01

    Purpose To investigate the effects of lenticule creation and subsequent corneal lenticule extraction on corneal deformation parameters during small incision lenticule extraction (SMILE) procedure. Materials and Methods In this prospective study, 18 eyes of 10 patients (27.90±7.11 years, −5.64±2.45 diopters) scheduled for SMILE procedure were enrolled. Changes in the corneal deformation parameters, including deformation amplitude (DA), applanation time(AT1 and AT2), applanation length(AL1 and AL2), corneal velocity(CV1 and CV2), peak distance(P.Dist.), radius and intraocular pressure values were measured preoperatively, immediately after lenticule creation and subsequent to corneal lenticule extraction in all eyes with the Corvis Scheimpflug Technology (Corvis ST, OCULUS, Wetzlar, Germany). Repeated measures analysis of variance (ANOVA) with bonferroni-adjusted post hoc comparisons was performed to investigate changes following each step of the procedure. Results All surgical procedures were uneventful. A significant difference was detected among the three time points (pre-operation, post-lenticule creation and post lenticule extraction) for AT1 (P<0.001), AT2 (P = 0.001), DA(P<0.001), and IOP(P = 0.002). Bonferroni-adjusted post hoc comparisons indicated that there was no significant change in AT1, AT2, DA, or IOP after lenticule creation (post hoc P>0.05), but there was a significant change in these parameters following subsequent corneal lenticule extraction (post hoc P<0.01), when compared to values obtained pre-operatively. The scheimpflug camera of the Corvis ST demonstrated the intralamellar small gas bubbles formed from the vaporisation of tissue after lenticule creation and a gray zone was observed between the cap and the residual stromal bed after lenticule extraction. Conclusions There is a significant change in corneal deformation parameters following SMILE procedure. The changes may be caused predominantly by stromal lenticule extraction, while lenticule creation with femtosecond laser may not have an obvious effect on corneal deformation properties. PMID:25121508

  16. Changes in corneal deformation parameters after lenticule creation and extraction during small incision lenticule extraction (SMILE) procedure.

    PubMed

    Shen, Yang; Zhao, Jing; Yao, Peijun; Miao, Huamao; Niu, Lingling; Wang, Xiaoying; Zhou, Xingtao

    2014-01-01

    To investigate the effects of lenticule creation and subsequent corneal lenticule extraction on corneal deformation parameters during small incision lenticule extraction (SMILE) procedure. In this prospective study, 18 eyes of 10 patients (27.90 ± 7.11 years, -5.64 ± 2.45 diopters) scheduled for SMILE procedure were enrolled. Changes in the corneal deformation parameters, including deformation amplitude (DA), applanation time(AT1 and AT2), applanation length(AL1 and AL2), corneal velocity(CV1 and CV2), peak distance(P.Dist.), radius and intraocular pressure values were measured preoperatively, immediately after lenticule creation and subsequent to corneal lenticule extraction in all eyes with the Corvis Scheimpflug Technology (Corvis ST, OCULUS, Wetzlar, Germany). Repeated measures analysis of variance (ANOVA) with bonferroni-adjusted post hoc comparisons was performed to investigate changes following each step of the procedure. All surgical procedures were uneventful. A significant difference was detected among the three time points (pre-operation, post-lenticule creation and post lenticule extraction) for AT1 (P<0.001), AT2 (P = 0.001), DA(P<0.001), and IOP(P = 0.002). Bonferroni-adjusted post hoc comparisons indicated that there was no significant change in AT1, AT2, DA, or IOP after lenticule creation (post hoc P>0.05), but there was a significant change in these parameters following subsequent corneal lenticule extraction (post hoc P<0.01), when compared to values obtained pre-operatively. The scheimpflug camera of the Corvis ST demonstrated the intralamellar small gas bubbles formed from the vaporisation of tissue after lenticule creation and a gray zone was observed between the cap and the residual stromal bed after lenticule extraction. There is a significant change in corneal deformation parameters following SMILE procedure. The changes may be caused predominantly by stromal lenticule extraction, while lenticule creation with femtosecond laser may not have an obvious effect on corneal deformation properties.

  17. Moving Beyond Univariate Post-Hoc Testing in Exercise Science: A Primer on Descriptive Discriminate Analysis.

    PubMed

    Barton, Mitch; Yeatts, Paul E; Henson, Robin K; Martin, Scott B

    2016-12-01

    There has been a recent call to improve data reporting in kinesiology journals, including the appropriate use of univariate and multivariate analysis techniques. For example, a multivariate analysis of variance (MANOVA) with univariate post hocs and a Bonferroni correction is frequently used to investigate group differences on multiple dependent variables. However, this univariate approach decreases power, increases the risk for Type 1 error, and contradicts the rationale for conducting multivariate tests in the first place. The purpose of this study was to provide a user-friendly primer on conducting descriptive discriminant analysis (DDA), which is a post-hoc strategy to MANOVA that takes into account the complex relationships among multiple dependent variables. A real-world example using the Statistical Package for the Social Sciences syntax and data from 1,095 middle school students on their body composition and body image are provided to explain and interpret the results from DDA. While univariate post hocs increased the risk for Type 1 error to 76%, the DDA identified which dependent variables contributed to group differences and which groups were different from each other. For example, students in the very lean and Healthy Fitness Zone categories for body mass index experienced less pressure to lose weight, more satisfaction with their body, and higher physical self-concept than the Needs Improvement Zone groups. However, perceived pressure to gain weight did not contribute to group differences because it was a suppressor variable. Researchers are encouraged to use DDA when investigating group differences on multiple correlated dependent variables to determine which variables contributed to group differences.

  18. Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

    PubMed

    Kimura, Go; Ueda, Takeshi

    2017-03-01

    A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

  19. Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer—updated results

    PubMed Central

    Ueda, Takeshi

    2017-01-01

    Abstract A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28–1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18–0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. PMID:28003320

  20. Efficacy of lacosamide by focal seizure subtype.

    PubMed

    Sperling, Michael R; Rosenow, Felix; Faught, Edward; Hebert, David; Doty, Pamela; Isojärvi, Jouko

    2014-10-01

    The purpose of this post hoc exploratory analysis was to determine the effects of the antiepileptic drug, lacosamide, on focal (partial-onset) seizure subtypes. Patient data from the three lacosamide pivotal trials were grouped and pooled by focal seizure subtype at Baseline: simple partial seizures (SPS), complex partial seizures (CPS), and secondarily generalized partial seizures (SGPS). Both efficacy outcomes (median percent change from Baseline to Maintenance Phase in seizure frequency per 28 days and the proportion of patients experiencing at least a 50% reduction in seizures) were evaluated by lacosamide dose (200, 400, or 600 mg/day) compared to placebo for each seizure subtype. An additional analysis was performed to determine whether a shift from more severe focal seizure subtypes to less severe occurred upon treatment with lacosamide. In patients with CPS or SGPS at Baseline, lacosamide 400 mg/day (maximum recommended daily dose) and 600 mg/day reduced the frequency of CPS and SGPS compared to placebo. Likewise, a proportion of patients with CPS and SGPS at Baseline experienced at least a 50% reduction in the frequency of CPS and SGPS (≥50% responder rate) in the lacosamide 400 and 600 mg/day groups compared with placebo. For both outcomes, numerically greatest responses were observed in the lacosamide 600 mg/day group among patients with SGPS at Baseline. In patients with SPS at Baseline, no difference between placebo and lacosamide was observed for either efficacy outcome. An additional exploratory analysis suggests that in patients with SPS at Baseline, CPS and SGPS may have been shifted to less severe SPS upon treatment with lacosamide. The results of these exploratory analyses revealed reductions in CPS and SGPS frequency with adjunctive lacosamide. Reduction in CPS and SGPS may confound assessment of SPS since the CPS or SGPS may possibly change to SPS by effective treatment. Copyright © 2014 Elsevier B.V. All rights reserved.

  1. Evaluation of pseudoprogression rates and tumor progression patterns in a phase III trial of bevacizumab plus radiotherapy/temozolomide for newly diagnosed glioblastoma.

    PubMed

    Wick, Wolfgang; Chinot, Olivier L; Bendszus, Martin; Mason, Warren; Henriksson, Roger; Saran, Frank; Nishikawa, Ryo; Revil, Cedric; Kerloeguen, Yannick; Cloughesy, Timothy

    2016-10-01

    Evaluation of glioblastoma disease status may be complicated by treatment-induced changes and discordance between enhancing and nonenhancing MRI. Exploratory analyses are presented (prospectively assessed pseudoprogression and therapy-related tumor pattern changes) from the AVAglio trial (bevacizumab or placebo plus radiotherapy/temozolomide for newly diagnosed glioblastoma). MRI was done every 8 weeks (beginning 4 wk after chemoradiotherapy) using prespecified and standardized T1 and T2 protocols. Progressive disease (PD) at 10 weeks was reconfirmed at 18 weeks to distinguish pseudoprogression. Progression-free survival (PFS), excluding cases of confirmed pseudoprogression, was assessed (post-hoc/exploratory). Tumor progression patterns were determined at each disease assessment/PD (prespecified/exploratory). Of patients with PD in the bevacizumab and placebo arms, 143/354 (40.4%) and 155/387 (40.1%), respectively, had PD due to contrast-enhancing lesions, and 51/354 (14.4%) and 53/387 (13.7%) had PD due to nonenhancing lesions. Of all patients in the bevacizumab arm (n = 458), 2.2% had confirmed pseudoprogression versus 9.3% in the placebo arm (n = 463). Baseline characteristics did not differ between patients with/without pseudoprogression (including for MGMT status). Excluding confirmed pseudoprogression, PFS (hazard ratio: 0.65, 95% CI: 0.56-0.75; P < .0001, bevacizumab vs placebo) was comparable to the intent-to-treat population. At PD, most patients had the same tumor focus (local/multifocal, >84%) and infiltrative profile (>88%) as at baseline; no shift to a diffuse or multifocal phenotype was observed. Pseudoprogression complicated progression assessment in a small but relevant number of patients but had negligible impact on PFS. Bevacizumab did not appear to adversely impact tumor progression patterns. © The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  2. Association of Baseline Visual Acuity and Retinal Thickness With 1-Year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema.

    PubMed

    Wells, John A; Glassman, Adam R; Jampol, Lee M; Aiello, Lloyd Paul; Antoszyk, Andrew N; Baker, Carl W; Bressler, Neil M; Browning, David J; Connor, Crystal G; Elman, Michael J; Ferris, Frederick L; Friedman, Scott M; Melia, Michele; Pieramici, Dante J; Sun, Jennifer K; Beck, Roy W

    2016-02-01

    Comparisons of the relative effect of 3 anti-vascular endothelial growth factor agents to treat diabetic macular edema warrant further assessment. To provide additional outcomes from a randomized trial evaluating 3 anti-vascular endothelial growth factor agents for diabetic macular edema within subgroups based on baseline visual acuity (VA) and central subfield thickness (CST) as evaluated on optical coherence tomography. Post hoc exploratory analyses were conducted of randomized trial data on 660 adults with diabetic macular edema and decreased VA (Snellen equivalent, approximately 20/32 to 20/320). The original study was conducted between August 22, 2012, and August 28, 2013. Analysis was conducted from January 7 to June 2, 2015. Repeated 0.05-mL intravitreous injections of 2.0 mg of aflibercept (224 eyes), 1.25 mg of bevacizumab (218 eyes), or 0.3 mg of ranibizumab (218 eyes) as needed per protocol. One-year VA and CST outcomes within prespecified subgroups based on both baseline VA and CST thresholds, defined as worse (20/50 or worse) or better (20/32 to 20/40) VA and thicker (≥400 µm) or thinner (250 to 399 µm) CST. In the subgroup with worse baseline VA (n = 305), irrespective of baseline CST, aflibercept showed greater improvement than bevacizumab or ranibizumab for several VA outcomes. In the subgroup with better VA and thinner CST at baseline (61-73 eyes across 3 treatment groups), VA outcomes showed little difference between groups; mean change was +7.2, +8.4, and +7.6 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively. However, in the subgroup with better VA and thicker CST at baseline (31-43 eyes), there was a suggestion of worse VA outcomes in the bevacizumab group; mean change from baseline to 1 year was +9.5, +5.4, and +9.5 letters in the aflibercept, bevacizumab, and ranibizumab groups, respectively, and VA letter score was greater than 84 (approximately 20/20) in 21 of 33 (64%), 7 of 31 (23%), and 21 of 43 (49%) eyes, respectively. The adjusted differences and 95% CIs were 39% (17% to 60%) for aflibercept vs bevacizumab, 25% (5% to 46%) for ranibizumab vs bevacizumab, and 13% (-8% to 35%) for aflibercept vs ranibizumab. These post hoc secondary findings suggest that for eyes with better initial VA and thicker CST, some VA outcomes may be worse in the bevacizumab group than in the aflibercept and ranibizumab groups. Given the exploratory nature of these analyses and the small sample size within subgroups, caution is suggested when using the data to guide treatment considerations for patients. clinicaltrials.gov Identifier: NCT01627249.

  3. Can people catastrophize barriers? An exploratory analysis of the association between pain catastrophizing and perceptions of environmental factors.

    PubMed

    Ravesloot, Craig; Berendts, Cathy; Schiwal, Alex

    2017-01-01

    Measurement of the environment is taking on increased importance for understanding variability in participation. Most measures of the environment use subjective ratings, yet little is known about how people appraise the environment. /Hypothesis: We conducted this post-hoc study to examine whether or not catastrophizing, an important variable for understanding how pain contributes to disability, may be related to ratings of the environment. We hypothesized higher pain catastrophizing scores would be associated with greater environmental barriers and fewer facilitators. Individuals with functional impairments (N = 525) were recruited from a population-based random sample of households in a small western city in the United States to complete a paper-based survey about their health and community living experiences. We conducted exploratory regression analyses to investigate associations with environmental factor ratings. We found substantial associations between pain catastrophizing and both environmental barriers and personal factor problems after controlling for demographics, participation assessed by community trips per week, health conditions, impairment and pain level. The models accounted for 28% of the variance in environmental factor ratings and 52% of the variability personal factor ratings. We also present odds ratios for the association between personal characteristics and the likelihood of endorsing EF and PF. A variety of individual characteristics are associated with ratings of both environmental and personal factors that impact participation. Among these, pain catastrophizing is a robust predictor of EF and PF ratings which suggests future research designed specifically to test this relationship may generate useful results for developing interventions to increase participation. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Leadership content important in athletic training education with implications for allied health care.

    PubMed

    Kutz, Matthew R; Scialli, Joan

    2008-01-01

    A two-phase exploratory and comparative research study using a Delphi technique and a web-based national survey was done to determine leadership content (i.e., theories, styles, or practices) important to include in athletic training education. Eighteen athletic training experts participated in the Delphi technique, followed by 161 athletic trainers completing the national survey. Consensus of experts was reached after two rounds (77% interrater agreement, alpha = 0.80 and alpha = 0.93 per respective round) and identified 31 leadership content items important to include in athletic training education. The national sample then rated importance of each leadership content area for inclusion in four types of athletic training education programs (entry-level baccalaureate, entry-level master's degree, postgraduate certifications, and doctoral degree). The respondents ranked the leadership content in order of importance according to mean (mean = 1.53 +/- 0.84 to 2.55 +/- 0.55; scale, 0-3). Twenty-two content items (63%) were rated at least "very important" (mean > or = 2.0). Exploratory factor analysis established construct validity and organized leadership content by three factors: managerial leadership and knowledge management; leadership theories; and leadership issues, trends, and policies (alpha = 0.84-0.91). Repeated-measures analysis of variance (Sidak post-hoc adjustments) established criterion-related concurrent validity, which found increasing levels of importance as education type progressed (F = 4.88, p = 0.003-32.56, p = 0.000). Adding leadership content within athletic training enhances the professionalization of students, facilitates leadership competency among students and practicing professionals enrolled in postcertification educational programs, and facilitates job placement and role.

  5. The choice of product indicators in latent variable interaction models: post hoc analyses.

    PubMed

    Foldnes, Njål; Hagtvet, Knut Arne

    2014-09-01

    The unconstrained product indicator (PI) approach is a simple and popular approach for modeling nonlinear effects among latent variables. This approach leaves the practitioner to choose the PIs to be included in the model, introducing arbitrariness into the modeling. In contrast to previous Monte Carlo studies, we evaluated the PI approach by 3 post hoc analyses applied to a real-world case adopted from a research effort in social psychology. The measurement design applied 3 and 4 indicators for the 2 latent 1st-order variables, leaving the researcher with a choice among more than 4,000 possible PI configurations. Sixty so-called matched-pair configurations that have been recommended in previous literature are of special interest. In the 1st post hoc analysis we estimated the interaction effect for all PI configurations, keeping the real-world sample fixed. The estimated interaction effect was substantially affected by the choice of PIs, also across matched-pair configurations. Subsequently, a post hoc Monte Carlo study was conducted, with varying sample sizes and data distributions. Convergence, bias, Type I error and power of the interaction test were investigated for each matched-pair configuration and the all-pairs configuration. Variation in estimates across matched-pair configurations for a typical sample was substantial. The choice of specific configuration significantly affected convergence and the interaction test's outcome. The all-pairs configuration performed overall better than the matched-pair configurations. A further advantage of the all-pairs over the matched-pairs approach is its unambiguity. The final study evaluates the all-pairs configuration for small sample sizes and compares it to the non-PI approach of latent moderated structural equations. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  6. Acute exercise and motor memory consolidation: Does exercise type play a role?

    PubMed

    Thomas, R; Flindtgaard, M; Skriver, K; Geertsen, S S; Christiansen, L; Korsgaard Johnsen, L; Busk, D V P; Bojsen-Møller, E; Madsen, M J; Ritz, C; Roig, M; Lundbye-Jensen, J

    2017-11-01

    A single bout of high-intensity exercise can augment off-line gains in skills acquired during motor practice. It is currently unknown if the type of physical exercise influences the effect on motor skill consolidation. This study investigated the effect of three types of high-intensity exercise following visuomotor skill acquisition on the retention of motor memory in 40 young (25.3 ±3.6 years), able-bodied male participants randomly assigned to one of four groups either performing strength training (STR), circuit training (CT), indoor hockey (HOC) or rest (CON). Retention tests of the motor skill were performed 1 (R1h) and 24 h (R1d) post acquisition. For all exercise groups, mean motor performance scores decreased at R1h compared to post acquisition (POST) level; STR (P = 0.018), CT (P = 0.02), HOC (P = 0.014) and performance scores decreased for CT compared to CON (P = 0.049). Mean performance scores increased from POST to R1d for all exercise groups; STR (P = 0.010), CT (P = 0.020), HOC (P = 0.007) while performance scores for CON decreased (P = 0.043). Changes in motor performance were thus greater for STR (P = 0.006), CT (P < 0.001) and HOC (P < 0.001) compared to CON from POST to R1d. The results demonstrate that high-intensity, acute exercise can lead to a decrease in motor performance assessed shortly after motor skill practice (R1h), but enhances offline effects promoting long-term retention (R1d). Given that different exercise modalities produced similar positive off-line effects on motor memory, we conclude that exercise-induced effects beneficial to consolidation appear to depend primarily on the physiological stimulus rather than type of exercise and movements employed. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Analysis of the Metabolic and Structural Brain Changes in Patients With Torture-Related Post-Traumatic Stress Disorder (TR-PTSD) Using 18F-FDG PET and MRI

    PubMed Central

    Zandieh, Shahin; Bernt, Reinhard; Knoll, Peter; Wenzel, Thomas; Hittmair, Karl; Haller, Joerg; Hergan, Klaus; Mirzaei, Siroos

    2016-01-01

    Abstract Many people exposed to torture later suffer from torture-related post-traumatic stress disorder (TR-PTSD). The aim of this study was to analyze the morphologic and functional brain changes in patients with TR-PTSD using magnetic resonance imaging (MRI) and positron emission tomography (PET). This study evaluated 19 subjects. Thirteen subcortical brain structures were evaluated using FSL software. On the T1-weighted images, normalized brain volumes were measured using SIENAX software. The study compared the volume of the brain and 13 subcortical structures in 9 patients suffering from TR-PTSD after torture and 10 healthy volunteers (HV). Diffusion-weighted imaging (DWI) was performed in the transverse plane. In addition, the 18F-FDG PET data were evaluated to identify the activity of the elected regions. The mean left hippocampal volume for the TR-PTSD group was significantly lower than in the HV group (post hoc test (Bonferroni) P < 0.001). There was a significant difference between the gray matter volume of the patients with TR-PTSD and the HV group (post hoc test (Bonferroni) P < 0.001). The TR-PTSD group showed low significant expansion of the ventricles in contrast to the HV group (post hoc test (Bonferroni) P < 0.001). Diffusion-weighted imaging revealed significant differences in the right frontal lobe and the left occipital lobe between the TR-PTSD and HV group (post hoc test (Bonferroni) P < 0.001). Moderate hypometabolism was noted in the occipital lobe in 6 of the 9 patients with TR-PTSD, in the temporal lobe in 1 of the 9 patients, and in the caudate nucleus in 5 of the 9 patients. In 2 cases, additional hypometabolism was observed in the posterior cingulate cortex and in the parietal and frontal lobes. The findings from this study show that TR-PTSD might have a deleterious influence on a set of specific brain structures. This study also demonstrated that PET combined with MRI is sensitive in detecting possible metabolic and structural brain changes in TR-PTSD. PMID:27082610

  8. Analysis of the Metabolic and Structural Brain Changes in Patients With Torture-Related Post-Traumatic Stress Disorder (TR-PTSD) Using ¹⁸F-FDG PET and MRI.

    PubMed

    Zandieh, Shahin; Bernt, Reinhard; Knoll, Peter; Wenzel, Thomas; Hittmair, Karl; Haller, Joerg; Hergan, Klaus; Mirzaei, Siroos

    2016-04-01

    Many people exposed to torture later suffer from torture-related post-traumatic stress disorder (TR-PTSD). The aim of this study was to analyze the morphologic and functional brain changes in patients with TR-PTSD using magnetic resonance imaging (MRI) and positron emission tomography (PET). This study evaluated 19 subjects. Thirteen subcortical brain structures were evaluated using FSL software. On the T1-weighted images, normalized brain volumes were measured using SIENAX software. The study compared the volume of the brain and 13 subcortical structures in 9 patients suffering from TR-PTSD after torture and 10 healthy volunteers (HV). Diffusion-weighted imaging (DWI) was performed in the transverse plane. In addition, the 18F-FDG PET data were evaluated to identify the activity of the elected regions. The mean left hippocampal volume for the TR-PTSD group was significantly lower than in the HV group (post hoc test (Bonferroni) P < 0.001). There was a significant difference between the gray matter volume of the patients with TR-PTSD and the HV group (post hoc test (Bonferroni) P < 0.001). The TR-PTSD group showed low significant expansion of the ventricles in contrast to the HV group (post hoc test (Bonferroni) P < 0.001). Diffusion-weighted imaging revealed significant differences in the right frontal lobe and the left occipital lobe between the TR-PTSD and HV group (post hoc test (Bonferroni) P < 0.001). Moderate hypometabolism was noted in the occipital lobe in 6 of the 9 patients with TR-PTSD, in the temporal lobe in 1 of the 9 patients, and in the caudate nucleus in 5 of the 9 patients. In 2 cases, additional hypometabolism was observed in the posterior cingulate cortex and in the parietal and frontal lobes. The findings from this study show that TR-PTSD might have a deleterious influence on a set of specific brain structures. This study also demonstrated that PET combined with MRI is sensitive in detecting possible metabolic and structural brain changes in TR-PTSD.

  9. Post Hoc Ergo Propter Hoc? Using Causation Diagrams to Empower Sixth-Form Students in Their Historical Thinking about Cause and Effect

    ERIC Educational Resources Information Center

    Alcoe, Alex

    2015-01-01

    Alex Alcoe was concerned that mastery of certain keywords and question formulae at GCSE perhaps obscured fundamental gaps in his students' understanding of the nature of causation. These gaps were revealed when he invited Year 12 students to make explicit, by annotating a diagram, their understanding of the relationship between particular causal…

  10. The 'Big Five'. Hypothesis generation: a multidisciplinary intervention package reduces disease-specific hospitalisations from long-term care: a post hoc analysis of the ARCHUS cluster-randomised controlled trial.

    PubMed

    Connolly, Martin J; Broad, Joanna B; Boyd, Michal; Zhang, Tony Xian; Kerse, Ngaire; Foster, Susan; Lumley, Thomas; Whitehead, Noeline

    2016-05-01

    long-term care (LTC) residents have higher hospitalisation rates than non-LTC residents. Rapid decline may follow hospitalisations, hence the importance of preventing unnecessary hospitalisations. Literature describes diagnosis-specific interventions (for cardiac failure, ischaemic heart disease, chronic obstructive pulmonary disease, stroke, pneumonia-termed 'big five' diagnoses), impacting on hospitalisations of older community-dwellers, but few RCTs show reductions in acute admissions from LTC. LTC facilities with higher than expected hospitalisations were recruited for a cluster-randomised controlled trial (RCT) of facility-based complex, non-disease-specific, 9-month intervention comprising gerontology nurse specialist (GNS)-led staff education, facility benchmarking, GNS resident review and multidisciplinary discussion of residents selected using standard criteria. In this post hoc exploratory analysis, the outcome was acute hospitalisations for 'big five' diagnoses. Re-randomisation analyses were used for end points during months 1-14. For end points during months 4-14, proportional hazards models are adjusted for within-facility clustering. we recruited 36 facilities with 1,998 residents (1,408 female; mean age 82.9 years); 1,924 were alive at 3 months. The intervention did not impact overall rates of acute hospitalisations or mortality (previously published), but resulted in fewer 'big five' admissions (RR = 0.73, 95% CI = 0.54-0.99; P = 0.043) with no significant difference in the rate of other acute admissions. When considering events occurring after 3 months (only), the intervention group were 34.7% (HR = 0.65; 95% CI = 0.49-0.88; P = 0.005) less likely to have a 'big five' acute admission than controls, with no differences in likelihood of acute admissions for other diagnoses (P = 0.96). this generic intervention may reduce admissions for common conditions which the literature shows are impacted by disease-specific admission reduction strategies. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Does Aerobic Exercise Influence Intrinsic Brain Activity? An Aerobic Exercise Intervention among Healthy Old Adults

    PubMed Central

    Flodin, Pär; Jonasson, Lars S.; Riklund, Katrin; Nyberg, Lars; Boraxbekk, C. J.

    2017-01-01

    Previous studies have indicated that aerobic exercise could reduce age related decline in cognition and brain functioning. Here we investigated the effects of aerobic exercise on intrinsic brain activity. Sixty sedentary healthy males and females (64–78 years) were randomized into either an aerobic exercise group or an active control group. Both groups recieved supervised training, 3 days a week for 6 months. Multimodal brain imaging data was acquired before and after the intervention, including 10 min of resting state brain functional magnetic resonance imaging (rs-fMRI) and arterial spin labeling (ASL). Additionally, a comprehensive battery of cognitive tasks assessing, e.g., executive function and episodic memory was administered. Both the aerobic and the control group improved in aerobic capacity (VO2-peak) over 6 months, but a significant group by time interaction confirmed that the aerobic group improved more. Contrary to our hypothesis, we did not observe any significant group by time interactions with regard to any measure of intrinsic activity. To further probe putative relationships between fitness and brain activity, we performed post hoc analyses disregarding group belongings. At baseline, VO2-peak was negativly related to BOLD-signal fluctuations (BOLDSTD) in mid temporal areas. Over 6 months, improvements in aerobic capacity were associated with decreased connectivity between left hippocampus and contralateral precentral gyrus, and positively to connectivity between right mid-temporal areas and frontal and parietal regions. Independent component analysis identified a VO2-related increase in coupling between the default mode network and left orbitofrontal cortex, as well as a decreased connectivity between the sensorimotor network and thalamus. Extensive exploratory data analyses of global efficiency, connectome wide multivariate pattern analysis (connectome-MVPA), as well as ASL, did not reveal any relationships between aerobic fitness and intrinsic brain activity. Moreover, fitness-predicted changes in functional connectivity did not relate to changes in cognition, which is likely due to absent cross-sectional or longitudinal relationships between VO2-peak and cognition. We conclude that the aerobic exercise intervention had limited influence on patterns of intrinsic brain activity, although post hoc analyses indicated that individual changes in aerobic capacity preferentially influenced mid-temporal brain areas. PMID:28848424

  12. Does Aerobic Exercise Influence Intrinsic Brain Activity? An Aerobic Exercise Intervention among Healthy Old Adults.

    PubMed

    Flodin, Pär; Jonasson, Lars S; Riklund, Katrin; Nyberg, Lars; Boraxbekk, C J

    2017-01-01

    Previous studies have indicated that aerobic exercise could reduce age related decline in cognition and brain functioning. Here we investigated the effects of aerobic exercise on intrinsic brain activity. Sixty sedentary healthy males and females (64-78 years) were randomized into either an aerobic exercise group or an active control group. Both groups recieved supervised training, 3 days a week for 6 months. Multimodal brain imaging data was acquired before and after the intervention, including 10 min of resting state brain functional magnetic resonance imaging (rs-fMRI) and arterial spin labeling (ASL). Additionally, a comprehensive battery of cognitive tasks assessing, e.g., executive function and episodic memory was administered. Both the aerobic and the control group improved in aerobic capacity (VO 2 -peak) over 6 months, but a significant group by time interaction confirmed that the aerobic group improved more. Contrary to our hypothesis, we did not observe any significant group by time interactions with regard to any measure of intrinsic activity. To further probe putative relationships between fitness and brain activity, we performed post hoc analyses disregarding group belongings. At baseline, VO 2 -peak was negativly related to BOLD-signal fluctuations (BOLD STD ) in mid temporal areas. Over 6 months, improvements in aerobic capacity were associated with decreased connectivity between left hippocampus and contralateral precentral gyrus, and positively to connectivity between right mid-temporal areas and frontal and parietal regions. Independent component analysis identified a VO 2 -related increase in coupling between the default mode network and left orbitofrontal cortex, as well as a decreased connectivity between the sensorimotor network and thalamus. Extensive exploratory data analyses of global efficiency, connectome wide multivariate pattern analysis (connectome-MVPA), as well as ASL, did not reveal any relationships between aerobic fitness and intrinsic brain activity. Moreover, fitness-predicted changes in functional connectivity did not relate to changes in cognition, which is likely due to absent cross-sectional or longitudinal relationships between VO 2 -peak and cognition. We conclude that the aerobic exercise intervention had limited influence on patterns of intrinsic brain activity, although post hoc analyses indicated that individual changes in aerobic capacity preferentially influenced mid-temporal brain areas.

  13. Influence of prolonged intermittent high-intensity exercise on knee flexor strength in male and female soccer players.

    PubMed

    Mercer, Tom H; Gleeson, Nigel P; Wren, Karen

    2003-06-01

    This study investigated the effect of an acute, prolonged, intermittent, high-intensity single-leg pedalling exercise task (PIHIET) on the isokinetic leg strength of the knee flexors in six male and seven female collegiate soccer players. Following determination of single-leg VO(2peak), subjects completed a PIHIET designed to simulate the energetics of soccer match play (approximately 90 min in total; approximately 70% single-leg VO(2peak)). Pre-, mid- and post-PIHIET gravity-corrected indices of knee flexion peak torque (PT) and range of motion-relativised torque at 15% of knee flexion (RRT(15%); 0% = full knee extension) were assessed at a lever-arm angular velocity of 1.05 rad.s(-1)for intervention and control limbs using an isokinetic dynamometer. Repeated measures ANOVAs revealed significant condition (PIHIET, control) x time (pre-, mid-, post-PIHIET) interactions for knee flexion PT (F([2,22])=26.2; P<0.001) and RRT(15%) (F([2,22])=20.1; P<0.001). Flexion PT and RRT(15% )were observed to decrease, pre- to post-intervention, from 92.8 (28.7) N.m to 72.1 (28.0) N.m and from 63.8 (17.5) N.m to 47.9 (18.4) N.m respectively, for the intervention limb alone. These data corresponded to 22.3% and 24.9% mean reductions pre-post intervention in PT and RRT(15%). Exploratory post hoc analysis of the pattern of the relative deterioration (%) of PT and RRT(15%), for the intervention limb alone, revealed a three-way interaction [group (male, female) x parameter (PT, RRT(15%)) x assessment phase (pre- to mid-PIHIET, mid- to post-PIHIET)] (F(1,11)=5.2; P<0.05). This interaction characterised a greater deterioration of strength performance during the mid- to post-PIHIET assessment phase, at the extremes of range of motion (RRT(15%)) for the female group. The greater percentage of mid-post phase strength loss observed in women near the end-range extension may potentially be implicated in the higher incidence of knee injury reported in female soccer players.

  14. Evaluation Study of the Exploratory Visit: An Innovative Outreach Activity of the ILGWU's Friendly Visiting Program

    ERIC Educational Resources Information Center

    Wright, Holly; And Others

    1977-01-01

    The exploratory visit to recent retirees, an outreach component of the International Ladies Garment Workers Union Friendly Visiting Program, was evaluated. A post-test only control group effect study revealed exploratory visits were effective in establishing a link between the program and the retiree. (Author)

  15. POWER for reproductive health: results from a social marketing campaign promoting female and male condoms.

    PubMed

    Bull, Sheana S; Posner, Samuel F; Ortiz, Charlene; Beaty, Brenda; Benton, Kathryn; Lin, Lillian; Pals, Sherri L; Evans, Tom

    2008-07-01

    To evaluate effects of a 6-month social marketing campaign on awareness of, attitudes toward and use of female as well as male condoms for 15-25 year-old-women. Using a time-space sampling methodology, we conducted a cross-sectional survey of 3407 women at pre-campaign in 12 western U.S. neighborhoods on female and male condom awareness, attitudes, and use. Six of the 12 study neighborhoods were randomly selected to receive the POWER social marketing campaign designed to impact condom knowledge, attitudes, and use. The campaign was followed with another cross-sectional survey of 3,003 women in all 12 study neighborhoods on condom knowledge, attitudes, use and awareness of POWER materials. We compared pre-and post-campaign surveys to determine the efficacy of POWER and conducted post hoc analyses on post-campaign data to determine if exposure to POWER was related to higher levels of positive condom attitudes and norms and condom use. We found no differences between neighborhoods with and without the POWER campaign with regard to our primary outcomes. To diagnose reasons for this null effect, we examined outcomes post hoc examining the influence of POWER exposure. Post hoc analyses show some evidence that exposure to POWER was associated with condom use. In the context of the nested trial, this raises concerns that post test only evaluations are limited. Establishing the efficacy of a social marketing campaign is challenging. This group randomized trial showed a null effect. Social marketing campaigns may need to have more media channels and saturation before they can show behavioral effects. Using a nested design with randomization at the community level and probability sampling introduces rigor not commonly seen in evaluations of social marketing campaigns.

  16. Differences between motor point and innervation zone locations in the biceps brachii. An exploratory consideration for the treatment of spasticity with botulinum toxin.

    PubMed

    Guzmán-Venegas, Rodrigo A; Araneda, Oscar F; Silvestre, Rony A

    2014-12-01

    Botulinum toxin (BTX) acts on the neuromuscular junction which can be located by the innervation zone (IZ). Clinically, the motor point (MP) is homologous to the IZ and it is used as the injection site of BTX. Differences in the effectiveness of the application of BTX between MP and IZ locations have been determined. Compare the location of the MP obtained using electrical stimulation and the location of the IZ using a linear surface electrodes array on the biceps brachii muscle. The biceps brachii muscle of twenty men was assessed. The MP was located using the torque measurement generated by electrical stimulation. The IZ was detected using a linear surface electrodes array. A difference between the MP and the IZ positions (75.8 vs. 86.5mm, delta 10.7 mm; p=0.003, post-hoc power 0.89) was observed. The magnitude of the difference between the MP and the IZ may be clinically relevant. The IZ location using surface electromyography as a guide to optimize BTX injection is proposed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Influence of Hip Abductor Strength on Functional Outcomes Before and After Total Knee Arthroplasty: Post Hoc Analysis of a Randomized Controlled Trial.

    PubMed

    Loyd, Brian J; Jennings, Jason M; Judd, Dana L; Kim, Raymond H; Wolfe, Pamela; Dennis, Douglas A; Stevens-Lapsley, Jennifer E

    2017-09-01

    Total knee arthroplasty (TKA) is associated with declines in hip abductor (HA) muscle strength; however, a longitudinal analysis demonstrating the influence of TKA on trajectories of HA strength change has not been conducted. The purpose of this study was to quantify changes in HA strength from pre-TKA through 3 months post-TKA and to characterize the relationship between HA strength changes and physical performance. This study is a post hoc analysis of a randomized controlled trial. Data from 162 participants (89 women, mean age = 63 y) were used for analysis. Data were collected by masked assessors preoperatively and at 1 and 3 months following surgery. Outcomes included: Timed "Up and Go" test (TUG), Stair Climbing Test (SCT), Six-Minute Walk Test (6MWT), and walking speed. Paired t tests were used for between- and within-limb comparisons of HA strength. Multivariable regression was used to determine contributions of independent variables, HA and knee extensor strength, to the dependent variables of TUG, SCT, 6MWT, and walking speed at each time point. Hip abductor strength was significantly lower in the surgical limb pre-TKA (mean = 0.015; 95% CI = 0.010-0.020), 1 month post-TKA (0.028; 0.023-0.034), and 3 months post-TKA (0.02; 0.014-0.025) compared with the nonsurgical limb. Hip abductor strength declined from pre-TKA to 1 month post-TKA (18%), but not at the 3-month time point (0%). Hip abductor strength independently contributed to performance-based outcomes pre-TKA; however, this contribution was not observed post-TKA. The post hoc analysis prevents examining all outcomes likely to be influenced by HA strength. Surgical limb HA strength is impaired prior to TKA, and worsens following surgery. Furthermore, HA strength contributes to performance-based outcomes, supporting the hypothesis that HA strength influences functional recovery. © 2017 American Physical Therapy Association

  18. Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

    PubMed

    Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

    2018-06-01

    Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p < .001, partial η 2  = 0.18) and in associated symptomatology, which persisted through 6 months of follow-up. There were no significant differences regarding symptom reduction between the treatment groups. Women benefited more compared to men irrespective of treatment group. Men showed the most pronounced changes under MAP. In the current study, MAP was not superior to PE regarding symptom reduction in adult ADHD. Both interventions, mindfulness meditation and PE, were efficacious in reducing symptom load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

  19. A comparison of subgroup analyses in grant applications and publications.

    PubMed

    Boonacker, Chantal W B; Hoes, Arno W; van Liere-Visser, Karen; Schilder, Anne G M; Rovers, Maroeska M

    2011-07-15

    In this paper, the authors compare subgroup analyses as outlined in grant applications and their related publications. Grants awarded by the Netherlands Organization for Health Research and Development (ZonMw) from 2001 onward that were finalized before March 1, 2010, were studied. Of the 79 grant proposals, 50 (63%) were intervention studies, 18 (23%) were diagnostic studies, and 6 (8%) were prognostic studies. Subgroups were mentioned in 49 (62%) grant applications and in 53 (67%) publications. In 20 of the 79 projects (25%), the publications were completely in agreement with the grant proposal; that is, subgroups that were prespecified in the grant proposal were reported and no new subgroup analyses were introduced in the publications. Of the 149 prespecified subgroups, 46 (31%) were reported in the final report or scientific publications, and 143 of the 189 (76%) reported subgroups were based on post-hoc findings. For 77% of the subgroup analyses in the publications, there was no mention of whether these were prespecified or post hoc. Justification for subgroup analysis and methods to study subgroups were rarely reported. The authors conclude that there is a large discrepancy between grant applications and final publications regarding subgroup analyses. Both nonreporting prespecified subgroup analyses and reporting post-hoc subgroup analyses are common. More guidance is clearly needed.

  20. Electric Field Stimulation Enhances Healing of Post-Traumatic Osteoarthritic Cartilage

    DTIC Science & Technology

    2017-10-01

    expected. Statistics: Comparisons were analyzed using ANOVA with Tukey’s post -hoc test (pɘ.05). RESULTS: In study 1, a proportion of synovial...AWARD NUMBER: W81XWH-14-1-0591 TITLE: Electric Field Stimulation Enhances Healing of Post -Traumatic Osteoarthritic Cartilage PRINCIPAL...2016 – 29 Sep 2017 4. TITLE AND SUBTITLE Cartilage 5a. CONTRACT NUMBER Electric Field Stimulation Enhances Healing of Post -Traumatic Osteoarthritic

  1. Droxidopa in patients with neurogenic orthostatic hypotension associated with Parkinson's disease (NOH306A).

    PubMed

    Hauser, Robert A; Hewitt, L Arthur; Isaacson, Stuart

    2014-01-01

    Neurogenic orthostatic hypotension (nOH) is common in Parkinson's disease (PD), and represents a failure to generate norepinephrine responses appropriate for postural change. Droxidopa (L-threo-3,4-dihydroxyphenylserine) is an oral norepinephrine prodrug. Interim analyses of the initial patients enrolled in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial of droxidopa for nOH in PD (ClinicalTrials.gov Identifier: NCT01176240). PD patients with documented nOH underwent ≤ 2 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment (100-600 mg t.i.d.). The primary efficacy measure was change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to Week 8. Key secondary variables included dizziness/lightheadedness score (OHQ item 1) and patient-reported falls. Among 24 droxidopa and 27 placebo recipients, mean OHQ composite-score change at Week 8 was -2.2 versus -2.1 (p = 0.98); in response to this pre-planned futility analysis, the study was temporarily stopped and all data from these patients were considered exploratory. At Week 1, mean dizziness/lightheadedness score change favored droxidopa by 1.5 units (p = 0.24), with subsequent numerical differences favoring droxidopa throughout the observation period, and at Week 1, mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg (p = 0.04). Compared with placebo, the droxidopa group exhibited an approximately 50% lower rate of reported falls (p = 0.16) and fall-related injuries (post-hoc analysis). This exploratory analysis of a small dataset failed to show benefit of droxidopa, as compared with placebo by the primary endpoint. Nonetheless, there were signals of potential benefit for nOH, including improvement in dizziness/lightheadedness and reduction in falls, meriting evaluation in further trials.

  2. Practice leadership and active support in residential services for people with intellectual disabilities: an exploratory study.

    PubMed

    Beadle-Brown, J; Mansell, J; Ashman, B; Ockenden, J; Iles, R; Whelton, B

    2014-09-01

    We hypothesised that a key factor determining the quality of active support was 'practice leadership' - provided by the first-line manager to focus staff attention and develop staff skills in providing direct support to enable people with intellectual disabilities to have a good quality of life. This exploratory study focused on what levels of practice leadership were found and its role in explaining variation in active support. Relevant aspects of management, including practice leadership, were assessed by questionnaires administered to staff in residential settings alongside observational measures of active support and resident engagement in meaningful activity. Relationships between these variables were explored using regression and post hoc group comparisons. There was wide variation, with average levels of practice leadership being low, though improving over the period studied. Practice leadership had a significant impact on active support, but was fully mediated by the effect of quality of management. When the quality of management was higher better practice leadership did produce a significant difference in active support. However, higher quality of management on its own did not produce better active support. A number of limitations are acknowledged and further research is required. Practice leadership appears to be an important factor in enabling staff to provide active support but as part of generally good management. Given the rather low levels found, attention needs to be given to the training, career development and support of practice leaders and also to how to protect their time from their many other responsibilities. © 2013 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

  3. Failure to replicate the structure of a Spanish-language brief Wisconsin Inventory of Smoking Dependence Motives across three samples of Latino smokers.

    PubMed

    Castro, Yessenia; Correa-Fernández, Virmarie; Cano, Miguel Á; Mazas, Carlos; Gonzalez, Karla; Vidrine, Damon J; Vidrine, Jennifer I; Wetter, David W

    2014-09-01

    Research in smoking is hindered by a lack of validated measures available in languages other than English. Availability of measures in languages other than English is vital to the inclusion of diverse groups in smoking research. To help address this gap, this study attempted to validate a Spanish-language version of the brief Wisconsin Inventory of Smoking Dependence Motives (Brief WISDM). Data from 3 independent, diverse samples of Spanish-speaking Latino smokers seeking cessation counseling were utilized. Confirmatory factor analyses of 3 known structures of the Brief WISDM were examined for fit within each sample. A separate analysis was also conducted with the 3 samples combined. A post-hoc exploratory factor analyses with the combined sample was also conducted. Across 12 confirmatory factor analyses, none of the 3 structures demonstrated good fit in any of the samples independently or in the combined sample. Across the 3 samples, high intercorrelations (>.90) were found among the Loss of Control, Craving, Tolerance, and Cue Exposure scales, suggesting great redundancy among these scales. An exploratory factor analyses (EFAs) further supported these high intercorrelations. Some subscales remained intact in the EFA but accounted for little variance. Overall, this study was unable to replicate the structure of a Spanish-language Brief WISDM in 3 independent samples of smokers. Possible explanations include inadequate translation of the measure and/or true and meaningful differences in the construct of dependence among Spanish-speaking Latino smokers. Both possibilities merit further research. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. Physical activity and adolescents: an exploratory randomized controlled trial investigating the influence of affective and instrumental text messages.

    PubMed

    Sirriyeh, Reema; Lawton, Rebecca; Ward, Jane

    2010-11-01

    The present study attempts to develop and pilot the feasibility and efficacy of a novel intervention using affective messages as a strategy to increase physical activity (PA) levels in adolescents. Design An exploratory pilot randomized control trial was used to compare behaviour change over 2 weeks. A modified form of the International Physical Activity Questionnaire was used to assess PA behaviour. A total of 120 adolescents (16-19 years) from 4 sixth forms in West Yorkshire completed the field-based study. Participants were randomly assigned to one of three experimental conditions, or the control condition (N=28). Participants in experimental conditions received 1 short messaging service (SMS) text message per day over the 2 weeks, which included manipulations of either affective beliefs (enjoyable/unenjoyable; N=31), instrumental beliefs (beneficial/harmful; N=30), or a combination of these (N=31). Control participants received one SMS text message per week. Outcomes were measured at baseline and at the end of the 2 week intervention. PA levels increased by the equivalent of 31.5  minutes of moderate (four metabolic equivalent) activity per week during the study. Main effects of condition (p=.049), and current physical activity level (p=.002) were identified, along with a significant interaction between condition and current activity level (p=.006). However, when the sample was split at baseline into active and inactive participants, a main effect of condition remained for inactive participants only (p=.001). Post hoc analysis revealed that inactive participants who received messages targeting affective beliefs increased their activity levels significantly more than the instrumental (p=.012), combined (p=.002), and control groups (p=.018). Strategies based on affective associations may be more effective for increasing PA levels in inactive individuals.

  5. Clinically inappropriate post hoc exclusion of study participants from test accuracy calculations: the ROMA score, an example from a recent NICE diagnostic assessment.

    PubMed

    Lang, Shona; Armstrong, Nigel; Deshpande, Sohan; Ramaekers, Bram; Grimm, Sabine; de Kock, Shelley; Kleijnen, Jos; Westwood, Marie

    2018-01-01

    Objective To explore how the definition of the target condition and post hoc exclusion of participants can limit the usefulness of diagnostic accuracy studies. Methods We used data from a systematic review, conducted for a NICE diagnostic assessment of risk scores to inform secondary care decisions about specialist referral for women with suspected ovarian cancer, to explore how the definition of the target condition and post hoc exclusion of participants can limit the usefulness of diagnostic accuracy studies to inform clinical practice. Results Fourteen of the studies evaluated the ROMA score, nine used Abbott ARCHITECT tumour marker assays, five used Roche Elecsys. The summary sensitivity estimate (Abbott ARCHITECT) was highest, 95.1% (95% CI: 92.4 to 97.1%), where analyses excluded participants with borderline tumours or malignancies other than epithelial ovarian cancer and lowest, 75.0% (95% CI: 60.4 to 86.4%), where all participants were included. Results were similar for Roche Elecsys tumour marker assays. Although the number of patients involved was small, data from studies that reported diagnostic accuracy for both the whole study population and with post hoc exclusion of those with borderline or non-epithelial malignancies suggested that patients with borderline or malignancies other than epithelial ovarian cancer accounts for between 50 and 85% of false-negative ROMA scores. Conclusions Our results illustrate the potential consequences of inappropriate population selection in diagnostic studies; women with non-epithelial ovarian cancers or non-ovarian primaries, and those borderline tumours may be disproportionately represented among those with false negative, 'low risk' ROMA scores. These observations highlight the importance of giving careful consideration to how the target condition has been defined when assessing whether the diagnostic accuracy estimates reported in clinical studies will translate into clinical utility in real-world settings.

  6. Could Bertrand Russell's barber have bitten his own teeth? A problem of logic and definitions.

    PubMed

    Aitken, Kenneth John

    2014-08-01

    Guiding the positive evolution of behavior is an admirable goal. Wilson et al.'s arguments are based largely on studies of problem correction. The methodology is sound, but not the post hoc ergo procter hoc extrapolation. What is required is evidence that it can proactively generate positive change. The evolution of human behavior to date has been affected by many factors that include unmalleable and unpredicted environmental changes.

  7. Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: Post-hoc analysis from a randomized controlled trial.

    PubMed

    Garland, Suzanne M; Paavonen, Jorma; Jaisamrarn, Unnop; Naud, Paulo; Salmerón, Jorge; Chow, Song-Nan; Apter, Dan; Castellsagué, Xavier; Teixeira, Júlio C; Skinner, S Rachel; Hedrick, James; Limson, Genara; Schwarz, Tino F; Poppe, Willy A J; Bosch, F Xavier; de Carvalho, Newton S; Germar, Maria Julieta V; Peters, Klaus; Del Rosario-Raymundo, M Rowena; Catteau, Grégory; Descamps, Dominique; Struyf, Frank; Lehtinen, Matti; Dubin, Gary

    2016-12-15

    We evaluated the efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in preventing HPV-related disease after surgery for cervical lesions in a post-hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15-25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV-16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post-hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV-related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post-surgery. Other outcomes included the incidence of HPV-related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post-surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post-surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (-21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post-surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV-16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+. © 2016 UICC.

  8. Electric Field Stimulation Enhances Healing of Post-Traumatic Osteoarthritic Cartilage

    DTIC Science & Technology

    2016-10-01

    analyzed using ANOVA with Tukey’s post -hoc test (pɘ.05). RESULTS: In study 1, a proportion of synovial fibroblasts migrated to a maximum depth of ~250...AWARD NUMBER: W81XWH-14-1-0591 TITLE: Electric Field Stimulation Enhances Healing of Post -Traumatic Osteoarthritic Cartilage PRINCIPAL...COVERED 30 Sep 2015 – 29 Sep 2016 4. TITLE AND SUBTITLE Cartilage 5a. CONTRACT NUMBER Electric Field Stimulation Enhances Healing of Post -Traumatic

  9. A SAS(®) macro implementation of a multiple comparison post hoc test for a Kruskal-Wallis analysis.

    PubMed

    Elliott, Alan C; Hynan, Linda S

    2011-04-01

    The Kruskal-Wallis (KW) nonparametric analysis of variance is often used instead of a standard one-way ANOVA when data are from a suspected non-normal population. The KW omnibus procedure tests for some differences between groups, but provides no specific post hoc pair wise comparisons. This paper provides a SAS(®) macro implementation of a multiple comparison test based on significant Kruskal-Wallis results from the SAS NPAR1WAY procedure. The implementation is designed for up to 20 groups at a user-specified alpha significance level. A Monte-Carlo simulation compared this nonparametric procedure to commonly used parametric multiple comparison tests. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  10. Effects of supervised exercise on progression-free survival in lymphoma patients: an exploratory follow-up of the HELP Trial.

    PubMed

    Courneya, Kerry S; Friedenreich, Christine M; Franco-Villalobos, Conrado; Crawford, Jennifer J; Chua, Neil; Basi, Sanraj; Norris, Mary K; Reiman, Tony

    2015-02-01

    Few randomized controlled trials in exercise oncology have examined survival outcomes. Here, we report an exploratory follow-up of progression-free survival (PFS) from the Healthy Exercise for Lymphoma Patients (HELP) Trial. The HELP Trial randomized 122 lymphoma patients between 2005 and 2008 to either control (n = 62) or 12 weeks of supervised aerobic exercise (n = 60). PFS events were abstracted from medical records in 2013. In addition to the randomized comparison, we explored the effects of exercise adherence (<80 % vs. ≥80 %) and control group crossover (no vs. yes). After a median follow-up of 61 months (interquartile range 36-67), the adjusted 5-year PFS was 64.8 % for the exercise group compared with 65.0 % for the control group (Hazard ratio [HR] 1.01, 95 % CI 0.51-2.01, p = 0.98). In the secondary analysis, the adjusted 5-year PFS was 59.0 % in the control group without crossover compared with 69.2 % for the control group with crossover (HR 0.68, 95 % CI 0.22-2.06, p = 0.49), 67.7 % for the exercise group with <80 % adherence (HR 0.72, 95 % CI 0.28-1.85, p = 0.50), and 68.4 % for the exercise group with ≥80 % adherence (HR 0.70, 95 % CI 0.32-1.56, p = 0.39). In a post hoc analysis combining the three groups that received supervised exercise, the adjusted 5-year PFS for the supervised exercise groups was 68.5 % compared with 59.0 % for the group that received no supervised exercise (HR 0.70, 95 % CI 0.35-1.39, p = 0.31). This exploratory follow-up of the HELP Trial suggests that supervised aerobic exercise may be associated with improved PFS in lymphoma patients. Larger trials designed to answer this question are needed.

  11. Therapeutic effects of nandrolone and testosterone in adult male HIV patients with AIDS wasting syndrome (AWS): a randomized, double-blind, placebo-controlled trial.

    PubMed

    Sardar, Partha; Jha, Ayan; Roy, Deeptarka; Majumdar, Uddalak; Guha, Pradipta; Roy, Sabyasachi; Banerjee, Ramtanu; Banerjee, Amit Kumar; Bandyopadhyay, Dipanjan

    2010-01-01

    We aimed to compare therapeutic effects of intramuscular (IM) nandrolone decanoate and IM testosterone enanthate in male HIV patients with AIDS wasting syndrome (AWS) with placebo control. In this randomized, double-blind, placebo-controlled, 12-week trial, 104 patients with AWS who satisfied our inclusion criteria were randomly allotted in a 2:2:1 ratio to the 3 intervention groups: nandrolone, testosterone, and placebo. We administered 150 mg nandrolone and 250 mg testosterone (both IM, biweekly). The primary outcome measure was a comparison of absolute change in weight at 12 weeks between the nandrolone decanoate, testosterone, and placebo groups. Intent-to-treat analysis was done. The nandrolone group recorded maximum mean increase in weight (3.20 kg; post hoc P < .01 compared to placebo). Body mass index (BMI) of subjects in the nandrolone group had a significantly greater increase (mean = 1.28) compared to both testosterone (post hoc P < .05) and placebo (post hoc P < .01). Waist circumference and triceps skinfold thickness of patients on nandrolone showed similar results. Nandrolone also ensured a better quality of life. Patients with low testosterone level (<3 ng/mL) benefited immensely from nandrolone therapy, which increased their weight and BMI significantly compared to placebo (P < .05). Our trial demonstrates the superior therapeutic effects of nandrolone in male AWS patients, including the androgen deficient.

  12. Coverbal Gestures in the Recovery from Severe Fluent Aphasia: A Pilot Study

    ERIC Educational Resources Information Center

    Carlomagno, Sergio; Zulian, Nicola; Razzano, Carmelina; De Mercurio, Ilaria; Marini, Andrea

    2013-01-01

    This post hoc study investigated coverbal gesture patterns in two persons with chronic Wernicke's aphasia. They had both received therapy focusing on multimodal communication therapy, and their pre- and post-therapy verbal and gestural skills in face-to-face conversational interaction with their speech therapist were analysed by administering a…

  13. Comparing Distance vs. Campus-Based Delivery of Research Methods Courses

    ERIC Educational Resources Information Center

    Girod, Mark; Wojcikiewicz, Steve

    2009-01-01

    A causal-comparative pre-test, post-test design was used to investigate differences in learning in a research methods course for face-to-face and web-based delivery models. Analyses of participant achievement (N = 205) revealed almost no differences but post-hoc analyses revealed important differences in pedagogy between delivery models despite…

  14. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    PubMed

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P < .001) or ranibizumab (+13.6 [8.5]; 95% CI, +0.7 to +6.0; P = .009). When VA was 20/50 or worse at baseline, bevacizumab reduced CST less than the other agents at 1 year, but at 2 years the differences had diminished. In subgroups stratified by baseline VA, anti-VEGF agent, and whether focal/grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P < .001). Although post hoc analyses should be viewed with caution given the potential for bias, in eyes with a VA of 20/50 or worse, aflibercept has the greatest improvement in VA over 2 years. Focal/grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years. clinicaltrials.gov Identifier NCT01627249.

  15. Glutamine and antioxidants in the critically ill patient: a post hoc analysis of a large-scale randomized trial.

    PubMed

    Heyland, Daren K; Elke, Gunnar; Cook, Deborah; Berger, Mette M; Wischmeyer, Paul E; Albert, Martin; Muscedere, John; Jones, Gwynne; Day, Andrew G

    2015-05-01

    The recent large randomized controlled trial of glutamine and antioxidant supplementation suggested that high-dose glutamine is associated with increased mortality in critically ill patients with multiorgan failure. The objectives of the present analyses were to reevaluate the effect of supplementation after controlling for baseline covariates and to identify potentially important subgroup effects. This study was a post hoc analysis of a prospective factorial 2 × 2 randomized trial conducted in 40 intensive care units in North America and Europe. In total, 1223 mechanically ventilated adult patients with multiorgan failure were randomized to receive glutamine, antioxidants, both glutamine and antioxidants, or placebo administered separate from artificial nutrition. We compared each of the 3 active treatment arms (glutamine alone, antioxidants alone, and glutamine + antioxidants) with placebo on 28-day mortality. Post hoc, treatment effects were examined within subgroups defined by baseline patient characteristics. Logistic regression was used to estimate treatment effects within subgroups after adjustment for baseline covariates and to identify treatment-by-subgroup interactions (effect modification). The 28-day mortality rates in the placebo, glutamine, antioxidant, and combination arms were 25%, 32%, 29%, and 33%, respectively. After adjusting for prespecified baseline covariates, the adjusted odds ratio of 28-day mortality vs placebo was 1.5 (95% confidence interval, 1.0-2.1, P = .05), 1.2 (0.8-1.8, P = .40), and 1.4 (0.9-2.0, P = .09) for glutamine, antioxidant, and glutamine plus antioxidant arms, respectively. In the post hoc subgroup analysis, both glutamine and antioxidants appeared most harmful in patients with baseline renal dysfunction. No subgroups suggested reduced mortality with supplements. After adjustment for baseline covariates, early provision of high-dose glutamine administered separately from artificial nutrition was not beneficial and may be associated with increased mortality in critically ill patients with multiorgan failure. For both glutamine and antioxidants, the greatest potential for harm was observed in patients with multiorgan failure that included renal dysfunction upon study enrollment. © 2014 American Society for Parenteral and Enteral Nutrition.

  16. Prognostic Effect of Carcinoma In Situ in Muscle-invasive Urothelial Carcinoma Patients Receiving Neoadjuvant Chemotherapy

    PubMed Central

    Thomas, Derek E.; Kaimakliotis, Hristos Z.; Rice, Kevin R.; Pereira, Jose A.; Johnston, Paul; Moore, Marietta L.; Reed, Angela; Cregar, Dylan M.; Franklin, Cindy; Loman, Rhoda L.; Koch, Michael O.; Bihrle, Richard; Foster, Richard S.; Masterson, Timothy A.; Gardner, Thomas A.; Sundaram, Chandru P.; Powell, Charles R.; Beck, Stephen D.W.; Grignon, David J.; Cheng, Liang; Albany, Costantine; Hahn, Noah M.

    2017-01-01

    We performed a single-institution retrospective analysis of 137 patients with muscle-invasive urothelial carcinoma who underwent neoadjuvant chemotherapy and radical cystectomy to assess the prognostic significance of carcinoma in situ (CIS). The pathologic complete response rates were significantly decreased for patients with CIS identified on transurethral resection of the bladder tumor before treatment. The long-term follow-up data from patients with isolated CIS at cystectomy revealed prolonged progression-free and overall survival. Background Carcinoma in situ (CIS) is a poor prognostic finding in urothelial carcinoma. However, its significance in muscle-invasive urothelial carcinoma (MIUC) treated with neoadjuvant chemotherapy (NAC) is uncertain. We assessed the effect of CIS found in pretreatment transurethral resection of bladder tumor (TURBT) biopsies on the pathologic and clinical outcomes. Materials and Methods Subjects with MIUC treated with NAC before cystectomy were identified. The pathologic complete response (pCR) rates stratified by TURBT CIS status were compared. The secondary analyses included tumor response, progression-free survival (PFS), overall survival (OS), and an exploratory post hoc analysis of patients with pathologic CIS only (pTisN0) at cystectomy. Results A total of 137 patients with MIUC were identified. TURBT CIS was noted in 30.7% of the patients. The absence of TURBT CIS was associated with a significantly increased pCR rate (23.2% vs. 9.5%; odds ratio, 4.08; 95% confidence interval, 1.19–13.98; P = .025). Stage pTisN0 disease was observed in 19.0% of the TURBT CIS patients. TURBT CIS status did not significantly affect the PFS or OS outcomes. Post hoc analysis of the pTisN0 patients revealed prolonged median PFS (104.5 vs. 139.9 months; P = .055) and OS (104.5 vs. 152.3 months; P = .091) outcomes similar to those for the pCR patients. Conclusion The absence of CIS on pretreatment TURBT in patients with MIUC undergoing NAC was associated with increased pCR rates, with no observed differences in PFS or OS. Isolated CIS at cystectomy was frequently observed, with lengthy PFS and OS durations similar to those for pCR patients. Further studies aimed at understanding the biology and clinical effect of CIS in MIUC are warranted. PMID:28040424

  17. Preliminary Evidence of "Other-Race Effect"-Like Behavior Induced by Cathodal-tDCS over the Right Occipital Cortex, in the Absence of Overall Effects on Face/Object Processing.

    PubMed

    Costantino, Andrea I; Titoni, Matilde; Bossi, Francesco; Premoli, Isabella; Nitsche, Michael A; Rivolta, Davide

    2017-01-01

    Neuromodulation techniques such as tDCS have provided important insight into the neurophysiological mechanisms that mediate cognition. Albeit anodal tDCS (a-tDCS) often enhances cognitive skills, the role of cathodal tDCS (c-tDCS) in visual cognition is largely unexplored and inconclusive. Here, in a single-blind, sham-controlled study, we investigated the offline effects of 1.5 mA c-tDCS over the right occipital cortex of 86 participants on four tasks assessing perception and memory of both faces and objects. Results demonstrated that c-tDCS does not overall affect performance on the four tasks. However, post-hoc exploratory analysis on participants' race (Caucasian vs. non-Caucasians), showed a "face-specific" performance decrease (≈10%) in non-Caucasian participants only . This preliminary evidence suggests that c-tDCS can induce "other-race effect (ORE)-like" behavior in non-Caucasian participants that did not show any ORE before stimulation (and in case of sham stimulation). Our results add relevant information about the breadth of cognitive processes and visual stimuli that can be modulated by c-tDCS, about the design of effective neuromodulation protocols, and have important implications for the potential neurophysiological bases of ORE.

  18. Pharmacological interactions between brivaracetam and ethanol in healthy males.

    PubMed

    Kruithof, Annelieke C; Watanabe, Shikiko; Peeters, Pierre Am; de Kam, Marieke L; Zuiker, Rob Gja; Stevens, Jasper; van Gerven, Joop Ma; Stockis, Armel

    2017-07-01

    This double-blind, randomized, three-way crossover study explored the potential pharmacokinetic and pharmacodynamic interactions between ethanol and brivaracetam in 18 healthy males, as required for the development of CNS-active drugs. Subjects received (A) ethanol+brivaracetam, (B) ethanol placebo+brivaracetam and (C) ethanol+brivaracetam placebo. Ethanol was infused as a 5.5-hour intravenous clamp with the first 0.5-hour as loading phase to a target level of 0.6 g/L, and brivaracetam was orally administered as a single 200 mg dose. No relevant pharmacokinetic interactions were observed. Co-administration of brivaracetam and ethanol resulted in decreased saccadic peak velocity, smooth pursuit, adaptive tracking and VAS alertness, and increased body sway, saccadic reaction time and VAS score for ethanol effect compared with brivaracetam alone or ethanol alone. Additionally, the immediate word recall scores were generally lower when brivaracetam was co-administered with ethanol, whereas the delayed word test did not show clear additional effects. A post-hoc exploratory analysis for supra-additivity suggested that most pharmacodynamic effects were likely to be additive in nature, except for adaptive tracking, which appeared to be slightly supra-additive. In conclusion, brivaracetam increased ethanol effects on psychomotor function, attention and memory in healthy males. Intake of brivaracetam with alcohol is not recommended.

  19. Hierarchical clusters in families with type 2 diabetes.

    PubMed

    García-Solano, Beatriz; Gallegos-Cabriales, Esther C; Gómez-Meza, Marco V; García-Madrid, Guillermina; Flores-Merlo, Marcela; García-Solano, Mauro

    2015-01-01

    Families represent more than a set of individuals; family is more than a sum of its individual members. With this classification, nurses can identify the family health-illness beliefs obey family as a unit concept, and plan family inclusion into the type 2 diabetes treatment, whom is not considered in public policy, despite families share diet, exercise, and self-monitoring with a member who suffers type 2 diabetes. The aim of this study was to determine whether the characteristics, functionality, routines, and family and individual health in type 2 diabetes describes the differences and similarities between families to consider them as a unit. We performed an exploratory, descriptive hierarchical cluster analysis of 61 families using three instruments and a questionnaire, in addition to weight, height, body fat percentage, hemoglobin A1c, total cholesterol, triglycerides, low-density lipoprotein and high-density lipoprotein. The analysis produced three groups of families. Wilk's lambda demonstrated statistically significant differences provided by age (Λ = 0.778, F = 2.098, p = 0.010) and family health (Λ = 0.813, F = 2.650, p = 0.023). A post hoc Tukey test coincided with the three subsets. Families with type 2 diabetes have common elements that make them similar, while sharing differences that make them unique.

  20. Sexual function and quality of life in genitourinary medicine (GUM) outpatients and preliminary validation of a self-report questionnaire measure.

    PubMed

    Daker-White, Gavin; Crowley, Tessa

    2003-05-01

    A cross-sectional questionnaire survey of 216 men and 191 women attending a genitourinary medicine (GUM) clinic was undertaken to explore the relationship between sexual symptoms and quality of sexual life, and to test the psychometric validity of a pilot self-report measure of Sexual Function and Quality of Sexual Life (SFQoSL). Statistical comparisons were made with three reference groups: volunteers attending GUM for psychosexual counselling, outpatients at an Obstetrics and Gynaecology Department, and staff. Exploratory principal components analysis (with varimax rotation) of questionnaire item responses suggested an 11 (in women) and 13 (in men) factor solution, incorporating four multi-item scales. Internal consistency (Cronbach's alpha) of core items was 0.84 in 186 women (19 items) and 0.87 in 210 men (22 items). Construct validity was supported in comparisons with reference groups using one-way analysis of variance and post-hoc Scheffé testing. Overall, 116 (54%) male and 132 (69%) female GUM outpatients had scores indicating sexual dysfunction. Thirty-seven (17%) men reported erectile dysfunction; 54 (28%) women reported vaginal dryness affecting sex; 48 (25%) women reported genital changes affecting sex; 45 (21%) men and 64 (34%) women reported problems reaching orgasm.

  1. Fidaxomicin versus vancomycin for Clostridium difficile infection: meta-analysis of pivotal randomized controlled trials.

    PubMed

    Crook, Derrick W; Walker, A Sarah; Kean, Yin; Weiss, Karl; Cornely, Oliver A; Miller, Mark A; Esposito, Roberto; Louie, Thomas J; Stoesser, Nicole E; Young, Bernadette C; Angus, Brian J; Gorbach, Sherwood L; Peto, Timothy E A

    2012-08-01

    Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%-51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%-60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13-40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI.

  2. Yoga May Mitigate Decreases in High School Grades

    PubMed Central

    Butzer, Bethany; van Over, Max; Noggle Taylor, Jessica J.; Khalsa, Sat Bir S.

    2015-01-01

    This study involves an exploratory examination of the effects of a 12-week school-based yoga intervention on changes in grade point average (GPA) in 9th and 10th grade students. Participants included 95 high school students who had registered for physical education (PE) in spring 2010. PE class sections were group randomized to receive either a yoga intervention or a PE-as-usual control condition. The yoga intervention took place during the entire third quarter and half of the fourth quarter of the school year, and quarterly GPA was collected via school records at the end of the school year. Results revealed a significant interaction between group and quarter suggesting that GPA differed between the yoga and control groups over time. Post hoc tests revealed that while both groups exhibited a general decline in GPA over the school year, the control group exhibited a significantly greater decline in GPA from quarter 1 to quarter 3 than the yoga group. Both groups showed equivalent declines in GPA in quarter 4 after the yoga intervention had ended. The results suggest that yoga may have a protective effect on academic performance by preventing declines in GPA; however these preventive effects may not persist once yoga practice is discontinued. PMID:26347787

  3. Machine driving of wooden and steel highway guardrail posts under adverse conditions

    Treesearch

    Charles J. Gatchell; Edwin L. Lucas; Edwin L. Lucas

    1971-01-01

    In an exploratory study, we drove 32 wooden posts and 26 steel posts into a rock-filled base that was topped with limestone gravel and shale. We found that, though both post materials perform well, wood is superior to steel in resisting damage below the groundline.

  4. Jupyter and Galaxy: Easing entry barriers into complex data analyses for biomedical researchers.

    PubMed

    Grüning, Björn A; Rasche, Eric; Rebolledo-Jaramillo, Boris; Eberhard, Carl; Houwaart, Torsten; Chilton, John; Coraor, Nate; Backofen, Rolf; Taylor, James; Nekrutenko, Anton

    2017-05-01

    What does it take to convert a heap of sequencing data into a publishable result? First, common tools are employed to reduce primary data (sequencing reads) to a form suitable for further analyses (i.e., the list of variable sites). The subsequent exploratory stage is much more ad hoc and requires the development of custom scripts and pipelines, making it problematic for biomedical researchers. Here, we describe a hybrid platform combining common analysis pathways with the ability to explore data interactively. It aims to fully encompass and simplify the "raw data-to-publication" pathway and make it reproducible.

  5. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis

    PubMed Central

    le Roux, Carel; Aroda, Vanita; Hemmingsson, Joanna; Cancino, Ana Paula; Christensen, Rune; Pi-Sunyer, Xavier

    2018-01-01

    Objective To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D). Methods A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup. Results Significantly greater weight loss (0–56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups. Conclusion This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m². PMID:29145215

  6. A post hoc analysis of subgroup outcomes and creatinine in the phase III clinical trial (EMPOWER) of dexpramipexole in ALS.

    PubMed

    Bozik, Michael E; Mitsumoto, Hiroshi; Brooks, Benjamin R; Rudnicki, Stacy A; Moore, Dan H; Zhang, Bing; Ludolph, Albert; Cudkowicz, Merit E; van den Berg, Leonard H; Mather, James; Petzinger, Thomas; Archibald, Donald

    2014-09-01

    Our objective was to compare the phase II and phase III (EMPOWER) studies of dexpramipexole in ALS and evaluate potential EMPOWER responder subgroups and biomarkers based on significant inter-study population differences. In a post hoc analysis, we compared the baseline population characteristics of both dexpramipexole studies and analyzed EMPOWER efficacy outcomes and laboratory measures in subgroups defined by significant inter-study differences. Results showed that, compared with phase II, the proportion of El Escorial criteria (EEC) definite participants decreased (p = 0.005), riluzole use increased (p = 0.002), and mean symptom duration increased (p = 0.037) significantly in EMPOWER. Baseline creatinine (p < 0.001) and on-study creatinine change (p < 0.001) correlated significantly with ALSFRS-R in EMPOWER. In the EMPOWER subgroup defined by EEC-definite ALS, riluzole use, and < median symptom duration (15.3 months), dexpramipexole-treated participants had reduced ALSFRS-R slope decline (p = 0.015), decreased mortality (p = 0.011), and reduced creatinine loss (p = 0.003). In conclusion, significant differences existed between the phase II and EMPOWER study populations in ALS clinical trials of dexpramipexole. In a post hoc analysis of EMPOWER subgroups defined by these differences, potential clinical benefits of dexpramipexole were identified in the subgroup of riluzole-treated, short-symptom duration, EEC-definite ALS participants. Creatinine loss correlated with disease progression and was reduced in dexpramipexole-treated participants, suggesting it as a candidate biomarker.

  7. Defibrotide for the treatment of hepatic veno-occlusive disease/sinusoidal obstruction syndrome following nontransplant-associated chemotherapy: Final results from a post hoc analysis of data from an expanded-access program.

    PubMed

    Kernan, Nancy A; Richardson, Paul G; Smith, Angela R; Triplett, Brandon M; Antin, Joseph H; Lehmann, Leslie; Messinger, Yoav; Liang, Wei; Hume, Robin; Tappe, William; Soiffer, Robert J; Grupp, Stephan A

    2018-06-06

    Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially fatal complication of conditioning for hematopoietic stem cell transplantation (HSCT) but can occur after nontransplant-associated chemotherapy. Following HSCT, VOD/SOS with multi-organ dysfunction (MOD) may be associated with >80% mortality. Defibrotide is approved to treat severe hepatic VOD/SOS post-HSCT in patients aged >1 month in the European Union and hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT in the United States. Prior to US approval, defibrotide was available to treat VOD/SOS through an expanded-access treatment (T-IND) program. A post hoc analysis of nontransplant-associated VOD/SOS patients treated with defibrotide initiated within 30 days of starting chemotherapy and followed for 70 days is presented. Patients were diagnosed by Baltimore or modified Seattle criteria or biopsy, and received defibrotide 25 mg/kg/day in four divided doses (≥21 days recommended). Of the 1,154 patients in the T-IND, 137 had nontransplant-associated VOD/SOS, 82 of whom developed VOD/SOS within 30 days of starting chemotherapy. Of them, 66 (80.5%) were aged ≤16 years. Across all the 82 patients, Kaplan-Meier estimated day +70 survival was 74.1%, 65.8% in patients with MOD (n = 38), and 81.3% in patients without MOD (n = 44). By age group, Kaplan-Meier estimated day +70 survival was 80.1% in pediatric patients (n = 66) and 50.0% in adults (n = 16). Treatment-related adverse events occurred in 26.8%. In this post hoc analysis of 82 patients initiating defibrotide within 30 days of starting chemotherapy, Kaplan-Meier estimated survival was 74.1% at 70 days after defibrotide initiation. Safety profile was consistent with prior defibrotide studies. © 2018 The Authors. Pediatric Blood & Cancer Published by Wiley Periodicals, Inc.

  8. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

    PubMed

    Fahlenkamp, Astrid V; Stoppe, Christian; Cremer, Jan; Biener, Ingeborg A; Peters, Dirk; Leuchter, Ricarda; Eisert, Albrecht; Apfel, Christian C; Rossaint, Rolf; Coburn, Mark

    2016-01-01

    Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV). We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis. 220 subjects with elevated PONV risk (Apfel score ≥2) undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up. Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044). Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138). After xenon, nausea occurred significantly earlier (p = 0.014), was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups. In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea. EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

  9. Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial

    PubMed Central

    Fahlenkamp, Astrid V.; Stoppe, Christian; Cremer, Jan; Biener, Ingeborg A.; Peters, Dirk; Leuchter, Ricarda; Eisert, Albrecht; Apfel, Christian C.; Rossaint, Rolf; Coburn, Mark

    2016-01-01

    Objective Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV). We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis. Methods 220 subjects with elevated PONV risk (Apfel score ≥2) undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up. Results Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02–5.19, p = 0.044). Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138). After xenon, nausea occurred significantly earlier (p = 0.014), was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups. Conclusion In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea. Trial Registration EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663 PMID:27111335

  10. Effects of post-weaning social isolation and environment al enrichment on exploratory behavior and ankiety in Wistar rats.

    PubMed

    Tanaś, Łukasz; Ostaszewski, Paweł; Iwan, Anna

    2015-01-01

    Adverse early experience is generally regarded as a risk factor for both externalizing and internalizing behavioral disorders in humans. It can be modeled in rats by a post-weaning social isolation procedure. Effects of social isolation might possibly be ameliorated by environmental enrichment. In the current study, 24 male Wistar rats were divided post-weaning into four rearing conditions: control, environmental enrichment (EE), social isolation (SI) and a combination of the two experimental conditions; (EE+SI). Two observations of the effects of rearing conditions on the rate of social and object interactions were conducted during the juvenile and post-pubertal stages of development. The SI condition led to a marked increase of social interactions during the juvenile phase, but did not affect object interactions. The EE condition increased the level of social interactions during both the juvenile and post-pubertal measurements. The effects of early rearing conditions on adult exploratory behavior were less clear, with a significant difference between the groups obtained in one of three behavioral tests. Results suggest a general robustness in the development of adult exploratory behavior and anxiety when rats were exposed to early social isolation and provided brief opportunities for social play during the juvenile period. Further studies, aimed at distinguishing play-related protective factors serving against long-term adverse effects of juvenile social isolation, are suggested.

  11. An Exploratory Study of the Impact of College Student Leadership Programs upon the Construct of Mindfulness

    ERIC Educational Resources Information Center

    Horowitz, Rich

    2012-01-01

    Mindfulness is a key skill that produces the greater psychological awareness identified by most leadership scholars as being essential to effective leadership. This study conducted an exploratory assessment of the effectiveness of mindfulness-based cocurricular collegiate leadership programs through pre- and post-participation application of the…

  12. An Exploratory Multiple Case Study about Using Game-Based Learning in STEM Classrooms

    ERIC Educational Resources Information Center

    Vu, Phu; Feinstein, Sheryl

    2017-01-01

    This exploratory multiple case study attempted to examine whether game-based learning activities had any impacts on students' academic performances and behaviors, and what perceptions the teachers had toward implementing games into their classrooms. Data used in this study included 101 students' pre and post-test scores, and four structured…

  13. Academic and Personal Development through Group Work: An Exploratory Study

    ERIC Educational Resources Information Center

    Steen, Sam

    2011-01-01

    This exploratory study linked academic and personal development within a group counseling intervention. A pre-test post-test research design compared social skills, learning behaviors, and achievement with a convenience sample and control group of students from three elementary schools. For the treatment group, grade point average in Language Arts…

  14. An Exploratory Study of Emotional Affordance of a Massive Open Online Course

    ERIC Educational Resources Information Center

    Cheng, Jeremy C. Y.

    2014-01-01

    This exploratory study examines emotional affordance of a massive open online course (MOOC). Postings in a discussion forum of a MOOC in computer science are analysed following a research design informed by virtual ethnography. Emotional affordance is investigated, focusing on non-achievement emotions which are not directly linked to achievement…

  15. Pharmacological and Behavioral Enhancement of Neuroplasticity in the MPTP Lesioned Mouse and Nonhuman Primate

    DTIC Science & Technology

    2007-05-01

    and post - synaptic dopamine biosynthesis, uptake and receptor expression as well as glutamatergic synapses. This hypothesis will be tested through...0.05) compared to mice at 7 days (9.6 ± 3.2%) or 30 days post -MPTP (16.5 ± 7.3%). The tail suspension test showed a significant increase in percent of...were compared using one-way analysis of variance (ANOVA), followed by the Fisher post hoc test for comparison of multiple means for the following

  16. Comparison of fracture resistance between cast, CAD/CAM milling, and direct metal laser sintering metal post systems.

    PubMed

    Bilgin, Mehmet Selim; Erdem, Ali; Dilber, Erhan; Ersoy, İbrahim

    2016-01-01

    The purpose of this study was to compare the fracture resistance of Co-Cr post-cores fabricated with 3 different techniques: traditional casting (TC), computer-aided design and manufacturing (CAD/CAM) milling (CCM) and direct metal laser sintering (DMLS). Forty intact human mandibular premolar were endodontically treated. The roots were then randomly divided into four groups according to the post systems: the control group was only filled with gutta percha. Co-Cr metal posts were fabricated with TC, CCM and DMLS in the other three groups. The posts were luted with a resin cement and subjected to compression test at a crosshead speed of 1mm/min. The statistical analysis of the data was performed using one-way analysis of variance (ANOVA) and multiple comparison post hoc Tukey tests (α=.05). The samples were examined under a stereomicroscope with ×20 magnification for the evaluation of the fracture types. The mean fracture loads were 432.69 N for control, 608.89 N for TC, 689.40 N for DMLS and 959.26 N for CCM. One-way ANOVA revealed significant difference between the groups (p<0.01). In the post hoc Tukey test, there were significant differences between groups except DMLS and TC. While Co-Cr posts fabricated by TC and DMLS systems performed similarly in terms of fracture resistance, posts fabricated by CCM techniques showed higher fracture resistance values. Co-Cr metal posts fabricated by CCM and DMLS could be an alternative to TC processing in daily clinical application. Copyright © 2015 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  17. Characteristics of Cardiac Arrest Occurring in the Workplace: A Post Hoc Analysis of the Paris Area Fire Brigade Registry.

    PubMed

    Palaghita, Andreea; Jost, Daniel; Despreaux, Thomas; Bougouin, Wulfran; Beganton, Frankie; Loeb, Thomas; Tourtier, Jean Pierre; Descatha, Alexis

    2016-08-01

    The aim of this study was to describe the characteristics of out-of-hospital cardiac arrest (OHCA) in different workplaces, their management, and the survival rate. A post hoc analysis included all the OHCA cases that occurred at the workplace and were listed in the Fire Brigade of Paris database registry (2010 to 2014). Utstein-style variables, survival, and types of workplace were analyzed. The study included 298 OHCA cases, mostly young (44% between 18 and 50 years), male (86%), and nontraumatic (86%). Differences in the survival chain were found to be related to the types of work location: bystander cardiopulmonary resuscitation was performed in 0% to 55% of cases, and workplace-automated external defibrillators were used in 0% to 20% of cases. Long-term survival without major incapacity was 0% to 23%. The characteristics of OHCA differ as a function of the type of workplace.

  18. The effect of budesonide/formoterol maintenance and reliever therapy on the risk of severe asthma exacerbations following episodes of high reliever use: an exploratory analysis of two randomised, controlled studies with comparisons to standard therapy

    PubMed Central

    2012-01-01

    Background Divergent strategies have emerged for the management of severe asthma. One strategy utilises high and fixed doses of maintenance treatment, usually inhaled corticosteroid/long-acting β2-agonist (ICS/LABA), supplemented by a short-acting β2-agonist (SABA) as needed. Alternatively, budesonide/formoterol is used as both maintenance and reliever therapy. The latter is superior to fixed-dose treatment in reducing severe exacerbations while achieving similar or better asthma control in other regards. Exacerbations may be reduced by the use of budesonide/formoterol as reliever medication during periods of unstable asthma. We examined the risk of a severe exacerbation in the period after a single day with high reliever use. Methods Episodes of high reliever use were quantified and exacerbations occurring post-index day with these episodes were examined post hoc in two double-blind studies comparing the efficacy and safety of budesonide/formoterol maintenance and reliever therapy (Symbicort SMART™, Turbuhaler®) 160/4.5 μg twice daily plus as needed with similar or higher maintenance doses of ICS/LABA plus SABA or formoterol. Results Budesonide/formoterol maintenance and reliever therapy significantly reduced the risk of episodes of high reliever use (>6 inhalations/day) vs. all alternative ICS/LABA regimens. With conventional fixed-dose treatment the need for exacerbation treatment within 21 days ranged from 6.0–10.1% of days post-index for all regimens compared with 2.5–3.4% of days with budesonide/formoterol maintenance and reliever therapy. Conclusions Budesonide/formoterol maintenance and reliever therapy reduces the incidence of high reliever episodes and the exacerbation burden immediately following these episodes vs. alternative ICS/LABA plus SABA regimens at up to double the maintenance dose of ICS. Trial registration These studies do not have registration numbers as they were conducted before clinical trial registration was required PMID:22816878

  19. Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS).

    PubMed

    Jang, Saeheon; Jung, Sungwon; Pae, Chiun; Kimberly, Blanchard Portland; Craig Nelson, J; Patkar, Ashwin A

    2013-12-01

    We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥ 14 and a CGI-S score of ≥ 3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e., lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD. © 2013 Published by Elsevier B.V.

  20. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.

    PubMed

    le Roux, Carel; Aroda, Vanita; Hemmingsson, Joanna; Cancino, Ana Paula; Christensen, Rune; Pi-Sunyer, Xavier

    2017-01-01

    To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D). A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup. Significantly greater weight loss (0-56 weeks) was observed with liraglutide 3.0 mg versus placebo in all patient groups while on treatment. There was no evidence that the weight-lowering effect of liraglutide 3.0 mg differed between BMI subgroups (interaction p > 0.05). Similarly, for most secondary endpoints significantly greater improvements were observed with liraglutide 3.0 mg versus placebo, with no indication treatment effects differing between subgroups. The safety profile of liraglutide 3.0 mg was broadly similar across BMI subgroups. This post-hoc analysis did not indicate any differences in the treatment effects, or safety profile, of liraglutide 3.0 mg for individuals with BMI 27 to <35 or ≥35 kg/m². Liraglutide 3.0 mg can therefore be considered for individuals with a BMI of ≥35 as well as for those with a BMI of 27 to <35 kg/m². © 2017 The Author(s) Published by S. Karger GmbH, Freiburg.

  1. A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    PubMed

    2017-10-01

    Our first phase III study failed to demonstrate efficacy of edaravone for amyotrophic lateral sclerosis (ALS) compared to placebo. Here, we performed post-hoc subgroup analysis to identify a subgroup in which edaravone might be expected to show efficacy. We focussed on two newly defined subgroups, EESP and dpEESP2y. The EESP was defined as the efficacy-expected subpopulation with % forced vital capacity of ≥80%, and ≥2 points for all item scores in the revised ALS functional rating scale (ALSFRS-R) score before treatment. The dpEESP2y was defined as the greater-efficacy-expected subpopulation within EESP having a diagnosis of 'definite' or 'probable' ALS according to the El Escorial revised Airlie House diagnostic criteria and onset of disease within two years. The primary endpoint of the post-hoc analysis was the change in the ALSFRS-R score during the 24-week treatment period. The intergroup differences of the least-squares mean change in the ALSFRS-R score ± standard error during treatment were 0.65 ± 0.78 (p = 0.4108) in the full analysis set, 2.20 ± 1.03 (p = 0.0360) in the EESP, and 3.01 ± 1.33 (p = 0.0270) in the dpEESP2y. Edaravone exhibited efficacy in the dpEESP2y subgroup. A further clinical study in patients meeting dpEESP2y criteria is warranted.

  2. Fracture strength of different soldered and welded orthodontic joining configurations with and without filling material.

    PubMed

    Bock, Jens Johannes; Bailly, Jacqueline; Gernhardt, Christian Ralf; Fuhrmann, Robert Andreas Werner

    2008-01-01

    The aim of this study was to compare the mechanical strength of different joints made by conventional brazing, TIG and laser welding with and without filling material. Five standardized joining configurations of orthodontic wire in spring hard quality were used: round, cross, 3 mm length, 9 mm length and 7 mm to orthodontic band. The joints were made by five different methods: brazing, tungsten inert gas (TIG) and laser welding with and without filling material. For the original orthodontic wire and for each kind of joint configuration or connecting method 10 specimens were carefully produced, totalizing 240. The fracture strengths were measured with a universal testing machine (Zwick 005). Data were analyzed by ANOVA (p=0.05) and Bonferroni post hoc test (p=0.05). In all cases, brazing joints were ruptured on a low level of fracture strength (186-407 N). Significant differences between brazing and TIG or laser welding (p<0.05, Bonferroni post hoc test) were found in each joint configuration. The highest fracture strength means were observed for laser welding with filling material and 3 mm joint length (998 N). Using filling materials, there was a clear tendency to higher mean values of fracture strength in TIG and laser welding. However, statistically significant differences were found only in the 9-mm long joints (p<0.05, Bonferroni post hoc test). In conclusion, the fracture strength of welded joints was positively influenced by the additional use of filling material. TIG welding was comparable to laser welding except for the impossibility of joining orthodontic wire with orthodontic band.

  3. FRACTURE STRENGTH OF DIFFERENT SOLDERED AND WELDED ORTHODONTIC JOINING CONFIGURATIONS WITH AND WITHOUT FILLING MATERIAL

    PubMed Central

    Bock, Jens Johannes; Bailly, Jacqueline; Gernhardt, Christian Ralf; Fuhrmann, Robert Andreas Werner

    2008-01-01

    The aim of this study was to compare the mechanical strength of different joints made by conventional brazing, TIG and laser welding with and without filling material. Five standardized joining configurations of orthodontic wire in spring hard quality were used: round, cross, 3 mm length, 9 mm length and 7 mm to orthodontic band. The joints were made by five different methods: brazing, tungsten inert gas (TIG) and laser welding with and without filling material. For the original orthodontic wire and for each kind of joint configuration or connecting method 10 specimens were carefully produced, totalizing 240. The fracture strengths were measured with a universal testing machine (Zwick 005). Data were analyzed by ANOVA (p=0.05) and Bonferroni post hoc test (p=0.05). In all cases, brazing joints were ruptured on a low level of fracture strength (186-407 N). Significant differences between brazing and TIG or laser welding (p<0.05, Bonferroni post hoc test) were found in each joint configuration. The highest fracture strength means were observed for laser welding with filling material and 3 mm joint length (998 N). Using filling materials, there was a clear tendency to higher mean values of fracture strength in TIG and laser welding. However, statistically significant differences were found only in the 9-mm long joints (p<0.05, Bonferroni post hoc test). In conclusion, the fracture strength of welded joints was positively influenced by the additional use of filling material. TIG welding was comparable to laser welding except for the impossibility of joining orthodontic wire with orthodontic band. PMID:19089229

  4. Illustrating, Quantifying, and Correcting for Bias in Post-hoc Analysis of Gene-Based Rare Variant Tests of Association

    PubMed Central

    Grinde, Kelsey E.; Arbet, Jaron; Green, Alden; O'Connell, Michael; Valcarcel, Alessandra; Westra, Jason; Tintle, Nathan

    2017-01-01

    To date, gene-based rare variant testing approaches have focused on aggregating information across sets of variants to maximize statistical power in identifying genes showing significant association with diseases. Beyond identifying genes that are associated with diseases, the identification of causal variant(s) in those genes and estimation of their effect is crucial for planning replication studies and characterizing the genetic architecture of the locus. However, we illustrate that straightforward single-marker association statistics can suffer from substantial bias introduced by conditioning on gene-based test significance, due to the phenomenon often referred to as “winner's curse.” We illustrate the ramifications of this bias on variant effect size estimation and variant prioritization/ranking approaches, outline parameters of genetic architecture that affect this bias, and propose a bootstrap resampling method to correct for this bias. We find that our correction method significantly reduces the bias due to winner's curse (average two-fold decrease in bias, p < 2.2 × 10−6) and, consequently, substantially improves mean squared error and variant prioritization/ranking. The method is particularly helpful in adjustment for winner's curse effects when the initial gene-based test has low power and for relatively more common, non-causal variants. Adjustment for winner's curse is recommended for all post-hoc estimation and ranking of variants after a gene-based test. Further work is necessary to continue seeking ways to reduce bias and improve inference in post-hoc analysis of gene-based tests under a wide variety of genetic architectures. PMID:28959274

  5. MAOA genotype, childhood maltreatment, and their interaction in the etiology of adult antisocial behaviors.

    PubMed

    Haberstick, Brett C; Lessem, Jeffrey M; Hewitt, John K; Smolen, Andrew; Hopfer, Christian J; Halpern, Carolyn T; Killeya-Jones, Ley A; Boardman, Jason D; Tabor, Joyce; Siegler, Ilene C; Williams, Redford B; Mullan Harris, Kathleen

    2014-01-01

    Maltreatment by an adult or caregiver during childhood is a prevalent and important predictor of antisocial behaviors in adulthood. A functional promoter polymorphism in the monoamine oxidase A (MAOA) gene has been implicated as a moderating factor in the relationship between childhood maltreatment and antisocial behaviors. Although there have been numerous attempts at replicating this observation, results remain inconclusive. We examined this gene-environment interaction hypothesis in a sample of 3356 white and 960 black men (aged 24-34) participating in the National Longitudinal Study of Adolescent Health. Primary analysis indicated that childhood maltreatment was a significant risk factor for later behaviors that violate rules and the rights of others (p < .05), there were no main effects of MAOA genotype, and MAOA genotype was not a significant moderator of the relationship between maltreatment and antisocial behaviors in our white sample. Post hoc analyses identified a similar pattern of results among our black sample in which maltreatment was not a significant predictor of antisocial behavior. Post hoc analyses also revealed a main effect of MAOA genotype on having a disposition toward violence in both samples and for violent convictions among our black sample. None of these post hoc findings, however, survived correction for multiple testing (p > .05). Power analyses indicated that these results were not due to insufficient statistical power. We could not confirm the hypothesis that MAOA genotype moderates the relationship between childhood maltreatment and adult antisocial behaviors. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  6. Steroid use in Lyme disease-associated facial palsy is associated with worse long-term outcomes.

    PubMed

    Jowett, Nate; Gaudin, Robert A; Banks, Caroline A; Hadlock, Tessa A

    2017-06-01

    The purpose of this study was to determine whether differences in long-term facial function outcomes following acute Lyme disease-associated facial palsy (LDFP) exist between patients who received antibiotic monotherapy (MT); dual therapy (DT) with antibiotics and corticosteroids; and triple therapy (TT) with antibiotics, corticosteroids, and antivirals. Retrospective cohort. All patients with a prior diagnosis of unilateral LDFP who presented to our center between 2002 and 2015 were retrospectively assessed for inclusion. Two blinded experts graded static, dynamic, and synkinesis parameters of facial functions using standardized video documentation of facial function. Fifty-one patients were included. The mean time of assessment following LDFP onset was 15.1 months (range 0.3-84 months). Significantly worse facial outcomes were seen among those who received DT and TT as compared to those who received MT, most pronounced among those assessed 12 months or later following onset of LDFP (Dynamic-P = 0.031, post hoc MT vs. TT: mean difference [MD], 15.83; 95% confidence interval [CI], 1.54-30.13; P = 0.030. Synkinesis-P = 0.026, post hoc MT vs. DT: MD, 21.50; 95% CI, 0.68-42.32; P = 0.043, post hoc MT vs. TT: MD, 19.22; 95% CI, 2.23-36.22; P = 0.027). An association between corticosteroid use in acute LDFP and worse long-term facial function outcomes has been demonstrated. Care should be taken in differentiating viral or idiopathic facial palsy (e.g., Bell palsy) from LDFP. 4. Laryngoscope, 127:1451-1458, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  7. Brain BLAQ: Post-hoc thick-section histochemistry for localizing optogenetic constructs in neurons and their distal terminals

    PubMed Central

    Kupferschmidt, David A.; Cody, Patrick A.; Lovinger, David M.; Davis, Margaret I.

    2015-01-01

    Optogenetic constructs have revolutionized modern neuroscience, but the ability to accurately and efficiently assess their expression in the brain and associate it with prior functional measures remains a challenge. High-resolution imaging of thick, fixed brain sections would make such post-hoc assessment and association possible; however, thick sections often display autofluorescence that limits their compatibility with fluorescence microscopy. We describe and evaluate a method we call “Brain BLAQ” (Block Lipids and Aldehyde Quench) to rapidly reduce autofluorescence in thick brain sections, enabling efficient axon-level imaging of neurons and their processes in conventional tissue preparations using standard epifluorescence microscopy. Following viral-mediated transduction of optogenetic constructs and fluorescent proteins in mouse cortical pyramidal and dopaminergic neurons, we used BLAQ to assess innervation patterns in the striatum, a region in which autofluorescence often obscures the imaging of fine neural processes. After BLAQ treatment of 250–350 μm-thick brain sections, axons and puncta of labeled afferents were visible throughout the striatum using a standard epifluorescence stereomicroscope. BLAQ histochemistry confirmed that motor cortex (M1) projections preferentially innervated the matrix component of lateral striatum, whereas medial prefrontal cortex projections terminated largely in dorsal striosomes and distinct nucleus accumbens subregions. Ventral tegmental area dopaminergic projections terminated in a similarly heterogeneous pattern within nucleus accumbens and ventral striatum. Using a minimal number of easily manipulated and visualized sections, and microscopes available in most neuroscience laboratories, BLAQ enables simple, high-resolution assessment of virally transduced optogenetic construct expression, and post-hoc association of this expression with molecular markers, physiology and behavior. PMID:25698938

  8. Comparison of Different Instructional Multimedia Designs for Improving Student Science-Process Skill Learning

    NASA Astrophysics Data System (ADS)

    Chien, Yu-Ta; Chang, Chun-Yen

    2012-02-01

    This study developed three forms of computer-based multimedia, including Static Graphics (SG), Simple Learner-Pacing Animation (SLPA), and Full Learner-Pacing Animation (FLPA), to assist students in learning topographic measuring. The interactive design of FLPA allowed students to physically manipulate the virtual measuring mechanism, rather than passively observe dynamic or static images. The students were randomly assigned to different multimedia groups. The results of a one-way ANOVA analysis indicated that (1) there was a significant difference with a large effect size ( f = .69) in mental effort ratings among three groups, and the post-hoc test indicated that FLPA imposed less cognitive load on students than did SG ( p = .007); (2) the differences of practical performance scores among groups reached the statistic significant level with a large effect size ( f = .76), and the post-hoc test indicated that FLPA fostered better learning outcomes than both SLPA and SG ( p = .004 and p = .05, respectively); (3) the difference in instructional efficiency that was computed by the z-score combination of students' mental effort ratings and practical performance scores among the three groups obtained the statistic significant level with a large effect size ( f = .79), and the post-hoc test indicated that FLPA brought students higher instructional efficiency than those of both SLPA and SG ( p = .01 and .005, respectively); (4) no significant effect was found in instructional time-spans between groups ( p = .637). Overall, FLPA was recommended as the best multimedia form to facilitate topographic measurement learning. The implications of instructional multimedia design were discussed from the perspective of cognitive load theory.

  9. Parental history of depression and higher basal salivary cortisol in unaffected child and adolescent offspring.

    PubMed

    Zhang, Jihui; Lam, Siu Ping; Li, Shirley Xin; Liu, Yaping; Chan, Joey Wing Yan; Chan, Michael Ho Ming; Ho, Chung Shun; Li, Albert Martin; Wing, Yun Kwok

    2018-07-01

    There are contradictory findings regarding the associations of parental depression on the hypothalamic-pituitary-adrenal axis activity of their offspring. We aimed to explore the associations of parental depression on the diurnal salivary cortisol profile in their child and adolescent offspring. A total of 189 unaffected child and adolescent offspring as determined by structured clinical interview were divided into 3 groups according to their parental history of depression, namely current parental depression (CPD, n = 27), past parental depression (PPD, n = 57), and no parental depression (NPD, n = 105). Diurnal saliva samples were collected to measure the cortisol awakening response and diurnal cortisol profile. CPD group had significantly higher basal cortisol level (mean ± SE = 11.9 ± 0.80 nmol/dl) than PPD group (mean ± SE = 9.7 ± 0.73 nmol/dl, post hoc p = .024) and NPD group (mean ± SE = 10.2 ± 0.52 nmol/dl, post hoc p = .031) and lower cortisol level at noon, but comparable cortisol levels in other time points. The cortisol awakening response reference to increase (AUCi) were significantly blunted in CPD group when compared with PPD and NPD (post hoc p < .01). Adjustment for potential confounding factors did not change major findings. Further analyses revealed that main influences were derived from current maternal depression. A single day of saliva sample. Current but not past (lifetime) parental depression is associated with higher basal salivary cortisol and blunted cortisol awakening response in their children and adolescents. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study

    PubMed Central

    2012-01-01

    Background Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment. Methods This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites’ medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics. Results At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study. Conclusions In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted. PMID:23216976

  11. An Exploratory Examination of "Pockets of Success" in Creating Urban High Schools of Opportunity for LSES Students

    ERIC Educational Resources Information Center

    Gaines, Frank

    2013-01-01

    The purpose of this exploratory study was to examine "pockets of success" through the voices of participant stakeholders in low socio-economic status urban high schools and communities to identify opportunities and structures that can improve post-secondary outcomes for students. Examining those pockets of success to rise above the…

  12. Evaluating the Relationship between Equilibrium Passive Sampler Uptake and Aquatic Organism Bioaccumulation.

    EPA Science Inventory

    For decades, biomonitoring organisms have been used to assess the bioavailability of hydrophobic organic contaminants (HOCs) at contaminated sediment Superfund sites across the country. Specific applications include evaluating remedy effectiveness and pre- and post-remediation l...

  13. Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study.

    PubMed

    Moljord, I E O; Lara-Cabrera, M L; Salvesen, Ø; Rise, M B; Bjørgen, D; Antonsen, D Ø; Olsø, T M; Evensen, G H; Gudde, C B; Linaker, O M; Steinsbekk, A; Eriksen, L

    2017-06-01

    To investigate the effect of having a contract for self-referral to inpatient treatment (SRIT) in patients with severe mental disorders. A randomized controlled trial with 53 adult patients; 26 participants received a SRIT contract, which they could use to refer themselves into a Community Mental Health Centre up to five days for each referral without contacting a doctor in advance. Outcomes were assessed after 12 months with the self-report questionnaires Patient Activation Measure (PAM-13), Recovery Assessment Scale (RAS), and the Behavior and Symptom Identification Scale (BASIS-32) and analyzed using linear mixed and regression models. There was no significant effect on PAM-13 (estimated mean difference (emd) -0.41, 95% CI (CI):-7.49-6.67), nor on the RAS (emd 0.02, CI:-0.27-0.31) or BASIS-32 (0.09, CI:-0.28-0.45). An exploratory post hoc analysis showed effect of SRIT in those with low PAM below ≤47 (p=0.049). There were no group differences after 12 months, but both groups maintained their baseline levels. SRIT contracts can be recommended as it supports the rights to self-determination, promote user participation in decision-making in own treatment without any indication of adverse effects. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.

  14. The Development of a Multiple-Item Annoyance Scale (MIAS) for Transportation Noise Annoyance

    PubMed Central

    Belke, Christin; Spilski, Jan

    2018-01-01

    In 2001, Team#6 of the International Commission on Biological Effects of Noise (ICBEN) recommended the use of two single international standardised questions and response scales. This recommendation has been widely accepted in the scientific community. Nevertheless, annoyance can be regarded as a multidimensional construct comprising the three elements: (1) experience of an often repeated noise-related disturbance and the behavioural response to cope with it, (2) an emotional/attitudinal response to the sound and its disturbing impact, and (3) the perceived control or coping capacity with regard to the noise situation. The psychometric properties of items reflecting these three elements have been explored for aircraft noise annoyance. Analyses were conducted using data of the NORAH-Study (Noise-Related Annoyance, Cognition, and Health), and a multi-item noise annoyance scale (MIAS) has been developed and tested post hoc by using a stepwise process (exploratory and confirmatory factor analyses). Preliminary results were presented to the 12th ICBEN Congress in 2017. In this study, the validation of MIAS is done for aircraft noise and extended to railway and road traffic noise. The results largely confirm the concept of MIAS as a second-order construct of annoyance for all of the investigated transportation noise sources; however, improvements can be made, in particular with regard to items addressing the perceived coping capacity. PMID:29757228

  15. Neuronal Function in Male Sprague Dawley Rats During Normal Ageing.

    PubMed

    Idowu, A J; Olatunji-Bello, I I; Olagunju, J A

    2017-03-06

    During normal ageing, there are physiological changes especially in high energy demanding tissues including the brain and skeletal muscles. Ageing may disrupt homeostasis and allow tissue vulnerability to disease. To establish an appropriate animal model which is readily available and will be useful to test therapeutic strategies during normal ageing, we applied behavioral approaches to study age-related changes in memory and motor function as a basis for neuronal function in ageing in male Sprague Dawley rats. 3 months, n=5; 6 months, n=5 and 18 months, n=5 male Sprague Dawley Rats were tested using the Novel Object Recognition Task (NORT) and the Elevated plus Maze (EPM) Test. Data was analyzed by ANOVA and the Newman-Keuls post hoc test. The results showed an age-related gradual decline in exploratory behavior and locomotor activity with increasing age in 3 months, 6 months and 18 months old rats, although the values were not statistically significant, but grooming activity significantly increased with increasing age. Importantly, we established a novel finding that the minimum distance from the novel object was statistically significant between 3 months and 18 months old rats and this may be an index for age-related memory impairment in the NORT. Altogether, we conclude that the male Sprague Dawley rat show age-related changes in neuronal function and may be a useful model for carrying out investigations into the mechanisms involved in normal ageing.

  16. The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder.

    PubMed

    Dueñas, Héctor; Lara, Carmen; Walton, Richard J; Granger, Renee E; Dossenbach, Martin; Raskin, Joel

    2011-09-01

    To assess the reliability and validity of the Integral Inventory for Depression (IID) scale using post hoc analyses of data from a multi-country study (ClinicalTrials.gov: NCT00561509) of patients with major depressive disorder (MDD). Patients (N = 1629) completed the IID (comprising two separate dimensions for emotional and physically painful symptoms; maximum score of 65) and a reference scale (16-item Quick Inventory of Depressive Symptomatology Self-Report) at baseline and at follow-up (8 and 24 weeks). Physicians rated MDD symptoms using the Clinical Global Impressions of Severity scale at each visit. Inter-item correlation, internal consistency, external validity, factor structure, and exploratory analysis of an optimal severity cut-off point were assessed. The IID displayed two distinct dimensions (i.e. painful and emotional) with little item redundancy and good internal consistency (Cronbach's α > 0.83 at each visit). The IID displayed good external validity (Pearson's correlations coefficients >0.60 at each visit) and statistically significant agreement (McNemar's test; P < 0.001 at follow-up) with the reference scale. Results suggest that a cut-off score of ≤24 had adequate precision (>80%) to identify patients with and without moderate MDD. Results suggest that the IID may be a reliable and valid tool for assessing emotional and painful symptoms of MDD.

  17. Fidaxomicin Versus Vancomycin for Clostridium difficile Infection: Meta-analysis of Pivotal Randomized Controlled Trials

    PubMed Central

    Crook, Derrick W.; Walker, A. Sarah; Kean, Yin; Weiss, Karl; Cornely, Oliver A.; Miller, Mark A.; Esposito, Roberto; Louie, Thomas J.; Stoesser, Nicole E.; Young, Bernadette C.; Angus, Brian J.; Gorbach, Sherwood L.; Peto, Timothy E. A.

    2012-01-01

    Two recently completed phase 3 trials (003 and 004) showed fidaxomicin to be noninferior to vancomycin for curing Clostridium difficile infection (CDI) and superior for reducing CDI recurrences. In both studies, adults with active CDI were randomized to receive blinded fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times a day for 10 days. Post hoc exploratory intent-to-treat (ITT) time-to-event analyses were undertaken on the combined study 003 and 004 data, using fixed-effects meta-analysis and Cox regression models. ITT analysis of the combined 003/004 data for 1164 patients showed that fidaxomicin reduced persistent diarrhea, recurrence, or death by 40% (95% confidence interval [CI], 26%–51%; P < .0001) compared with vancomycin through day 40. A 37% (95% CI, 2%–60%; P = .037) reduction in persistent diarrhea or death was evident through day 12 (heterogeneity P = .50 vs 13–40 days), driven by 7 (1.2%) fidaxomicin versus 17 (2.9%) vancomycin deaths at <12 days. Low albumin level, low eosinophil count, and CDI treatment preenrollment were risk factors for persistent diarrhea or death at 12 days, and CDI in the previous 3 months was a risk factor for recurrence (all P < .01). Fidaxomicin has the potential to substantially improve outcomes from CDI. PMID:22752871

  18. Icosapent ethyl: Eicosapentaenoic acid concentration and triglyceride-lowering effects across clinical studies.

    PubMed

    Bays, Harold E; Ballantyne, Christie M; Doyle, Ralph T; Juliano, Rebecca A; Philip, Sephy

    2016-09-01

    Icosapent ethyl is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester approved at a dose of 4g/day as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. This post-hoc exploratory analysis examined the relationship of icosapent ethyl dose with EPA concentrations in plasma and red blood cells (RBCs) across 3 clinical studies-a phase 1 pharmacokinetic study in healthy adult volunteers and 2 pivotal phase 3 studies (MARINE and ANCHOR) in adult patients with hypertriglyceridemia-and examined the relationship between EPA levels and TG-lowering effects in MARINE and ANCHOR. In all 3 studies, icosapent ethyl produced dose-dependent increases in the concentrations of EPA in plasma and RBCs. In both MARINE and ANCHOR, these dose-dependent EPA increases correlated with the degree of TG level lowering (all P<0.01). In patients with high TG levels (≥200mg/dL) and treated with icosapent ethyl 4g/day, the end-of-treatment plasma and RBC EPA concentrations were >170μg/mL and>70μg/mL, respectively. These studies support icosapent ethyl as producing predictable dose-dependent pharmacokinetics/pharmacodynamics, with TG level lowering dependent upon icosapent ethyl dose and EPA concentrations in plasma and RBCs. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Addressing Potential Cumulative Impacts of Development on Threatened Species: The Case of the Endangered Black-Throated Finch

    PubMed Central

    Vanderduys, Eric Peter; Reside, April E.; Grice, Anthony; Rechetelo, Juliana

    2016-01-01

    Where threatened biodiversity is adversely affected by development, policies often state that "no net loss" should be the goal and biodiversity offsetting is one mechanism available to achieve this. However, developments are often approved on an ad hoc basis and cumulative impacts are not sufficiently examined. We demonstrate the potential for serious threat to an endangered subspecies when multiple developments are planned. We modelled the distribution of the black-throated finch (Poephila cincta cincta) using bioclimatic data and Queensland's Regional Ecosystem classification. We overlaid granted, extant extractive and exploratory mining tenures within the known and modelled ranges of black-throated finches to examine the level of incipient threat to this subspecies in central Queensland, Australia. Our models indicate that more than half of the remaining P. cincta cincta habitat is currently under extractive or exploratory tenure. Therefore, insufficient habitat exists to offset all potential development so "no net loss" is not possible. This has implications for future conservation of this and similarly distributed species and for resource development planning, especially the use of legislated offsets for biodiversity protection. PMID:26934622

  20. Convenience and Community? An Exploratory Investigation into Learners' Experiences of Web Conferencing

    ERIC Educational Resources Information Center

    Cornelius, Sarah

    2013-01-01

    This paper presents the findings of an exploratory study into the experiences of a small group of learners who have made extensive use of web conferencing as part of their studies over the academic year 2009/10. The paper outlines the design of the programme and structure of web conferencing workshops. It draws on findings from a post-programme…

  1. Time to significant pain reduction following DETP application vs placebo for acute soft tissue injuries.

    PubMed

    Yanchick, J; Magelli, M; Bodie, J; Sjogren, J; Rovati, S

    2010-08-01

    Nonsteroidal anti-inflammatory drugs (NSAIDs) provide fast and effective acute pain relief, but systemic administration has increased risk for some adverse reactions. The diclofenac epolamine 1.3% topical patch (DETP) is a topical NSAID with demonstrated safety and efficacy in treatment of acute pain from minor soft tissue injuries. Significant pain reduction has been observed in clinical trials within several hours following DETP application, suggesting rapid pain relief; however, this has not been extensively studied for topical NSAIDs in general. This retrospective post-hoc analysis examined time to onset of significant pain reduction after DETP application compared to a placebo patch for patients with mild-to-moderate acute ankle sprain, evaluating the primary efficacy endpoint from two nearly identical studies. Data from two double-blind, randomized, parallel-group, placebo-controlled studies (N = 274) of safety and efficacy of the DETP applied once daily for 7 days for acute ankle sprain were evaluated post-hoc using statistical modeling to estimate time to onset of significant pain reduction following DETP application. Pain on active movement on a 100 mm Visual Analog Scale (VAS) recorded in patient diaries; physician- and patient-assessed tolerability; and adverse events. DETP treatment resulted in significant pain reduction within approximately 3 hours compared to placebo. Within-treatment post-hoc analysis based on a statistical model suggested significant pain reduction occurred as early as 1.27 hours for the DETP group. The study may have been limited by the retrospective nature of the analyses. In both studies, the DETP was well tolerated with few adverse events, limited primarily to application site skin reactions. The DETP is an effective treatment for acute minor soft tissue injury, providing pain relief as rapidly as 1.27 hours post-treatment. Statistical modeling may be useful in estimating time to onset of pain relief for comparison of topical and oral NSAIDs.

  2. Effect of concomitant use of memantine on mortality and efficacy outcomes of galantamine-treated patients with Alzheimer's disease: post-hoc analysis of a randomized placebo-controlled study.

    PubMed

    Hager, Klaus; Baseman, Alan S; Nye, Jeffrey S; Brashear, H Robert; Han, John; Sano, Mary; Davis, Bonnie; Richards, Henry M

    2016-11-15

    A large, prospective, 2-year, randomized study in patients with mild-to-moderate Alzheimer's disease or mixed dementia demonstrated reductions in mortality and cognitive/functional decline in galantamine-treated patients. A post-hoc analysis was conducted to study the effect of (the presence or absence of) concomitant memantine use on treatment outcome. Randomized patients (N = 2045) were divided into subgroups based on memantine use. Analyses included demographic and clinical characteristics (age, nursing home placement, Mini-Mental State Examination (MMSE) and Disability Assessment for Dementia (DAD) scores) and mortality endpoints. Overall, 496 (24.3 %) patients were memantine users and were older (mean (SD), 74.0 (8.76) vs 72.8 (8.76), p = 0.008), with lower MMSE scores (18.2 (4.16) vs 19.2 (4.02), p < 0.0001) and DAD scores (58.0 (23.49) vs 62.5 (20.52), p < 0.0001) than nonusers. Mortality rates (per 100 patient-years) in memantine nonusers (n = 1549) were lower for galantamine (1.39) vs placebo-treated patients (4.15). In memantine users, mortality rates were similar for placebo-treated (4.49) and galantamine-treated patients (5.57). In memantine nonusers at 24 months, the decline in MMSE scores (effect size (95 % CI) 0.25 (0.14; 0.36)) and DAD scores (0.17 (0.06; 0.28)) from baseline was lower in galantamine patients vs placebo patients. The absence of these benefits in memantine users could not be explained by baseline age, MMSE, or DAD scores. This post-hoc analysis shows that the beneficial effects of galantamine at 2 years post treatment were not observed in patients who had been placed on background memantine. The reasons for memantine treatment and the possibility of interaction between memantine and galantamine merit further investigation. ClinicalTrials.gov NCT00679627 . Registered 15 May 2008.

  3. Remission and recovery associated with lurasidone in the treatment of major depressive disorder with subthreshold hypomanic symptoms (mixed features): post-hoc analysis of a randomized, placebo-controlled study with longer-term extension.

    PubMed

    Goldberg, Joseph F; Ng-Mak, Daisy; Siu, Cynthia; Chuang, Chien-Chia; Rajagopalan, Krithika; Loebel, Antony

    2017-04-01

    This post-hoc analysis assessed rates of symptomatic and functional remission, as well as recovery (combination of symptomatic and functional remission), in patients treated with lurasidone for major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features). Patients with MDD plus two or three manic symptoms (defined as per the DSM-5 mixed-features specifier) were randomly assigned to flexible-dose lurasidone 20-60 mg/day (n=109) or placebo (n=100) for 6 weeks, followed by a 3-month open-label, flexible-dose extension study for U.S. sites only (n=48). Cross-sectional recovery was defined as the presence of both symptomatic remission (Montgomery-Åsberg Depression Rating Scale score ≤ 12) and functional remission (all Sheehan Disability Scale [SDS] domain scores ≤3) at week 6, and at both months 1 and 3 of the extension study ("sustained recovery"). A significantly higher proportion of lurasidone-treated patients (31.3%) achieved recovery (assessed cross-sectionally) compared to placebo (12.2%, p=0.002) at week 6. The number of manic symptoms at baseline moderated the effect size for attaining cross-sectional recovery for lurasidone treatment (vs. placebo) (p=0.028). Sustained recovery rates were higher in patients initially treated with lurasidone (20.8%) versus placebo (12.5%). In this post-hoc analysis of a placebo-controlled study with open-label extension that involved patients with MDD and mixed features, lurasidone was found to significantly improve the rate of recovery at 6 weeks (vs. placebo) that was sustained at month 3 of the extension study. The presence of two (as opposed to three) manic symptoms moderated recovery at the acute study endpoint.

  4. Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease.

    PubMed

    Schapira, A H V; Stocchi, F; Borgohain, R; Onofrj, M; Bhatt, M; Lorenzana, P; Lucini, V; Giuliani, R; Anand, R

    2013-02-01

    Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist (DA) therapy for early Parkinson's disease (PD). Study 017 was a 12-month, randomized, double-blind, placebo-controlled pre-planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; post hoc analyses were performed on each separate dose group. Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log-rank test; P = 0.3342). In post hoc analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and a delay in median time to intervention of 9 days (P < 0.05; 240- to 540-day analysis). The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. Post hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

  5. Long-Term Effects of Safinamide on Dyskinesia in Mid- to Late-Stage Parkinson's Disease: A Post-Hoc Analysis.

    PubMed

    Cattaneo, Carlo; Ferla, R La; Bonizzoni, Erminio; Sardina, Marco

    2015-01-01

    Safinamide is a novel α-aminoamide with dopaminergic and non-dopaminergic properties developed as adjunctive therapy for patients with PD. Results from a 24-month double-blind controlled study suggested that as add-on to levodopa (and other PD medications) the benefits of safinamide on dyskinesia may be related to severity of dyskinesia at baseline. This post-hoc analysis further characterized the effects of safinamide on dyskinesia in mid- to late-stage PD patients. Patients were stratified by the presence or absence of dyskinesia at baseline, and by whether or not the dose of levodopa had been changed during the 24-month treatment period. Differences between safinamide and placebo were evaluated using the Wilcoxon rank-sum test. For the overall treated population (with or without baseline dyskinesia), safinamide 100 mg/day significantly improved the dyskinesia rating scale score, compared with placebo, in the subgroup of patients with no change in levodopa dose (p = 0.0488). For patients with baseline dyskinesia, improvements over placebo were also significant (p = 0.0153) in patients with or without changes in levodopa dose, and nearly significant (p = 0.0546) in patients with no change in levodopa dose, suggesting that these improvements were not due to levodopa dose reductions. While no statistically significant difference in mean DRS scores was seen between safinamide and placebo in the original study population, the present post-hoc analysis helps to provide a meaningful interpretation of the long-term effects of safinamide on dyskinesia. These results may be related to safinamide state- and use-dependent inhibition of sodium channels and stimulated glutamate release, and are unlikely due to reduced dopaminergic stimulation.

  6. Long-Term Effects of Safinamide on Dyskinesia in Mid- to Late-Stage Parkinson’s Disease: A Post-Hoc Analysis

    PubMed Central

    Cattaneo, Carlo; Ferla, R. La; Bonizzoni, Erminio; Sardina, Marco

    2015-01-01

    Abstract Background: Safinamide is a novel α-aminoamide with dopaminergic and non-dopaminergic properties developed as adjunctive therapy for patients with PD. Results from a 24-month double-blind controlled study suggested that as add-on to levodopa (and other PD medications) the benefits of safinamide on dyskinesia may be related to severity of dyskinesia at baseline. Objective: This post-hoc analysis further characterized the effects of safinamide on dyskinesia in mid- to late-stage PD patients. Methods: Patients were stratified by the presence or absence of dyskinesia at baseline, and by whether or not the dose of levodopa had been changed during the 24-month treatment period. Differences between safinamide and placebo were evaluated using the Wilcoxon rank-sum test. Results: For the overall treated population (with or without baseline dyskinesia), safinamide 100 mg/day significantly improved the dyskinesia rating scale score, compared with placebo, in the subgroup of patients with no change in levodopa dose (p = 0.0488). For patients with baseline dyskinesia, improvements over placebo were also significant (p = 0.0153) in patients with or without changes in levodopa dose, and nearly significant (p = 0.0546) in patients with no change in levodopa dose, suggesting that these improvements were not due to levodopa dose reductions. Conclusions: While no statistically significant difference in mean DRS scores was seen between safinamide and placebo in the original study population, the present post-hoc analysis helps to provide a meaningful interpretation of the long-term effects of safinamide on dyskinesia. These results may be related to safinamide state- and use-dependent inhibition of sodium channels and stimulated glutamate release, and are unlikely due to reduced dopaminergic stimulation. PMID:26406127

  7. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    PubMed

    Takei, Koji; Takahashi, Fumihiro; Liu, Shawn; Tsuda, Kikumi; Palumbo, Joseph

    2017-10-01

    Post-hoc analyses of the ALS Functional Rating Scale-Revised (ALSFRS-R) score data, the primary endpoint in the 24-week double-blind placebo-controlled study of edaravone (MCI186-19, NCT01492686), were performed to confirm statistical robustness of the result. The previously reported original analysis had used a last observation carried forward (LOCF) method and also excluded patients with fewer than three completed treatment cycles. The post-hoc sensitivity analyses used different statistical methods as follows: 1) including all patients regardless of treatment cycles received (ALL LOCF); 2) a mixed model for repeated measurements (MMRM) analysis; and 3) the Combined Assessment of Function and Survival (CAFS) endpoint. Findings were consistent with the original primary analysis in showing superiority of edaravone over placebo. We also investigated the distribution of change in ALSFRS-R total score across all patients in the study as well as which ALSFRS-R items and domains may have contributed to the overall efficacy findings. The distribution of changes in ALSFRS-R total score from baseline to the end of cycle 6 (ALL LOCF) shifted in favour of edaravone compared to placebo. Edaravone was descriptively favoured for each ALSFRS-R item and each of the four ALSFRS-R domains at the end of cycle 6 (ALL LOCF), suggesting a generalised effect of edaravone in slowing functional decline across all anatomical regions. The effect of edaravone appeared to be similar in patients with bulbar onset and limb onset. Together, these observations would be consistent with its putative neuroprotective effects against the development of oxidative damage unspecific to anatomical regions.

  8. Archeological Echocardiography: Digitization and Speckle Tracking Analysis of Archival Echocardiograms in the HyperGEN Study.

    PubMed

    Aguilar, Frank G; Selvaraj, Senthil; Martinez, Eva E; Katz, Daniel H; Beussink, Lauren; Kim, Kwang-Youn A; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R; Arnett, Donna K; Shah, Sanjiv J

    2016-03-01

    Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. In the NHLBI HyperGEN study (N = 2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter-/intra-observer agreement was calculated. Accuracy was evaluated in: (1) a separate second study (N = 50) comparing prospective digital strain versus post hoc analog-to-digital strain, and (2) in a third study (N = 95) comparing prospectively obtained TDI e' velocities with post hoc STE e' velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intra-observer agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post hoc STE to prospective digital STE for strain analysis. STE-derived e' velocities correlated with, but systematically underestimated, TDI e' velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β = -2.4 [95% CI -3.6, -1.2]% per 1-SD increase in fasting glucose; P < 0.001). Archeological echocardiography, the digitization and speckle tracking analysis of archival echocardiograms, is feasible and generates indices of cardiac mechanics similar to contemporary studies. © 2015, Wiley Periodicals, Inc.

  9. Archeological Echocardiography: Digitization and Speckle-Tracking Analysis of Archival Echocardiograms in the HyperGEN Study

    PubMed Central

    Aguilar, Frank G.; Selvaraj, Senthil; Martinez, Eva E.; Katz, Daniel H.; Beussink, Lauren; Kim, Kwang-Youn A.; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R.; Arnett, Donna K.; Shah, Sanjiv J.

    2015-01-01

    Background Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle-tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. Methods In the NHLBI HyperGEN study (N=2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter/intraobserver agreement was calculated. Accuracy was evaluated in (1) a separate second study (N=50) comparing prospective digital strain vs. post-hoc analog-to-digital strain; and (2) in a third study (N=95) comparing prospectively-obtained TDI e′ velocities with post-hoc STE e′ velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Results Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intraobserver agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post-hoc STE to prospective digital STE for strain analysis. STE-derived e′ velocities correlated with, but systematically underestimated, TDI e′ velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β =−2.4 [95% CI −3.6,−1.2]% per 1-SD increase in fasting glucose; P<0.001). Conclusions Archeological echocardiography, the digitization and speckle-tracking analysis of archival echocardiograms, is feasible and generates parameters of cardiac mechanics similar to contemporary studies. PMID:26525308

  10. N-terminal pro-B-type Natriuretic Peptides' Prognostic Utility Is Overestimated in Meta-analyses Using Study-specific Optimal Diagnostic Thresholds.

    PubMed

    Potgieter, Danielle; Simmers, Dale; Ryan, Lisa; Biccard, Bruce M; Lurati-Buse, Giovanna A; Cardinale, Daniela M; Chong, Carol P W; Cnotliwy, Miloslaw; Farzi, Sylvia I; Jankovic, Radmilo J; Lim, Wen Kwang; Mahla, Elisabeth; Manikandan, Ramaswamy; Oscarsson, Anna; Phy, Michael P; Rajagopalan, Sriram; Van Gaal, William J; Waliszek, Marek; Rodseth, Reitze N

    2015-08-01

    N-terminal fragment B-type natriuretic peptide (NT-proBNP) prognostic utility is commonly determined post hoc by identifying a single optimal discrimination threshold tailored to the individual study population. The authors aimed to determine how using these study-specific post hoc thresholds impacts meta-analysis results. The authors conducted a systematic review of studies reporting the ability of preoperative NT-proBNP measurements to predict the composite outcome of all-cause mortality and nonfatal myocardial infarction at 30 days after noncardiac surgery. Individual patient-level data NT-proBNP thresholds were determined using two different methodologies. First, a single combined NT-proBNP threshold was determined for the entire cohort of patients, and a meta-analysis conducted using this single threshold. Second, study-specific thresholds were determined for each individual study, with meta-analysis being conducted using these study-specific thresholds. The authors obtained individual patient data from 14 studies (n = 2,196). Using a single NT-proBNP cohort threshold, the odds ratio (OR) associated with an increased NT-proBNP measurement was 3.43 (95% CI, 2.08 to 5.64). Using individual study-specific thresholds, the OR associated with an increased NT-proBNP measurement was 6.45 (95% CI, 3.98 to 10.46). In smaller studies (<100 patients) a single cohort threshold was associated with an OR of 5.4 (95% CI, 2.27 to 12.84) as compared with an OR of 14.38 (95% CI, 6.08 to 34.01) for study-specific thresholds. Post hoc identification of study-specific prognostic biomarker thresholds artificially maximizes biomarker predictive power, resulting in an amplification or overestimation during meta-analysis of these results. This effect is accentuated in small studies.

  11. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study.

    PubMed

    Loebel, Antony; Siu, Cynthia; Rajagopalan, Krithika; Pikalov, Andrei; Cucchiaro, Josephine; Ketter, Terence A

    2015-11-01

    In this post-hoc analysis, rates of remission and recovery were evaluated in patients with bipolar depression treated with lurasidone. Outpatients meeting DSM-IV-TR criteria for bipolar I depression, were randomized to 6 weeks of once-daily, double-blind treatment with lurasidone 20-60mg, lurasidone 80-120mg or placebo, followed by a 6-month, open-label, flexible-dose, lurasidone continuation study. Recovery was defined as meeting criteria for combined symptomatic remission (Montgomery-Asberg Depression Rating Scale total score ≤12) and functional remission (all Sheehan Disability Scale domain scores ≤3) sustained for at least 3 months in the 6-month continuation study. A significantly higher proportion of lurasidone-treated patients met criteria for combined symptomatic remission and functional remission (33.3%, 91/273) compared to the placebo group (21.0%, 30/143, p<0.05, NNT=9) at the 6-week study endpoint. In the 6-month continuation study, the proportion of lurasidone-treated patients achieving sustained recovery was 60.7% (85/140) and 44.9% (31/69), for patients who continued lurasidone treatment and who switched from placebo to lurasidone, respectively. The definition of recovery used has not been previously validated and the analysis was post hoc. Lack of a control group in the continuation study limits data interpretation. Recovery in patients with bipolar depression was assessed based on rates of combined symptomatic and functional remission sustained over time. A majority of patients initially treated with lurasidone in the acute phase achieved recovery status in the continuation study. Treatment with lurasidone (vs. placebo) earlier in the course of the bipolar depressive episode increased the likelihood of subsequent recovery. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  12. Insight and Treatment Outcomes in Schizophrenia: Post-hoc Analysis of a Long-term, Double-blind Study Comparing Lurasidone and Quetiapine XR.

    PubMed

    Harvey, Philip D; Siu, Cynthia O; Loebel, Antony D

    2017-12-01

    Objective: The objective of this post-hoc analysis was to evaluate the effect of lurasidone and quetiapine extended-release (XR) on insight and judgment and assess the longitudinal relationships between improvement in insight and cognitive performance, functional capacity, quality of well-being, and depressive symptoms in patients with schizophrenia. Design: Clinically unstable patients with schizophrenia (N=488) were randomized to once-daily, fixed-dose treatment with lurasidone 80mg, lurasidone 160mg, quetiapine XR 600mg, or placebo, followed by a long-term, double-blind, flexible-dose continuation study involving these agents. Results: Significantly greater improvement in insight and judgment (assessed by the Positive and Negative Syndrome Scale G12 item) for the lurasidone and quetiapine XR groups, compared to the placebo group, was observed at Week 6. Over a subsequent six-month continuation period, the flexible dose lurasidone group showed significantly greater improvement in insight from acute phase baseline compared to the flexible-dose quetiapine XR group (QXR-QXR) (p=0.032). Improvement in insight was significantly correlated with improvement in cognition ( p =0.014), functional capacity (p=0.006, UPSA-B), quality of well-being ( p =0.033, QWB), and depressive symptoms ( p =0.05, Montgomery-Åsberg Depression Rating Scale [MADRS] score) across treatment groups and study periods. Conclusion: In this post-hoc analysis, flexibly dosed lurasidone 40 to 160mg/d was found to be associated with significantly greater improvement in insight compared to flexibly dosed quetiapine XR 200 to 800mg/d over long-term treatment in patients with schizophrenia. Across treatment groups, improvement in insight and judgment was significantly associated with improvement in cognition, functional capacity, quality of well-being, and depressive symptoms over time.

  13. Posttransplant reduction in preexisting donor-specific antibody levels after belatacept- versus cyclosporine-based immunosuppression: Post hoc analyses of BENEFIT and BENEFIT-EXT.

    PubMed

    Bray, R A; Gebel, H M; Townsend, R; Roberts, M E; Polinsky, M; Yang, L; Meier-Kriesche, H-U; Larsen, C P

    2018-03-24

    BENEFIT and BENEFIT-EXT were phase III studies of cytotoxic T-cell crossmatch-negative kidney transplant recipients randomized to belatacept more intense (MI)-based, belatacept less intense (LI)-based, or cyclosporine-based immunosuppression. Following study completion, presence/absence of HLA-specific antibodies was determined centrally via solid-phase flow cytometry screening. Stored sera from anti-HLA-positive patients were further tested with a single-antigen bead assay to determine antibody specificities, presence/absence of donor-specific antibodies (DSAs), and mean fluorescent intensity (MFI) of any DSAs present. The effect of belatacept-based and cyclosporine-based immunosuppression on MFI was explored post hoc in patients with preexisting DSAs enrolled to BENEFIT and BENEFIT-EXT. In BENEFIT, preexisting DSAs were detected in 4.6%, 4.9%, and 6.3% of belatacept MI-treated, belatacept LI-treated, and cyclosporine-treated patients, respectively. The corresponding values in BENEFIT-EXT were 6.0%, 5.7%, and 9.2%. In both studies, most preexisting DSAs were of class I specificity. Over the first 24 months posttransplant, a greater proportion of preexisting DSAs in belatacept-treated versus cyclosporine-treated patients exhibited decreases or no change in MFI. MFI decline was more apparent with belatacept MI-based versus belatacept LI-based immunosuppression in both studies and more pronounced in BENEFIT-EXT versus BENEFIT. Although derived post hoc, these data suggest that belatacept-based immunosuppression decreases preexisting DSAs more effectively than cyclosporine-based immunosuppression. © 2018 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.

  14. The experience of agency: an interplay between prediction and postdiction

    PubMed Central

    Synofzik, Matthis; Vosgerau, Gottfried; Voss, Martin

    2013-01-01

    The experience of agency, i.e., the registration that I am the initiator of my actions, is a basic and constant underpinning of our interaction with the world. Whereas several accounts have underlined predictive processes as the central mechanism (e.g., the comparator model by C. Frith), others emphasized postdictive inferences (e.g., post-hoc inference account by D. Wegner). Based on increasing evidence that both predictive and postdictive processes contribute to the experience of agency, we here present a unifying but at the same time parsimonious approach that reconciles these accounts: predictive and postdictive processes are both integrated by the brain according to the principles of optimal cue integration. According to this framework, predictive and postdictive processes each serve as authorship cues that are continuously integrated and weighted depending on their availability and reliability in a given situation. Both sensorimotor and cognitive signals can serve as predictive cues (e.g., internal predictions based on an efferency copy of the motor command or cognitive anticipations based on priming). Similarly, other sensorimotor and cognitive cues can each serve as post-hoc cues (e.g., visual feedback of the action or the affective valence of the action outcome). Integration and weighting of these cues might not only differ between contexts and individuals, but also between different subject and disease groups. For example, schizophrenia patients with delusions of influence seem to rely less on (probably imprecise) predictive motor signals of the action and more on post-hoc action cues like e.g., visual feedback and, possibly, the affective valence of the action outcome. Thus, the framework of optimal cue integration offers a promising approach that directly stimulates a wide range of experimentally testable hypotheses on agency processing in different subject groups. PMID:23508565

  15. Patient Background Factors Affecting the Therapeutic Outcomes in Response to Eszopiclone in Adult Patients with Chronic Insomnia: A Post Hoc Analysis of a Double-Blind Phase III Study in Japan

    PubMed Central

    Inoue, Yuichi; Kamijo, Atsushi; Nagai, Reiko

    2015-01-01

    Study Objective: To identify whether baseline demographic factors or subjective sleep variables are associated with the outcomes following treatment with eszopiclone using data from a recent randomized controlled trial of 78 Japanese subjects with insomnia who were treated with 2 mg eszopiclone per day. Methods: We performed a post hoc analysis of factors including sleep latency (SL), wake time after sleep onset (WASO) (both assessed via sleep diaries), and several demographic variables. Subjects with a SL or WASO > 30 min at baseline and with evaluable SL/WASO data at Week 4 were included in SL and WASO remitter analyses, respectively; those with a SL or WASO ≤ 30 min at Week 4 were defined as SL or WASO remitters, respectively. Threshold baseline SL and WASO values for identification of remitters were determined. Results: No relationships between subjectively assessed therapeutic outcomes and demographic factors were identified. Patients with shorter SL and lower WASO values at baseline showed better outcomes following treatment with eszopiclone in terms of SL and WASO changes, respectively. Baseline SL of 75 min and baseline WASO of 80 min were selected as arbitrary cutoff values for determination of SL and WASO remitters/non-remitters, respectively. Conclusions: These findings may help clinicians to predict their patients' outcomes in response to standard doses of eszopiclone in clinical practice. Citation: Inoue Y, Kamijo A, Nagai R. Patient background factors affecting the therapeutic outcomes in response to eszopiclone in adult patients with chronic insomnia: a post hoc analysis of a double-blind phase III study in Japan. J Clin Sleep Med 2015;11(10):1171–1178. PMID:26094929

  16. Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis.

    PubMed

    Swann, Alan C; Fava, Maurizio; Tsai, Joyce; Mao, Yongcai; Pikalov, Andrei; Loebel, Antony

    2017-04-01

    The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability. The data in this analysis were derived from a study of patients meeting DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/d (n=109) or placebo (n=100). We defined "irritability" as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability. Some 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (-22.6 vs. -9.5, p<0.0001, effect size [ES]=1.4) and without (-19.9 vs. -13.8, p<0.0001, ES=0.7) irritability. In patients with irritable features, treatment with lurasidone was associated with significant week 6 changes vs. placebo in both the YMRS irritability item (-1.4 vs. -0.3, p=0.0012, ES=1.0) and the YMRS disruptive-aggressive item (-1.0 vs. -0.3, p=0.0002, ES=1.2). In our post-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.

  17. Impact of 6-month earlier versus postponed initiation of rotigotine on long-term outcome: post hoc analysis of patients with early Parkinson's disease with mild symptom severity.

    PubMed

    Timmermann, Lars; Asgharnejad, Mahnaz; Boroojerdi, Babak; Dohin, Elisabeth; Woltering, Franz; Elmer, Lawrence W

    2015-01-01

    Investigate impact of 6-month earlier versus postponed initiation of rotigotine in patients with early Parkinson's disease (PD) with mild symptom severity. Long-term benefit of rotigotine in early-PD has been demonstrated: SP702 (NCT00594165) and SP716 (NCT00599196) were long-term, open-label extensions of double-blind, placebo-controlled studies of 6-month maintenance; rotigotine was well tolerated for up to 6 years, and demonstrated efficacy (Unified Parkinson's Disease Rating Scale [UPDRS] II + III below baseline) for ∼ 2 years (SP702) and ∼ 4 years (SP716). Post hoc analysis of patients at Hoehn and Yahr 1-2; groups defined by treatment received in 6-month double-blind studies: 'Rotigotine-Rotigotine' received rotigotine (n = 221), 'Placebo-Rotigotine' received placebo (n = 125). At the start of open-label rotigotine maintenance, UPDRS II + III mean ± SD change from double-blind baseline was: -8.5 ± 10.6 'Rotigotine-Rotigotine', -7.7 ± 9.0 'Placebo-Rotigotine.' After this initial improvement scores gradually increased: It took ∼ 45 months for mean scores to cross baseline in 'Rotigotine-Rotigotine', and ∼ 21 months in 'Placebo-Rotigotine.' At the time mean UPDRS II + III had crossed baseline in 'Placebo-Rotigotine' (open-label week 84; ∼ 21 months), treatment difference (LS-mean) to 'Rotigotine-Rotigotine' change from baseline was -3.89 (95% CI -6.94, -0.84); p = 0.013. In this post hoc analysis, 6-month earlier initiation of rotigotine resulted in slower return to baseline mean UPDRS II + III; initiation of rotigotine in patients with minimal/no functional disability or impairment may lead to an extended benefit.

  18. Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

    PubMed

    Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

    2012-03-01

    IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  19. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder.

    PubMed

    Earley, Willie; Durgam, Suresh; Lu, Kaifeng; Ruth, Adam; Németh, György; Laszlovszky, István; Yatham, Lakshmi N

    2018-01-15

    Rates of response and remission are measures that endorse the clinical significance of treatment. Cariprazine is FDA approved for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Post hoc analyses of pooled data from 3 pivotal trials of cariprazine in manic/mixed episodes associated with bipolar I disorder were conducted to investigate the effect of cariprazine on various criteria of response and remission. The constituent studies were 3-week randomized, double-blind, placebo-controlled, multicenter, parallel-group phase II/III studies in adult patients (age 18-65 years) with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668). Post hoc analyses included Young Mania Rating Scale (YMRS) outcomes for response (≥50% decrease in score), remission (total score ≤12 and ≤8), cumulative remission, and global improvement. Additionally, composite remission (YMRS total score ≤12 plus Montgomery-Åsberg Depression Rating Scale total score ≤12) and worsening/switch to depression (MADRS total score ≥15) by week were investigated. Rates of response and remission were significantly greater for cariprazine versus placebo on every measure evaluated (P < .01 all analyses); the estimated number needed to treat for each measure was ≤10. There was no evidence of worsening/switch to depression. Post hoc analyses, short treatment duration, no active comparator. Cariprazine-treated patients with bipolar I disorder attained clinically significant improvement in manic symptoms as shown by significantly greater rates of response and remission versus placebo; improvement in manic symptoms did not induce depressive symptoms. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  20. Clinical Outcomes from Androgen Signaling-directed Therapy after Treatment with Abiraterone Acetate and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302.

    PubMed

    Smith, Matthew R; Saad, Fred; Rathkopf, Dana E; Mulders, Peter F A; de Bono, Johann S; Small, Eric J; Shore, Neal D; Fizazi, Karim; Kheoh, Thian; Li, Jinhui; De Porre, Peter; Todd, Mary B; Yu, Margaret K; Ryan, Charles J

    2017-07-01

    In the COU-AA-302 trial, abiraterone acetate plus prednisone significantly increased overall survival for patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Limited information exists regarding response to subsequent androgen signaling-directed therapies following abiraterone acetate plus prednisone in patients with mCRPC. We investigated clinical outcomes associated with subsequent abiraterone acetate plus prednisone (55 patients) and enzalutamide (33 patients) in a post hoc analysis of COU-AA-302. Prostate-specific antigen (PSA) response was assessed. Median time to PSA progression was estimated using the Kaplan-Meier method. The PSA response rate (≥50% PSA decline, unconfirmed) was 44% and 67%, respectively. The median time to PSA progression was 3.9 mo (range 2.6-not estimable) for subsequent abiraterone acetate plus prednisone and 2.8 mo (range 1.8-not estimable) for subsequent enzalutamide. The majority of patients (68%) received intervening chemotherapy before subsequent abiraterone acetate plus prednisone or enzalutamide. While acknowledging the limitations of post hoc analyses and high censoring (>75%) in both treatment groups, these results suggest that subsequent therapy with abiraterone acetate plus prednisone or enzalutamide for patients who progressed on abiraterone acetate is associated with limited clinical benefit. This analysis showed limited clinical benefit for subsequent abiraterone acetate plus prednisone or enzalutamide in patients with metastatic castration-resistant prostate cancer following initial treatment with abiraterone acetate plus prednisone. This analysis does not support prioritization of subsequent abiraterone acetate plus prednisone or enzalutamide following initial therapy with abiraterone acetate plus prednisone. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  1. The relationship of renal function to outcome: A post hoc analysis from the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study.

    PubMed

    Lip, Gregory Y H; Al-Saady, Naab; Ezekowitz, Michael D; Banach, Maciej; Goette, Andreas

    2017-11-01

    The ENSURE-AF study (NCT 02072434) of anticoagulation for electrical cardioversion in nonvalvular atrial fibrillation (NVAF) showed comparable low rates of bleeding and thromboembolism between the edoxaban and the enoxaparin-warfarin treatment arms. This post hoc analysis investigated the relationship between renal function and clinical outcomes. ENSURE-AF was a multicenter, PROBE evaluation trial of edoxaban 60 mg, or dose reduced to 30 mg/d for weight≤60 kg, creatinine clearance (CrCl; Cockcroft-Gault) ≤50 mL/min, or concomitant P-glycoprotein inhibitors compared with therapeutically monitored enoxaparin-warfarin in 2,199 NVAF patients undergoing electrical cardioversion. Efficacy and safety outcomes and time in therapeutic range in the warfarin arm were analyzed in relation to CrCl in prespecified ranges ≥15 and ≤30, >30 and ≤50, >50 and <80, and ≥80 mL/min, and an exploratory ≥95-mL/min analysis. A total of 1,095 subjects were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64.3±10 and 64.2±11 years. Mean time in therapeutic range was progressively lower with reducing CrCl strata, being 66.8% in those with CrCl >30 to ≤50 compared with 71.8% in those with CrCl ≥80. The odds ratios for the primary efficacy and safety end points were comparable for the different predefined renal function strata; given the small numbers, the 95% CI included 1.0. In the subset of those with CrCl ≥95, the odds ratios showed consistency with the other CrCl strata. When CrCl was assessed as a continuous variable, there was a nonsignificant trend toward higher major or clinically relevant nonmajor bleeding with reducing CrCl levels, with no significant differences between the 2 treatment arms. When we assessed CrCl at baseline compared with end of treatment, there were no significant differences in CrCl change between the edoxaban and enoxaparin-warfarin arms. The proportions with worsening of renal function (defined as a decrease of >20% from baseline) were similar in the 2 treatment arms. Given the small number of events in ENSURE-AF, no effect of renal (dys)function was demonstrated in comparing edoxaban to enoxaparin-warfarin for cardioversion; efficacy and safety of edoxaban remained consistent even in patients with normal or supranormal renal function. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Clinician Ratings of Interpreter Mediated Visits in Underserved Primary Care Settings with Ad hoc, In-person Professional, and Video Conferencing Modes

    PubMed Central

    Nápoles, Anna M.; Santoyo-Olsson, Jasmine; Karliner, Leah S.; O’Brien, Helen; Gregorich, Steven E.; Pérez-Stable, Eliseo J.

    2013-01-01

    Language interpretation ameliorates health disparities among underserved limited English-proficient patients, yet few studies have compared clinician satisfaction with these services. Self-administered clinician post-visit surveys compared the quality of interpretation and communication, visit satisfaction, degree of patient engagement, and cultural competence of visits using untrained people acting as interpreters (ad hoc), in-person professional, or video conferencing professional interpretation for 283 visits. Adjusting for clinician and patient characteristics, the quality of interpretation of in-person and video conferencing modes were rated similarly (OR=1.79; 95% CI 0.74, 4.33). The quality of in-person (OR=5.55; 95% CI 1.50, 20.51) and video conferencing (OR=3.10; 95% CI 1.16, 8.31) were rated higher than ad hoc interpretation. Self-assessed cultural competence was better for in-person versus video conferencing interpretation (OR=2.32; 95% CI 1.11, 4.86). Video conferencing interpretation increases access without compromising quality, but cultural nuances may be better addressed by in-person interpreters. Professional interpretation is superior to ad hoc (OR=4.15; 95% CI 1.43, 12.09). PMID:20173271

  3. 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.

    PubMed

    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 analysis, modified intention-to-treat analyses, high dropout rates and missing vital status data. Results from the company's economic evaluation showed that the deterministic incremental cost-effectiveness ratio (ICER) for rivaroxaban in combination with aspirin plus clopidogrel or with aspirin alone compared with aspirin plus clopidogrel or aspirin alone was £6203 per quality-adjusted life-year (QALY) gained. In contrast, the ERG's preferred base case estimate was £5622 per QALY gained. The ICER did not rise above £10,000 per QALY gained in any of the sensitivity analyses undertaken by the ERG, although the inflexibility of the company's economic model precluded the ERG from formally undertaking all desired exploratory analyses. As such, only a crude exploration of the impact of additional bleeding events could be undertaken. The NICE Appraisal Committee concluded that the ICERs presented were all within the range that could be considered cost effective and that the results of the ERG's exploratory sensitivity and scenario analyses suggested that the ICER was unlikely to increase to the extent that it would become unacceptable. The Appraisal Committee therefore concluded that rivaroxaban in combination with aspirin plus clopidogrel, or with aspirin alone, was a cost-effective use of National Health Service (NHS) resources for preventing atherothrombotic events in people with ACS and elevated cardiac biomarkers.

  4. Truth in research labelling.

    PubMed

    Noble, John H

    2017-01-01

    This report describes the background and context of a currently circulating petition to the US Congress that seeks amendment of Section 801 of the Public Health Services Act (42 U.S.C. 282) to close a loophole in existing law which makes possible post hoc adjustment of randomised controlled trial (RCT) results reported to the Food and Drug Administration that differ from those reported to ClinicalTrials.gov and to medical journals. The report describes the petition's rationale, underlying assumptions, and support for its proposed remedy in deontological, consequentialist, and casuist philosophical ethics theories. It addresses the several reservations of the World Association of Medical Editors (WAME) with citations of evidence for the petition's assertions. The report suggests that some medical journals are not unknowing victims but rather complicit enablers of the post hoc adjusted RCT results that they publish. Its closing remarks dwell on the negative impact that embrace of a neoliberal, anti-regulatory philosophy of government will likely have on any regulatory reform to promote the integrity of biomedical science and the future of evidence-based medicine.

  5. Preparing for in situ processing on upcoming leading-edge supercomputers

    DOE PAGES

    Kress, James; Churchill, Randy Michael; Klasky, Scott; ...

    2016-10-01

    High performance computing applications are producing increasingly large amounts of data and placing enormous stress on current capabilities for traditional post-hoc visualization techniques. Because of the growing compute and I/O imbalance, data reductions, including in situ visualization, are required. These reduced data are used for analysis and visualization in a variety of different ways. Many of he visualization and analysis requirements are known a priori, but when they are not, scientists are dependent on the reduced data to accurately represent the simulation in post hoc analysis. The contributions of this paper is a description of the directions we are pursuingmore » to assist a large scale fusion simulation code succeed on the next generation of supercomputers. Finally, these directions include the role of in situ processing for performing data reductions, as well as the tradeoffs between data size and data integrity within the context of complex operations in a typical scientific workflow.« less

  6. More challenges since Wikipedia: the effects of exposure to internet information about the Rorschach on selected comprehensive system variables.

    PubMed

    Schultz, Douglas S; Brabender, Virginia M

    2013-01-01

    To determine the effects of reading the Wikipedia article on the Rorschach on Comprehensive System variables, participants in this study (recruited from parent-teacher associations, online message boards, and graduate schools; N = 50) were provided with either a copy of the Wikipedia article on the Rorschach (from April 2010) or an irrelevant article, then administered the Rorschach and instructed to "fake good." Monetary incentives were used to increase motivation to dissimulate. Initial results indicated that participants given the Wikipedia article produced a lower number of responses (R) and had higher scores on Populars, X+%, XA%, and WDA% as compared to controls. However, post-hoc analyses revealed that when the influence of Populars was controlled, significant differences for X+%, XA%, and WDA% disappeared. No significant differences were found for Form%, Zf, Blends, or PER, although post-hoc analyses controlling for differences in R revealed a significant difference between groups on Zf%. Limitations of the study and implications for clinical and forensic practice are discussed.

  7. The dose-response effects of aerobic exercise on musculoskeletal injury: a post hoc analysis of a randomized trial.

    PubMed

    Brown, Justin C; Schmitz, Kathryn H

    2017-01-01

    In a post hoc analysis, we quantified the risk of musculoskeletal injury (MSI) associated with different volumes of aerobic exercise in a randomized trial. Premenopausal women (n = 119) were randomized to one of three groups: low-dose aerobic exercise (150 min·per week), high-dose aerobic exercise (300 min·per week) or control (usual activity) for 5 months. Compared to the control group, the risk of reporting an acute MSI increased with higher volumes of aerobic exercise, with a similar pattern observed for recurrent MSI. The risk of reporting an MSI severe enough to impair activities of daily living did not increase with higher volumes of aerobic exercise. Approximately half of MSI were causally attributed to aerobic exercise. The risk of experiencing an acute or recurrent MSI increases with higher volumes of aerobic exercise; however, the risk of experiencing an MSI severe enough to impair activities of daily living does not increase with higher volumes of aerobic exercise.

  8. Nursing student evaluation of NIOSH workplace violence prevention for nurses online course.

    PubMed

    Brann, Maria; Hartley, Dan

    2017-02-01

    As primary targets of workplace violence in health care settings, nurses may suffer negative physical and psychological consequences. NIOSH created an online course to educate nurses about violence prevention techniques. A mixed-methods approach assessed workplace violence awareness and knowledge among nursing students. A pre/post/post-test survey and focus group discussions evaluated participant awareness and knowledge, assessed course design, and solicited recommendations for increasing participation and strategies for improving message retention. The mean awareness scores differed significantly between pre-course and both post-course time points (Wilk's λ=0.319, F(2, 46)=49.01, p<0.001). Post hoc tests using the Bonferroni correction revealed that course participation increased awareness of workplace violence from pre-course scores (M=0.75, SD=0.438) to immediate post-course (M=2.13, SD=0.789) and four-week post-course (M=1.96, SD=0.771) scores on a 3-item measure. Similarly, mean knowledge scores increased between pre-course and both post-course time points (Wilk's λ=0.495, F(1.57, 73.66)=37.26, p<0.001). Post hoc tests using the Bonferroni correction revealed that course participation increased knowledge of workplace violence from pre-course scores (M=6.65, SD=1.45) to immediate post-course (M=8.56, SD=1.32) and four-week post-course (M=8.19, SD=1.42) scores on a 10-item measure. Qualitative data from the focus groups reinforced the quantitative findings. Participants citing benefits from the content strongly recommended including the course in nursing curriculums. Incorporating the course early in the nursing educational experience will better prepare students to deal with workplace violence when they enter health care professions. The results indicate that NIOSH and its partners created an effective online workplace violence awareness and prevention course. Practical applications: Nursing students and professionals can be effectively educated about workplace violence using an online format. Copyright © 2016 National Safety Council and Elsevier Ltd. All rights reserved.

  9. Evaluation of degenerative disease of the lumbar spine: MR/MR myelography versus conventional myelography/post-myelography CT.

    PubMed

    Shiban, Ehab; von Lehe, Marec; Simon, Matthias; Clusmann, Hans; Heinrich, Petra; Ringel, Florian; Wilhelm, Kai; Urbach, Horst; Meyer, Bernhard; Stoffel, Michael

    2016-08-01

    To compare the use of magnetic resonance (MR)/MR myelography (MRM) with conventional myelography/post-myelography CT (convM) for detailed surgery planning in degenerative lumbar disease. Twenty-six patients with suspected complex lumbar degenerative disease underwent MRM in addition to convM as preoperative workup. Surgery was planned based on convM-as usual at our department. Post hoc, surgical planning was repeated planned again-now based on MRM. Furthermore, the MRM-based planning was performed by six independent neurosurgeons (three groups) of different degrees of specialisation. In only 31 % of the patients, post hoc MRM-based planning resulted in the same surgical decision as originally performed, whereas in 69 % (n = 18) a different procedure was indicated. In patients with non-concurring convM- and MRM-based surgical plans, a less extended procedure was the result of MRM in six patients (23 %), a more extended one in five (19 %), and a related to side/level of decompression or nucleotomy different plan in six patients (23 %). In one patient (4 %), the MRM-based planning would have led to a completely different surgery compared to convM. Overall interobserver agreement on the MRM-based planning was substantial. Detailed planning of operative procedures for complex lumbar degenerative disease is highly dependent on the image modality used.

  10. Understanding the Requirements for Open Source Software

    DTIC Science & Technology

    2009-06-17

    GNOME and K Development Environment ( KDE ) for end-user interfaces, the Eclipse and NetBeans interactive development environments for Java-based Web...17 4.1. Informal Post-hoc Assertion of OSS Requirements vs . Requirements Elicitation...18 4.2. Requirements Reading, Sense-making, and Accountability vs . Requirements Analysis

  11. Coping Strategies Used by Distance Rehabilitation Counseling Interns

    ERIC Educational Resources Information Center

    Kampfe, Charlene M.; Smith, Mae S.; Manyibe, Edward O.; Sales, Amos P.; Moore, Susan F.

    2009-01-01

    This study investigated coping strategies used by distance master's level student interns from one rehabilitation counseling program. Analysis of variance revealed a significant difference among five coping strategies. Post hoc comparisons showed that interns used problem-focused and seeking social support more frequently than self-blame, wishful…

  12. Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302

    PubMed Central

    Saad, Fred; Shore, Neal; Van Poppel, Hendrik; Rathkopf, Dana E.; Smith, Matthew R.; de Bono, Johann S.; Logothetis, Christopher J.; de Souza, Paul; Fizazi, Karim; Mulders, Peter F.A.; Mainwaring, Paul; Hainsworth, John D.; Beer, Tomasz M.; North, Scott; Fradet, Yves; Griffin, Thomas A.; De Porre, Peter; Londhe, Anil; Kheoh, Thian; Small, Eric J.; Scher, Howard I.; Molina, Arturo; Ryan, Charles J.

    2016-01-01

    Background Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy. Objective Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients. Design, setting, and participants This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial. Intervention Patients were grouped by concomitant BTT use or no BTT use. Outcome measurements and statistical analysis Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models. Results and limitations While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p = 0.01) and increased the time to ECOG deterioration (HR 0.75; p < 0.001) and time to opiate use for cancer-related pain (HR 0.80; p = 0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients. Conclusions AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT. Patient summary Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone. Trial registration ClinicalTrials.gov NCT00887198. PMID:25985882

  13. Exploratory analysis of textual data from the Mother and Child Handbook using the text-mining method: Relationships with maternal traits and post-partum depression.

    PubMed

    Matsuda, Yoshio; Manaka, Tomoko; Kobayashi, Makiko; Sato, Shuhei; Ohwada, Michitaka

    2016-06-01

    The aim of the present study was to examine the possibility of screening apprehensive pregnant women and mothers at risk for post-partum depression from an analysis of the textual data in the Mother and Child Handbook by using the text-mining method. Uncomplicated pregnant women (n = 58) were divided into two groups according to State-Trait Anxiety Inventory grade (high trait [group I, n = 21] and low trait [group II, n = 37]) or Edinburgh Postnatal Depression Scale score (high score [group III, n = 15] and low score [group IV, n = 43]). An exploratory analysis of the textual data from the Maternal and Child Handbook was conducted using the text-mining method with the Word Miner software program. A comparison of the 'structure elements' was made between the two groups. The number of structure elements extracted by separated words from text data was 20 004 and the number of structure elements with a threshold of 2 or more as an initial value was 1168. Fifteen key words related to maternal anxiety, and six key words related to post-partum depression were extracted. The text-mining method is useful for the exploratory analysis of textual data obtained from pregnant woman, and this screening method has been suggested to be useful for apprehensive pregnant women and mothers at risk for post-partum depression. © 2016 Japan Society of Obstetrics and Gynecology.

  14. An Exploratory Study of Specific Factors in a Prison Environment That Affect a Manpower Training Project.

    ERIC Educational Resources Information Center

    Barton, Marlin C.; And Others

    An exploratory study of a prison community is presented. The study employed a three-phase design: (1) a pre-survey of the prison community, (2) limited intervention, based on findings of the pre-survey, and (3) a post-survey to determine effects of intervention and to validate findings of the pre-survey for which no intervention had been designed.…

  15. Issues and Problems Related to the Research on Teenage Fathers: A Critical Analysis.

    ERIC Educational Resources Information Center

    Robinson, Bryan E.; Barret, Robert L.

    1982-01-01

    Research on teenage pregnancies has usually neglected young fathers. Most studies ignore fathers entirely, or use data confused or confounded by biased reporting techniques. Retrospective and post hoc analyses often produce inaccurate conclusions, and subject samples often are unrepresentative. A closer examination of adolescent fathers is…

  16. An Analysis of the Readability of Financial Accounting Textbooks.

    ERIC Educational Resources Information Center

    Smith, Gerald; And Others

    1981-01-01

    The Flesch formula was used to calculate the readability of 15 financial accounting textbooks. The 15 textbooks represented introductory, intermediate, and advanced levels and also were classified by five different publishers. Two-way analysis of variance and Tukey's post hoc analysis revealed some significant differences. (Author/CT)

  17. 76 FR 56158 - Certain Frozen Warmwater Shrimp From the Socialist Republic of Vietnam: Final Results and Final...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... post-Preliminary Results surrogate value information to value factors of production (``FOP'') for the... value information from the Processors. \\2\\ This includes the Ad Hoc Shrimp Trade Action Committee... vannemei), banana prawn (Penaeus merguiensis), fleshy prawn (Penaeus chinensis), giant river prawn...

  18. Rater Drift and Time Trends in Classroom Observations

    ERIC Educational Resources Information Center

    Casabianca, Jodi M.; Lockwood, J. R.

    2013-01-01

    Classroom observation protocols, in which observers rate multiple dimensions of teaching according to established protocols (either live in the classroom, or post-hoc from lesson videos), are increasingly being used in both research and policy contexts. However, scores generated from these protocols have many sources of error. Day to day variation…

  19. Career Development in Language Education Programs

    ERIC Educational Resources Information Center

    Shawer, Saad Fathy; Alkahtani, Saad Ali

    2013-01-01

    This study assesses the influence of a two-year language program evaluation on program directors and faculty career development. The study makes use of mixed-paradigms (positivism and qualitative interpretive), mixed-strategies (survey research and qualitative evaluation), one-way analysis of variance (ANOVA) and a post-hoc test of multiple…

  20. Does STES-Oriented Science Education Promote 10th-Grade Students' Decision-Making Capability?

    NASA Astrophysics Data System (ADS)

    Levy Nahum, Tami; Ben-Chaim, David; Azaiza, Ibtesam; Herskovitz, Orit; Zoller, Uri

    2010-07-01

    Today's society is continuously coping with sustainability-related complex issues in the Science-Technology-Environment-Society (STES) interfaces. In those contexts, the need and relevance of the development of students' higher-order cognitive skills (HOCS) such as question-asking, critical-thinking, problem-solving and decision-making capabilities within science teaching have been argued by several science educators for decades. Three main objectives guided this study: (1) to establish "base lines" for HOCS capabilities of 10th grade students (n = 264) in the Israeli educational system; (2) to delineate within this population, two different groups with respect to their decision-making capability, science-oriented (n = 142) and non-science (n = 122) students, Groups A and B, respectively; and (3) to assess the pre-post development/change of students' decision-making capabilities via STES-oriented HOCS-promoting curricular modules entitled Science, Technology and Environment in Modern Society (STEMS). A specially developed and validated decision-making questionnaire was used for obtaining a research-based response to the guiding research questions. Our findings suggest that a long-term persistent application of purposed decision-making, promoting teaching strategies, is needed in order to succeed in affecting, positively, high-school students' decision-making ability. The need for science teachers' involvement in the development of their students' HOCS capabilities is thus apparent.

  1. The moderating effect of ANKK1 on the association of family environment with longitudinal executive function following traumatic brain injury in early childhood: A preliminary study.

    PubMed

    Smith-Paine, Julia; Wade, Shari L; Treble-Barna, Amery; Zhang, Nanhua; Zang, Huaiyu; Martin, Lisa J; Yeates, Keith Owen; Taylor, H Gerry; Kurowski, Brad G

    2018-05-02

    This study examined whether the ankyrin repeat and kinase domain containing 1 gene (ANKK1) C/T single-nucleotide polymorphism (SNP) rs1800497 moderated the association of family environment with long-term executive function (EF) following traumatic injury in early childhood. Caregivers of children with traumatic brain injury (TBI) and children with orthopedic injury (OI) completed the Behavior Rating Inventory of Executive Function (BRIEF) at post injury visits. DNA was collected to identify the rs1800497 genotype in the ANKK1 gene. General linear models examined gene-environment interactions as moderators of the effects of TBI on EF at two times post injury (12 months and 7 years). At 12 months post injury, analyses revealed a significant 3-way interaction of genotype with level of permissive parenting and injury type. Post-hoc analyses showed genetic effects were more pronounced for children with TBI from more positive family environments, such that children with TBI who were carriers of the risk allele (T-allele) had significantly poorer EF compared to non-carriers only when they were from more advantaged environments. At 7 years post injury, analyses revealed a significant 2-way interaction of genotype with level of authoritarian parenting. Post-hoc analyses found that carriers of the risk allele had significantly poorer EF compared to non-carriers only when they were from more advantaged environments. These results suggest a gene-environment interaction involving the ANKK1 gene as a predictor of EF in a pediatric injury population. The findings highlight the importance of considering environmental influences in future genetic studies on recovery following TBI and other traumatic injuries in childhood.

  2. The influence of cognitive dysfunction on benefit from learning and memory rehabilitation in MS: A sub-analysis of the MEMREHAB trial.

    PubMed

    Chiaravalloti, Nancy D; DeLuca, John

    2015-10-01

    This study examined the influence of processing speed (PS) on benefit from treatment with the modified Story Memory Technique(©) (mSMT), a behavioral intervention shown to improve new learning and memory in multiple sclerosis (MS). This double-blind, placebo-controlled, randomized clinical trial included 85 participants with clinically definite MS, 45 assigned to the treatment group and 40 to the placebo-control group. Participants completed baseline and follow-up neuropsychological assessment. The present study represents a post-hoc analysis to examine the role of PS on treatment efficacy. The treatment group showed a significantly improved CVLT learning slope relative to the placebo group post-treatment, after co-varying PS performance. SDMT performance was a significant predictor of benefit from mSMT treatment, beyond group assignment. Post-hoc analysis indicated a significant correlation between the SDMT and overall cognition, indicating that the SDMT may be serving as a proxy for overall cognitive impairment. Performance on measures of cognitive dysfunction aside from learning and memory impact the benefit of mSMT treatment. While the current study focused on PS as a critical factor, PS may be serving as a marker for generalized cognitive dysfunction. Implications for cognitive rehabilitation in MS are discussed. © The Author(s), 2015.

  3. Post-Baccalaureate Reverse Transfer Students in Iowa: 2006 to 2008

    ERIC Educational Resources Information Center

    Leigh, Rachel A.

    2009-01-01

    The purpose of this descriptive, exploratory study investigates the number of students who hold a bachelor's degree or higher attending Iowa's fifteen community colleges between fiscal years 2006 and 2008. This group of students is referred to as post-baccalaureate reverse transfer (PBRT) students in the literature and in this paper. This study…

  4. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    PubMed

    2017-10-01

    Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety. Patients given edaravone in the first 24-week phase III study (Cycles 1-6) were randomised to edaravone (E-E) or placebo (E-P) in the subsequent 24-week double-blind period (Cycles 7-12). Patients given placebo in phase III were switched to edaravone (P-E). Subsequently, all patients received edaravone for 12 weeks (Cycles 13-15). Efficacy endpoints included revised ALS Functional Rating Scale (ALSFRS-R) score. Analysis populations were the full analysis set (FAS) and the efficacy-expected subpopulation (EESP) defined by post-hoc analysis of the first phase III study. The least-squares mean and standard error of the intergroup difference (E-E vs. E-P) of change in the ALSFRS-R score from Cycles 7-12 was 1.16 ± 0.93 (p = 0.2176) in the FAS, and 1.85 ± 1.14 (p = 0.1127) in the EESP. The ALSFRS-R score changed almost linearly in the E-E group throughout Cycles 1-15 (60 weeks). The incidence of serious adverse events associated with ALS progression was higher in E-E than in E-P. Edaravone might have potential efficacy for up to 15 cycles when used to treat patients in the EESP with careful safety monitoring.

  5. Interaction Between 2 Nutraceutical Treatments and Host Immune Status in the Pediatric Critical Illness Stress-Induced Immune Suppression Comparative Effectiveness Trial.

    PubMed

    Carcillo, Joseph A; Dean, J Michael; Holubkov, Richard; Berger, John; Meert, Kathleen L; Anand, Kanwaljeet J S; Zimmerman, Jerry J; Newth, Christopher J L; Harrison, Rick; Burr, Jeri; Willson, Douglas F; Nicholson, Carol; Bell, Michael J; Berg, Robert A; Shanley, Thomas P; Heidemann, Sabrina M; Dalton, Heidi; Jenkins, Tammara L; Doctor, Allan; Webster, Angie; Tamburro, Robert F

    2017-11-01

    The pediatric Critical Illness Stress-induced Immune Suppression (CRISIS) trial compared the effectiveness of 2 nutraceutical supplementation strategies and found no difference in the development of nosocomial infection and sepsis in the overall population. We performed an exploratory post hoc analysis of interaction between nutraceutical treatments and host immune status related to the development of nosocomial infection/sepsis. Children from the CRISIS trial were analyzed according to 3 admission immune status categories marked by decreasing immune competence: immune competent without lymphopenia, immune competent with lymphopenia, and previously immunocompromised. The comparative effectiveness of the 2 treatments was analyzed for interaction with immune status category. There were 134 immune-competent children without lymphopenia, 79 previously immune-competent children with lymphopenia, and 27 immunocompromised children who received 1 of the 2 treatments. A significant interaction was found between treatment arms and immune status on the time to development of nosocomial infection and sepsis ( P < .05) and on the rate of nosocomial infection and sepsis per 100 patient days ( P < .05). Whey protein treatment protected immune-competent patients without lymphopenia from infection and sepsis, both nutraceutical strategies were equivalent in immune-competent patients with lymphopenia, and zinc, selenium, glutamine, and metoclopramide treatment protected immunocompromised patients from infection and sepsis. The science of immune nutrition is more complex than previously thought. Future trial design should consider immune status at the time of trial entry because differential effects of nutraceuticals may be related to this patient characteristic.

  6. Analysis of PAC1 receptor gene variants in Caucasian and African American infants dying of sudden infant death syndrome.

    PubMed

    Barrett, Karlene T; Rodikova, Ekaterina; Weese-Mayer, Debra E; Rand, Casey M; Marazita, Mary L; Cooper, Margaret E; Berry-Kravis, Elizabeth M; Bech-Hansen, N Torben; Wilson, Richard J A

    2013-12-01

    Stress peptide, pituitary adenylate cyclase-activating polypeptide (PACAP), has been implicated in sudden infant death syndrome (SIDS). The aim of this exploratory study was to determine whether variants in the gene encoding the PACAP-specific receptor, PAC1, are associated with SIDS in Caucasian and African American infants. Polymerase chain reaction and Sanger DNA sequencing was used to compare variants in the 5'-untranslated region, exons and intron-exon boundaries of the PAC1 gene in 96 SIDS cases and 96 race- and gender-matched controls. The intron 3 variant, A/G: rs758995 (variant 'h'), and the intron 6 variant, C/T: rs10081254 (variant 'n'), were significantly associated with SIDS in Caucasians and African Americans, respectively (p < 0.05). Also associated with SIDS were interactions between the variants rs2302475 (variant 'i') in PAC1 and rs8192597 and rs2856966 in PACAP among Caucasians (p < 0.02) and rs2267734 (variant 'q') in PAC1 and rs1893154 in PACAP among African Americans (p < 0.01). However, none of these differences survived post hoc analysis. Overall, this study does not support a strong association between variants in the PAC1 gene and SIDS; however, a number of potential associations between race-specific variants and SIDS were identified that warrant targeted investigations in future studies. ©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  7. Neonatal intensive care practices: perceptions of parents, professionals, and managers.

    PubMed

    Lantz, Björn; Ottosson, Cornelia

    2014-06-01

    This article explores the differences and similarities in opinions of neonatal intensive care issues between parents, neonatal intensive care unit (NICU) healthcare professionals (nurses and physicians), and managers (neonatal unit managers and pediatric division managers). An exploratory survey (n = 624) was conducted in Sweden during 2012-2013 on the basis of a validated questionnaire composed of 92 neonatal care-related Likert items. A total of 141 parents, 443 professionals, and 40 managers completed the survey. The parents were recruited consecutively from 5 NICUs of the Västra Götaland region in Sweden and the professionals and managers from all 40 NICUs in Sweden. Data were analyzed with analysis of variances, and post hoc analyses were conducted through pairwise t tests with Bonferroni corrections. Professionals and managers differed significantly on 1 item. Parents, however, found 54 items significantly less important than professionals did, but found only 4 to be significantly more important than professionals did. In line with previous research, we found that a gap exists between views of neonatal intensive care practices, with parents on one side and professionals and managers on the other. The nature of this gap, however, differs substantially from previous research, where parents found many items to be more important than professionals did. To develop and improve neonatal intensive care, this gap must be acknowledged and addressed, both in research and in practice. NICU managers need to develop strategies and routines that allow professionals to understand and adjust to the specific priorities of individual parents and families.

  8. Pharmacy ownership in Canada: implications for the authority and autonomy of community pharmacy managers.

    PubMed

    Dobson, Roy Thomas; Perepelkin, Jason

    2011-12-01

    In recent years, the number of independently owned pharmacies has declined even as the total number of pharmacies in Canada has increased. With increasing corporate ownership, there is concern that this trend will adversely affect the profession's ability to influence pharmacy practice and practice change. To examine the relationship between ownership type and community pharmacy managers in terms of professional and employer authority, managerial autonomy, decision making, and amount of control. This study consisted of a cross-sectional survey of community pharmacy managers in Canada by means of a self-administered postal questionnaire sent to a stratified sample of community pharmacies. Statistical analysis consisted of exploratory factor analysis with reliability testing on identified constructs. Frequencies, 1-way analyses of variance, Scheffe post hoc tests, and general linear modeling were used to determine significant differences among groups based on ownership type. In total, 646 of 1961 questionnaires from pharmacy managers were completed and returned (response rate 32.9%). Respondents rated their authority similarly across ownership types. Autonomy, decision-making capabilities, and control needed to carry out the professional role appear most limited among corporate respondents and, to a lesser extent, franchise managers. Pharmacy managers currently perceive a high level of authority; but with limited autonomy among corporate managers, it is unclear whether this authority is sufficient to prevent the subordination of both patient and professional interests to financial interests. Copyright © 2011 Elsevier Inc. All rights reserved.

  9. Poor sleep quality is associated with increased cortical atrophy in community-dwelling adults.

    PubMed

    Sexton, Claire E; Storsve, Andreas B; Walhovd, Kristine B; Johansen-Berg, Heidi; Fjell, Anders M

    2014-09-09

    To examine the relationship between sleep quality and cortical and hippocampal volume and atrophy within a community-based sample, explore the influence of age on results, and assess the possible confounding effects of physical activity levels, body mass index (BMI), and blood pressure. In 147 community-dwelling adults (92 female; age 53.9 ± 15.5 years), sleep quality was measured using the Pittsburgh Sleep Quality Index and correlated with cross-sectional measures of volume and longitudinal measures of atrophy derived from MRI scans separated by an average of 3.5 years. Exploratory post hoc analysis compared correlations between different age groups and included physical activity, BMI, and blood pressure as additional covariates. Poor sleep quality was associated with reduced volume within the right superior frontal cortex in cross-sectional analyses, and an increased rate of atrophy within widespread frontal, temporal, and parietal regions in longitudinal analyses. Results were largely driven by correlations within adults over the age of 60, and could not be explained by variation in physical activity, BMI, or blood pressure. Sleep quality was not associated with hippocampal volume or atrophy. We found that longitudinal measures of cortical atrophy were widely correlated with sleep quality. Poor sleep quality may be a cause or a consequence of brain atrophy, and future studies examining the effect of interventions that improve sleep quality on rates of atrophy may hold key insights into the direction of this relationship. © 2014 American Academy of Neurology.

  10. #Vapelife: An Exploratory Study of Electronic Cigarette Use and Promotion on Instagram.

    PubMed

    Laestadius, Linnea I; Wahl, Megan M; Cho, Young I

    2016-10-14

    The growth of social networking services has enabled the sharing of electronic cigarette opinions and experiences via user-generated content. This exploratory study analyzed electronic cigarette content found on the visual social networking service, Instagram, in order to highlight public health challenges created by this content and support understanding of electronic cigarette promotion and usage. A qualitative content analysis was performed on Instagram posts made with the hashtags #ecig or #vape in October 2014. Images, text, and hashtags from 85 posts (43 #ecig, 42 #vape) were analyzed. In addition, the total number of posts made with eight key electronic cigarette hashtags was recorded at four points between March 2014 and October 2015. The total number of #vape posts on Instagram grew by 4,163,274 during the study period, while #ecig posts increased by 741,916. Of the posts examined in-depth, corporate users made up over half of posts. No posts were critical of electronic cigarettes. Few mentioned electronic cigarettes in the context of health benefits. No posts included major brands, and mod style electronic cigarettes were mentioned or depicted in over half of posts. A majority of posts included hashtags expressing vaping identity and community. In addition, users mentioned novel practices such as sub-ohming. Conclusions/Importance: Instagram users in our sample characterized electronic cigarettes primarily as novel devices rather than equivalents to cigarettes. Further, hashtag communities and identities appear to be forming around vaping. Future research should consider the public health implications of these hashtags, as well as novel electronic cigarette practices.

  11. Efficacy and safety of N-acetylcysteine in prevention of noise induced hearing loss: a randomized clinical trial.

    PubMed

    Kopke, Richard; Slade, Martin D; Jackson, Ronald; Hammill, Tanisha; Fausti, Stephen; Lonsbury-Martin, Brenda; Sanderson, Alicia; Dreisbach, Laura; Rabinowitz, Peter; Torre, Peter; Balough, Ben

    2015-05-01

    Despite a robust hearing conservation program, military personnel continue to be at high risk for noise induced hearing loss (NIHL). For more than a decade, a number of laboratories have investigated the use of antioxidants as a safe and effective adjunct to hearing conservation programs. Of the antioxidants that have been investigated, N-acetylcysteine (NAC) has consistently reduced permanent NIHL in the laboratory, but its clinical efficacy is still controversial. This study provides a prospective, randomized, double-blinded, placebo-controlled clinical trial investigating the safety profile and the efficacy of NAC to prevent hearing loss in a military population after weapons training. Of the 566 total study subjects, 277 received NAC while 289 were given placebo. The null hypothesis for the rate of STS was not rejected based on the measured results. While no significant differences were found for the primary outcome, rate of threshold shifts, the right ear threshold shift rate difference did approach significance (p = 0.0562). No significant difference was found in the second primary outcome, percentage of subjects experiencing an adverse event between placebo and NAC groups (26.7% and 27.4%, respectively, p = 0.4465). Results for the secondary outcome, STS rate in the trigger hand ear, did show a significant difference (34.98% for placebo-treated, 27.14% for NAC-treated, p-value = 0.0288). Additionally, post-hoc analysis showed significant differences in threshold shift rates when handedness was taken into account. While the secondary outcomes and post-hoc analysis suggest that NAC treatment is superior to the placebo, the present study design failed to confirm this. The lack of significant differences in overall hearing loss between the treatment and placebo groups may be due to a number of factors, including suboptimal dosing, premature post-exposure audiograms, or differences in risk between ears or subjects. Based on secondary outcomes and post hoc analyses however, further studies seem warranted and are needed to clarify dose response and the factors that may have played a role in the observed results. Copyright © 2015 Elsevier B.V. All rights reserved.

  12. Benchmarking the Importance and Use of Labor Market Surveys by Certified Rehabilitation Counselors

    ERIC Educational Resources Information Center

    Barros-Bailey, Mary; Saunders, Jodi L.

    2013-01-01

    The purpose of this research was to benchmark the importance and use of labor market survey (LMS) among U.S. certified rehabilitation counselors (CRCs). A secondary post hoc analysis of data collected via the "Rehabilitation Skills Inventory--Revised" for the 2011 Commission on Rehabilitation Counselor Certification job analysis resulted in…

  13. USE OF LIDAR TO MAP STREAM MORPHOLOGY AND MONITOR CHANGES DUE TO URBANIZATION OF A SMALL SUBURBAN WATERSHED

    EPA Science Inventory

    Urbanization has been associated with changes in stream flow regime, morphology, and water
    quality of rural watersheds being developed. Most studies of the effect of urbanization on stream morphology have been done post hoc -after development has occurred -and involve the ext...

  14. Classes in the Balance: Latent Class Analysis and the Balance Scale Task

    ERIC Educational Resources Information Center

    Boom, Jan; ter Laak, Jan

    2007-01-01

    Latent class analysis (LCA) has been successfully applied to tasks measuring higher cognitive functioning, suggesting the existence of distinct strategies used in such tasks. With LCA it became possible to classify post hoc. This important step forward in modeling and analyzing cognitive strategies is relevant to the overlapping waves model for…

  15. Some Simultaneous Inference Procedures for A Priori Contrasts.

    ERIC Educational Resources Information Center

    Convey, John J.

    The testing of a priori contrasts, post hoc contrasts, and experimental error rates are discussed. Methods for controlling the experimental error rate for a set of a priori contrasts tested simultaneously have been developed by Dunnett, Dunn, Sidak, and Krishnaiah. Each of these methods is discussed and contrasted as to applicability, power, and…

  16. Planned Comparisons as Better Alternatives to ANOVA Omnibus Tests.

    ERIC Educational Resources Information Center

    Benton, Roberta L.

    Analyses of data are presented to illustrate the advantages of using a priori or planned comparisons rather than omnibus analysis of variance (ANOVA) tests followed by post hoc or posteriori testing. The two types of planned comparisons considered are planned orthogonal non-trend coding contrasts and orthogonal polynomial or trend contrast coding.…

  17. Evaluation Methodologies for Estimating the Likelihood of Program Implementation Failure

    ERIC Educational Resources Information Center

    Durand, Roger; Decker, Phillip J.; Kirkman, Dorothy M.

    2014-01-01

    Despite our best efforts as evaluators, program implementation failures abound. A wide variety of valuable methodologies have been adopted to explain and evaluate the "why" of these failures. Yet, typically these methodologies have been employed concurrently (e.g., project monitoring) or to the post-hoc assessment of program activities.…

  18. Use of "t"-Test and ANOVA in Career-Technical Education Research

    ERIC Educational Resources Information Center

    Rojewski, Jay W.; Lee, In Heok; Gemici, Sinan

    2012-01-01

    Use of t-tests and analysis of variance (ANOVA) procedures in published research from three scholarly journals in career and technical education (CTE) during a recent 5-year period was examined. Information on post hoc analyses, reporting of effect size, alpha adjustments to account for multiple tests, power, and examination of assumptions…

  19. 78 FR 31890 - Antidisruptive Practices Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... trade when the settlement price is determined under the rules of that registered entity.\\14\\ \\13\\ Id...) does not require a pattern of activity, even a single instance of trading activity can be disruptive of... post hoc analysis which labels a trade or a series of trades ``disruptive.' ''). \\61\\ See, e.g., CME at...

  20. Identifying Students with Dyslexia in Higher Education

    ERIC Educational Resources Information Center

    Tops, Wim; Callens, Maaike; Lammertyn, Jan; Van Hees, Valerie; Brysbaert, Marc

    2012-01-01

    An increasing number of students with dyslexia enter higher education. As a result, there is a growing need for standardized diagnosis. Previous research has suggested that a small number of tests may suffice to reliably assess students with dyslexia, but these studies were based on post hoc discriminant analysis, which tends to overestimate the…

  1. Using Observational Methods to Research the Student Experience

    ERIC Educational Resources Information Center

    Cotton, Debby R. E.; Stokes, Alison; Cotton, Peter A.

    2010-01-01

    Much pedagogic research undertaken in geography and other disciplines relies on post-hoc methods such as surveys or interviews to investigate the student experience of higher education (often based on self-reports of behaviour). However, observation of students provides a far more direct route to obtain information about their behaviour, and there…

  2. Personality Typologies as a Predictor of Being a Successful Elementary School Principal

    ERIC Educational Resources Information Center

    Mendiburu, John G.

    2010-01-01

    Purpose: The purpose of this study was to examine personality typologies as a predictor of being a successful elementary school principal. Methodology: A post-hoc analysis design was used to describe the personality typologies as a predictor of being a successful elementary school principal. Eighteen principals were selected to participate in…

  3. When Leadership Matters: Perspectives from a Teacher Team Implementing Response to Intervention

    ERIC Educational Resources Information Center

    Meyer, Michele M.; Behar-Horenstein, Linda S.

    2015-01-01

    Previous research investigating the effectiveness of response to intervention (RTI) has relied on post hoc data analyses and surveys, although few studies have explored interactions among teacher teams. Understanding the synergistic impact of teacher work within the RTI framework may have implications for how school leaders can support teacher…

  4. Atomoxetine Treatment for ADHD: Younger Adults Compared with Older Adults

    ERIC Educational Resources Information Center

    Durell, Todd; Adler, Lenard; Wilens, Timothy; Paczkowski, Martin; Schuh, Kory

    2010-01-01

    Objective: Atomoxetine is a nonstimulant medication for treating child, adolescent, and adult ADHD. This meta-analysis compared the effects in younger and older adults. Method: A post hoc analysis was conducted using data from two double-blind, placebo-controlled clinical trials. Data from patients aged 18-25 years were compared with data from…

  5. Undergraduate Physical Activity and Depressive Symptoms: A National Study

    ERIC Educational Resources Information Center

    Elliot, Catherine A.; Kennedy, Catherine; Morgan, George; Anderson, Sharon K.; Morris, Debra

    2012-01-01

    Objective: To study the effects of college students' physical activity and gender on depressive and suicidal symptoms. Method: The National College Health Assessment survey was administered to college students nationwide. Data were analyzed with 4x2 ANOVAs and Games-Howell post hoc tests when appropriate. Results: More frequent physical activity…

  6. Human Parvovirus 4 Infection, Cameroon

    PubMed Central

    Lavoie, Myriam; Sharp, Colin P.; Pennington, Christopher; Foupouapouognigni, Yacouba; Pybus, Oliver G.; Njouom, Richard; Simmonds, Peter

    2012-01-01

    In a post hoc analysis of samples collected in 2009, we determined seroprevalence of parvovirus 4 (PARV4) among elderly Cameroonians. PARV4 seropositivity was associated with receipt of intravenous antimalarial drugs, intramuscular streptomycin, or an intramuscular contraceptive, but not hepatitis C virus seropositivity. Findings suggest parenteral acquisition of some PARV4 infections. PMID:22469425

  7. Quantitative Research Methods in Chaos and Complexity: From Probability to Post Hoc Regression Analyses

    ERIC Educational Resources Information Center

    Gilstrap, Donald L.

    2013-01-01

    In addition to qualitative methods presented in chaos and complexity theories in educational research, this article addresses quantitative methods that may show potential for future research studies. Although much in the social and behavioral sciences literature has focused on computer simulations, this article explores current chaos and…

  8. A Pilot Study of Collective Parent Engagement and Children's Academic Achievement

    ERIC Educational Resources Information Center

    Alameda-Lawson, Tania

    2014-01-01

    Parent involvement (PI) programs typically represent an important improvement strategy for schools serving low-income children of color. This pilot study offers an alternative to conventional PI approaches, collective parent engagement (CPE). The study relied on a post hoc, quasiexperimental design, and data were collected from 32 low-income,…

  9. A user-friendly approach to cost accounting in laboratory animal facilities.

    PubMed

    Baker, David G

    2011-08-19

    Cost accounting is an essential management activity for laboratory animal facility management. In this report, the author describes basic principles of cost accounting and outlines steps for carrying out cost accounting in laboratory animal facilities. Methods of post hoc cost accounting analysis for maximizing the efficiency of facility operations are also described.

  10. Social and Religious Factors in Adolescents' Drug Use

    ERIC Educational Resources Information Center

    Jones, Sandra C.; Rossiter, John R.

    2009-01-01

    The original purpose of this study was to test several types of anti-cannabis messages. Analysis of the results led to a second, post hoc purpose: to explain why pre-intervention substance usage rates varied so greatly between the sampled schools. Participants were Australian ninth-grade students at a state government high school and a…

  11. "Is post hoc development of risk management in weed biocontrol too late? Lessons learned from Cactoblastis cactorum"

    USDA-ARS?s Scientific Manuscript database

    Cactoblastis cactorum is renowned for its success as a biological control agent against exotic Opuntia spp. in many locations including Australia, South Africa and Hawaii. However, in 1957, its introduction into the Caribbean to control native Opuntia spp. ultimately resulted in its arrival to sout...

  12. Is post hoc development of risk management in weed biocontrol too late? Lessons learned from Cactoblastis cactorum.

    USDA-ARS?s Scientific Manuscript database

    Cactoblastis cactorum is renowned for its success as a biological control agent against exotic Opuntia spp. in many locations including Australia, South Africa and Hawaii. However, in 1957, its introduction into the Caribbean to control native Opuntia spp. ultimately resulted in its arrival to sout...

  13. Anger, disgust, and presumption of harm as reactions to taboo-breaking behaviors.

    PubMed

    Gutierrez, Roberto; Giner-Sorolla, Roger

    2007-11-01

    Three experiments investigated the relationship between the presumption of harm in harmfree violations of creatural norms (taboos) and the moral emotions of anger and disgust. In Experiment 1, participants made a presumption of harm to others from taboo violations, even in conditions described as harmless and not involving other people; this presumption was predicted by anger and not disgust. Experiment 2 manipulated taboo violation and included a cognitive load task to clarify the post hoc nature of presumption of harm. Experiment 3 was similar but more accurately measured presumed harm. In Experiments 2 and 3, only without load was symbolic harm presumed, indicating its post hoc function to justify moral anger, which was not affected by load. In general, manipulations of harmfulness to others predicted moral anger better than moral disgust, whereas manipulations of taboo predicted disgust better. The presumption of harm was found on measures of symbolic rather than actual harm when a choice existed. These studies clarify understanding of the relationship between emotions and their justification when people consider victimless, offensive acts.

  14. An evaluation of various methods of treatment for Legg-Calvé-Perthes disease.

    PubMed

    Wang, L; Bowen, J R; Puniak, M A; Guille, J T; Glutting, J

    1995-05-01

    An analysis of 5 methods of treatment for Legg-Calvé-Perthes disease was done on 124 patients with 141 affected hips. Before treatment, all groups were statistically similar concerning initial Mose measurement, age at onset of the disease, gender, and Catterall class. Treatments included the Scottish Rite orthosis (41 hips), nonweight bearing and exercises (41 hips), Petrie cast (29 hips), femoral varus osteotomy (15 hips), or Salter osteotomy (15 hips). Hips treated by the Scottish Rite orthosis had a significantly worse Mose measurement across time interaction (repeated measures analysis of variance, post hoc analyses, p < 0.05). For the other 4 treatment methods, there was no statistically different change. At followup, the Mose measurements for hips treated with the Scottish Rite orthosis were significantly worse than those for hips treated by nonweight bearing and exercises, Petrie cast, varus osteotomy, or Salter osteotomy (repeated measures analysis of variance, post hoc analyses, p < 0.05). There was, however, no significant difference in the distribution of hips according to the Stulberg et al classification at the last followup.

  15. Differential Effects of Social Networks on Mammography Use by Poverty Status.

    PubMed

    Yeo, Younsook

    2016-01-01

    This study examines whether social networks have differential effects on mammography use depending on poverty status. Data were analyzed on US women (40+), employing logistic regression and simple slope analyses for a post hoc probing of moderating effects. Among women not in poverty, living with a spouse/partner and attending church, regardless of frequency, were positively associated with mammography use; family size was negatively associated. Among women living in poverty, mammography showed a positive association only with weekly church attendance. Mammography was negatively associated with health-related social interactions occurring through the Internet. Post hoc probing showed significant moderating effects of poverty on the relationship between online health-related interactions and mammography use. To make the Internet a meaningful health empowerment tool for women in poverty, future research should identify how health-related interactions that occur online affect women in poverty's psychological and behavioral reactions that will contribute to our understanding of why they are discouraged from having mammograms. The mechanisms behind the differential effects of church attendance and poverty status on mammography also need further clarification.

  16. Reframing climate change as a public health issue: an exploratory study of public reactions

    PubMed Central

    2010-01-01

    Background Climate change is taking a toll on human health, and some leaders in the public health community have urged their colleagues to give voice to its health implications. Previous research has shown that Americans are only dimly aware of the health implications of climate change, yet the literature on issue framing suggests that providing a novel frame - such as human health - may be potentially useful in enhancing public engagement. We conducted an exploratory study in the United States of people's reactions to a public health-framed short essay on climate change. Methods U.S. adult respondents (n = 70), stratified by six previously identified audience segments, read the essay and were asked to highlight in green or pink any portions of the essay they found "especially clear and helpful" or alternatively "especially confusing or unhelpful." Two dependent measures were created: a composite sentence-specific score based on reactions to all 18 sentences in the essay; and respondents' general reactions to the essay that were coded for valence (positive, neutral, or negative). We tested the hypothesis that five of the six audience segments would respond positively to the essay on both dependent measures. Results There was clear evidence that two of the five segments responded positively to the public health essay, and mixed evidence that two other responded positively. There was limited evidence that the fifth segment responded positively. Post-hoc analysis showed that five of the six segments responded more positively to information about the health benefits associated with mitigation-related policy actions than to information about the health risks of climate change. Conclusions Presentations about climate change that encourage people to consider its human health relevance appear likely to provide many Americans with a useful and engaging new frame of reference. Information about the potential health benefits of specific mitigation-related policy actions appears to be particularly compelling. We believe that the public health community has an important perspective to share about climate change, a perspective that makes the problem more personally relevant, significant, and understandable to members of the public. PMID:20515503

  17. Exploring hepsin functional genetic variation association with disease specific protein expression in bipolar disorder: Applications of a proteomic informed genomic approach.

    PubMed

    Nassan, Malik; Jia, Yun-Fang; Jenkins, Greg; Colby, Colin; Feeder, Scott; Choi, Doo-Sup; Veldic, Marin; McElroy, Susan L; Bond, David J; Weinshilboum, Richard; Biernacka, Joanna M; Frye, Mark A

    2017-12-01

    In a prior discovery study, increased levels of serum Growth Differentiation Factor 15 (GDF15), Hepsin (HPN), and Matrix Metalloproteinase-7 (MMP7) were observed in bipolar depressed patients vs controls. This exploratory post-hoc analysis applied a proteomic-informed genomic research strategy to study the potential functional role of these proteins in bipolar disorder (BP). Utilizing the Genotype-Tissue Expression (GTEx) database to identify cis-acting blood expression quantitative trait loci (cis-eQTLs), five eQTL variants from the HPN gene were analyzed for association with BP cases using genotype data of cases from the discovery study (n = 58) versus healthy controls (n = 777). After adjusting for relevant covariates, we analyzed the relationship between these 5 cis-eQTLs and HPN serum level in the BP cases. All 5 cis-eQTL minor alleles were significantly more frequent in BP cases vs controls [(rs62122114, OR = 1.6, p = 0.02), (rs67003112, OR = 1.6, p = 0.02), (rs4997929, OR = 1.7, p = 0.01), (rs12610663, OR = 1.7, p = 0.01), (rs62122148, OR = 1.7, P = 0.01)]. The minor allele (A) in rs62122114 was significantly associated with increased serum HPN level in BP cases (Beta = 0.12, P = 0.049). However, this same minor allele was associated with reduced gene expression in GTEx controls. These exploratory analyses suggest that genetic variation in/near the gene encoding for hepsin protein may influence risk of bipolar disorder. This genetic variation, at least for the rs62122114-A allele, may have functional impact (i.e. differential expression) as evidenced by serum HPN protein expression. Although limited by small sample size, this study highlights the merits of proteomic informed functional genomic studies as a tool to investigate with greater precision the genetic risk of bipolar disorder and secondary relationships to protein expression recognizing, and encouraging in subsequent studies, high likelihood of epigenetic modification of genetic disease risk. Copyright © 2017. Published by Elsevier Ltd.

  18. Reframing climate change as a public health issue: an exploratory study of public reactions.

    PubMed

    Maibach, Edward W; Nisbet, Matthew; Baldwin, Paula; Akerlof, Karen; Diao, Guoqing

    2010-06-01

    Climate change is taking a toll on human health, and some leaders in the public health community have urged their colleagues to give voice to its health implications. Previous research has shown that Americans are only dimly aware of the health implications of climate change, yet the literature on issue framing suggests that providing a novel frame--such as human health--may be potentially useful in enhancing public engagement. We conducted an exploratory study in the United States of people's reactions to a public health-framed short essay on climate change. U.S. adult respondents (n = 70), stratified by six previously identified audience segments, read the essay and were asked to highlight in green or pink any portions of the essay they found "especially clear and helpful" or alternatively "especially confusing or unhelpful." Two dependent measures were created: a composite sentence-specific score based on reactions to all 18 sentences in the essay; and respondents' general reactions to the essay that were coded for valence (positive, neutral, or negative). We tested the hypothesis that five of the six audience segments would respond positively to the essay on both dependent measures. There was clear evidence that two of the five segments responded positively to the public health essay, and mixed evidence that two other responded positively. There was limited evidence that the fifth segment responded positively. Post-hoc analysis showed that five of the six segments responded more positively to information about the health benefits associated with mitigation-related policy actions than to information about the health risks of climate change. Presentations about climate change that encourage people to consider its human health relevance appear likely to provide many Americans with a useful and engaging new frame of reference. Information about the potential health benefits of specific mitigation-related policy actions appears to be particularly compelling. We believe that the public health community has an important perspective to share about climate change, a perspective that makes the problem more personally relevant, significant, and understandable to members of the public.

  19. Pravastatin and cardiovascular outcomes stratified by baseline eGFR in the lipid-lowering component of ALLHAT

    PubMed Central

    Rahman, Mahboob; Baimbridge, Charles; Davis, Barry R.; Barzilay, Joshua I.; Basile, Jan N.; Henriquez, Mario A.; Huml, Anne; Kopyt, Nelson; Louis, Gail T.; Pressel, Sara L.; Rosendorff, Clive; Sastrasinh, Sithiporn; Stanford, Carol

    2013-01-01

    Background/Aims: The role of statins in preventing cardiovascular outcomes in patients with chronic kidney disease (CKD) is unclear. This paper compares cardiovascular outcomes with pravastatin vs. usual care, stratified by baseline estimated glomerular filtration rate (eGFR). Methods: Post-hoc analyses of a prospective randomized open-label clinical trial; 10,151 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (lipid-lowering component) were randomized to pravastatin 40 mg/day or usual care. Mean follow-up was 4.8 years. Results: Through Year 6, total cholesterol declined in pravastatin (–20.7%) and usual-care groups (–11.2%). Use of statin therapy in the pravastatin group was 89.8% (Year 2) and 87.0% (Year 6). Usual-care group statin use increased from 8.2% (Year 2) to 23.5% (Year 6). By primary intention-to-treat analyses, no significant differences were seen between groups for coronary heart disease (CHD), total mortality or combined cardiovascular disease; findings were consistent across eGFR strata. In exploratory “as-treated” analyses (patients actually using pravastatin vs. not using), pravastatin therapy was associated with lower mortality (HR = 0.76 (0.68 – 0.85), p < 0.001) and lower CHD (HR = 0.84 (0.73 – 0.97), p = 0.01), but not combined cardiovascular disease (HR = 0.95 (0.88 – 1.04), p = 0.30). Total cholesterol reduction of 10 mg/dl from baseline to Year 2 was associated with 5% lower CHD risk. Conclusions: In hypertensive patients with moderate dyslipidemia, pravastatin was not superior to usual care in preventing total mortality or CHD independent of baseline eGFR level. However, exploratory “as-treated” analyses suggest improved mortality and CHD risk in participants using pravastatin, and decreased CHD events associated with achieved reduction in total cholesterol. Potential benefit from statin therapy may depend on degree of reduction achieved in total and LDL-cholesterol and adherence to therapy. PMID:23816477

  20. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set

    PubMed Central

    Grothey, Axel; Yoshino, Takayuki; Bodoky, Gyorgy; Ciuleanu, Tudor; Garcia-Carbonero, Rocio; García-Alfonso, Pilar; Van Cutsem, Eric; Muro, Kei; Mytelka, Daniel S; Li, Li; Lipkovich, Olga; Hsu, Yanzhi; Sashegyi, Andreas; Ferry, David; Nasroulah, Federico; Tabernero, Josep

    2018-01-01

    Background In the RAISE trial, ramucirumab+leucovorin/fluorouracil/irinotecan (FOLFIRI) improved the median overall survival (mOS) of patients with previously treated metastatic colorectal cancer versus patients treated with placebo+FOLFIRI but had a higher incidence of neutropaenia, leading to more chemotherapy dose modifications and discontinuations. Thus, we conducted an exploratory post-hoc analysis of RAISE and a retrospective, observational analysis of electronic medical record (EMR) data to determine and verify the association of neutropaenia, baseline absolute neutrophil count (ANC) and survival. Methods The RAISE analysis used the study safety population (n=1057). IMS Health Oncology Database (IMS EMR) was the source for the real-world data set (n=617). Results RAISE patients with treatment-emergent neutropaenia had improved mOS compared with those without (ramucirumab arm: 16.1 vs 10.7 months, HR=0.57, p<0.0001; placebo arm: 12.7 vs 10.7 months, HR=0.76, p=0.0065). RAISE patients with low ANC versus high baseline ANC also had longer mOS (ramucirumab arm: 15.2 vs 8.9 months, HR=0.49, p<0.0001; placebo arm: 13.2 vs 7.3 months, HR=0.50, p<0.0001). The results were similar for IMS EMR low versus high baseline ANC (bevacizumab+FOLFIRI patients: 14.9 vs 7.7 months, HR=0.59, p<0.0001; FOLFIRI alone: 14.6 vs 5.4 months, HR=0.37, p<0.0001). Patients in the RAISE trial with low baseline ANC were more likely to develop neutropaenia (OR: ramucirumab arm=2.62, p<0.0001; placebo arm=2.16, p=0.0003). Conclusion Neutropaenia during treatment, and subsequent dose modifications or discontinuations, do not compromise treatment efficacy. Baseline ANC is a strong prognostic factor for survival and is associated with treatment-emergent neutropaenia in the analysed population. Trial registration number NCT01183780, Results. PMID:29713498

  1. The mesencephalic trigeminal sensory nucleus is involved in acquisition of active exploratory behavior induced by changing from a diet of exclusively milk formula to food pellets in mice.

    PubMed

    Ishii, Toshiaki; Furuoka, Hidefumi; Kitamura, Nobuo; Muroi, Yoshikage; Nishimura, Masakazu

    2006-09-21

    Post-weaning mice fed exclusively milk display low-frequency exploratory behavior [Ishii, T., Itou, T., and Nishimura, M. (2005) Life Sci. 78, 174-179] compared to mice fed a food pellet diet. This low-frequency exploratory behavior switched to high-frequency exploration after a switch from exclusively milk formula to a food pellet diet. Acquisition of the high-frequency exploratory behavior was irreversible. Recently, we demonstrated that the mesencephalic trigeminal nucleus (Me5) is involved in the control of feeding and exploratory behavior in mice without modulating the emotional state [Ishii, T., Furuoka, H., Itou, T., Kitamura, N., and Nishimura, M. (2005) Brain Res. 1048, 80-86]. We therefore investigated whether the Me5 is involved in acquisition of high-frequency exploratory behavior induced by the switch in diet from an exclusively milk formula to food pellets. Mouse feeding and exploratory behaviors were analyzed using a food search compulsion apparatus, which was designed to distinguish between the two behaviors under standard living conditions. Immunohistochemical analysis of immediate early genes indicated that the Me5, which receives signals from oral proprioceptors, is transiently activated after the diet change. The change from low-frequency to high-frequency exploratory behavior was prevented in milk-fed mice by bilateral lesion of the Me5. These results suggest that the Me5 is activated by signals associated with mastication-induced proprioception and contributes to the acquisition of active exploratory behavior.

  2. Bardoxolone Methyl Improves Kidney Function in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study

    PubMed Central

    Chin, Melanie P.; Bakris, George L.; Block, Geoffrey A.; Chertow, Glenn M.; Goldsberry, Angie; Inker, Lesley A.; Heerspink, Hiddo J.L.; O'Grady, Megan; Pergola, Pablo E.; Wanner, Christoph; Warnock, David G.; Meyer, Colin J.

    2018-01-01

    Background Increases in measured inulin clearance, measured creatinine clearance, and estimated glomerular filtration rate (eGFR) have been observed with bardoxolone methyl in 7 studies enrolling approximately 2,600 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The largest of these studies was Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), a multinational, randomized, double-blind, placebo-controlled phase 3 trial which enrolled patients with T2D and CKD stage 4. The BEACON trial was terminated after preliminary analyses showed that patients randomized to bardoxolone methyl experienced significantly higher rates of heart failure events. We performed post-hoc analyses to characterize changes in kidney function induced by bardoxolone methyl. Methods Patients in ­BEACON (n = 2,185) were randomized 1: 1 to receive once-daily bardoxolone methyl (20 mg) or placebo. We compared the effects of bardoxolone methyl and placebo on a post-hoc composite renal endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, and end-stage renal disease (ESRD) events (provision of dialysis or kidney transplantation). Results Consistent with prior studies, patients randomized to bardoxolone methyl experienced mean increases in eGFR that were sustained through study week 48. Moreover, increases in eGFR from baseline were sustained 4 weeks after cessation of treatment. Patients randomized to bardoxolone methyl were significantly less likely to experience the composite renal endpoint (hazards ratio 0.48 [95% CI 0.36–0.64]; p < 0.0001). Conclusions Bardoxolone methyl preserves kidney function and may delay the onset of ESRD in patients with T2D and stage 4 CKD. PMID:29402767

  3. Bardoxolone Methyl Improves Kidney Function in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study.

    PubMed

    Chin, Melanie P; Bakris, George L; Block, Geoffrey A; Chertow, Glenn M; Goldsberry, Angie; Inker, Lesley A; Heerspink, Hiddo J L; O'Grady, Megan; Pergola, Pablo E; Wanner, Christoph; Warnock, David G; Meyer, Colin J

    2018-01-01

    Increases in measured inulin clearance, measured creatinine clearance, and estimated glomerular filtration rate (eGFR) have been observed with bardoxolone methyl in 7 studies enrolling approximately 2,600 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The largest of these studies was Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), a multinational, randomized, double-blind, placebo-controlled phase 3 trial which enrolled patients with T2D and CKD stage 4. The BEACON trial was terminated after preliminary analyses showed that patients randomized to bardoxolone methyl experienced significantly higher rates of heart failure events. We performed post-hoc analyses to characterize changes in kidney function induced by bardoxolone methyl. Patients in -BEACON (n = 2,185) were randomized 1: 1 to receive once-daily bardoxolone methyl (20 mg) or placebo. We compared the effects of bardoxolone methyl and placebo on a post-hoc composite renal endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, and end-stage renal disease (ESRD) events (provision of dialysis or kidney transplantation). Consistent with prior studies, patients randomized to bardoxolone methyl experienced mean increases in eGFR that were sustained through study week 48. Moreover, increases in eGFR from baseline were sustained 4 weeks after cessation of treatment. Patients randomized to bardoxolone methyl were significantly less likely to experience the composite renal endpoint (hazards ratio 0.48 [95% CI 0.36-0.64]; p < 0.0001). Bardoxolone methyl preserves kidney function and may delay the onset of ESRD in patients with T2D and stage 4 CKD. © 2018 The Author(s) Published by S. Karger AG, Basel.

  4. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis.

    PubMed

    Takahashi, Fumihiro; Takei, Koji; Tsuda, Kikumi; Palumbo, Joseph

    2017-10-01

    In the 24-week double-blind study of edaravone in ALS (MCI186-16), edaravone did not show a statistically significant difference versus placebo for the primary efficacy endpoint. For post-hoc analyses, two subpopulations were identified in which edaravone might be expected to show efficacy: the efficacy-expected subpopulation (EESP), defined by scores of ≥2 points on all 12 items of the ALS Functional Rating Scale-Revised (ALSFRS-R) and a percent predicted forced vital capacity (%FVC) ≥80% at baseline; and the definite/probable EESP 2 years (dpEESP2y) subpopulation which, in addition to EESP criteria, had definite or probable ALS diagnosed by El Escorial revised criteria, and disease duration of ≤2 years. In the 36-week extension study of MCI186-16, a 24-week double-blind comparison followed by 12 weeks of open-label edaravone (MCI186-17; NCT00424463), analyses of ALSFRS-R scores of the edaravone-edaravone group and edaravone-placebo group for the full analysis set (FAS) and EESP, as prospectively defined, were reported in a previous article. Here we additionally report results in patients who met dpEESP2y criteria at the baseline of MCI186-16. In the dpEESP2y, the difference in ALSFRS-R changes from 24 to 48 weeks between the edaravone-edaravone and edaravone-placebo groups was 2.79 (p = 0.0719), which was greater than the differences previously reported for the EESP and the FAS. The pattern of adverse events in the dpEESP2y did not show any additional safety findings to those from the earlier prospective study. In conclusion, this post-hoc analysis suggests a potential effect of edaravone between 24 and 48 weeks in patients meeting dpEESP2y criteria at baseline.

  5. Perioperative Mortality, 2010 to 2014: A Retrospective Cohort Study Using the National Anesthesia Clinical Outcomes Registry.

    PubMed

    Whitlock, Elizabeth L; Feiner, John R; Chen, Lee-Lynn

    2015-12-01

    The National Anesthesia Clinical Outcomes Registry collects demographic and outcome data from anesthesia cases, with the goal of improving safety and quality across the specialty. The authors present a preliminary analysis of the National Anesthesia Clinical Outcomes Registry database focusing on the rates of and associations with perioperative mortality (within 48 h of anesthesia induction). The authors retrospectively analyzed 2,948,842 cases performed between January 1, 2010, and May 31, 2014. Cases without procedure information and vaginal deliveries were excluded. Mortality and other outcomes were reported by the anesthesia provider. Hierarchical logistic regression was performed on cases with complete information for patient age group, sex, American Society of Anesthesiologists physical status, emergency case status, time of day, and surgery type, controlling for random effects within anesthesia practices. The final analysis included 2,866,141 cases and 944 deaths (crude mortality rate, 33 per 100,000). Increasing American Society of Anesthesiologists physical status, emergency case status, cases beginning between 4:00 PM and 6:59 AM, and patient age less than 1 yr or greater than or equal to 65 yr were independently associated with higher perioperative mortality. A post hoc subgroup analysis of 279,154 patients limited to 22 elective case types, post hoc models incorporating either more granular estimate of surgical risk or work relative value units, and a post hoc propensity score-matched cohort confirmed the association with time of day. Several factors were associated with increased perioperative mortality. A case start time after 4:00 PM was associated with an adjusted odds ratio of 1.64 (95% CI, 1.22 to 2.21) for perioperative death, which suggests a potentially modifiable target for perioperative risk reduction. Limitations of this study include nonstandardized mortality reporting and limited ability to adjust for missing data.

  6. Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms; post-hoc analyses of three randomized controlled trials.

    PubMed

    Kerwin, Edward; Barnes, Neil; Gibbs, Michael; Leather, David; Forth, Richard; Jacques, Loretta; Yates, Louisa J

    2017-08-07

    Symptoms, including night-time awakenings, affect the quality of life of people with asthma. Fluticasone furoate/vilanterol (FF/VI) reduces exacerbations, improves lung function, and rescue-free and symptom-free 24-hour periods in patients with asthma. These post-hoc analyses compared daytime and night-time symptoms in patients with asthma who received FF/VI, versus FF, fluticasone propionate (FP) or placebo. Daytime and night-time symptoms were collected via electronic daily diary cards in three Phase III randomized studies of once-daily FF/VI in patients with uncontrolled asthma on inhaled corticosteroids (ICS) ±long-acting beta 2 -agonists (LABA) (n = 609/1039/586). Endpoints included: change from baseline in symptom-free days and nights (analyzed by Analysis of Covariance, covariates: baseline, region, sex, age, treatment), time for patients to achieve 7 consecutive symptom-free nights (analyzed by Cox proportional hazards model, covariates as above), and proportion of patients experiencing 100% symptom-free nights per week (analyzed by logistic regression, covariates: percentage of symptom-free nights, sex, age, treatment). Improvements in symptom-free days and nights were generally observed for all treatments. More patients who received FF/VI experienced 100% symptom-free nights in the last week of the treatment period than patients who received ICS alone or placebo. FF/VI also reduced time to 7 consecutive symptom-free nights. Patients with at least one night of symptoms at baseline experienced an additional 2.7 and 2.0 symptom-free nights per week with FF/VI 100/25 µg, versus 1.9 and 1.7 with FF alone; similar findings were seen with FF/VI 200/25 µg. Benefits in terms of symptom-free days and nights were observed for patients receiving FF/VI versus comparators in these post-hoc analyses.

  7. Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study.

    PubMed

    Ohta, Hiroaki; Hamaya, Etsuro; Taketsuna, Masanori; Sowa, Hideaki

    2015-01-01

    To assess the effect of active vitamin D3 on quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis. This is a post hoc analysis of a previous prospective postmarketing observational study conducted without a comparator group. This study was conducted in 60 Japanese hospitals from September 2007 to February 2009. We compared changes from baseline in QOL and pain in patients receiving raloxifene plus active vitamin D3 with those in patients receiving raloxifene monotherapy at 8 and 24 weeks after treatment. Japan Pharmaceutical Information Center (JapicCTI-070465). QOL and pain were assessed using Short Form-8 (SF-8), European Quality of Life Instrument 5 Dimensions (EQ-5D), Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), visual analogue pain scales (VAS pain), and pain frequency scores. A total of 506 patients were included in the post hoc analysis. Both raloxifene monotherapy (RLX, n = 354) and active vitamin D3 cotreatment (COMBI, n = 152) significantly improved QOL and reduced pain from the baseline at Week 8 and Week 24. The COMBI group had significantly greater improvements in JOQOL total score and activity of daily living (total) domain at Week 24 and last observation carried forward (LOCF) than the RLX group. The COMBI group also had significantly greater improvements in SF-8 domains of general health (at Week 8, Week 24, and LOCF), role physical (at Week 24 and LOCF), and mental health (at LOCF) than the RLX group. The COMBI group also had significantly greater reduction in VAS pain at LOCF than the RLX group (mean [SD]: RLX = -0.99 [2.72], COMBI = -1.54 [2.21], P = 0.042). Active vitamin D3 supplementation to raloxifene treatment for 24 weeks may have additional benefits in improving QOL and relieving pain in Japanese women with postmenopausal osteoporosis.

  8. Lurasidone for major depressive disorder with mixed features and anxiety: a post-hoc analysis of a randomized, placebo-controlled study.

    PubMed

    Tsai, Joyce; Thase, Michael E; Mao, Yongcai; Ng-Mak, Daisy; Pikalov, Andrei; Loebel, Antony

    2017-04-01

    The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety. The data in this analysis were derived from a study of patients meeting the DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM-A≤14) and moderate-to-severe anxiety (HAM-A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures. Treatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (-18.4 vs. -12.8, p<0.01, effect size [ES]=0.59) and moderate-to-severe anxiety (-22.0 vs. -13.0, p<0.001, ES=0.95). Treatment with lurasidone was associated with a significant week 6 change versus placebo in HAM-A total score for patients with both mild anxiety (-7.6 vs. -4.0, p<0.01, ES=0.62), and moderate-to-severe anxiety (-11.4 vs. -6.1, p<0.0001, ES=0.91). In this post-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.

  9. The relation between self-determination and retirement satisfaction among active retired individuals.

    PubMed

    Stephan, Yannick; Fouquereau, Evelyne; Fernandez, Anne

    2008-01-01

    Little is known about the motivational forces leading retired individuals to engage in post-retirement activities and how they could be related to satisfaction with retirement. Using the self-determination framework, the purpose of the present exploratory study was to examine the nature of active retirees' motivation and its impact on satisfaction with life in retirement. The Global Motivation Scale and measures of satisfaction with retirement were administered to 150 active retired individuals engaged in organized post-retirement activities in a University-based organization. Results revealed that these individuals were mainly characterized by higher levels of intrinsic motivation for knowledge, stimulation and accomplishment, rather than extrinsic dimensions. Regression analysis further demonstrated that intrinsic motivation for both accomplishment and stimulation were positively related to satisfaction with retirement, over and above the significant contribution of time since retirement, anticipated satisfaction with retirement, and subjective health. This exploratory study highlights the motivational mechanisms through which post-retirement behaviors could positively influence satisfaction with life in retirement among active retirees.

  10. An Exploratory Study of Rape Survivors' Prescription Drug Use as a Means of Coping with Sexual Assault

    ERIC Educational Resources Information Center

    Sturza, Marisa L.; Campbell, Rebecca

    2005-01-01

    In this study we examined rape survivors' post assault use of prescription drugs, including sedatives, tranquilizers, and antidepressants. In a community-based sample of 102 sexual assault survivors, 44% had used prescription drugs post rape. Consistent with prior research on alcohol as a postassault coping mechanism, the current study found…

  11. An Exploratory Study on the Post-Implementation of Threat and Error Management Training in Australian General Aviation

    ERIC Educational Resources Information Center

    Lee, Seung Yong; Bates, Paul R.; Murray, Patrick S.; Martin, Wayne L.

    2017-01-01

    Threat and Error Management (TEM) training, endorsed and recommended by the International Civil Aviation Organisation (ICAO), was mandated in Australia with the aim of improving aviation safety. However, to date, there has been very limited, if any, formal post-implementation review, assessment or evaluation to examine the "after-state"…

  12. Alcohol Consumption Decisions among Nonabusing Drinkers Diagnosed with Hepatitis C: An Exploratory Sequential Mixed Methods Study

    PubMed Central

    Stoller, Eleanor Palo; Webster, Noah J.; Blixen, Carol E.; McCormick, Richard A.; Hund, Andrew J.; Perzynski, Adam T.; Kanuch, Stephanie W.; Thomas, Charles L.; Kercher, Kyle; Dawson, Neal V.

    2009-01-01

    Most studies of decisions to curtail alcohol consumption reflect experiences of abusing drinkers. We employ an exploratory sequential research design to explore the applicability of this research to the experience of nonabusing drinkers advised to curtail alcohol consumption after a Hepatitis C diagnosis. A qualitative component identified 17 new decision factors not reflected in an inventory of factors based on synthesis of existing scales. We triangulated qualitative data by supplementing semi-structured interviews with Internet postings. A quantitative component estimated prevalence and association with current drinking of these new decision factors. Patients who quit drinking tended to attribute post-diagnosis drinking to occasional triggers, whereas patients who were still drinking were more likely to endorse rationales not tied to specific triggers. PMID:20046861

  13. Southern Chinese Collegiate Stage of Exercise Behavior Changes and Exercise Self-Efficacy

    ERIC Educational Resources Information Center

    Keating, Xiaofen Deng; Huang, Yong; Deng, Minying; Chen, Li; Dwan, Chuanwei; Bridges, Dwan

    2009-01-01

    This study aimed to examine southern Chinese college student (N = 1983) stage of exercise behavior changes (SEBC) and their exercise self-efficacy (ESE). The SEBC and ESE scales were used to collect data. ANOVA was performed to investigate the differences in ESE by SEBC. Post Hoc Tukey tests were employed to determine which variables contributed…

  14. Mixed Effects Modeling of Morris Water Maze Data: Advantages and Cautionary Notes

    ERIC Educational Resources Information Center

    Young, Michael E.; Clark, M. H.; Goffus, Andrea; Hoane, Michael R.

    2009-01-01

    Morris water maze data are most commonly analyzed using repeated measures analysis of variance in which daily test sessions are analyzed as an unordered categorical variable. This approach, however, may lack power, relies heavily on post hoc tests of daily performance that can complicate interpretation, and does not target the nonlinear trends…

  15. The Impact of Advanced Placement Courses on High School Students Taking the Scholastic Aptitude Test.

    ERIC Educational Resources Information Center

    Thomas, L. M.; Thomas, Suzanne G.

    This obtrusive post-hoc quasi-experimental study investigated Scholastic Assessment Test (SAT) scores of 111 high school students in grades 10 through 12. Fifty-three students were enrolled in at least one Advanced Placement (AP) course at the time of the study. General factorial analysis of variance (ANOVA) tested for significant differences…

  16. Lip Movements for an Unfamiliar Vowel: Mandarin Front Rounded Vowel Produced by Japanese Speakers

    ERIC Educational Resources Information Center

    Saito, Haruka

    2016-01-01

    Purpose: The study was aimed at investigating what kind of lip positions are selected by Japanese adult participants for an unfamiliar Mandarin rounded vowel /y/ and if their lip positions are related to and/or differentiated from those for their native vowels. Method: Videotaping and post hoc tracking measurements for lip positions, namely…

  17. Teachers Making Sense of Result-Oriented Teams: A Cognitive Anthropological Approach to Educational Change

    ERIC Educational Resources Information Center

    Wierenga, Sijko J.; Kamsteeg, Frans H.; Simons, P. Robert Jan; Veenswijk, Marcel

    2015-01-01

    Studies on educational change efforts abound but generally limit themselves to post hoc explanations of failure and success. Such explanations are rarely turned into attempts at providing models for predicting change outcomes. The present study tries to develop such a model based on the teachers' impact analysis of a management-driven…

  18. Who Should Be the Winner: A "Post Hoc" Analysis of the 2000 US Election

    ERIC Educational Resources Information Center

    Wu, D. W.

    2006-01-01

    The 2000 US presidential election between Al Gore and George W. Bush has been the most intriguing and controversial in American history. Using the Florida ballot data, Wu showed that the 2000 election result could have been reversed had the "butterfly ballot effect" been eliminated. Through a combinatorial approach, Harger concluded that…

  19. Impact of Early-Exposure Environmental Education on a Child's Selection of Words and Creativity

    ERIC Educational Resources Information Center

    Fisher, Reid

    2013-01-01

    Environmental education researchers have long identified a connection between formative play experiences in nature settings and pro-environmental behaviors (i.e., career paths) of their subjects later in life. Most studies have been post-hoc retrospective looks that have not had the ability to assess causation. As more children are removed from…

  20. Lexical Difficulty--Using Elicited Imitation to Study Child L2

    ERIC Educational Resources Information Center

    Campfield, Dorota E.

    2017-01-01

    This paper reports a post-hoc analysis of the influence of lexical difficulty of cue sentences on performance in an elicited imitation (EI) task to assess oral production skills for 645 child L2 English learners in instructional settings. This formed part of a large-scale investigation into effectiveness of foreign language teaching in Polish…

  1. Clinically Relevant Changes in Emotional Expression in Children with ADHD Treated with Lisdexamfetamine Dimesylate

    ERIC Educational Resources Information Center

    Katic, Alain; Ginsberg, Lawrence; Jain, Rakesh; Adeyi, Ben; Dirks, Bryan; Babcock, Thomas; Scheckner, Brian; Richards, Cynthia; Lasser, Robert; Turgay, Atilla; Findling, Robert L.

    2012-01-01

    Objective: To describe clinically relevant effects of lisdexamfetamine dimesylate (LDX) on emotional expression (EE) in children with ADHD. Method: Children with ADHD participated in a 7-week, open-label, LDX dose-optimization study. Expression and Emotion Scale for Children (EESC) change scores were analyzed post hoc using two methods to…

  2. School Improvement Plans and Student Learning in Jamaica

    ERIC Educational Resources Information Center

    Lockheed, Marlaine; Harris, Abigail; Jayasundera, Tamara

    2010-01-01

    A school improvement program that provided support to poor-performing schools on the basis of needs identified in a school improvement plan was implemented in 72 government schools in Jamaica, from 1998 to 2005. In this independent evaluation of the program, we use propensity score matching to create, post hoc, a control group of schools that were…

  3. A Model for Post Hoc Evaluation.

    ERIC Educational Resources Information Center

    Theimer, William C., Jr.

    Often a research department in a school system is called on to make an after the fact evaluation of a program or project. Although the department is operating under a handicap, it can still provide some data useful for evaluative purposes. It is suggested that all the classical methods of descriptive statistics be brought into play. The use of…

  4. Cultural and Bilingual Influences on Artistic Creativity Performances: Comparison of German and Chinese Students

    ERIC Educational Resources Information Center

    Yi, Xinfa; Hu, Weiping; Scheithauer, Herbert; Niu, Weihua

    2013-01-01

    Empirical research on the relationship between culture and creativity has thus far yielded no consistent results. Investigations of the differences are mostly post-hoc, and results are inconclusive. A creativity-value-oriented theory is proposed to explain cultural differences, as an alternative to ethnic and language effects. This study was…

  5. Diapers, Dissertations, and Other Holy Things: The Experiences of Mothers Working in Christian Colleges and Universities

    ERIC Educational Resources Information Center

    Hall, M. Elizabeth Lewis; Anderson, Tamara L.; Willingham, Michele M.

    2004-01-01

    Academic institutions present specific challenges to women attempting to balance work and family responsibilities. This type of involvement within the subculture of evangelical Christianity presents its own variations. Interviews with 30 mothers working in Christian academia were analyzed using a post hoc content analysis informed by principles of…

  6. Perceptions of Harm from Substance Use and Social Self-Efficacy among Early Adolescents

    ERIC Educational Resources Information Center

    Zullig, Keith J.; Valois, Robert F.

    2016-01-01

    Researchers examined the association between perceptions of harm from substance use and social self-efficacy (SSE) in a sample of early adolescents in public middle schools (n = 4,122). One-way analysis of covariance and post hoc tests were used to assess the relationships between perceptions of harm from tobacco, alcohol, marijuana, and cocaine…

  7. 3-D Resistivity Tomography for Cliff Stability Study at the D-Day Pointe du Hoc Historic Site in Normandy, France

    NASA Astrophysics Data System (ADS)

    Udphuay, S.; Everett, M. E.; Guenther, T.; Warden, R. R.

    2007-12-01

    The D-Day invasion site at Pointe du Hoc in Normandy, France is one of the most important World War II battlefields. The site remains today a valuable historic cultural resource. However the site is vulnerable to cliff collapses that could endanger the observation post building and U.S. Ranger memorial located just landward of the sea stack, and an anti-aircraft gun emplacement, Col. Rudder's command post, located on the cliff edge about 200 m east of the observation post. A 3-D resistivity tomography incorporating extreme topography is used in this study to provide a detailed site stability assessment with special attention to these two buildings. Multi-electrode resistivity measurements were made across the cliff face and along the top of the cliff around the two at-risk buildings to map major subsurface fracture zones and void spaces that could indicate possible accumulations and pathways of groundwater. The ingress of acidic groundwater through the underlying carbonate formations enlarges pre-existing tectonic fractures via limestone dissolution and weakens the overall structural integrity of the cliff. The achieved 3-D resistivity tomograms provide diagnostic subsurface resistivity distributions. Resistive zones associated with subsurface void spaces have been located. These void spaces constitute a stability geohazard as they become significant drainage routes during and after periods of heavy rainfalls.

  8. Learning from the Failures of Others: The Effects of Post-Exit Knowledge Spillovers on Recipient Firms

    ERIC Educational Resources Information Center

    Amankwah-Amoah, Joseph

    2011-01-01

    Purpose: The purpose of this study is to examine the effects of post-exit knowledge diffusion created by departed firms on recipient firms. Design/methodology/approach: This is an inductive and exploratory study which tries to understand questions of how and why. The research used a qualitative interview methodology and data analysis using within…

  9. A Ten-Year Analysis of the Post-Secondary Outcomes of Students with Disabilities at the Pennsylvania State University

    ERIC Educational Resources Information Center

    Hong, Barbara S. S.; Herbert, James T.; Petrin, Robert A.

    2011-01-01

    This proposed exploratory study represents the largest and first investigation in the USA that will purposefully analyse and track students who have sought disability services over a 10-year span (academic years 2000-2011). Using "ex post-facto" data on a non-probability purposive sample of approximately 6000 undergraduates, the research…

  10. Neonatal olfactory bulbectomy enhances locomotor activity, exploratory behavior and binding of NMDA receptors in pre-pubertal rats.

    PubMed

    Flores, G; Ibañez-Sandoval, O; Silva-Gómez, A B; Camacho-Abrego, I; Rodríguez-Moreno, A; Morales-Medina, J C

    2014-02-14

    In this study, we investigated the effect of neonatal olfactory bulbectomy (nOBX) on behavioral paradigms related to olfaction such as exploratory behavior, locomotor activity in a novel environment and social interaction. We also studied the effect of nOBX on the activity of the N-methyl-d-aspartate (NMDA) subtype of glutamate receptors during development. The behavioral effects of nOBX (postnatal day 7, PD7) were investigated in pre- (PD30) and post-pubertal (PD60) Wistar rats. NMDA receptor activity was measured with [(125)I]MK-801 in the brain regions associated with the olfactory circuitry. A significant increase in the novelty-induced locomotion was seen in the pre-pubertal nOBX rats. Although the locomotor effect was less marked than in pre-pubertal rats, the nOBX rats tested post-pubertally failed to habituate to the novel situation as quickly as the sham- and normal- controls. Pre-pubertally, the head-dipping behavior was enhanced in nOBX rats compared with sham-operated and normal controls, while normal exploratory behavior was observed between groups in adulthood. In contrast, social interaction was increased in post-pubertal animals that underwent nOBX. Both pre- and post-pubertal nOBX rats recovered olfaction. Interestingly, pre-pubertal rats showed a significant increase in the [(125)I]MK-801 binding in the piriform cortex, dorsal hippocampus, inner and outer layers of the frontal cortex and outer layer of the cingulate cortex. At post-pubertal age, no significant differences in [(125)I]MK-801 binding were observed between groups at any of the brain regions analyzed. These results suggest that nOBX produces pre-pubertal behavioral disturbances and NMDA receptor changes that are transitory with recovery of olfaction early in adulthood. Copyright © 2013 IBRO. Published by Elsevier Ltd. All rights reserved.

  11. Supporting Dynamic Quantization for High-Dimensional Data Analytics.

    PubMed

    Guzun, Gheorghi; Canahuate, Guadalupe

    2017-05-01

    Similarity searches are at the heart of exploratory data analysis tasks. Distance metrics are typically used to characterize the similarity between data objects represented as feature vectors. However, when the dimensionality of the data increases and the number of features is large, traditional distance metrics fail to distinguish between the closest and furthest data points. Localized distance functions have been proposed as an alternative to traditional distance metrics. These functions only consider dimensions close to query to compute the distance/similarity. Furthermore, in order to enable interactive explorations of high-dimensional data, indexing support for ad-hoc queries is needed. In this work we set up to investigate whether bit-sliced indices can be used for exploratory analytics such as similarity searches and data clustering for high-dimensional big-data. We also propose a novel dynamic quantization called Query dependent Equi-Depth (QED) quantization and show its effectiveness on characterizing high-dimensional similarity. When applying QED we observe improvements in kNN classification accuracy over traditional distance functions. Gheorghi Guzun and Guadalupe Canahuate. 2017. Supporting Dynamic Quantization for High-Dimensional Data Analytics. In Proceedings of Ex-ploreDB'17, Chicago, IL, USA, May 14-19, 2017, 6 pages. https://doi.org/http://dx.doi.org/10.1145/3077331.3077336.

  12. LGIST: Learning Generalized Image Schemas for Transfer

    DTIC Science & Technology

    2008-02-01

    and learning methods as developmental psychologists do, as plausible mechanisms for human cognitive development . Why might DARPA care about... cognitive development , and possibly extending to all sensori-motor perceptual modalities [21, 22]. Almost all image-schematic “ theories ” are post-hoc...Warfighter Interface Division NUMBER( S ) Cognitive Systems Branch Wright-Patterson AFB OH 45433-7022 AFRL-RH-WP-TR-2008-0041 12

  13. Optimizing Soft Tissue Management and Spacer Design in Segmental Bone Defects

    DTIC Science & Technology

    2015-10-01

    were found with Tukey’s HSD post hoc analysis. Several target genes such as Oct4, Sox2, TGFB, and Col1A1 were generally up-regulated in all sections...samples presented several upregulated target genes such as Oct4, Sox2, TGFB, and Col1A1 in all sections. No significant main effects were found for

  14. Learning French as a Second Official Language in Canada: Comparing Monolingual and Bilingual Students at Grade 6

    ERIC Educational Resources Information Center

    Mady, Callie

    2014-01-01

    This paper presents the results of a study that compared the French as a second official achievement of three groups of students: (1) Canadian-born English speaking (CBE), (2) Canadian-born multilingual (CBM), and (3) immigrant multilinguals (IMM) as determined by multiskills test results. ANOVAs and subsequent post hoc tests revealed that the…

  15. Accuracy and Precision of the Pediatric Evaluation of Disability Inventory Computer-Adaptive Tests (PEDI-CAT)

    ERIC Educational Resources Information Center

    Haley, Stephen M.; Coster, Wendy J.; Dumas, Helene M.; Fragala-Pinkham, Maria A.; Kramer, Jessica; Ni, Pengsheng; Tian, Feng; Kao, Ying-Chia; Moed, Rich; Ludlow, Larry H.

    2011-01-01

    Aim: The aims of the study were to: (1) build new item banks for a revised version of the Pediatric Evaluation of Disability Inventory (PEDI) with four content domains: daily activities, mobility, social/cognitive, and responsibility; and (2) use post-hoc simulations based on the combined normative and disability calibration samples to assess the…

  16. Guidelines for Conducting a Post-Graduate Module within a Blended Synchronous Learning Environment, Facilitator and Student Perspectives

    ERIC Educational Resources Information Center

    Upfold, Christopher

    2016-01-01

    Technology facilitated teaching and learning can now influence the way both lecturers and students collaborate. The problem is that many of these interventions are conducted in a non-systematic ad-hoc way. There are concerns that merely adopting a traditional lecturing approach to a technology based environment provides little if any advantage to…

  17. Distance Coaching for Pre-Service Teachers: Impacts on Children's Functional Communication in Inclusive Preschool Classrooms

    ERIC Educational Resources Information Center

    Storie, Sloan; Coogle, Christan Grygas; Rahn, Naomi; Ottley, Jennifer Riggie

    2017-01-01

    This article reports the results of a post hoc analysis of child data from a single-case multiple-probe study of pre-service teachers' use of communication strategies before, while, and after receiving distance coaching. Data were analyzed for the number of functional communication utterances used by groups of preschool children with and without…

  18. Self-Control Behavior of Drinking Drivers beyond the Context of a Behavioral Self-Control Program.

    ERIC Educational Resources Information Center

    Werch, Chudley E.

    This paper reports on the post hoc analysis of specific types of self-control behaviors being employed by drinking drivers who were exposed to a behavioral self-control training program. The underlying assumption of this study is that the success of health promotion and intervention programs most probably depends on the development of greater…

  19. Speech Abilities in Preschool Children with Speech Sound Disorder with and without Co-Occurring Language Impairment

    ERIC Educational Resources Information Center

    Macrae, Toby; Tyler, Ann A.

    2014-01-01

    Purpose: The authors compared preschool children with co-occurring speech sound disorder (SSD) and language impairment (LI) to children with SSD only in their numbers and types of speech sound errors. Method: In this post hoc quasi-experimental study, independent samples t tests were used to compare the groups in the standard score from different…

  20. The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

    PubMed

    An, Ming-Wen; Lu, Xin; Sargent, Daniel J; Mandrekar, Sumithra J

    2015-01-01

    A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed. Here, we illustrate the modularity of the direct assignment option by applying it to the setting of two predefined subgroups and testing for separate subgroup main effects. We power the 2-subgroup direct assignment option design with 1 IA (DAD-1) to test for separate subgroup main effects, with assessment of power to detect an interaction in a post-hoc test. Simulations assessed the statistical properties of this design compared to the 2-subgroup balanced randomized design with 1 IA, BRD-1. Different response rates for treatment/control in subgroup 1 (0.4/0.2) and in subgroup 2 (0.1/0.2, 0.4/0.2) were considered. The 2-subgroup DAD-1 preserves power and type I error rate compared to the 2-subgroup BRD-1, while exhibiting reasonable power in a post-hoc test for interaction. The direct assignment option is a flexible design component that can be incorporated into broader design frameworks, while maintaining desirable statistical properties, clinical appeal, and logistical simplicity.

  1. The efficacy of extrafine beclomethasone dipropionate–formoterol fumarate in COPD patients who are not “frequent exacerbators”: a post hoc analysis of the FORWARD study

    PubMed Central

    Singh, Dave; Vezzoli, Stefano; Petruzzelli, Stefano; Papi, Alberto

    2017-01-01

    The GOLD 2017 strategy document recommends that the pharmacological management of COPD patients be based on the risk of future exacerbations and the severity of symptoms. A threshold of two moderate exacerbations or one hospitalization is used to define high-risk patients. The FORWARD study was a randomized, double-blind, parallel-group trial that compared 48 weeks’ treatment with extrafine beclomethasone dipropionate plus formoterol fumarate (BDP-FF) versus FF in severe COPD patients with a history of one or more exacerbations in the previous year. The new GOLD 2017 recommendations mean that many patients in the FORWARD study are now reclassified as GOLD B. We conducted a post hoc analysis of the FORWARD study, in order to investigate the effects of extrafine BDP/FF in patients with one exacerbation in the previous year, focusing on those categorized as group B using the GOLD 2017 definition. The analysis showed a 35% reduction in exacerbation rate with an inhaled corticosteroid (ICS) + long-acting β-agonist (LABA) versus LABA. We propose that ICS-LABA treatment is a therapeutic option for COPD patients with one exacerbation in the previous year. PMID:29138555

  2. A simple method for measurement of maximal downstroke power on friction-loaded cycle ergometer.

    PubMed

    Morin, Jean-Benoît; Belli, Alain

    2004-01-01

    The aim of this study was to propose and validate a post-hoc correction method to obtain maximal power values taking into account inertia of the flywheel during sprints on friction-loaded cycle ergometers. This correction method was obtained from a basic postulate of linear deceleration-time evolution during the initial phase (until maximal power) of a sprint and included simple parameters as flywheel inertia, maximal velocity, time to reach maximal velocity and friction force. The validity of this model was tested by comparing measured and calculated maximal power values for 19 sprint bouts performed by five subjects against 0.6-1 N kg(-1) friction loads. Non-significant differences between measured and calculated maximal power (1151+/-169 vs. 1148+/-170 W) and a mean error index of 1.31+/-1.20% (ranging from 0.09% to 4.20%) showed the validity of this method. Furthermore, the differences between measured maximal power and power neglecting inertia (20.4+/-7.6%, ranging from 9.5% to 33.2%) emphasized the usefulness of power correcting in studies about anaerobic power which do not include inertia, and also the interest of this simple post-hoc method.

  3. Correction factors for self-selection when evaluating screening programmes.

    PubMed

    Spix, Claudia; Berthold, Frank; Hero, Barbara; Michaelis, Jörg; Schilling, Freimut H

    2016-03-01

    In screening programmes there is recognized bias introduced through participant self-selection (the healthy screenee bias). Methods used to evaluate screening programmes include Intention-to-screen, per-protocol, and the "post hoc" approach in which, after introducing screening for everyone, the only evaluation option is participants versus non-participants. All methods are prone to bias through self-selection. We present an overview of approaches to correct for this bias. We considered four methods to quantify and correct for self-selection bias. Simple calculations revealed that these corrections are actually all identical, and can be converted into each other. Based on this, correction factors for further situations and measures were derived. The application of these correction factors requires a number of assumptions. Using as an example the German Neuroblastoma Screening Study, no relevant reduction in mortality or stage 4 incidence due to screening was observed. The largest bias (in favour of screening) was observed when comparing participants with non-participants. Correcting for bias is particularly necessary when using the post hoc evaluation approach, however, in this situation not all required data are available. External data or further assumptions may be required for estimation. © The Author(s) 2015.

  4. Arsenic levels in drinking water and mortality of liver cancer in Taiwan.

    PubMed

    Lin, Hung-Jung; Sung, Tzu-I; Chen, Chi-Yi; Guo, How-Ran

    2013-11-15

    The carcinogenic effect of arsenic is well documented, but epidemiologic data on liver cancer were limited. To evaluate the dose-response relationship between arsenic in drinking water and mortality of liver cancer, we conducted a study in 138 villages in the southwest coast area of Taiwan. We assessed arsenic levels in drinking water using data from a survey conducted by the government and reviewed death certificates from 1971 to 1990 to identify liver cancer cases. Using village as the unit, we conducted multi-variate regression analyses and then performed post hoc analyses to validate the findings. During the 20-year period, 802 male and 301 female mortality cases of liver cancer were identified. After adjusting for age, arsenic levels above 0.64 mg/L were associated with an increase in the liver cancer mortality in both genders, but no significant effect was observed for lower exposure categories. Post hoc analyses and a review of literature supported these findings. We concluded that exposures to high arsenic levels in drinking water are associated with the occurrence of liver cancer, but such an effect is not prominent at exposure levels lower than 0.64 mg/L. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Post-hoc simulation study to adopt a computerized adaptive testing (CAT) for a Korean Medical License Examination.

    PubMed

    Seo, Dong Gi; Choi, Jeongwook

    2018-05-17

    Computerized adaptive testing (CAT) has been adopted in license examinations due to a test efficiency and accuracy. Many research about CAT have been published to prove the efficiency and accuracy of measurement. This simulation study investigated scoring method and item selection methods to implement CAT in Korean medical license examination (KMLE). This study used post-hoc (real data) simulation design. The item bank used in this study was designed with all items in a 2017 KMLE. All CAT algorithms for this study were implemented by a 'catR' package in R program. In terms of accuracy, Rasch and 2parametric logistic (PL) model performed better than 3PL model. Modal a Posteriori (MAP) or Expected a Posterior (EAP) provided more accurate estimates than MLE and WLE. Furthermore Maximum posterior weighted information (MPWI) or Minimum expected posterior variance (MEPV) performed better than other item selection methods. In terms of efficiency, Rasch model was recommended to reduce test length. Simulation study should be performed under varied test conditions before adopting a live CAT. Based on a simulation study, specific scoring and item selection methods should be predetermined before implementing a live CAT.

  6. Symptomatic efficacy of rasagiline monotherapy in early Parkinson's disease: post-hoc analyses from the ADAGIO trial.

    PubMed

    Jankovic, Joseph; Berkovich, Elijahu; Eyal, Eli; Tolosa, Eduardo

    2014-06-01

    The ADAGIO study included a large cohort of patients with early PD (baseline total-UPDRS = 20) who were initially randomized to rasagiline and placebo, thereby allowing analyses of symptomatic efficacy. Post-hoc analyses comparing the efficacy of rasagiline 1 mg/day (n = 288) versus placebo (n = 588) on key symptoms at 36 weeks, and on total-UPDRS scores over 72 weeks (completer population: rasagiline 1 mg/day n = 221, placebo n = 392) were performed. Treatment with rasagiline resulted in significantly better tremor, bradykinesia, rigidity and postural-instability-gait-difficulty scores at week 36 versus placebo. Whereas the placebo group experienced progressive deterioration from baseline (2.6 UPDRS points at week 36), patients in the rasagiline group were maintained at baseline values at week 60 (UPDRS-change of 0.3 points). At week 72, patients who had received continuous monotherapy with rasagiline experienced a worsening of only 1.6 points. Treatment with rasagiline maintained motor function to baseline values for at least a year with significant benefits observed in all key PD motor symptoms. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Comparison of the effect of three autogenous bone harvesting methods on cell viability in rabbits

    PubMed Central

    Moradi Haghgoo, Janet; Arabi, Seyed Reza; Hosseinipanah, Seyyed Mohammad; Solgi, Ghasem; Rastegarfard, Neda; Farhadian, Maryam

    2017-01-01

    Background. This study was designed to compare the viability of autogenous bone grafts, harvested using different methods, in order to determine the best harvesting technique with respect to more viable cells. Methods. In this animal experimental study, three harvesting methods, including manual instrument (chisel), rotary device and piezosurgery, were used for harvesting bone grafts from the lateral body of the mandible on the left and right sides of 10 rabbits. In each group, 20 bone samples were collected and their viability was assessed using MTS kit. Statistical analyses, including ANOVA and post hoc Tukey tests, were used for evaluating significant differences between the groups. Results. One-way ANOVA showed significant differences between all the groups (P=0.000). Data analysis using post hoc Tukey tests indicated that manual instrument and piezosurgery had no significant differences with regard to cell viability (P=0.749) and the cell viability in both groups was higher than that with the use of a rotary instrument (P=0.000). Conclusion. Autogenous bone grafts harvested with a manual instrument and piezosurgery had more viable cells in comparison to the bone chips harvested with a rotary device. PMID:28748046

  8. Pharmacogenomics in cardiovascular clinical trials.

    PubMed

    Shah, R; Darne, B; Atar, D; Abadie, E; Adams, K F; Zannad, F

    2004-12-01

    Genomics - having quickly emerged as the central discipline in basic science and biomedical research - is poised to take the center stage in clinical medicine as well over the next few decades. Although there is no specific regulatory guideline on the application of pharmacogenetics to drug development, some recommendations are already included in several published guidelines on drug development. The patients more likely to provide the most valuable information on the specific contribution of a given gene or its variant are those who fail to respond to a drug ('therapeutic failures') and those who develop toxicity to the drug. However, before drawing definite conclusions on subgroups following pharmacogenomic analyses, one must be aware of disease classification, data collection, and how much is known about the disease process. It seems reasonable to collect genomic DNA from all patients enrolled in clinical drug trials (along with appropriate consent to permit pharmacogenetic studies) for the purpose of post hoc analyses. One exception to post hoc genomic analysis is when patients with a specific genotype are excluded from randomization into a clinical trial. Physicians will need to understand the concept of genetic variability, its interactions with the environment (e.g. drug-drug or drug-disease interactions), and its implication for patient care.

  9. User Perceptions and Reactions to an Online Cancer Risk Assessment Tool: a Process Evaluation of Cancer Risk Check.

    PubMed

    Hovick, Shelly R; Bevers, Therese B; Vidrine, Jennifer Irvin; Kim, Stephanie; Dailey, Phokeng M; Jones, Lovell A; Peterson, Susan K

    2017-03-01

    Online cancer risk assessment tools, which provide personalized cancer information and recommendations based on personal data input by users, are a promising cancer education approach; however, few tools have been evaluated. A randomized controlled study was conducted to compare user impressions of one tool, Cancer Risk Check (CRC), to non-personalized educational information delivered online as series of self-advancing slides (the control). CRC users (N = 1452) rated the tool to be as interesting as the control (p > .05), but users were more likely to report that the information was difficult to understand and not applicable to them (p < .05). Information seeking and sharing also were lower among CRC users; thus, although impressions of CRC were favorable, it was not shown to be superior to existing approaches. We hypothesized CRC was less effective because it contained few visual and graphical elements; therefore, CRC was compared to a text-based control (online PDF file) post hoc. CRC users rated the information to be more interesting, less difficult to understand, and better able to hold their attention (p < .05). Post hoc results suggest the visual presentation of risk is critical to tool success.

  10. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302.

    PubMed

    de Bono, Johann S; Smith, Matthew R; Saad, Fred; Rathkopf, Dana E; Mulders, Peter F A; Small, Eric J; Shore, Neal D; Fizazi, Karim; De Porre, Peter; Kheoh, Thian; Li, Jinhui; Todd, Mary B; Ryan, Charles J; Flaig, Thomas W

    2017-04-01

    Treatment patterns for metastatic castration-resistant prostate cancer (mCRPC) have changed substantially in the last few years. In trial COU-AA-302 (chemotherapy-naïve men with mCRPC), abiraterone acetate plus prednisone (AA) significantly improved radiographic progression-free survival and overall survival (OS) when compared to placebo plus prednisone (P). This post hoc analysis investigated clinical responses to docetaxel as first subsequent therapy (FST) among patients who progressed following protocol-specified treatment with AA, and characterized subsequent treatment patterns among older (≥75 yr) and younger (<75 yr) patient subgroups. Data were collected at the final OS analysis (96% of expected death events). Subsequent therapy data were prospectively collected, while response and discontinuation data were collected retrospectively following discontinuation of the study drug. At the discretion of the investigator, 67% (365/546) of patients from the AA arm received subsequent treatment with one or more agents approved for mCRPC. Efficacy analysis was performed for patients for whom baseline and at least one post-baseline prostate-specific antigen (PSA) values were available. Baseline and at least one post-baseline PSA values were available for 100 AA patients who received docetaxel as FST. While acknowledging the limitations of post hoc analyses, 40% (40/100) of these patients had an unconfirmed ≥50% PSA decline with first subsequent docetaxel therapy, and 27% (27/100) had a confirmed ≥50% PSA decline. The median docetaxel treatment duration among these 100 patients was 4.2 mo. Docetaxel was the most common FST among older and younger patients from each treatment arm. However, 43% (79/185) of older patients who progressed on AA received no subsequent therapy for mCRPC, compared with 17% (60/361) of younger patients. Patients with mCRPC who progress with AA treatment may still derive benefit from subsequent docetaxel therapy. These data support further assessment of treatment patterns following AA treatment for mCRPC, particularly among older patients. ClinicalTrials.gov NCT00887198. Treatment patterns for advanced prostate cancer have changed substantially in the last few years. This additional analysis provides evidence of clinical benefit for subsequent chemotherapy in men with advanced prostate cancer whose disease progressed after treatment with abiraterone acetate. Older patients were less likely to be treated with subsequent therapy. Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  11. Assessment of urinary microparticles in normotensive patients with type 1 diabetes.

    PubMed

    Lytvyn, Yuliya; Xiao, Fengxia; Kennedy, Christopher R J; Perkins, Bruce A; Reich, Heather N; Scholey, James W; Cherney, David Z; Burger, Dylan

    2017-03-01

    Assessment of urinary extracellular vesicles including exosomes and microparticles (MPs) is an emerging approach for non-invasive detection of renal injury. We have previously reported that podocyte-derived MPs are increased in diabetic mice in advance of albuminuria. Here, we hypothesised that type 1 diabetes and acute hyperglycaemia would increase urinary podocyte MP levels in uncomplicated diabetes. In this post hoc exploratory analysis, we examined archived urine samples from normoalbuminuric patients with uncomplicated type 1 diabetes studied under clamped euglycaemia and hyperglycaemia and compared with healthy controls. Urinary vesicles were assessed by electron microscopy and nanoparticle tracking while podocyte MPs were assessed by flow cytometry. Neither vesicle size nor total number were significantly altered in type 1 diabetes or acute hyperglycaemia. By contrast, urinary podocyte MP levels were higher in type 1 diabetes (0.47 [0.00-3.42] MPs/μmol creatinine [Cr]) compared with healthy controls (0.00 [0.00-0.00] MPs/μmol Cr, p < 0.05) and increased under hyperglycaemic clamp (0.36 [0.00-4.15] MPs/μmol Cr during euglycaemia vs 2.70 [0.00-15.91] MPs/μmol Cr during hyperglycaemia, p < 0.05). Levels of urinary albumin to creatinine ratio and nephrin (surrogates of podocyte injury) were unchanged by type 1 diabetes or acute hyperglycaemia. Taken together, our data show that urinary podocyte MP levels are higher in patients with type 1 diabetes in advance of changes in other biomarkers (albuminuria, nephrin). Examination of podocyte MPs may serve as an early biomarker of glomerular injury in uncomplicated type 1 diabetes.

  12. The Impact of Role Models on Health Outcomes for Lesbian, Gay, Bisexual and Transgender Youth

    PubMed Central

    Bird, Jason D. P.; Kuhns, Lisa; Garofalo, Robert

    2011-01-01

    Purpose There is little research on the impact of role models on health outcomes for Lesbian, Gay, Bisexual, and Transgender (LGBT) youth. This exploratory study describes the presence and availability of LGBT affirming role models and examines the relationship between the accessibility of role models and health outcomes among a community-based sample of LGBT youth. Methods A convenience sample of 496 ethnically-diverse, 16–24 year old LGBT youth was recruited to complete a computer-assisted interview using standardized instruments validated with adolescents. The prevalence and characteristics of role models was described. Differences in subgroup distribution were assessed using Pearson Chi-square (p<0.05). Differences in health outcomes for those with and without role models and the nature of those role models were determined using analysis of co-variance (ANCOVA) models, with post hoc Bonferroni tests to probe significant global findings. Results Sixty-percent of the participants reported having a role model, with younger participants significantly more likely to report having a role model. A majority of the participants reported having inaccessible role models, especially among younger participants. The presence and accessibility of a role model did not have a significant relationship to binge drinking, drug use, or STI diagnoses; however, participants with inaccessible role models showed increased psychological distress versus those with accessible or no role models. Conclusions Inaccessible role models may not be sufficient for protecting youth from negative outcomes and formal mechanisms for connecting LGBT youth with caring adults who can serve as role models, such as mentoring programs, are critical. PMID:22443838

  13. Cue reactivity and its inhibition in pathological computer game players.

    PubMed

    Lorenz, Robert C; Krüger, Jenny-Kathinka; Neumann, Britta; Schott, Björn H; Kaufmann, Christian; Heinz, Andreas; Wüstenberg, Torsten

    2013-01-01

    Despite a rising social relevance of pathological computer game playing, it remains unclear whether the neurobiological basis of this addiction-like behavioral disorder and substance-related addiction are comparable. In substance-related addiction, attentional bias and cue reactivity are often observed. We conducted a functional magnetic resonance study using a dot probe paradigm with short-presentation (attentional bias) and long-presentation (cue reactivity) trials in eight male pathological computer game players (PCGPs) and nine healthy controls (HCs). Computer game-related and neutral computer-generated pictures, as well as pictures from the International Affective Picture System with positive and neutral valence, served as stimuli. PCGPs showed an attentional bias toward both game-related and affective stimuli with positive valence. In contrast, HCs showed no attentional bias effect at all. PCGPs showed stronger brain responses in short-presentation trials compared with HCs in medial prefrontal cortex (MPFC) and anterior cingulate gyrus and in long-presentation trials in lingual gyrus. In an exploratory post hoc functional connectivity analyses, for long-presentation trials, connectivity strength was higher between right inferior frontal gyrus, which was associated with inhibition processing in previous studies, and cue reactivity-related regions (left orbitofrontal cortex and ventral striatum) in PCGPs. We observed behavioral and neural effects in PCGPs, which are comparable with those found in substance-related addiction. However, cue-related brain responses were depending on duration of cue presentation. Together with the connectivity result, these findings suggest that top-down inhibitory processes might suppress the cue reactivity-related neural activity in long-presentation trials. © 2012 The Authors, Addiction Biology © 2012 Society for the Study of Addiction.

  14. Validation of alternative indicators of social support in perinatal outcomes research using quality of the partner relationship.

    PubMed

    Kruse, Julie A; Low, Lisa Kane; Seng, Julia S

    2013-07-01

    To test alternatives to the current research and clinical practice of assuming that married or partnered status is a proxy for positive social support. Having a partner is assumed to relate to better health status via the intermediary process of social support. However, women's health research indicates that having a partner is not always associated with positive social support. An exploratory post hoc analysis focused on posttraumatic stress and childbearing was conducted using a large perinatal database from 2005-2009. To operationalize partner relationship, four variables were analysed: partner ('yes' or 'no'), intimate partner violence ('yes' or 'no'), the combination of those two factors, and the woman's appraisal of the quality of her partner relationship via a single item. Construct validity of these four alternative variables was assessed in relation to appraisal of the partner's social support in labour and the postpartum using linear regression standardized betas and adjusted R-squares. Predictive validity was assessed using unadjusted and adjusted linear regression modelling. Four groups were compared. Married, abused women differed most from married, not abused women in relation to the social support, and depression outcomes used for validity checks. The variable representing the women's appraisals of their partner relationships accounts for the most variance in predicting depression scores. Our results support the validity of operationalizing the impact of the partner relationship on outcomes using a combination of partnered status and abuse status or using a subjective rating of quality of the partner relationship. © 2012 Blackwell Publishing Ltd.

  15. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy.

    PubMed

    Polydefkis, Michael; Arezzo, Joseph; Nash, Marshall; Bril, Vera; Shaibani, Aziz; Gordon, Robert J; Bradshaw, Kate L; Junor, Roderick W J

    2015-12-01

    We examined the efficacy and safety of ranirestat in patients with diabetic sensorimotor polyneuropathy (DSPN). Patients (18-75 years) with stable type 1/2 diabetes mellitus and DSPN were eligible for this global, double-blind, phase II/III study (ClinicalTrials.gov NCT00927914). Patients (n = 800) were randomized 1 : 1 : 1 to placebo, ranirestat 40 mg/day or 80 mg/day (265 : 264 : 271). Change in peroneal motor nerve conduction velocity (PMNCV) from baseline to 24 months was the primary endpoint with a goal improvement vs. placebo ≥1.2 m/s. Other endpoints included symptoms, quality-of-life, and safety. Six hundred thirty-three patients completed the study. The PMNCV difference from placebo was significant at 6, 12, and 18 months in both ranirestat groups, but <1.2 m/s. The mean improvement from baseline at 24 months was +0.49, +0.95, and +0.90 m/s for placebo, ranirestat 40 mg and 80 mg, respectively (NS). The treatment difference vs. placebo reached significance when ranirestat groups were combined in a post hoc analysis (+0.44 m/s; p = 0.0237). There was no effect of ranirestat on safety assessments, secondary or exploratory endpoints vs. placebo. Ranirestat was well tolerated and improved PMNCV, but did not achieve any efficacy endpoints. The absence of PMNCV worsening in the placebo group underscores the challenges of DSPN studies in patients with well-controlled diabetes. © 2015 Peripheral Nerve Society.

  16. The association between alcohol, marijuana use, and new and emerging tobacco products in a young adult population.

    PubMed

    Cohn, Amy; Villanti, Andrea; Richardson, Amanda; Rath, Jessica M; Williams, Valerie; Stanton, Cassandra; Mermelstein, Robin

    2015-09-01

    Young adults have the highest rates of alcohol, tobacco, and other drug use relative to any other age group. Few studies have examined the co-occurrence of substance use with new and emerging tobacco products in this vulnerable group, or the underlying personality factors that may explain these associations. To address this gap, this study examined the association of current alcohol and marijuana use with the use of cigarettes and emerging tobacco products in a nationally representative sample of young adults. Data were drawn from 18 to 24year olds in Wave 4 (January 2013; n=1609) of the Legacy Young Adult Cohort, a nationally-representative sample of men and women. Never, ever (lifetime), and past 30-day use of little cigars/cigarillos (LCCs), hookah, e-cigarettes, and cigarettes were assessed separately in current (everyday or some days) alcohol and marijuana users. Using weighted estimates, multivariable multinomial logistic regression models showed that current alcohol and marijuana use were associated with lifetime and past 30-day use of cigarettes, LCCs, e-cigarettes, and hookah, with different magnitudes of association found across each product. Post-hoc exploratory analyses showed that sensation-seeking traits moderated the relationship of alcohol (but not marijuana) use to current use of select tobacco products. Marijuana and alcohol use may enhance risk for emerging tobacco products use in young adulthood. Prevention and intervention programs may need to target poly-use of alcohol, marijuana, and tobacco rather than focusing on a single risk behavior during these critical years. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. The effect of efavirenz on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and norgestimate in healthy HIV-negative women.

    PubMed

    Sevinsky, Heather; Eley, Timothy; Persson, Anna; Garner, Dennis; Yones, Cynthia; Nettles, Richard; Krantz, Kathryn; Bertz, Richard; Zhang, Jenny

    2011-01-01

    Women of childbearing age represent a growing proportion of people living with HIV. Preventing pregnancy is important in HIV-infected women receiving efavirenz as part of their antiretroviral therapy. The effects of coadministration of efavirenz (600 mg once daily) on the pharmacokinetics (PK) of the active components (ethinyl estradiol [EE] and 17-deacetyl norgestimate [NGMN]) of Ortho Cyclen(®) (Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ, USA) were investigated in 28 healthy HIV-negative women. The peak plasma concentration (C(max)), area under the concentration-time curve for a dosing interval (AUC([τ])), and lowest plasma concentration (C(min)) for EE and NGMN during cycles of treatment with Ortho Cyclen with and without coadministration of efavirenz were compared. Additionally, a post hoc exploratory analysis was conducted to assess the effect of efavirenz on the PK of an additional progestin, levonorgestrel (LNG). Exposures to EE were similar during coadministration of efavirenz and Ortho Cyclen to those during administration of Ortho Cyclen alone. Exposures to NGMN were substantially decreased following coadministration of efavirenz and Ortho Cyclen (adjusted geometric means for C(max), AUC([τ]) and C(min) decreased by 46%, 64% and 82%, respectively) compared with Ortho Cyclen alone. Consistent with NGMN, LNG exposures were decreased 80-86% by efavirenz. Although efavirenz had no significant effect on the PK of EE, exposures to the progestin components of Ortho Cyclen, NGMN and LNG, were substantially reduced. The results reinforce the need to use reliable methods of barrier contraception, even when taking oral contraceptives and efavirenz.

  18. Prolonged-release fampridine treatment improved subject-reported impact of multiple sclerosis: Item-level analysis of the MSIS-29.

    PubMed

    Gasperini, Claudio; Hupperts, Raymond; Lycke, Jan; Short, Christine; McNeill, Manjit; Zhong, John; Mehta, Lahar R

    2016-11-15

    Prolonged-release (PR) fampridine is approved to treat walking impairment in persons with multiple sclerosis (MS); however, treatment benefits may extend beyond walking. MOBILE was a phase 2, 24-week, double-blind, placebo-controlled exploratory study to assess the impact of 10mg PR-fampridine twice daily versus placebo on several subject-assessed measures. This analysis evaluated the physical and psychological health outcomes of subjects with progressing or relapsing MS from individual items of the Multiple Sclerosis Impact Scale (MSIS-29). PR-fampridine treatment (n=68) resulted in greater improvements from baseline in the MSIS-29 physical (PHYS) and psychological (PSYCH) impact subscales, with differences of 89% and 148% in mean score reduction from baseline (n=64) at week 24 versus placebo, respectively. MSIS-29 item analysis showed that a higher percentage of PR-fampridine subjects had mean improvements in 16/20 PHYS and 6/9 PSYCH items versus placebo after 24weeks. Post hoc analysis of the 12-item Multiple Sclerosis Walking Scale (MSWS-12) improver population (≥8-point mean improvement) demonstrated differences in mean reductions from baseline of 97% and 111% in PR-fampridine MSIS-29 PHYS and PSYCH subscales versus the overall placebo group over 24weeks. A higher percentage of MSWS-12 improvers treated with PR-fampridine showed mean improvements in 20/20 PHYS and 8/9 PSYCH items versus placebo at 24weeks. In conclusion, PR-fampridine resulted in physical and psychological benefits versus placebo, sustained over 24weeks. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  19. HDL Cholesterol, Apolipoproteins, and Cardiovascular Risk in Hemodialysis Patients

    PubMed Central

    Genser, Bernd; Drechsler, Christiane; Scharnagl, Hubert; Grammer, Tanja B.; Stojakovic, Tatjana; Krane, Vera; Ritz, Eberhard; Wanner, Christoph; März, Winfried

    2015-01-01

    High concentrations of HDL cholesterol are considered to indicate efficient reverse cholesterol transport and to protect from atherosclerosis. However, HDL has been suggested to be dysfunctional in ESRD. Hence, our main objective was to investigate the effect of HDL cholesterol on outcomes in maintenance hemodialysis patients with diabetes. Moreover, we investigated the associations between the major protein components of HDL (apoA1, apoA2, and apoC3) and end points. We performed an exploratory, post hoc analysis with 1255 participants (677 men and 578 women) of the German Diabetes Dialysis study. The mean age was 66.3 years and the mean body mass index was 28.0 kg/m2. The primary end point was a composite of cardiac death, myocardial infarction, and stroke. The secondary end point included all-cause mortality. The mean duration of follow-up was 3.9 years. A total of 31.3% of the study participants reached the primary end point and 49.1% died from any cause. HDL cholesterol and apoA1 and apoC3 quartiles were not related to end points. However, there was a trend toward an inverse association between apoA2 and all-cause mortality. The hazard ratio for death from any cause in the fourth quartile compared with the first quartile of apoA2 was 0.63 (95% confidence interval, 0.40 to 0.89). The lack of an association between HDL cholesterol and cardiovascular risk may support the concept of dysfunctional HDL in hemodialysis. The possible beneficial effect of apoA2 on survival requires confirmation in future studies. PMID:25012163

  20. An exploratory study demonstrating the diagnostic ability of healthcare professionals in primary care using online case studies for common skin conditions.

    PubMed

    Tucker, Rod; Patel, Mahendra; Layton, Alison L; Walton, Shernaz

    2014-04-01

    To compare the diagnostic ability of pharmacists, nurses and general practitioners (GPs) for a range of skin conditions. An online study comprising 10 specifically developed dermatological case studies containing a digital image of the skin condition and a short case history. A total of 60 participants (20 representing each of pharmacists, GPs and primary care nurses) were required to identify the skin condition as well as the features in the case history that supported the diagnosis and the recommended first-line management approach for the condition. The mean diagnostic scores for each group were GPs = 8.8 (95% confidence interval, CI, 7.9-9.6), pharmacists = 6.2 (95% CI, 5.4-6.9) and nurses = 7.0 (95% CI, 6.1-7.9). Post hoc analysis revealed that the difference in mean diagnostic scores was significant (P < 0.05) between GPs and both pharmacists and nurses. However, pharmacists' diagnostic accuracy was similar to GPs' for some skin conditions such as tinea corporis, scabies and plantar warts and overall at least 40% of pharmacists correctly identified all conditions. This small study has demonstrated that for all of the skin conditions considered, pharmacists' overall diagnostic scores were significantly different from those of GPs but similar to those of nurses for the conditions assessed. However, further work with a larger sample is required to determine the accuracy of these preliminary findings and to establish whether advice given by pharmacists in practice results in the appropriate course of action being taken. © 2013 Royal Pharmaceutical Society.

  1. META-ANALYSIS OF ACUTE EXERCISE EFFECTS ON STATE ANXIETY: AN UPDATE OF RANDOMIZED CONTROLLED TRIALS OVER THE PAST 25 YEARS.

    PubMed

    Ensari, Ipek; Greenlee, Tina A; Motl, Robert W; Petruzzello, Steven J

    2015-08-01

    One prominent and well-cited meta-analysis published nearly 25 years ago reported that an acute or single bout of exercise reduced state anxiety by approximately ¼ standard deviation. We conducted a meta-analysis of randomized controlled trials (RCTs) published after that meta-analysis for updating our understanding of the acute effects of exercise on state anxiety. We searched PubMed, EBSCOHost, Medline, PsycINFO, ERIC, and ScienceDirect for RCTs of acute exercise and state anxiety as an outcome. There were 36 RCTs that met inclusion criteria and yielded data for effect size (ES) generation (Cohen's d). An overall ES was calculated using a random effects model and expressed as Hedge's g. The weighted mean ES was small (Hedge's g = 0.16, standard error (SE) = 0.06), but statistically significant (P < 0.05), and indicated that a single bout of exercise resulted in an improvement in state anxiety compared with control. The overall ES was heterogeneous and post hoc, exploratory analyses using both random- and fixed-effects models identified several variables as moderators including sample age, sex and health status, baseline activity levels, exercise intensity, modality and control condition, randomization, overall study quality, and the anxiety measure (P < 0.05). The cumulative evidence from high quality studies indicates that acute bouts of exercise can yield a small reduction in state anxiety. The research is still plagued by floor effects associated with recruiting persons with normal or lower levels of state anxiety, and this should be overcome in subsequent trials. © 2015 Wiley Periodicals, Inc.

  2. The Impact of Simulated Nature on Patient Outcomes: A Study of Photographic Sky Compositions.

    PubMed

    Pati, Debajyoti; Freier, Patricia; O'Boyle, Michael; Amor, Cherif; Valipoor, Shabboo

    2016-01-01

    To examine whether incorporation of simulated nature, in the form of ceiling mounted photographic sky compositions, influences patient outcomes. Previous studies have shown that most forms of nature exposure have a positive influence on patients. However, earlier studies have mostly focused on wall-hung nature representations. The emergence of simulated nature products has raised the question regarding the effects of the new product on patient outcomes. A between-subject experimental design was adopted, where outcomes from five inpatient rooms with sky composition ceiling fixture were compared to corresponding outcomes in five identical rooms without the intervention. Data were collected from a total of 181 subjects on 11 outcomes. Independent sample tests were performed to identify differences in mean outcomes. Significant positive outcomes were observed in environmental satisfaction and diastolic blood pressure (BP). Environmental satisfaction in the experimental group was 12.4% higher than the control group. Direction of association for diastolic BP, nausea/indigestion medication, acute stress, anxiety, pain, and environmental satisfaction were consistent with a priori hypothesis. A post hoc exploratory assessment involving patients who did not self-request additional pain and sleep medication demonstrated confirmatory directions for all outcomes except Systolic BP, and statistically significant outcomes for Acute Stress and Anxiety-Acute Stress and Anxiety levels of the experimental group subjects was 53.4% and 34.79% lower, respectively, than that of the control group subjects. Salutogenic benefits of photographic sky compositions render them better than traditional ceiling tiles and offer an alternative to other nature interventions. © The Author(s) 2015.

  3. Acculturation, cultural values, and Latino parental beliefs about the etiology of ADHD.

    PubMed

    Lawton, Kathryn E; Gerdes, Alyson C; Haack, Lauren M; Schneider, Brian

    2014-03-01

    Attention-deficit/hyperactivity disorder (ADHD) is one of the most prevalent mental health disorders of childhood. Despite the availability of several evidence-based interventions, Latino children are more likely than non-minority children to have an unmet need for services related to ADHD. Given that parental beliefs about the etiology of ADHD likely influence service utilization, research needs to focus on cultural factors that may influence parental beliefs about the etiology of child behavior problems. Thus, the goal of the current study was to investigate the role of acculturation and cultural values of familism, respect, spirituality, and traditional gender roles in explaining parental etiological beliefs about ADHD in a sample of Latino parents. Findings suggest that behavioral acculturation was not significantly correlated with biopsychosocial or sociological/spiritual etiological beliefs; however, the cultural values of familism and traditional gender roles were positively correlated with sociological/spiritual beliefs. Further, exploratory analyses suggested that after controlling for SES, familism and traditional gender roles accounted for 30.5 % of the total variance in sociological/spiritual beliefs about ADHD. Finally, post hoc analyses revealed that cultural values were associated with several individual belief categories within the sociological/spiritual domain, including beliefs about friends, spirituality, and nature disharmony. The current study supports the inclusion of etiological beliefs and cultural factors in research examining help-seeking and access to mental health services among Latino families and suggests that the incorporation of alternative etiological beliefs about child behavior may be an important factor in culturally-appropriate mental health services.

  4. Neuropsychological phenotypes among men with and without HIV disease in the multicenter AIDS cohort study.

    PubMed

    Molsberry, Samantha A; Cheng, Yu; Kingsley, Lawrence; Jacobson, Lisa; Levine, Andrew J; Martin, Eileen; Miller, Eric N; Munro, Cynthia A; Ragin, Ann; Sacktor, Ned; Becker, James T

    2018-05-11

    Mild forms of HIV-associated neurocognitive disorder (HAND) remain prevalent in the combination anti-retroviral therapy (cART) era. This study's objective was to identify neuropsychological subgroups within the Multicenter AIDS Cohort Study (MACS) based on the participant-based latent structure of cognitive function and to identify factors associated with subgroups. The MACS is a four-site longitudinal study of the natural and treated history of HIV disease among gay and bisexual men. Using neuropsychological domain scores we used a cluster variable selection algorithm to identify the optimal subset of domains with cluster information. Latent profile analysis was applied using scores from identified domains. Exploratory and post-hoc analyses were conducted to identify factors associated with cluster membership and the drivers of the observed associations. Cluster variable selection identified all domains as containing cluster information except for Working Memory. A three-profile solution produced the best fit for the data. Profile 1 performed below average on all domains, Profile 2 performed average on executive functioning, motor, and speed and below average on learning and memory, Profile 3 performed at or above average across all domains. Several demographic, cognitive, and social factors were associated with profile membership; these associations were driven by differences between Profile 1 and the other profiles. There is an identifiable pattern of neuropsychological performance among MACS members determined by all domains except Working Memory. Neither HIV nor HIV-related biomarkers were related with cluster membership, consistent with other findings that cognitive performance patterns do not map directly onto HIV serostatus.

  5. Psychosocial predictors of coronary artery calcification progression in postmenopausal women.

    PubMed

    Low, Carissa A; Matthews, Karen A; Kuller, Lewis H; Edmundowicz, Daniel

    2011-01-01

    Coronary artery calcification (CAC) has been associated with psychosocial factors in some but not all cross-sectional analyses. The goal of this study was to determine whether positive and negative psychosocial factors prospectively predict CAC progression in postmenopausal women. Participants from the Healthy Women Study who also participated in the Pittsburgh Mind-Body Center protocol (n = 149) completed self-report psychosocial measures before two electron beam computed tomographic scans of CAC separated by an average of 3.3 years. Results of exploratory factor analysis were used to create aggregate psychosocial indices: psychological risk (depressive symptoms, perceived stress, cynicism, and anger-in) and psychosocial resources (optimism, purpose in life, mastery, self-esteem, and social support). The psychological risk index predicted significantly greater CAC progression over 3 years (β = 0.16, p = .035, ΔR(2) = 0.03), whereas the psychosocial resources index was not predictive of CAC progression (β = -0.08, p = .30, ΔR(2) = 0.01). On individual scales, higher scores on cynicism emerged as a significant predictor of CAC progression, along with a trend linking anger-in to atherosclerosis progression. A post hoc analysis showed a significant interaction between cynicism and anger-in (β = 0.20, p = .01, ΔR(2) = 0.03), such that women reporting high levels of both cynicism and anger suppression exhibited the most CAC progression. These findings highlight psychosocial risk factors that may accelerate the progression of subclinical atherosclerosis in older women, suggest the potential importance of examining combinations of psychosocial risk factors, and identify potential targets for psychological interventions to reduce cardiovascular risk.

  6. The influence of four dual-cure resin cements and surface treatment selection to bond strength of fiber post

    PubMed Central

    Liu, Chang; Liu, Hong; Qian, Yue-Tong; Zhu, Song; Zhao, Su-Qian

    2014-01-01

    In this study, we evaluate the influence of post surface pre-treatments on the bond strength of four different cements to glass fiber posts. Eighty extracted human maxillary central incisors and canines were endodontically treated and standardized post spaces were prepared. Four post pre-treatments were tested: (i) no pre-treatment (NS, control), (ii) sandblasting (SA), (iii) silanization (SI) and (iv) sandblasting followed by silanization (SS). Per pre-treatment, four dual-cure resin cements were used for luting posts: DMG LUXACORE Smartmix Dual, Multilink Automix, RelyX Unicem and Panavia F2.0. All the specimens were subjected to micro push-out test. Two-way analysis of variance and Tukey post hoc tests were performed (α=0.05) to analyze the data. Bond strength was significantly affected by the type of resin cement, and bond strengths of RelyX Unicem and Panavia F2.0 to the fiber posts were significantly higher than the other cement groups. Sandblasting significantly increased the bond strength of DMG group to the fiber posts. PMID:24177170

  7. An evaluation of the lag of accommodation using photorefraction.

    PubMed

    Seidemann, Anne; Schaeffel, Frank

    2003-02-01

    The lag of accommodation which occurs in most human subjects during reading has been proposed to explain the association between reading and myopia. However, the measured lags are variable among different published studies and current knowledge on its magnitude rests largely on measurements with the Canon R-1 autorefractor. Therefore, we have measured it with another technique, eccentric infrared photorefraction (the PowerRefractor), and studied how it can be modified. Particular care was taken to ensure correct calibration of the instrument. Ten young adult subjects were refracted both in the fixation axis of the right eye and from the midline between both eyes, while they read text both monocularly and binocularly at 1.5, 2, 3, 4 and 5 D distance ("group 1"). A second group of 10 subjects ("group 2"), measured from the midline between both eyes, was studied to analyze the effects of binocular vs monocular vision, addition of +1 or +2 D lenses, and of letter size. Spherical equivalents (SE) were analyzed in all cases. The lag of accommodation was variable among subjects (standard deviations among groups and viewing distances ranging from 0.18 to 1.07 D) but was significant when the measurements were done in the fixation axis (0.35 D at 3 D target distance to 0.60 D at 5 D with binocular vision; p<0.01 or better all cases). Refracting from the midline between both eyes tended to underestimate the lag of accommodation although this was significant only at 5 D (ANOVA: p<0.0001, post hoc t-test: p<0.05). There was a small improvement in accommodation precision with binocular compared to monocular viewing but significance was reached only for the 5 D reading target (group 1--lags for a 3/4/5 D target: 0.35 vs 0.41 D/0.48 vs 0.47 D/0.60 vs 0.66 D, ANOVA: p<0.0001, post hoc t-test: p<0.05; group 2--0.29 vs 0.12 D, 0.33 vs 0.16 D, 0.23 vs -0.31 D, ANOVA: p<0.0001, post hoc t-test: p<0.05). Adjusting the letter height for constant angular subtense (0.2 deg) induced scarcely more accommodation than keeping letter size constantly at 3.5 mm (ANOVA: p<0.0001, post hoc t-test: n.s.). Positive trial lenses reduced the lag of accommodation under monocular viewing conditions and even reversed it with binocular vision. After consideration of possible sources of measurement error, the lag of accommodation measured with photorefraction at 3 D (0.41 D SE monocular and 0.35 D SE binocular) was in the range of published values from the Canon R-1 autorefractor. With the measured lag, simulations of the retinal images for a diffraction limited eye suggest surprisingly poor letter contrast on the retina.

  8. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial

    PubMed Central

    Merom, Dafna; Mathieu, Erin; Cerin, Ester; Morton, Rachael L.; Simpson, Judy M.; Anstey, Kaarin J.; Sherrington, Catherine; Lord, Stephen R.; Cumming, Robert G.

    2016-01-01

    Background The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. Methods and Findings A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. Main outcomes: falls during the 12 mo trial and Trail Making Tests. Secondary outcomes: The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control participants (82%, p = 0.04). Mean attendance at dance classes was 51%. During the period, 444 falls were recorded; there was no significant difference in fall rates between the control group (0.80 per person-year) and the dance group (1.03 per person-year). Using negative binomial regression with robust standard errors the adjusted Incidence Rate Ratio (IRR) was 1.19 (95% CI: 95% CI = 0.83, 1.71). In exploratory post hoc subgroup analysis, the rate of falls was higher among dance participants with a history of multiple falls (IRR = 2.02, 95% CI: 1.15, 3.54, p = 0.23 for interaction) and with the folk dance intervention (IRR = 1.68, 95% CI: 1.03, 2.73). There were no significant between-group differences in executive function test (TMT-B = 2.8 s, 95% CI: −6.2, 11.8). Intention to treat (ITT) analysis revealed no between-group differences at 12-mo follow-up in the secondary outcome measures, with the exception of postural sway, favouring the control group. Exploratory post hoc analysis by study completers and style indicated that ballroom dancing participants apparently improved their gait speed by 0.07 m/s relative to control participants (95% CI: 0.00, 0.14, p = 0.05). Study limitations included allocation to style based on logistical considerations rather than at random; insufficient power to detect differential impacts of different dance styles and smaller overall effects; variation of measurement conditions across villages; and no assessment of more complex balance tasks, which may be more sensitive to changes brought about by dancing. Conclusions Social dancing did not prevent falls or their associated risk factors among these retirement villages' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation. Trial Registration The Australian New Zealand Clinical Trials Registry ACTRN12612000889853 PMID:27575534

  9. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    PubMed

    Merom, Dafna; Mathieu, Erin; Cerin, Ester; Morton, Rachael L; Simpson, Judy M; Rissel, Chris; Anstey, Kaarin J; Sherrington, Catherine; Lord, Stephen R; Cumming, Robert G

    2016-08-01

    The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. falls during the 12 mo trial and Trail Making Tests. The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control participants (82%, p = 0.04). Mean attendance at dance classes was 51%. During the period, 444 falls were recorded; there was no significant difference in fall rates between the control group (0.80 per person-year) and the dance group (1.03 per person-year). Using negative binomial regression with robust standard errors the adjusted Incidence Rate Ratio (IRR) was 1.19 (95% CI: 95% CI = 0.83, 1.71). In exploratory post hoc subgroup analysis, the rate of falls was higher among dance participants with a history of multiple falls (IRR = 2.02, 95% CI: 1.15, 3.54, p = 0.23 for interaction) and with the folk dance intervention (IRR = 1.68, 95% CI: 1.03, 2.73). There were no significant between-group differences in executive function test (TMT-B = 2.8 s, 95% CI: -6.2, 11.8). Intention to treat (ITT) analysis revealed no between-group differences at 12-mo follow-up in the secondary outcome measures, with the exception of postural sway, favouring the control group. Exploratory post hoc analysis by study completers and style indicated that ballroom dancing participants apparently improved their gait speed by 0.07 m/s relative to control participants (95% CI: 0.00, 0.14, p = 0.05). Study limitations included allocation to style based on logistical considerations rather than at random; insufficient power to detect differential impacts of different dance styles and smaller overall effects; variation of measurement conditions across villages; and no assessment of more complex balance tasks, which may be more sensitive to changes brought about by dancing. Social dancing did not prevent falls or their associated risk factors among these retirement villages' residents. Modified dance programmes that contain "training elements" to better approximate structured exercise programs, targeted at low and high-risk participants, warrant investigation. The Australian New Zealand Clinical Trials Registry ACTRN12612000889853.

  10. Resistivity tomography of Pointe du Hoc cliffs for stability assessment

    NASA Astrophysics Data System (ADS)

    Udphuay, S.; Everett, M. E.; Warden, R.

    2008-12-01

    Pointe du Hoc WWII battlefield overlooking the English Channel in western Normandy, France, is an important cultural resource, being an integral component of the June 6 1944 D-Day invasion. Two major buildings, the forward observation post (OP) and Col. Rudder's command post (RCP), are now perched perilously close to the cliff's edge owing to six decades of cliff retreat. Geophysical surveys were carried out in March 2008 to investigate the risk of cliff failure and to inform possible geotechnical remediation strategies with a final goal toward re-opening the observation post that is now closed to visitors. The geophysical surveying is accomplished by high-resolution resistivity tomography, conducted in extreme topography and in the midst of dense cultural clutter. The results of the OP tomography indicate that the highest mass movement hazard is associated with the marine caverns at the base of the cliff at the point of strongest wave attack. These caverns occupy the future site of a sea arch which will threaten the OP building. There is a high probability of a soil wedge failure on the east facing cliff edge close to the OP building. Such a failure could damage or destroy the building. The possibility of a sudden catastrophic failure along any one of these fractures cannot be ruled out. The greatest risk at the RCP site, which is under less immediate threat, is associated with soil wedge failures at the top of the cliffs.

  11. Cliff stability assessment using electrical resistivity tomography at the historic WWII D-Day invasion site, Pointe du Hoc, France

    NASA Astrophysics Data System (ADS)

    Everett, M. E.; Udphuay, S.; Warden, R.

    2007-05-01

    The 1944 D-Day invasion site at Pointe du Hoc, Normandy, France is an important WWII battlefield and cultural resource but is at risk from chalk cliff collapse. The American Battle Monuments Commission tasked us to evaluate the geohazard to the observation post and other cliff-side buildings of historical significance. Geophysical multi-electrode resistivity profiling is used to study cliff stability and the condition of the observation- post foundations. Preliminary 2-D geological interpretations are provided of individual profiles. The copious steel, concrete and void spaces at the site renders hydrogeological interpretation challenging but tractable. The cliff face appears to be relatively intact and well-drained. Several routes taken by groundwater into fractures within the chalk were identified mainly on the western side of the site. The eastern side is drier and somewhat sheltered from the Atlantic storms but may contain large void spaces that could efficiently transmit groundwater flow during heavy precipitation events, thereby imperiling the major antiaircraft gun emplacement occupied by Col. Rudder in the early days of the Allied invasion. The forward German observation post perched close to the sea stack, which now hosts the U.S. Ranger memorial, may be moving with the soil and not securely anchored to bedrock. A complex failure mechanism is identified as a combination of groundwater dissolution of the fractured chalk and sea wave attack at the cliff base.

  12. Three-dimensional resistivity tomography in extreme coastal terrain amidst dense cultural signals: application to cliff stability assessment at the historic D-Day site

    NASA Astrophysics Data System (ADS)

    Udphuay, Suwimon; Günther, Thomas; Everett, Mark E.; Warden, Robert R.; Briaud, Jean-Louis

    2011-04-01

    Pointe du Hoc overlooking the English Channel in Normandy, France was host to one of the most important military engagements of World War II but is vulnerable to cliff collapses that threaten important German fortifications including the forward observation post (OP) and Rudder's command post. The objective of this study is to apply advanced 3-D resistivity tomography towards a detailed site stability assessment with special attention to the two at-risk buildings. 3-D resistivity tomography data sets at Pointe du Hoc in the presence of extreme topography and dense cultural clutter have been successfully acquired, inverted and interpreted. A cliff stability hazard assessment scheme has been designed in which regions of high resistivity are interpreted as zones of open, dry fractures with a moderate mass movement potential. Regions of low resistivity are zones of wet, clay-filled fractures with a high mass movement potential. The OP tomography results indicate that the highest mass movement hazard appears to be associated with the marine caverns at the base of the cliff that are positioned at the point of strongest wave attack. These caverns likely occupy the future site of development of a sea arch that will threaten the OP building. The mass movement potential at the Rudder's command post area is low to moderate. The greatest risk there is associated with soil wedge failures at the top of the cliffs.

  13. Comparing Cultural Differences in Two Quality Measures in Chinese Kindergartens: The Early Childhood Environment Rating Scale-Revised and the Kindergarten Quality Rating System

    ERIC Educational Resources Information Center

    Hu, Bi Ying

    2015-01-01

    This study examined the degrees of congruence between two early childhood evaluation systems on various quality concepts: the Early Childhood Environment Rating Scale-Revised (ECERS-R) and Zhejiang's Kindergarten Quality Rating System (KQRS). Analysis of variance and post hoc least significant difference tests were employed to show the extent to…

  14. Welfare Reform and Addiction: A Priori Hypotheses, Post Hoc Explorations, and Assisted Sensemaking in Evaluating the Effects of Terminating Benefits for Chronic Substance Abusers

    ERIC Educational Resources Information Center

    Orwin, Robert G.; Campbell, Bernadette; Campbell, Kevin; Krupski, Antoinette

    2004-01-01

    The passage of the Contract with America Advancement Act terminated the Social Security Administrations Disability Insurance and Supplemental Security Income benefits for persons diagnosed with drug or alcohol addiction (also known as DA&A recipients), effective January 1, 1997. From an evaluation standpoint, the law created the opportunity…

  15. Distinct Plasma Profile of Polar Neutral Amino Acids, Leucine, and Glutamate in Children with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Tirouvanziam, Rabindra; Obukhanych, Tetyana V.; Laval, Julie; Aronov, Pavel A.; Libove, Robin; Banerjee, Arpita Goswami; Parker, Karen J.; O'Hara, Ruth; Herzenberg, Leonard A.; Herzenberg, Leonore A.; Hardan, Antonio Y.

    2012-01-01

    The goal of this investigation was to examine plasma amino acid (AA) levels in children with Autism Spectrum Disorders (ASD, N = 27) and neuro-typically developing controls (N = 20). We observed reduced plasma levels of most polar neutral AA and leucine in children with ASD. This AA profile conferred significant post hoc power for discriminating…

  16. An Examination of the Relations between Oral Vocabulary and Phonological Awareness in Early Childhood

    ERIC Educational Resources Information Center

    Cassano, Christina M.; Schickedanz, Judith A.

    2015-01-01

    This article reports a post hoc analysis conducted as part of a larger study in which 61 typically developing, 3-, 4-, and 5-year-olds were assessed in phonological awareness (PA), vocabulary (i.e., receptive, expressive, and definitional), and grammatical skill at baseline and 3, 6, and 9 months later. The larger study's purpose was to shed light…

  17. Pruning and Prioritising: A Case Study of a Pragmatic Method for Managing a Rapid Systematic Review with Limited Resources

    ERIC Educational Resources Information Center

    Harnan, Sue Elizabeth; Cooper, Katy; Jones, Sarah Lynne; Jones, Elaine

    2015-01-01

    Full systematic reviews are time and resource heavy. We describe a method successfully used to produce a rapid review of yoga for health and wellbeing, with limited resources, using mapping methods. Inclusion and exclusion criteria were developed a priori and refined "post hoc," with the review team blind to the study results to minimise…

  18. Word Problems versus Image-Rich Problems: An Analysis of Effects of Task Characteristics on Students' Performance on Contextual Mathematics Problems

    ERIC Educational Resources Information Center

    Hoogland, Kees; Pepin, Birgit; de Koning, Jaap; Bakker, Arthur; Gravemeijer, Koeno

    2018-01-01

    This article reports on a "post hoc" study using a randomised controlled trial with 31,842 students in the Netherlands and an instrument consisting of 21 paired problems. The trial showed a variability in the differences of students' results in solving contextual mathematical problems with either a descriptive or a depictive…

  19. Factors That Affect Age of Identification of Children with an Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Adelman, Chana R.; Kubiszyn, Thomas

    2017-01-01

    This study explored factors associated with age of identification of autism spectrum disorder (ASD). Results of a one-way ANOVA indicated differences in age of diagnosis among the four regions in the United States, F(3, 650) = 7.618, p = 0.01. Tukey's post hoc comparisons of the groups indicated that the mean age of diagnosis in the Midwest (M =…

  20. Patient Simulation for Assessment of Layperson Management of Opioid Overdose with Intranasal Naloxone in a Recently-Released Prisoner Cohort

    PubMed Central

    Kobayashi, Leo; Green, Traci C.; Bowman, Sarah E.; Ray, Madeline C.; McKenzie, Michelle S.; Rich, Josiah D.

    2016-01-01

    Introduction Investigators applied simulation to an experimental program that educated, trained and assessed at-risk, volunteering prisoners on opioid overdose (OD) prevention, recognition and layperson management with intranasal (IN) naloxone. Methods Consenting inmates were assessed for OD-related experience and knowledge then exposed on-site to standardized didactics and educational DVD (without simulation). Subjects were provided with IN naloxone kits at time of release and scheduled for post-release assessment. At follow-up, subjects were evaluated for their performance of layperson opioid OD resuscitative skills during video-recorded simulations. Two investigators independently scored each subject’s resuscitative actions with a 21-item checklist; post-hoc video reviews were separately completed to adjudicate subjects’ interactions for overall benefit or harm. Results One hundred and three prisoners completed the baseline assessment and study intervention then were prescribed IN naloxone kits. One-month follow-up and simulation data were available for 85 subjects (82.5% of trained recruits) who had been released and resided in the community. Subjects’ simulation checklist median score was 12.0 (IQR 11.0–15.0) out of 21 total indicated actions. Forty-four participants (51.8%) correctly administered naloxone; 16 additional subjects (18.8%) suboptimally administered naloxone. Non-indicated actions, primarily chest compressions, were observed in 49.4% of simulations. Simulated resuscitative actions by 80 subjects (94.1%) were determined post-hoc to be beneficial overall for patients overdosing on opioids. Conclusions As part of an opioid OD prevention research program for at-risk inmates, investigators applied simulation to 1-month follow-up assessments of knowledge retention and skills acquisition in post-release participants. Simulation supplemented traditional research tools for investigation of layperson OD management. PMID:28146450

  1. Post hoc support vector machine learning for impedimetric biosensors based on weak protein-ligand interactions.

    PubMed

    Rong, Y; Padron, A V; Hagerty, K J; Nelson, N; Chi, S; Keyhani, N O; Katz, J; Datta, S P A; Gomes, C; McLamore, E S

    2018-04-30

    Impedimetric biosensors for measuring small molecules based on weak/transient interactions between bioreceptors and target analytes are a challenge for detection electronics, particularly in field studies or in the analysis of complex matrices. Protein-ligand binding sensors have enormous potential for biosensing, but achieving accuracy in complex solutions is a major challenge. There is a need for simple post hoc analytical tools that are not computationally expensive, yet provide near real time feedback on data derived from impedance spectra. Here, we show the use of a simple, open source support vector machine learning algorithm for analyzing impedimetric data in lieu of using equivalent circuit analysis. We demonstrate two different protein-based biosensors to show that the tool can be used for various applications. We conclude with a mobile phone-based demonstration focused on the measurement of acetone, an important biomarker related to the onset of diabetic ketoacidosis. In all conditions tested, the open source classifier was capable of performing as well as, or better, than the equivalent circuit analysis for characterizing weak/transient interactions between a model ligand (acetone) and a small chemosensory protein derived from the tsetse fly. In addition, the tool has a low computational requirement, facilitating use for mobile acquisition systems such as mobile phones. The protocol is deployed through Jupyter notebook (an open source computing environment available for mobile phone, tablet or computer use) and the code was written in Python. For each of the applications, we provide step-by-step instructions in English, Spanish, Mandarin and Portuguese to facilitate widespread use. All codes were based on scikit-learn, an open source software machine learning library in the Python language, and were processed in Jupyter notebook, an open-source web application for Python. The tool can easily be integrated with the mobile biosensor equipment for rapid detection, facilitating use by a broad range of impedimetric biosensor users. This post hoc analysis tool can serve as a launchpad for the convergence of nanobiosensors in planetary health monitoring applications based on mobile phone hardware.

  2. The Effect of IV Amino Acid Supplementation on Mortality in ICU Patients May Be Dependent on Kidney Function: Post Hoc Subgroup Analyses of a Multicenter Randomized Trial.

    PubMed

    Zhu, Ran; Allingstrup, Matilde J; Perner, Anders; Doig, Gordon S

    2018-05-15

    We investigated whether preexisting kidney function determines if ICU patients may benefit from increased (2.0 g/kg/d) protein intake. Post hoc, hypothesis-generating, subgroup analysis of a multicenter, phase 2, randomized clinical trial. All analyses were conducted by intention to treat and maintained group allocation. Ninety-day mortality was the primary outcome. ICUs of 16 hospitals throughout Australia and New Zealand. Adult critically ill patients expected to remain in the study ICU for longer than 2 days. Random allocation to receive a daily supplement of up to 100 g of IV amino acids to achieve a total protein intake of 2.0 g/kg/d or standard nutrition care. A total of 474 patients were randomized: 235 to standard care and 239 to IV amino acid supplementation. There was a statistically significant interaction between baseline kidney function and supplementation with study amino acids (p value for interaction = 0.026). Within the subgroup of patients with normal kidney function at randomization, patients who were allocated to receive the study amino acid supplement were less likely to die before study day 90 (covariate-adjusted risk difference, -7.9%; 95% CI, -15.1 to -0.7; p = 0.034). Furthermore, amino acid supplementation significantly increased estimated glomerular filtration rate in these patients (repeated-measures treatment × time interaction p = 0.009). Within the subgroup of patients with baseline kidney dysfunction and/or risk of progression of acute kidney injury, a significant effect of the study intervention on mortality was not found (covariate-adjusted risk difference, -0.6%; 95% CI, -16.2 to 15.2; p = 0.95). In this post hoc, hypothesis-generating, subgroup analysis, we observed reduced mortality and improved estimated glomerular filtration rate in ICU patients with normal kidney function who were randomly allocated to receive increased protein intake (up to 2.0 g/kg/d). We strongly recommend confirmation of these results in trials with low risk of bias before this treatment is recommended for routine care.

  3. Influencing Anesthesia Provider Behavior Using Anesthesia Information Management System Data for Near Real-Time Alerts and Post Hoc Reports.

    PubMed

    Epstein, Richard H; Dexter, Franklin; Patel, Neil

    2015-09-01

    In this review article, we address issues related to using data from anesthesia information management systems (AIMS) to deliver near real-time alerts via AIMS workstation popups and/or alphanumeric pagers and post hoc reports via e-mail. We focus on reports and alerts for influencing the behavior of anesthesia providers (i.e., anesthesiologists, anesthesia residents, and nurse anesthetists). Multiple studies have shown that anesthesia clinical decision support (CDS) improves adherence to protocols and increases financial performance through facilitation of billing, regulatory, and compliance documentation; however, improved clinical outcomes have not been demonstrated. We inform developers and users of feedback systems about the multitude of concerns to consider during development and implementation of CDS to increase its effectiveness and to mitigate its potentially disruptive aspects. We discuss the timing and modalities used to deliver messages, implications of outlier-only versus individualized feedback, the need to consider possible unintended consequences of such feedback, regulations, sustainability, and portability among systems. We discuss statistical issues related to the appropriate evaluation of CDS efficacy. We provide a systematic review of the published literature (indexed in PubMed) of anesthesia CDS and offer 2 case studies of CDS interventions using AIMS data from our own institution illustrating the salient points. Because of the considerable expense and complexity of maintaining near real-time CDS systems, as compared with providing individual reports via e-mail after the fact, we suggest that if the same goal can be accomplished via delayed reporting versus immediate feedback, the former approach is preferable. Nevertheless, some processes require near real-time alerts to produce the desired improvement. Post hoc e-mail reporting from enterprise-wide electronic health record systems is straightforward and can be accomplished using system-independent pathways (e.g., via built-in e-mail support provided by the relational database management system). However, for some of these enterprise-wide systems, near real-time data access, necessary for CDS that generates concurrent alerts, has been challenging to implement.

  4. Influence of Various Acidic Beverages on Tooth Erosion. Evaluation by a New Method

    PubMed Central

    Zimmer, Stefan; Kirchner, Georg; Bizhang, Mozhgan; Benedix, Mathias

    2015-01-01

    Material & Methods We have analyzed the loss of enamel and dentine after exposure to different non-alcoholic drinks with a simple new method using bovine teeth. 100 enamel and 100 dentine specimens from freshly extracted bovine incisors were randomly attributed to 10 groups (n=10 for enamel and dentine each). Prior to the start of the experiment all specimens were weighed using a precision balance. The mean initial masses (SD) were 35.8 mg (7.2) for enamel and 24.7 mg (7.0) for dentine. No statistically significant differences were found between groups for initial masses (p>0.05, ANOVA with Bonferroni post hoc test). Thereafter, all specimens of one group were simultaneously placed in 200 ml of the following fluids: Coca-Cola, Coca-Cola light, Sprite, apple juice, Red Bull, orange juice, Bonaqua Fruits (Mango-Acai), tap water, chlorinated swimming pool water, and lemon juice. Fluids were continuously ventilated at 37° C for 7 days. Thereafter the specimens were weighed again and the mean mass loss was calculated. Results The values were (enamel/dentine): Coca-Cola 7.5 mg/6.6 mg; Coca-Cola light 5.2 mg/3.5 mg, Sprite 26.1 mg/17.7 mg, apple juice 27.1 mg/15.2 mg, Red Bull 16.6 mg/17.0 mg, orange juice 24.3 mg/20.2 mg, Bonaqua Fruits (Mango-Acai) 17.8 mg/16.2 mg, tap water -0.2 mg/-0.3 mg, swimming pool water -0.3 mg/-0.2 mg, and lemon juice 32.0 mg/28.3 mg. From all drinks, Cola and Cola light showed the least erosivity (p<0.001, ANOVA with Bonferroni post hoc test) whereas lemon juice showed statistically significant higher erosivity than all other drinks except Sprite and apple juice (p<0.01, ANOVA with Bonferroni post hoc test). Conclusions In conclusion, erosivity of common non-alcoholic drinks varies widely. For example, Sprite, apple juice, and orange juice are about five times more erosive than Coca-Cola light. The findings from the present study should be taken into account in choosing a diet that provides satisfactory nutrition while minimizing tooth erosion. PMID:26035729

  5. Duodenal and ileal glucose infusions differentially alter gastrointestinal peptides, appetite response, and food intake: a tube feeding study.

    PubMed

    Poppitt, Sally D; Shin, Hyun Sang; McGill, Anne-Thea; Budgett, Stephanie C; Lo, Kim; Pahl, Malcolm; Duxfield, Janice; Lane, Mark; Ingram, John R

    2017-09-01

    Background: Activation of the ileal brake through the delivery of nutrients into the distal small intestine to promote satiety and suppress food intake provides a new target for weight loss. Evidence is limited, with support from naso-ileal lipid infusion studies. Objective: The objective of the study was to investigate whether glucose infused into the duodenum and ileum differentially alters appetite response, food intake, and secretion of satiety-related gastrointestinal peptides. Design: Fourteen healthy male participants were randomly assigned to a blinded 4-treatment crossover, with each treatment of single-day duration. On the day before the intervention (day 0), a 380-cm multilumen tube (1.75-mm diameter) with independent port access to the duodenum and ileum was inserted, and position was confirmed by X-ray. Subsequently (days 1-4), a standardized breakfast meal was followed midmorning by a 90-min infusion of isotonic glucose (15 g, 235 kJ) or saline to the duodenum or ileum. Appetite ratings were assessed with the use of visual analog scales (VASs), blood samples collected, and ad libitum energy intake (EI) measured at lunch, afternoon snack, and dinner. Results: Thirteen participants completed the 4 infusion days. There was a significant effect of nutrient infused and site (treatment × time, P < 0.05) such that glucose-to-ileum altered VAS-rated fullness, satisfaction, and thoughts of food compared with saline-to-ileum (Tukey's post hoc, P < 0.05); decreased ad libitum EI at lunch compared with glucose-to-duodenum [-22%, -988 ± 379 kJ (mean ± SEM), Tukey's post hoc, P < 0.05]; and increased glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) compared with all other treatments (Tukey's post hoc, P < 0.05). Conclusions: Macronutrient delivery to the proximal and distal small intestine elicits different outcomes. Glucose infusion to the ileum increased GLP-1 and PYY secretion, suppressed aspects of VAS-rated appetite, and decreased ad libitum EI at a subsequent meal. Although glucose to the duodenum also suppressed appetite ratings, eating behavior was not altered. This trial was registered at www.anzctr.org.au as ACTRN12612000429853. © 2017 American Society for Nutrition.

  6. Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial.

    PubMed

    van de Ven, J; Fransen, A F; Schuit, E; van Runnard Heimel, P J; Mol, B W; Oei, S G

    2017-09-01

    Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial. J van de Ven, AF Fransen, E Schuit, PJ van Runnard Heimel, BW Mol, SG Oei OBJECTIVE: To investigate whether the effect of a one-day simulation-based obstetric team training on patient outcome changes over time. Post-hoc analysis of a multicentre, open, randomised controlled trial that evaluated team training in obstetrics (TOSTI study).We studied women with a singleton pregnancy beyond 24 weeks of gestation in 24 obstetric units. Included obstetric units were randomised to either a one-day, multi-professional simulation-based team training focusing on crew resource management in a medical simulation centre (12 units) or to no team training (12 units). We assessed whether outcomes differed between both groups in each of the first four quarters following the team training and compared the effect of team training over quarters. Primary outcome was a composite outcome of low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischemic encephalopathy. During a one year period after the team training the rate of obstetric complications, both on the composite level and the individual component level, did not differ between any of the quarters. For trauma due to shoulder dystocia team training led to a significant decrease in the first quarter (0.06% versus 0.26%, OR 0.19, 95% CI 0.03 to 0.98) but in the subsequent quarters no significant reductions were observed. Similar results were found for invasive treatment for severe postpartum haemorrhage where a significant increase was only seen in the first quarter (0.4% versus 0.03%, OR 19, 95% CI 2.5-147), and not thereafter. The beneficial effect of a one-day, simulation-based, multiprofessional, obstetric team training seems to decline after three months. If team training is further evaluated or implemented, repetitive training sessions every three months seem therefore recommended. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Influence of various acidic beverages on tooth erosion. Evaluation by a new method.

    PubMed

    Zimmer, Stefan; Kirchner, Georg; Bizhang, Mozhgan; Benedix, Mathias

    2015-01-01

    We have analyzed the loss of enamel and dentine after exposure to different non-alcoholic drinks with a simple new method using bovine teeth. 100 enamel and 100 dentine specimens from freshly extracted bovine incisors were randomly attributed to 10 groups (n=10 for enamel and dentine each). Prior to the start of the experiment all specimens were weighed using a precision balance. The mean initial masses (SD) were 35.8 mg (7.2) for enamel and 24.7 mg (7.0) for dentine. No statistically significant differences were found between groups for initial masses (p>0.05, ANOVA with Bonferroni post hoc test). Thereafter, all specimens of one group were simultaneously placed in 200 ml of the following fluids: Coca-Cola, Coca-Cola light, Sprite, apple juice, Red Bull, orange juice, Bonaqua Fruits (Mango-Acai), tap water, chlorinated swimming pool water, and lemon juice. Fluids were continuously ventilated at 37° C for 7 days. Thereafter the specimens were weighed again and the mean mass loss was calculated. The values were (enamel/dentine): Coca-Cola 7.5 mg/6.6 mg; Coca-Cola light 5.2 mg/3.5 mg, Sprite 26.1 mg/17.7 mg, apple juice 27.1 mg/15.2 mg, Red Bull 16.6 mg/17.0 mg, orange juice 24.3 mg/20.2 mg, Bonaqua Fruits (Mango-Acai) 17.8 mg/16.2 mg, tap water -0.2 mg/-0.3 mg, swimming pool water -0.3 mg/-0.2 mg, and lemon juice 32.0 mg/28.3 mg. From all drinks, Cola and Cola light showed the least erosivity (p<0.001, ANOVA with Bonferroni post hoc test) whereas lemon juice showed statistically significant higher erosivity than all other drinks except Sprite and apple juice (p<0.01, ANOVA with Bonferroni post hoc test). In conclusion, erosivity of common non-alcoholic drinks varies widely. For example, Sprite, apple juice, and orange juice are about five times more erosive than Coca-Cola light. The findings from the present study should be taken into account in choosing a diet that provides satisfactory nutrition while minimizing tooth erosion.

  8. An exploratory study of adolescent response to fluoxetine using psychological and biological predictors.

    PubMed

    Zohar, Ada H; Eilat, Tamar; Amitai, Maya; Taler, Michal; Bari, Romi; Chen, Alon; Apter, Alan; Weizman, Avraham; Fennig, Silvana

    2018-01-01

    Not enough is known about predicting therapeutic response to serotonin-specific reuptake inhibitors, and specifically to fluoxetine. This exploratory study used psychological and biological markers for (retrospective) prediction of treatment-response to fluoxetine in depressed and/or anxious adolescents. Forty-one consecutive adolescent outpatients with a primary diagnosis of severe affective and/or anxiety disorders were assessed and treated with an open-label 8-week trial of fluoxetine. Type D personality was assessed with the 14-item questionnaire, the DS14. In addition, TNFα, IL-6, and IL-1b were measured pre- and post-treatment. There was an elevation of Type D personality in patients, compared to the adolescent population rate. Post-treatment, 44% of patients were classified as non-responders; the relative risk of non-response for Type D personality patients was 2.8. Binary logistic regression predicting response vs. non-response showed a contribution of initial TNFα levels as well as Type D personality to non-response. In this exploratory study, the most significant contributor to non-response was Type D personality. However, the measurement of Type D was not prospective, and thus may be confounded with psychiatric morbidity. The measurement of personality in psychiatric settings may contribute to the understanding of treatment response and have clinical utility.

  9. Evaluation of a modified 16-item Readiness for Interprofessional Learning Scale (RIPLS): Exploratory and confirmatory factor analyses.

    PubMed

    Yu, Tzu-Chieh; Jowsey, Tanisha; Henning, Marcus

    2018-04-18

    The Readiness for Interprofessional Learning Scale (RIPLS) was developed to assess undergraduate readiness for engaging in interprofessional education (IPE). It has become an accepted and commonly used instrument. To determine utility of a modified 16-item RIPLS instrument, exploratory and confirmatory factor analyses were performed. Data used were collected from a pre- and post-intervention study involving 360 New Zealand undergraduate students from one university. Just over half of the participants were enrolled in medicine (51%) while the remainder were in pharmacy (27%) and nursing (22%). The intervention was a two-day simulation-based IPE course focused on managing unplanned acute medical problems in hospital wards ("ward calls"). Immediately prior to the course, 288 RIPLS were collected and immediately afterwards, 322 (response rates 80% and 89%, respectively). Exploratory factor analysis involving principal axis factoring with an oblique rotation method was conducted using pre-course data. The scree plot suggested a three-factor solution over two- and four-factor solutions. Subsequent confirmatory factor analysis performed using post-course data demonstrated partial goodness-of-fit for this suggested three-factor model. Based on these findings, further robust psychometric testing of the RIPLS or modified versions of it is recommended before embarking on its use in evaluative research in various healthcare education settings.

  10. The Air Force Critical Care Air Transport Team (CCATT): Using the Estimating Supplies Program (ESP) to Validate Clinical Requirements

    DTIC Science & Technology

    2005-04-05

    categories are postsurgical cases, and represent thoracic, staged exploratory laparotomy, vascular/amputation, and craniotomy PCs for which surgical...Post Surgical Craniotomy J – Environmental Emergency E – Burns > 20% BSA K – Medical, Anaphylaxis/Asthma F – Class III and IV Hemorrhagic Shock...Amputation G – Crush/Blunt Injury K – Med, Anaphylaxis Asthma D – Post Surgical Craniotomy H – Head Injury

  11. Validation of post-operative residual contrast enhancing tumor volume as an independent prognostic factor for overall survival in newly diagnosed glioblastoma.

    PubMed

    Ellingson, Benjamin M; Abrey, Lauren E; Nelson, Sarah J; Kaufmann, Timothy J; Garcia, Josep; Chinot, Olivier; Saran, Frank; Nishikawa, Ryo; Henriksson, Roger; Mason, Warren P; Wick, Wolfgang; Butowski, Nicholas; Ligon, Keith L; Gerstner, Elizabeth R; Colman, Howard; de Groot, John; Chang, Susan; Mellinghoff, Ingo; Young, Robert J; Alexander, Brian M; Colen, Rivka; Taylor, Jennie W; Arrillaga-Romany, Isabel; Mehta, Arnav; Huang, Raymond Y; Pope, Whitney B; Reardon, David; Batchelor, Tracy; Prados, Michael; Galanis, Evanthia; Wen, Patrick Y; Cloughesy, Timothy F

    2018-04-05

    In the current study, we pooled imaging data in newly diagnosed GBM patients from international multicenter clinical trials, single institution databases, and multicenter clinical trial consortiums to identify the relationship between post-operative residual enhancing tumor volume and overall survival (OS). Data from 1,511 newly diagnosed GBM patients from 5 data sources were included in the current study: 1) a single institution database from UCLA (N=398; Discovery); 2) patients from the Ben and Cathy Ivy Foundation for Early Phase Clinical Trials Network Radiogenomics Database (N=262 from 8 centers; Confirmation); 3) the chemoradiation placebo arm from an international phase III trial (AVAglio; N=394 from 120 locations in 23 countries; Validation); 4) the experimental arm from AVAglio examining chemoradiation plus bevacizumab (N=404 from 120 locations in 23 countries; Exploratory Set 1); and 5) an Alliance (N0874) Phase I/II trial of vorinostat plus chemoradiation (N=53; Exploratory Set 2). Post-surgical, residual enhancing disease was quantified using T1 subtraction maps. Multivariate Cox regression models were used to determine influence of clinical variables, MGMT status, and residual tumor volume on OS. A log-linear relationship was observed between post-operative, residual enhancing tumor volume and OS in newly diagnosed GBM treated with standard chemoradiation. Post-operative tumor volume is a prognostic factor for OS (P<0.01), regardless of therapy, age, and MGMT promoter methylation status. Post-surgical, residual contrast-enhancing disease significantly negatively influences survival in patients with newly diagnosed glioblastoma treated with chemoradiation with or without concomitant experimental therapy.

  12. A comparative study on the effects of systemic manual acupuncture, periauricular electroacupuncture, and digital electroacupuncture to treat tinnitus: A randomized, paralleled, open-labeled exploratory trial.

    PubMed

    Kim, Bong Hyun; Kim, Kyuseok; Nam, Hae Jeong

    2017-01-31

    Many previous studies of electroacupuncture used combined therapy of electroacupuncture and systemic manual acupuncture, so it was uncertain which treatment was effective. This study evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. A randomized, parallel, open-labeled exploratory trial was conducted. Subjects aged 20-75 years who had suffered from idiopathic tinnitus for > 2 weeks were recruited from May 2013 to April 2014. The subjects were divided into three groups by systemic manual acupuncture group (MA), periauricular electroacupuncture group (PE), and distal electroacupuncture group (DE). The groups were selected by random drawing. Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of eight sessions over 4 weeks. Outcomes were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud , and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. Thirty-nine subjects were eligible and their data were analyzed. No difference in THI and VAS loudness scores was observed in between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. There was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS uncomfortable . KCT0001991 by CRIS (Clinical Research Information Service), 2016-8-1, retrospectively registered.

  13. Targeted Temperature Management After Pediatric Cardiac Arrest Due To Drowning: Outcomes and Complications.

    PubMed

    Moler, Frank W; Hutchison, Jamie S; Nadkarni, Vinay M; Silverstein, Faye S; Meert, Kathleen L; Holubkov, Richard; Page, Kent; Slomine, Beth S; Christensen, James R; Dean, J Michael

    2016-08-01

    To describe outcomes and complications in the drowning subgroup from the Therapeutic Hypothermia After Pediatric Cardiac Arrest Out-of-Hospital trial. Exploratory post hoc cohort analysis. Twenty-four PICUs. Pediatric drowning cases. Therapeutic hypothermia versus therapeutic normothermia. An exploratory study of pediatric drowning from the Therapeutic Hypothermia After Pediatric Cardiac Arrest Out-of-Hospital trial was conducted. Comatose patients aged more than 2 days and less than 18 years were randomized up to 6 hours following return-of-circulation to hypothermia (n = 46) or normothermia (n = 28). Outcomes assessed included 12-month survival with a Vineland Adaptive Behavior Scale score of greater than or equal to 70, 1-year survival rate, change in Vineland Adaptive Behavior Scale-II score from prearrest to 12 months, and select safety measures. Seventy-four drowning cases were randomized. In patients with prearrest Vineland Adaptive Behavior Scale-II greater than or equal to 70 (n = 65), there was no difference in 12-month survival with Vineland Adaptive Behavior Scale-II score of greater than or equal to 70 between hypothermia and normothermia groups (29% vs 17%; relative risk, 1.74; 95% CI, 0.61-4.95; p = 0.27). Among all evaluable patients (n = 68), the Vineland Adaptive Behavior Scale-II score change from baseline to 12 months did not differ (p = 0.46), and 1-year survival was similar (49% hypothermia vs 42%, normothermia; relative risk, 1.16; 95% CI, 0.68-1.99; p = 0.58). Hypothermia was associated with a higher prevalence of positive bacterial culture (any blood, urine, or respiratory sample; 67% vs 43%; p = 0.04); however, the rate per 100 days at risk did not differ (11.1 vs 8.4; p = 0.46). Cumulative incidence of blood product use, serious arrhythmias, and 28-day mortality were not different. Among patients with cardiopulmonary resuscitation durations more than 30 minutes or epinephrine doses greater than 4, none had favorable Pediatric Cerebral Performance Category outcomes (≤ 3). In comatose survivors of out-of-hospital pediatric cardiac arrest due to drowning, hypothermia did not result in a statistically significant benefit in survival with good functional outcome or mortality at 1 year, as compared with normothermia. High risk of culture-proven bacterial infection was observed in both groups.

  14. Migraine and triggers: Post hoc ergo propter hoc?

    PubMed Central

    Hoffmann, Jan; Recober, Ana

    2013-01-01

    The influence of environmental factors on the clinical manifestation of migraine has been a matter of extensive debate over the past decades. Migraineurs commonly report foods, alcohol, meteorologic or atmospheric changes, exposure to light, sounds, or odors, as factors that trigger or aggravate their migraine attacks. In the same way, physicians frequently follow this belief in their recommendations in how migraineurs may reduce their attack frequency, especially with regard to the consumption of certain food components. Interestingly, despite being such a common belief, most of the clinical studies have shown conflicting results. The aim of the review is to critically analyze clinical and pathophysiological facts that support or refute a correlation between certain environmental stimuli and the occurrence of migraine attacks. Given the substantial discrepancy between patients' reports and objective clinical data, the methodological difficulties of investigating the link between environmental factors and migraine are highlighted. PMID:23996725

  15. Influence of Skip Patterns on Item Non-Response in a Substance Use Survey of 7th to 12th Grade Students

    ERIC Educational Resources Information Center

    Ding, Kele; Olds, R. Scott; Thombs, Dennis L.

    2009-01-01

    This retrospective case study assessed the influence of item non-response error on subsequent response to questionnaire items assessing adolescent alcohol and marijuana use. Post-hoc analyses were conducted on survey results obtained from 4,371 7th to 12th grade students in Ohio in 2005. A skip pattern design in a conventional questionnaire…

  16. Creating a Common Scale by Post-Hoc IRT Equating to Investigate the Effects of the New National Educational Policy in Japan

    ERIC Educational Resources Information Center

    Saida, Chisato

    2017-01-01

    The new national educational policy was implemented at secondary schools in 2002 in Japan. The revised Course of Study for foreign language education corresponding to the national educational policy decreased the number of English lessons per week from four to three at the junior high school level, which resulted in a 25% decrease in English…

  17. Imperatives for Effective Post-Conflict Reconstruction Contracting

    DTIC Science & Technology

    2007-03-15

    the transfer of authority from the CPA to the Interim Iraqi Government ( IIG ) in June 2004, the PMO was disestablished. All remaining DFI funds were...turned over the IIG . The Project and Contracting Office (PCO), another ad-hoc temporary organization was created and given the responsibility for...500K for division commanders with respective single transaction limits of $50K and $100K, respectively; weekly reporting; and for projects greater than

  18. Examining statewide capacity for school health and mental health promotion: a post hoc application of a district capacity-building framework.

    PubMed

    Maras, Melissa A; Weston, Karen J; Blacksmith, Jennifer; Brophy, Chelsey

    2015-03-01

    Schools must possess a variety of capacities to effectively support comprehensive and coordinated school health promotion activities, and researchers have developed a district-level capacity-building framework specific to school health promotion. State-level school health coalitions often support such capacity-building efforts and should embed this work within a data-based, decision-making model. However, there is a lack of guidance for state school health coalitions on how they should collect and use data. This article uses a district-level capacity-building framework to interpret findings from a statewide coordinated school health needs/resource assessment in order to examine statewide capacity for school health promotion. Participants included school personnel (N = 643) from one state. Descriptive statistics were calculated for survey items, with further examination of subgroup differences among school administrators and nurses. Results were then interpreted via a post hoc application of a district-level capacity-building framework. Findings across districts revealed statewide strengths and gaps with regard to leadership and management capacities, internal and external supports, and an indicator of global capacity. Findings support the utility of using a common framework across local and state levels to align efforts and embed capacity-building activities within a data-driven, continuous improvement model. © 2014 Society for Public Health Education.

  19. Epiphany sealer penetration into dentinal tubules: Confocal laser scanning microscopic study.

    PubMed

    Ravi, S V; Nageswar, Rao; Swapna, Honwad; Sreekant, Puthalath; Ranjith, Madhavan; Mahidhar, Surabhi

    2014-03-01

    The aim of the following study was to evaluate the percentage and average depth of epiphany sealer penetration into dentinal tubules among the coronal, middle and apical thirds of the root using the confocal laser scanning microscopy (CLSM). A total of 10 maxillary central incisors were prepared and obturated with Resilon-Epiphany system. Sealer was mixed with fluorescent rhodamine B isothiyocyanate dye for visibility under confocal microscope. Teeth were cross-sectioned into coronal, middle and apical sections-2 mm thick. Sections were observed under CLSM. Images were analyzed for percentage and average depth of sealer penetration into dentinal tubules using the lasso tool in Adobe Photoshop CS3 (Adobe systems incorporated, San jose, CA) and laser scanning microscopy (LSM 5) image analyzer. One-way analysis of variance with Student Neuman Keuls post hoc tests, Kruskal-Wallis test and Wilcoxon signed-rank post hoc tests. The results showed that a higher percentage of sealer penetration in coronal section-89.23%, followed by middle section-84.19% and the apical section-64.9%. Average depth of sealer penetration for coronal section was 526.02 μm, middle-385.26 μm and apical-193.49 μm. Study concluded that there was higher epiphany sealer penetration seen in coronal followed by middle and least at apical third of the roots.

  20. Differences in gray matter structure correlated to nationalism and patriotism

    PubMed Central

    Takeuchi, Hikaru; Taki, Yasuyuki; Sekiguchi, Atsushi; Nouchi, Rui; Kotozaki, Yuka; Nakagawa, Seishu; Miyauchi, Carlos Makoto; Iizuka, Kunio; Yokoyama, Ryoichi; Shinada, Takamitsu; Yamamoto, Yuki; Hanawa, Sugiko; Araki, Tsuyoshi; Hashizume, Hiroshi; Kunitoki, Keiko; Sassa, Yuko; Kawashima, Ryuta

    2016-01-01

    Nationalism and patriotism both entail positive evaluations of one’s nation. However, the former inherently involves derogation of other nations, whereas the latter is independent of comparisons with other nations. We used voxel-based morphometry and psychological measures and determined nationalism and patriotism’s association with gray matter density (rGMD) and their cognitive nature in healthy individuals (433 men and 344 women; age, 20.7 ± 1.9 years) using whole-brain multiple regression analyses and post hoc analyses. We found higher nationalism associated with greater rGMD in (a) areas of the posterior cingulate cortex and greater rGMD in (b) the orbitofrontal cortex, and smaller rGMD in (c) the right amygdala area. Furthermore, we found higher patriotism associated with smaller rGMD in the (d) rostrolateral prefrontal cortex. Post hoc analyses revealed the mean rGMD of the cluster (a) associated with compassion, that of (b) associated with feeling of superiority, that of (c) associated with suicide ideation, and that of (d) associated with quality of life. These results indicate that individual nationalism may be mediated by neurocognitive mechanisms in social-related areas and limbic neural mechanisms, whereas patriotism may be mediated by neurocognitive mechanisms in areas related to well-being. PMID:27418362

  1. Effect of feedback techniques for lower back pain on gluteus maximus and oblique abdominal muscle activity and angle of pelvic rotation during the clam exercise.

    PubMed

    Koh, Eun-Kyung; Park, Kyue-Nam; Jung, Do-Young

    2016-11-01

    This study was conducted in order to determine the effect of feedback tools on activities of the gluteus maximus (Gmax) and oblique abdominal muscles and the angle of pelvic rotation during clam exercise (CE). Comparative study using repeated measures. University laboratory. Sixteen subjects with lower back pain. Each subject performed the CE without feedback, the CE using a pressure biofeedback unit (CE-PBU), and the CE with palpation and visual feedback (CE-PVF). Electromyographic (EMG) activity and the angles of pelvic rotation were measured using surface EMG and a three-dimensional motion-analysis system, respectively. One-way repeated-measures ANOVA followed by the Bonferroni post hoc test were used to compare the EMG activity in each muscle as well as the angle of pelvic rotation during the CE, CE-PBU, and CE-PVF. The results of post-hoc testing showed a significantly reduced angle of pelvic rotation and significantly more Gmax EMG activity during the CE-PVF compared with during the CE and CE-PBU. These findings suggest that palpation and visual feedback is effective for activating the Gmax and controlling pelvic rotation during the CE in subjects with lower back pain. Copyright © 2016 Elsevier Ltd. All rights reserved.

  2. Evidence that genetic variation in the oxytocin receptor (OXTR) gene influences social cognition in ADHD.

    PubMed

    Park, J; Willmott, M; Vetuz, G; Toye, C; Kirley, A; Hawi, Z; Brookes, K J; Gill, M; Kent, L

    2010-05-30

    Some children with ADHD also have social and communication difficulties similar to those seen in children with autistic spectrum disorders and this may be due to shared genetic liability. As the oxytocin receptor (OXTR) gene has been implicated in social cognition and autistic spectrum disorders, this study investigated whether OXTR polymorphisms previously implicated in autism were associated with ADHD and whether they influenced OXTR mRNA expression in 27 normal human amygdala brain samples. The family-based association sample consisted of 450 DSM-IV diagnosed ADHD probands and their parents. Although there was no association with the ADHD phenotype, an association with social cognitive impairments in a subset of the ADHD probands (N=112) was found for SNP rs53576 (F=5.24, p=0.007) with post-hoc tests demonstrating that the AA genotype was associated with better social ability compared to the AG genotype. Additionally, significant association was also found for rs13316193 (F=3.09, p=0.05) with post-hoc tests demonstrating that the CC genotype was significantly associated with poorer social ability than the TT genotype. No significant association between genotype and OXTR mRNA expression was found. This study supports previous evidence that the OXTR gene is implicated in social cognition. Copyright 2010 Elsevier Inc. All rights reserved.

  3. Multidisciplinary and biodanza intervention for the management of fibromyalgia.

    PubMed

    Carbonell-Baeza, Ana; Ruiz, Jonatan R; Aparicio, Virginia A; Martins-Pereira, Clelia M; Gatto-Cardia, M Claudia; Martinez, Jose M; Ortega, Francisco B; Delgado-Fernandez, Manuel

    2012-01-01

    To evaluate and compare the effectiveness of a 16-week multidisciplinary (exercise plus psychological therapy) and biodanza intervention in women with fibromyalgia. Thirty-eight women with fibromyalgia were distributed to a 16-week multidisciplinary (3-times/week) intervention (n=21) or Biodanza (1-time/week) intervention (n=17). We assessed tender point, body composition, physical fitness and psychological outcomes (Fibromyalgia Impact Questionnaire, the Short-Form Health Survey 36 questionnaire (SF-36), the Hospital Anxiety and Depression Scale, Vanderbilt Pain Management Inventory (VPMI), Rosenberg Self-Esteem Scale and General Self-Efficacy Scale). We observed a significant group*time interaction effect for the scales of SF-36 physical role (P=0.038) and social functioning (P=0.030) and for the passive coping scale in VPMI (P=0.043). Post hoc analysis revealed a significant improvement on social functioning (P=0.030) in the multidisciplinary group whereas it did not change in the Biodanza group. Post hoc analysis revealed a reduction in the use of passive coping (positive) (P less than 0.001) in the multidisciplinary group. There was no significant interaction or time effect in body composition and physical fitness. 16 weeks of multidisciplinary intervention induced greater benefits than a Biodanza intervention for social functioning and the use of passive coping strategies in women with fibromyalgia.

  4. The effect of mirror therapy integrating functional electrical stimulation on the gait of stroke patients.

    PubMed

    Ji, Sang-Goo; Cha, Hyun-Gyu; Kim, Myoung-Kwon; Lee, Chang-Ryeol

    2014-04-01

    [Purpose] The aim of the present study was to examine whether mirror therapy in conjunction with FES in stroke patients can improve gait ability. [Subjects] This study was conducted with 30 subjects who were diagnosed with hemiparesis due to stroke. [Methods] Experimental group I contained 10 subjects who received mirror therapy in conjunction with functional electrical stimulation, experimental group II contained 10 subjects who received mirror therapy, and the control group contained 10 subjects who received a sham therapy. A gait analysis was performed using a three-dimensional motion capture system, which was a real-time tracking device that delivers data in an infrared mode via reflective markers using six cameras. [Results] The results showed a significant difference in gait velocity between groups after the experiment, and post hoc analysis revealed significant differences between experimental group I and the control group and between experimental group II and the control group, respectively. There were also significant differences in step length and stride length between the groups after the experiment, and post hoc analysis revealed significant differences between experimental group I and control group. [Conclusion] The present study showed that mirror therapy in conjunction with FES is more effective for improving gait ability than mirror therapy alone.

  5. Development and preliminary validation of a post-fistula repair reintegration instrument among Ugandan women.

    PubMed

    El Ayadi, Alison; Nalubwama, Hadija; Barageine, Justus; Neilands, Torsten B; Obore, Susan; Byamugisha, Josaphat; Kakaire, Othman; Mwanje, Haruna; Korn, Abner; Lester, Felicia; Miller, Suellen

    2017-09-02

    Obstetric fistula is a debilitating and traumatic birth injury affecting 2-3 million women globally, mostly in sub-Saharan Africa and Asia. Affected women suffer physically, psychologically and socioeconomically. International efforts have increased access to surgical treatment, yet attention to a holistic outcome of post-surgical rehabilitation is nascent. We sought to develop and pilot test a measurement instrument to assess post-surgical family and community reintegration. We conducted an exploratory sequential mixed-methods study, beginning with 16 in-depth interviews and four focus group discussions with 17 women who underwent fistula surgery within two previous years to inform measure development. The draft instrument was validated in a longitudinal cohort of 60 women recovering from fistula surgery. Qualitative data were analyzed through thematic analysis. Socio-demographic characteristics were described using one-way frequency tables. We used exploratory factor analysis to determine the latent structure of the scale, then tested the fit of a single higher-order latent factor. We evaluated internal consistency and temporal stability reliability through Raykov's ρ and Pearson's correlation coefficient, respectively. We estimated a series of linear regression models to explore associations between the standardized reintegration measure and validated scales representing theoretically related constructs. Themes central to women's experiences following surgery included resuming mobility, increasing social interaction, improved self-esteem, reduction of internalized stigma, resuming work, meeting their own needs and the needs of dependents, meeting other expected and desired roles, and negotiating larger life issues. We expanded the Return to Normal Living Index to reflect these themes. Exploratory factor analysis suggested a four-factor structure, titled 'Mobility and social engagement', 'Meeting family needs', 'Comfort with relationships', and 'General life satisfaction', and goodness of fit statistics supported a higher-order latent variable of 'Reintegration.' Reintegration score correlated significantly with quality of life, depression, self-esteem, stigma, and social support in theoretically expected directions. As more women undergo surgical treatment for obstetric fistula, attention to the post-repair period is imperative. This preliminary validation of a reintegration instrument represents a first step toward improving measurement of post-surgical reintegration and has important implications for the evidence base of post-surgical reintegration epidemiology and the development and evaluation of fistula programming.

  6. Deficits in novelty exploration after controlled cortical impact.

    PubMed

    Wagner, Amy K; Postal, Brett A; Darrah, Shaun D; Chen, Xiangbai; Khan, Amina S

    2007-08-01

    Experimental models of traumatic brain injury (TBI) have been utilized to characterize the behavioral derangements associated with brain trauma. Several studies exist characterizing motor function in the controlled cortical impact (CCI) injury model of TBI, but less research has focused on how CCI affects exploratory behavior. The goal of this study was to characterize deficits in three novelty exploration tasks after the CCI. Under anesthesia, 37 adult male Sprague Dawley rats received CCI (2.7 mm and 2.9 mm; 4 m/sec) over the right parietal cortex or sham surgery. For days 1-6 post-surgery, the beam balance and beam walking tasks were used to assess motor deficits. The Open Field, Y-Maze, and Free Choice Novelty (FCN) tasks were used to measure exploratory deficits from days 7-14 post-surgery. Injured rats displayed a significant, but transient, deficit on each motor task (p < 0.0001). Open Field results showed that injured rats had lower activity levels than shams (p < 0.0001), displayed less habituation to the task, and had more anxiety related behaviors (thigmotaxis) across days (p < 0.0001). Y-maze results suggest that injured rats spent less time in the novel arm versus the familiar arms when compared to shams (p < 0.0001). For FCN, injured rats were less active (p < 0.05) and spent less time and had fewer interactions with objects in the novel environment compared to shams (p < 0.05). These results suggest that several ethological factors contribute to exploratory deficits after CCI and can be effectively characterized with the behavioral tasks described. Future work will utilize these tasks to evaluate the neural substrates underlying exploratory deficits after TBI.

  7. Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration.

    PubMed

    McBrayer, Zofeyah L; Dimova, Jiva; Pisansky, Marc T; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C; O'Connor, Michael B

    2015-01-01

    To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors.

  8. Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration

    PubMed Central

    McBrayer, Zofeyah L.; Dimova, Jiva; Pisansky, Marc T.; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C.; O’Connor, Michael B.

    2015-01-01

    To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors. PMID:26444546

  9. Gene expression associated with suicide attempts in US veterans (Open Access)

    DTIC Science & Technology

    2017-09-05

    schizophrenia who had died from suicide. This gene codes for a cytokine that is part of the tumor necrosis factor family. In addition, the PIK3C3...expression level of eIF2 (and mTOR and WNT) was downregulated in one published report examining post- mortem tissue in people who had a schizophrenia ...HK. Suicide candidate genes associated with bipolar disorder and schizophrenia : an exploratory gene expression profiling analysis of post-mortem

  10. Optimizing Interactive Development of Data-Intensive Applications

    PubMed Central

    Interlandi, Matteo; Tetali, Sai Deep; Gulzar, Muhammad Ali; Noor, Joseph; Condie, Tyson; Kim, Miryung; Millstein, Todd

    2017-01-01

    Modern Data-Intensive Scalable Computing (DISC) systems are designed to process data through batch jobs that execute programs (e.g., queries) compiled from a high-level language. These programs are often developed interactively by posing ad-hoc queries over the base data until a desired result is generated. We observe that there can be significant overlap in the structure of these queries used to derive the final program. Yet, each successive execution of a slightly modified query is performed anew, which can significantly increase the development cycle. Vega is an Apache Spark framework that we have implemented for optimizing a series of similar Spark programs, likely originating from a development or exploratory data analysis session. Spark developers (e.g., data scientists) can leverage Vega to significantly reduce the amount of time it takes to re-execute a modified Spark program, reducing the overall time to market for their Big Data applications. PMID:28405637

  11. Querying Archetype-Based Electronic Health Records Using Hadoop and Dewey Encoding of openEHR Models.

    PubMed

    Sundvall, Erik; Wei-Kleiner, Fang; Freire, Sergio M; Lambrix, Patrick

    2017-01-01

    Archetype-based Electronic Health Record (EHR) systems using generic reference models from e.g. openEHR, ISO 13606 or CIMI should be easy to update and reconfigure with new types (or versions) of data models or entries, ideally with very limited programming or manual database tweaking. Exploratory research (e.g. epidemiology) leading to ad-hoc querying on a population-wide scale can be a challenge in such environments. This publication describes implementation and test of an archetype-aware Dewey encoding optimization that can be used to produce such systems in environments supporting relational operations, e.g. RDBMs and distributed map-reduce frameworks like Hadoop. Initial testing was done using a nine-node 2.2 GHz quad-core Hadoop cluster querying a dataset consisting of targeted extracts from 4+ million real patient EHRs, query results with sub-minute response time were obtained.

  12. Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study.

    PubMed

    Wallace, Daniel J; Kalunian, Kenneth; Petri, Michelle A; Strand, Vibeke; Houssiau, Frederic A; Pike, Marilyn; Kilgallen, Brian; Bongardt, Sabine; Barry, Anna; Kelley, Lexy; Gordon, Caroline

    2014-01-01

    To identify a suitable dosing regimen of the CD22-targeted monoclonal antibody epratuzumab in adults with moderately to severely active systemic lupus erythematosus (SLE). A phase IIb, multicentre, randomised controlled study (NCT00624351) was conducted with 227 patients (37-39 per arm) receiving either: placebo, epratuzumab 200 mg cumulative dose (cd) (100 mg every other week (EOW)), 800 mg cd (400 mg EOW), 2400 mg cd (600 mg weekly), 2400 mg cd (1200 mg EOW), or 3600 mg cd (1800 mg EOW). The primary endpoint (not powered for significance) was the week 12 responder rate measured using a novel composite endpoint, the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA). Proportion of responders was higher in all epratuzumab groups than with placebo (overall treatment effect test p=0.148). Exploratory pairwise analysis demonstrated clinical improvement in patients receiving a cd of 2400 mg epratuzumab (OR for 600 mg weekly vs placebo: 3.2 (95% CI 1.1 to 8.8), nominal p=0.03; OR for 1200 mg EOW vs placebo: 2.6 (0.9 to 7.1), nominal p=0.07). Post-hoc comparison of all 2400 mg cd patients versus placebo found an overall treatment effect (OR=2.9 (1.2 to 7.1), nominal p=0.02). Incidence of adverse events (AEs), serious AEs and infusion reactions was similar between epratuzumab and placebo groups, without decreases in immunoglobulin levels and only partial reduction in B-cell levels. Treatment with epratuzumab 2400 mg cd was well tolerated in patients with moderately to severely active SLE, and associated with improvements in disease activity. Phase III studies are ongoing.

  13. Healthy Aging 5 Years After a Period of Daily Supplementation With Antioxidant Nutrients: A Post Hoc Analysis of the French Randomized Trial SU.VI.MAX.

    PubMed

    Assmann, Karen E; Andreeva, Valentina A; Jeandel, Claude; Hercberg, Serge; Galan, Pilar; Kesse-Guyot, Emmanuelle

    2015-10-15

    This study's objective was to investigate healthy aging in older French adults 5 years after a period of daily nutritional-dose supplementation with antioxidant nutrients. The study was based on the double-blind, randomized trial, Supplementation with Antioxidant Vitamins and Minerals (SU.VI.MAX) Study (1994-2002) and the SU.VI.MAX 2 Follow-up Study (2007-2009). During 1994-2002, participants received a daily combination of vitamin C (120 mg), β-carotene (6 mg), vitamin E (30 mg), selenium (100 µg), and zinc (20 mg) or placebo. Healthy aging was assessed in 2007-2009 by using multiple criteria, including the absence of major chronic disease and good physical and cognitive functioning. Data from a subsample of the SU.VI.MAX 2 cohort, initially free of major chronic disease, with a mean age of 65.3 years in 2007-2009 (n = 3,966), were used to calculate relative risks. Supplementation was associated with a greater healthy aging probability among men (relative risk = 1.16, 95% confidence interval: 1.04, 1.29) but not among women (relative risk = 0.98, 95% confidence interval: 0.86, 1.11) or all participants (relative risk = 1.07, 95% confidence interval: 0.99, 1.16). Moreover, exploratory subgroup analyses indicated effect modification by initial serum concentrations of zinc and vitamin C. In conclusion, an adequate supply of antioxidant nutrients (equivalent to quantities provided by a balanced diet rich in fruits and vegetables) may have a beneficial role for healthy aging. © The Author 2015. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. The characteristics of depressive symptoms in medical students during medical education and training: a cross-sectional study.

    PubMed

    Baldassin, Sergio; Alves, Tânia Correa de Toledo Ferraz; de Andrade, Arthur Guerra; Nogueira Martins, Luiz Antonio

    2008-12-11

    Medical education and training can contribute to the development of depressive symptoms that might lead to possible academic and professional consequences. We aimed to investigate the characteristics of depressive symptoms among 481 medical students (79.8% of the total who matriculated). The Beck Depression Inventory (BDI) and cluster analyses were used in order to better describe the characteristics of depressive symptoms. Medical education and training in Brazil is divided into basic (1st and 2nd years), intermediate (3rd and 4th years), and internship (5th and 6th years) periods. The study organized each item from the BDI into the following three clusters: affective, cognitive, and somatic. Statistical analyses were performed using analysis of variance (ANOVA) with post-hoc Tukey corrected for multiple comparisons. There were 184 (38.2%) students with depressive symptoms (BDI > 9). The internship period resulted in the highest BDI scores in comparison to both the basic (p < .001) and intermediate (p < .001) periods. Affective, cognitive, and somatic clusters were significantly higher in the internship period. An exploratory analysis of possible risk factors showed that females (p = .020) not having a parent who practiced medicine (p = .016), and the internship period (p = .001) were factors for the development of depressive symptoms. There is a high prevalence towards depressive symptoms among medical students, particularly females, in the internship level, mainly involving the somatic and affective clusters, and not having a parent who practiced medicine. The active assessment of these students in evaluating their depressive symptoms is important in order to prevent the development of co-morbidities and suicide risk.

  15. The characteristics of depressive symptoms in medical students during medical education and training: a cross-sectional study

    PubMed Central

    Baldassin, Sergio; Alves, Tânia Correa de Toledo Ferraz; de Andrade, Arthur Guerra; Nogueira Martins, Luiz Antonio

    2008-01-01

    Background Medical education and training can contribute to the development of depressive symptoms that might lead to possible academic and professional consequences. We aimed to investigate the characteristics of depressive symptoms among 481 medical students (79.8% of the total who matriculated). Methods The Beck Depression Inventory (BDI) and cluster analyses were used in order to better describe the characteristics of depressive symptoms. Medical education and training in Brazil is divided into basic (1st and 2nd years), intermediate (3rd and 4th years), and internship (5th and 6th years) periods. The study organized each item from the BDI into the following three clusters: affective, cognitive, and somatic. Statistical analyses were performed using analysis of variance (ANOVA) with post-hoc Tukey corrected for multiple comparisons. Results There were 184 (38.2%) students with depressive symptoms (BDI > 9). The internship period resulted in the highest BDI scores in comparison to both the basic (p < .001) and intermediate (p < .001) periods. Affective, cognitive, and somatic clusters were significantly higher in the internship period. An exploratory analysis of possible risk factors showed that females (p = .020) not having a parent who practiced medicine (p = .016), and the internship period (p = .001) were factors for the development of depressive symptoms. Conclusion There is a high prevalence towards depressive symptoms among medical students, particularly females, in the internship level, mainly involving the somatic and affective clusters, and not having a parent who practiced medicine. The active assessment of these students in evaluating their depressive symptoms is important in order to prevent the development of co-morbidities and suicide risk. PMID:19077227

  16. Anxiolytic and antidepressant profile of the methanolic extract of Piper nigrum fruits in beta-amyloid (1-42) rat model of Alzheimer's disease.

    PubMed

    Hritcu, Lucian; Noumedem, Jaurès A; Cioanca, Oana; Hancianu, Monica; Postu, Paula; Mihasan, Marius

    2015-03-29

    Piper nigrum L. (Piperaceae) is employed in traditional medicine of many countries as analgesic, antiinflammatory, anticonvulsant, antioxidant, antidepressant and cognitive-enhancing agent. This study was undertaken in order to evaluate the possible anxiolytic, antidepressant and antioxidant properties of the methanolic extract of Piper nigrum fruits in beta-amyloid (1-42) rat model of Alzheimer's disease. The anxiolytic- and antidepressant-like effects of the methanolic extract were studied by means of in vivo (elevated plus-maze and forced swimming tests) approaches. Also, the antioxidant activity in the amygdala was assessed using superoxide dismutase, glutathione peroxidase and catalase specific activities, the total content of the reduced glutathione, protein carbonyl and malondialdehyde levels. Statistical analyses were performed using one-way analysis of variance (ANOVA). Significant differences were determined by Tukey's post hoc test. F values for which p < 0.05 were regarded as statistically significant. Pearson's correlation coefficient and regression analysis were used in order to evaluate the connection between behavioral measures, the antioxidant defence and lipid peroxidation. The beta-amyloid (1-42)-treated rats exhibited the following: decrease of the exploratory activity, the percentage of the time spent and the number of entries in the open arm within elevated plus-maze test and decrease of swimming time and increase of immobility time within forced swimming test. Administration of the methanolic extract significantly exhibited anxiolytic- and antidepressant-like effects and also antioxidant potential. Taken together, our results suggest that the methanolic extract ameliorates beta-amyloid (1-42)-induced anxiety and depression by attenuation of the oxidative stress in the rat amygdala.

  17. The effects of strength and power training on single-step balance recovery in older adults: a preliminary study.

    PubMed

    Pamukoff, Derek N; Haakonssen, Eric C; Zaccaria, Joseph A; Madigan, Michael L; Miller, Michael E; Marsh, Anthony P

    2014-01-01

    Improving muscle strength and power may mitigate the effects of sarcopenia, but it is unknown if this improves an older adult's ability to recover from a large postural perturbation. Forward tripping is prevalent in older adults and lateral falls are important due to risk of hip fracture. We used a forward and a lateral single-step balance recovery task to examine the effects of strength training (ST) or power (PT) training on single-step balance recovery in older adults. Twenty older adults (70.8±4.4 years, eleven male) were randomly assigned to either a 6-week (three times/week) lower extremity ST or PT intervention. Maximum forward (FLean(max)) and lateral (LLean(max)) lean angle and strength and power in knee extension and leg press were assessed at baseline and follow-up. Fifteen participants completed the study (ST =7, PT =8). Least squares means (95% CI) for ΔFLean(max) (ST: +4.1° [0.7, 7.5]; PT: +0.6° [-2.5, 3.8]) and ΔLLean(max) (ST: +2.2° [0.4, 4.1]; PT: +2.6° [0.9, 4.4]) indicated no differences between groups following training. In exploratory post hoc analyses collapsed by group, ΔFLean(max) was +2.4° (0.1, 4.7) and ΔLLean(max) was +2.4° (1.2, 3.6). These improvements on the balance recovery tasks ranged from ~15%-30%. The results of this preliminary study suggest that resistance training may improve balance recovery performance, and that, in this small sample, PT did not lead to larger improvements in single-step balance recovery compared to ST.

  18. Characterizing biased cancer-related cognitive processing: relationships with BRCA1/2 genetic mutation status, personal cancer history, age, and prophylactic surgery.

    PubMed

    Carpenter, Kristen M; Eisenberg, Stacy; Weltfreid, Sharone; Low, Carissa A; Beran, Tammy; Stanton, Annette L

    2014-09-01

    This study evaluated associations of cancer-related cognitive processing with BRCA1/2 mutation carrier status, personal cancer history, age, and election of prophylactic surgery in women at high risk for breast cancer. In a 2 (BRCA1/2 mutation carrier status) × 2 (personal cancer history) matched-control design, with age as an additional predictor, participants (N = 115) completed a computerized cancer Stroop task. Dependent variables were response latency to cancer-related stimuli (reaction time [RT]) and cancer-related cognitive interference (cancer RT minus neutral RT). RT and interference were tested as predictors of prophylactic surgery in the subsequent four years. RT for cancer-related words was significantly slower than other word groups, indicating biased processing specific to cancer-related stimuli. Participants with a cancer history evidenced longer RT to cancer-related words than those without a history; moreover, a significant Cancer History × Age interaction indicated that, among participants with a cancer history, the typical advantage associated with younger age on Stroop tasks was absent. BRCA mutation carriers demonstrated more cancer-related cognitive interference than noncarriers. Again, the typical Stroop age advantage was absent among carriers. Exploratory analyses indicated that BRCA+ status and greater cognitive interference predicted greater likelihood of undergoing prophylactic surgery. Post hoc tests suggest that cancer-related distress does not account for these relationships. In the genetic testing context, younger women with a personal cancer history or who are BRCA1/2 mutation carriers might be particularly vulnerable to biases in cancer-related cognitive processing. Biased processing was associated marginally with greater likelihood of prophylactic surgery. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  19. Effect of maternal death reviews and training on maternal mortality among cesarean delivery: post-hoc analysis of a cluster-randomized controlled trial.

    PubMed

    Zongo, Augustin; Dumont, Alexandre; Fournier, Pierre; Traore, Mamadou; Kouanda, Séni; Sondo, Blaise

    2015-02-01

    To explore the differential effect of a multifaceted intervention on hospital-based maternal mortality between patients with cesarean and vaginal delivery in low-resource settings. We reanalyzed the data from a major cluster-randomized controlled trial, QUARITE (Quality of care, Risk management and technology in obstetrics). These subgroup analyses were not pre-specified and were treated as exploratory. The intervention consisted of an initial interactive workshop and quarterly educational clinically oriented and evidence-based outreach visits focused on maternal death reviews (MDR) and best practices implementation. The trial originally recruited 191,167 patients who delivered in each of the 46 participating hospitals in Mali and Senegal, between 2007 and 2011. The primary endpoint was hospital-based maternal mortality. Subgroup-specific Odds Ratios (ORs) of maternal mortality were computed and tested for differential intervention effect using generalized linear mixed model between two subgroups (cesarean: 40,975; and vaginal delivery: 150,192). The test for homogeneity of intervention effects on hospital-based maternal mortality among the two delivery mode subgroups was statistically significant (p-value: 0.0201). Compared to the control, the adjusted OR of maternal mortality was 0.71 (95% CI: 0.58-0.82, p=0.0034) among women with cesarean delivery. The intervention had no significant effect among women with vaginal delivery (adjusted OR 0.87, 95% CI 0.69-1.11, p=0.6213). This differential effect was particularly marked for district hospitals. Maternal deaths reviews and on-site training on emergency obstetric care may be more effective in reducing maternal mortality among high-risk women who need a cesarean section than among low-risk women with vaginal delivery. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  20. Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.

    PubMed

    Grant, Aileen; Dreischulte, Tobias; Treweek, Shaun; Guthrie, Bruce

    2012-08-28

    Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.

  1. Two Years of Relationship-Focused Mentoring for First Nations, Métis, and Inuit Adolescents: Promoting Positive Mental Health.

    PubMed

    Crooks, Claire V; Exner-Cortens, Deinera; Burm, Sarah; Lapointe, Alicia; Chiodo, Debbie

    2017-04-01

    First Nations, Métis, and Inuit (FNMI) youth are disproportionately affected by a range of negative health outcomes including poor emotional and psychosocial well-being. At the same time, there is increasing awareness of culturally-specific protective factors for these youth, such as cultural connectedness and identity. This article reports the findings of a mixed-methods, exploratory longitudinal study on the effects of a culturally-relevant school-based mentoring program for FNMI youth that focuses on promoting mental well-being and the development of cultural identity. Participants included a cohort of FNMI adolescents whom we tracked across the transition from elementary to secondary school. We utilized data from annual surveys (n = 105) and a subset of youth whom we interviewed (n = 28). Quantitative analyses compared youth who participated in 1 or 2 years of mentoring programs with those who did not participate. At Wave 3, the 2-year mentoring group demonstrated better mental health and improved cultural identity, accounting for Wave 1 functioning. These results were maintained when sex and school climate were accounted for in the models. Sex did not emerge as a significant moderator; however, post hoc analyses with simple slopes indicated that the mentoring program benefited girls more than boys for both outcomes. Interview data were coded and themed through a multi-phase process, and revealed that the mentoring program helped participants develop their intrapersonal and interpersonal skills, and enhanced their cultural and healthy relationships knowledge base. Collectively, the quantitative and qualitative components of this study identify multiple years of culturally-relevant mentoring as a promising approach for promoting well-being among FNMI youth.

  2. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial.

    PubMed

    Cortés, Javier; Rugo, Hope S; Awada, Ahmad; Twelves, Chris; Perez, Edith A; Im, Seock-Ah; Gómez-Pardo, Patricia; Schwartzberg, Lee S; Diéras, Veronique; Yardley, Denise A; Potter, David A; Mailliez, Audrey; Moreno-Aspitia, Alvaro; Ahn, Jin-Seok; Zhao, Carol; Hoch, Ute; Tagliaferri, Mary; Hannah, Alison L; O'Shaughnessy, Joyce

    2017-09-01

    Conventional chemotherapy has limited activity in patients with breast cancer and brain metastases (BCBM). Etirinotecan pegol (EP), a novel long-acting topoisomerase-1 inhibitor, was designed using advanced polymer technology to preferentially accumulate in tumor tissue including brain metastases, providing sustained cytotoxic SN38 levels. The phase 3 BEACON trial enrolled 852 women with heavily pretreated locally recurrent or metastatic breast cancer between 2011 and 2013. BEACON compared EP with treatment of physician's choice (TPC; eribulin, vinorelbine, gemcitabine, nab-paclitaxel, paclitaxel, ixabepilone, or docetaxel) in patients previously treated with anthracycline, taxane, and capecitabine, including those with treated, stable brain metastases. The primary endpoint, overall survival (OS), was assessed in a pre-defined subgroup of BCBM patients; an exploratory post hoc analysis adjusting for the diagnosis-specific graded prognostic assessment (GPA) index was also conducted. In the trial, 67 BCBM patients were randomized (EP, n = 36; TPC, n = 31). Treatment subgroups were balanced for baseline characteristics and GPA indices. EP was associated with a significant reduction in the risk of death (HR 0.51; P < 0.01) versus TPC; median OS was 10.0 and 4.8 months, respectively. Improvement in OS was observed in both poorer and better GPA prognostic groups. Survival rates at 12 months were 44.4% for EP versus 19.4% for TPC. Consistent with the overall BEACON population, fewer patients on EP experienced grade ≥3 toxicity (50 vs. 70%). The significant improvement in survival in BCBM patients provides encouraging data for EP in this difficult-to-treat subgroup of patients. A phase three trial of EP in BCBM patients is underway (ClinicalTrials.gov NCT02915744).

  3. Widespread reductions of white matter integrity in patients with long-term remission of Cushing's disease.

    PubMed

    van der Werff, Steven J A; Andela, Cornelie D; Nienke Pannekoek, J; Meijer, Onno C; van Buchem, Mark A; Rombouts, Serge A R B; van der Mast, Roos C; Biermasz, Nienke R; Pereira, Alberto M; van der Wee, Nic J A

    2014-01-01

    Hypercortisolism leads to various physical, psychological and cognitive symptoms, which may partly persist after the treatment of Cushing's disease. The aim of the present study was to investigate abnormalities in white matter integrity in patients with long-term remission of Cushing's disease, and their relation with psychological symptoms, cognitive impairment and clinical characteristics. In patients with long-term remission of Cushing's disease (n = 22) and matched healthy controls (n = 22) we examined fractional anisotropy (FA) values of white matter in a region-of-interest (ROI; bilateral cingulate cingulum, bilateral hippocampal cingulum, bilateral uncinate fasciculus and corpus callosum) and the whole brain, using 3 T diffusion tensor imaging (DTI) and a tract-based spatial statistics (TBSS) approach. Psychological and cognitive functioning were assessed with validated questionnaires and clinical severity was assessed using the Cushing's syndrome Severity Index. The ROI analysis showed FA reductions in all of the hypothesized regions, with the exception of the bilateral hippocampal cingulum, in patients when compared to controls. The exploratory whole brain analysis showed multiple regions with lower FA values throughout the brain. Patients reported more apathy (p = .003) and more depressive symptoms (p < .001), whereas depression symptom severity in the patient group was negatively associated with FA in the left uncinate fasciculus (p < 0.05). Post-hoc analyses showed increased radial and mean diffusivity in the patient group. Patients with a history of endogenous hypercortisolism in present remission show widespread changes of white matter integrity in the brain, with abnormalities in the integrity of the uncinate fasciculus being related to the severity of depressive symptoms, suggesting persistent structural effects of hypercortisolism.

  4. Widespread reductions of white matter integrity in patients with long-term remission of Cushing's disease

    PubMed Central

    van der Werff, Steven J.A.; Andela, Cornelie D.; Nienke Pannekoek, J.; Meijer, Onno C.; van Buchem, Mark A.; Rombouts, Serge A.R.B.; van der Mast, Roos C.; Biermasz, Nienke R.; Pereira, Alberto M.; van der Wee, Nic J.A.

    2014-01-01

    Background Hypercortisolism leads to various physical, psychological and cognitive symptoms, which may partly persist after the treatment of Cushing's disease. The aim of the present study was to investigate abnormalities in white matter integrity in patients with long-term remission of Cushing's disease, and their relation with psychological symptoms, cognitive impairment and clinical characteristics. Methods In patients with long-term remission of Cushing's disease (n = 22) and matched healthy controls (n = 22) we examined fractional anisotropy (FA) values of white matter in a region-of-interest (ROI; bilateral cingulate cingulum, bilateral hippocampal cingulum, bilateral uncinate fasciculus and corpus callosum) and the whole brain, using 3 T diffusion tensor imaging (DTI) and a tract-based spatial statistics (TBSS) approach. Psychological and cognitive functioning were assessed with validated questionnaires and clinical severity was assessed using the Cushing's syndrome Severity Index. Results The ROI analysis showed FA reductions in all of the hypothesized regions, with the exception of the bilateral hippocampal cingulum, in patients when compared to controls. The exploratory whole brain analysis showed multiple regions with lower FA values throughout the brain. Patients reported more apathy (p = .003) and more depressive symptoms (p < .001), whereas depression symptom severity in the patient group was negatively associated with FA in the left uncinate fasciculus (p < 0.05). Post-hoc analyses showed increased radial and mean diffusivity in the patient group. Conclusion Patients with a history of endogenous hypercortisolism in present remission show widespread changes of white matter integrity in the brain, with abnormalities in the integrity of the uncinate fasciculus being related to the severity of depressive symptoms, suggesting persistent structural effects of hypercortisolism. PMID:24936417

  5. HDL cholesterol, apolipoproteins, and cardiovascular risk in hemodialysis patients.

    PubMed

    Silbernagel, Günther; Genser, Bernd; Drechsler, Christiane; Scharnagl, Hubert; Grammer, Tanja B; Stojakovic, Tatjana; Krane, Vera; Ritz, Eberhard; Wanner, Christoph; März, Winfried

    2015-02-01

    High concentrations of HDL cholesterol are considered to indicate efficient reverse cholesterol transport and to protect from atherosclerosis. However, HDL has been suggested to be dysfunctional in ESRD. Hence, our main objective was to investigate the effect of HDL cholesterol on outcomes in maintenance hemodialysis patients with diabetes. Moreover, we investigated the associations between the major protein components of HDL (apoA1, apoA2, and apoC3) and end points. We performed an exploratory, post hoc analysis with 1255 participants (677 men and 578 women) of the German Diabetes Dialysis study. The mean age was 66.3 years and the mean body mass index was 28.0 kg/m(2). The primary end point was a composite of cardiac death, myocardial infarction, and stroke. The secondary end point included all-cause mortality. The mean duration of follow-up was 3.9 years. A total of 31.3% of the study participants reached the primary end point and 49.1% died from any cause. HDL cholesterol and apoA1 and apoC3 quartiles were not related to end points. However, there was a trend toward an inverse association between apoA2 and all-cause mortality. The hazard ratio for death from any cause in the fourth quartile compared with the first quartile of apoA2 was 0.63 (95% confidence interval, 0.40 to 0.89). The lack of an association between HDL cholesterol and cardiovascular risk may support the concept of dysfunctional HDL in hemodialysis. The possible beneficial effect of apoA2 on survival requires confirmation in future studies. Copyright © 2015 by the American Society of Nephrology.

  6. Lipid peroxidation biomarkers in adolescents with or at high-risk for bipolar disorder.

    PubMed

    Scola, Gustavo; McNamara, Robert K; Croarkin, Paul E; Leffler, Jarrod M; Cullen, Kathryn R; Geske, Jennifer R; Biernacka, Joanna M; Frye, Mark A; DelBello, Melissa P; Andreazza, Ana C

    2016-03-01

    Prior work suggests that adult bipolar disorder (BD) is associated with increased oxidative stress and inflammation. This exploratory study examined markers of lipid and protein oxidation and inflammation in adolescents with and at varying risk for BD type I (BD-I). Blood was obtained from four groups of adolescents (9-20 years of age): (1) healthy comparison subjects with no personal or family history of psychiatric disorders (n=13), (2) subjects with no psychiatric diagnosis and at least one parent with BD-I ('high-risk', n=15), (3) subjects with at least one parent with BD-I and a diagnosis of depressive disorder not-otherwise-specified ('ultra-high-risk', n=20), and (4) first-episode patients exhibiting mixed or manic symptoms that received a diagnosis of BD-I (n=16). Plasma levels of lipid peroxidation (LPH, 4-HNE, 8-ISO), protein carbonyl, and inflammation (IL-1α-β, IL-6, IL-10, IFNγ, TNFα) were assessed using analysis of variance and covariance models. LPH was lower in adolescents with fully syndromal BD than controls, while LPH levels in the at-risk groups were between healthy controls and fully syndromal BD. Post-hoc analysis showed a non-significant increase in the (4-HNE+8-ISO)/LPH ratio suggesting a potential conversion of LPH into late-stage markers of lipid peroxidation. There were no significant differences among protein carbonyl content and inflammatory markers. In adolescents, fully syndromal BD is associated with significant reductions in LPH levels, and LPH levels decrease along the spectrum of risk for BD-I. Quantifying lipid peroxidation in longitudinal studies may help clarify the role of LPH in BD risk progression. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Differences in Fruit and Vegetable Intake by Race/Ethnicity and by Hispanic Origin and Nativity Among Women in the Special Supplemental Nutrition Program for Women, Infants, and Children, 2015.

    PubMed

    Di Noia, Jennifer; Monica, Dorothy; Cullen, Karen Weber; Pérez-Escamilla, Rafael; Gray, Heewon Lee; Sikorskii, Alla

    2016-08-25

    The objective of this exploratory study was to determine whether fruit and vegetable consumption differed by race/ethnicity, by origin and nativity among Hispanics, and by language preference (as an indicator of acculturation) among foreign-born Hispanics. We recruited 723 women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and orally administered a questionnaire containing demographic items, validated measures of food security status and social desirability trait, and the Behavioral Risk Factor Surveillance System fruit and vegetable module. Differences in intakes of 100% fruit juice, fruit, cooked or canned beans, and dark green, orange-colored, and other vegetables were assessed by using analysis of covariance with Bonferroni post hoc tests. Analyses were controlled for age, pregnancy status, breastfeeding status, food security status, educational attainment, and social desirability trait. The frequency of vegetable intake differed by race/ethnicity (cooked or canned beans were consumed more often among Hispanic than non-Hispanic black and non-Hispanic white or other participants, orange-colored vegetables were consumed more often among Hispanics than non-Hispanic black participants, and other vegetables were consumed more often among non-Hispanic white or other than among non-Hispanic black and Hispanic participants), origin (other vegetables were consumed more often among Columbian and other Hispanics than Dominican participants) and nativity (orange-colored vegetables were consumed more often among foreign-born than US-born Hispanics). Fruit and vegetable intake did not differ by language preference among foreign-born Hispanics. Differences in fruit and vegetable consumption among WIC participants by race/ethnicity and by Hispanic origin and nativity may have implications for WIC nutrition policies and nutrition education efforts.

  8. Differences in Fruit and Vegetable Intake by Race/Ethnicity and by Hispanic Origin and Nativity Among Women in the Special Supplemental Nutrition Program for Women, Infants, and Children, 2015

    PubMed Central

    Monica, Dorothy; Cullen, Karen Weber; Pérez-Escamilla, Rafael; Gray, Heewon Lee; Sikorskii, Alla

    2016-01-01

    Introduction The objective of this exploratory study was to determine whether fruit and vegetable consumption differed by race/ethnicity, by origin and nativity among Hispanics, and by language preference (as an indicator of acculturation) among foreign-born Hispanics. Methods We recruited 723 women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and orally administered a questionnaire containing demographic items, validated measures of food security status and social desirability trait, and the Behavioral Risk Factor Surveillance System fruit and vegetable module. Differences in intakes of 100% fruit juice, fruit, cooked or canned beans, and dark green, orange-colored, and other vegetables were assessed by using analysis of covariance with Bonferroni post hoc tests. Analyses were controlled for age, pregnancy status, breastfeeding status, food security status, educational attainment, and social desirability trait. Results The frequency of vegetable intake differed by race/ethnicity (cooked or canned beans were consumed more often among Hispanic than non-Hispanic black and non-Hispanic white or other participants, orange-colored vegetables were consumed more often among Hispanics than non-Hispanic black participants, and other vegetables were consumed more often among non-Hispanic white or other than among non-Hispanic black and Hispanic participants), origin (other vegetables were consumed more often among Columbian and other Hispanics than Dominican participants) and nativity (orange-colored vegetables were consumed more often among foreign-born than US-born Hispanics). Fruit and vegetable intake did not differ by language preference among foreign-born Hispanics. Conclusion Differences in fruit and vegetable consumption among WIC participants by race/ethnicity and by Hispanic origin and nativity may have implications for WIC nutrition policies and nutrition education efforts. PMID:27560723

  9. Effect of Active Music Therapy and Individualized Listening to Music on Dementia: A Multicenter Randomized Controlled Trial.

    PubMed

    Raglio, Alfredo; Bellandi, Daniele; Baiardi, Paola; Gianotti, Marta; Ubezio, Maria Chiara; Zanacchi, Elisa; Granieri, Enrico; Imbriani, Marcello; Stramba-Badiale, Marco

    2015-08-01

    To assess the effects of active music therapy (MT) and individualized listening to music (LtM) on behavioral and psychological symptoms of dementia (BPSDs) in persons with dementia (PWDs). Randomized controlled trial. Nine Italian institutions. Persons with moderate to severe dementia and BPSDs (N = 120) were randomized to one of three treatments. All groups received standard care (SC), and two groups attended 20 individualized MT or LtM sessions, twice a week, in addition to SC. The Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Cornell-Brown Scale for Quality of Life in Dementia (CBS-QoL) were administered before treatment, after treatment, and at follow-up to evaluate behavioral and psychological outcomes. A specific coding scheme (Music Therapy Check List-Dementia) was used to evaluate the MT process. Behavioral assessment did not show significant differences between groups. All groups showed a reduction over time in NPI global score (P ≤ .001), CSDD (P = .001), and CBS-QoL (P = .01). The NPI global score fell 28% in the MT group, 12% in the LtM group, and 21% in the SC group at the end of treatment. An exploratory post hoc analysis showed similar within-group improvements for the NPI Delusion, Anxiety, and Disinhibition subscales. In the MT group, communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment. The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs. Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  10. Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source.

    PubMed

    Amarenco, Pierre; Albers, Gregory W; Denison, Hans; Easton, J Donald; Evans, Scott R; Held, Peter; Hill, Michael D; Jonasson, Jenny; Kasner, Scott E; Ladenvall, Per; Minematsu, Kazuo; Molina, Carlos A; Wang, Yongjun; Wong, K S Lawrence; Johnston, S Claiborne

    2017-09-01

    Ticagrelor is an effective antiplatelet therapy among patients with atherosclerotic disease and, therefore, could be more effective than aspirin in preventing recurrent stroke and cardiovascular events among patients with embolic stroke of unknown source (ESUS), which includes patients with ipsilateral stenosis <50% and aortic arch atherosclerosis. We randomized 13 199 patients with a noncardioembolic, nonsevere ischemic stroke or high-risk transient ischemic attack to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2-90) or aspirin (300 mg on day 1 followed by 100 mg daily for days 2-90) within 24 hours of symptom onset. In all patients, investigators informed on the presence of ipsilateral stenosis ≥50%, small deep infarct <15 mm, and on cardiac source of embolism detected after enrollment or rare causes, which allowed to construct an ESUS category in all other patients with documented brain infarction. The primary end point was the time to the occurrence of stroke, myocardial infarction, or death within 90 days. ESUS was identified in 4329 (32.8%) patients. There was no treatment-by-ESUS category interaction ( P =0.83). Hazard ratio in ESUS patients was 0.87 (95% confidence interval, 0.68-1.10; P =0.24). However, hazard ratio was 0.51 (95% confidence interval, 0.29-0.90; P =0.02) in ESUS patients with ipsilateral stenosis <50% or aortic arch atherosclerosis (n=961) and 0.98 (95% confidence interval, 0.76-1.27; P =0.89) in the remaining ESUS patients (n=3368; P for heterogeneity =0.04). In this post hoc, exploratory analysis, we found no treatment-by-ESUS category interaction. ESUS subgroups have heterogeneous response to treatment (Funded by AstraZeneca). URL: http://www.clinicaltrials.gov. Unique identifier: NCT01994720. © 2017 American Heart Association, Inc.

  11. Risk Factors Associated With Chemotherapy-Induced Nausea in the Week Prior to the Next Cycle and Impact of Nausea on Quality of Life Outcomes.

    PubMed

    Singh, Komal P; Kober, Kord M; Dhruva, Anand A; Flowers, Elena; Paul, Steve M; Hammer, Marilyn J; Cartwright, Frances; Wright, Fay; Conley, Yvette P; Levine, Jon D; Miaskowski, Christine

    2018-05-29

    Despite current advances in antiemetic treatments, between 19% to 58% of oncology patients experience chemotherapy-induced nausea (CIN). Aims of this post hoc exploratory analysis were to determine occurrence, severity, and distress of CIN and evaluate for differences in demographic and clinical characteristics, symptom severity, stress; and quality of life (QOL) outcomes between oncology patients who did and did not report CIN in the week prior to CTX. Demographic, clinical, symptom, and stress characteristics associated with CIN occurrence were determined. Patients (n=1296) completed questionnaires that provided information on demographic and clinical characteristics, symptom severity, stress, and QOL. Univariate analyses evaluated for differences in demographic and clinical characteristics, symptom severity, stress, and QOL scores between the two patient groups. Multiple logistic regression analysis was used to evaluate for factors associated with nausea group membership. Of the 1296 patients, 47.5% reported CIN. In the CIN group, 15% rated CIN as severe and 23% reported high distress. Factors associated with CIN included: less education; having childcare responsibilities; poorer functional status; higher levels of depression, sleep disturbance, evening fatigue, and intrusive thoughts; as well as receipt of CTX on a 14-day CTX cycle and receipt of an antiemetic regimen that contained serotonin receptor antagonist and steroid. Patients in the CIN group experienced clinically meaningful decrements in QOL. This study identified new factors (e.g., poorer functional status, stress) associated with CIN occurrence. CIN negatively impacted patients' QOL. Pre-emptive and ongoing interventions may alleviate CIN occurrence in high risk patients. Copyright © 2018. Published by Elsevier Inc.

  12. Meta-analysis of pharmacogenetic interactions in amyotrophic lateral sclerosis clinical trials.

    PubMed

    van Eijk, Ruben P A; Jones, Ashley R; Sproviero, William; Shatunov, Aleksey; Shaw, Pamela J; Leigh, P Nigel; Young, Carolyn A; Shaw, Christopher E; Mora, Gabriele; Mandrioli, Jessica; Borghero, Giuseppe; Volanti, Paolo; Diekstra, Frank P; van Rheenen, Wouter; Verstraete, Esther; Eijkemans, Marinus J C; Veldink, Jan H; Chio, Adriano; Al-Chalabi, Ammar; van den Berg, Leonard H; van Es, Michael A

    2017-10-31

    To assess whether genetic subgroups in recent amyotrophic lateral sclerosis (ALS) trials responded to treatment with lithium carbonate, but that the treatment effect was lost in a large cohort of nonresponders. Individual participant data were obtained from 3 randomized trials investigating the efficacy of lithium carbonate. We matched clinical data with data regarding the UNC13A and C9orf72 genotype. Our primary outcome was survival at 12 months. On an exploratory basis, we assessed whether the effect of lithium depended on the genotype. Clinical data were available for 518 of the 606 participants. Overall, treatment with lithium carbonate did not improve 12-month survival (hazard ratio [HR] 1.0, 95% confidence interval [CI] 0.7-1.4; p = 0.96). Both the UNC13A and C9orf72 genotype were independent predictors of survival (HR 2.4, 95% CI 1.3-4.3; p = 0.006 and HR 2.5, 95% CI 1.1-5.2; p = 0.032, respectively). The effect of lithium was different for UNC13A carriers ( p = 0.027), but not for C9orf72 carriers ( p = 0.22). The 12-month survival probability for UNC13A carriers treated with lithium carbonate improved from 40.1% (95% CI 23.2-69.1) to 69.7% (95% CI 50.4-96.3). This study incorporated genetic data into past ALS trials to determine treatment effects in a genetic post hoc analysis. Our results suggest that we should reorient our strategies toward finding treatments for ALS, start focusing on genotype-targeted treatments, and standardize genotyping in order to optimize randomization and analysis for future clinical trials. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  13. Nurses' health promoting lifestyle behaviors in a community hospital.

    PubMed

    Kurnat-Thoma, Emma; El-Banna, Majeda; Oakcrum, Monica; Tyroler, Jill

    2017-06-01

    To examine nurses' health-promoting lifestyle behaviors, describe their self-reported engagement in employee wellness program benefit options, and explore relationships between nurse demographic factors, health characteristics and lifestyle behaviors. Nurses adopting unhealthy lifestyle behaviors are at significantly higher risk for developing a number of chronic diseases and are at increased susceptibility to exhaustion, job dissatisfaction and turnover. Strengthening professional nurses' abilities to engage in healthy lifestyle behaviors could serve as a valuable tool in combating negative workplace stress, promote improved work-life balance and personal well-being, and help retain qualified health-care providers. In a 187-bed community hospital in the Washington D.C. metropolitan area, we conducted an IRB-approved exploratory descriptive study. We examined 127 nurses' demographic characteristics, self-reported employer wellness program use, and measured their healthy lifestyle behaviors using the 52-item Health-Promoting Lifestyle Profile-II (HPLP-II) survey instrument. Nurse demographic and HPLP-II scores were analyzed in SPSS v20.0. Inferential univariate statistical testing examined relationships between nurse demographic factors, health and job characteristics, and HPLP-II score outcomes. Nurses over 40years old were more likely to report participation in hospital wellness program options. Statistically significant age differences were identified in total HPLP-II score (p=0.005), and two subscale scores-spiritual growth (p=0.002) and interpersonal relations (p=0.000). Post-hoc testing identified nurse participants 40-49years old and ≥50years old experienced slightly lower total HPLP-II score, subscale scores in comparison to younger colleagues. Nurses ≥40years old may benefit from additional employer support and guidance to promote and maintain healthy lifestyles, personal well-being, and positive interpersonal relationships. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Depressive and Anxiety Symptom Trajectories From School-Age Through Young Adulthood in Samples With Autism Spectrum Disorder and Developmental Delay

    PubMed Central

    Gotham, Katherine; Brunwasser, Steven M.; Lord, Catherine

    2015-01-01

    Objective To (1) model growth in anxiety and depressive symptoms from late school age through young adulthood in individuals with autism spectrum disorder (ASD) and controls with developmental delay (DD); and (2) assess relationships between internalizing growth patterns, participant characteristics, baseline predictors, and distal outcomes. Method Data were collected between 6-24 years of age in 165 participants (n=109 with ASD; n=56 with nonspectrum DD), most of whom received diagnostic evaluations in both childhood and early adulthood. Questionnaires were collected approximately every 3-6 months between ages 9-24. Parent-rated Child and Adult Behavior Checklists (CBCL; ABCL) and Developmental Behavior Checklist anxiety- and depression-related subscale distributions were modeled with mixed-effects Poisson models, covarying diagnosis, age, verbal IQ (VIQ), gender, and significant two- and three-way interactions. Results Anxiety was positively associated with VIQ, and controlling for VIQ, both anxiety and depressive symptoms were greater in ASD than nonspectrum participants. Female gender predicted greater increases over time in anxiety and depressive symptoms for both diagnostic groups. Lower maternal education was associated with increasing internalizing symptoms in a subset of less verbal individuals with ASD. In exploratory post-hoc analyses, internalizing symptoms were associated with poorer emotional regulation in school age, and with lower life satisfaction and greater social difficulties in early adulthood. Conclusion Findings support previous claims that individuals with ASD are at particular risk for affect- and anxiety-specific problems. While symptom levels in females increase at a faster rate throughout adolescence, males with ASD appear to have elevated levels of depressive symptoms in school age that are maintained into young adulthood. PMID:25901773

  15. Depressive and anxiety symptom trajectories from school age through young adulthood in samples with autism spectrum disorder and developmental delay.

    PubMed

    Gotham, Katherine; Brunwasser, Steven M; Lord, Catherine

    2015-05-01

    The objectives of this study were to model growth in anxiety and depressive symptoms from late school age through young adulthood in individuals with autism spectrum disorder (ASD) and controls with developmental delay (DD), and to assess relationships among internalizing growth patterns, participant characteristics, baseline predictors, and distal outcomes. Data were collected between ages 6 and 24 years in 165 participants (n = 109 with ASD; n = 56 with nonspectrum DD), most of whom received diagnostic evaluations in both childhood and early adulthood. Questionnaires were collected approximately every 3 to 6 months between ages 9 and 24 years. Parent-rated Child Behavior Checklist (CBCL), Adult Behavior Checklist (ABCL), and Developmental Behaviour Checklist anxiety- and depression-related subscale distributions were modeled with mixed-effects Poisson models, covarying diagnosis, age, verbal IQ (VIQ), gender, and significant 2- and 3-way interactions. Anxiety was positively associated with VIQ, and controlling for VIQ, both anxiety and depressive symptoms were greater in ASD than nonspectrum participants. Female gender predicted greater increases over time in anxiety and depressive symptoms for both diagnostic groups. Lower maternal education was associated with increasing internalizing symptoms in a subset of less verbal individuals with ASD. In exploratory post hoc analyses, internalizing symptoms were associated with poorer emotional regulation in school age, and with lower life satisfaction and greater social difficulties in early adulthood. Findings support previous claims that individuals with ASD are at particular risk for affect- and anxiety-specific problems. Although symptom levels in females increase at a faster rate throughout adolescence, males with ASD appear to have elevated levels of depressive symptoms in school age that are maintained into young adulthood. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  16. Reduction in salivary α-amylase levels following a mind-body intervention in cancer survivors--an exploratory study.

    PubMed

    Lipschitz, David L; Kuhn, Renee; Kinney, Anita Y; Donaldson, Gary W; Nakamura, Yoshio

    2013-09-01

    The main aim of this exploratory study was to assess whether salivary α-amylase (sAA) and salivary cortisol levels would be positively modulated by sleep-focused mind-body interventions in female and male cancer survivors. We conducted a randomized controlled trial in which 57 cancer survivors with self-reported sleep disturbance received either a Sleep Hygiene Education (SHE; n=18) control, or one of two experimental mind-body interventions, namely, Mind-Body Bridging (MBB; n=19) or Mindfulness Meditation (MM; n=20). Interventions were three sessions each conducted once per week for three consecutive weeks. Saliva cortisol and sAA were measured at baseline and 1 week after the last session. Participants also completed a sleep scale at the same time points when saliva was collected for biomarker measurement. Our study revealed that at post-intervention assessment, mean sAA levels upon awakening ("Waking" sample) declined in MBB compared with that of SHE. Mean Waking cortisol levels did not differ among treatment groups but declined slightly in SHE. Self-reported sleep improved across the three interventions at Post-assessment, with largest improvements in the MBB intervention. In this exploratory study, sleep focused mind-body intervention (MBB) attenuated Waking sAA levels, suggesting positive influences of a mind-body intervention on sympathetic activity in cancer survivors with sleep disturbance. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. Enduring effects of post-weaning rearing condition on depressive- and anxiety-like behaviors and motor activity in male rats.

    PubMed

    Mosaferi, Belal; Babri, Shirin; Ebrahimi, Hadi; Mohaddes, Gisou

    2015-04-01

    Environmental manipulation at early critical periods could have long-lasting effects. In spite of the great interest in the biological effects of the environmental condition so far, its long-lasting effects are less documented. This study looks at the enduring effects of rearing condition on tasks that measure affective responses and exploratory behavior in male Wistar rats. The animals were reared from weaning to adulthood in an enriched environment, standard laboratory condition, or isolated condition. Then, all rats were housed in standard laboratory cages to provide a common environment, and successively exposed to different tests between 0 and 11 weeks post-manipulation. The open field test indicated a more efficient exploratory behavior in the enriched group, and an enhanced spontaneous motor activity in both standard and isolated groups. In addition, rats reared in standard condition showed heightened motor activity in forced swimming test and elevated plus maze. Forced swimming test showed an antidepressive-like effect in the enriched environment group by increased climbing behavior. In respect to the anxiety behavior, environmental enrichment improved threat detection ability. It is concluded that rearing condition from weaning to adulthood has important and long-lasting effects on depressive- and anxiety-like and exploratory behaviors as well as motor activity. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial.

    PubMed

    Bechman, Katie; Sin, Fang En; Ibrahim, Fowzia; Norton, Sam; Matcham, Faith; Scott, David Lloyd; Cope, Andrew; Galloway, James

    2018-01-01

    Tapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms. This study aims to investigate if psychological states predict flare in patients' dose tapering their anti-TNF therapy. This study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form Survey (SF-36)) were collected at baseline. The primary outcome was flare, defined as an increase in 28-joint count Disease Activity Score (DAS28) ≥0.6 and ≥1 swollen joint. Discrete-time survival models were used to identify patient-reported outcomes that predict flare. Ninety-seven patients were randomised to taper their anti-TNF dose by either 33% or 66%. Forty-one patients flared. Higher baseline DAS28 score was associated with flare (adjusted HR 1.96 (95% CI 1.18 to 3.24), p=0.01). Disability (SF-36 physical component score), fatigue (FACIT-F) and mental health (SF-36 mental health subscale (MH)) predicted flare in unadjusted models. In multivariate analyses, only SF-36 MH remained a statistically significant predictor of flare (adjusted HR per 10 units 0.74 (95% CI 0.60 to 0.93), p=0.01). Baseline DAS28 and mental health status are independently associated with flare in patients who taper their anti-TNF therapy. Fatigue and function also associate with flare but the effect disappears when adjusting for confounders. Given these findings, mental health and functional status should be considered in anti-TNF tapering decisions in order to optimise the likelihood of success. EudraCT Number: 2010-020738-24; ISRCTN: 28955701; Post-results.

  19. Mental health, fatigue and function are associated with increased risk of disease flare following TNF inhibitor tapering in patients with rheumatoid arthritis: an exploratory analysis of data from the Optimizing TNF Tapering in RA (OPTTIRA) trial

    PubMed Central

    Bechman, Katie; Sin, Fang En; Ibrahim, Fowzia; Norton, Sam; Matcham, Faith; Scott, David Lloyd; Cope, Andrew; Galloway, James

    2018-01-01

    Background Tapering of anti-tumour necrosis factor (TNF) therapy appears feasible, safe and effective in selected patients with rheumatoid arthritis (RA). Depression is highly prevalent in RA and may impact on flare incidence through various mechanisms. This study aims to investigate if psychological states predict flare in patients’ dose tapering their anti-TNF therapy. Methods This study is a post-hoc analysis of the Optimizing TNF Tapering in RA trial, a multicentre, randomised, open-label study investigating anti-TNF tapering in RA patients with sustained low disease activity. Patient-reported outcomes (Health Assessment Questionnaire, EuroQol 5-dimension scale, Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-F), 36-Item Short Form Survey (SF-36)) were collected at baseline. The primary outcome was flare, defined as an increase in 28-joint count Disease Activity Score (DAS28) ≥0.6 and ≥1 swollen joint. Discrete-time survival models were used to identify patient-reported outcomes that predict flare. Results Ninety-seven patients were randomised to taper their anti-TNF dose by either 33% or 66%. Forty-one patients flared. Higher baseline DAS28 score was associated with flare (adjusted HR 1.96 (95% CI 1.18 to 3.24), p=0.01). Disability (SF-36 physical component score), fatigue (FACIT-F) and mental health (SF-36 mental health subscale (MH)) predicted flare in unadjusted models. In multivariate analyses, only SF-36 MH remained a statistically significant predictor of flare (adjusted HR per 10 units 0.74 (95% CI 0.60 to 0.93), p=0.01). Conclusions Baseline DAS28 and mental health status are independently associated with flare in patients who taper their anti-TNF therapy. Fatigue and function also associate with flare but the effect disappears when adjusting for confounders. Given these findings, mental health and functional status should be considered in anti-TNF tapering decisions in order to optimise the likelihood of success. Trial registration numbers EudraCT Number: 2010-020738-24; ISRCTN: 28955701; Post-results. PMID:29862047

  20. Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study

    PubMed Central

    Romanowski, Barbara; Schwarz, Tino F; Ferguson, Linda; Peters, Klaus; Dionne, Marc; Behre, Ulrich; Schulze, Karin; Hillemanns, Peter; Suryakiran, Pemmaraju; Thomas, Florence; Struyf, Frank

    2016-01-01

    In this randomized, partially-blind study (clinicaltrials.gov; NCT00541970), the licensed formulation of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (20 μg each of HPV-16/18 antigens) was found highly immunogenic up to 4 y after first vaccination, whether administered as a 2-dose (2D) schedule in girls 9–14 y or 3-dose (3D) schedule in women 15–25 y. This end-of-study analysis extends immunogenicity and safety data until Month (M) 60, and presents antibody persistence predictions estimated by piecewise and modified power law models. Healthy females (age stratified: 9–14, 15–19, 20–25 y) were randomized to receive 2D at M0,6 (N = 240 ) or 3D at M0,1,6 (N = 239). Here, results are reported for girls 9–14 y (2D) and women 15–25 y (3D). Seropositivity rates, geometric mean titers (by enzyme-linked immunosorbent assay) and geometric mean titer ratios (GMRs; 3D/2D; post-hoc exploratory analysis) were calculated. All subjects seronegative pre-vaccination in the according-to-protocol immunogenicity cohort were seropositive for anti-HPV-16 and −18 at M60. Antibody responses elicited by the 2D and 3D schedules were comparable at M60, with GMRs close to 1 (anti-HPV-16: 1.13 [95% confidence interval: 0.82–1.54]; anti-HPV-18: 1.06 [0.74–1.51]). Statistical modeling predicted that in 95% of subjects, antibodies induced by 2D and 3D schedules could persist above natural infection levels for ≥ 21 y post-vaccination. The vaccine had a clinically acceptable safety profile in both groups. In conclusion, a 2D M0,6 schedule of the HPV-16/18 AS04-adjuvanted vaccine was immunogenic for up to 5 y in 9–14 y-old girls. Statistical modeling predicted that 2D-induced antibodies could persist for longer than 20 y. PMID:26176261

  1. Sheehan Suicidality Tracking Scale (Sheehan-STS)

    PubMed Central

    2009-01-01

    Objective: Accurate and prospective assessments of treatment-emergent suicidal thoughts and behaviors are essential to both clinical care and randomized clinical trials. The Sheehan Suicidality Tracking Scale is a prospective, patient self-report or clinician-administered rating scale that tracks both treatment-emergent suicidal ideation and behaviors. The Sheehan Suicidality Tracking Scale was incorporated into a multicenter, randomized, double-blind, placebo-controlled, and active comparator study examining the efficacy of an experimental corticotropin-releasing factor antagonist (BMS-562086) for the treatment of generalized anxiety disorder. Method: The Sheehan Suicidality Tracking Scale was administered to subjects at baseline, Week 2, Week 4, and Week 8 or early termination. Subjects completed theSheehan Suicidality Tracking Scale by self report. The Sheehan Suicidality Tracking Scale was designated as an exploratory outcome measure in the study protocol, and post-hoc analyses were performed to examine the performance of the Sheehan Suicidality Tracking Scale. Results: A total of 82 subjects completed the Sheehan Suicidality Tracking Scale during the course of the study. Altogether, these subjects provided 297 completed Sheehan Suicidality Tracking Scale ratings across the study time points. Sixty-one subjects (n=25 placebo, n=24 BMS-562086, and n=12 escitalopram) had a baseline and at least one post-baseline Sheehan Suicidality Tracking Scale measurement. The mean change from baseline at Week 8 in the Sheehan Suicidality Tracking Scale total score was -0.10, -0.02, and -0.06 for escitalopram, placebo, and BMS-562086 groups, respectively. The sensitivity of the Sheehan Suicidality Tracking Scale and HAM-D Item #3 (suicide) for identifying subjects with suicidal thoughts or behaviors was 100 percent and 63 percent, respectively. Conclusions: The Sheehan Suicidality Tracking Scale may be a sensitive psychometric tool to prospectively assess for treatment-emergent suicidal thoughts and behaviors. Despite the small sample size and low occurrence of suicidal ideation during the course of this clinical trial, the self-reported Sheehan Suicidality Tracking Scale demonstrated increased sensitivity over the rater administered HAM-D Item #3 in identifying suicide related ideations and behaviors. Further research in larger study samples as well as in other psychiatric disorders are needed. PMID:19724740

  2. A comparison of two follow-up analyses after multiple analysis of variance, analysis of variance, and descriptive discriminant analysis: A case study of the program effects on education-abroad programs

    Treesearch

    Alvin H. Yu; Garry Chick

    2010-01-01

    This study compared the utility of two different post-hoc tests after detecting significant differences within factors on multiple dependent variables using multivariate analysis of variance (MANOVA). We compared the univariate F test (the Scheffé method) to descriptive discriminant analysis (DDA) using an educational-tour survey of university study-...

  3. Tri-Squared Mean Cross Comparative Analysis: An Advanced Post Hoc Qualitative and Quantitative Metric for a More In-Depth Examination of the Initial Research Outcomes of the Tri-Square Test

    ERIC Educational Resources Information Center

    Osler, James Edward

    2013-01-01

    This monograph provides an epistemological rational for the design of an advanced novel analysis metric. The metric is designed to analyze the outcomes of the Tri-Squared Test. This methodology is referred to as: "Tri-Squared Mean Cross Comparative Analysis" (given the acronym TSMCCA). Tri-Squared Mean Cross Comparative Analysis involves…

  4. Comparative Study of Motor Performance of Deaf and Hard of Hearing Students in Reaction Time, Visual-Motor Control and Upper Limb Speed and Dexterity Abilities

    ERIC Educational Resources Information Center

    Gkouvatzi, Anastasia N.; Mantis, Konstantinos; Kambas, Antonis

    2010-01-01

    Using the Bruininks-Oseretsky Test the motor performance of 34 deaf--hard-of-hearing pupils, 6-14 year, was evaluated in reaction time, visual-motor control and upper limb speed and dexterity. The two-way ANOVA variance analysis for two independent variables, group, age, and the Post Hoc (Scheffe test) for multiple comparisons were used. The…

  5. Organophosphate Related Alterations in Myelin and Axonal Transport in the Living Mammalian Brain

    DTIC Science & Technology

    2015-10-01

    examine post hoc differences when indicated. Statistical significance was assessed using an alpha level of 0.05. 3. Results 3.1. Body weights Test subjects...REPORT: Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved...not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. 2 REPORT

  6. Dissecting an online intervention for cancer survivors: four exploratory analyses of internet engagement and its effects on health status and health behaviors.

    PubMed

    Chen, Zhenghao; Koh, Pang Wei; Ritter, Philip L; Lorig, Kate; Bantum, Erin O'Carroll; Saria, Suchi

    2015-02-01

    The Internet has been used extensively to offer health education content and also for social support. More recently, we have seen the advent of Internet-based health education interventions that combine content with structured social networking. In many ways this is the Internet equivalent to small group interventions. While we have some knowledge about the efficacy of these interventions, few studies have examined how participants engage with programs and how that might affect outcomes. This study seeks to explore (a) the content of posts and (b) the nature of participant engagement with an online, 6-week workshop for cancer survivors and how such engagement may affect health outcomes. Using methodologies related to computational linguistics (latent Dirichlet allocation) and more standard statistical approaches, we identified (a) discussion board themes; (b) the relationship between reading and posting messages and outcomes; (c) how making, completing, or not completing action plans is related to outcome; and (d) how self-tailoring relates to outcomes. When considering all posts, emotional support is a key theme. However, different sets of themes are expressed in the first workshop post where participants are asked to express their primary concern. Writing posts was related to improved outcomes, but reading posts was less important. Completing, but not merely making, action plans and self-tailoring are statistically associated with future positive health outcomes. The findings from these exploratory studies can be considered when shaping future electronically mediated social networking interventions. In addition, the methods used here can be used in analyzing other large electronically mediated social-networking interventions. © 2014 Society for Public Health Education.

  7. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    PubMed

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  8. Stress Management Training for Hospice Personnel: An Exploratory Study.

    ERIC Educational Resources Information Center

    Clark, Susan; And Others

    There is very little published research specifically addressing the stress management skills of hospice caregivers. In order to ascertain if breathing exercises, biofeedback training, relaxation exercises, and cognitive therapy would be beneficial, pre- and post-treatment questionnaires and six 30-minute treatment sessions were administered to…

  9. Does the moment of fiber post cutting influence on the retention to root dentin?

    PubMed

    Borges, Marcela G; Faria-e-Silva, André L; Santos-Filho, Paulo C F; Silva, Fernanda P; Martins, Luís R M; Menezes, Murilo de Sousa

    2015-01-01

    Despite several advantages associated with pre-fabricated glass-fiber posts, the coronal portion of these posts must be cut to allow their use in various clinical situations. However, cutting the cemented post can generate stress on the bonding interface and affect the bond strength. The aim of this study was to investigate the effect the of fiber post cutting on the bond strength of root canals. Sixty bovine incisor roots were included in resin cylinders with simulated periodontal ligaments. Glass-fiber posts were luted using regular resin cement RelyX ARC (3M ESPE) or self-adhesive cement RelyX Unicem (3M ESPE). The posts were cut prior to cementation, immediately after luting or after building up the core (n=10). After storage for 24 h, the samples were cut and subject to push-out testing using a mechanical testing machine (EMIC DL 2000). Data were analyzed using two-way ANOVA (resin cement x moment of post cutting) and Tukey's post hoc test (α=0.05). The moment of fiber post cutting did not affect the bond strength when Unicem was used. However, the bond strength was reduced when ARC was used and when the post was cut immediately. In conclusion, the moment of fiber post cutting may affect the retention of root canal posts when a regular resin cement is used.

  10. Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

    PubMed Central

    2009-01-01

    Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS) scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis of predictors of the placebo versus treatment response. Whilst this study does not explore neurobiological mechanisms, these observations are consistent with the hypotheses that 'drug' effects and placebo effects are not necessarily additive, and that mutually exclusive mechanisms may be operating in the two arms. The need for more research in the area of mechanisms and mediators of placebo versus active responses is supported. Trial Registration International Clinical Trials Registry ISRCTN98972974. PMID:19549306

  11. Serum Bicarbonate and Kidney Disease Progression and Cardiovascular Outcome in Patients With Diabetic Nephropathy: A Post Hoc Analysis of the RENAAL (Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan) Study and IDNT (Irbesartan Diabetic Nephropathy Trial).

    PubMed

    Schutte, Elise; Lambers Heerspink, Hiddo J; Lutgers, Helen L; Bakker, Stephan J L; Vart, Priya; Wolffenbuttel, Bruce H R; Umanath, Kausik; Lewis, Julia B; de Zeeuw, Dick; Gansevoort, Ron T

    2015-09-01

    Low serum bicarbonate level has been reported to be an independent predictor of kidney function decline and mortality in patients with chronic kidney disease. Mechanisms underlying low serum bicarbonate levels may differ in patients with and without diabetes. We aimed to specifically investigate the association of serum bicarbonate level with kidney disease progression and cardiovascular outcome in a cohort of patients with type 2 diabetes and nephropathy. Post hoc analysis of 2 multicenter randomized controlled trials. 2,628 adults with type 2 diabetes and nephropathy. Serum bicarbonate level. Incidence of: (1) end-stage renal disease (ESRD), (2) ESRD or doubling of serum creatinine level, (3) all-cause mortality, (4) cardiovascular events (fatal/nonfatal stroke/myocardial infarction), and (5) heart failure. Serum bicarbonate was measured at baseline as total carbon dioxide. Associations of baseline serum bicarbonate level with end points were investigated using Cox regression models. Serum bicarbonate levels were studied as a continuous variable and stratified in quartiles. Follow-up was 2.8±1.0 (SD) years. Cox regression analyses showed that serum bicarbonate level had inverse associations with incident ESRD (HR, 0.91; 95% CI, 0.89-0.93; P<0.001) and incidence of the combined end point of ESRD or serum creatinine doubling (HR, 0.94; 95% CI, 0.92-0.96; P<0.001). These associations were independent of age, sex, and cardiovascular risk factors, but disappeared after adjustment for baseline estimated glomerular filtration rate (all P>0.05). Analysis of bicarbonate quartiles showed similar results for the quartile with the lowest bicarbonate (≤21 mEq/L) versus the quartile with normal bicarbonate levels (24-26 mEq/L). There was no association of bicarbonate level with cardiovascular events and heart failure. Post hoc analysis and single measurement of serum bicarbonate. In this cohort of patients with type 2 diabetes with nephropathy, serum bicarbonate level associations with kidney disease end points were not retained after adjustment for estimated glomerular filtration rate, which is in contrast to results of earlier studies in nondiabetic populations. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  12. Effect of aripiprazole 2 to 15 mg/d on health-related quality of life in the treatment of irritability associated with autistic disorder in children: a post hoc analysis of two controlled trials.

    PubMed

    Varni, James W; Handen, Benjamin L; Corey-Lisle, Patricia K; Guo, Zhenchao; Manos, George; Ammerman, Diane K; Marcus, Ronald N; Owen, Randall; McQuade, Robert D; Carson, William H; Mathew, Suja; Mankoski, Raymond

    2012-04-01

    There are limited published data on the impact of treatment on the health-related quality of life (HRQOL) in individuals with autistic disorder. The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder. This post hoc analysis assessed data from two 8-week, double-blind, randomized, placebo-controlled studies that compared the efficacy of aripiprazole (fixed-dose study, 5, 10, and 15 mg/d; flexible-dose study, 2-15 mg/d) with placebo in the treatment of irritability associated with autistic disorder. HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory (PedsQL™) scales. Clinically relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 standard error of measurement. In total, 316 patients were randomly assigned to receive treatment with aripiprazole (fixed-dose study, 166; flexible-dose study, 47) or placebo (fixed-dose study, 52; flexible-dose study, 51). Aripiprazole was associated with significantly greater improvement than placebo in PedsQL combined-scales total score (difference, 7.8; 95% CI, 3.8-11.8; P < 0.001) and in 3 PedsQL scale scores (differences [95% CI]: Emotional Functioning, 7.8 [3.4-12.2]; Social Functioning, 6.2 [0.7-11.8]; Cognitive Functioning, 9.3 [3.8-14.9]; all, P < 0.05). Patients who received aripiprazole were significantly more likely than those who received placebo to have a clinically meaningful improvement on the combined-scales total score (odds ratio [OR] = 1.9; 95% CI, 1.0-3.3; P < 0.05), Emotional Functioning scale (OR = 2.2; 95% CI, 1.2-4.0; P < 0.05) and Social Functioning scale (OR = 2.2; 95% CI, 1.2-4.1; P < 0.05), and were significantly less likely to experience deterioration (OR: 0.3, 95% CI: 0.1-0.8; P < 0.05) when "Stable" was used as the reference group. The findings from the present post hoc analysis suggest that aripiprazole was associated with improved HRQOL, as assessed using 3 PedsQL scales, in pediatric patients with irritability associated with autistic disorder. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

  13. Analysing Time to Event Data in Dementia Prevention Trials: The Example of the GuidAge Study of EGb761.

    PubMed

    Scherrer, B; Andrieu, S; Ousset, P J; Berrut, G; Dartigues, J F; Dubois, B; Pasquier, F; Piette, F; Robert, P; Touchon, J; Garnier, P; Mathiex-Fortunet, H; Vellas, B

    2015-12-01

    Time-to-event analysis is frequently used in medical research to investigate potential disease-modifying treatments in neurodegenerative diseases. Potential treatment effects are generally evaluated using the logrank test, which has optimal power and sensitivity when the treatment effect (hazard ratio) is constant over time. However, there is generally no prior information as to how the hazard ratio for the event of interest actually evolves. In these cases, the logrank test is not necessarily the most appropriate to use. When the hazard ratio is expected to decrease or increase over time, alternative statistical tests such as the Fleming-Harrington test, provide a better sensitivity. An example of this comes from a large, five-year randomised, placebo-controlled prevention trial (GuidAge) in 2854 community-based subjects making spontaneous memory complaints to their family physicians, which evaluated whether treatment with EGb761 can modify the risk of developing AD. The primary outcome measure was the time to conversion from memory complaint to Alzheimer's type dementia. Although there was no significant difference in the hazard function of conversion between the two treatment groups according to the preplanned logrank test, a significant treatment-by-time interaction for the incidence of AD was observed in a protocol-specified subgroup analysis, suggesting that the hazard ratio is not constant over time. For this reason, additional post hoc analyses were performed using the Fleming-Harrington test to evaluate whether there was a signal of a late effect of EGb761. Applying the Fleming-Harrington test, the hazard function for conversion to dementia in the placebo group was significantly different from that in the EGb761 treatment group (p = 0.0054), suggesting a late effect of EGb761. Since this was a post hoc analysis, no definitive conclusions can be drawn as to the effectiveness of the treatment. This post hoc analysis illustrates the interest of performing another randomised clinical trial of EGb761 explicitly testing the hypothesis of a late treatment effect, as well as of using of better adapted statistical approaches for long term preventive trials when it is expected that prevention cannot have an immediate effect but rather a delayed effect that increases over time.

  14. Effect of age and sex on lacosamide pharmacokinetics in healthy adult subjects and adults with focal epilepsy.

    PubMed

    Schaefer, Carina; Cawello, Willi; Waitzinger, Josef; Elshoff, Jan-Peer

    2015-04-01

    Age- and sex-related differences in body composition could affect the pharmacokinetic parameters of administered drugs. The purpose of this post hoc analysis was to investigate the influences of age and sex on the pharmacokinetics of lacosamide. This post hoc analysis used pharmacokinetic data taken at steady state from (i) two phase I studies of oral lacosamide in healthy adult subjects (n = 66), and (ii) a population pharmacokinetic analysis carried out using data from two phase III studies of adjunctive oral lacosamide in adults (n = 565) with focal epilepsy taking 1-3 concomitant anti-epileptic drugs. Phase I data were stratified by age and sex as 'younger female' (aged 18-40 years), 'younger male' (aged 18-45 years) or 'elderly male/female' (aged ≥65 years), then normalized by body weight (lean body weight or fat-free mass), height or volume of distribution, and analysed using non-compartmental analysis. Population pharmacokinetic data were stratified by sex and analysed using a one-compartment model. Minor numerical differences between lacosamide exposure [the area under the concentration-time curve at steady state over the dosage interval (AUCτ,ss)] and the maximum plasma concentration at steady state (C max,ss) in subjects of different ages or sexes were noted. The differences could be explained by a scaling factor between the drug applied and the plasma concentration. Following normalization by lean body weight or volume of distribution, an analysis of relative bioavailability resulted in 90 % confidence intervals of the ratios for AUCτ,ss and C max,ss for age (elderly to younger) or sex (male to female) falling within the range accepted for equivalence (80-125 %); without normalization, the 90 % confidence intervals were outside this range. Minor numerical differences in lacosamide plasma concentrations were noted in the comparison between male and female patients (aged 16-71 years) with focal epilepsy. Simulations using different body weights demonstrated a minimal effect of body weight on lacosamide plasma concentrations in adult patients with focal epilepsy. Age and sex had no relevant effects on the rates of absorption and elimination of lacosamide in this post hoc analysis, as the minor numerical differences could be explained by the main scaling factor for body weight or volume of distribution. The pharmacokinetic profile of lacosamide was unaffected by age or sex in adults with focal epilepsy.

  15. Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease)

    PubMed Central

    Ondo, William G.; Grieger, Frank; Moran, Kimberly; Kohnen, Ralf; Roth, Thomas

    2016-01-01

    Study Objectives: Determine the minimal clinically important change (MCIC), a measure determining the minimum change in scale score perceived as clinically beneficial, for the international restless legs syndrome (IRLS) and restless legs syndrome 6-item questionnaire (RLS-6) in patients with moderate to severe restless legs syndrome (RLS/Willis-Ekbom disease) treated with the rotigotine transdermal system. Methods: This post hoc analysis analyzed data from two 6-mo randomized, double-blind, placebo-controlled studies (SP790 [NCT00136045]; SP792 [NCT00135993]) individually and as a pooled analysis in rotigotine-treated patients, with baseline and end of maintenance IRLS and Clinical Global Impressions of change (CGI Item 2) scores available for analysis. An anchor-based approach and receiver operating characteristic (ROC) curves were used to determine the MCIC for the IRLS and RLS-6. We specifically compared “much improved vs minimally improved,” “much improved/very much improved vs minimally improved or worse,” and “minimally improved or better vs no change or worse” on the CGI-2 using the full analysis set (data as observed). Results: The MCIC IRLS cut-off scores for SP790 and SP792 were similar. Using the pooled SP790+SP792 analysis, the MCIC total IRLS cut-off score (sensitivity, specificity) for “much improved vs minimally improved” was −9 (0.69, 0.66), for “much improved/very much improved vs minimally improved or worse” was −11 (0.81, 0.84), and for “minimally improved or better vs no change or worse” was −9 (0.79, 0.88). MCIC ROC cut-offs were also calculated for each RLS-6 item. Conclusions: In patients with RLS, the MCIC values derived in the current analysis provide a basis for defining meaningful clinical improvement based on changes in the IRLS and RLS-6 following treatment with rotigotine. Citation: Ondo WG, Grieger F, Moran K, Kohnen R, Roth T. Post hoc analysis of data from two clinical trials evaluating the minimal clinically important change in international restless legs syndrome sum score in patients with restless legs syndrome (Willis-Ekbom Disease). J Clin Sleep Med 2016;12(1):63–70. PMID:26446245

  16. Predictors of Graduation among College Students with Disabilities

    ERIC Educational Resources Information Center

    Pingry O'Neill, Laura N.; Markward, Martha J.; French, Joshua P.

    2012-01-01

    This exploratory study determined which set of student characteristics and disability-related services explained graduation success among college students with disabilities. The archived records of 1,289 unidentified students with disabilities in three public universities were examined ex-post-facto to collect demographic data on the students, the…

  17. Actors and Avatars: Why Learners Prefer Digital Agents

    ERIC Educational Resources Information Center

    Donovan, Paul

    2015-01-01

    Purpose: The purpose of this study is to compare learner experiences of recorded instructional videos (DVDs) with Machinima. Design/methodology/approach: In this exploratory study, sets of learning sequences in management skills training were delivered to 32 learners using both methods, and learner reactions were gathered using post-event…

  18. Schooling Experiences of Central California Indian People across Generations

    ERIC Educational Resources Information Center

    Williams, Tara

    2012-01-01

    This exploratory study took a post-colonialist lens to record, examine and document schooling experiences of California Indian people across several generations representing three Central Valley tribes: the Mono, the Tachi Yokuts of Santa Rosa Rancheria, and the Tule River Tribe. Past and present perceptions of Indian schooling were elicited…

  19. Higher Education and Linguistic Dualism in the Arab Gulf

    ERIC Educational Resources Information Center

    Findlow, Sally

    2006-01-01

    This paper examines the spread of English as a medium of higher education in the Arab world, addressing questions about the relationship between higher education, language shift and cultural (re)production through such post-colonial educational bilingualism. Drawing on exploratory ethnographic research, it documents how both Arabic and English…

  20. Students from Non-Dominant Linguistic Backgrounds Making Sense of Cosmology Visualizations

    ERIC Educational Resources Information Center

    Buck Bracey, Zoë E.

    2017-01-01

    This article presents the results of exploratory research with community college students from non-dominant linguistic backgrounds (NDLB) in an introductory astronomy class as they collaborated to reconstruct dynamic cosmology visualizations through drawing. Data included student discourse during the drawing activity, post-activity interviews, and…

  1. Post-Positivist Research: Two Examples of Methodological Pluralism.

    ERIC Educational Resources Information Center

    Wildemuth, Barbara M.

    1993-01-01

    Discussion of positivist and interpretive approaches to research and postpositivism focuses on two studies that apply interpretive research in different ways: an exploratory study of user-developed computing applications conducted prior to a positivist study and a study of end-user searching behaviors conducted concurrently with a positivist…

  2. Mature Students Speak Up: Career Exploration and the Working Alliance

    ERIC Educational Resources Information Center

    Pott, Terilyn

    2015-01-01

    This exploratory study was undertaken to learn more about how mature students perceive the career counselling process in a post-secondary institution. Through the use of critical incident technique this study examined how three mature students interpret their relationship between themselves and their counsellors. Significant factors identified as…

  3. Insights into STEM Education Praxis: An Assessment Scheme for Course Syllabi

    ERIC Educational Resources Information Center

    Corlu, M. Sencer

    2013-01-01

    Post-secondary institutions within the European Higher Education Area have been adapting quality assurance mechanisms for course design, delivery, and evaluation following a learner-centered approach. The purpose of this exploratory study was to delineate the teaching practices in science, technology, engineering, and mathematics at the…

  4. Artificial intelligence and robotics in high throughput post-genomics.

    PubMed

    Laghaee, Aroosha; Malcolm, Chris; Hallam, John; Ghazal, Peter

    2005-09-15

    The shift of post-genomics towards a systems approach has offered an ever-increasing role for artificial intelligence (AI) and robotics. Many disciplines (e.g. engineering, robotics, computer science) bear on the problem of automating the different stages involved in post-genomic research with a view to developing quality assured high-dimensional data. We review some of the latest contributions of AI and robotics to this end and note the limitations arising from the current independent, exploratory way in which specific solutions are being presented for specific problems without regard to how these could be eventually integrated into one comprehensible integrated intelligent system.

  5. Etude Exploratoire sur l’Etat de Stress Post-Traumatique dans Deux Unites Operationnelles de l’Armee de Terre (Exploratory Study of the Condition of Post-Traumatic Stress Disorder from Two Operational Units of Ground Forces)

    DTIC Science & Technology

    2006-04-01

    reconnues que dans leur dimension très particulière de confrontation soudaine , violente, avec l’éventualité de sa propre mort. Dans cette perspective, elles...traumatic stress disorder in Australian Vietnam veterans. J. Trauma. Stress 1999 ; 12 (4) : 625-640. [8] STRECH R.H., MARLOWE D.H., WRGHT M.K. et al ... al . Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. Journal of Traumatic Stress 1993 ; 6 : 459-473. [10

  6. Reforming the Police in Post-Soviet States: Georgia and Kyrgyzstan

    DTIC Science & Technology

    2013-11-01

    expected to be dedicated to their profes- sion “because it is difficult, dangerous , routine, you deal with crazy people.”43 Most servicemen return for...transnational threats such as terrorism, drug trafficking, and organized crime. Still, most of OSCE projects were ad hoc, not following any coher- ent...newsletter, please subscribe on the SSI website at www.StrategicStudiesInstitute.army.mil/newsletter. ISBN 1-58487-601-8 v FOREWORD In most Soviet successor

  7. Up-Regulation of Autophagy in Small Intestine Paneth Cells in Response to Total-Body gamma-Irradiation

    DTIC Science & Technology

    2009-01-01

    standard error of the mean (SEM). Analysis of variance procedures with Tukey post hoc correction examined the existence and nature of temporal trends ...apoptosis. Cell 2006;126:121–134. 20. Yorimitsu T, Klionsky DJ. Eating the enoplasmic reticulum: quality control by autophagy. Trends Cell Biol 2007;17...oxide signaling to iron- regulatory protein: direct control of ferritin mRNA translation and transferrin receptor mRNA stability in transfected

  8. Plasticity and Activation of Spared Intraspinal Respiratory Circuits Following Spinal Cord Injury

    DTIC Science & Technology

    2017-12-01

    ipsilateral to the C2Hx lesion. Tracheal pressures were evaluated to explore the potential of a biomechanical impact of ISMS- induced muscle contract...different from 500 µA. %P 0.05, different from 2 wk at same stimulus current. Data were evaluated using 2-way repeated-measures ANOVA with Holm...outcomes assessed. Data were evaluated using 2-way repeated-measures ANOVA with Holm-Sidak post hoc tests for individual comparisons (groups: 2

  9. A Summative Evaluation of the Effectiveness of Classroom-Embedded, Individualistic, Computer-Based Learning for Middle School Students Placed at Academic Risk in Schools with a High Proportion of Title I Eligible Students

    ERIC Educational Resources Information Center

    DeLoach, Regina M.

    2011-01-01

    The purpose of this "post hoc," summative evaluation was to evaluate the effectiveness of classroom-embedded, individualistic, computer-based learning for middle school students placed at academic risk in schools with a high proportion of Title I eligible students. Data were mined from existing school district databases. For data (n = 393)…

  10. Clobazam-Treated Patients with Lennox Gastaut Syndrome Experienced Fewer Seizure-Related Injuries than Placebo Patients During Trail OV-1012

    DTIC Science & Technology

    2016-08-19

    injuries based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms from all adverse event (AE) listings. Patients receiving...injuries For this post hoc analysis, medical review of all adverse event (AE) listings, based on Medical Dictionary for Regu- latory Activities (MedDRA...study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011;77:1473–1481. 5. Medical Dictionary for Regulatory Activities. Available at: http

  11. Emotion recognition ability in mothers at high and low risk for child physical abuse.

    PubMed

    Balge, K A; Milner, J S

    2000-10-01

    The study sought to determine if high-risk, compared to low-risk, mothers make more emotion recognition errors when they attempt to recognize emotions in children and adults. Thirty-two demographically matched high-risk (n = 16) and low-risk (n = 16) mothers were asked to identify different emotions expressed by children and adults. Sets of high- and low-intensity, visual and auditory emotions were presented. Mothers also completed measures of stress, depression, and ego-strength. High-risk, compared to low-risk, mothers showed a tendency to make more errors on the visual and auditory emotion recognition tasks, with a trend toward more errors on the low-intensity, visual stimuli. However, the observed trends were not significant. Only a post-hoc test of error rates across all stimuli indicated that high-risk, compared to low-risk, mothers made significantly more emotion recognition errors. Although situational stress differences were not found, high-risk mothers reported significantly higher levels of general parenting stress and depression and lower levels of ego-strength. Since only trends and a significant post hoc finding of more overall emotion recognition errors in high-risk mothers were observed, additional research is needed to determine if high-risk mothers have emotion recognition deficits that may impact parent-child interactions. As in prior research, the study found that high-risk mothers reported more parenting stress and depression and less ego-strength.

  12. Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study.

    PubMed

    Inagaki, Nobuya; Goda, Maki; Yokota, Shoko; Maruyama, Nobuko; Iijima, Hiroaki

    2015-01-01

    The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown. We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI < 22 kg/m(2); group II, BMI ≥ 22 to < 25 kg/m(2); group III, BMI ≥ 25 to < 30 kg/m(2) and group IV, BMI ≥ 30 kg/m(2). The overall safety was similar among the four BMI subgroups, although there were slight differences in terms of the incidences of hypoglycemia, asymptomatic hypoglycemia, female genital infections and proportions of patients with total ketone body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose. Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

  13. Preventive effect of a high fluoride toothpaste and arginine-carbonate toothpaste on dentinal tubules exposure followed by acid challenge: a dentine permeability evaluation

    PubMed Central

    2014-01-01

    Background Considering the current high use of high fluoride toothpastes, the aim of the study was to quantify alterations in the root dentine permeability submitted to treatment with a high fluoride toothpaste and 8% arginine, calcium carbonate, sodium monofluorophosphate toothpaste as a preventive treatment for dentinal tubules exposure followed by acid challenge. Methods Thirty-third molars were sectioned below the cementoenamel. The root segments were connected to a hydraulic pressure apparatus to measure dentine permeability after the following sequential steps (n = 10 per group): I) Baseline; II) treatment with phosphoric acid for 30 s (maximum permeability); III) Toothbrushing (1 min) according to the experimental groups (G1- control; G2- 5000 ppm fluoride toothpaste; G3- 8% arginine-calcium carbonate toothpaste); IV) acid challenge for 5 min (orange juice). The data were converted into percentage, considering stage II as 100%. Results The results have shown a statistically significant decreasing on dentine permeability after treatment with toothpaste (Friedman test and Dunn’s post hoc test). Comparison among groups demonstrated a high increasing on dentine permeability when acid challenge was performed after toothbrushing with distilled water (control group) (Kruskal-Wallis and Dunn’s post hoc test). Conclusion The toothpaste treatment may provide sufficient resistance on dentine surface, preventing dentinal tubules exposure after acid challenge. PMID:24958423

  14. Impact of time to therapy and reperfusion modality on the efficacy of adenosine in acute myocardial infarction: the AMISTAD-2 trial.

    PubMed

    Kloner, Robert A; Forman, Mervyn B; Gibbons, Raymond J; Ross, Allan M; Alexander, R Wayne; Stone, Gregg W

    2006-10-01

    The purpose of this analysis was to determine whether the efficacy of adenosine vs. placebo was dependent on the timing of reperfusion therapy in the second Acute Myocardial Infarction Study of Adenosine (AMISTAD-II). Patients presenting with ST-segment elevation anterior AMI were randomized to receive placebo vs. adenosine (50 or 70 microg/kg/min) for 3 h starting within 15 min of reperfusion therapy. In the present post hoc hypothesis generating study, the results were stratified according to the timing of reperfusion, i.e. > or = or < the median 3.17 h, and by reperfusion modality. In patients receiving reperfusion < 3.17 h, adenosine compared with placebo significantly reduced 1-month mortality (5.2 vs. 9.2%, respectively, P = 0.014), 6-month mortality (7.3 vs. 11.2%, P = 0.033), and the occurrence of the primary 6-month composite clinical endpoint of death, in-hospital CHF, or rehospitalization for CHF at 6 months (12.0 vs. 17.2%, P = 0.022). Patients reperfused beyond 3 h did not benefit from adenosine. In this post hoc analysis, 3 h adenosine infusion administered as an adjunct to reperfusion therapy within the first 3.17 h onset of evolving anterior ST-segment elevation AMI enhanced early and late survival, and reduced the composite clinical endpoint of death or CHF at 6 months.

  15. The self-adjusting file instrumentation results in less debris extrusion apically when compared to WaveOne and ProTaper NEXT

    PubMed Central

    Pawar, Ajinkya M.; Pawar, Mansing G.; Metzger, Zvi; Kokate, Sharad R.

    2015-01-01

    Aim: The present ex vivo study aimed to evaluate the debris extrusion after instrumenting the root canals by three different files systems. Materials and Methods: Sixty extracted human mandibular premolars with single canals were selected and randomly divided into three groups (n = 20) for instrumentation with three different files. Group 1: WaveOne (primary) single reciprocating file (WO; Dentsply Maillefer, Ballaigues, Switzerland) (25/08), Group 2: Self-adjusting file (SAF; ReDent-Nova, Ra’anana, Israel) (1.5 mm), and Group 3: ProTaper NEXT X1 and X2 (PTN; Dentsply Tulsa Dental, Tulsa, OK) (25/06). Debris extruding by instrumentation were collected into pre-weighed Eppendorf tubes. These tubes were then stored in an incubator at 70°C for 5 days. The tubes were then weighed to obtain the final weight, with the extruded debris. Statistical analysis for the debris extruded apically was performed using one-way analysis of variance and post hoc Tukey's test. Results: The statistical analysis showed a significant difference between all the three groups tested (P < 0.01). The following post hoc Tukey's test confirmed that Group 2 (SAF) exhibited significantly least (P < 0.01) debris extrusion between the three groups tested. Conclusions: The SAF resulted in significantly less extrusion of debris when compared to reciprocating WO and rotary PTN. PMID:25829683

  16. Apical extrusion of debris by supplementary files used for retreatment: An ex vivo comparative study

    PubMed Central

    Pawar, Ajinkya M.; Pawar, Mansing; Metzger, Zvi; Thakur, Bhagyashree

    2016-01-01

    Aim: This study evaluated whether using supplementary files for removing root canal filling residues after ProTaper Universal Retreatment files (RFs) increased the debris extrusion apically. Materials and Methods: Eighty mandibular premolars with single root and canal were instrumented with ProTaper Universal rotary system (SX-F3) and obturated. The samples were divided randomly into four groups (n = 20). Group 1 served as a control; only ProTaper Universal RFs D1–D3 were used, and the extruded debris was weighed. Groups 2, 3, and 4 were the experimental groups, receiving a twofold retreatment protocol: Removal of the bulk, followed by the use of supplementary files. The bulk was removed by RFs, followed by the use of ProTaper NEXT (PTN), WaveOne (WO), and Self-Adjusting File (SAF) for removal of the remaining root filling residues. Debris extruded apically were weighed and compared to the control group. Statistical analysis was performed using one-way analysis of variance (ANOVA) and post hoc Tukey's test. Results: All the three experimental groups presented significant difference (P < .01). The post hoc Tukey's test confirmed that Group 4 (SAF) exhibited significantly less (P < .01) debris extrusion between the three groups tested. Conclusion: SAF results in less extrusion of debris when used as supplementary file to remove root-filling residues, compared to WO and PTN. PMID:27099416

  17. Post-Hoc Study: Intravenous Hydration Treatment in Chinese Patients with High Risk of Contrast-Induced Nephropathy Following Percutaneous Coronary Intervention

    PubMed Central

    Bei, Weijie; Li, Hualong; Lin, Kaiyang; Wang, Kun; Chen, Shiqun; Guo, Xiaosheng; Liu, Yong; Tan, Ning; Chen, Jiyan; Yang, Xiangtai; Su, Xi; Du, Zhimin; Zeng, Qiutang; Fang, Zhenfei; Wang, Yan; Jiang, Hong; Xiong, Longgen; Hou, Yuqing; Yuan, Yong; Li, Tianfa; Hong, Lang; Wu, Yanqing; Liu, Yin; Lin, Wenhua; Jiang, Tiemin; Fu, Junhua; An, Yi; Yu, Bo; Tian, Ye; Zheng, Yang; Liu, Bin; Yang, Ping; Jiang, Xianyan; Wang, Hao; Qu, Peng; Cui, Lianqun; Li, Xueqi; Qi, Xiaoyong; Ma, Zengcai; Li, Jifu; Zhang, Lili; Liu, Shengquan; Pang, Wenyue; Li, Yibo; Yang, Manguang; Ji, Zheng; Zhao, Pitian; Li, Lu; Ge, Junbo; Jin, Huigen; Pan, Weimin; Song, Yaoming; Li, Jianmei; Xiao, Jianming; Liu, Hanxiong; Tao, Jianhong; Wu, Zhongdong; Tuo, Buxiong; Li, Wei; Xu, Yixian; Zhang, Zhaoqi; Chen, Yundai; Wang, Lefeng; Zhang, Jinying; Wang, Fengling; Jia, Yongping; Wang, Bin; Tang, Fakuan; Tang, Qiang; Wang, Wei; Sun, Yuemin; Su, Weiqing

    2017-01-01

    Contrast-induced nephropathy (CIN) develops after the injection of iodinated contrast media. This is a post hoc analysis of the data obtained from the TRUST study, which was a prospective, multicentre, observational study conducted to evaluate the safety and tolerability of the contrast medium iopromide in patients undergoing cardiac catheterization from August 2010 to September 2011 in China, conducted to explore the current status, trends and risk predictors of hydration treatment. The status of hydration to prevent CIN in each patient was recorded. Of the total 17,139 patients from the TRUST study (mean age, 60.33 ± 10.38 years), the overall hydration usage was 46.1% in patients undergoing percutaneous coronary intervention (PCI) and 77.4%, 51.7%, and 48.5% in patients with pre-existing renal disease, diabetes mellitus, and hypertension, respectively. The proportion of hydration use increased from 36.5% to 55.5% from August 2010 to September 2011, which was independently associated with risk predictors like older age, pre-existing renal disease, hypertension, diabetes mellitus, prior myocardial infarction, ST segment elevation MI, high contrast dose, multi-vessel disease and reduced LVEF (<45%). Overall, the usage of intravenous hydration treatment for patients with a high risk of CIN following PCI was high in China. PMID:28337989

  18. Nuclear factor κB and cyclooxygenase-2 immunoexpression in oral dysplasia and oral squamous cell carcinoma.

    PubMed

    Pontes, Hélder Antônio Rebelo; Pontes, Flávia Sirotheau Corrêa; Fonseca, Felipe Paiva; de Carvalho, Pedro Luiz; Pereira, Erika Martins; de Abreu, Michelle Carvalho; de Freitas Silva, Brunno Santos; dos Santos Pinto, Décio

    2013-02-01

    Oral leukoplakia is the main potentially malignant oral lesion, and oral squamous cell carcinoma accounts for more than 95% of all malignant neoplasms in the oral cavity. Therefore, the aim of this study was to verify the immunoexpression of nuclear factor κB (NF-κB) and cyclooxygenase-2 (COX-2) proteins in dysplastic oral lesions and oral squamous cell carcinoma. Immunohistochemical reactions were performed on 6 inflammatory fibrous hyperplasia, 28 oral leukoplakia, and 15 oral squamous cell carcinoma paraffin-embedded samples. Immunoperoxidase reaction for NF-κB and COX-2 was applied on the specimens, and the positivity of the reactions was calculated for 1000 epithelial cells. Using the analysis of variance and the Tukey post hoc statistical analyses, a significantly increased immunoexpression for NF-κB was observed when oral squamous cell carcinoma samples were compared with the other groups studied. However, using the Kruskal-Wallis and the Dunn post hoc tests, a statistically significant result for COX-2 expression was obtained only when the moderate dysplasia group was compared with the inflammatory fibrous hyperplasia group. Nuclear factor κB may participate in the malignant phenotype acquisition process of the oral squamous cell carcinoma in its late stages, whereas COX-2 may be involved in the early stages of oral carcinogenesis process. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.

    PubMed

    Tanghetti, Emil A; Dover, Jeffrey S; Goldberg, David J; Dhawan, Sunil S; Luo, Lei; Berk, David R; Ahluwalia, Gurpreet; Alvandi, Nancy

    2018-06-01

    Persistent facial erythema is a clinically challenging feature of rosacea. To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea. In two identically designed, phase 3, multicenter trials, adults with moderate to severe persistent facial erythema of rosacea (Clinician Erythema Assessment [CEA] grade ≥3 and Subject Self-Assessment [SSA] grade ≥3) were randomized 1:1 to once-daily topical oxymetazoline or vehicle; the primary efficacy endpoint was ≥2-grade composite CEA and SSA improvement from baseline on day 29. This post hoc analysis evaluated the proportion of patients achieving ≥1-grade composite and individual CEA and SSA improvement at 1, 3, 6, 9, and 12 hours postdose on day 1 (N=885). Significantly more patients achieved ≥1-grade composite and individual CEA and SSA improvement with the first application of oxymetazoline than with vehicle (P less than 0.001) at all postdose time points, beginning with hour 1. Day 1 safety assessments were similar between treatments. Short-term, post hoc analysis. A ≥1-grade improvement in persistent erythema achieved after the first dose of once-daily topical oxymetazoline demonstrated clinically meaningful improvement from the beginning of therapy. J Drugs Dermatol. 2018;17(6):621-626.

  20. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial

    PubMed Central

    Kesari, Santosh; Ram, Zvi

    2017-01-01

    Background: This post hoc analysis of the EF-14 trial (NCT00916409) of tumor-treating fields (TTFields) plus temozolomide versus temozolomide alone in newly diagnosed glioblastoma compared the efficacy of TTFields plus chemotherapy (physician’s choice) versus chemotherapy alone after first recurrence. Methods: Patients on TTFields plus temozolomide continued TTFields plus second-line chemotherapy after first recurrence. Some patients on temozolomide alone crossed over after approval of TTFields for recurrent GBM. The primary efficacy outcome was overall survival (OS). Results: After disease progression, 131 patients received TTFields plus chemotherapy and 73 chemotherapy alone. Thirteen patients in the original temozolomide-alone group crossed over to receive TTFields plus chemotherapy after disease progression, resulting in 144 patients receiving TTFields plus chemotherapy and 60 chemotherapy alone. Median follow-up was 12.6 months. Bevacizumab, alone or with cytotoxic chemotherapy, was the most frequent treatment. Median OS in the TTFields plus chemotherapy group was significantly longer versus chemotherapy alone (11.8 vs 9.2 months; HR: 0.70; 95% CI, 0.48–1.00; p=0.049). TTFields showed a low toxicity safety profile, as previously reported, with no grade 3/4 device-related adverse events. Conclusion: TTFields plus chemotherapy after first disease recurrence on TTFields plus temozolomide or temozolomide alone prolonged OS in patients in the EF-14 trial. PMID:28399638

  1. An In vitro Comparison and Evaluation of Sealing Ability of Newly Introduced C-point System, Cold Lateral Condensation, and Thermoplasticized Gutta-Percha Obturating Technique: A Dye Extraction Study.

    PubMed

    Sinhal, Tapati Manohar; Shah, Ruchi Rani Purvesh; Jais, Pratik Subhas; Shah, Nimisha Chinmay; Hadwani, Krupali Dhirubhai; Rothe, Tushar; Sinhal, Neha Nilesh

    2018-01-01

    The aim of this study is to compare and to evaluate sealing ability of newly introduced C-point system, cold lateral condensation, and thermoplasticized gutta-percha obturating technique using a dye extraction method. Sixty extracted maxillary central incisors were decoronated below the cementoenamel junction. Working length was established, and biomechanical preparation was done using K3 rotary files with standard irrigation protocol. Teeth were divided into three groups according to the obturation protocol; Group I-Cold lateral condensation, Group II-Thermoplasticized gutta-percha, and Group III-C-Point obturating system. After obturation all samples were subjected to microleakage assessment using dye extraction method. Obtained scores will be statistical analyzed using ANOVA test and post hoc Tukey's test. One-way analysis of variance revealed that there is significant difference among the three groups with P value (0.000 < 0.05). Tukey's HSD post hoc tests for multiple comparisons test shows that the Group II and III perform significantly better than Group I. Group III performs better than Group II with no significant difference. All the obturating technique showed some degree of microleakage. Root canals filled with C-point system showed least microleakage followed by thermoplasticized obturating technique with no significant difference among them. C-point obturation system could be an alternative to the cold lateral condensation technique.

  2. Once-monthly injection of paliperidone palmitate in patients with recently diagnosed and chronic schizophrenia: a post-hoc comparison of efficacy and safety.

    PubMed

    Si, Tianmei; Zhuo, Jianmin; Turkoz, Ibrahim; Mathews, Maju; Tan, Wilson; Feng, Yu

    2017-12-01

    The use of long-acting injectable antipsychotics in recently diagnosed schizophrenia remains less explored. We evaluated the efficacy and safety of paliperidone palmitate once-monthly (PP1M) treatment in adult patients with recently diagnosed vs. chronic schizophrenia. These post-hoc analyses included two multicenter studies. Study 1 (NCT01527305) enrolled recently diagnosed (≤5 years) and chronic (>5 years) patients; Study 2 (NCT01051531) enrolled recently diagnosed patients only. Recently diagnosed patients were further sub-grouped into ≤2 years or 2-5 years. The primary efficacy endpoint was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score. In Study 1, 41.5% patients had recent diagnosis (≤2 years: 56.8%; 2-5 years: 43.2%); 58.5% had chronic schizophrenia. In Study 2, 52.8% and 47.2% patients were grouped into ≤2 years and 2-5 years, respectively. PANSS total score showed significantly greater improvement in patients with recently diagnosed vs. chronic schizophrenia. Similar results were obtained for PANSS responder rate, improvements in PANSS, and CGI-S scores. PP1M was efficacious in both recently diagnosed and chronic schizophrenia, with the benefits being more pronounced in patients with recently diagnosed schizophrenia. This adds to growing evidence recommending long-acting antipsychotic interventions at early stages of schizophrenia.

  3. Leg Strength Comparison between Younger and Middle-age Adults

    PubMed Central

    Kim, Sukwon; Lockhart, Thurmon; Nam, Chang S.

    2009-01-01

    Although a risk of occupational musculoskeletal diseases has been identified with age-related strength degradation, strength measures from working group are somewhat sparse. This is especially true for the lower extremity strength measures in dynamic conditions (i.e., isokinetic). The objective of this study was to quantify the lower extremity muscle strength characteristics of three age groups (young, middle, and the elderly). Total of 42 subjects participated in the study: 14 subjects for each age group. A commercial dynamometer was used to evaluate isokinetic and isometric strength at ankle and knee joints. 2 × 2 (Age group (younger, middle-age, and older adult groups) × Gender (male and female)) between-subject design and Post-hoc analysis were performed to evaluate strength differences among three age groups. Post-hoc analysis indicated that, overall, middle-age workers’ leg strengths (i.e. ankle and knee muscles) were significantly different from younger adults while middle-age workers’ leg strengths were virtually identical to older adults’ leg strengths. These results suggested that, overall, 14 middle-age workers in the present study could be at a higher risk of musculoskeletal injuries. Future studies looking at the likelihood of musculoskeletal injuries at different work places and from different working postures at various age levels should be required to validate the current findings. The future study would be a valuable asset in finding intervention strategies such that middle-age workers could stay healthier longer. PMID:20436934

  4. Efficacy response in CF patients treated with ivacaftor: post-hoc analysis.

    PubMed

    Konstan, Michael W; Plant, Barry J; Elborn, J Stuart; Rodriguez, Sally; Munck, Anne; Ahrens, Richard; Johnson, Charles

    2015-05-01

    Clinical studies in patients with cystic fibrosis and G551D-CFTR showed that the group treated with ivacaftor had improved clinical outcomes. To better understand the effect of ivacaftor therapy across the distribution of individual FEV(1) responses, data from Phase 3 studies (STRIVE/ENVISION) were re-examined. In this post-hoc analysis of patients (n = 209) who received 48 weeks of ivacaftor or placebo, patients were assigned to tertiles according to FEV(1) response. These groups were then used to evaluate response (FEV(1), sweat chloride, weight, CFQ-R, and pulmonary exacerbation). The number needed to treat (NNT) was calculated for specific thresholds for each outcome. Across all tertiles, numerical improvements in FEV(1), sweat chloride, CFQ-R and the frequency of pulmonary exacerbations were observed in ivacaftor-treated patients: the treatment difference versus placebo was statistically significant for all outcomes in the upper tertile and for some outcomes in the lower and middle tertiles. The NNT for a ≥ 5% improvement in %predicted FEV(1) was 1.90, for a ≥ 5% body weight increase was 5.74, and to prevent a pulmonary exacerbation was 3.85. This analysis suggests that the majority of patients with clinical characteristics similar to STRIVE/ENVISION patients have the potential to benefit from ivacaftor therapy. © 2015 Wiley Periodicals, Inc.

  5. Telavancin for Acute Bacterial Skin and Skin Structure Infections, a Post Hoc Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance

    PubMed Central

    Pushkin, Richard; Barriere, Steven L.; Corey, G. Ralph; Stryjewski, Martin E.

    2015-01-01

    Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This post hoc analysis included patients with lesion sizes of ≥75 cm2 and excluded patients with ulcers or burns (updated all-treated population; n = 1,127). Updated day 3 (early) clinical response was defined as a ≥20% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a ≥90% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of −4.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, −0.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin. PMID:26248356

  6. Predictors of cancer fear: the association between mass media and fear of cancer among cancer diagnosed and nondiagnosed individuals.

    PubMed

    Nelissen, Sara; Beullens, Kathleen; Lemal, Marijke; Van den Bulck, Jan

    2015-03-01

    Few studies have explored the impact of mass media on fear of cancer levels. This study investigates whether television and Internet use are associated with fear of cancer, and whether this association is different for cancer diagnosed and nondiagnosed individuals. A quantitative, standardized survey was used and administered to 2008 respondents in Flanders (Belgium), of which 621 individuals were diagnosed with cancer. For statistical analyses, hierarchical regression analyses, independent samples T-tests and post hoc mediation analyses were conducted. The results indicated that cancer diagnosed individuals differed from nondiagnosed individuals in terms of perceived cancer susceptibility, perceived cancer severity, fear of cancer, and media use. Furthermore, television exposure was directly and positively related to fear of cancer, whereas Internet use was not. The relationship between television and Internet use and fear of cancer was not different for cancer diagnosed and nondiagnosed individuals. Additional post hoc mediation analyses, however, seemed to suggest that watching more television and surfing more on the Internet could both lead to having a more negative perceived health and this was in turn associated with higher fear of cancer. To help reduce the burden of fear of cancer, cancer educators and individuals working with cancer patients need to be aware of the possible negative effects media use might have on health perception and on the levels of fear of cancer.

  7. Paranoid Schizophrenia is Characterized by Increased CB1 Receptor Binding in the Dorsolateral Prefrontal Cortex

    PubMed Central

    Dalton, Victoria S; Long, Leonora E; Weickert, Cyndi Shannon; Zavitsanou, Katerina

    2011-01-01

    A number of studies suggest a dysregulation of the endogenous cannabinoid system in schizophrenia (SCZ). In the present study, we examined cannabinoid CB1 receptor (CB1R) binding and mRNA expression in the dorsolateral prefrontal cortex (DLPFC) (Brodmann's area 46) of SCZ patients and controls, post-mortem. Receptor density was investigated using autoradiography with the CB1R ligand [3H] CP 55 940 and CB1R mRNA expression was measured using quantitative RT-PCR in a cohort of 16 patients with paranoid SCZ, 21 patients with non-paranoid SCZ and 37 controls matched for age, post-mortem interval and pH. All cases were obtained from the University of Sydney Tissue Resource Centre. Results were analyzed using one-way analysis of variance (ANOVA) and post hoc Bonferroni tests and with analysis of covariance (ANCOVA) to control for demographic factors that would potentially influence CB1R expression. There was a main effect of diagnosis on [3H] CP 55 940 binding quantified across all layers of the DLPFC (F(2,71)=3.740, p=0.029). Post hoc tests indicated that this main effect was due to patients with paranoid SCZ having 22% higher levels of CB1R binding compared with the control group. When ANCOVA was employed, this effect was strengthened (F(2,67)=6.048, p=0.004) with paranoid SCZ patients differing significantly from the control (p=0.004) and from the non-paranoid group (p=0.016). In contrast, no significant differences were observed in mRNA expression between the different disease subtypes and the control group. Our findings confirm the existence of a CB1R dysregulation in SCZ and underline the need for further investigation of the role of this receptor particularly in those diagnosed with paranoid SCZ. PMID:21471953

  8. Paranoid schizophrenia is characterized by increased CB1 receptor binding in the dorsolateral prefrontal cortex.

    PubMed

    Dalton, Victoria S; Long, Leonora E; Weickert, Cyndi Shannon; Zavitsanou, Katerina

    2011-07-01

    A number of studies suggest a dysregulation of the endogenous cannabinoid system in schizophrenia (SCZ). In the present study, we examined cannabinoid CB(1) receptor (CB(1)R) binding and mRNA expression in the dorsolateral prefrontal cortex (DLPFC) (Brodmann's area 46) of SCZ patients and controls, post-mortem. Receptor density was investigated using autoradiography with the CB(1)R ligand [(3)H] CP 55,940 and CB(1)R mRNA expression was measured using quantitative RT-PCR in a cohort of 16 patients with paranoid SCZ, 21 patients with non-paranoid SCZ and 37 controls matched for age, post-mortem interval and pH. All cases were obtained from the University of Sydney Tissue Resource Centre. Results were analyzed using one-way analysis of variance (ANOVA) and post hoc Bonferroni tests and with analysis of covariance (ANCOVA) to control for demographic factors that would potentially influence CB(1)R expression. There was a main effect of diagnosis on [(3)H] CP 55,940 binding quantified across all layers of the DLPFC (F(2,71) = 3.740, p = 0.029). Post hoc tests indicated that this main effect was due to patients with paranoid SCZ having 22% higher levels of CB(1)R binding compared with the control group. When ANCOVA was employed, this effect was strengthened (F(2,67) = 6.048, p = 0.004) with paranoid SCZ patients differing significantly from the control (p = 0.004) and from the non-paranoid group (p = 0.016). In contrast, no significant differences were observed in mRNA expression between the different disease subtypes and the control group. Our findings confirm the existence of a CB(1)R dysregulation in SCZ and underline the need for further investigation of the role of this receptor particularly in those diagnosed with paranoid SCZ.

  9. On-line confidence monitoring during decision making.

    PubMed

    Dotan, Dror; Meyniel, Florent; Dehaene, Stanislas

    2018-02-01

    Humans can readily assess their degree of confidence in their decisions. Two models of confidence computation have been proposed: post hoc computation using post-decision variables and heuristics, versus online computation using continuous assessment of evidence throughout the decision-making process. Here, we arbitrate between these theories by continuously monitoring finger movements during a manual sequential decision-making task. Analysis of finger kinematics indicated that subjects kept separate online records of evidence and confidence: finger deviation continuously reflected the ongoing accumulation of evidence, whereas finger speed continuously reflected the momentary degree of confidence. Furthermore, end-of-trial finger speed predicted the post-decisional subjective confidence rating. These data indicate that confidence is computed on-line, throughout the decision process. Speed-confidence correlations were previously interpreted as a post-decision heuristics, whereby slow decisions decrease subjective confidence, but our results suggest an adaptive mechanism that involves the opposite causality: by slowing down when unconfident, participants gain time to improve their decisions. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Linking Satellites Via Earth "Hot Spots" and the Internet to Form Ad Hoc Constellations

    NASA Technical Reports Server (NTRS)

    Mandl, Dan; Frye, Stu; Grosvenor, Sandra; Ingram, Mary Ann; Langley, John; Miranda, Felix; Lee, Richard Q.; Romanofsky, Robert; Zaman, Afoz; Popovic, Zoya

    2004-01-01

    As more assets are placed in orbit, opportunities emerge to combine various sets of satellites in temporary constellations to perform collaborative image collections. Often, new operations concepts for a satellite or set of satellites emerge after launch. To the degree with which new space assets can be inexpensively and rapidly integrated into temporary or "ad hoc" constellations, will determine whether these new ideas will be implemented or not. On the Earth Observing 1 (EO-1) satellite, a New Millennium Program mission, a number of experiments were conducted and are being conducted to demonstrate various aspects of an architecture that, when taken as a whole, will enable progressive mission autonomy. In particular, the target architecture will use adaptive ground antenna arrays to form, as close as possible, the equivalent of wireless access points for low earth orbiting satellites. Coupled with various ground and flight software and the Internet. the architecture enables progressive mission autonomy. Thus, new collaborative sensing techniques can be implemented post-launch. This paper will outline the overall operations concept and highlight details of both the research effort being conducted in

  11. Effect of tracheostomy tube on work of breathing: Comparison of pre- and post-decannulation.

    PubMed

    Villalba, Darío; Feld, Viviana; Leiva, Valeria; Scrigna, Mariana; Distéfano, Eduardo; Pratto, Romina; Rodriguez, Matías; Collins, Jesica; Rocco, Ana; Matesa, Amelia; Rossi, Damián; Areas, Laura; Virgilio, Sacha; Golfarini, Nicolás; Gil-Rosetti, Gregorio; Diaz-Ballve, Pablo; Planells, Fernando

    2016-01-01

    To describe and compare the work of breathing (WOB) during spontaneous breathing under four conditions: (1) breathing through a tracheostomy tube with an inflated cuff, (2) breathing through the upper airway (UA) with a deflated cuff and occluded tube, (3) breathing through the UA with an occluded cuffless tube, and (4) postdecannulation. Patients who tolerated an occluded cuffless tube were included. Ventilatory variables and esophageal pressure were recorded. The pressure-time product (PTP), PTP/min, and PTP/min/tidal volume (PTP/min/VT) were measured. Each condition was measured for 5 min with a 15 min time interval between evaluations. Quantitative data are expressed as mean ± standard deviation. Single-factor analysis of variance was used, and the Games-Howell test was used for post hoc analysis of comparisons between group means ( P ≤ 0.05). Eight patients were studied under each of the four conditions described above. Statistically significant differences were found for PTP, PTP/min, and PTP/min/VT. In the post hoc analysis for PTP, significant differences among all conditions were found. For PTP/min, there was no significant difference between Conditions 2 and 4 ( P = 0.138), and for PTP/min/VT, there was no significant difference between Conditions 1 and 2 ( P = 0.072) or between Conditions 2 and 3 ( P = 0.106). A trend toward a higher PTP, PTP/min, and PTP/min/VT was observed when breathing through a cuffless tracheostomy tube. The four conditions differed with respect to WOB. Cuff inflation could result in a reduced WOB because there is less dead space. Cuffless tracheostomy tubes generate increased WOB, perhaps due to the material deformity caused by body temperature.

  12. Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

    PubMed

    Elmunzer, B Joseph; Higgins, Peter D R; Saini, Sameer D; Scheiman, James M; Parker, Robert A; Chak, Amitabh; Romagnuolo, Joseph; Mosler, Patrick; Hayward, Rodney A; Elta, Grace H; Korsnes, Sheryl J; Schmidt, Suzette E; Sherman, Stuart; Lehman, Glen A; Fogel, Evan L

    2013-03-01

    A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

  13. Is herpes zoster an additional complication in old age alongside comorbidity and multiple medications? Results of the post hoc analysis of the 12-month longitudinal prospective observational ARIZONA cohort study

    PubMed Central

    Pickering, Gisèle; Gavazzi, Gaëtan; Gaillat, Jacques; Paccalin, Marc; Bloch, Karine; Bouhassira, Didier

    2016-01-01

    Objectives To examine the burden of comorbidity, polypharmacy and herpes zoster (HZ), an infectious disease, and its main complication post-herpetic neuralgia (PHN) in young (50–70 years of age: 70−) and old (≥70 years of age: 70+) patients. Design Post hoc analysis of the results of the 12-month longitudinal prospective multicentre observational ARIZONA cohort study. Settings and participants The study took place in primary care in France from 20 November 2006 to 12 September 2008. Overall, 644 general practitioners (GPs) collected data from 1358 patients aged 50 years or more with acute eruptive HZ. Outcome measures Presence of HZ-related pain or PHN (pain persisting >3 months) was documented at day 0 and at months 3, 6, and 12. To investigate HZ and PHN burden, pain, quality of life (QoL) and mood were self-assessed using validated questionnaires (Zoster Brief Pain Inventory, 12-item Short-Form health survey and Hospital Anxiety and Depression Scale, respectively). Results As compared with younger patients, older patients more frequently presented with comorbidities, more frequently took analgesics and had poorer response on all questionnaires, indicating greater burden, at inclusion. Analgesics were more frequently prescribed to relieve acute pain or PHN in 70+ than 70− patients. Despite higher levels of medication prescription, poorer pain relief and poorer response to all questionnaires were reported in 70+ than 70− patients. Conclusions Occurrence of HZ and progression to PHN adds extra burden on top of pharmacological treatment and impaired quality of life, especially in older patients who already have health problems to cope with in everyday life. PMID:26892790

  14. Glass transition temperature of hard chairside reline materials after post-polymerisation treatments.

    PubMed

    Urban, Vanessa M; Machado, Ana L; Alves, Marinês O; Maciel, Adeilton P; Vergani, Carlos E; Leite, Edson R

    2010-09-01

    This study evaluated the effect of post-polymerisation treatments on the glass transition temperature (T(g)) of five hard chairside reline materials (Duraliner II-D, Kooliner-K, New Truliner-N, Ufi Gel hard-U and Tokuso Rebase Fast-T). Specimens (10 x 10 x 1 mm) were made following the manufacturers' instructions and divided into three groups (n = 5). Control group specimens were left untreated. Specimens from the microwave group were irradiated with pre-determined power/time combinations, and specimens from the water-bath group were immersed in hot water at 55 degrees C for 10 min. Glass transition ( degrees C) was performed by differential scanning calorimetry. Data were analysed using anova, followed by post hoc Tukey's test (alpha = 0.05). Both post-polymerisation treatments promoted a significant (p < 0.05) increase in the T(g) of reline material K. Materials K, D and N showed the lowest T(g) (p < 0.05). No significant difference between T and U specimens was observed. Post-polymerisation treatments improved the glass transition of material Kooliner, with the effect being more pronounced for microwave irradiation.

  15. Stress distributions in maxillary central incisors restored with various types of post materials and designs.

    PubMed

    Madfa, A A; Kadir, M R Abdul; Kashani, J; Saidin, S; Sulaiman, E; Marhazlinda, J; Rahbari, R; Abdullah, B J J; Abdullah, H; Abu Kasim, N H

    2014-07-01

    Different dental post designs and materials affect the stability of restoration of a tooth. This study aimed to analyse and compare the stability of two shapes of dental posts (parallel-sided and tapered) made of five different materials (titanium, zirconia, carbon fibre and glass fibre) by investigating their stress transfer through the finite element (FE) method. Ten three-dimensional (3D) FE models of a maxillary central incisor restored with two different designs and five different materials were constructed. An oblique loading of 100 N was applied to each 3D model. Analyses along the centre of the post, the crown-cement/core and the post-cement/dentine interfaces were computed, and the means were calculated. One-way ANOVAs followed by post hoc tests were used to evaluate the effectiveness of the post materials and designs (p=0.05). For post designs, the tapered posts introduced significantly higher stress compared with the parallel-sided post (p<0.05), especially along the centre of the post. Of the materials, the highest level of stress was found for stainless steel, followed by zirconia, titanium, glass fibre and carbon fibre posts (p<0.05). The carbon and glass fibre posts reduced the stress distribution at the middle and apical part of the posts compared with the stainless steel, zirconia and titanium posts. The opposite results were observed at the crown-cement/core interface. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

  16. Effects of 4 Weeks of High-Intensity Interval Training and β-Hydroxy-β-Methylbutyric Free Acid Supplementation on the Onset of Neuromuscular Fatigue.

    PubMed

    Miramonti, Amelia A; Stout, Jeffrey R; Fukuda, David H; Robinson, Edward H; Wang, Ran; La Monica, Michael B; Hoffman, Jay R

    2016-03-01

    This study investigated the effects of high-intensity interval training (HIIT) and β-hydroxy-β-methylbutyric free acid (HMB) supplementation on physical working capacity at the onset of neuromuscular fatigue threshold (PWC(FT)). Thirty-seven participants (22 men, 15 women; 22.8 ± 3.4 years) completed an incremental cycle ergometer test (graded exercise test [GXT]); electromyographic amplitude from the right vastus lateralis was recorded. Assessments occurred preceding (PRE) and after 4 weeks of supplementation (POST). Participants were randomly assigned to control (C, n = 9), placebo (P, n = 14), or supplementation (S, n = 14) groups. Both P and S completed 12 HIIT sessions, whereas C maintained normal diet and activity patterns. The PWC(FT) (W) was determined using the maximal perpendicular distance (D(MAX)) method. Electromyographic amplitude (μVrms) over time was used to generate a cubic regression. Onset of fatigue (TF) was the x-value of the point on the regression that was at D(MAX) from a line between the first and last data points. The PWC(FT) was estimated using TF and GXT power-output increments. The 2-way analysis of variance (ANOVA) (group × time) resulted in a significant interaction for PWC(FT) (F = 6.69, p = 0.004). Post hoc analysis with 1-way ANOVA resulted in no difference in PWC(FT) among groups at PRE (F = 0.87, p = 0.43); however, a difference in PWC(FT) was shown for POST (F = 5.46, p = 0.009). Post hoc analysis among POST values revealed significant differences between S and both P (p = 0.034) and C (p = 0.003). No differences (p = 0.226) were noted between P and C. Paired samples t-tests detected significant changes after HIIT for S (p < 0.001) and P (p = 0.016), but no change in C (p = 0.473). High-intensity interval training increased PWC(FT), but HMB with HIIT was more effective than HIIT alone. Furthermore, it seems that adding HMB supplementation with HIIT in untrained men and women may further improve endurance performance measures.

  17. Annoyance evaluation and the effect of noise on the health of bus drivers.

    PubMed

    Bruno, Portela S; Marcos, Queiroga R; Amanda, Constantini; Paulo, Zannin H T

    2013-01-01

    In the present study, we evaluated annoyance and the effects of noise on the health of bus drivers. For that, 200 bus drivers from a public transport company participated in a cross-sectional study. Annoyance and effects on health was measured with analog scale: Sleep quality, occurrence of tinnitus, headache, irritation, and annoyance from bus engine, traffic, and passengers. Data of age and working time of bus drivers also were obtained. For noise exposure, LA eq was evaluated in 80 buses. Statistical analysis consisted of mean, standard deviation, minimum, and maximum, Kruskal-Wallis test with post-hoc Dunn, one-way ANOVA with post-hoc Tukey and Spearman's correlation coefficient. Results indicate three groups of bus drivers (not annoyed: (N.A.), a little annoyed (L.A.) and highly annoyed (H.A.)). The group H.A. was younger and with less working time in relation to others, with a significant difference only for age. Regarding sleep quality, there was no significant difference. For results on the occurrence of tinnitus, headache and irritation after work, group H.A. had significantly higher means. Result of annoyance to the bus engine was significantly higher in H.A. than in L.A. and N.A. Annoyance to traffic and passengers, no significant differences were found, but the highest results were found for L.A., followed by H.A. and N.A. Equivalent sound pressure level in buses was above of the limit for occupational comfort. It was concluded that bus drivers has considerable level of noise annoyance and some health effects are perceived. The noise is a factor discomfort ergonomic that may cause effects on health of bus drivers. This study aims to evaluate annoyance and the effects of noise on the health of bus drivers. Cross-sectional study with buses and bus drivers. For that, 200 bus drivers from a public transport company participated in a cross-sectional study. Annoyance and effects on health was measured with analog scale: Sleep quality, occurrence of tinnitus, headache, irritation and annoyance from bus engine, traffic, and passengers. Data of age and working time of bus drivers also were obtained. For noise exposure, LA eq was evaluated in 80 buses. Statistical analysis consisted of mean, standard deviation, minimum and maximum, Kruskal-Wallis test with post-hoc Dunn, one-way ANOVA with post-hoc Tukey and Spearman's correlation coefficient. Results indicate three groups of bus drivers (N.A., a L.A. and H.A.). The group H.A. was younger and with less working time in relation to others, with a significant difference only for age. Regarding sleep quality, there was no significant difference. For results on the occurrence of tinnitus, headache and irritation after work, group H.A. had significantly higher means. Result of annoyance to the bus engine was significantly higher in H.A. than in L.A. and N.A. Annoyance to traffic and passengers, no significant differences were found, but the highest results were found for L.A., followed by H.A. and N.A. Equivalent sound pressure level in buses was above of the limit for occupational comfort. It was concluded that bus drivers has considerable level of noise annoyance and some health effects are perceived.

  18. Strategic planning for post-disaster temporary housing.

    PubMed

    Johnson, Cassidy

    2007-12-01

    Temporary housing programmes suffer from excessively high cost, late delivery, poor location, improper unit designs and other inherent issues. These issues can be attributed in part to a prevalence of ad hoc tactical planning, rather than pre-disaster strategic planning, for reconstruction undertaken by governments and non-governmental organisations (NGOs) in the chaotic post-disaster environment. An analysis of the process and outcomes from six case studies of temporary housing programmes after disasters in Turkey and Colombia in 1999, Japan in 1995, Greece in 1986, Mexico in 1985, and Italy in 1976 yields information about the extent to which strategic planning is employed in temporary housing programmes, as well as common issues in temporary housing. Based on an understanding of these common issues, this paper proposes a framework for strategic planning for temporary housing that identifies organisational designs and available resources for temporary housing before the disaster, but allows modifications to fit the specific post-disaster situation.

  19. Modification of irrational ideas and test anxiety through rational stage directed hypnotherapy [RSDH].

    PubMed

    Boutin, G E; Tosi, D J

    1983-05-01

    Examined the effects of four treatment conditions on the modification of Irrational Ideas and test anxiety in female nursing students. The treatments were Rational Stage Directed Hypnotherapy, a cognitive behavioral approach that utilized hypnosis and vivid-emotive-imagery, a hypnosis-only treatment, a placebo condition, and a no-treatment control. The 48 Ss were assigned randomly to one of these treatment groups, which met for 1 hour per week for 6 consecutive weeks with in-vivo homework assignments also utilized. Statistically significant treatment effects on cognitive, affective, behavioral, and physiological measures were noted for both the RSDH and hypnosis group at the posttest and at a 2-month follow-up. Post-hoc analyses revealed the RSDH treatment group to be significantly more effective than the hypnosis only group on both the post- and follow-up tests. The placebo and control groups showed no significant effects either at post-treatment or at follow-up.

  20. [Employment opportunities and education needs of physicians with specialty training in Hygiene and Preventive Medicine.].

    PubMed

    Fara, Gaetano M; Nardi, Giuseppe; Signorelli, Carlo; Fanti, Mila

    2005-01-01

    This survey was carried out under the sponsorship of the Italian Society of Hygiene (SItI), to evaluate the current professional position of physicians who completed their post-graduate professional training in Hygiene and Preventive Medicine in the years 2000 through 2003. An ad-hoc questionnaire was administered to 689 such specialists across Italy with a response rate of 40%. The results show that specialists in Hygiene and Preventive Medicine are generally satisfied with their professional choice though most specialists were found to have only temporary employment. Post-specialty training courses of major interest to specialists in Hygiene and Preventive medicine are those regarding occupational health, statistical analysis and epidemiology, and quality of health care.

  1. Preliminary Investigation of a Stress Prevention and Mindfulness Group for Teachers

    ERIC Educational Resources Information Center

    Reiser, Jenson E.; McCarthy, Christopher J.

    2018-01-01

    This exploratory study evaluated a short-term (6-8 weeks) psychoeducation and support group for teachers focused on stress prevention and mindfulness (labeled SPAM group). A total of 4 groups were implemented in different schools, and evaluation was conducted with quantitative (pre- and post-measures of teacher vulnerability to stress, job…

  2. Principals' Perception and Self-Efficacy: Addressing Achievement in a Post Annual Yearly Progress Environment

    ERIC Educational Resources Information Center

    Staumont, John

    2017-01-01

    Purpose: The purpose of this single-case study was to explore principals' perceptions of self-efficacy beliefs as effective instructional leaders during a period of educational transition in a semiurban, unified school district in Southern California. Methodology: The researcher used exploratory case study, conducting semistructured, open-ended,…

  3. Support Services for Students with Asperger's Syndrome in Higher Education

    ERIC Educational Resources Information Center

    Smith, Caroline P.

    2007-01-01

    The study examines the following research question: "What are the needs of students with Asperger's Syndrome (AS), and what are the services and accommodations available to them at the post-secondary level?" An increasing number of individuals diagnosed with AS are entering institutions of higher education. This study is exploratory in nature,…

  4. Examining the Language Skills of Children with ADHD Following a Play-Based Intervention

    ERIC Educational Resources Information Center

    Docking, Kimberley; Munro, Natalie; Cordier, Reinie; Ellis, Prudence

    2013-01-01

    Communication and play skills are important aspects of development yet are largely uncharted in children with attention deficit hyperactivity disorder (ADHD). This exploratory study examined whether changes in pragmatic skills and problem-solving skills were observed in children with ADHD pre- and post-participation in a play-based intervention…

  5. Does Feedback Influence Student Postings to Online Discussions?

    ERIC Educational Resources Information Center

    Meyer, Katrina A.

    2007-01-01

    Feedback theory proposes that feedback influences the behavior of a system and its parts and that is governed by rules. This exploratory study attempts to test this theory in a graduate-level class on leadership theory. Twelve students were asked to participate in five online discussions, each lasting one week. The questions for each discussion…

  6. Cross-Cultural Conflicts within Sports Teams

    ERIC Educational Resources Information Center

    Stura, Claudia; Johnston, Linda M.

    2018-01-01

    Since sports are increasingly used a way to bring formerly conflicting parties together post-conflict, more work needs to be done to ensure that sports are actually conducted in a way that promotes peace rather than exacerbates the conflict. Since many sports-for-peace programs cross cultural boundaries, this exploratory study was conducted to…

  7. Adapting the Revised Self-Leadership Questionnaire to the Portuguese Context

    ERIC Educational Resources Information Center

    Marques-Quinteiro, Pedro; Curral, Luis Alberto; Passos, Ana Margarida

    2012-01-01

    This study aimed to adapt the Revised Self-Leadership Questionnaire (RSLQ) (Houghton and Neck in J Manag Psychol 17(8):672-691, 2002) for the Portuguese population. 720 professionals, and university and post-graduate students participated in this study. The RSLQ factorial structure was accessed through exploratory and multi group confirmatory…

  8. Inheriting Failure: An Exploratory Study of Post-Colonial Somalia

    DTIC Science & Technology

    2014-12-01

    12b. DISTRIBUTION CODE A 13. ABSTRACT (maximum 200 words) ] Throughout its history , Somalia has experienced varying degrees of instability that has...Defense Analysis iii THIS PAGE INTENTIONALLY LEFT BLANK iv ABSTRACT Throughout its history , Somalia has experienced varying degrees of...1 A. STATE-SOCIETY RELATIONS...................................................................3 II. THE COLONIAL HISTORY OF SOMALIA

  9. Young Adult Couples Transitioning to Work: The Intersection of Career and Relationship

    ERIC Educational Resources Information Center

    Domene, Jose F.; Nee, Jessica J.; Cavanaugh, Ashley K.; McLelland, Serita; Stewart, Becky; Stephenson, Michelle; Kauffman, Bradley; Tse, Christopher K.; Young, Richard A.

    2012-01-01

    Contextual action theory was used to frame an exploratory qualitative study of young adult couples' experiences of transitioning from post-secondary education into the labor force, addressing the specific research question ''What kinds of projects for future work and life together do young adult couples jointly construct and pursue as they…

  10. Using the Mean Shift Algorithm to Make Post Hoc Improvements to the Accuracy of Eye Tracking Data Based on Probable Fixation Locations

    DTIC Science & Technology

    2010-08-01

    astigmatism and other sources, and stay constant from time to time (LC Technologies, 2000). Systematic errors can sometimes reach many degrees of visual angle...Taking the average of all disparities would mean treating each as equally important regardless of whether they are from correct or incorrect mappings. In...likely stop somewhere near the centroid because the large hM basically treats every point equally (or nearly equally if using the multivariate

  11. Defining the Molecular Actions of Dietary Fatty Acids in Breast Cancer: Selective Modulation of Peroxisome Proliferator-Activated Receptor Gamma. Addendum

    DTIC Science & Technology

    2008-05-01

    0.05 significance threshold. Fol- owing ANOVA, Fisher’s least significant difference, LSD , air-wise comparison was implemented post-hoc. Briefly, the SD...average absolute difference etween any two groups was greater than the LSD critical alue, then the pair-wise comparison for those two groups ere...Xu, Y., Hin- shaw , J.C., Zimmerman, G.A., Hama, K., Aoki, J., Arai, H., Prestwich, G.D., 2003. Identification of an intracellular receptor for

  12. Platform for Rapid Delivery of Biologics and Drugs to Ocular Cells and Tissues Following Combat Associated Trauma

    DTIC Science & Technology

    2016-09-01

    by DOD to further develop and test protein delivery for the retina. Ongoing Research Support W81XWH-16-1-0650 09/30/16-09/29/19 U.S...Medical Research Institute to test small molecules for inhibition of MAC in laser induced choroidal neovascularization PI Robert Liddington; No...streptavidin594 conjugation and dosing studies. Bonferroni’s multiple comparison tests were used for Post hoc analysis. One-way analysis of variance

  13. Translational Pharmacologic Efficacy Studies of Glial Growth Factor 2 (GGF2) in Spinal Cord Injury Models and in the Veterinary Clinical Setting

    DTIC Science & Technology

    2015-07-01

    optimal dosage was examined using a model of rodent SCI and testing several dose levels delivered either subcutaneously (SC) or intravenously (IV...to saline treated controls. ANOVA with Dunett’s post hoc test , pɘ.05. Based on these results, the studies in year 2 compared effects of SC...ventrally and ventral- laterally . The lesion in the Acorda model was characterized by a dorsal-ventral flattening of the cord profile with a highly

  14. Intravenous versus intramuscular cobinamide compared to intravenous saline (control) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa).

    DTIC Science & Technology

    2017-11-09

    FWH20140070A, “Intravenous versus intramuscular // compared to intravenous saline ( control ) in the treatment of acute, survivable, hydrogen sulfide toxicity... control ) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa). 4. Principal Investigator (PI): Name Rank Date...remainder of the study. Animals were treated with IV HOC, IV Cobinamide or control (no treatment) 1 minute post apnea. There were no significant

  15. General Movements in preterm infants undergoing craniosacral therapy: a randomised controlled pilot-trial.

    PubMed

    Raith, Wolfgang; Marschik, Peter B; Sommer, Constanze; Maurer-Fellbaum, Ute; Amhofer, Claudia; Avian, Alexander; Löwenstein, Elisabeth; Soral, Susanne; Müller, Wilhelm; Einspieler, Christa; Urlesberger, Berndt

    2016-01-13

    The objective of this study was to investigate neurological short-term effects of craniosacral therapy as an ideal form of osteopathic manipulative treatment (OMT) due to the soft kinaesthetic stimulation. Included were 30 preterm infants, with a gestational age between 25 and 33 weeks, who were admitted to the neonatal intensive care unit of the University Hospital of Graz, Austria. The infants were randomized either into the intervention group (IG) which received standardised craniosacral therapy, or the control group (CG) which received standard care. To guarantee that only preterm infants with subsequent normal neurodevelopment were included, follow up was done regularly at the corrected age (= actual age in weeks minus weeks premature) of 12 and 24 months. After 2 years 5 infants had to be excluded (IG; n = 12; CG: n = 13). General Movements (GMs) are part of the spontaneous movement repertoire and are present from early fetal life onwards until the end of the first half year of life. To evaluate the immediate result of such an intervention, we selected the General Movement Assessment (GMA) as an appropriate tool. Besides the global GMA (primary outcome) we used as detailed GMA, the General Movement Optimality Score (GMOS- secondary outcome), based on Prechtl's optimality concept. To analyse GMOS (secondary outcome) a linear mixed model with fixed effects for session, time point (time point refers to the comparisons of the measurements before vs. after each session) and intervention (IG vs. CG), random effect for individual children and a first order autoregressive covariance structure was used for calculation of significant differences between groups and interactions. Following interaction terms were included in the model: session*time point, session*intervention, time point*intervention and session*time point*intervention. Exploratory post hoc analyses (interaction: session*time point*intervention) were performed to determine group differences for all twelve measurement (before and after all 6 sessions) separately. Between groups no difference in the global GMA (primary outcome) could be observed. The GMOS (secondary outcome) did not change from session to session (main effect session: p = 0.262) in the IG or the CG. Furthermore no differences between IG and CG (main effect group: p = 0.361) and no interaction of time*session could be observed (p = 0.658). Post hoc analysis showed a trend toward higher values before (p = 0.085) and after (p = 0.075) the first session in CG compared to IG. At all other time points GMOS were not significantly different between groups. We were able to indicate that a group of "healthy" preterm infants undergoing an intervention with craniosacral therapy (IG) showed no significant changes in GMs compared to preterm infants without intervention (CG). In view of the fact that the global GMA (primary outcome) showed no difference between groups and the GMOS (detailed GMA-secondary outcome) did not deteriorate in the IG, craniosacral therapy seems to be safe in preterm infants. German Clinical Trials Register DRKS00004258 .

  16. Pullout bond strength of fiber posts luted to different depths and submitted to artificial aging.

    PubMed

    Macedo, V C; Souza, N A Y; Faria e Silva, A L; Cotes, C; da Silva, C; Martinelli, M; Kimpara, E T

    2013-01-01

    The extension of fiber post cementation often does not seem to influence the fracture resistance of restorations. This study evaluated the effects of cementation depths on the retention of fiber posts submitted to artificial aging. One hundred and sixty bovine incisors were selected to assess post retention. Following endodontic treatment, the canals were flared with diamonds burs. Postholes were prepared in lengths of 5 or 10 mm, after which fiber posts were relined with composite resin and luted with RelyX ARC or RelyX Unicem. The samples were then submitted to thermal and/or mechanical cycling before testing their pullout bond strengths. Absence of cycling was used as a control. The results of each cement were submitted to two-way and post hoc Tukey tests (α=0.05). Independent of the aging protocol, a depth of 10 mm showed higher pullout bond strength than did 5 mm, except for RelyX Unicem without cycling. For RelyX ARC, thermomechanical cycling resulted in lower values than in the absence of cycling. Mechanical cycling alone promoted the highest bond strength when the posts were luted with RelyX Unicem. The effect of artificial aging on the pullout bond strength is dependent on the type of material and the depth.

  17. Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN Patients with Intermittent Claudication Injected with ALDH Bright Cells (PACE) Trial

    PubMed Central

    Perin, Emerson C.; Murphy, Michael P.; March, Keith L.; Bolli, Roberto; Loughran, John; Yang, Phillip C.; Leeper, Nicholas J.; Dalman, Ronald L.; Alexander, Jason; Henry, Timothy D.; Traverse, Jay H.; Pepine, Carl J.; Anderson, R. David; Berceli, Scott; Willerson, James T.; Muthupillai, Raja; Gahremanpour, Amir; Raveendran, Ganesh; Velasquez, Omaida; Hare, Joshua M.; Schulman, Ivonne Hernandez; Kasi, Vijaykumar S.; Hiatt, William R.; Ambale-Venkatesh, Bharath; Lima, João A.; Taylor, Doris A.; Resende, Micheline; Gee, Adrian P.; Durett, April G.; Bloom, Jeanette; Richman, Sara; G’Sell, Patricia; Williams, Shari; Khan, Fouzia; Ross, Elsie Gyang; Santoso, Michelle R.; Goldman, JoAnne; Leach, Dana; Handberg, Eileen; Cheong, Benjamin; Piece, Nichole; DiFede, Darcy; Bruhn-Ding, Barb; Caldwell, Emily; Bettencourt, Judy; Lai, Dejian; Piller, Linda; Simpson, Lara; Cohen, Michelle; Sayre, Shelly L.; Vojvodic, Rachel W.; Moyé, Lem; Ebert, Ray F.; Simari, Robert D.; Hirsch, Alan T.

    2017-01-01

    Background Atherosclerotic peripheral artery disease (PAD) affects 8–12% of Americans over 65 and is associated with a major decline in functional status, increased myocardial infarction and stroke rates, and increased risk of ischemic amputation. Current treatment strategies for claudication have limitations. PACE is an NHLBI-sponsored, randomized, double-blind, placebo-controlled phase 2, exploratory clinical trial designed to assess safety and efficacy of autologous bone marrow–derived aldehyde dehydrogenase bright (ALDHbr) cells in PAD patients and to explore associated claudication physiologic mechanisms. Methods All participants, randomized 1:1 to receive ALDHbr cells or placebo, underwent bone marrow aspiration and isolation of ALDHbr cells, followed by ten injections into the thigh and calf of the index leg. The co-primary endpoints were: change from baseline to six months in peak walking time (PWT), collateral count, peak hyperemic popliteal flow, and capillary perfusion measured by magnetic resonance imaging (MRI); as well as safety. Results A total of 82 patients with claudication and infra-inguinal PAD were randomized at nine sites, of which 78 had analyzable data (57 male, 21 female; mean age 66±9 years). The mean differences in the change over six months between study groups for PWT (mean ± standard error of the mean [SEM]) (0.9±0.8 minutes; 95% CI −0.6 to 2.5; p=0.238), collateral count (0.9±0.6 arteries; 95% CI −0.2 to 2.1; p=0.116), peak hyperemic popliteal flow (0.0±0.4 mL/sec; 95% CI −0.8 to 0.8; p=0.978), and capillary perfusion (−0.2±0.6%; 95% CI −1.3 to 0.9; p=0.752) were not significant. Additionally, there were no significant differences for the secondary endpoints, including quality of life measures. There were no adverse safety outcomes. Correlative relationships between MRI measures and PWT were not significant. A post-hoc exploratory analysis suggested that ALDHbr cell administration might be associated with an increase in the number of collateral arteries (1.5±0.7; 95% CI 0.1 to 2.9; p=0.047) in participants with completely occluded femoral arteries. Conclusions ALDHbr cell administration did not improve PWT or MR outcomes, and the changes in PWT were not associated with the anatomic or physiologic MRI endpoints. Future PAD cell therapy investigational trial design may be informed by new anatomic and perfusion insights. PMID:28209728

  18. Consequences of common data analysis inaccuracies in CNS trauma injury basic research.

    PubMed

    Burke, Darlene A; Whittemore, Scott R; Magnuson, David S K

    2013-05-15

    The development of successful treatments for humans after traumatic brain or spinal cord injuries (TBI and SCI, respectively) requires animal research. This effort can be hampered when promising experimental results cannot be replicated because of incorrect data analysis procedures. To identify and hopefully avoid these errors in future studies, the articles in seven journals with the highest number of basic science central nervous system TBI and SCI animal research studies published in 2010 (N=125 articles) were reviewed for their data analysis procedures. After identifying the most common statistical errors, the implications of those findings were demonstrated by reanalyzing previously published data from our laboratories using the identified inappropriate statistical procedures, then comparing the two sets of results. Overall, 70% of the articles contained at least one type of inappropriate statistical procedure. The highest percentage involved incorrect post hoc t-tests (56.4%), followed by inappropriate parametric statistics (analysis of variance and t-test; 37.6%). Repeated Measures analysis was inappropriately missing in 52.0% of all articles and, among those with behavioral assessments, 58% were analyzed incorrectly. Reanalysis of our published data using the most common inappropriate statistical procedures resulted in a 14.1% average increase in significant effects compared to the original results. Specifically, an increase of 15.5% occurred with Independent t-tests and 11.1% after incorrect post hoc t-tests. Utilizing proper statistical procedures can allow more-definitive conclusions, facilitate replicability of research results, and enable more accurate translation of those results to the clinic.

  19. Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin.

    PubMed

    Del Prato, Stefano; Rosenstock, Julio; Garcia-Sanchez, Ricardo; Iqbal, Nayyar; Hansen, Lars; Johnsson, Eva; Chen, Hungta; Mathieu, Chantal

    2018-06-01

    The safety of triple oral therapy with dapagliflozin plus saxagliptin plus metformin versus dual therapy with dapagliflozin or saxagliptin plus metformin was compared in a post-hoc analysis of 3 randomized trials of sequential or concomitant add-on of dapagliflozin and saxagliptin to metformin. In the concomitant add-on trial, patients with type 2 diabetes on stable metformin received dapagliflozin 10 mg/d plus saxagliptin 5 mg/d. In sequential add-on trials, patients on metformin plus either saxagliptin 5 mg/d or dapagliflozin 10 mg/d received dapagliflozin 10 mg/d or saxagliptin 5 mg/d, respectively, as add-on therapy. After 24 weeks, incidences of adverse events and serious adverse events were similar between triple and dual therapy and between concomitant and sequential add-on regimens. Urinary tract infections were more common with sequential than with concomitant add-on therapy; genital infections were reported only with sequential add-on of dapagliflozin to saxagliptin plus metformin. Hypoglycaemia incidence was <2.0% across all analysis groups. In conclusion, the safety and tolerability of triple therapy with dapagliflozin, saxagliptin and metformin, as either concomitant or sequential add-on, were similar to dual therapy with either agent added to metformin. © 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  20. Visualizing histopathologic deep learning classification and anomaly detection using nonlinear feature space dimensionality reduction.

    PubMed

    Faust, Kevin; Xie, Quin; Han, Dominick; Goyle, Kartikay; Volynskaya, Zoya; Djuric, Ugljesa; Diamandis, Phedias

    2018-05-16

    There is growing interest in utilizing artificial intelligence, and particularly deep learning, for computer vision in histopathology. While accumulating studies highlight expert-level performance of convolutional neural networks (CNNs) on focused classification tasks, most studies rely on probability distribution scores with empirically defined cutoff values based on post-hoc analysis. More generalizable tools that allow humans to visualize histology-based deep learning inferences and decision making are scarce. Here, we leverage t-distributed Stochastic Neighbor Embedding (t-SNE) to reduce dimensionality and depict how CNNs organize histomorphologic information. Unique to our workflow, we develop a quantitative and transparent approach to visualizing classification decisions prior to softmax compression. By discretizing the relationships between classes on the t-SNE plot, we show we can super-impose randomly sampled regions of test images and use their distribution to render statistically-driven classifications. Therefore, in addition to providing intuitive outputs for human review, this visual approach can carry out automated and objective multi-class classifications similar to more traditional and less-transparent categorical probability distribution scores. Importantly, this novel classification approach is driven by a priori statistically defined cutoffs. It therefore serves as a generalizable classification and anomaly detection tool less reliant on post-hoc tuning. Routine incorporation of this convenient approach for quantitative visualization and error reduction in histopathology aims to accelerate early adoption of CNNs into generalized real-world applications where unanticipated and previously untrained classes are often encountered.

  1. Timing of intervention in high-risk non-ST-elevation acute coronary syndromes in PCI versus non-PCI centres : Sub-group analysis of the ELISA-3 trial.

    PubMed

    Badings, E A; Remkes, W S; Dambrink, J-H E; The, S H K; Van Wijngaarden, J; Tjeerdsma, G; Rasoul, S; Timmer, J R; van der Wielen, M L J; Lok, D J A; van 't Hof, A W J

    2016-03-01

    To compare the effect of timing of intervention in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) in percutaneous coronary intervention (PCI) versus non-PCI centres. A post-hoc sub-analysis was performed of the ELISA III trial, a randomised multicentre trial investigating outcome of early (< 12 h) versus late (> 48 h) angiography and revascularisation in 542 patients with high-risk NSTE-ACS. 90 patients were randomised in non-PCI centres and tended to benefit more from an early invasive strategy than patients included in the PCI centre (relative risk 0.23 vs. 0.85 [p for interaction = 0.089] for incidence of the combined primary endpoint of death, reinfarction and recurrent ischaemia after 30 days of follow-up). This was largely driven by reduction in recurrent ischaemia. In non-PCI centres, patients randomised to the late group had a 4 and 7 day longer period until PCI or coronary artery bypass grafting, respectively. This difference was less pronounced in the PCI centre. This post-hoc analysis from the ELISA-3 trial suggests that NSTE-ACS patients initially hospitalised in non-PCI centres show the largest benefit from early angiography and revascularisation, associated with a shorter waiting time to revascularisation. Improved patient logistics and transfer between non-PCI and PCI centres might therefore result in better clinical outcome.

  2. Effect of implementing instructional videos in a physical examination course: an alternative paradigm for chiropractic physical examination teaching.

    PubMed

    Zhang, Niu; Chawla, Sudeep

    2012-01-01

    This study examined the effect of implementing instructional video in ophthalmic physical examination teaching on chiropractic students' laboratory physical examination skills and written test results. Instructional video clips of ophthalmic physical examination, consisting of both standard procedures and common mistakes, were created and used for laboratory teaching. The video clips were also available for student review after class. Students' laboratory skills and written test results were analyzed and compared using one-way analysis of variance (ANOVA) and post hoc multiple comparison tests among three study cohorts: the comparison cohort who did not utilize the instructional videos as a tool, the standard video cohort who viewed only the standard procedure of video clips, and the mistake-referenced video cohort who viewed video clips containing both standard procedure and common mistakes. One-way ANOVA suggested a significant difference of lab results among the three cohorts. Post hoc multiple comparisons further revealed that the mean scores of both video cohorts were significantly higher than that of the comparison cohort (p < .001). There was, however, no significant difference of the mean scores between the two video cohorts (p > .05). However, the percentage of students having a perfect score was the highest in the mistake-referenced video cohort. There was no significant difference of written test scores among all three cohorts (p > .05). The instructional video of the standard procedure improves chiropractic students' ophthalmic physical examination skills, which may be further enhanced by implementing a mistake-referenced instructional video.

  3. Functional impairment related to painful physical symptoms in patients with generalized anxiety disorder with or without comorbid major depressive disorder: post hoc analysis of a cross-sectional study

    PubMed Central

    2011-01-01

    Background Generalized anxiety disorder (GAD) is the most frequent anxiety disorder in primary care patients. It is known that painful physical symptoms (PPS) are associated with GAD, regardless the presence of comorbid major depressive disorder (MDD). However the specific role of such symptoms in patients' functional impairment is not well understood. The objective of the present study is to assess functional impairment related to the presence of PPS in patients with GAD. Methods This is a post hoc analysis of a cross-sectional study. Functioning, in the presence (overall pain score >30; Visual Analog Scale) or absence of PPS, was assessed using the Sheehan Disability Scale (SDS) in three groups of patients; 1) GAD and comorbid MDD (GAD+MDD+), 2) GAD without comorbid MDD (GAD+MDD-), 3) controls (GAD-MDD-). ANCOVA models were used. Results Of those patients with GAD+MDD+ (n = 559), 436 (78.0%) had PPS, compared with GAD+MDD- (249 of 422, 59%) and controls (95 of 336, 28.3%). Functioning worsened in both GAD groups in presence of PPS (SDS least squares mean total score: 16.1 vs. 9.8, p < 0.0001, GAD+MDD+; 14.3 vs. 8.2, p < 0.0001, GAD+MDD-). The presence of PPS was significantly associated with less productivity. Conclusions Functional impairment related to the presence of PPS was relevant. Clinical implications should be considered. PMID:21510887

  4. Single-Level Degenerative Cervical Disc Disease and Driving Disability: Results from a Prospective, Randomized Trial

    PubMed Central

    Kelly, Michael P.; Mitchell, M. David; Hacker, Robert J.; Riew, K. Daniel; Sasso, Rick C.

    2013-01-01

    Study Design Post hoc analysis of prospective, randomized trial. Objective To investigate the disability associated with driving and single-level degenerative, cervical disc disease and to investigate the effect of surgery on driving disability. Methods Post hoc analysis of data obtained from three sites participating in a multicenter, randomized, controlled trial comparing cervical disc arthroplasty (TDA) with anterior cervical discectomy and fusion (ACDF). The driving subscale of the Neck Disability Index (NDI) was analyzed for all patients. A dichotomous severity score was created from the NDI. Statistical comparisons were made within and between groups. Results Two-year follow-up was available for 118/135 (87%) patients. One half of the study population (49.6%) reported moderate or severe preoperative driving difficulty. This disability associated with driving was similar among the two groups (ACDF: 2.5 ± 1.1, TDA: 2.6 ± 1.0, p = 0.646). The majority of patients showed improvement, with no or little driving disability, at the sixth postoperative week (ACDF: 75%, TDA: 90%, p = 0.073). At no follow-up point did a difference exist between groups according to the severity index. Conclusions Many patients suffering from radiculopathy or myelopathy from cervical disc disease are limited in their ability to operate an automobile. Following anterior cervical spine surgery, most patients are able to return to comfortable driving at 6 weeks. PMID:24436875

  5. An evaluation of video cameras for collecting observational data on sanctuary-housed chimpanzees (Pan troglodytes).

    PubMed

    Hansen, Bethany K; Fultz, Amy L; Hopper, Lydia M; Ross, Stephen R

    2018-05-01

    Video cameras are increasingly being used to monitor captive animals in zoo, laboratory, and agricultural settings. This technology may also be useful in sanctuaries with large and/or complex enclosures. However, the cost of camera equipment and a lack of formal evaluations regarding the use of cameras in sanctuary settings make it challenging for facilities to decide whether and how to implement this technology. To address this, we evaluated the feasibility of using a video camera system to monitor chimpanzees at Chimp Haven. We viewed a group of resident chimpanzees in a large forested enclosure and compared observations collected in person and with remote video cameras. We found that via camera, the observer viewed fewer chimpanzees in some outdoor locations (GLMM post hoc test: est. = 1.4503, SE = 0.1457, Z = 9.951, p < 0.001) and identified a lower proportion of chimpanzees (GLMM post hoc test: est. = -2.17914, SE = 0.08490, Z = -25.666, p < 0.001) compared to in-person observations. However, the observer could view the 2 ha enclosure 15 times faster by camera compared to in person. In addition to these results, we provide recommendations to animal facilities considering the installation of a video camera system. Despite some limitations of remote monitoring, we posit that there are substantial benefits of using camera systems in sanctuaries to facilitate animal care and observational research. © 2018 Wiley Periodicals, Inc.

  6. Intensity of care and withdrawal of life-sustaining therapies in severe traumatic brain injury patients: a post-hoc analysis of a multicentre retrospective cohort study.

    PubMed

    Gerges, Peter R A; Moore, Lynne; Léger, Caroline; Lauzier, François; Shemilt, Michèle; Zarychanski, Ryan; Scales, Damon C; Burns, Karen E A; Bernard, Francis; Zygun, David; Neveu, Xavier; Turgeon, Alexis F

    2018-06-14

    The intensity of care provided to critically ill patients has been shown to be associated with mortality. In patients with traumatic brain injury (TBI), specialized neurocritical care is often required, but whether it affects clinically significant outcomes is unknown. We aimed to determine the association of the intensity of care on mortality and the incidence of withdrawal of life-sustaining therapies in critically ill patients with severe TBI. We conducted a post hoc analysis of a multicentre retrospective cohort study of critically ill adult patients with severe TBI. We defined the intensity of care as a daily cumulative sum of interventions during the intensive care unit stay. Our outcome measures were all-cause hospital mortality and the incidence of withdrawal of life-sustaining therapies. Seven hundred sixteen severe TBI patients were included in our study. Most were male (77%) with a mean (standard deviation) age of 42 (20.5) yr and a median [interquartile range] Glasgow Coma Scale score of 3 [3-6]. Our results showed an association between the intensity of care and mortality (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.63 to 0.74) and the incidence of withdrawal of life-sustaining therapy (HR, 0.73; 95% CI, 0.67 to 0.79). In general, more intense care was associated with fewer deaths and a lower incidence of withdrawal of life-sustaining therapies in critically ill patients with severe TBI.

  7. [Effects of radiation emitted from mobile phones on short- term heart rate variability parameters].

    PubMed

    Yıldız, Metin; Yılmaz, Derya; Güler, Inan; Akgüllü, Cağdaş

    2012-08-01

    In this study, the effects of radiation emitted from mobile phone (MP) on heart rate variability (HRV) which is accepted a non-invasive indicator of autonomic nervous system (ANS) were investigated with considering the deficiency of previous studies. A randomized controlled study has been designed and utilized with 30 young and healthy volunteers. During the experiment that had three periods, the electrocardiogram (ECG) and respiration signals were recorded and MP was attached to subjects' right ear with a bone. Ten subjects selected randomly were exposed to high -level radiation during the second period (Experimental Group 1). Ten of others were exposed during the third period with maximum level radiation (Experimental Group 2). Ten records were also made while MP was closed as a control. Short -term HRV parameters were obtained and repeated measures ANOVA and suitable post-hoc tests applied to the results. According to the results of the repeated measures ANOVA; there were no significant main effects of groups. However, there were some significant differences in measuring time periods and groups*period interactions. The post-hoc tests showed that mean R to R interval and HF power are significantly changed by maximum radiation emitted from MP. Due to the radiation emitted from MPs at maximum power, some changes may occur in HRV parameters that are associated with increased parasympathetic activity. But, the level of these changes is similar to daily activities as excitement, and stand up.

  8. Effect of Extended Release Niacin on Cardiovascular Events and Kidney Function in Chronic Kidney Disease: A Post-Hoc Analysis of the AIM-HIGH Trial

    PubMed Central

    Kalil, Roberto S.; Wang, Jeffrey H.; de Boer, Ian H.; Mathew, Roy O.; Ix, Joachim H.; Asif, Arif; Shi, Xuefeng; Boden, William E.

    2014-01-01

    Chronic kidney disease (CKD) in patients is strongly associated with cardiovascular morbidity and mortality, and prevalent abnormal lipid metabolism. The AIM-HIGH trial examined the benefits of adding extended-release niacin (ERN) to simvastatin in patients with established coronary heart disease. Here we conducted a post-hoc analysis of the AIM-HIGH trial examining whether participants derived cardiovascular or renal benefits when stratified by renal function. Of 3414 participants, 505 had stage 3 CKD at baseline. Among the CKD subset, demographics and cardiovascular disease (CVD) risk factors were well balanced in the ERN and placebo arms. Compared to placebo, CKD participants receiving ERN had a significant decrease in triglycerides by a median of 59.0 mg/dL, and high density lipoprotein-cholesterol significantly increased by a mean of 11.3 mg/dL over a mean follow-up of 3 years. CVD events were similar between CKD participants in both arms. However, all-cause mortality was significantly higher in the ERN group (hazard ratio of 1.73). Mean change in eGFR among ERN-treated CKD participants was not significantly different between study arms. Thus, among AIM-HIGH participants with CKD, the addition of ERN to simvastatin for secondary prevention of CVD improved triglyceride and high density lipoprotein-cholesterol concentrations but did not improve cardiovascular outcomes or kidney function, and was associated with higher all-cause mortality. PMID:25651367

  9. Effect of extended-release niacin on cardiovascular events and kidney function in chronic kidney disease: a post hoc analysis of the AIM-HIGH trial.

    PubMed

    Kalil, Roberto S; Wang, Jeffrey H; de Boer, Ian H; Mathew, Roy O; Ix, Joachim H; Asif, Arif; Shi, Xuefeng; Boden, William E

    2015-06-01

    Chronic kidney disease (CKD) in patients is strongly associated with cardiovascular morbidity and mortality, and prevalent abnormal lipid metabolism. The AIM-HIGH trial examined the benefits of adding extended-release niacin (ERN) to simvastatin in patients with established coronary heart disease. Here we conducted a post hoc analysis of the AIM-HIGH trial examining whether participants derived cardiovascular or renal benefits when stratified by renal function. Of 3414 participants, 505 had stage 3 CKD at baseline. Among the CKD subset, demographics and cardiovascular disease (CVD) risk factors were well balanced in the ERN and placebo arms. Compared with placebo, CKD participants receiving ERN had a significant decrease in triglycerides by a median of 59.0 mg/dl, and high-density lipoprotein cholesterol significantly increased by a mean of 11.3 mg/dl over a mean follow-up of 3 years. CVD events were similar between CKD participants in both arms. However, all-cause mortality was significantly higher in the ERN group (hazard ratio of 1.73). Mean change in eGFR among ERN-treated CKD participants was not significantly different between study arms. Thus, among AIM-HIGH participants with CKD, the addition of ERN to simvastatin for secondary prevention of CVD improved triglyceride and high-density lipoprotein-cholesterol concentrations but did not improve cardiovascular outcomes or kidney function, and was associated with higher all-cause mortality.

  10. Nurses' attitudes towards computers: cross sectional questionnaire study.

    PubMed

    Brumini, Gordan; Kovic, Ivor; Zombori, Dejvid; Lulic, Ileana; Petrovecki, Mladen

    2005-02-01

    To estimate the attitudes of hospital nurses towards computers and the influence of gender, age, education, and computer usage on these attitudes. The study was conducted in two Croatian hospitals where integrated hospital information system is being implemented. There were 1,081 nurses surveyed by an anonymous questionnaire consisting of 8 questions about demographic data, education, and computer usage, and 30 statements on attitudes towards computers. The statements were adapted to a Likert type scale. Differences in attitudes towards computers were compared using one-way ANOVA and Tukey-b post-hoc test. The total score was 120+/-15 (mean+/-standard deviation) out of maximal 150. Nurses younger than 30 years had a higher total score than those older than 30 years (124+/-13 vs 119+/-16 for 30-39 age groups and 117+/-15 for>39 age groups, P<0.001). Nurses with a bachelor's degree (119+/-16 vs 122+/-14, P=0.002) and nurses who had attended computer science courses had a higher total score compared to the others (124+/-13 vs 118+/-16, P<0.001). Nurses using computers more than 5 hours per week had higher total score than those who used computers less than 5 hours (127+/-13 vs 124+/-12 for 1-5 h and and 119+/-14 for <1 hour per day, P<0.001, post-hoc test). Nurses in general have positive attitudes towards computers. These results are important for the planning and implementing an integrated hospital information system.

  11. Increased fear-potentiated startle in major depressive disorder patients with lifetime history of suicide attempt.

    PubMed

    Ballard, Elizabeth D; Ionescu, Dawn F; Vande Voort, Jennifer L; Slonena, Elizabeth E; Franco-Chaves, Jose A; Zarate, Carlos A; Grillon, Christian

    2014-06-01

    Suicide is a common reason for psychiatric emergency and morbidity, with few effective treatments. Anxiety symptoms have emerged as potential modifiable risk factors in the time before a suicide attempt, but few studies have been conducted using laboratory measures of fear and anxiety. We operationally defined fear and anxiety as increased startle reactivity during anticipation of predictable (fear-potentiated startle) and unpredictable (anxiety-potentiated startle) shock. We hypothesized that a lifetime history of suicide attempt (as compared to history of no suicide attempt) would be associated with increased fear-potentiated startle. A post-hoc analysis of fear- and anxiety-potentiated startle was conducted in 28 medication-free patients with Major Depressive Disorder (MDD) divided according to suicide attempt history. The magnitude of fear-potentiated startle was increased in depressed patients with lifetime suicide attempts compared to those without a lifetime history of suicide attempt (F(1,26)=5.629, p=.025). There was no difference in anxiety-potentiated startle by suicide attempt history. This is a post-hoc analysis of previously analyzed patient data from a study of depressed inpatients. Further replication of the finding with a larger patient sample is indicated. Increased fear-potentiated startle in suicide attempters suggests the role of amygdala in depressed patients with a suicide attempt history. Findings highlight the importance of anxiety symptoms in the treatment of patients at increased suicide risk. Published by Elsevier B.V.

  12. Regional differences in baseline disease activity and remission rates following golimumab treatment for RA: results from the GO-MORE trial.

    PubMed

    Durez, Patrick; Pavelka, Karel; Lazaro, Maria Alicia; Garcia-Kutzbach, Abraham; Moots, Robert J; Amital, Howard; Govoni, Marinella; Vastesaeger, Nathan

    2018-05-01

    GO-MORE (NCT00975130) was a large open-label, multinational, multicenter, prospective phase 3 trial evaluating add-on therapy with golimumab in biologic-naïve patients with active rheumatoid arthritis (RA). The objective of this post hoc analysis was to examine regional differences in baseline disease activity and remission rates following golimumab treatment for RA. This was a planned, descriptive post hoc analysis of data from the GO-MORE trial. Baseline disease activity and remission were defined as moderate or severe based on EULAR criteria. This analysis included 3280 participants from the GO-MORE trial. All participants included in this analysis had high or moderate disease activity at baseline. At baseline, high disease activity was least common in Europe (71.0%), Canada (77.0%), and the Middle East (78.2%) and most common in Latin America (90.7%), South Africa (91.5%), and Asia (92.5%). Month 6 remission rates were highest in South Africa (29.1%), Europe (27.9%), and the Middle East (27.3%) and lowest in Canada (19.7%), Latin America (17.2%), and Asia (15.0%). Higher rates of remission in each geographical region generally corresponded with lower baseline disease activity. We suspect that access to care and implementation of the treat-to-target strategy were the most important determinants, but this apparent relationship needs to be confirmed in further studies that include a statistical analysis of prognostic indicators.

  13. Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis.

    PubMed

    Takeuchi, Tsutomu; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Eguchi, Katsumi; Watanabe, Akira; Origasa, Hideki; Kobayashi, Mariko; Shoji, Toshiharu; Togo, Osamu; Miyasaka, Nobuyuki; Koike, Takao

    2016-07-01

    To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile.

  14. Chlorhexidine Prevents Root Dentine Mineral Loss and Fracture Caused by Calcium Hydroxide over Time

    PubMed Central

    Thomaz, Érika Bárbara Abreu Fonseca; Lima, Darlon Martins; Bauer, José

    2017-01-01

    Purpose. To evaluate the mineral ion loss of root dentine after treatment with 2% chlorhexidine solution (CHX) and to compare its yield and flexural strength (fs) after exposure to calcium hydroxide [Ca(OH)2]. Materials and Methods. Dentine bars (DB) were made from 90 roots of bovine incisors and randomized into three groups: GControl: distilled/deionized water (DDW), GNaOCl: 2.5% sodium hypochlorite + 17% EDTA, and GCHX: CHX + DDW. The release of phosphate (PO4) and calcium (Ca) ions was measured by spectrophotometry. The DB were exposed to Ca(OH)2 paste for 0, 30, 90, and 180 days. DB were subjected to the three-point bending test to obtain yield and fs values. The fracture patterns were evaluated (20x). Data were analyzed using Kruskal-Wallis and Dunn's post hoc tests or one- and two-way ANOVA followed by Tukey's post hoc test (α = 0.05). Results. GCHX showed lower PO43− and Ca2+ ionic release than GNaOCl (p < 0.001). For yield and fs, GCHX > GNaOCl in all periods (p < 0.001), except for yield strength values on 90 days (p = 0.791). A larger frequency of vertical fractures was observed in GNaOCl and that of oblique fractures in GCHX (p < 0.05). Conclusions. CHX prevented PO43− and Ca2+ loss and showed a tendency to preserve the yield and fs of root dentine over time following exposure to Ca(OH)2 paste. PMID:28539937

  15. Who Goes Where? An Exploratory Study of Recent York Graduates.

    ERIC Educational Resources Information Center

    Grayson, J. Paul

    Surveys were conducted to examine the post-college plans of York University (Canada) graduates of the Faculties of Arts, Fine Arts, Pure and Applied Science and the Schulich School of Business. The first survey population included all bachelor's degree candidates who had graduated in fall of 1995 and the second involved all June 1996 graduates;…

  16. Gender Gaps in College Enrollment and Degree Attainment: An Exploratory Analysis

    ERIC Educational Resources Information Center

    Adebayo, Bob

    2008-01-01

    Post-secondary institutions are increasingly interested in the collection of data to support institutional planning. With increase in the proportion of women going to college today than they did a decade ago, our understanding of how gender gaps in college enrollment affect the nature and the types of degrees being conferred by colleges and…

  17. Addiction Studies: Exploring Students' Attitudes toward Research in a Graduate Program

    ERIC Educational Resources Information Center

    James, Raven; Simons, Lori

    2011-01-01

    An exploratory study was conducted to compare addiction studies and community counseling students' attitudes toward research. A survey of 66 addiction studies and 17 community counseling students in graduate programs was used to explore interest and self-efficacy in research and the research training environment. A pre/post test design was used to…

  18. Changes in College Students' Perceptions of Use of Web-Based Resources for Academic Tasks with Wikipedia Projects: A Preliminary Exploration

    ERIC Educational Resources Information Center

    Traphagan, Tomoko; Traphagan, John; Dickens, Linda Neavel; Resta, Paul

    2014-01-01

    Motivated by the need to facilitate Net Generation students' information literacy (IL), or more specifically, to promote student understanding of legitimate, effective use of Web-based resources, this exploratory study investigated how analyzing, writing, posting, and monitoring Wikipedia entries might help students develop critical…

  19. Social Interactions and Instructional Artifacts: Emergent Socio-Technical Affordances and Constraints for Children's Geometric Thinking

    ERIC Educational Resources Information Center

    Evans, Michael A.; Wilkins, Jesse L. M.

    2011-01-01

    The reported exploratory study consisted primarily of classroom visits, videotaped sessions, and post-treatment interviews whereby second graders (n = 12) worked on problems in planar geometry, individually and in triads, using physical and virtual manipulatives. The goal of the study was to: 1) characterize the nature of geometric thinking found…

  20. Security and Vulnerability Assessment of Social Media Sites: An Exploratory Study

    ERIC Educational Resources Information Center

    Zhao, Jensen; Zhao, Sherry Y.

    2015-01-01

    While the growing popularity of social media has brought many benefits to society, it has also resulted in privacy and security threats. The authors assessed the security and vulnerability of 50 social media sites. The findings indicate that most sites (a) posted privacy and security policies but only a minority stated clearly their execution of…

  1. The Afro-American Work/Family Nexus: An Exploratory Analysis.

    ERIC Educational Resources Information Center

    Collins, Patricia Hill

    1986-01-01

    Sketches out a framework linking black labor market trends in the post World War II era to actual and potential changes in black family patterns. Summarizes selected scholarship and then provides a gender-specific analysis of the changing employment status of black Americans. Urgres that links be made between black family life and the political…

  2. Shifting Selves: The Emergence of New Identities in South African Schools

    ERIC Educational Resources Information Center

    Vandeyar, Saloshna

    2008-01-01

    This is an exploratory study on the nature and extent of racial integration in South African schools in the post-apartheid period. While there is vigilant media attention to occasional, dramatic incidents of racial conflict in white schools, there is very little research on the ways in which student identities are framed, challenged, asserted and…

  3. Jejunal perforation due to porcupine quill ingestion in a horse

    PubMed Central

    Anderson, Stacy L.; Panizzi, Luca; Bracamonte, Jose

    2014-01-01

    An 8-month-old Andalusian filly was treated for jejunal perforations due to ingestion of a porcupine quill. During exploratory laparotomy, 2 separate stapled side-to-side jejunojejunal resection and anastomoses were performed. Post-operative complications after 2 years follow-up included mild incisional herniation following incisional infection and chronic intermittent colic. PMID:24489394

  4. Evaluating fire-damaged components of historic covered bridges

    Treesearch

    Brian Kukay; Charles Todd; Tyler Jahn; Jenson Sannon; Logan Dunlap; Robert White; Mark Dietenberger

    2016-01-01

    Arson continues to claim many historic covered bridges. Site-specific, post-fire evaluations of the structural integrity of a bridge are often necessary in a fire’s aftermath. Decisions on whether individual wood components can be rehabilitated, reconstructed, or replaced must be made. This report includes coverage of existing approaches and exploratory approaches that...

  5. The Relation between Self-Determination and Retirement Satisfaction among Active Retired Individuals

    ERIC Educational Resources Information Center

    Stephan, Yannick; Fouquereau, Evelyne; Fernandez, Anne

    2008-01-01

    Little is known about the motivational forces leading retired individuals to engage in post-retirement activities and how they could be related to satisfaction with retirement. Using the self-determination framework, the purpose of the present exploratory study was to examine the nature of active retirees' motivation and its impact on satisfaction…

  6. Metacognitive Analysis of Pre-Service Teacher Conception of Teaching Games for Understanding (TGfU) Using Blogs

    ERIC Educational Resources Information Center

    Dudley, Dean; Baxter, David

    2013-01-01

    Previous studies have sought to ascertain Teaching Games for Understanding (TGfU) conception in pre-service teachers. This exploratory study investigated the problems outlined in the literature surrounding the development of TGfU understanding among pre-service teachers ("n" = 44) of the curriculum instruction model. Blog postings were…

  7. Structural effects of sprifermin in knee osteoarthritis: a post-hoc analysis on cartilage and non-cartilaginous tissue alterations in a randomized controlled trial.

    PubMed

    Roemer, Frank W; Aydemir, Aida; Lohmander, Stefan; Crema, Michel D; Marra, Monica Dias; Muurahainen, Norma; Felson, David T; Eckstein, Felix; Guermazi, Ali

    2016-07-09

    A recent publication on efficacy of Sprifermin for knee osteoarthritis (OA) using quantitatively MRI-defined central medial tibio-femoral compartment cartilage thickness as the structural primary endpoint reported no statistically significant dose response. However, Sprifermin was associated with statistically significant, dose-dependent reductions in loss of total and lateral tibio-femoral cartilage thickness. Based on these preliminary promising data a post-hoc analysis of secondary assessment and endpoints was performed to evaluate potential effects of Sprifermin on semi-quantitatively evaluated structural MRI parameters. Aim of the present analysis was to determine effects of sprifermin on several knee joint tissues over a 12 month period. 1.5 T or 3 T MRIs were acquired at baseline and 12 months follow-up using a standard protocol. MRIs were read according to the Whole-Organ Magnetic Resonance Imaging Score (WORMS) scoring system (in 14 articular subregions) by four muskuloskeletal radiologists independently. Analyses focused on semiquantitative changes in the 100 μg subgroup and matching placebo of multiple MRI-defined structural alterations. Analyses included a delta-subregional and delta-sum approach for the whole knee and the medial and lateral tibio-femoral (MTFJ, LTFJ), and patello-femoral (PFJ) compartments, taking into account number of subregions showing no change, improvement or worsening and changes in the sum of subregional scores. Mann-Whitney - Wilcoxon tests assessed differences between groups. Fifty-seven and 18 patients were included in the treatment and matched placebo subgroups. Less worsening of cartilage damage was observed from baseline to 12 months in the PFJ (0.02, 95 % confidence interval (CI) (-0.04, 0.08) vs. placebo 0.22, 95 % CI (-0.05, 0.49), p = 0.046). For bone marrow lesions (BMLs), more improvement was observed from 6 to 12 months for whole knee analyses (-0.14, 95 % CI (-0.48, 0.19) vs. placebo 0.44, 95 % CI (-0.15, 1.04), p = 0.042) although no significant effects were seen from the baseline visit, or in Hoffa-synovitis, effusion-synovitis, menisci and osteophytes. In this post-hoc analysis cartilage showed less worsening from baseline to 12 months in the PFJ, and BMLs showed more improvement from 6 to 12 months for the whole knee. ClinicalTrials.gov identifier: NCT01033994 .

  8. Characteristics of menstrual vs nonmenstrual migraine: a post hoc, within-woman analysis of the usual-care phase of a nonrandomized menstrual migraine clinical trial.

    PubMed

    MacGregor, E Anne; Victor, Timothy W; Hu, Xiaojun; Xiang, Qinfang; Puenpatom, Rajitkanok A; Chen, Wei; Campbell, John C

    2010-04-01

    To compare, using a within-woman analysis, the severity, duration, and relapse of menstrual vs nonmenstrual episodes of migraine during treatment with usual migraine therapy. Studies comparing the clinical characteristics of menstrual and nonmenstrual migraine attacks have yielded conflicting results, contributing to disagreement regarding whether menstrual migraine attacks are clinically more problematic than nonmenstrual migraine attacks. Post hoc within-woman analysis of the usual-care phase (month 1) of a 2-month, multicenter, prospective, open-label study at 21 US medical practices (predominantly primary care). Participants were women > or =18 years of age with regular predictable menstrual cycles (28 +/- 4 days) who self-reported a > or =1-year history of migraine attacks occurring between days -2 and +3 (menses onset = day +1) and > or =8 such attacks within the previous 12 cycles. Migraine treatment episodes were categorized as menstrual (occurring on days -2 to +3 of menses) or nonmenstrual (occurring on days +4 to -3 of menses). Pain severity, functional impairment, duration, relapse in 24 hours, and use of rescue medication were compared. Sources of variability (within- or between-patient) were determined using mathematical modeling. The http://www.clinicaltrial.gov code for trial is NCT00904098. Women (n = 153; intent to treat) reported 212 menstrual (59.2%) and 146 nonmenstrual (40.8%) migraine treatment episodes. Compared with nonmenstrual treatment episodes, menstrual episodes were more likely to cause impairment (unadjusted odds ratio, 1.65, 95% CI, 1.05-2.60; P = .03), were longer (unadjusted hazard ratio 1.68; 95% CI, 1.31-2.16; P < .001), and were more likely to relapse within 24 hours (unadjusted odds ratio, 2.66; 95% CI, 1.25-5.68; P = .01). Within-patient effects accounted for only 18-33% of the total variance in these outcomes. Post hoc, within-woman analysis of migraine treatment episodes categorized based on International Headache Society criteria showed that menstrual treatment episodes were more impairing, longer lasting, and more likely to relapse than nonmenstrual treatment episodes in this selected population of women with frequent menstrual migraine. The current analysis indicates that most of the variability in these outcomes is due to differences between headache types and not within-patient differences for a given type of headache, suggesting that menstrual episodes are potentially treatable. These findings underscore the differences between menstrual and nonmenstrual episodes of migraine and the need to offer effective migraine treatment to women.

  9. Efficacy of Blended Preservice Training for Resource Parents

    PubMed Central

    White, Lee; Delaney, Richard; Pacifici, Caesar; Nelson, Carol; Whitkin, Josh; Lovejoy, Maureen; Smalley, Betsy Keefer

    2017-01-01

    To evaluate a new way of meeting the growing demand for training prospective resource parents, our study compared the efficacy of a blended online and in-person approach with a traditional classroom-only approach. Findings based on a sample of 111 resource parent prospects showed significantly greater gains in knowledge from pre- to posttest for the blended approach over the classroom-only approach. The blended approach also produced dramatically lower dropout rates during preservice training. Both groups made significant gains in parenting awareness from pre to post, but those gains were greater for the classroom-only approach. Post hoc analyses examined this finding more closely. Satisfaction with training was comparably high for both groups. Gains in knowledge and awareness were sustained at a 3-month follow-up assessment. PMID:28626240

  10. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.

    PubMed

    2017-07-01

    In a previous phase 3 study in patients with amyotrophic lateral sclerosis (ALS), edaravone did not show a significant difference in the Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo. Post-hoc analysis of these data revealed that patients in an early stage with definite or probable diagnosis of ALS, defined by the revised El Escorial criteria, who met a select set of inclusion criteria showed a greater magnitude of effect than did the full study population. We aimed to substantiate this post-hoc result and assess safety and efficacy of edaravone in a phase 3 trial that focused on patients with early stage ALS who met the post-hoc analysis inclusion criteria. In this phase 3, randomised, double-blind, parallel-group study, patients aged 20-75 years with ALS of grade 1 or 2 in the Japan ALS Severity Classification, scores of at least 2 points on all 12 items of ALSFRS-R, forced vital capacity of 80% or more, definite or probable ALS according to the revised El Escorial criteria, and disease duration of 2 years or less were recruited from 31 hospitals in Japan. Eligible patients also had a decrease of 1-4 points in the ALSFRS-R score during a 12-week observation period before randomisation. Patients meeting all criteria were then randomly assigned 1:1 to receive 60 mg intravenous edaravone or intravenous saline placebo for 6 cycles (4 weeks per cycle with 2 weeks on, 2 weeks off) for a total treatment duration of 24 weeks. In cycle 1, the study drug or placebo was administered once per day for 14 days within a 14 day period, followed by the drug-free period. In cycle 2 and thereafter, the study drug or placebo was administered for 10 days within a 14 day period, followed by a 2 week drug-free period. Participants and investigators, including those assessing outcomes, were masked to treatment allocation. The primary efficacy outcome was the change in ALSFRS-R score from the baseline to 24 weeks (or at discontinuation if this was after the third cycle) after randomisation. The primary outcome was assessed in all patients who had received at least one treatment infusion, had at least one assessment post-baseline, and reached the end of cycle 3. For patients with missing values at the end of cycle 6, data were imputed by the last observation carried forward (LOCF) method, provided the patients had completed at least cycle 3. Safety was assessed in all patients who had received at least one treatment infusion and had at least one assessment post-baseline. This trial is registered with ClinicalTrials.gov, NCT01492686. Between Nov 28, 2011, and Sept 3, 2014, we screened 213 patients, and enrolled 192 as potential participants. Of these, 137 patients completed the observation period: 69 were randomly assigned to receive edaravone, and 68 were randomly assigned to receive placebo. 68 patients taking edaravone and 66 taking placebo were included in the primary efficacy analysis. For the primary outcome, the change in ALSFRS-R score was -5·01 (SE 0·64) in the edavarone group and -7·50 (0·66) in the placebo group. The least-squares mean difference between groups was 2·49 (SE 0·76, 95% CI 0·99-3·98; p=0·0013) in favour of edaravone. Treatment-emergent adverse events were reported in 58 (84%) patients receiving edaravone and 57 (84%) patients receiving placebo. 11 (16%) patients taking edaravone and 16 (24%) taking placebo had serious adverse events, and one (1%) patient receiving edaravone and four (6%) patients receiving placebo had adverse events (one dysphagia in edaravone group and one dyspnoea, two respiratory disorder, and one rash in the placebo group) that led to withdrawal. Edaravone showed efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase 3 study, showing a significantly smaller decline of ALSFRS-R score compared with placebo. There is no indication that edaravone might be effective in a wider population of patients with ALS who do not meet the criteria. Mitsubishi Tanabe Pharma Corporation. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Temperature Increase during Different Post Space Preparation Systems: An In Vitro Study

    PubMed Central

    Nazari Moghadam, Kiumars; Shahab, Shahriar; Shirvani, Soghra; Kazemi, Ali

    2011-01-01

     INTRODUCTION: The purpose of this study was to evaluate external root surface temperature rise during post space preparation using LA Axxess bur, Beefill pack System, and Peeso Reamer drill. MATERIALS AND METHODS: The distal canals of forty-five extracted human permanent mandibular first molars were instrumented in crown-apical manner and obturated with lateral condensation technique. Teeth were then randomly divided into three groups according to post space preparation technique including: group 1. LA Axxess bur (Sybronendo Co., CA, USA), group 2 Beefill pack System (VD W Co., Munich, Germany) and group 3 Peeso Reamer drill (Mani Co., Tochigi-ken, Japan). Temperature was measured by means of digital thermometer MT-405 (Comercio Co., Sao Paulo, Brazil) which was installed on the root surfaces. Data was collected and submitted to one-way ANOVA and Post hoc analysis. RESULTS: Root surface temperatures were found to be significantly higher (7.3±2.7 vs. 4.3±2.1 and 4±2.4,) in samples of Beefill pack System compared with the two other groups (P<0.02). CONCLUSION: Using Beefill pack System during post space preparation may be potentially hazardous for periodontal tissues. PMID:24778690

  12. Temperature Increase during Different Post Space Preparation Systems: An In Vitro Study.

    PubMed

    Nazari Moghadam, Kiumars; Shahab, Shahriar; Shirvani, Soghra; Kazemi, Ali

    2011-01-01

      The purpose of this study was to evaluate external root surface temperature rise during post space preparation using LA Axxess bur, Beefill pack System, and Peeso Reamer drill. The distal canals of forty-five extracted human permanent mandibular first molars were instrumented in crown-apical manner and obturated with lateral condensation technique. Teeth were then randomly divided into three groups according to post space preparation technique including: group 1. LA Axxess bur (Sybronendo Co., CA, USA), group 2 Beefill pack System (VD W Co., Munich, Germany) and group 3 Peeso Reamer drill (Mani Co., Tochigi-ken, Japan). Temperature was measured by means of digital thermometer MT-405 (Comercio Co., Sao Paulo, Brazil) which was installed on the root surfaces. Data was collected and submitted to one-way ANOVA and Post hoc analysis. Root surface temperatures were found to be significantly higher (7.3±2.7 vs. 4.3±2.1 and 4±2.4,) in samples of Beefill pack System compared with the two other groups (P<0.02). Using Beefill pack System during post space preparation may be potentially hazardous for periodontal tissues.

  13. Substance abuse treatment response in a Latino sample: the influence of family conflict.

    PubMed

    Fish, Jessica N; Maier, Candice A; Priest, Jacob B

    2015-02-01

    Latino Americans report underutilization of treatment and poor treatment response for substance use and abuse compared to other racial/ethnic groups; thus, it is important to assess factors that contribute to these disparities. The current study objective was to assess the influence of family conflict on substance abuse treatment response in a sample of Latino Americans using two different yet complementary analyses. First, ordinary least squares regression was used to assess the association between overall family conflict and pre- and post-treatment substance use. Second, repeated measures latent class analysis was used to identify groups based on family member conflict and timing of conflict during treatment. Findings indicated that family conflict contributed unique variance to concurrent substance use; however pre-treatment family conflict was not related to post-treatment outcomes. Results also identified three distinct family conflict groups: no/low conflict, pre-treatment conflict, and post-treatment conflict who differed in pre- and post-treatment substance use. Post hoc investigation revealed that those who experienced pre-treatment conflict but low post-treatment conflict showed the greatest decrease in substance use. Findings highlight the importance of considering family conflict during all stages of treatment for Latino American substance users. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. Early Life Stress and Sleep Restriction as Risk Factors in PTSD: An Integrative Pre-Clinical Approach

    DTIC Science & Technology

    2015-04-01

    dDG GABAAR alpha 1 expression in both J+UWT(+),EE (J) and EE (A) rats compered to Control. In addition, EE (A) rats exhibit lower expression of BLA...GABAAR alpha 1 expression compered to Control. (*= pɘ.05,**= pɘ.01). 48 7: One way ANOVA [F (3,47)= 4.79, pɘ.01] revealed a significant main...effect for the exposure. Further Post hoc comparisons revealed increased vDG GABAAR alpha 1 expression in both J+UWT(+) and EE (A) rats compered to EE (J

  15. Analysis of carpooling in Missouri and an evaluation of Missouri's carpool services

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Barnett, D.R.

    1984-12-10

    The evaluation of Missouri's carpool services was conducted as a post hoc evaluation and relied on both primary and secondary data. The period from 1978 through 1983 was analyzed for the purpose of evaluating carpool activities of the Missouri Division of Energy as they related to geographic trends associated with carpooling during that time period. The end focus of the report was on carpooling characteristics and program impacts documented from telephone and mail surveys of those persons who requested carpool matches during the years of 1982 and 1983.

  16. Analyzing Infrequent Events: Once You Find Them Your Troubles Begin.

    DTIC Science & Technology

    1980-04-01

    e €ical kepmt. 80-3 /J,, p r - ...... Running Head: Analyzing Infrequent Events -_ Prepared with the support of the Organizatio-Effec-Uanasa Research...of post hoc groups defines after the occurrences of the event - , 1473 ,FI ,, o , ov 5 IS 0:, l.FTr , • . IS i N , { I , ; 0 1 4 - 0& E ct U m I r Y...AA8 048 ILLINOIS WdIV AT URBANA-CHAMPAIGN DEPT OP PSYCHOLOGY F/B 5/10 ANALYZING INFREQUENT EVENTS: ONCE YOU FIND THEN YOUR TROUBLES B-ETC(U) APR 80 C

  17. Understanding the Effects of Mental Health on Reproductive Health Service Use: A Mixed Methods Approach

    PubMed Central

    Bell, Sue Anne; Lori, Jody; Redman, Richard; Seng, Julia

    2016-01-01

    Appropriate and woman-led health care for displaced women is essential to respecting basic human rights. In this paper, we describe the results of an analysis of the association between mental health and reproductive health service use from a sample of Congolese refugee women residing in short and long term camps in Rwanda, with a post-hoc qualitative potion added to expand upon the data-based results. Our findings suggest that structural factors including health policy initiatives affect or even inhibit individual care choices. PMID:26086238

  18. A History of the Savannah District U.S. Army Corps of Engineers

    DTIC Science & Technology

    1989-01-01

    civil mission of the Corps changed to meet the needs of a post- industrialized society for energy , recreation, and careful regulation of the use of...34J . SA Cl<t(.R ’’’’ 00 .sUP[RVISION HIRtO LABOA AND CONTRACT IN$P(( l ION . HelION /("Cl P’ COI.lAA!. T OIUOGtNGJ , ... /It * POiIl JON, A.HOC...the Department of Energy (DOE), and the Federal Energy Regulatory Commission. This assistance usually take the form of feasibility studies or

  19. Increase in Blood-Brain Barrier Perrmeability, Oxidative Stress, and Activated Microglia in a Rat Model of Blast-Induced Traumatic Brain Injury

    DTIC Science & Technology

    2010-01-01

    a critical role in the secondary it~ury process following TBI. In recent work, our coiJeagues demonstrated that, in both controlled cortical...Animals were then placed inco the end of the expansion chamber of an air-driven shock tube (2.5 ft com- pression chamber conn!:cted to a 15 ft expansion...Significance with A NOVA fo llowed by post hoc analysis (SNK) as follows: * P < 0.05. progression of neuropatho logical processes tha t could be relevant to

  20. Microarrays in brain research: the good, the bad and the ugly.

    PubMed

    Mirnics, K

    2001-06-01

    Making sense of microarray data is a complex process, in which the interpretation of findings will depend on the overall experimental design and judgement of the investigator performing the analysis. As a result, differences in tissue harvesting, microarray types, sample labelling and data analysis procedures make post hoc sharing of microarray data a great challenge. To ensure rapid and meaningful data exchange, we need to create some order out of the existing chaos. In these ground-breaking microarray standardization and data sharing efforts, NIH agencies should take a leading role

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