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

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.

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.

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

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.

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.

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.

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

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.

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.

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)

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.

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.

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.

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

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.

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.

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.

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.

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

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

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

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.

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.

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.

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.

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

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.

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.

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.

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

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…

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…

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…

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.

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

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.

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.

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

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.

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.

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

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.

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).

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.

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

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.

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.

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.

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.

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.

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

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…

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

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…

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.

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-...

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.

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…

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…

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.

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

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…

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.

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

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.

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.…

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…

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...

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…

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…

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

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.

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…

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

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.

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.

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.

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

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.

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

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…

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…

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…

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…

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…

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…

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…

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

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

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.

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

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.

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.

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.

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.

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

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…

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…

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.

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.

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…

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…

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…

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.

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.

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.

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

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.

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

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.

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

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.

Optimization of Soft Tissue Management, Spacer Design, and Grafting Strategies for Large Segmental Bone Defects using the Chronic Caprine Tibial Defect Model

DTIC Science & Technology

2015-12-01

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. In...expression analysis from the Aim 1 samples presented several upregulated target genes such as Oct4, Sox2, TGFB, and Col1A1 in all sections. No...TGFB, and Col1A1 . • Data from cellular analysis, histology, gene expression analysis and microCT are being assembled for the predictive model

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.

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.

[Generalization of the results of clinical studies through the analysis of subgroups].

PubMed

Costa, João; Fareleira, Filipa; Ascensão, Raquel; Vaz Carneiro, António

2012-01-01

Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.

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.

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.

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.

In vivo microvascular and macrovascular endothelial function is not associated with circulating dimethylarginines in patients with rheumatoid arthritis: a prospective analysis of the DRACCO cohort.

PubMed

Dimitroulas, Theodoros; Sandoo, Aamer; Hodson, James; Smith, Jacqueline P; Kitas, George D

2016-07-01

To examine associations between asymmetric (ADMA), symmetric dimethylarginine (SDMA) and ADMA:SDMA ratio with assessments of endothelial function and coronary artery perfusion in RA patients. ADMA and SDMA levels were measured in 197 RA individuals [144 (77.4%) females, median age: 66 years (quartiles: 59-73)]. Patients underwent assessments of microvascular endothelium-dependent and endothelium-independent function, macrovascular endothelium-dependent and endothelium-independent function and vascular morphology (pulse wave analysis, carotid intima-media thickness (cIMT), and carotid plaque). Coronary perfusion was assessed by subendocardial viability ratio (SEVR). SEVR correlated with SDMA (r = 0.172, p = 0.026) and ADMA:SDMA (r = -0.160, p = 0.041) in univariable analysis, but not in multivariable analysis accounting for confounding factors. Neither ADMA:SDMA ratio nor SDMA were significantly correlated with microvascular or macrovascular endothelial function, or with arterial stiffness and cIMT. Within subgroup of patients (n = 26) with high inflammatory markers, a post-hoc analysis showed that SDMA and the ADMA:SDMA ratio were significantly associated with endothelium-dependent microvascular function in univariable analysis, with Pearson's r correlation coefficients of -0.440 (p = 0.031) and 0.511 (p = 0.011), respectively. Similar finding were established between ADMA:SDMA ratio and arterial stiffness in univariable analysis, with Pearson's r of 0.493, (p = 0.024). Dimethylarginines were not found to be significantly associated with several assessments of vascular function and morphology in patients with RA, however, post-hoc analysis indicates that there may be associations in patients with raised inflammatory markers. Our results suggest that dysregulated NO metabolism may not be the sole mechanism for the development of preclinical atherosclerosis in RA.

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…

The electrical heart axis and ST events in fetal monitoring: A post-hoc analysis following a multicentre randomised controlled trial.

PubMed

Vullings, Rik; Verdurmen, Kim M J; Hulsenboom, Alexandra D J; Scheffer, Stephanie; de Lau, Hinke; Kwee, Anneke; Wijn, Pieter F F; Amer-Wåhlin, Isis; van Laar, Judith O E H; Oei, S Guid

2017-01-01

Reducing perinatal morbidity and mortality is one of the major challenges in modern health care. Analysing the ST segment of the fetal electrocardiogram was thought to be the breakthrough in fetal monitoring during labour. However, its implementation in clinical practice yields many false alarms and ST monitoring is highly dependent on cardiotocogram assessment, limiting its value for the prediction of fetal distress during labour. This study aims to evaluate the relation between physiological variations in the orientation of the fetal electrical heart axis and the occurrence of ST events. A post-hoc analysis was performed following a multicentre randomised controlled trial, including 1097 patients from two participating centres. All women were monitored with ST analysis during labour. Cases of fetal metabolic acidosis, poor signal quality, missing blood gas analysis, and congenital heart disease were excluded. The orientation of the fetal electrical heart axis affects the height of the initial T/QRS baseline, and therefore the incidence of ST events. We grouped tracings with the same initial baseline T/QRS value. We depicted the number of ST events as a function of the initial baseline T/QRS value with a linear regression model. A significant increment of ST events was observed with increasing height of the initial T/QRS baseline, irrespective of the fetal condition; correlation coefficient 0.63, p<0.001. The most frequent T/QRS baseline is 0.12. The orientation of the fetal electrical heart axis and accordingly the height of the initial T/QRS baseline should be taken into account in fetal monitoring with ST analysis.

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

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.

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.

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…

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.

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.

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

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.

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.

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.

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

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.

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

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

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.

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

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.

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

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

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

Effects of Safinamide on Pain in Fluctuating Parkinson's Disease Patients: A Post-Hoc Analysis.

PubMed

Cattaneo, Carlo; Barone, Paolo; Bonizzoni, Erminio; Sardina, Marco

2017-01-01

Pain, a frequent non-motor symptom in Parkinson's Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients. To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE. This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson's Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment. The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the "Bodily discomfort" domain.Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect. These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit.

Characterization of abdominal pain during methylnaltrexone treatment of opioid-induced constipation in advanced illness: a post hoc analysis of two clinical trials.

PubMed

Slatkin, Neal E; Lynn, Richard; Su, Chinyu; Wang, Wenjin; Israel, Robert J

2011-11-01

Methylnaltrexone is a selective peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioids without affecting centrally mediated analgesia. In two double-blind, placebo-controlled, Phase III studies of methylnaltrexone for opioid-induced constipation in patients with advanced illness, abdominal pain was the most common adverse event (AE) reported. This analysis sought to further characterize the Medical Dictionary for Regulatory Activities-defined abdominal pain AEs experienced in these studies. A post hoc analysis of verbatim descriptions was used to further assess AEs characterized as abdominal pain in both trials. Descriptive summary statistics were used to assess severity of abdominal pain, effect of abdominal pain on global pain scores, and other characteristics. Logistic regression analysis was used to determine the association of baseline characteristics with abdominal pain. Most verbatim descriptions of abdominal pain referred to "abdominal cramps" or "cramping." Abdominal pain AEs were mostly mild to moderate in severity and did not affect patients' global evaluation of pain. The incidence of abdominal pain AEs in methylnaltrexone-treated patients was greatest after the first dose and decreased with subsequent doses. No association between abdominal pain AEs and most baseline patient characteristics was noted. Abdominal pain AEs in methylnaltrexone-treated patients in clinical trials are usually described as "cramps" or "cramping," are mostly mild to moderate in severity, and decrease in incidence with subsequent dosing. Copyright © 2011 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Assessment of Online Patient Education Materials from Major Dermatologic Associations

PubMed Central

John, Ann M.; John, Elizabeth S.; Hansberry, David R.

2016-01-01

Objective: Patients increasingly use the internet to find medical information regarding their conditions and treatments. Physicians often supplement visits with written education materials. Online patient education materials from major dermatologic associations should be written at appropriate reading levels to optimize utility for patients. The purpose of this study is to assess online patient education materials from major dermatologic associations and determine if they are written at the fourth to sixth grade level recommended by the American Medical Association and National Institutes of Health. Design: This is a descriptive and correlational design. Setting: Academic institution. Participants/measurements: Patient education materials from eight major dermatology websites were downloaded and assessed using 10 readability scales. A one-way analysis of variance and Tukey’s Honestly Statistically Different post hoc analysis were performed to determine the difference in readability levels between websites. Results: Two hundred and sixty patient education materials were assessed. Collectively, patient education materials were written at a mean grade level of 11.13, with 65.8 percent of articles written above a tenth grade level and no articles written at the American Medical Association/National Institutes of Health recommended grade levels. Analysis of variance demonstrated a significant difference between websites for each reading scale (p<0.001), which was confirmed with Tukey’s Honestly Statistically Different post hoc analysis. Conclusion: Online patient education materials from major dermatologic association websites are written well above recommended reading levels. Associations should consider revising patient education materials to allow more effective patient comprehension. (J ClinAesthet Dermatol. 2016;9(9):23–28.) PMID:27878059

Assessment of Online Patient Education Materials from Major Dermatologic Associations.

PubMed

John, Ann M; John, Elizabeth S; Hansberry, David R; Lambert, William Clark

2016-09-01

Objective: Patients increasingly use the internet to find medical information regarding their conditions and treatments. Physicians often supplement visits with written education materials. Online patient education materials from major dermatologic associations should be written at appropriate reading levels to optimize utility for patients. The purpose of this study is to assess online patient education materials from major dermatologic associations and determine if they are written at the fourth to sixth grade level recommended by the American Medical Association and National Institutes of Health. Design: This is a descriptive and correlational design. Setting: Academic institution. Participants/measurements: Patient education materials from eight major dermatology websites were downloaded and assessed using 10 readability scales. A one-way analysis of variance and Tukey's Honestly Statistically Different post hoc analysis were performed to determine the difference in readability levels between websites. Results: Two hundred and sixty patient education materials were assessed. Collectively, patient education materials were written at a mean grade level of 11.13, with 65.8 percent of articles written above a tenth grade level and no articles written at the American Medical Association/National Institutes of Health recommended grade levels. Analysis of variance demonstrated a significant difference between websites for each reading scale (p<0.001), which was confirmed with Tukey's Honestly Statistically Different post hoc analysis. Conclusion: Online patient education materials from major dermatologic association websites are written well above recommended reading levels. Associations should consider revising patient education materials to allow more effective patient comprehension. (J ClinAesthet Dermatol. 2016;9(9):23-28.).

Computational Analysis of Pharyngeal Swallowing Mechanics in Patients with Motor Neuron Disease: A Pilot Investigation.

PubMed

Garand, K L; Schwertner, Ryan; Chen, Amy; Pearson, William G

2018-04-01

Swallowing impairment (dysphagia) is a common sequela in patients with motor neuron disease (MND). The purpose of this retrospective, observational pilot investigation was to characterize how pharyngeal swallowing mechanics are impacted in patients with MND using a comparison with healthy, non-dysphagic control group. Computational analysis of swallowing mechanics (CASM) was used to determine covariate biomechanics of pharyngeal swallowing from videofluoroscopic assessment in 15 patients with MND and 15 age- and sex-matched healthy controls. Canonical variant analysis with post hoc discriminate function analysis (DFA) was performed on coordinate data mapping functional muscle groups underlying pharyngeal swallowing. Differences in swallowing mechanics associated with group (MND; control), motor neuron predominance (upper; lower), onset (bulbar; spinal), and swallow task (thin, pudding) were evaluated and visualized. Pharyngeal swallowing mechanics differed significantly in patients with MND compared with healthy controls (D = 2.01, p < 0.0001). Post hoc DFA pairwise comparisons suggest differences in pharyngeal swallow mechanics by motor neuron predominance (D = 5.03, p < 0.0001), onset (D = 2.03, p < 0.0001), and swallow task (D = 1.04, p < 0.0001). Pharyngeal swallowing mechanics of patients with MND differ from and are more heterogeneous than healthy controls. These findings suggest patients with MND may compensate reductions in pharyngeal shortening and tongue base retraction by extending the head and neck and increasing hyolaryngeal excursion. This work and further CASM investigations will lead to further insights into development and evaluation of targeted clinical treatments designed to prolong safe and efficient swallowing function in patients with MND.

A quantitative readability analysis of patient education resources from gastroenterology society websites.

PubMed

Hansberry, David R; Patel, Sahil R; Agarwal, Prateek; Agarwal, Nitin; John, Elizabeth S; John, Ann M; Reynolds, James C

2017-06-01

The lay public frequently access and rely on online information as a source of their medical knowledge. Many medical societies are unaware of national patient education material guidelines and subsequently fail to meet them. The goal of the present study was to evaluate the readability of patient education materials within the medical field of gastroenterology. Two hundred fourteen articles pertaining to patient education materials were evaluated with ten well-established readability scales. The articles were available on the websites for the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), the American Society of Gastrointestinal Endoscopy (ASGE), the British Society of Gastroenterology (BSG), and the NIH section National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). One-way analysis of variance (ANOVA) and Tukey's honest significant difference (HSD) post hoc analysis were conducted to determine any differences in level of readability between websites. The 214 articles were written at an 11.8 ± 2.1 grade level with a range of 8.0 to 16.0 grade level. A one-way ANOVA and Tukey's HSD post hoc analysis determined the ACG was written at a significantly (p < 0.05) more difficult level when compared to the AGA, the BSG, and the NIDDK websites. No differences were noted when comparing the ASGE website. None of the patient education materials were written at a level that met national guidelines. If the materials are redrafted, the general American public will likely have a greater understanding of the gastroenterology content.

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.

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.

Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial

PubMed Central

Coghlan, John Gerry; Galiè, Nazzareno; Barberà, Joan Albert; Frost, Adaani E; Ghofrani, Hossein-Ardeschir; Hoeper, Marius M; Kuwana, Masataka; McLaughlin, Vallerie V; Peacock, Andrew J; Simonneau, Gérald; Vachiéry, Jean-Luc; Blair, Christiana; Gillies, Hunter; Miller, Karen L; Harris, Julia H N; Langley, Jonathan; Rubin, Lewis J

2017-01-01

Background Patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), in particular systemic sclerosis (SSc), had an attenuated response compared with idiopathic PAH in most trials. Thus, there is uncertainty regarding the benefit of PAH-targeted therapy in some forms of CTD-PAH. Objective To explore the safety and efficacy of initial combination therapy with ambrisentan and tadalafil versus ambrisentan or tadalafil monotherapy in patients with CTD-PAH and SSc-PAH enrolled in the AMBITION trial. Methods This was a post hoc analysis of patients with CTD-PAH and SSc-PAH from AMBITION, an event-driven, double-blind trial in patients with WHO functional class II/III PAH. Treatment-naive patients were randomised 2:1:1 to once-daily initial combination therapy with ambrisentan plus tadalafil or monotherapy with ambrisentan or tadalafil, respectively. The primary endpoint was time to the first clinical failure event (first occurrence of death, hospitalisation for worsening PAH, disease progression or unsatisfactory long-term clinical response). Results In the primary analysis set (N=500), 187 patients had CTD-PAH, of whom 118 had SSc-PAH. Initial combination therapy reduced the risk of clinical failure versus pooled monotherapy in each subgroup: CTD-PAH (HR 0.43 (95% CI 0.24 to 0.77)) and SSc-PAH (0.44 (0.22 to 0.89)). The most common AE was peripheral oedema, which was reported more frequently with initial combination therapy than monotherapy in the two PAH subgroups. The relative frequency of adverse events between those on combination therapy versus monotherapy was similar across subgroups. Conclusions This post hoc subgroup analysis provides evidence that CTD-PAH and SSc-PAH patients benefit from initial ambrisentan and tadalafil combination therapy. Trial registration number NCT01178073, post results. PMID:28039187

Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial.

PubMed

Coghlan, John Gerry; Galiè, Nazzareno; Barberà, Joan Albert; Frost, Adaani E; Ghofrani, Hossein-Ardeschir; Hoeper, Marius M; Kuwana, Masataka; McLaughlin, Vallerie V; Peacock, Andrew J; Simonneau, Gérald; Vachiéry, Jean-Luc; Blair, Christiana; Gillies, Hunter; Miller, Karen L; Harris, Julia H N; Langley, Jonathan; Rubin, Lewis J

2017-07-01

Patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), in particular systemic sclerosis (SSc), had an attenuated response compared with idiopathic PAH in most trials. Thus, there is uncertainty regarding the benefit of PAH-targeted therapy in some forms of CTD-PAH. To explore the safety and efficacy of initial combination therapy with ambrisentan and tadalafil versus ambrisentan or tadalafil monotherapy in patients with CTD-PAH and SSc-PAH enrolled in the AMBITION trial. This was a post hoc analysis of patients with CTD-PAH and SSc-PAH from AMBITION, an event-driven, double-blind trial in patients with WHO functional class II/III PAH. Treatment-naive patients were randomised 2:1:1 to once-daily initial combination therapy with ambrisentan plus tadalafil or monotherapy with ambrisentan or tadalafil, respectively. The primary endpoint was time to the first clinical failure event (first occurrence of death, hospitalisation for worsening PAH, disease progression or unsatisfactory long-term clinical response). In the primary analysis set (N=500), 187 patients had CTD-PAH, of whom 118 had SSc-PAH. Initial combination therapy reduced the risk of clinical failure versus pooled monotherapy in each subgroup: CTD-PAH (HR 0.43 (95% CI 0.24 to 0.77)) and SSc-PAH (0.44 (0.22 to 0.89)). The most common AE was peripheral oedema, which was reported more frequently with initial combination therapy than monotherapy in the two PAH subgroups. The relative frequency of adverse events between those on combination therapy versus monotherapy was similar across subgroups. This post hoc subgroup analysis provides evidence that CTD-PAH and SSc-PAH patients benefit from initial ambrisentan and tadalafil combination therapy. NCT01178073, post results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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 .

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

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.

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.

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

The latent structure of post-traumatic stress disorder among Arabic-speaking refugees receiving psychiatric treatment in Denmark.

PubMed

Vindbjerg, Erik; Carlsson, Jessica; Mortensen, Erik Lykke; Elklit, Ask; Makransky, Guido

2016-09-05

Refugees are known to have high rates of post-traumatic stress disorder (PTSD). Although recent years have seen an increase in the number of refugees from Arabic speaking countries in the Middle East, no study so far has validated the construct of PTSD in an Arabic speaking sample of refugees. Responses to the Harvard Trauma Questionnaire (HTQ) were obtained from 409 Arabic-speaking refugees diagnosed with PTSD and undergoing treatment in Denmark. Confirmatory factor analysis was used to test and compare five alternative models. All four- and five-factor models provided sufficient fit indices. However, a combination of excessively small clusters, and a case of mistranslation in the official Arabic translation of the HTQ, rendered results two of the models inadmissible. A post hoc analysis revealed that a simpler factor structure is supported, once local dependence is addressed. Overall, the construct of PTSD is supported in this sample of Arabic-speaking refugees. Apart from pursuing maximum fit, future studies may wish to test simpler, potentially more stable models, which allow a more informative analysis of individual items.

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

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

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.

Validation of previously reported predictors for radiation-induced hypothyroidism in nasopharyngeal cancer patients treated with intensity-modulated radiation therapy, a post hoc analysis from a Phase III randomized trial.

PubMed

Lertbutsayanukul, Chawalit; Kitpanit, Sarin; Prayongrat, Anussara; Kannarunimit, Danita; Netsawang, Buntipa; Chakkabat, Chakkapong

2018-05-10

This study aimed to validate previously reported dosimetric parameters, including thyroid volume, mean dose, and percentage thyroid volume, receiving at least 40, 45 and 50 Gy (V40, V45 and V50), absolute thyroid volume spared (VS) from 45, 50 and 60 Gy (VS45, VS50 and VS60), and clinical factors affecting the development of radiation-induced hypothyroidism (RHT). A post hoc analysis was performed in 178 euthyroid nasopharyngeal cancer (NPC) patients from a Phase III study comparing sequential versus simultaneous-integrated boost intensity-modulated radiation therapy. RHT was determined by increased thyroid-stimulating hormone (TSH) with or without reduced free thyroxin, regardless of symptoms. The median follow-up time was 42.5 months. The 1-, 2- and 3-year freedom from RHT rates were 78.4%, 56.4% and 43.4%, respectively. The median latency period was 21 months. The thyroid gland received a median mean dose of 53.5 Gy. Female gender, smaller thyroid volume, higher pretreatment TSH level (≥1.55 μU/ml) and VS60 < 10 cm3 were significantly associated with RHT in univariate analyses. Only pretreatment TSH ≥ 1.55 μU/ml and VS60 < 10 cm3 were significant predictors in multivariate analysis. Our results suggested that patients with pretreatment TSH ≥ 1.55 μU/ml should be cautious about the risk of RHT. The VS60 ≥ 10 cm3 is recommended for treatment planning.

Strain of ascending aorta on cardiac magnetic resonance in 1027 patients: Relation with age, gender, and cardiovascular disease.

PubMed

Scarabello, Marco; Codari, Marina; Secchi, Francesco; Cannaò, Paola M; Alì, Marco; Di Leo, Giovanni; Sardanelli, Francesco

2018-02-01

To evaluate ascending aortic strain (AAS) with cardiac magnetic resonance (CMR) in a large consecutive series of patients with different types of cardiovascular disease (CVD). Two-dimensional phase-contrast gradient-echo sequences of the ascending aorta were retrospectively reviewed in 1027 patients (726 males, 301 females). Aortic lumen area was segmented using a semi-automatic approach to calculate AAS values. Subgroup analysis was performed for patients with normal CMR, tetralogy of Fallot (ToF), and ischemic heart disease (IHD). Multivariate and post-hoc analyses were performed to evaluate the effect of age, gender, and CVD on AAS values. Shapiro-Wilk, three- and two-way ANOVA, Mann-Whitney U, and Spearman correlation statistics were used. Multivariate analysis showed significant differences in AAS among decades of age (p<0.001), genders (p=0.006) and CVD subgroups (p<0.001) without interaction among these factors. A gender-related difference (higher AAS in females) was significant in ToF (p=0.008), while an AAS reduction during aging was observed in all CVD subgroups. Post-hoc analysis showed a significantly lower AAS in ToF and IHD patients compared to subjects with normal CMR (p<0.001). Differences in age, gender, and CVD independently affect AAS. The lower AAS observed in ToF fosters its assessment during follow-up in adulthood. Future studies on causes and clinical implications of a higher AAS in females affected by ToF are warranted. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of Safinamide on Pain in Fluctuating Parkinson’s Disease Patients: A Post-Hoc Analysis

PubMed Central

Cattaneo, Carlo; Barone, Paolo; Bonizzoni, Erminio; Sardina, Marco

2016-01-01

Background: Pain, a frequent non-motor symptom in Parkinson’s Disease (PD), significantly impacts on quality of life. Safinamide is a new drug with dopaminergic and non-dopaminergic properties, approved in Europe as adjunct therapy to levodopa for the treatment of fluctuating PD patients. Results from two 24-month, double-blind, placebo-controlled studies demonstrated that safinamide has positive effects on both motor functions and quality of life in PD patients. Objective: To investigate the effects of safinamide on pain management in PD patients with motor fluctuations using pooled data from studies 016 and SETTLE. Methods: This post-hoc analysis evaluated the reduction of concomitant pain treatments and the changes in the scores of the items related to pain of the Parkinson’s Disease Quality of Life Questionnaire (PDQ-39). A path analysis was performed in order to examine direct and indirect associations between safinamide and PDQ-39 pain-related items assessed after 6-months of treatment. Results: The percentage of patients with no pain treatments at the end of the trials was significantly lower in the safinamide group compared to the placebo group. Safinamide 100 mg/day significantly reduced on average the individual use of pain treatments by ≈24% and significantly improved two out of three PDQ-39 pain-related items of the “Bodily discomfort” domain. Path analysis showed that the direct effect of safinamide on pain accounted for about 80% of the total effect. Conclusions: These results suggest that safinamide may have a positive effect on pain, one of the most underestimated non-motor symptoms. Prospective studies are warranted to investigate this potential benefit. PMID:27802242

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).

Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period.

PubMed

Weiden, Peter J; Du, Yangchun; Liu, Chih-Chin; Stanford, Arielle D

2018-06-26

Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL). This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed. In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. The 12-week completion rate was high (92.1%) and similar across the different preswitch oral antipsychotic groups. Overall, adverse event (AE) rates experienced over 12 weeks were modest; no AEs were considered serious. The most common AEs in the initiation phase were injection site pain (5.8%), insomnia (5.8%), and akathisia (3.2%). No apparent relationship was observed between preswitch medication and early-onset AEs. Mean Positive and Negative Syndrome Scale total scores remained stable during this period across preswitch antipsychotic groups. Switching from an oral antipsychotic to AL was feasible in an outpatient setting for patients with schizophrenia, and the 12-week retention rate was favorable.

The Perceived Importance of Role-Specific Competencies for Health Care Leaders Establishes the Need to Expand Role Theory.

PubMed

Babinski, Paul J

2016-01-01

This cross-sectional quantitative study was undertaken to determine the extent to which individuals who have differing health care leadership roles perceived the importance of selected leadership competencies in their specific roles based on their experience. A total of 313 participants responded to the health care questionnaire. Principal component analysis identified factor structure and Cronbach α at .96 supported the reliability of the factor analysis. Multivariate analysis of variance tested the 4 health care leadership roles to determine if an effect was present among the competencies. A subsequent analysis of variance test was conducted on the competencies to confirm an effect was present, and a Games-Howell post hoc test followed. These tests indicated that there was a significant difference in rating the perceived importance of specific leadership competencies by the health care leaders in each competency domain. The participants included in this study consisted of the chief executive officer (CEO), director of nursing (DON), operating room director (ORD), and director of radiology (DOR). Based on the Games-Howell post hoc test, a commonality existed between the leaders. The CEOs and DONs often indicated no significant difference in competency perception to one another in relation to the dependent variables, yet indicated a significant difference in competency perception when compared with the ORDs and DORs. Similarly, the ORD and DOR variables often indicated no significant difference in competency perception to one another in relation to the dependent variables, yet indicated a significant difference in competency perception compared with the CEO and DON variables. This study positively indicated that health care leadership's perception of competencies does differ between the various leadership roles.

An analysis of science versus pseudoscience

NASA Astrophysics Data System (ADS)

Hooten, James T.

2011-12-01

This quantitative study identified distinctive features in archival datasets commissioned by the National Science Foundation (NSF) for Science and Engineering Indicators reports. The dependent variables included education level, and scores for science fact knowledge, science process knowledge, and pseudoscience beliefs. The dependent variables were aggregated into nine NSF-defined geographic regions and examined for the years 2004 and 2006. The variables were also examined over all years available in the dataset. Descriptive statistics were determined and tests for normality and homogeneity of variances were performed using Statistical Package for the Social Sciences. Analysis of Variance was used to test for statistically significant differences between the nine geographic regions for each of the four dependent variables. Statistical significance of 0.05 was used. Tukey post-hoc analysis was used to compute practical significance of differences between regions. Post-hoc power analysis using G*Power was used to calculate the probability of Type II errors. Tests for correlations across all years of the dependent variables were also performed. Pearson's r was used to indicate the strength of the relationship between the dependent variables. Small to medium differences in science literacy and education level were observed between many of the nine U.S. geographic regions. The most significant differences occurred when the West South Central region was compared to the New England and the Pacific regions. Belief in pseudoscience appeared to be distributed evenly across all U.S. geographic regions. Education level was a strong indicator of science literacy regardless of a respondent's region of residence. Recommendations for further study include more in-depth investigation to uncover the nature of the relationship between education level and belief in pseudoscience.

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

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

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.

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

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.

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.

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.

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.

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.

[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.

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…

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…

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.

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.

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.

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.

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

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

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.

Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome

PubMed Central

Iyer, Kishore R.; Kunecki, Marek; Boullata, Joseph I.; Fujioka, Ken; Joly, Francisca; Gabe, Simon; Pape, Ulrich-Frank; Schneider, Stéphane M.; Virgili Casas, María Nuria; Ziegler, Thomas R.; Li, Benjamin; Youssef, Nader N.; Jeppesen, Palle B.

2016-01-01

Background: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. Materials and Methods: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. Results: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. Conclusion: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence. PMID:27875291

Role strain among male RNs in the critical care setting: Perceptions of an unfriendly workplace.

PubMed

Carte, Nicholas S; Williams, Collette

2017-12-01

Traditionally, nursing has been a female-dominated profession. Men employed as registered nurses have been in the minority and little is known about the experiences of this demographic. The purpose of this descriptive, quantitative study was to understand the relationship between the variables of demographics and causes of role strain among male nurses in critical care settings. The Sherrod Role Strain Scale assesses role strain within the context of role conflict, role overload, role ambiguity and role incongruity. Data analysis of the results included descriptive and inferential statistics. Inferential statistics involved the use of repeated measures ANOVA testing for significant difference in the causes of role strain between male nurses employed in critical care settings and a post hoc comparison of specific demographic data using multivariate analyses of variance (MANOVAs). Data from 37 male nurses in critical care settings from the northeast of the United States were used to calculate descriptive statistics standard deviation, mean of the data analysis and results of the repeated ANOVA and the post hoc secondary MANOVA analysis. The descriptive data showed that all participants worked full-time. There was an even split from those participants who worked day shift (46%) vs. night shift (43%), most the participants indicated they had 15 years or more experience as an registered nurse (54%). Significant findings of this study include two causes of role strain in male nurses employed in critical care settings which are: role ambiguity and role overload based on ethnicity. Consistent with previous research findings, the results of this study suggest that male registered nurses employed in critical care settings do experience role strain. The two main causes of role strain in male nurses are role ambiguity and role overload. Copyright © 2017. Published by Elsevier Ltd.

Comparison of micronized tretinoin gel 0.05% and tretinoin gel microsphere 0.1% in young adolescents with acne: a post hoc analysis of efficacy and tolerability data.

PubMed

Lucky, Anne W; Sugarman, Jeffrey

2011-06-01

Acne vulgaris is common in young adolescents. Retinoids are widely used but may be associated with poor tolerability. This post hoc analysis of 483 participants aged 10 to 14 years with mild to moderate acne compared efficacy and tolerability of once-daily treatment with micronized tretinoin gel 0.05%, tretinoin gel microsphere 0.1%, and vehicle over 12 weeks. In study 1, inflammatory and noninflammatory lesion reduction and treatment success was comparable between tretinoin gel 0.05% and tretinoin gel microsphere 0.1%. Inflammatory (46.3%) and noninflammatory (45.7%) lesion reductions with tretinoin gel 0.05% were significantly greater than vehicle (37.1% and 27.9%, respectively) (both P<.001). In study 2, inflammatory and noninflammatory lesion reductions and treatment success with tretinoin gel 0.05% (30.6%, 39.1%, and 19%, respectively) were significantly greater than vehicle (10.9%, 16.9% [both P<.001], and 4% [P=.008], respectively). Tretinoin gel 0.05% was significantly better tolerated than tretinoin gel microsphere 0.1% (P<.001); the majority of adverse events (AEs) were mild, occurring in the first 2 weeks. Fourteen percent of participants reported dry skin, 8% skin burning sensation, 5% erythema, and 5% dermatitis exfoliative with tretinoin gel 0.05% compared with 32%, 11%, 23%, and 23%, respectively, with tretinoin gel microsphere 0.1% (all P<.001, except skin burning sensation). In this secondary analysis of acne in young adolescents aged 10 to 14 years, micronized tretinoin gel 0.05% provided a comparable lesion reduction and treatment success versus tretinoin gel microsphere 0.1%, with a better cutaneous tolerability profile.

Tiotropium and Salmeterol in COPD Patients at Risk of Exacerbations: A Post Hoc Analysis from POET-COPD(®).

PubMed

Vogelmeier, Claus F; Asijee, Guus M; Kupas, Katrin; Beeh, Kai M

2015-06-01

Among patients with chronic obstructive pulmonary disease (COPD), the frequency and severity of past exacerbations potentiates future events. The impact of current therapies on exacerbation frequency and severity in patients with different exacerbation risks is not well known. A post hoc analysis of patients at low (≤1 exacerbation [oral steroids/antibiotics requirement] and no COPD-related hospitalization in the year preceding trial entry) or high (≥2 exacerbations [oral steroids/antibiotics requirement] or ≥1 COPD-related hospitalization[s] in the year preceding trial entry) exacerbation risk, from the Prevention of Exacerbations with Tiotropium in Chronic Obstructive Pulmonary Disease (POET-COPD(®)) database. Compared with salmeterol, tiotropium significantly increased time to first COPD exacerbation (hazard ratio 0.84; 95% confidence interval [CI] 0.76-0.92; p = 0.0002) and reduced the number of COPD exacerbations (rate ratio 0.90; 95% CI 0.81-0.99; p = 0.0383) in patients at high exacerbation risk. With treatment, the risk of remaining in the high-risk exacerbator subgroup was statistically lower with tiotropium versus salmeterol (risk ratio [RR] 0.89; 95% CI 0.80-1.00; p = 0.0478). For low-risk patients, time to first COPD exacerbation and number of COPD exacerbations were numerically lower with tiotropium versus salmeterol. With treatment, the risk of transitioning from a low to a high exacerbation risk was lower with tiotropium versus salmeterol (RR 0.87; 95% CI 0.71-1.07; p = 0.1968). This analysis confirms the higher efficacy of tiotropium versus salmeterol in prolonging time to first COPD exacerbation and reducing number of exacerbations in patients both at low and high exacerbation risk. Boehringer Ingelheim and Pfizer. ClinicalTrials.gov NCT00563381.

Association of dietary soy genistein intake with lung function and asthma control: a post-hoc analysis of patients enrolled in a prospective multicentre clinical trial

PubMed Central

Bime, Christian; Wei, Christine Y; Holbrook, Janet; Smith, Lewis J; Wise, Robert A

2013-01-01

Background Broad dietary patterns have been linked to asthma but the relative contribution of specific nutrients is unclear. Soy genistein has important anti-inflammatory and other biological effects that might be beneficial in asthma. A positive association was previously reported between soy genistein intake and lung function but not with asthma exacerbations. Aims To conduct a post-hoc analysis of patients with inadequately controlled asthma enrolled in a prospective multicentre clinical trial to replicate this association. Methods A total of 300 study participants were included in the analysis. Dietary soy genistein intake was measured using the Block Soy Foods Screener. The level of soy genistein intake (little or no intake, moderate intake, or high intake) was compared with baseline lung function (pre-bronchodilator forced expiratory volume in 1 second (FEV1)) and asthma control (proportion of participants with an episode of poor asthma control (EPAC) and annualised rates of EPACs over a 6-month follow-up period. Results Participants with little or no genistein intake had a lower baseline FEV1 than those with a moderate or high intake (2.26L vs. 2.53L and 2.47L, respectively; p=0.01). EPACs were more common among those with no genistein intake than in those with a moderate or high intake (54% vs. 35% vs. 40%, respectively; p<0.001). These findings remained significant after adjustment for patient demographics and body mass index. Conclusions In patients with asthma, consumption of a diet with moderate to high amounts of soy genistein is associated with better lung function and better asthma control. PMID:22885561

Protective effect of yerba mate intake on the cardiovascular system: a post hoc analysis study in postmenopausal women.

PubMed

da Veiga, D T A; Bringhenti, R; Copes, R; Tatsch, E; Moresco, R N; Comim, F V; Premaor, M O

2018-01-01

The prevalence of cardiovascular and metabolic diseases is increased in postmenopausal women, which contributes to the burden of illnesses in this period of life. Yerba mate (Ilex paraguariensis) is a native bush from Southern South America. Its leaves are rich in phenolic components, which may have antioxidant, vasodilating, hypocholesterolemic, and hypoglycemic proprieties. This post hoc analysis of the case-control study nested in the Obesity and Bone Fracture Cohort evaluated the consumption of yerba mate and the prevalence of hypertension, dyslipidemia, and coronary diseases in postmenopausal women. Ninety-five postmenopausal women were included in this analysis. A questionnaire was applied to evaluate the risk factors and diagnosis of cardiovascular diseases and consumption of yerba mate infusion. Student's t-test and chi-square test were used to assess significant differences between groups. The group that consumed more than 1 L/day of mate infusion had significantly fewer diagnoses of coronary disease, dyslipidemia, and hypertension (P<0.049, P<0.048, and P<0.016, respectively). Furthermore, the serum levels of glucose were lower in the group with a higher consumption of yerba mate infusion (P<0.013). The serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides were similar between the groups. This pragmatic study points out the benefits of yerba mate consumption for the cardiovascular and metabolic systems. The ingestion of more than 1 L/day of mate infusion was associated with fewer self-reported cardiovascular diseases and lower serum levels of glucose. Longitudinal studies are needed to evaluate the association between yerba mate infusion and reduction of cardiovascular diseases in postmenopausal women.

Protective effect of yerba mate intake on the cardiovascular system: a post hoc analysis study in postmenopausal women

PubMed Central

da Veiga, D.T.A.; Bringhenti, R.; Copes, R.; Tatsch, E.; Moresco, R.N.; Comim, F.V.; Premaor, M.O.

2018-01-01

The prevalence of cardiovascular and metabolic diseases is increased in postmenopausal women, which contributes to the burden of illnesses in this period of life. Yerba mate (Ilex paraguariensis) is a native bush from Southern South America. Its leaves are rich in phenolic components, which may have antioxidant, vasodilating, hypocholesterolemic, and hypoglycemic proprieties. This post hoc analysis of the case-control study nested in the Obesity and Bone Fracture Cohort evaluated the consumption of yerba mate and the prevalence of hypertension, dyslipidemia, and coronary diseases in postmenopausal women. Ninety-five postmenopausal women were included in this analysis. A questionnaire was applied to evaluate the risk factors and diagnosis of cardiovascular diseases and consumption of yerba mate infusion. Student's t-test and chi-square test were used to assess significant differences between groups. The group that consumed more than 1 L/day of mate infusion had significantly fewer diagnoses of coronary disease, dyslipidemia, and hypertension (P<0.049, P<0.048, and P<0.016, respectively). Furthermore, the serum levels of glucose were lower in the group with a higher consumption of yerba mate infusion (P<0.013). The serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides were similar between the groups. This pragmatic study points out the benefits of yerba mate consumption for the cardiovascular and metabolic systems. The ingestion of more than 1 L/day of mate infusion was associated with fewer self-reported cardiovascular diseases and lower serum levels of glucose. Longitudinal studies are needed to evaluate the association between yerba mate infusion and reduction of cardiovascular diseases in postmenopausal women. PMID:29694507

Volume analysis of heat-induced cracks in human molars: A preliminary study

PubMed Central

Sandholzer, Michael A.; Baron, Katharina; Heimel, Patrick; Metscher, Brian D.

2014-01-01

Context: Only a few methods have been published dealing with the visualization of heat-induced cracks inside bones and teeth. Aims: As a novel approach this study used nondestructive X-ray microtomography (micro-CT) for volume analysis of heat-induced cracks to observe the reaction of human molars to various levels of thermal stress. Materials and Methods: Eighteen clinically extracted third molars were rehydrated and burned under controlled temperatures (400, 650, and 800°C) using an electric furnace adjusted with a 25°C increase/min. The subsequent high-resolution scans (voxel-size 17.7 μm) were made with a compact micro-CT scanner (SkyScan 1174). In total, 14 scans were automatically segmented with Definiens XD Developer 1.2 and three-dimensional (3D) models were computed with Visage Imaging Amira 5.2.2. The results of the automated segmentation were analyzed with an analysis of variance (ANOVA) and uncorrected post hoc least significant difference (LSD) tests using Statistical Package for Social Sciences (SPSS) 17. A probability level of P < 0.05 was used as an index of statistical significance. Results: A temperature-dependent increase of heat-induced cracks was observed between the three temperature groups (P < 0.05, ANOVA post hoc LSD). In addition, the distributions and shape of the heat-induced changes could be classified using the computed 3D models. Conclusion: The macroscopic heat-induced changes observed in this preliminary study correspond with previous observations of unrestored human teeth, yet the current observations also take into account the entire microscopic 3D expansions of heat-induced cracks within the dental hard tissues. Using the same experimental conditions proposed in the literature, this study confirms previous results, adds new observations, and offers new perspectives in the investigation of forensic evidence. PMID:25125923

Glycaemic responses in Asian and non-Asian people with type 2 diabetes initiating insulin glargine 100 units/mL: A patient-level pooled analysis of 16 randomised controlled trials.

PubMed

Chan, Juliana C N; Bunnag, Pongamorn; Chan, Siew P; Tan, Iris T I; Tsai, Shih-Tzer; Gao, Ling; Landgraf, Wolfgang

2018-01-01

To compare outcomes between Asian and non-Asian patients with type 2 diabetes (T2D) inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin glargine 100 units (U)/mL (Gla-100) in randomised controlled clinical trials. Post hoc analysis of patient-level data (Asian n = 235; non-Asian n = 3351) from 16 trials. At baseline, Asian patients were younger with lower body mass index (BMI), fasting C-peptide, and fasting plasma glucose (FPG) than non-Asian patients (all P < .001). Asian patients had a higher mean glycosylated haemoglobin (HbA1c) at Week 24 and less reduction in HbA1c from baseline (7.4% vs. 7.2%; -1.3% vs. -1.6%, respectively; P = .0001), and were less likely to achieve HbA1c <7.0% (40% vs. 47%; P = .002) than non-Asian patients. Reductions in FPG and rates of hypoglycaemia were similar between Asian and non-Asian patients. Asian patients had less weight gain than non-Asian patients (+1.3 vs. +1.9 kg, respectively, P = .013). In our post hoc meta-analysis, Gla-100 effectively lowers HbA1c and FPG in Asian patients with T2D uncontrolled on OADs with similar incidence of hypoglycaemia and less absolute weight gain compared with non-Asian patients. At a similar FPG reduction, fewer Asian patients achieved HbA1c target <7.0%, suggesting that prandial glucose needs to be addressed. Copyright © 2017. Published by Elsevier B.V.

Nurses' and midwives' clinical leadership development needs: a mixed methods study.

PubMed

Casey, Mary; McNamara, Martin; Fealy, Gerard; Geraghty, Ruth

2011-07-01

This paper is a report of a descriptive study of nurses' and midwives' clinical leadership development needs. Nurses and midwives are expected to fulfil a leadership role at all levels, yet efforts to strategically support them are often unfocused. An analysis of clinical leadership development needs can provide the foundation for leadership initiatives to support staff. A mixed methods design was used. A questionnaire was sent to 911 nurses and midwives and 22 focus groups comprising 184 participants were conducted. Data were collected between March and June 2009 across all promotional grades of nurses and midwives in Ireland. Repeated measures anova with Greenhouse-Geisser adjustment was used for post hoc pair wise comparisons of the subscale dimensions of clinical leadership. anova with Tukey's post hoc method was used for comparison between grades on each individual subscale. Thematic analysis was undertaken on the focus group data. Results reveal that needs related to development of the profession were the highest for all grades. The staff grade expressed a higher need in relation to 'managing clinical area', 'managing the patient care' and 'skills for clinical leadership' than managers. Qualitative analysis yielded five themes; (1) clinical leadership and leaders from a nursing and midwifery perspective; (2) quality service from a nursing and midwifery perspective; (3) clinical leaders' roles and functions; (4) capital and (5) competences for clinical leaders and leadership and the context of clinical leadership. Clinical leadership concerns quality, safety and effectiveness. Nurses and midwives are ideally placed to offer the clinical leadership that is required to ensure these patient care outcomes. Development initiatives must address the leader and leadership competencies to support staff. © 2011 Blackwell Publishing Ltd.

The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials.

PubMed

Schulman, Gerald; Berl, Tomas; Beck, Gerald J; Remuzzi, Giuseppe; Ritz, Eberhard; Shimizu, Miho; Shobu, Yuko; Kikuchi, Mami

2016-09-30

The orally administered spherical carbon adsorbent AST-120 is used on-label in Asian countries to slow renal disease progression in patients with progressive chronic kidney disease (CKD). Recently, two multinational, randomized, double-blind, placebo-controlled, phase 3 trials (Evaluating Prevention of Progression in Chronic Kidney Disease [EPPIC] trials) examined AST-120's efficacy in slowing CKD progression. This study assessed the efficacy of AST-120 in the subgroup of patients from the United States of America (USA) in the EPPIC trials. In the EPPIC trials, 2035 patients with moderate to severe CKD were studied, of which 583 were from the USA. The patients were randomly assigned to two groups of equal size that were treated with AST-120 or placebo (9 g/day). The primary end point was a composite of dialysis initiation, kidney transplantation, or serum creatinine doubling. The Kaplan-Meier curve for the time to achieve the primary end point in the placebo-treated patients from the USA was similar to that projected before the study. The per protocol subgroup analysis of the population from the USA which included patients with compliance rates of ≥67 % revealed a significant difference between the treatment groups in the time to achieve the primary end point (Hazard Ratio, 0.74; 95 % Confidence Interval, 0.56-0.97). This post hoc subgroup analysis of EPPIC study data suggests that treatment with AST-120 might delay the time to primary end point in CKD patients from the USA. A further randomized controlled trial in progressive CKD patients in the USA is necessary to confirm the beneficial effect of adding AST-120 to standard therapy regimens. ClinicalTrials.gov NCT00500682 ; NCT00501046 .

Digital versus conventional techniques for pattern fabrication of implant-supported frameworks

PubMed Central

Alikhasi, Marzieh; Rohanian, Ahmad; Ghodsi, Safoura; Kolde, Amin Mohammadpour

2018-01-01

Objective: The aim of this experimental study was to compare retention of frameworks cast from wax patterns fabricated by three different methods. Materials and Methods: Thirty-six implant analogs connected to one-piece abutments were divided randomly into three groups according to the wax pattern fabrication method (n = 12). Computer-aided design/computer-aided manufacturing (CAD/CAM) milling machine, three-dimensional printer, and conventional technique were used for fabrication of waxing patterns. All laboratory procedures were performed by an expert-reliable technician to eliminate intra-operator bias. The wax patterns were cast, finished, and seated on related abutment analogs. The number of adjustment times was recorded and analyzed by Kruskal–Wallis test. Frameworks were cemented on the corresponding analogs with zinc phosphate cement and tensile resistance test was used to measure retention value. Statistical Analysis Used: One-way analysis of variance (ANOVA) and post hoc Tukey tests were used for statistical analysis. Level of significance was set at P < 0.05. Results: The mean retentive values of 680.36 ± 21.93 N, 440.48 ± 85.98 N, and 407.23 ± 67.48 N were recorded for CAD/CAM, rapid prototyping, and conventional group, respectively. One-way ANOVA test revealed significant differences among the three groups (P < 0.001). The post hoc Tukey test showed significantly higher retention for CAD/CAM group (P < 0.001), while there was no significant difference between the two other groups (P = 0.54). CAD/CAM group required significantly more adjustments (P < 0.001). Conclusions: CAD/CAM-fabricated wax patterns showed significantly higher retention for implant-supported cement-retained frameworks; this could be a valuable help when there are limitations in the retention of single-unit implant restorations. PMID:29657528

Impulse control disorder related behaviours during long-term rotigotine treatment: a post hoc analysis.

PubMed

Antonini, A; Chaudhuri, K R; Boroojerdi, B; Asgharnejad, M; Bauer, L; Grieger, F; Weintraub, D

2016-10-01

Dopamine agonists in Parkinson's disease (PD) are associated with impulse control disorders (ICDs) and other compulsive behaviours (together called ICD behaviours). The frequency of ICD behaviours reported as adverse events (AEs) in long-term studies of rotigotine transdermal patch in PD was evaluated. This was a post hoc analysis of six open-label extension studies up to 6 years in duration. Analyses included patients treated with rotigotine for at least 6 months and administered the modified Minnesota Impulse Disorders Interview. ICD behaviours reported as AEs were identified and categorized. For 786 patients, the mean (±SD) exposure to rotigotine was 49.4 ± 17.6 months. 71 (9.0%) patients reported 106 ICD AEs cumulatively. Occurrence was similar across categories: 2.5% patients reported 'compulsive sexual behaviour', 2.3% 'buying disorder', 2.0% 'compulsive gambling', 1.7% 'compulsive eating' and 1.7% 'punding behaviour'. Examining at 6-month intervals, the incidence was relatively low during the first 30 months; it was higher over the next 30 months, peaking in the 54-60-month period. No ICD AEs were serious, and 97% were mild or moderate in intensity. Study discontinuation occurred in seven (9.9%) patients with ICD AEs; these then resolved in five patients. Dose reduction occurred for 23 AEs, with the majority (73.9%) resolving. In this analysis of >750 patients with PD treated with rotigotine, the frequency of ICD behaviour AEs was 9.0%, with a specific incidence timeline observed. Active surveillance as duration of treatment increases may help early identification and management; once ICD behaviours are present rotigotine dose reduction may be considered. © 2016 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

Characterization of Low-Molecular-Weight Heparins by Strong Anion-Exchange Chromatography.

PubMed

Sadowski, Radosław; Gadzała-Kopciuch, Renata; Kowalkowski, Tomasz; Widomski, Paweł; Jujeczka, Ludwik; Buszewski, Bogusław

2017-11-01

Currently, detailed structural characterization of low-molecular-weight heparin (LMWH) products is an analytical subject of great interest. In this work, we carried out a comprehensive structural analysis of LMWHs and applied a modified pharmacopeial method, as well as methods developed by other researchers, to the analysis of novel biosimilar LMWH products; and, for the first time, compared the qualitative and quantitative composition of commercially available drugs (enoxaparin, nadroparin, and dalteparin). For this purpose, we used strong anion-exchange (SAX) chromatography with spectrophotometric detection because this method is more helpful, easier, and faster than other separation techniques for the detailed disaccharide analysis of new LMWH drugs. In addition, we subjected the obtained results to statistical analysis (factor analysis, t-test, and Newman-Keuls post hoc test).

Developmental effects of tobacco smoke exposure during human embryonic stem cell differentiation are mediated through the transforming growth factor-β superfamily member, Nodal

PubMed Central

Liszewski, Walter; Ritner, Carissa; Aurigui, Julian; Wong, Sharon S. Y.; Hussain, Naveed; Krueger, Winfried; Oncken, Cheryl; Bernstein, Harold S.

2012-01-01

While the pathologies associated with in utero smoke exposure are well established, their underlying molecular mechanisms are incompletely understood. We differentiated human embryonic stem cells in the presence of physiological concentrations of tobacco smoke and nicotine. Using post hoc microarray analysis, quantitative PCR, and immunoblot analysis, we demonstrated that tobacco smoke has lineage- and stage-specific effects on human embryonic stem cell differentiation, through both nicotine-dependent and -independent pathways. We show that three major stem cell pluripotency/differentiation pathways, Notch, canonical Wnt, and transforming growth factor-β, are affected by smoke exposure, and that Nodal signaling through SMAD2 is specifically impacted by effects on Lefty1, Nodal, and FoxH1. These events are associated with upregulation of microRNA-302a, a post-transcriptional silencer of Lefty1. The described studies provide insight into the mechanisms by which tobacco smoke influences fetal development at the cellular level, and identify specific transcriptional, post-transcriptional, and signaling pathways by which this likely occurs. PMID:22381624

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

PubMed Central

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F.; Mt-Isa, Shahrul; Luo, Sheng

2018-01-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. PMID:29505866

Risk reductions for cardiovascular disease with pravastatin treatment by dyslipidemia phenotype: a post hoc analysis of the MEGA Study.

PubMed

Nishiwaki, Masato; Ikewaki, Katsunori; Ayaori, Makoto; Mizuno, Kyoichi; Ohashi, Yasuo; Ohsuzu, Fumitaka; Ishikawa, Toshitsugu; Nakamura, Haruo

2013-03-01

The beneficial effect of statins for cardiovascular disease (CVD) prevention has been well established. However, the effectiveness among different phenotypes of dyslipidemia has not been confirmed. We evaluated the effect of pravastatin on the incidence of CVD in relation to the phenotype of dyslipidemia. The MEGA Study evaluated the effect of low-dose pravastatin on primary prevention of CVD in 7832 Japanese patients, who were randomized to diet alone or diet plus pravastatin and followed for more than 5 years. These patients were classified into phenotype IIa (n=5589) and IIb (n=2041) based on the electrophoretic pattern for this post hoc analysis. In the diet group there was no significant difference in the incidence of coronary heart disease (CHD), stroke, CVD, and total mortality between the two phenotypes. Phenotype IIb patients, compared to phenotype IIa, had lower levels of high-density lipoprotein cholesterol (HDL-C) and a significantly higher incidence of CVD in relation to a low HDL-C level (<47.5mg/dL; p=0.02). Furthermore, pravastatin decreased the relative risk for each major endpoint in both type IIa and type IIb dyslipidemia. Significant risk reductions were observed for CHD by 38% (p=0.04) and CVD by 31% (p=0.02) in type IIa dyslipidemia but not in phenotype IIb. Pravastatin therapy provided significant risk reductions for CHD and CVD in patients with phenotype IIa dyslipidemia, but not in those with phenotype IIb dyslipidemia. Copyright © 2012 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Crack-cocaine users have less family cohesion than alcohol users.

PubMed

Marchi, Nino C; Scherer, Juliana N; Pachado, Mayra P; Guimarães, Luciano S; Siegmund, Gerson; de Castro, Melina N; Halpern, Silvia; Benzano, Daniela; Formigoni, Maria L; Cruz, Marcelo; Pechansky, Flavio; Kessler, Felix H

2017-01-01

Many studies correlate characteristics of family functioning and the development of drug addiction. This study sought to evaluate and compare the family environment styles of two groups of psychoactive substance users: 1) alcohol-only users and 2) crack-cocaine users. Three hundred and sixty-four users of alcohol, crack-cocaine, and other drugs, recruited from research centers in four Brazilian capitals participated in this study. Subjects were evaluated through the Family Environment Scale and the Addiction Severity Index, 6th version (ASI-6). ASI-6 t-scores were compared by analysis of variance (ANOVA) and post-hoc tests. A final model was obtained using a logistic regression analysis. All analyses were adjusted for partner, age, and psychiatric t-score. We found a significant difference between groups in the cohesion subscale (p = 0.044). The post-hoc test revealed a difference of 1.06 points (95%CI 0.11-2.01) between groups 1 (6.45±0.28) and 2 (5.38±0.20). No significant between-group differences were observed in the other subscales. However, categorical analyses of variables regarding family dynamic showed that crack users more often reported that sometimes people in their family hit each other (30.4% vs. 13.2%, p = 0.007) and that people in their family frequently compared each other regarding work and/or school achievement (57.2% vs. 42.6%, p = 0.041). These results suggest that families of crack-cocaine users are less cohesive than families of alcohol users. This type of family environment may affect treatment outcome, and should thus be adequately approached.

Processing speed can monitor stimulant-medication effects in adults with attention deficit disorder with hyperactivity.

PubMed

Nielsen, Niels Peter; Wiig, Elisabeth H; Bäck, Svante; Gustafsson, Jan

2017-05-01

Treatment responses to methylphenidate by adults with ADHD are generally monitored against DSM-IV/DSM-V symptomatology, rating scales or interviews during reviews. To evaluate the use of single- and dual-dimension processing-speed and efficiency measures to monitor the effects of pharmacological treatment with methylphenidate after a short period off medication. A Quick Test of Cognitive Speed (AQT) monitored the effects of immediate-release methylphenidate in 40 previously diagnosed and medicated adults with ADHD. Processing speed was evaluated with prior prescription medication, without medication after a 2-day period off ADHD medication, and with low-dose (10/20 mg) and high-dose (20/40 mg) methylphenidate hydrochloride (Medikinet IR). Thirty-three participants responded to the experimental treatments. One-way ANOVA with post-hoc analysis (Scheffe) indicated significant main effects for single dimension colour and form and dual-dimension colour-form naming. Post-hoc analysis indicated statistical differences between the no- and high-dose medication conditions for colour and form, measures of perceptual speed. For colour-form naming, a measure of cognitive speed, there was a significant difference between no- and low-dose medication and between no- and high-dose medications, but not between low- and high-dose medications. Results indicated that the AQT tests effectively monitored incremental effects of the methylphenidate dose on processing speed after a 2-day period off medication. Thus, perceptual (colour and form) and cognitive speed (two-dimensional colour-form naming) and processing efficiency (lowered shift costs) increased measurably with high-dose medication. These preliminary findings warrant validation with added measures of associated behavioural and cognitive changes.

The effect of intensive glucose lowering therapy among major racial/ethnic groups in the Veterans Affairs Diabetes Trial

PubMed Central

Saremi, Aramesh; Schwenke, Dawn C.; Bahn, Gideon; Ge, Ling; Emanuele, Nicholas; Reaven, Peter D.

2014-01-01

Objective To examine the effect of intensive glycemic control on cardiovascular disease events (CVD) among the major race/ethnic groups in a post-hoc analysis of the VADT. Materials and Methods Participants included 1111 non-Hispanic Whites, 307 Hispanics and 306 non-Hispanic Blacks randomized to intensive or standard glucose treatment in VADT. Multivariable Cox proportional hazards models were constructed to assess the effect of intensive glucose treatment on CVD events among race/ethnic groups. Results Mean age was 60.4 years and median follow-up was 5.6 years. By design, modifiable risk factors were managed equally well in both treatment arms and only differed modestly between race/ethnic groups. HbA1c decreased significantly from baseline with intensive glucose treatment in each race/ethnic group, with a trend for a greater response in Hispanics (P=0.02 for overall comparison between groups). Intensive glucose treatment was associated with reduced risk of CVD events for Hispanics but not for others (hazard ratios ranged from 0.54 to 0.75 for Hispanics whereas they were consistently close to 1 for others). Sensitivity analyses with different definitions of race/ethnicity or limited to individuals free of previous known CVD yielded similar results. Conclusions The results of these analyses support the hypothesis that race/ethnicity is worthy of consideration when tailoring intensive treatment for individuals with long-standing type 2 diabetes. However, additional studies are needed to confirm the findings of this post-hoc analysis. PMID:25456099

Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis

PubMed Central

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

2016-01-01

Abstract Objectives: 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. Methods: 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. Results: 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]). Conclusions: 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. PMID:26472043

Efficacy and safety of rotigotine in elderly patients with Parkinson's disease in comparison with the non-elderly: a post hoc analysis of randomized, double-blind, placebo-controlled trials.

PubMed

Nomoto, Masahiro; Iwaki, Hirotaka; Kondo, Hiroyuki; Sakurai, Masaya

2018-02-01

Rotigotine-a non-ergot dopamine agonist-has two advantages; it can stimulate all dopamine receptors (D1-D5) like innate dopamine, and its transdermal administration provides continuous dopaminergic stimulation. The age of the patient impacts the effect and adverse events of anti-parkinsonian treatment. We conducted a post hoc analysis on three randomized, double-blind, placebo-controlled trials performed in Japan to clarify the difference of anti-parkinsonian treatment in elderly and non-elderly patients. Data from two combination therapy trials (with levodopa) in advanced stage Parkinson's disease patients and one monotherapy trial in early stage patients were pooled and grouped by age (non-elderly aged < 70, elderly aged 70 +). In each age group, efficacy of rotigotine was compared to placebo. In the combination therapy, total Unified Parkinson's Disease Rating Scale Part III scores and some subtotal scores, including those for tremor, akinesia and gait disturbance, significantly improved in both elderly and non-elderly patients. Regarding safety, the incidence of total adverse event tended to be lower in elderly patients than non-elderly patients, although it was not significant. No difference was observed in maintenance dosage of rotigotine between the two groups. In conclusion, the improvement in motor symptoms and frequency of adverse events were shown to be similar in elderly and non-elderly patients with rotigotine-levodopa combination therapy. Further, there was no major difference in maintenance dosage of rotigotine between the age groups. These results suggest good tolerability of rotigotine among elderly patients.

Efficacy and safety of a medication dose reminder feature in a digital health offering with the use of sensor-enabled medicines.

PubMed

Moorhead, Penjit; Zavala, Ana; Kim, Yoona; Virdi, Naunihal S

Over one-half of patients with chronic diseases, such as hypertension and type 2 diabetes (DM), do not take medicines as prescribed. This study assessed the efficacy and safety of "seeing" versus "not seeing" medication dose reminders regarding medication adherence and risk for overdose. Post hoc analysis. Outpatient setting. Adult subjects (18 years of age or older) with uncontrolled hypertension and DM. Subjects enrolled in this institutional review board-approved study were assigned to either use digital health (DH) with the use of sensor-enabled medicines (coencapsulated medicines with an ingestible sensor) for 4 or 12 weeks or receive usual care based on a cluster-randomized design. All subjects were followed for 12 weeks. Subjects using DH were included in the post hoc study consisting of an efficacy analysis and a safety analysis. A main efficacy outcome of comparison of subjects taking medicine with or without "seeing" DH medication dose reminders was assessed. Safety analysis assessed risk of overdosing after DH medication dose reminders. In 57 subjects included in the efficacy analysis, DH device reminder messages were associated with a 16 ± 16% increase (75 ± 18% when seeing vs. 59 ± 24% when not seeing mobile dose reminders) in medication taking if not taken before dose reminder. The mean overall adherence for all subjects was 86 ± 12%; the mean on-time adherence was 69.7 ± 19.7%. Subjects with lower adherence benefited more from seeing DH reminder messages. In the safety study (n = 74 subjects and 24,426 medication ingestions), no events of overdoses related to DH medication dose reminders occurred. This study demonstrates benefits of DH medication dose reminders to improve medication adherence, especially in patients with lower adherence; DH medication dose reminders also appear to be safe. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Comparison of anterior chamber depth measurements by 3-dimensional optical coherence tomography, partial coherence interferometry biometry, Scheimpflug rotating camera imaging, and ultrasound biomicroscopy.

PubMed

Nakakura, Shunsuke; Mori, Etsuko; Nagatomi, Nozomi; Tabuchi, Hitoshi; Kiuchi, Yoshiaki

2012-07-01

To evaluate the congruity of anterior chamber depth (ACD) measurements using 4 devices. Saneikai Tsukazaki Hospital, Himeji City, Japan. Comparative case series. In 1 eye of 42 healthy participants, the ACD was measured by 3-dimensional corneal and anterior segment optical coherence tomography (CAS-OCT), partial coherence interferometry (PCI), Scheimpflug imaging, and ultrasound biomicroscopy (UBM). The differences between the measurements were evaluated by 2-way analysis of variance and post hoc analysis. Agreement between the measurements was evaluated using Bland-Altman analysis. To evaluate the true ACD using PCI, the automatically calculated ACD minus the central corneal thickness measured by CAS-OCT was defined as PCI true. Two ACD measurements were also taken with CAS-OCT. The mean ACD was 3.72 mm ± 0.23 (SD) (PCI), 3.18 ± 0.23 mm (PCI true), 3.24 ± 0.25 mm (Scheimpflug), 3.03 ± 0.25 mm (UBM), 3.14 ± 0.24 mm (CAS-OCT auto), and 3.12 ± 0.24 mm (CAS-OCT manual). A significant difference was observed between PCI biometry, Scheimpflug imaging, and UBM measurements and the other methods. Post hoc analysis showed no significant differences between PCI true and CAS-OCT auto or between CAS-OCT auto and CAS-OCT manual. Strong correlations were observed between all measurements; however, Bland-Altman analysis showed good agreement only between PCI true and Scheimpflug imaging and between CAS-OCT auto and CAS OCT manual. The ACD measurements obtained from PCI biometry, Scheimpflug imaging, CAS-OCT, and UBM were significantly different and not interchangeable except for PCI true and CAS-OCT auto and CAS-OCT auto and CAS-OCT manual. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease.

PubMed

Wilson, Rosamund J; Keith, Michael S; Preston, Peter; Copley, J Brian

2013-12-01

Sevelamer hydrochloride (SH) and lanthanum carbonate (LC) are calcium-free phosphate binders used for the management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objective of this analysis was to evaluate the real-world dose-relativity between SH and LC monotherapy in US patients with ESRD. This was a post hoc analysis of a 16-week, real-world study (Vemuri et al. in BMC Nephrol 12:49, 2011) of the efficacy of conversion to LC monotherapy from other phosphate binders. The SH:LC dose-relativity ratio, based on the mean daily dose, was calculated in the subset of patients from the Vemuri study who converted from SH to LC monotherapy and had available SH and LC dose data. A total of 950 patients converted from SH to LC monotherapy and had recorded dose data. The post hoc analysis population comprised 691 patients with available dose data for both SH at baseline and LC at week 16. The mean (SD) serum phosphate level at baseline was 5.91 (1.66) mg/dL. After conversion to LC monotherapy for 16 weeks, the mean (SD) serum phosphate level was 5.93 (1.85) mg/dL. The mean (SD) daily baseline SH dose was 7,703 (3,642) mg and the mean (SD) daily LC dose at week 16 was 2,800 (939) mg (9.6 versus 2.8 tablets, respectively; P < 0.0001), resulting in a SH:LC dose-relativity ratio of 2.8. The median individual patient SH:LC dose-relativity ratio was 2.6 (95% CI 2.6-2.8). Across baseline SH dose subgroups (2,400-4,800, >4,800-7,200, >7,200-9,600, and >9,600 mg/day), the mean daily SH dose was 4,051, 7,047, 9,253, and 13,150 mg, respectively. In comparison, the mean daily LC dose was 2,445-3,156 mg. Thus, patients requiring baseline SH doses >7,200 mg/day (41% of the analysis population) had higher SH:LC dose-relativity ratios of 3.1-4.2 (median individual patient ratios 3.1-4.0). In this post hoc analysis of real-world dose-relativity, the overall SH:LC dose-relativity ratio was 2.8 (median individual patient ratio 2.6 (95% CI 2.6-2.8). These findings are consistent with the World Health Organization-defined daily dose and previous studies of the relative phosphate binding capacity of the two drugs. Patients requiring SH doses >7,200 mg/day had higher SH:LC dose-relativities of 3.1-4.2 (median individual patient ratios 3.1-4.0). These findings have implications for the tablet burden and cost-effectiveness of SH and LC in the treatment of hyperphosphatemia.

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

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.

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.

The social construction of "evidence-based'' drug prevention programs: a reanalysis of data from the Drug Abuse Resistance Education (DARE) program.

PubMed

Gorman, Dennis M; Huber, J Charles

2009-08-01

This study explores the possibility that any drug prevention program might be considered ;;evidence-based'' given the use of data analysis procedures that optimize the chance of producing statistically significant results by reanalyzing data from a Drug Abuse Resistance Education (DARE) program evaluation. The analysis produced a number of statistically significant differences between the DARE and control conditions on alcohol and marijuana use measures. Many of these differences occurred at cutoff points on the assessment scales for which post hoc meaningful labels were created. Our results are compared to those from evaluations of programs that appear on evidence-based drug prevention lists.

Performance Analysis of Hierarchical Group Key Management Integrated with Adaptive Intrusion Detection in Mobile ad hoc Networks

DTIC Science & Technology

2016-04-05

applications in wireless networks such as military battlefields, emergency response, mobile commerce , online gaming, and collaborative work are based on the...www.elsevier.com/locate/peva Performance analysis of hierarchical group key management integrated with adaptive intrusion detection in mobile ad hoc...Accepted 19 September 2010 Available online 26 September 2010 Keywords: Mobile ad hoc networks Intrusion detection Group communication systems Group

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

PubMed

Kotsias, Andreas; Mularski, Sven; Kühn, Björn; Hanna, Michael; Suess, Olaf

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( n  = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( n  = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

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.

Engaging men and women as allies: a workplace curriculum module to challenge gender norms about domestic violence, male bullying and workplace violence and encourage ally behavior.

PubMed

Wagner, K C; Yates, Diane; Walcott, Quentin

2012-01-01

This post-hoc analysis discusses a replicable workplace behavior change module called Men and Women As Allies, that was designed and implemented by a team of labor, management and community anti-violence educators at a private sector telecommunications employer. A job site-specific educational seminar linked issues of domestic violence to male bullying and workplace violence. It challenged social stereotypes about gender, taught skills to engage ally peer behavior and provided information on how to seek assistance from union, workplace and external community resources.

Toward a perceptual image quality assessment of color quantized images

NASA Astrophysics Data System (ADS)

Frackiewicz, Mariusz; Palus, Henryk

2018-04-01

Color image quantization is an important operation in the field of color image processing. In this paper, we consider new perceptual image quality metrics for assessment of quantized images. These types of metrics, e.g. DSCSI, MDSIs, MDSIm and HPSI achieve the highest correlation coefficients with MOS during tests on the six publicly available image databases. Research was limited to images distorted by two types of compression: JPG and JPG2K. Statistical analysis of correlation coefficients based on the Friedman test and post-hoc procedures showed that the differences between the four new perceptual metrics are not statistically significant.

Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial

PubMed Central

Brouwer, Marc A; Wojdyla, Daniel M; Thomas, Laine; Lopes, Renato D; Washam, Jeffrey B; Lanas, Fernando; Xavier, Denis; Husted, Steen; Wallentin, Lars; Alexander, John H; Granger, Christopher B; Verheugt, Freek W A

2016-01-01

Objective To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation. Design Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)—a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011. Participants 18 201 ARISTOTLE trial participants. Interventions In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, ≥9 drugs) with a median follow-up of 1.8 years. Main outcome measures Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country). Results Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (≥5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, ≥9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (Pinteraction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers of concomitant drugs (Pinteraction=0.017). Patients with interacting (potentiating) drugs for warfarin or apixaban had similar outcomes and consistent treatment effects of apixaban versus warfarin. Conclusions In the ARISTOTLE trial, three quarters of patients had polypharmacy; this subgroup had an increased comorbidity, more interacting drugs, increased mortality, and higher rates of thromboembolic and bleeding complications. In terms of a potential differential response to anticoagulation therapy in patients with atrial fibrillation and polypharmacy, apixaban was more effective than warfarin, and is at least just as safe. Trial registration ARISTOTLE trial, ClinicalTrials.gov NCT00412984. PMID:27306620

Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial.

PubMed

Jaspers Focks, Jeroen; Brouwer, Marc A; Wojdyla, Daniel M; Thomas, Laine; Lopes, Renato D; Washam, Jeffrey B; Lanas, Fernando; Xavier, Denis; Husted, Steen; Wallentin, Lars; Alexander, John H; Granger, Christopher B; Verheugt, Freek W A

2016-06-15

 To determine whether the treatment effect of apixaban versus warfarin differs with increasing numbers of concomitant drugs used by patients with atrial fibrillation.  Post hoc analysis performed in 2015 of results from ARISTOTLE (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation)-a multicentre, double blind, double dummy trial that started in 2006 and ended in 2011.  18 201 ARISTOTLE trial participants.  In the ARISTOTLE trial, patients were randomised to either 5 mg apixaban twice daily (n=9120) or warfarin (target international normalised ratio range 2.0-3.0; n=9081). In the post hoc analysis, patients were divided into groups according to the number of concomitant drug treatments used at baseline (0-5, 6-8, ≥9 drugs) with a median follow-up of 1.8 years.  Clinical outcomes and treatment effects of apixaban versus warfarin (adjusted for age, sex, and country).  Each patient used a median of six drugs (interquartile range 5-9); polypharmacy (≥5 drugs) was seen in 13 932 (76.5%) patients. Greater numbers of concomitant drugs were used in older patients, women, and patients in the United States. The number of comorbidities increased across groups of increasing numbers of drugs (0-5, 6-8, ≥9 drugs), as did the proportions of patients treated with drugs that interact with warfarin or apixaban. Mortality also rose significantly with the number of drug treatments (P<0.001), as did rates of stroke or systemic embolism (1.29, 1.48, and 1.57 per 100 patient years, for 0-5, 6-8, and ≥9 drugs, respectively) and major bleeding (1.91, 2.46, and 3.88 per 100 patient years, respectively). Relative risk reductions in stroke or systemic embolism for apixaban versus warfarin were consistent, regardless of the number of concomitant drugs (Pinteraction=0.82). A smaller reduction in major bleeding was seen with apixaban versus warfarin with increasing numbers of concomitant drugs (Pinteraction=0.017). Patients with interacting (potentiating) drugs for warfarin or apixaban had similar outcomes and consistent treatment effects of apixaban versus warfarin.  In the ARISTOTLE trial, three quarters of patients had polypharmacy; this subgroup had an increased comorbidity, more interacting drugs, increased mortality, and higher rates of thromboembolic and bleeding complications. In terms of a potential differential response to anticoagulation therapy in patients with atrial fibrillation and polypharmacy, apixaban was more effective than warfarin, and is at least just as safe.Trial registration ARISTOTLE trial, ClinicalTrials.gov NCT00412984. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study.

PubMed

Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Inui, Takashi; Yano, Toshiro; Yoshinari, Toru; Abe, Tohru; Koike, Takao

2017-09-02

Although both rheumatoid factor (RF) and anticyclic citrullinated peptide antibodies (anti-CCP) are useful for diagnosing rheumatoid arthritis (RA), the impact of these autoantibodies on the efficacy of tumor necrosis factor (TNF) inhibitors has been controversial. The aim of this post hoc analysis of a randomized double-blind study (the RISING study) was to investigate the influences of RF and anti-CCP on the clinical response to infliximab in patients with RA. Methotrexate-refractory patients with RA received 3 mg/kg of infliximab from weeks 0 to 6 and then 3, 6, or 10 mg/kg every 8 weeks from weeks 14 to 46. In this post hoc analysis, patients were stratified into three classes on the basis of baseline RF/anti-CCP titers: "low/low-C" (RF < 55 IU/ml, anti-CCP < 42 U/ml), "high/high-C" (RF ≥ 160 IU/ml, anti-CCP ≥ 100 U/ml), and "middle-C" (neither low/low-C nor high/high-C). Baseline plasma TNF level, serum infliximab level, and disease activity were compared between the three classes. Baseline RF and anti-CCP titers showed significant correlations with baseline TNF and infliximab levels in weeks 2-14. Comparison of the three classes showed that baseline TNF level was lowest in the low/low-C group and highest in the high/high-C group (median 0.73 versus 1.15 pg/ml), that infliximab levels at week 14 were highest in the low/low-C group and lowest in the high/high-C group (median 1.0 versus 0.1 μg/ml), and that Disease Activity Score in 28 joints based on C-reactive protein at week 14 was lowest in the low/low-C group and highest in the high/high-C group (median 3.17 versus 3.82). A similar correlation was observed at week 54 in the 3 mg/kg dosing group, but not in the 6 or 10 mg/kg group. Significant decreases in both RF and anti-CCP were observed during infliximab treatment. RF/anti-CCP titers correlated with TNF level. This might explain the association of RF/anti-CCP with infliximab level and clinical response in patients with RA. Baseline RF/anti-CCP titers may serve as indices that aid infliximab treatment. ClinicalTrials.gov, NCT00691028 . Retrospectively registered on 3 June 2008.

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.

Translating Cholesterol Guidelines Into Primary Care Practice: A Multimodal Cluster Randomized Trial

PubMed Central

Eaton, Charles B.; Parker, Donna R.; Borkan, Jeffrey; McMurray, Jerome; Roberts, Mary B.; Lu, Bing; Goldman, Roberta; Ahern, David K.

2011-01-01

PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines. METHODS A 1-year cluster randomized controlled trial was performed using 30 primary care practices (4,105 patients) in southeastern New England. The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein (LDL) and non–high-density lipoprotein (HDL) cholesterol goals. RESULTS After 1 year of intervention, both randomized practice groups improved screening (89% screened), and 74% of patients in both groups were at their LDL and non-HDL cholesterol goals (P <.001). Using intent-to-treat analysis, we found no statistically significant differences between practice groups in screening or percentage of patients who achieved LDL and non-HDL cholesterol goals. Post hoc analysis showed practices who made high use of the patient activation kiosk were more likely to have patients screened (odds ratio [OR] = 2.54; 95% confidence interval [CI], 1.97–3.27) compared with those who made infrequent or no use. Additionally, physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals (OR = 1.27; 95% CI, 1.07–1.50) and non-HDL goals (OR = 1.23; 95% CI, 1.04–1.46) than low-use or no-use physicians. CONCLUSION This study showed null results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practices. Post hoc analysis showed a potential benefit in practices that used the e-health tools more frequently in screening and management of dyslipidemia. Further research on how to incorporate and increase adoption of user-friendly, patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted. PMID:22084264

Relationship between Race and the Effect of Fluids on Long-term Mortality after Acute Respiratory Distress Syndrome. Secondary Analysis of the National Heart, Lung, and Blood Institute Fluid and Catheter Treatment Trial.

PubMed

Jolley, Sarah E; Hough, Catherine L; Clermont, Gilles; Hayden, Douglas; Hou, Suqin; Schoenfeld, David; Smith, Nicholas L; Thompson, Boyd Taylor; Bernard, Gordon R; Angus, Derek C

2017-09-01

Short-term follow-up in the Fluid and Catheter Treatment Trial (FACTT) suggested differential mortality by race with conservative fluid management, but no significant interaction. In a post hoc analysis of FACTT including 1-year follow-up, we sought to estimate long-term mortality by race and test for an interaction between fluids and race. We performed a post hoc analysis of FACTT and the Economic Analysis of Pulmonary Artery Catheters (EAPAC) study (which included 655 of the 1,000 FACTT patients with near-complete 1-year follow up). We fit a multistate Markov model to estimate 1-year mortality for all non-Hispanic black and white randomized FACTT subjects. The model estimated the distribution of time from randomization to hospital discharge or hospital death (available on all patients) and estimated the distribution of time from hospital discharge to death using data on patients after hospital discharge for patients in EAPAC. The 1-year mortality was found by combining these estimates. Non-Hispanic black (n = 217, 25%) or white identified subjects (n = 641, 75%) were included. There was a significant interaction between race and fluid treatment (P = 0.012). One-year mortality was lower for black subjects assigned to conservative fluids (38 vs. 54%; mean mortality difference, 16%; 95% confidence interval, 2-30%; P = 0.027 between conservative and liberal). Conversely, 1-year mortality for white subjects was 35% versus 30% for conservative versus liberal arms (mean mortality difference, -4.8%; 95% confidence interval, -13% to 3%; P = 0.23). In our cohort, conservative fluid management may have improved 1-year mortality for non-Hispanic black patients with ARDS. However, we found no long-term benefit of conservative fluid management in white subjects.

QC-ART: A tool for real-time quality control assessment of mass spectrometry-based proteomics data.

PubMed

Stanfill, Bryan A; Nakayasu, Ernesto S; Bramer, Lisa M; Thompson, Allison M; Ansong, Charles K; Clauss, Therese; Gritsenko, Marina A; Monroe, Matthew E; Moore, Ronald J; Orton, Daniel J; Piehowski, Paul D; Schepmoes, Athena A; Smith, Richard D; Webb-Robertson, Bobbie-Jo; Metz, Thomas O

2018-04-17

Liquid chromatography-mass spectrometry (LC-MS)-based proteomics studies of large sample cohorts can easily require from months to years to complete. Acquiring consistent, high-quality data in such large-scale studies is challenging because of normal variations in instrumentation performance over time, as well as artifacts introduced by the samples themselves, such as those due to collection, storage and processing. Existing quality control methods for proteomics data primarily focus on post-hoc analysis to remove low-quality data that would degrade downstream statistics; they are not designed to evaluate the data in near real-time, which would allow for interventions as soon as deviations in data quality are detected.  In addition to flagging analyses that demonstrate outlier behavior, evaluating how the data structure changes over time can aide in understanding typical instrument performance or identify issues such as a degradation in data quality due to the need for instrument cleaning and/or re-calibration.  To address this gap for proteomics, we developed Quality Control Analysis in Real-Time (QC-ART), a tool for evaluating data as they are acquired in order to dynamically flag potential issues with instrument performance or sample quality.  QC-ART has similar accuracy as standard post-hoc analysis methods with the additional benefit of real-time analysis.  We demonstrate the utility and performance of QC-ART in identifying deviations in data quality due to both instrument and sample issues in near real-time for LC-MS-based plasma proteomics analyses of a sample subset of The Environmental Determinants of Diabetes in the Young cohort. We also present a case where QC-ART facilitated the identification of oxidative modifications, which are often underappreciated in proteomic experiments. Published under license by The American Society for Biochemistry and Molecular Biology, Inc.

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.

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

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.

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

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.

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

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.

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

PubMed

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F; Mt-Isa, Shahrul; Luo, Sheng

2018-04-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. Copyright © 2018 Elsevier Inc. All rights reserved.

Gloss and Stain Resistance of Ceramic-Polymer CAD/CAM Restorative Blocks.

PubMed

Lawson, Nathaniel C; Burgess, John O

2016-03-01

To evaluate the gloss and stain resistance of several new ceramic-polymer CAD/CAM blocks Specimens (4 mm) were sectioned from: Enamic (polymer-infused ceramic), LAVA Ultimate (nano-ceramic reinforced polymer), e.max (lithium disilicate), Paradigm C (porcelain), and Paradigm MZ100 (composite). Specimens were wet polished on a polishing wheel to either 320 grit silicon paper (un-polished, N = 8) or 2000 grit silicon carbide papers followed by a 0.05 μm alumina slurry (polished, N = 8). Initial gloss and color (L*a*b*) values were measured. Specimens were stored in a staining solution at 37°C in darkness for 12 days (simulating 1 year). After storage, L*a*b* values re-measured. Change in color was reported as ΔE00 based on the CIEDE2000 formula. Gloss and ΔE00 were analyzed by two-way analysis of variance (ANOVA) (alpha = .05). Separate one-way ANOVA and Tukey post-hoc analyses were performed for both polish conditions and all materials. Two-way ANOVA showed that factors material, polish and their interaction were significant for both gloss and ΔE00 (p < .01). Post-hoc analysis reveals that polished specimens had significantly less color change than un-polished specimens for Paradigm C and LAVA Ultimate. E.max had significantly higher gloss and less color change than all other materials. The composition and polish of CAD/CAM materials affects gloss and stain resistance. Ceramic-polymer hybrid materials can achieve the high gloss required for esthetic restorations. These materials should be polished in order to minimize staining. If polished, all of the tested materials exhibited clinically acceptable color changes at 1 year of simulated staining. (J Esthet Restor Dent 28:S40-S45, 2016). © 2015 Wiley Periodicals, Inc.

Learning style-based teaching harvests a superior comprehension of respiratory physiology.

PubMed

Anbarasi, M; Rajkumar, G; Krishnakumar, S; Rajendran, P; Venkatesan, R; Dinesh, T; Mohan, J; Venkidusamy, S

2015-09-01

Students entering medical college generally show vast diversity in their school education. It becomes the responsibility of teachers to motivate students and meet the needs of all diversities. One such measure is teaching students in their own preferred learning style. The present study was aimed to incorporate a learning style-based teaching-learning program for medical students and to reveal its significance and utility. Learning styles of students were assessed online using the visual-auditory-kinesthetic (VAK) learning style self-assessment questionnaire. When respiratory physiology was taught, students were divided into three groups, namely, visual (n = 34), auditory (n = 44), and kinesthetic (n = 28), based on their learning style. A fourth group (the traditional group; n = 40) was formed by choosing students randomly from the above three groups. Visual, auditory, and kinesthetic groups were taught following the appropriate teaching-learning strategies. The traditional group was taught via the routine didactic lecture method. The effectiveness of this intervention was evaluated by a pretest and two posttests, posttest 1 immediately after the intervention and posttest 2 after a month. In posttest 1, one-way ANOVA showed a significant statistical difference (P=0.005). Post hoc analysis showed significance between the kinesthetic group and traditional group (P=0.002). One-way ANOVA showed a significant difference in posttest 2 scores (P < 0.0001). Post hoc analysis showed significance between the three learning style-based groups compared with the traditional group [visual vs. traditional groups (p=0.002), auditory vs. traditional groups (p=0.03), and Kinesthetic vs. traditional groups (p=0.001)]. This study emphasizes that teaching methods tailored to students' style of learning definitely improve their understanding, performance, and retrieval of the subject. Copyright © 2015 The American Physiological Society.

Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study.

PubMed

Jansen, Diahann T S L; Emery, Paul; Smolen, Josef S; Westhovens, Rene; Le Bars, Manuela; Connolly, Sean E; Ye, June; Toes, René E M; Huizinga, Tom W J

2018-01-01

To evaluate the effects of the T-cell costimulation blocker abatacept on anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF) in early rheumatoid arthritis (RA), and associations between changes in serological status and clinical response. Post hoc analysis of the phase III AGREE study in methotrexate (MTX)-naïve patients with early RA and poor prognostic factors. Patients were randomised to abatacept (~10 mg/kg intravenously according to weight range) or placebo, plus MTX over 12 months followed by open-label abatacept plus MTX for 12 months. Autoantibody titres were determined by ELISA at baseline and months 6 and 12 (double-blind phase). Conversion to seronegative status and its association with clinical response were assessed at months 6 and 12. Abatacept plus MTX was associated with a greater decrease in ACPA (but not RF) titres and higher rates of both ACPA and RF conversion to seronegative status versus MTX alone. More patients converting to ACPA seronegative status receiving abatacept plus MTX achieved remission according to Disease Activity Score in 28 joints (C-reactive protein) or Clinical Disease Activity Index than patients who remained ACPA seropositive. Patients who converted to ACPA seronegative status treated with abatacept plus MTX had a greater probability of achieving sustained remission and less radiographic progression than MTX alone or patients who remained ACPA seropositive (either treatment). Treatment with abatacept plus MTX was more likely to induce conversion to ACPA/RF seronegative status in patients with early, erosive RA. Conversion to ACPA seronegative status was associated with better clinical and radiographic outcomes. NCT00122382.

Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study

PubMed Central

Emery, Paul; Smolen, Josef S; Westhovens, Rene; Le Bars, Manuela; Connolly, Sean E; Ye, June; Toes, René E M; Huizinga, Tom W J

2018-01-01

Objective To evaluate the effects of the T-cell costimulation blocker abatacept on anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF) in early rheumatoid arthritis (RA), and associations between changes in serological status and clinical response. Methods Post hoc analysis of the phase III AGREE study in methotrexate (MTX)-naïve patients with early RA and poor prognostic factors. Patients were randomised to abatacept (~10 mg/kg intravenously according to weight range) or placebo, plus MTX over 12 months followed by open-label abatacept plus MTX for 12 months. Autoantibody titres were determined by ELISA at baseline and months 6 and 12 (double-blind phase). Conversion to seronegative status and its association with clinical response were assessed at months 6 and 12. Results Abatacept plus MTX was associated with a greater decrease in ACPA (but not RF) titres and higher rates of both ACPA and RF conversion to seronegative status versus MTX alone. More patients converting to ACPA seronegative status receiving abatacept plus MTX achieved remission according to Disease Activity Score in 28 joints (C-reactive protein) or Clinical Disease Activity Index than patients who remained ACPA seropositive. Patients who converted to ACPA seronegative status treated with abatacept plus MTX had a greater probability of achieving sustained remission and less radiographic progression than MTX alone or patients who remained ACPA seropositive (either treatment). Conclusions Treatment with abatacept plus MTX was more likely to induce conversion to ACPA/RF seronegative status in patients with early, erosive RA. Conversion to ACPA seronegative status was associated with better clinical and radiographic outcomes. Trial registration number NCT00122382 PMID:29657830

Open-label dose optimization of methylphenidate modified release long acting (MPH-LA): a post hoc analysis of real-life titration from a 40-week randomized trial.

PubMed

Huss, Michael; Ginsberg, Ylva; Arngrim, Torben; Philipsen, Alexandra; Carter, Katherine; Chen, Chien-Wei; Gandhi, Preetam; Kumar, Vinod

2014-09-01

In the management of attention-deficit hyperactivity disorder (ADHD) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses. Studies with methylphenidate modified release long acting (MPH-LA) in children have reported the need for treatment optimization for improved outcomes. We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized, placebo-controlled, multicenter 40-week study (9-week double-blind dose confirmation phase, 5-week open-label dose optimization phase, and 26-week double-blind maintenance of effect phase). Patients entering the open-label dose optimization phase initiated treatment with MPH-LA 20 mg/day; up/down titrated to their optimal dose (at which there was balance between control of symptoms and side effects) of 40, 60, or 80 mg/day in increments of 20 mg/week by week 12 or 13. Safety was assessed by monitoring the adverse events (AEs) and serious AEs. Efficacy was assessed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Attention-Deficit Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores. At the end of the dose confirmation phase, similar numbers of patients were treated optimally with each of the 40, 60, and 80 mg/day doses (152, 177, and 160, respectively) for MPH-LA. Mean improvement from baseline in the dose confirmation phase in total scores of DSM-IV ADHD RS and SDS were 23.5 ± 9.90 and 9.7 ± 7.36, respectively. Dose optimization with MPH-LA (40, 60, or 80 mg/day) improved treatment outcomes and was well-tolerated in adult ADHD patients.

Bioluminescence Analysis of Antibacterial Photodynamic Therapy Using Methylene Blue Mediated by Low-Intensity Level Laser Against Cariogenic Biofilms.

PubMed

Esteban Florez, Fernando Luis; Mendonça de Oliveira, Morgana Regina; de Oliveira Júnior, Osmir Batista; Hiers, Rochelle Denise; Khajotia, Sharukh Soli; Pretel, Hermes

2018-05-01

A non-destructive and real-time bioluminescence (BL) assay was used to determine the utility of antimicrobial photodynamic therapy (aPDT) treatments mediated by methylene blue (MB) and laser irradiation (LI) against intact biofilms that are capable of producing caries (cariogenic). The efficacy of antibacterial photodynamic treatments has been currently determined by using either viable colony counts (VCC) or metabolic assays (Alamar Blue) that were demonstrated to have critical limitations when used on microcolony-forming bacteria such as Streptococcus mutans. Resin composite specimens were fabricated, wet-polished, ultraviolet-sterilized, and stored in water (72 h). S. mutans (strain JM10) biofilms were grown [24 h; 0.65 × THY with 0.1% (w/v) sucrose] on the surfaces of sterile specimens. Antibacterial treatments were performed by using MB (0.0005% and 0.001%) with or without LI (660 ± 10 nm, 6 J/cm 2 ). Specimens treated with chlorhexidine gluconate served as the negative control group. The efficacy of aPDT treatments was determined in terms of BL for intact biofilms and VCC for sonicated bacteria. BL results were corrected by using the Greenhouse-Geisser method and were analyzed with repeated-measures analysis of variance and post hoc Bonferroni test (α = 0.05). VCC results were analyzed by using Kruskal-Wallis and Dunn's multiple-comparisons post hoc tests (α = 0.05). Our findings demonstrated that experimental treatments significantly decreased the viability of S. mutans biofilms (p < 0.05). Moderate reductions in cellular viability were observed on biofilms subjected to aPDT treatments. This study demonstrated that aPDT has promising potential to be used as an additional method to control oral cariogenic biofilms.

Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study

PubMed Central

Li, Huafang; Li, Yan; Feng, Yu; Zhuo, Jianmin; Turkoz, Ibrahim; Mathews, Maju; Tan, Wilson

2018-01-01

Purpose To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate. Patients and methods PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18–65 years) diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis. Results Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (P≤0.01), PANSS subscales (positive and general psychopathology; all P≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P≤0.01), Personal and Social Performance scale scores (P≤0.05) and Clinical Global Impression-Severity categorical summary (P≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup (P≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups. Conclusion Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization. PMID:29731633

Impact of time of initiation of once-monthly paliperidone palmitate in hospitalized Asian patients with acute exacerbation of schizophrenia: a post hoc analysis from the PREVAIL study.

PubMed

Li, Huafang; Li, Yan; Feng, Yu; Zhuo, Jianmin; Turkoz, Ibrahim; Mathews, Maju; Tan, Wilson

2018-01-01

To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate. PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18-65 years) diagnosed with schizophrenia ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis. Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates ( P ≤0.01), PANSS subscales (positive and general psychopathology; all P ≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all P ≤0.01), Personal and Social Performance scale scores ( P ≤0.05) and Clinical Global Impression-Severity categorical summary ( P ≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup ( P ≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups. Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization.

Morning pulse pressure is associated more strongly with elevated albuminuria than systolic blood pressure in patients with type 2 diabetes mellitus: post hoc analysis of a cross-sectional multicenter study.

PubMed

Ushigome, Emi; Fukui, Michiaki; Hamaguchi, Masahide; Matsumoto, Shinobu; Mineoka, Yusuke; Nakanishi, Naoko; Senmaru, Takafumi; Yamazaki, Masahiro; Hasegawa, Goji; Nakamura, Naoto

2013-09-01

Recently, focus has been directed toward pulse pressure as a potentially independent risk factor for micro- and macrovascular disease. This study was designed to examine the relationship between pulse pressure taken at home and elevated albuminuria in patients with type 2 diabetes. This study is a post hoc analysis of a cross-sectional multicenter study. Home blood pressure measurements were performed for 14 consecutive days in 858 patients with type 2 diabetes. We investigated the relationship between systolic blood pressure or pulse pressure in the morning or in the evening and urinary albumin excretion using univariate and multivariate analyses. Furthermore, we measured area under the receiver-operating characteristic curve (AUC) to compare the ability to identify elevated albuminuria, defined as urinary albumin excretion equal to or more than 30 mg/g creatinine, of systolic blood pressure or pulse pressure. Morning systolic blood pressure (β=0.339, P<0.001) and morning pulse pressure (β=0.378, P<0.001) were significantly associated with logarithm of urinary albumin excretion independent of other potential co-factors. AUC for elevated albuminuria in morning systolic blood pressure and morning pulse pressure were 0.668 (0.632-0.705; P<0.001) and 0.694 (0.659-0.730; P<0.001), respectively. AUC of morning pulse pressure was significantly greater than that of morning systolic blood pressure (P=0.040). Our findings implicate that morning pulse pressure is associated with elevated albuminuria in patients with type 2 diabetes, which suggests that lowering morning pulse pressure could prevent the development and progression of diabetic nephropathy. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Effect of dronedarone on clinical end points in patients with atrial fibrillation and coronary heart disease: insights from the ATHENA trial.

PubMed

Pisters, Ron; Hohnloser, Stefan H; Connolly, Stuart J; Torp-Pedersen, Christian; Naditch-Brûlé, Lisa; Page, Richard L; Crijns, Harry J G M

2014-02-01

This study aimed to assess safety and cardiovascular outcomes of dronedarone in patients with paroxysmal or persistent atrial fibrillation (AF) with coronary heart disease (CHD). Coronary heart disease is prevalent among AF patients and limits antiarrhythmic drug use because of their potentially life-threatening ventricular proarrhythmic effects. This post hoc analysis evaluated 1405 patients with paroxysmal or persistent AF and CHD from the ATHENA trial. Follow-up lasted 2.5 years, during which patients received either dronedarone (400 mg twice daily) or a double-blind matching placebo. Primary outcome was time to first cardiovascular hospitalization or death due to any cause. Secondary end points included first hospitalization due to cardiovascular events. The primary outcome occurred in 350 of 737 (47%) placebo patients vs. 252 of 668 (38%) dronedarone patients [hazard ratio (HR) = 0.73; 95% confidence interval (CI) = 0.62-0.86; P = 0.0002] without a significant increase in number of adverse events. In addition, 42 of 668 patients receiving dronedarone suffered from a first acute coronary syndrome compared with 67 of 737 patients from the placebo group (HR = 0.67; 95% CI = 0.46-0.99; P = 0.04). In this post hoc analysis, dronedarone on top of standard care in AF patients with CHD reduced cardiovascular hospitalization or death similar to that in the overall ATHENA population, and reduced a first acute coronary syndrome. Importantly, the safety profile in this subpopulation was also similar to that of the overall ATHENA population, with no excess in proarrhythmias. The mechanism of the cardiovascular protective effects is unclear and warrants further investigation.

Long-Term Response and Remission with Pixantrone in Patients with Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma: Post-Hoc Analysis of the Multicenter, Open-Label, Randomized PIX301 Trial.

PubMed

Pettengell, Ruth; Coiffier, Bertrand; Egorov, Anton; Singer, Jack; Sivcheva, Lilia

2018-06-01

Pixantrone is recommended in relapsed and refractory non-Hodgkin lymphoma (NHL) or heavily pretreated NHL patients. Its conditional approval in Europe was based on results from the open-label, randomized, phase 3 PIX301 study, comparing pixantrone monotherapy with physician's choice of treatment in 140 patients with relapsed or refractory aggressive NHL. This post-hoc analysis of the PIX301 study investigated possible correlations between patient characteristics and clinical response in 17 patients (24%) treated with pixantrone who achieved a complete response (CR) or an unconfirmed complete response (CRu) at study end. These patients (10 male and 7 female) had a median age of 61 (range 41-75) years, and the most common diagnoses were diffuse large B-cell lymphoma (n = 10) and transformed indolent lymphoma (n = 4). Most had received two prior lines of therapy (n = 12). There was wide variation in the time from diagnosis to study entry (219-4777 days). Among the 17 patients who achieved a CR/CRu with pixantrone, 6 had stable or progressive disease as a response to their last regimen, 7 had a partial response, and 4 had a CR/CRu. Four patients from the pixantrone group survived without progression for more than 400 days. Prior response to previous therapies did not appear to affect long-term response to pixantrone. These observations suggest that pixantrone monotherapy in patients with multiply relapsed or refractory aggressive NHL who had received at least two prior therapies can be associated with durable responses and long-term remission, and this may be unrelated to the clinical response to the last therapy.

Clinical and psychopathological features associated with treatment-emergent mania in bipolar-II depressed outpatients exposed to antidepressants.

PubMed

Fornaro, Michele; Anastasia, Annalisa; Monaco, Francesco; Novello, Stefano; Fusco, Andrea; Iasevoli, Felice; De Berardis, Domenico; Veronese, Nicola; Solmi, Marco; de Bartolomeis, Andrea

2018-07-01

Treatment-emergent affective switch (TEAS), including treatment-emergent mania (TEM), carry significant burden in the clinical management of bipolar depression, whereas the use of antidepressants raises both efficacy, safety and tolerability concerns. The present study assesses the prevalence and clinical correlates of TEM in selected sample of Bipolar Disorder (BD) Type-II (BD-II) acute depression outpatients. Post-hoc analysis of the clinical and psychopathological features associated with TEM among 91 BD-II depressed outpatients exposed to antidepressants. Second-generation antipsychotics (SGA) (p = .005), lithium (≤ .001), cyclothymic/irritable/hyperthymic temperaments (p = ≤ .001; p = .001; p = .003, respectively), rapid-cycling (p = .005) and depressive mixed features (p = .003) differed between TEM + cases vs. TEM - controls. Upon multinomial logistic regression, the accounted psychopathological features correctly classified as much as 88.6% of TEM + cases (35/91 overall sample, or 38.46% of the sample), yet not statistically significantly [Exp(B) = .032; p = ns]. Specifically, lithium [B = - 2.385; p = .001], SGAs [B = - 2.354; p = .002] predicted lower rates of TEM + in contrast to the number of lifetime previous psychiatric hospitalizations [B = 2.380; p = .002], whereas mixed features did not [B = 1.267; p = ns]. Post-hoc analysis. Lack of systematic pharmacological history record; chance of recall bias and Berkson's biases. Permissive operational criterion for TEM. Relatively small sample size. Cyclothymic temperament and mixed depression discriminated TEM + between TEM - cases, although only lithium and the SGAs reliably predicted TEM +/- grouping. Larger-sampled/powered longitudinal replication studies are warranted to allow firm conclusions on the matter, ideally contributing to the identification of clear-cut sub-phenotypes of BD towards patient-tailored-pharmacotherapy. Copyright © 2018 Elsevier B.V. All rights reserved.

The impact of treatment with indacaterol in patients with COPD: A post-hoc analysis according to GOLD 2011 categories A to D.

PubMed

Kerstjens, Huib A M; Deslée, Gaëtan; Dahl, Ronald; Donohue, James F; Young, David; Lawrence, David; Kornmann, Oliver

2015-06-01

Indacaterol is an inhaled, once-daily, ultra-long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease (COPD). We report on the effectiveness of indacaterol and other bronchodilators compared with placebo in patients across the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 categories A to D. A post-hoc, subgroup pooled analysis of 6-month efficacy data from three randomized, placebo-controlled, parallel-group studies involving 3862 patients was performed across GOLD 2011 categories A to D, according to baseline forced expiratory volume in 1 s (FEV1) % predicted, modified Medical Research Council (mMRC) dyspnea scale, and exacerbation history in the 12 months prior to entry. Efficacy of once-daily indacaterol 150 and 300 μg, open-label tiotropium 18 μg, twice-daily salmeterol 50 μg, and formoterol 12 μg was compared with placebo. End points analysed were trough FEV1, transition dyspnea index (TDI), and St George's Respiratory Questionnaire (SGRQ) total score, all at Week 26, and mean rescue medication use over 26 weeks. Indacaterol 150 and 300 μg significantly improved FEV1, compared with placebo across all GOLD groups. Indacaterol 150 and 300 μg also significantly improved TDI, SGRQ total score, and mean rescue medication use compared with placebo across most GOLD subgroups. Treatment selection according to patient's symptoms as well as lung function is an important consideration in maintenance treatment of COPD. Indacaterol 150 and 300 μg effectively improved lung function and symptoms in patients across all GOLD 2011 categories. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Does a 3-month multidisciplinary intervention improve pain, body composition and physical fitness in women with fibromyalgia?

PubMed

Carbonell-Baeza, Ana; Aparicio, Virginia A; Ortega, Francisco B; Cuevas, Ana M; Alvarez, Inmaculada C; Ruiz, Jonatan R; Delgado-Fernandez, Manuel

2011-12-01

To determine the effects of a 3-month multidisciplinary intervention on pain (primary outcome), body composition and physical fitness (secondary outcomes) in women with fibromyalgia (FM). 75 women with FM were allocated to a low-moderate intensity 3-month (three times/week) multidisciplinary (pool, land-based and psychological sessions) programme (n=33) or to a usual care group (n=32). The outcome variables were pain threshold, body composition (body mass index and estimated body fat percentage) and physical fitness (30 s chair stand, handgrip strength, chair sit and reach, back scratch, blind flamingo, 8 feet up and go and 6 min walk test). The authors observed a significant interaction effect (group*time) for the left (L) and right (R) side of the anterior cervical (p<0.001) and the lateral epicondyle R (p=0.001) tender point. Post hoc analysis revealed that pain threshold increased in the intervention group (positive) in the anterior cervical R (p<0.001) and L (p=0.012), and in the lateral epicondyle R (p=0.010), whereas it decreased (negative) in the anterior cervical R (p<0.001) and L (p=0.002) in the usual care group. There was also a significant interaction effect for chair sit and reach. Post hoc analysis revealed improvement in the intervention group (p=0.002). No significant improvement attributed to the training was observed in the rest of physical fitness or body composition variables. A 3-month multidisciplinary intervention three times/week had a positive effect on pain threshold in several tender points in women with FM. Though no overall improvements were observed in physical fitness or body composition, the intervention had positive effects on lower-body flexibility.

Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery.

PubMed

Oomens, M A E M; Lazzari, S; Heymans, M W; Forouzanfar, T

2016-01-01

The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and maxillofacial surgery (OMFS) published from January 2000 to May 2013 listed in PubMed. The methods used were scored using the risk of bias items given in a Delphi List. Sources of funding were recorded and categorised five ways: not funded, funded by industry, not funded by industry, supported by industry, and source of funds not clear. A total of 390 RCT met the inclusion criteria, and there was a correlation between funding and favourable main outcomes, although this was not significant. There was no correlation between the risk of bias and favourable results of the main outcome of a trial, or between the risk of bias and the reported source of funding in post-hoc analysis. We were unable to show a significant correlation between funding and a higher likelihood of a favourable result for the primary outcome in RCT in OMFS. We also failed to show a significant correlation between the risk of bias of a trial and its main outcome. In contrast, the source of funding proved to affect the risk of bias of a trial significantly, although not in post-hoc analysis. Funded trials were better organised, and so had a lower risk of bias. Copyright © 2015 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Does education level affect the efficacy of a community based salt reduction program? - A post-hoc analysis of the China Rural Health Initiative Sodium Reduction Study (CRHI-SRS).

PubMed

Wang, Xin; Li, Xian; Vaartjes, Ilonca; Neal, Bruce; Bots, Michiel L; Hoes, Arno W; Wu, Yangfeng

2016-08-11

Whether educational level influences the effects of health education is not clearly defined. This study examined whether the impact of a community-based dietary salt reduction program was affected by the level of education of participants. The China Rural Health Initiative Sodium Reduction Study (CRHI-SRS) was a cluster-randomized controlled trial conducted in 120 villages from five Northern Chinese provinces. The intervention comprised a village-wide health education program and availability of salt substitute at village shops. 24-h urine samples were collected among 1903 participants for primary evaluation of the intervention effect. A post-hoc analysis was done to explore for heterogeneity of intervention effects by education level using generalized estimating equations. All models were adjusted for age, sex, body mass index and province. Daily salt intake was lower in intervention than in control at all educational levels with no evidence of a difference in the effect of the intervention across different levels of education. P value for the interaction term between education level and the intervention was 0.35. There was likewise no evidence of an interaction for effects of the intervention on potassium intake (p = 0.71), the sodium to potassium ratio (p = 0.07), or knowledge and behaviors related to salt (all p > 0.05). The study suggests that the effects of the intervention were achieved regardless of the level of education and that the intervention should therefore be broadly effective in rural Chinese populations. The trial was registered with clinicaltrial.gov ( NCT01259700 ).

Strategies in maintenance for patients receiving long-term therapy (SIMPLE): a study of MMX mesalamine for the long-term maintenance of quiescent ulcerative colitis.

PubMed

Kane, Sunanda; Katz, Seymour; Jamal, M Mazen; Safdi, Michael; Dolin, Ben; Solomon, Dory; Palmen, Mary; Barrett, Karen

2012-06-01

This was a phase IV, multicenter, open-label, 12-14-month study to assess clinical recurrence in patients with ulcerative colitis (UC) who received maintenance treatment with MMX Multi Matrix System (MMX) mesalamine. A secondary outcome was the relationship between long-term efficacy and adherence. Patients with quiescent UC (no rectal bleeding; 0-1 bowel movements more than normal per day) were enrolled directly into a 12-month maintenance phase of the study during which they received MMX mesalamine 2.4 g/day given once daily (QD). Patients with active, mild-to-moderate UC at screening were enrolled into a 2-month acute phase; those who achieved quiescence could continue into the maintenance phase. The primary endpoint was clinical recurrence at Month 6. Of the 290 patients enrolled, 208 entered the maintenance phase; 152 directly and 56 via the acute phase. Following 6 and 12 months of treatment, 76.5% and 64.4% of evaluable patients, respectively, were recurrence-free. The majority of evaluable patients at Month 6 (81.6%) and Month 12 (79.4%) in the maintenance phase were ≥ 80% adherent to MMX mesalamine. At Month 6, clinical recurrence was observed in 20.6% of patients who were ≥ 80% adherent and 36.1% of patients with <80% adherence (P = 0.05 [post-hoc chi-square analysis]); 31.2% and 52.5% at Month 12 (P = 0.01 [post-hoc chi-square analysis]). MMX mesalamine 2.4 g/day QD is effective for maintaining quiescence in patients with UC. Furthermore, adherence to prescribed treatment yielded lower rates of clinical recurrence. Continued education regarding the importance of long-term 5-aminosalicylic acid therapy is warranted. Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.

Smoking and prevalence of nocturia in Japanese patients with type 2 diabetes mellitus: a post-hoc analysis of The Dogo Study.

PubMed

Furukawa, Shinya; Sakai, Takenori; Niiya, Tetsuji; Miyaoka, Hiroaki; Miyake, Teruki; Yamamoto, Shin; Kanzaki, Sayaka; Maruyama, Koutatsu; Tanaka, Keiko; Ueda, Teruhisa; Senba, Hidenori; Torisu, Masamoto; Minami, Hisaka; Onji, Morikazu; Tanigawa, Takeshi; Matsuura, Bunzo; Hiasa, Yoichi; Miyake, Yoshihiro

2017-06-01

No evidence exists regarding the association between smoking status and nocturia among patients with type 2 diabetes mellitus. We evaluated this association among Japanese patients with type 2 diabetes mellitus by post-hoc analysis. Study subjects were 817 Japanese patients with type 2 diabetes mellitus. Study subjects were considered to have nocturia if they answered "once or more" to the question: "Within one week, how many times do you typically wake up to urinate from sleeping at night until waking in the morning?" We used the following three outcomes: (1) nocturia was ≥1 voids per night; (2) moderate nocturia was ≥2 voids per night; and (3) severe nocturia was ≥3 voids per night. Adjustments were made for age, sex, body mass index, hypertension, dyslipidemia, stroke, glycated hemoglobin, current drinking, use of anti-hypertensive agent, use of insulin, use of oral anti-hyperglycemic agent, and diabetic retinopathy. The prevalence values of one void per night, two voids per night, and three or more voids per night were 39.5%, 27.1%, and 14.8%, respectively. Current smoking was independently inversely associated with severe nocturia compared with never or former smoking; the adjusted PR was 0.47 (95%CI: 0.25-0.89). Among the 443 patients who had ever smoked, compared with former smoking, current smoking was independently inversely related to severe nocturia; the adjusted PR was 0.44 (95%CI: 0.24-0.82). In Japanese patients with type 2 diabetes mellitus, current smoking may be independently inversely associated with severe nocturia. © 2016 Wiley Periodicals, Inc.

Idebenone reduces respiratory complications in patients with Duchenne muscular dystrophy.

PubMed

McDonald, Craig M; Meier, Thomas; Voit, Thomas; Schara, Ulrike; Straathof, Chiara S M; D'Angelo, M Grazia; Bernert, Günther; Cuisset, Jean-Marie; Finkel, Richard S; Goemans, Nathalie; Rummey, Christian; Leinonen, Mika; Spagnolo, Paolo; Buyse, Gunnar M

2016-08-01

In Duchenne muscular dystrophy (DMD), progressive loss of respiratory function leads to restrictive pulmonary disease and places patients at significant risk for severe respiratory complications. Of particular concern are ineffective cough, secretion retention and recurrent respiratory tract infections. In a Phase 3 randomized controlled study (DMD Long-term Idebenone Study, DELOS) in DMD patients 10-18 years of age and not taking concomitant glucocorticoid steroids, idebenone (900 mg/day) reduced significantly the loss of respiratory function over a 1-year study period. In a post-hoc analysis of DELOS we found that more patients in the placebo group compared to the idebenone group experienced bronchopulmonary adverse events (BAEs): placebo: 17 of 33 patients, 28 events; idebenone: 6 of 31 patients, 7 events. The hazard ratios (HR) calculated "by patient" (HR 0.33, p = 0.0187) and for "all BAEs" (HR 0.28, p = 0.0026) indicated a clear idebenone treatment effect. The overall duration of BAEs was 222 days (placebo) vs. 82 days (idebenone). In addition, there was also a difference in the use of systemic antibiotics utilized for the treatment of BAEs. In the placebo group, 13 patients (39.4%) reported 17 episodes of antibiotic use compared to 7 patients (22.6%) reporting 8 episodes of antibiotic use in the idebenone group. Furthermore, patients in the placebo group used systemic antibiotics for longer (105 days) compared to patients in the idebenone group (65 days). This post-hoc analysis of DELOS indicates that the protective effect of idebenone on respiratory function is associated with a reduced risk of bronchopulmonary complications and a reduced need for systemic antibiotics. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Digital versus conventional techniques for pattern fabrication of implant-supported frameworks.

PubMed

Alikhasi, Marzieh; Rohanian, Ahmad; Ghodsi, Safoura; Kolde, Amin Mohammadpour

2018-01-01

The aim of this experimental study was to compare retention of frameworks cast from wax patterns fabricated by three different methods. Thirty-six implant analogs connected to one-piece abutments were divided randomly into three groups according to the wax pattern fabrication method ( n = 12). Computer-aided design/computer-aided manufacturing (CAD/CAM) milling machine, three-dimensional printer, and conventional technique were used for fabrication of waxing patterns. All laboratory procedures were performed by an expert-reliable technician to eliminate intra-operator bias. The wax patterns were cast, finished, and seated on related abutment analogs. The number of adjustment times was recorded and analyzed by Kruskal-Wallis test. Frameworks were cemented on the corresponding analogs with zinc phosphate cement and tensile resistance test was used to measure retention value. One-way analysis of variance (ANOVA) and post hoc Tukey tests were used for statistical analysis. Level of significance was set at P < 0.05. The mean retentive values of 680.36 ± 21.93 N, 440.48 ± 85.98 N, and 407.23 ± 67.48 N were recorded for CAD/CAM, rapid prototyping, and conventional group, respectively. One-way ANOVA test revealed significant differences among the three groups ( P < 0.001). The post hoc Tukey test showed significantly higher retention for CAD/CAM group ( P < 0.001), while there was no significant difference between the two other groups ( P = 0.54). CAD/CAM group required significantly more adjustments ( P < 0.001). CAD/CAM-fabricated wax patterns showed significantly higher retention for implant-supported cement-retained frameworks; this could be a valuable help when there are limitations in the retention of single-unit implant restorations.

Determining registered nurses' readiness for evidence-based practice.

PubMed

Thiel, Linda; Ghosh, Yashowanto

2008-01-01

As health care systems worldwide move toward instituting evidence-based practice (EBP), its implementation can be challenging. Conducting a baseline assessment to determine nurses' readiness for EBP presents opportunities to plan strategies before implementation. Although a growing body of research literature is focused on implementing EBP, little attention has been paid to assessing nurses' readiness for EBP. The purpose of this study was to assess registered nurses' readiness for EBP in a moderate-sized acute care hospital in the Midwestern United States before implementation of a hospital-wide nursing EBP initiative. A descriptive cross-sectional survey design was used; 121 registered nurses completed the survey. The participants (n= 121) completed the 64-item Nurses' Readiness for Evidence-Based Practice Survey that allowed measurement of information needs, knowledge and skills, culture, and attitudes. Data were analyzed using descriptive statistics and a post hoc analysis. The majority (72.5%) of respondents indicated that when they needed information, they consulted colleagues and peers rather than using journals and books; 24% of nurses surveyed used the health database, Cumulative Index to Nursing & Allied Health Literature (CINAHL). The respondents perceived their EBP knowledge level as moderate. Cultural EBP scores were moderate, with unit scores being higher than organizational scores. The nurses' attitudes toward EBP were positive. The post hoc analysis showed many significant correlations. Nurses have access to technological resources and perceive that they have the ability to engage in basic information gathering but not in higher level evidence gathering. The elements important to EBP such as a workplace culture and positive attitudes are present and can be built upon. A "site-specific" baseline assessment provides direction in planning EBP initiatives. The Nurses' Readiness for EBP Survey is a streamlined tool with established reliability and validity.

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...

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.

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.

Analysis of the Space Propulsion System Problem Using RAVEN

DOE Office of Scientific and Technical Information (OSTI.GOV)

diego mandelli; curtis smith; cristian rabiti

This paper presents the solution of the space propulsion problem using a PRA code currently under development at Idaho National Laboratory (INL). RAVEN (Reactor Analysis and Virtual control ENviroment) is a multi-purpose Probabilistic Risk Assessment (PRA) software framework that allows dispatching different functionalities. It is designed to derive and actuate the control logic required to simulate the plant control system and operator actions (guided procedures) and to perform both Monte- Carlo sampling of random distributed events and Event Tree based analysis. In order to facilitate the input/output handling, a Graphical User Interface (GUI) and a post-processing data-mining module are available.more » RAVEN allows also to interface with several numerical codes such as RELAP5 and RELAP-7 and ad-hoc system simulators. For the space propulsion system problem, an ad-hoc simulator has been developed and written in python language and then interfaced to RAVEN. Such simulator fully models both deterministic (e.g., system dynamics and interactions between system components) and stochastic behaviors (i.e., failures of components/systems such as distribution lines and thrusters). Stochastic analysis is performed using random sampling based methodologies (i.e., Monte-Carlo). Such analysis is accomplished to determine both the reliability of the space propulsion system and to propagate the uncertainties associated to a specific set of parameters. As also indicated in the scope of the benchmark problem, the results generated by the stochastic analysis are used to generate risk-informed insights such as conditions under witch different strategy can be followed.« less

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.

Management of onychomycosis and co-existing tinea pedis.

PubMed

Lipner, Shari R; Scher, Richard K

2015-05-01

Onychomycosis is a common nail infection that often co-exists with tinea pedis. Surveys have suggested the diseases co-exist in at least one third of patients, although actual numbers may be a lot higher due to significant under-reporting. The importance of evaluating and treating both diseases is being increasingly recognized, however, data on improved outcomes, and the potential to minimize re-infection are limited. We review a recent post hoc analysis of two large studies treating mild to moderate onychomycosis with efinaconazole topical solution, 10%, demonstrating that complete cure rates of onychomycosis are significantly improved when any co-existing tinea pedis is also treated.

Filling the Silence: Reactivation, not Reconstruction

PubMed Central

Paape, Dario L. J. F.

2016-01-01

In a self-paced reading experiment, we investigated the processing of sluicing constructions (“sluices”) whose antecedent contained a known garden-path structure in German. Results showed decreased processing times for sluices with garden-path antecedents as well as a disadvantage for antecedents with non-canonical word order downstream from the ellipsis site. A post-hoc analysis showed the garden-path advantage also to be present in the region right before the ellipsis site. While no existing account of ellipsis processing explicitly predicted the results, we argue that they are best captured by combining a local antecedent mismatch effect with memory trace reactivation through reanalysis. PMID:26858674

Habit and Behavioral Intentions as Predictors of Social Behavior.

PubMed

Landis, Dan; Triandis, Harry C; Adamopoulos, John

1978-12-01

This research assessed the relative impact of habit and behavioral intentions in predicting classroom teacher behavior, using a model proposed by Triandis. Responses from a behavioral differential, as well as two hours of classroom observations, were taken on 77 male and female black and white junior high school teachers. The classroom observation technique (STOIC) obtained the frequencies of emitted behaviors (both verbal and nonverbal), categorized by race and sex of the target child. Results indicated that habit was a more potent predictor of classroom behavior than intentions. However, a post-hoc analysis supported the notion that intentions become important when the habit component can be suppressed.

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.

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

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.

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

APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

PubMed Central

Schnadig, Ian D; Agajanian, Richy; Dakhil, Christopher; Gabrail, Nashat; Vacirca, Jeffrey; Taylor, Charles; Wilks, Sharon; Braun, Eduardo; Mosier, Michael C; Geller, Robert B; Schwartzberg, Lee; Vogelzang, Nicholas

2017-01-01

Background APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial. Patients and methods This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg) or ondansetron 0.15 mg/kg intravenously (IV) (≤16 mg); stratification was by planned cisplatin ≥50 mg/m2 (yes/no). Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%). The primary end point was delayed-phase (>24–120 hours) complete response (CR). Results APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0–120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population. Conclusion APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging. PMID:28579832

Risk Scores for Occult Cancer in Patients with Venous Thromboembolism: A Post Hoc Analysis of the Hokusai-VTE Study.

PubMed

Kraaijpoel, Noémie; van Es, Nick; Raskob, Gary E; Büller, Harry R; Carrier, Marc; Zhang, George; Lin, Min; Grosso, Michael A; Di Nisio, Marcello

2018-06-04

Venous thromboembolism (VTE) may be the first sign of an undiagnosed cancer. In patients with unprovoked VTE, the risk is approximately 5% in the year following VTE diagnosis. Cancer-specific screening is therefore often considered in these patients, but the optimal screening strategy remains controversial. Recently, two risk classification scores have been proposed that may help in identifying patients at high risk of occult cancer in whom extensive screening may be warranted. In the present post hoc analysis of the Hokusai-VTE study, we evaluated the performance of the Registro Informatizado de Pacientes con Enfermedad TromboEmbólica (RIETE) and Screening for Occult Malignancy in Patients with Idiopathic Venous Thromboembolism (SOME) scores for occult cancer in patients with acute VTE. A total of 8,032 patients were included in the analysis of whom 218 (2.7%; 95% confidence interval [CI], 2.4-3.1) developed cancer between 30-day and 12-month follow-up. The c -statistics of the RIETE and SOME scores were 0.62 (95% CI, 0.57-0.66) and 0.59 (95% CI, 0.55-0.62), respectively. In patients classified as 'high risk', the cumulative incidence of cancer diagnosis during follow-up was 2.9% (95% CI, 2.1-3.9) for the RIETE score and 2.7% (95% CI, 1.9-3.7) for the SOME score, corresponding to hazard ratios of 1.8 (95% CI, 1.3-2.5) and 1.5 (95% CI, 1.04-2.2), respectively. In conclusion, the performance of both scores was poor. When used dichotomously, the scores were able to identify a group of patients with a significantly higher risk of occult cancer, although it remains unknown whether this translates into improved clinical important outcomes. Schattauer GmbH Stuttgart.

Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial.

PubMed

Hensley, Martee L; Patel, Shreyaskumar R; von Mehren, Margaret; Ganjoo, Kristen; Jones, Robin L; Staddon, Arthur; Rushing, Daniel; Milhem, Mohammed; Monk, Bradley; Wang, George; McCarthy, Sharon; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Demetri, George D

2017-09-01

Trabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%). Of 577 patients randomized 2:1 to receive trabectedin 1.5mg/m 2 by 24-hour IV infusion or dacarbazine 1g/m 2 by 20-120-minute IV infusion once every three weeks, 232 had uLMS (trabectedin: 144; dacarbazine: 88). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR: complete responses+partial responses+stable disease [SD] for at least 18weeks), duration of response (DOR), and safety. PFS for trabectedin was 4.0months compared with 1.5months for dacarbazine (hazard ratio [HR]=0.57; 95% CI 0.41-0.81; P=0.0012). OS was similar (trabectedin 13.4months vs. dacarbazine 12.9months, HR=0.89; 95% CI 0.65-1.24; P=0.51) between groups. ORR was 11% with trabectedin vs. 9% with dacarbazine (P=0.82). CBR for trabectedin was 31% vs. 18% with dacarbazine (P=0.05); median DOR was 6.5months for trabectedin vs. 4.1months for dacarbazine (P=0.32). Grade 3/4 treatment-emergent adverse events observed in ≥10% of patients in the trabectedin group included transient aminotransferase (aspartate/alanine) elevations, anemia, leukopenia, and thrombocytopenia. In this post hoc subset analysis of patients with uLMS who had received prior anthracycline therapy, trabectedin treatment resulted in significantly longer PFS versus dacarbazine, with an acceptable safety profile. There was no difference in OS. Copyright © 2017. Published by Elsevier Inc.

Risk of venous thromboembolism following influenza vaccination in adults aged 50years and older in the Vaccine Safety Datalink.

PubMed

Vickers, Elizabeth R; McClure, David L; Naleway, Allison L; Jacobsen, Steven J; Klein, Nicola P; Glanz, Jason M; Weintraub, Eric S; Belongia, Edward A

2017-10-13

Influenza-like illness and inflammation are known risk factors for venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). However, few studies have characterized the risk of VTE following influenza vaccination. We examined VTE risk after vaccination in adults 50years old and older within the Vaccine Safety Datalink (VSD). We used the self-controlled case series method to determine the risk of VTE among age-eligible adults who received influenza vaccine (with or without pandemic H1N1) and experienced a VTE during the months of September through December in 2007 through 2012. Presumptive VTE cases were identified among VSD participants using diagnostic codes, diagnostic tests, and oral anticoagulant prescription. Potential cases were validated by medical record review. The VTE incidence rate ratio was calculated among confirmed cases for the risk window 1 to 10days after vaccination relative to all other person-time from September through December. Of the 1,488 presumptive cases identified, 508 were reviewed, of which 492 (97%) were confirmed cases of VTE. The analysis included 396 incident, confirmed cases. Overall, there was no increased risk of VTE in the 1 to 10days after influenza vaccination (IRR=0.89, 95% CI 0.69-1.17) compared to the control period. Results were similar when all person-time was censored before vaccination. A post hoc analysis showed an increased risk among current tobacco smokers (IRR=2.57, 95% CI 1.06-6.23). No clustering of VTE was observed in the 1-42days after vaccination. Overall, there was no evidence that inactivated influenza vaccine was associated with VTE in adults ≥50years old. An increased risk was found among current smokers in a post hoc analysis. These findings are consistent with previous research and support the safety of annual vaccination in this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial.

PubMed

Devlin, Nancy; Herdman, Michael; Pavesi, Marco; Phung, De; Naidoo, Shevani; Beer, Tomasz M; Tombal, Bertrand; Loriot, Yohann; Ivanescu, Cristina; Parli, Teresa; Balk, Mark; Holmstrom, Stefan

2017-06-23

The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. NCT01212991.

Stroke Volume Variation-Guided Versus Central Venous Pressure-Guided Low Central Venous Pressure With Milrinone During Living Donor Hepatectomy: A Randomized Double-Blinded Clinical Trial.

PubMed

Lee, Jiwon; Kim, Won Ho; Ryu, Ho-Geol; Lee, Hyung-Chul; Chung, Eun-Jin; Yang, Seong-Mi; Jung, Chul-Woo

2017-08-01

We previously demonstrated the usefulness of milrinone for living donor hepatectomy. However, a less-invasive alternative to central venous catheterization and perioperative contributors to good surgical outcomes remain undetermined. The current study evaluated whether the stroke volume variation (SVV)-guided method can substitute central venous catheterization during milrinone-induced profound vasodilation. We randomly assigned 42 living liver donors to receive either SVV guidance or central venous pressure (CVP) guidance to obtain milrinone-induced low CVP. Target SVV of 9% was used as a substitute for CVP of 5 mm Hg. The surgical field grade evaluated by 2 attending surgeons on a 4-point scale was compared between the CVP- and SVV-guided groups (n = 19, total number of scores = 38 per group) as a primary outcome variable. Multivariable analysis was performed to identify independent factors associated with the best surgical field as a post hoc analysis. Surgical field grades, which were either 1 or 2, were not found to be different between the 2 groups via Mann-Whitney U test (P = .358). There was a very weak correlation between SVV and CVP during profound vasodilation such as CVP ≤ 5 mm Hg (R = -0.06; 95% confidence interval, -0.09 to -0.04; P < .001). Additional post hoc analysis suggested that younger age, lower baseline CVP, and longer duration of milrinone infusion might be helpful in providing the best surgical field. Milrinone-induced vasodilation resulted in favorable surgical environment regardless of guidance methods of low CVP during living donor hepatectomy. However, SVV was not a useful indicator of low CVP because of very weak correlation between SVV and CVP during profound vasodilation. In addition, factors contributing to the best surgical field such as donor age, proactive fasting, and proper dosing of milrinone need to be investigated further, ideally through prospective studies.

Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study.

PubMed

Basu, Sudeepta K; Kaiser, Jeffrey R; Guffey, Danielle; Minard, Charles G; Guillet, Ronnie; Gunn, Alistair J

2016-03-01

To investigate the association of neonatal hypoglycaemia and hyperglycaemia with outcomes in infants with hypoxic ischaemic encephalopathy (HIE). Post hoc analysis of the CoolCap Study. 25 perinatal centres in the UK, the USA and New Zealand during 1999-2002. 234 infants at ≥36 weeks' gestation with moderate-to-severe HIE enrolled in the CoolCap Study. 214 (91%) infants had documented plasma glucose and follow-up outcome data. Infants were randomised to head cooling for 72 h starting within 6 h of birth, or standard care. Plasma glucose levels were measured at predetermined time intervals after randomisation. The unfavourable primary outcome of the study was death and/or severe neurodevelopmental disability at 18 months. Hypoglycaemia (≤40 mg/dL, ≤2.2 mmol/L) and hyperglycaemia (>150 mg/dL, >8.3 mmol/L) during the first 12 h after randomisation were investigated for univariable and multivariable associations with unfavourable primary outcome. 121 (57%) infants had abnormal plasma glucose values within 12 h of randomisation. Unfavourable outcome was observed in 126 (60%) infants and was more common among subjects with hypoglycaemia (81%, p=0.004), hyperglycaemia (67%, p=0.01) and any glucose derangement within the first 12 h (67%, p=0.002) compared with normoglycaemic infants (48%) in univariable analysis. These associations remained significant after adjusting for birth weight, Apgar score, pH, Sarnat stage and hypothermia therapy. Both hypoglycaemia and hyperglycaemia in infants with moderate-to-severe HIE were independently associated with unfavourable outcome. Future studies are needed to investigate the prognostic significance of these associations and their role as biomarkers of brain injury. (ClinicalTrials.gov NCT00383305). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Efficacy and Safety of First-Line Necitumumab Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in East Asian Patients with Stage IV Squamous Non-small Cell Lung Cancer: A Subgroup Analysis of the Phase 3, Open-Label, Randomized SQUIRE Study.

PubMed

Park, Keunchil; Cho, Eun Kyung; Bello, Maximino; Ahn, Myung-Ju; Thongprasert, Sumitra; Song, Eun-Kee; Soldatenkova, Victoria; Depenbrock, Henrik; Puri, Tarun; Orlando, Mauro

2017-10-01

The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study. All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m²) and cisplatin (day 1, 75 mg/m²). Patients in the neci+GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models. In EA patients, there were improvements for neci+GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), grade ≥ 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC. Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.

Cervical and Incisal Marginal Discrepancy in Ceramic Laminate Veneering Materials: A SEM Analysis

PubMed Central

Ranganathan, Hemalatha; Ganapathy, Dhanraj M.; Jain, Ashish R.

2017-01-01

Context: Marginal discrepancy influenced by the choice of processing material used for the ceramic laminate veneers needs to be explored further for better clinical application. Aims: This study aimed to evaluate the amount of cervical and incisal marginal discrepancy associated with different ceramic laminate veneering materials. Settings and Design: This was an experimental, single-blinded, in vitro trial. Subjects and Methods: Ten central incisors were prepared for laminate veneers with 2 mm uniform reduction and heavy chamfer finish line. Ceramic laminate veneers fabricated over the prepared teeth using four different processing materials were categorized into four groups as Group I - aluminous porcelain veneers, Group II - lithium disilicate ceramic veneers, Group III - lithium disilicate-leucite-based veneers, Group IV - zirconia-based ceramic veneers. The cervical and incisal marginal discrepancy was measured using a scanning electron microscope. Statistical Analysis Used: ANOVA and post hoc Tukey honest significant difference (HSD) tests were used for statistical analysis. Results: The cervical and incisal marginal discrepancy for four groups was Group I - 114.6 ± 4.3 μm, 132.5 ± 6.5 μm, Group II - 86.1 ± 6.3 μm, 105.4 ± 5.3 μm, Group III - 71.4 ± 4.4 μm, 91.3 ± 4.7 μm, and Group IV - 123.1 ± 4.1 μm, 142.0 ± 5.4 μm. ANOVA and post hoc Tukey HSD tests observed a statistically significant difference between the four test specimens with regard to cervical marginal discrepancy. The cervical and incisal marginal discrepancy scored F = 243.408, P < 0.001 and F = 180.844, P < 0.001, respectively. Conclusion: This study concluded veneers fabricated using leucite reinforced lithium disilicate exhibited the least marginal discrepancy followed by lithium disilicate ceramic, aluminous porcelain, and zirconia-based ceramics. The marginal discrepancy was more in the incisal region than in the cervical region in all the groups. PMID:28839415

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

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.

Effects of Tiotropium on Exacerbations in Patients with COPD with Low or High Risk of Exacerbations: A Post-Hoc Analysis from the 4-Year UPLIFT® Trial

PubMed Central

Celli, Bartolome R.; Decramer, Marc; Asijee, Guus M.; Kupas, Katrin; Tashkin, Donald P.

2015-01-01

Background: A history of past exacerbations is a predictor of future events for patients with chronic obstructive pulmonary disease (COPD). Very little is known about the effect of pharmacologic therapies on patients with frequent or infrequent exacerbations. Methods: We conducted a post-hoc analysis of the Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT®)trial database. Patients were classified as having a low risk of exacerbations if they experienced ≤1 exacerbation and no COPD-related hospitalization(s) in the year preceding trial entry or as high risk of exacerbations if they had ≥2 exacerbations (courses of oral steroids/antibiotics) or ≥1 COPD-related hospitalization(s) in the year preceding the trial. Results: In patients at low risk or high risk for exacerbations, compared to placebo, tiotropium significantly reduced: 1) the time to first COPD exacerbation (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.74, 0.88; p <0.0001; HR: 0.89; 95% CI: 0.81, 0.97; p=0.0066, respectively); 2) the number of COPD exacerbations (rate ratio [RR]: 0.79; 95% CI: 0.72, 0.86; p<0.0001; RR: 0.88; 95% CI: 0.81; 0.95; p=0.0009). Furthermore, upon treatment with tiotropium, the proportion of patients transitioning from the low- to the high-risk exacerbations group was statistically lower compared to placebo (RR: 0.78; 95% CI: 0.67, 0.92; p=0.0030) Conclusions: This analysis shows that tiotropium reduces the risk of subsequent exacerbation and also prolongs time to first exacerbation, in both the high- and low-risk exacerbator subgroups. It also decreases the proportion of patients who shift from the low- to the high-risk exacerbations group compared to placebo. PMID:28848836

Global Coverage from Ad-Hoc Constellations in Rideshare Orbits

NASA Technical Reports Server (NTRS)

Ellis, Armin; Mercury, Michael; Brown, Shannon

2012-01-01

A promising area of small satellite development is in providing higher temporal resolution than larger satellites. Traditional constellations have required specific orbits and dedicated launch vehicles. In this paper we discuss an alternative architecture in which the individual elements of the constellation are launched as rideshare opportunities. We compare the coverage of such an ad-hoc constellation with more traditional constellations. Coverage analysis is based on actual historical data from rideshare opportunities. Our analysis includes ground coverage and temporal revisits for Polar, Tropics, Temperate, and Global regions, comparing ad-hoc and Walker constellation.

Effect of local and global geomagnetic activity on human cardiovascular homeostasis.

PubMed

Dimitrova, Svetla; Stoilova, Irina; Yanev, Toni; Cholakov, Ilia

2004-02-01

The authors investigated the effects of local and planetary geomagnetic activity on human physiology. They collected data in Sofia, Bulgaria, from a group of 86 volunteers during the periods of the autumnal and vernal equinoxes. They used the factors local/planetary geomagnetic activity, day of measurement, gender, and medication use to apply a four-factor multiple analysis of variance. They also used a post hoc analysis to establish the statistical significance of the differences between the average values of the measured physiological parameters in the separate factor levels. In addition, the authors performed correlation analysis between the physiological parameters examined and geophysical factors. The results revealed that geomagnetic changes had a statistically significant influence on arterial blood pressure. Participants expressed this reaction with weak local geomagnetic changes and when major and severe global geomagnetic storms took place.

Mechanical properties and superficial characterization of a milled CAD-CAM glass fiber post.

PubMed

Ruschel, George Hebert; Gomes, Érica Alves; Silva-Sousa, Yara Terezinha; Pinelli, Rafaela Giedra Pirondi; Sousa-Neto, Manoel Damião; Pereira, Gabriel Kalil Rocha; Spazzin, Aloísio Oro

2018-06-01

Computer-aided design and computer-aided manufacturing (CAD-CAM) technology may be used to produce custom intraradicular posts, but studies are lacking. The purpose of this in vitro study was to evaluate the flexural properties (strength and modulus), failure mode, superficial morphology, and roughness of two CAD-CAM glass fiber posts (milled at different angulations) compared with a commercially available prefabricated glass fiber post. Three groups were tested (n = 10): PF (control group)- prefabricated glass fiber post; C-Cd-diagonally milled post; and C-Cv-vertically milled post. A 3-dimensional virtual image was obtained from a prefabricated post, which guided the posterior milling of posts from a glass fiber disk (Trilor Blanks; Bioloren). Surface roughness and morphology were evaluated using confocal laser microscopy. Flexural strength and modulus were evaluated with the 3-point bend test. Data were submitted to one-way analysis of variance followed by the Student-Newman-Keuls post hoc test (α = 0.05). The fractured surfaces were evaluated with scanning electron microscopy. The superficial roughness was highest for PF and similar for the experimental groups. Morphological analysis shows different sizes and directions of the glass fibers along the post. The flexural strength was highest for PF (900.1 ± 30.4 > C-Cd - 357.2 ± 30.7 > C-Cv 101.8 ± 4.3 MPa) as was the flexural modulus (PF 19.3 ± 2.0 GPa > C-Cv 10.1 ± 1.9 GPa > C-Cd 7.8 ± 1.3 GPa). A CAD-CAM milled post seems a promising development, but processing requires optimizing, as the prefabricated post still shows better mechanical properties and superficial characteristics. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

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.

Ad Hoc Supervision of General Practice Registrars as a "Community of Practice": Analysis, Interpretation and Re-Presentation

ERIC Educational Resources Information Center

Clement, T.; Brown, J.; Morrison, J.; Nestel, D.

2016-01-01

General practice registrars in Australia undertake most of their vocational training in accredited general practices. They typically see patients alone from the start of their community-based training and are expected to seek timely ad hoc support from their supervisor. Such ad hoc encounters are a mechanism for ensuring patient safety, but also…

Comparison of data analysis strategies for intent-to-treat analysis in pre-test-post-test designs with substantial dropout rates.

PubMed

Salim, Agus; Mackinnon, Andrew; Christensen, Helen; Griffiths, Kathleen

2008-09-30

The pre-test-post-test design (PPD) is predominant in trials of psychotherapeutic treatments. Missing data due to withdrawals present an even bigger challenge in assessing treatment effectiveness under the PPD than under designs with more observations since dropout implies an absence of information about response to treatment. When confronted with missing data, often it is reasonable to assume that the mechanism underlying missingness is related to observed but not to unobserved outcomes (missing at random, MAR). Previous simulation and theoretical studies have shown that, under MAR, modern techniques such as maximum-likelihood (ML) based methods and multiple imputation (MI) can be used to produce unbiased estimates of treatment effects. In practice, however, ad hoc methods such as last observation carried forward (LOCF) imputation and complete-case (CC) analysis continue to be used. In order to better understand the behaviour of these methods in the PPD, we compare the performance of traditional approaches (LOCF, CC) and theoretically sound techniques (MI, ML), under various MAR mechanisms. We show that the LOCF method is seriously biased and conclude that its use should be abandoned. Complete-case analysis produces unbiased estimates only when the dropout mechanism does not depend on pre-test values even when dropout is related to fixed covariates including treatment group (covariate-dependent: CD). However, CC analysis is generally biased under MAR. The magnitude of the bias is largest when the correlation of post- and pre-test is relatively low.

Impact of paliperidone palmitate one-month formulation on relapse prevention in patients with schizophrenia: A post-hoc analysis of a one-year, open-label study stratified by medication adherence.

PubMed

Si, Tianmei; Li, Nan; Lu, Huafei; Cai, Shangli; Zhuo, Jianmin; Correll, Christoph U; Zhang, Lili; Feng, Yu

2018-06-01

Limited data are available to help identify patients with schizophrenia who are most likely to benefit from long-acting injectable antipsychotics. To investigate the efficacy of long-acting injectable antipsychotic paliperidone palmitate one-month formulation for preventing relapses, factors influencing time to first relapse, and the effect of different antipsychotic adherence levels on time to first relapse in Chinese patients with schizophrenia. This was a post-hoc analysis from an open-label, single-arm study of stable patients (Positive and Negative Syndrome Scale total score <70; n=367) receiving paliperidone palmitate one-month formulation at the end of an acute 13-week treatment phase, who entered a naturalistic one-year follow-up period, either continuing with flexibly dosed paliperidone palmitate one-month formulation (75-150 mg eq.) or switching to another antipsychotic(s). There were 362/367 patients (age=31.4±10.75 years) included in the analysis of time to first relapse (primary outcome) and 327/362 patients (39/327, poor antipsychotic adherence (<80%)) willing to receive antipsychotics were included in the exposure/adherence analysis. Overall, 84.6% (95% confidence interval=79.2-88.7) patients remained relapse-free. Poor adherence during follow-up (hazard ratio=2.97, 95% confidence interval=1.48-5.98, p=0.002) and frequent hospitalizations in the previous year (hazard ratio=1.29, 95% confidence interval=1.02-1.62, p=0.03) were associated with a significant risk of shorter time to first relapse in the univariate analysis. In patients with poor adherence, 'no use' (hazard ratio=13.13, 95% confidence interval=1.33-129.96, p=0.03) and 'interrupted use' (hazard ratio=11.04, 95% confidence interval=1.03-118.60, p=0.047) of paliperidone palmitate one-month formulation (vs continued use) showed a significantly higher risk of relapse; this was not observed in patients with good (≥80%) antipsychotic adherence. No new safety concerns were identified. Continued use of paliperidone palmitate one-month formulation/long-acting injectable antipsychotic was effective in preventing schizophrenia relapses, especially in patients with suboptimal antipsychotic adherence.

Concentrations of MUC16 and MUC5AC using three tear collection methods

PubMed Central

Nichols, Jason J.

2017-01-01

Purpose To determine the optimal tear collection method for analysis of ocular surface mucins MUC5AC and MUC16. Methods Fifteen subjects without ocular surface disease were recruited. Subjects presented for tear collection on three separate days for three different tear collection methods with the order of method randomized. Methods used to collect tears from right and left eyes included Schirmer’s strip, basal tear collection, and flush tear collection. All samples from the right eyes were individually analyzed for MUC5AC whereas the left eye samples were individually analyzed for MUC16. For each individual sample, 10 μg of protein were loaded per lane into a 1% (w/v) agarose gel and run in electrophoresis buffer for 2 h. After overnight capillary transfer, membranes were incubated with either MUC5AC antibody CLH2 or MUC16 antibody OC125 for western blot analysis. Blots were developed with enhanced chemiluminescence (ECL) and signals captured with the Odyssey Fc (LI-COR). The relative amounts of MUC5AC and MUC16 were quantified with densitometry using software and compared for statistically significant differences between tear collection methods using the Kruskal–Wallis test in SPSS 22 and GraphPad Prism 7.02. Dunn’s multiple comparisons test was used for pairwise post-hoc comparisons. Results Samples containing less than 10 μg of total protein were not used for analysis which left eight samples (out of 45) unusable. The calculated MUC5AC median signal intensities from Schirmer’s strip, basal tears, and flush tears were 2.86 (n = 15, the interquartile range [IQR] = 2.54–3.21), 1.65 (n = 14, IQR = 1.34–3.1), and 1.67 (n = 9, IQR = 1.42–1.72), respectively (H = 9.5, p = 0.009). Post-hoc pairwise comparisons showed a statistically significant difference between Schirmer’s strip and flush tears (p = 0.01). The calculated MUC16 median signal intensities from Schirmer’s strip, basal tears, and flush tears were 1.88 (n = 14, IQR = 1.43–2.61), 5.24 (n = 15, IQR = 4.16–6.21), and 2.45 (n = 7, IQR = 1.85–2.48), respectively (H = 18.1, p = 0.001). Post-hoc pairwise comparison showed statistically significant differences between basal tears and Schirmer’s strip (p = 0.0003) and between basal tears and flush tears (p = 0.006). Conclusions MUC5AC and MUC16 are present in human tear fluid and can be captured using various tear collection methods. Although basal tear collection yielded the highest relative concentration of MUC16, Schirmer’s strip tear collection yielded the highest MUC5AC concentration. Therefore, the tear collection method chosen depends on the mucin of interest. PMID:28761326

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.

Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial.

PubMed

Levy, Robert M; Harvey, Richard L; Kissela, Brett M; Winstein, Carolee J; Lutsep, Helmi L; Parrish, Todd B; Cramer, Steven C; Venkatesan, Lalit

2016-02-01

This prospective, single-blinded, multicenter study assessed the safety and efficacy of electrical epidural motor cortex stimulation (EECS) in improving upper limb motor function of ischemic stroke patients with moderate to moderately severe hemiparesis. Patients ≥ 4 months poststroke were randomized 2:1 to an investigational (n = 104) or control (n = 60) group, respectively. Investigational patients were implanted (n = 94) with an epidural 6-contact lead perpendicular to the primary motor cortex and a pulse generator. Both groups underwent 6 weeks of rehabilitation, but EECS was delivered to investigational patients during rehabilitation. The primary efficacy endpoint (PE) was defined as attaining a minimum improvement of 4.5 points in the upper extremity Fugl-Meyer (UEFM) scale as well as 0.21 points in the Arm Motor Ability Test (AMAT) 4 weeks postrehabilitation. Follow-up assessments were performed 1, 4, 12, and 24 weeks postrehabilitation. Safety was evaluated by monitoring adverse events (AEs) that occurred between enrollment and the end of rehabilitation. Primary intent-to-treat analysis showed no group differences at 4 weeks, with PE being met by 32% and 29% of investigational and control patients, respectively (P = .36). Repeated-measures secondary analyses revealed no significant treatment group differences in mean UEFM or AMAT scores. However, post hoc comparisons showed that a greater proportion of investigational (39%) than control (15%) patients maintained or achieved PE (P = .003) at 24 weeks postrehabilitation. Investigational group mean AMAT scores also improved significantly (P < .05) when compared to the control group at 24 weeks postrehabilitation. Post hoc analyses also showed that 69% (n = 9/13) of the investigational patients who elicited movement thresholds during stimulation testing met PE at 4 weeks, and mean UEFM and AMAT scores was also significantly higher (P < .05) in this subgroup at the 4-, 12-, and 24-week assessments when compared to the control group. Headache (19%), pain (13%), swelling (7%), and infection (7%) were the most commonly observed implant procedure-related AEs. Overall, there were 11 serious AEs in 9 investigational group patients (7 procedure related, 4 anesthesia related). The primary analysis pertaining to efficacy of EECS during upper limb motor rehabilitation in chronic stroke patients was negative at 4 weeks postrehabilitation. A better treatment response was observed in a subset of patients eliciting stimulation induced upper limb movements during motor threshold assessments performed prior to each rehabilitation session. Post hoc comparisons indicated treatment effect differences at 24 weeks, with the control group showing significant decline in the combined primary outcome measure relative to the investigational group. These results have the potential to inform future chronic stroke rehabilitation trial design. © The Author(s) 2015.

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.

Teaching Emotional Intelligence: A Control Group Study of a Brief Educational Intervention for Emergency Medicine Residents

PubMed Central

Gorgas, Diane L.; Greenberger, Sarah; Bahner, David P.; Way, David P.

2015-01-01

Introduction Emotional Intelligence (EI) is defined as an ability to perceive another’s emotional state combined with an ability to modify one’s own. Physicians with this ability are at a distinct advantage, both in fostering teams and in making sound decisions. Studies have shown that higher physician EI’s are associated with lower incidence of burn-out, longer careers, more positive patient-physician interactions, increased empathy, and improved communication skills. We explored the potential for EI to be learned as a skill (as opposed to being an innate ability) through a brief educational intervention with emergency medicine (EM) residents. Methods This study was conducted at a large urban EM residency program. Residents were randomized to either EI intervention or control groups. The intervention was a two-hour session focused on improving the skill of social perspective taking (SPT), a skill related to social awareness. Due to time limitations, we used a 10-item sample of the Hay 360 Emotional Competence Inventory to measure EI at three time points for the training group: before (pre) and after (post) training, and at six-months post training (follow up); and at two time points for the control group: pre- and follow up. The preliminary analysis was a four-way analysis of variance with one repeated measure: Group x Gender x Program Year over Time. We also completed post-hoc tests. Results Thirty-three EM residents participated in the study (33 of 36, 92%), 19 in the EI intervention group and 14 in the control group. We found a significant interaction effect between Group and Time (p≤0.05). Post-hoc tests revealed a significant increase in EI scores from Time 1 to 3 for the EI intervention group (62.6% to 74.2%), but no statistical change was observed for the controls (66.8% to 66.1%, p=0.77). We observed no main effects involving gender or level of training. Conclusion Our brief EI training showed a delayed but statistically significant positive impact on EM residents six months after the intervention involving SPT. One possible explanation for this finding is that residents required time to process and apply the EI skills training in order for us to detect measurable change. More rigorous measurement will be needed in future studies to aid in the interpretation of our findings. PMID:26594287

Critical Thinking and the Use of Nontraditional Instructional Methodologies.

PubMed

Orique, Sabrina B; McCarthy, Mary Ann

2015-08-01

The purpose of this study was to examine the relationship between critical thinking and the use of concept mapping (CM) and problem-based learning (PBL) during care plan development. A quasi-experimental study with a pretest-posttest design was conducted using a convenience sample (n = 49) of first-semester undergraduate baccalaureate nursing students. Critical thinking was measured using the Holistic Critical Thinking Scoring Rubric. Data analysis consisted of a repeated measures analysis of variance with post hoc mean comparison tests using the Bonferroni method. Findings indicated that mean critical thinking at phase 4 (CM and PBL) was significantly higher, compared with phase 1 (baseline), phase 2 (PBL), and phase 3 (CM [p < 0.001]). The results support the utilization of nontraditional instructional (CM and PBL) methodologies in undergraduate nursing curricula. Copyright 2015, SLACK Incorporated.

Attitudes toward aging: implications for a caring profession.

PubMed

Holroyd, Ann; Dahlke, Sherry; Fehr, Cindy; Jung, Piera; Hunter, Andrea

2009-07-01

With the predicted increase in the age of Canada's overall population, it is estimated that by 2020, up to 75% of nurses' time will be spent with older adults. It is recognized that care of older adults occurs in a cultural context in which the older members of society are poorly valued, often referred to as ageism. Based on the premise that attitudes affect behavior and knowledge acquisition, a comparative cross-sectional study using the Attitudes Toward Old People scale measured nursing students' attitudes at different points in a baccalaureate nursing program. Although analysis of variance revealed no significant differences in students' attitudes during the 4 years, post hoc analysis revealed a drop in positive attitudes and a rise in negative attitudes at the beginning of the second and fourth years of the baccalaureate program.

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.

Clinical Factors Associated with Dose of Loop Diuretics After Pediatric Cardiac Surgery: Post Hoc Analysis.

PubMed

Haiberger, Roberta; Favia, Isabella; Romagnoli, Stefano; Cogo, Paola; Ricci, Zaccaria

2016-06-01

A post hoc analysis of a randomized controlled trial comparing the clinical effects of furosemide and ethacrynic acid was conducted. Infants undergoing cardiac surgery with cardiopulmonary bypass were included in order to explore which clinical factors are associated with diuretic dose in infants with congenital heart disease. Overall, 67 patients with median (interquartile range) age of 48 (13-139) days were enrolled. Median diuretic dose was 0.34 (0.25-0.4) mg/kg/h at the end of postoperative day (POD) 0 and it significantly decreased (p = 0.04) over the following PODs; during this period, the ratio between urine output and diuretic dose increased significantly (p = 0.04). Age (r -0.26, p = 0.02), weight (r -0.28, p = 0.01), cross-clamp time (r 0.27, p = 0.03), administration of ethacrynic acid (OR 0.01, p = 0.03), and, at the end of POD0, creatinine levels (r 0.3, p = 0.009), renal near-infrared spectroscopy saturation (-0.44, p = 0.008), whole-blood neutrophil gelatinase-associated lipocalin levels (r 0.30, p = 0.01), pH (r -0.26, p = 0.02), urinary volume (r -0.2755, p = 0.03), and fluid balance (r 0.2577, p = 0.0266) showed a significant association with diuretic dose. At multivariable logistic regression cross-clamp time (OR 1.007, p = 0.04), use of ethacrynic acid (OR 0.2, p = 0.01) and blood pH at the end of POD0 (OR 0.0001, p = 0.03) was independently associated with diuretic dose. Early resistance to loop diuretics continuous infusion is evident in post-cardiac surgery infants: Higher doses are administered to patients with lower urinary output. Independently associated variables with diuretic dose in our population appeared to be cross-clamping time, the administration of ethacrynic acid, and blood pH.

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

Clinical relevance of detecting anti-infliximab antibodies with a drug-tolerant assay: post hoc analysis of the TAXIT trial.

PubMed

Van Stappen, Thomas; Vande Casteele, Niels; Van Assche, Gert; Ferrante, Marc; Vermeire, Séverine; Gils, Ann

2018-05-01

To evaluate the clinical relevance of antidrug antibodies (ADAs) measured using a drug-tolerant assay in a post hoc analysis of the Trough Concentration (TC) Adapted Infliximab Treatment (TAXIT) randomised controlled trial. ADA in serum samples (n=221) of 76 patients enrolled in TAXIT, who presented with an infliximab TC <3 µg/mL at screening, were reanalysed after optimisation and at the end of the study using a drug-tolerant ADA assay. Patients underwent dose escalation to achieve therapeutic TCs between 3 µg/mL and 7 µg/mL prior to randomisation. Patients were grouped into quartiles (Q1-4) according to ADA concentration at screening. Using a drug-tolerant assay, the immunogenicity detection rate increased from 21% (drug-sensitive assay) to 63% at screening, from 0% to 51% after optimisation and from 3% to 42% at the end of TAXIT. Patients in ADA Q4 required a higher cumulative infliximab dose (2390 (880-2998) mg) to achieve target TCs, resulting in a higher drug cost (€10 712 (4120-13 596)) compared with ADA-negative patients (€2060 (1648-3296)) and patients in ADA Q1/Q2 (€2060 (1648-4120)/€2060 (1751-3296), p<0.001). However, all but one patient belonging to ADA Q4 were also ADA-positive using a drug-sensitive assay. Upon dose intensification, low concentration ADAs, not detectable using a drug-sensitive assay, disappear in more than half of the patients over time and are clinically non-relevant. In contrast, high concentration ADAs which are typically also detected in a drug-sensitive assay, persist over time and necessitate a higher cumulative dose and drug cost. In the latter group, proactive drug switching may be more cost-efficient. 2011-002061-38; Post-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The Effect of Clinical Pilates on Functional Movement in Recreational Runners.

PubMed

Laws, Anna; Williams, Sean; Wilson, Cassie

2017-09-01

Biomechanical imbalances and inefficient functional movements are considered contributing factors to running-related injuries. Clinical Pilates uses a series of exercises focused on retraining normal movement patterns. This study investigated whether a 6-week course of Clinical Pilates improves functional movement and thereby, potentially, reduces the risk of running-related injuries associated with movement dysfunction. A modified functional movement screen was used to analyze the functional movement ability of forty runners. Forty participants completed a 6-week course of Clinical Pilates delivered by a Clinical Pilates instructor. The movement screen was carried out 3 times for each runner: 6 weeks pre-intervention (baseline), within one week pre-intervention (pre) and within one week post-intervention (post). Repeated-measures analysis of variance and post-hoc tests found significant increases in scores between baseline and post (mean±SD; 13.4±2.4 vs. 17.0±1.7, p<0.01) and pre and post (mean±SD; 13.5±2.5 vs. 17.0±1.7, p<0.01), but no significant difference between baseline and pre (p=0.3). A 6-week course of Clinical Pilates significantly improves functional movement in recreational runners, and this may lead to a reduction in the risk of running-related injuries. © Georg Thieme Verlag KG Stuttgart · New York.

Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo.

PubMed

Chang, Wei-Lun; Andersen, Carit Jacques; Berisha, Besa Shatri; Estrup, Olena; Wang, Shr-Jie

2018-05-08

Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Thirty-four torture/war victims with comorbid conditions enrolled in 2012-2013. Participants were randomly assigned to an "intervention" and a "waiting-list" group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18%) after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4-5 years, assuming the increased level is maintained. Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

Cold water immersion of the ankle decreases neuromuscular response of lower limb after inversion movement.

PubMed

Macedo, Christiane S G; Alonso, Carolina S; Liporaci, Rogério F; Vieira, Fernando; Guirro, Rinaldo R J

2014-01-01

Cryotherapy has been associated with a significant decrease in nerve conduction velocity and muscle contraction with possible effects on exercise and physical training. To quantify the electromyographic response of the lateral gastrocnemius, tibialis anterior, fibularis longus, rectus femoris and gluteus medius to ankle inversion following cold water immersion. The peak values of the root mean square (RMS) were obtained from 35 healthy and active university subjects after the use of a tilt platform to force the ankle into 30° of inversion before, immediately after, and 10, 20, and 30 minutes after water immersion at 4±2°C, for 20 minutes. The Shapiro-Wilk test, repeated measures analysis, Bonferroni's post-hoc, and linear regression analysis provided the results. Peak RMS was significantly lower at all times after cold water immersion, with residual effect of up to 30 minutes, when compared to pre-immersion for all muscles, except for immediate post-immersion for the gluteus medius. After cold water immersion of the ankle, special care should be taken in activities that require greater neuromuscular control.

Psychoanalysis, artistic obsession, and artistic motivation: the study of pathography.

PubMed

Kemler, David S

2014-02-01

A modern assessment of Freud's conceptualization of the creative process focusing on drives, ego psychology, and object relation theory is presented. 40 artists and musicians were interviewed employing 13 open-ended questions to provoke responses historically associated with the theoretical conceptualizations of Freud and post-Freudian theory related to the creative process. Creative process was defined as internal object relations that motivate the external connection between artist and the creative work. Measured responses concerning purpose and understanding; motivation before, during, and after performance; obstacles in performance; and needs through the creative process were assessed. Cluster analysis segregated the participants into high, medium, and low agreement groups based on similarity of responses. A multivariate stepwise regression revealed four questions (enlightenment, drives, obstacles, and ought self discrepancies) accounted for 83.9% of the variance. A post hoc discriminant function analysis identified 82.5% of the population to their correct groups. The findings support Spitz's (2005) suggestion that we regard "drives, ego psychology, and object relation theory not as separate approaches but as parts of a whole with varying stresses or accents" (p. 503).

Effects of curing protocol and storage time on the micro-hardness of resin cements used to lute fiber-reinforced resin posts

PubMed Central

RAMOS, Marcelo Barbosa; PEGORARO, Thiago Amadei; PEGORARO, Luiz Fernando; CARVALHO, Ricardo Marins

2012-01-01

Objectives To determine the micro-hardness profile of two dual cure resin cements (RelyX - U100®, 3M-ESPE and Panavia F 2.0®, Kuraray) used for cementing fiber-reinforced resin posts (Fibrekor® - Jeneric Pentron) under three different curing protocols and two water storage times. Material and methods Sixty 16mm long bovine incisor roots were endodontically treated and prepared for cementation of the Fibrekor posts. The cements were mixed as instructed, dispensed in the canal, the posts were seated and the curing performed as follows: a) no light activation; b) light-activation immediately after seating the post, and; c) light-activation delayed 5 minutes after seating the post. The teeth were stored in water and retrieved for analysis after 7 days and 3 months. The roots were longitudinally sectioned and the microhardness was determined at the cervical, middle and apical regions along the cement line. The data was analyzed by the three-way ANOVA test (curing mode, storage time and thirds) for each cement. The Tukey test was used for the post-hoc analysis. Results Light-activation resulted in a significant increase in the microhardness. This was more evident for the cervical region and for the Panavia cement. Storage in water for 3 months caused a reduction of the micro-hardness for both cements. The U100 cement showed less variation in the micro-hardness regardless of the curing protocol and storage time. Conclusions The micro-hardness of the cements was affected by the curing and storage variables and were material-dependent. PMID:23138743

Radiocarbon-based assessment of fossil fuel-derived contaminant associations in sediments.

PubMed

White, Helen K; Reddy, Christopher M; Eglinton, Timothy I

2008-08-01

Hydrophobic organic contaminants (HOCs) are associated with natural organic matter (OM) in the environment via mechanisms such as sorption or chemical binding. The latter interactions are difficult to quantitatively constrain, as HOCs can reside in different OM pools outside of conventional analytical windows. Here, we exploited natural abundance variations in radiocarbon (14C) to trace various fossil fuel-derived HOCs (14C-free) within chemically defined fractions of contemporary OM (modern 14C content) in 13 samples including marine and freshwater sediments and one dust and one soil sample. Samples were sequentially treated by solvent extraction followed by saponification. Radiocarbon analysis of the bulk sample and resulting residues was then performed. Fossil fuel-derived HOCs released by these treatments were quantified from an isotope mass balance approach as well as by gas chromatography-mass spectrometry. For the majority of samples (n = 13), 98-100% of the total HOC pool was solvent extractable. Nonextracted HOCs are only significant (29% of total HOC pool)in one sample containing p,p-2,2-bis(chlorophenyl)-1,1,1-trichloroethane and its metabolites. The infrequency of significant incorporation of HOCs into nonextracted OM residues suggests that most HOCs are mobile and bioavailable in the environment and, as such, have a greater potential to exert adverse effects.

Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial

PubMed Central

2013-01-01

Background Our aim was to evaluate the recovery effects of hydrotherapy after aerobic exercise in cardiovascular, performance and perceived fatigue. Methods A pragmatic controlled repeated measures; single-blind trial was conducted. Thirty-four recreational sportspeople visited a Sport-Centre and were assigned to a Hydrotherapy group (experimental) or rest in a bed (control) after completing a spinning session. Main outcomes measures including blood pressure, heart rate, handgrip strength, vertical jump, self-perceived fatigue, and body temperature were assessed at baseline, immediately post-exercise and post-recovery. The hypothesis of interest was the session*time interaction. Results The analysis revealed significant session*time interactions for diastolic blood pressure (P=0.031), heart rate (P=0.041), self perceived fatigue (P=0.046), and body temperature (P=0.001); but not for vertical jump (P=0.437), handgrip (P=0.845) or systolic blood pressure (P=0.266). Post-hoc analysis revealed that hydrotherapy resulted in recovered heart rate and diastolic blood pressure similar to baseline values after the spinning session. Further, hydrotherapy resulted in decreased self-perceived fatigue after the spinning session. Conclusions Our results support that hydrotherapy is an adequate strategy to facilitate cardiovascular recovers and perceived fatigue, but not strength, after spinning exercise. Trial registration ClinicalTrials.gov Identifier: NCT01765387 PMID:23866725

Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial.

PubMed

Cuesta-Vargas, Antonio I; Travé-Mesa, Alvaro; Vera-Cabrera, Alberto; Cruz-Terrón, Dario; Castro-Sánchez, Adelaida M; Fernández-de-las-Peñas, Cesar; Arroyo-Morales, Manuel

2013-07-18

Our aim was to evaluate the recovery effects of hydrotherapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures; single-blind trial was conducted. Thirty-four recreational sportspeople visited a Sport-Centre and were assigned to a Hydrotherapy group (experimental) or rest in a bed (control) after completing a spinning session. Main outcomes measures including blood pressure, heart rate, handgrip strength, vertical jump, self-perceived fatigue, and body temperature were assessed at baseline, immediately post-exercise and post-recovery. The hypothesis of interest was the session*time interaction. The analysis revealed significant session*time interactions for diastolic blood pressure (P=0.031), heart rate (P=0.041), self perceived fatigue (P=0.046), and body temperature (P=0.001); but not for vertical jump (P=0.437), handgrip (P=0.845) or systolic blood pressure (P=0.266). Post-hoc analysis revealed that hydrotherapy resulted in recovered heart rate and diastolic blood pressure similar to baseline values after the spinning session. Further, hydrotherapy resulted in decreased self-perceived fatigue after the spinning session. Our results support that hydrotherapy is an adequate strategy to facilitate cardiovascular recovers and perceived fatigue, but not strength, after spinning exercise. ClinicalTrials.gov Identifier: NCT01765387.

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...

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…

Job stress and burnout among urban and rural hospital physicians in Japan.

PubMed

Saijo, Yasuaki; Chiba, Shigeru; Yoshioka, Eiji; Kawanishi, Yasuyuki; Nakagi, Yoshihiko; Ito, Toshihiro; Sugioka, Yoshihiko; Kitaoka-Higashiguchi, Kazuyo; Yoshida, Takahiko

2013-08-01

To elucidate the differences in job stress and burnout status of Japanese hospital physicians between large cities, small cities, and towns and villages. Cross-sectional study. Postal self-administered questionnaires were distributed to 2937 alumni of Asahikawa Medical University. Four hundred and twenty-two hospital physicians. The Brief Job Stress Questionnaire was used to evaluate job demand, job control and social support. The Japanese version of the Maslach Burnout Inventory-General Survey (MBI-GS) was used to evaluate burnout. An analysis of covariance was conducted on the mean scores on the Brief Job Stress Questionnaire and the MBI-GS scales after adjusting for sex, age and specialties. In adjusted analyses, the job demand score was significantly different among physicians in the three areas. In Bonferroni post-hoc tests, scores in large cities was significantly higher than those in small cities and towns and villages. The job control score showed a significant difference and a marginally significant trend, with large cities associated with lower job control. There were significant differences in support from supervisors and that from family/friends, and scores in large cities was significantly higher than those in small cities in the post-hoc test. There was a significant effect on the exhaustion scale of the MBI-GS, with large cities associated with higher exhaustion, and scores in large cities was significantly higher than those in small cities. Urban hospital physicians had more job demand, less job control and exhaustion caused by burnout, and rural hospital physicians had less social support. © 2013 The Authors. Australian Journal of Rural Health © National Rural Health Alliance Inc.

Red flags in the clinical interview may forecast invalid neuropsychological testing.

PubMed

Keesler, Michael E; McClung, Kirstie; Meredith-Duliba, Tawny; Williams, Kelli; Swirsky-Sacchetti, Thomas

2017-04-01

Evaluating assessment validity is expected in neuropsychological evaluation, particularly in cases with identified secondary gain, where malingering or somatization may be present. Assessed with standalone measures and embedded indices, all within the testing portion of the examination, research on validity of self-report in the clinical interview is limited. Based on experience with litigation-involved examinees recovering from mild traumatic brain injury (mTBI), it was hypothesized that inconsistently reported date of injury (DOI) and/or loss of consciousness (LOC) might predict invalid performance on neurocognitive testing. This archival study examined cases of litigation-involved mTBI patients seen at an outpatient neuropsychological practice in Philadelphia, PA. Coded data included demographic variables, performance validity measures, and consistency between self-report and medicolegal records. A significant relationship was found between the consistency of examinees' self-report with records and their scores on performance validity testing, X 2 (1, N = 84) = 24.18, p < .01, Φ = .49. Post hoc testing revealed significant between-group differences in three of four comparisons, with medium to large effect sizes. A final post hoc analysis found significance between the number of performance validity tests (PVTs) failed and the extent to which an examinee incorrectly reported DOI r(83) = .49, p < .01. Using inconsistently reported LOC and/or DOI to predict an examinee's performance as invalid had a 75% sensitivity and a 75% specificity. Examinees whose reported DOI or LOC differs from records may be more likely to fail one or more PVTs, suggesting possible symptom exaggeration and/or under performance on cognitive testing.s.

Effects of Ankle Braces Upon Agility Course Performance in High School Athletes

PubMed Central

Beriau, Mark R.; Cox, William B.; Manning, James

1994-01-01

The purpose of this study was to compare the effects of wearing the AircastTM Sports Stirrup, AircastTM Training brace, Swede-OTM brace, and DonJoyTM Ankle Ligament Protector while running an agility course. Eighty-five high school athletes with no history of ankle injury and no experience in wearing any ankle support served as subjects. Each subject participated in four separate testing sessions. During sessions 1 and 4, subjects ran the agility course under the control (unbraced) conditions. Sessions 2 and 3 consisted of randomly wearing the ankle braces while running the agility course. A questionnaire concerning support, comfort, and restriction was completed by each subject after wearing each of the braces. An analysis of variance (ANOVA) with repeated measures revealed that a significant difference existed between the agility times. Tukey's post hoc test indicated that a significant difference existed between each ankle brace and the control 2 agility times as well as a control 1 and control 2 time difference. The control time difference was attributed to a learning effect. An ANOVA with repeated measures of only the four braces revealed that a significant difference existed between the agility times. Tukey's post hoc test showed the only difference was between the DonJoy Ankle Ligament Protector and the Aircast Training brace. We concluded: 1) there is limited practical performance effect upon agility while wearing an ankle brace; and 2) an athlete's perceived comfort, support, and performance restriction are contributing factors that may directly influence the effectiveness of ankle bracing. PMID:16558284

Pregabalin reduces acute inflammatory and persistent pain associated with nerve injury and cancer in rat models of orofacial pain.

PubMed

Hummig, Wagner; Kopruszinski, Caroline Machado; Chichorro, Juliana Geremias

2014-01-01

To assess the analgesic effect of pregabalin in orofacial models of acute inflammatory pain and of persistent pain associated with nerve injury and cancer, and so determine its effectiveness in controlling orofacial pains having different underlying mechanisms. Orofacial capsaicin and formalin tests were employed in male Wistar rats to assess the influence of pregabalin (or vehicle) pretreatment in acute pain models, and the results from these experiments were analyzed by one-way analysis of variance (ANOVA) followed by Newman Keuls post-hoc test. Pregabalin (or vehicle) treatment was also tested on the facial heat hyperalgesia that was evaluated in rats receiving injection of the inflammatory irritant carrageenan into the upper lip, as well as after constriction of the infraorbital nerve (a model of trigeminal neuropathic pain), or after inoculation of tumor cells into the facial vibrissal pad; two-way repeated measures ANOVA followed by Newman-Keuls post-hoc test was used to analyze data from these experiments. Facial grooming induced by capsaicin was abolished by pretreatment with pregabalin at 10 and 30 mg/kg. However, pregabalin failed to modify the first phase of the formalin response, but reduced the second phase at both doses (10 and 30 mg/kg). In addition, treatment of rats with pregabalin reduced the heat hyperalgesia induced by carrageenan, as well as by nerve injury and facial cancer. Pregabalin produced a marked antinociceptive effect in rat models of facial inflammatory pain as well as in facial neuropathic and cancer pain models, suggesting that it may represent an important agent for the clinical control of orofacial pain.

Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized, double-blind, placebo-controlled trials.

PubMed

Thase, Michael E; Edwards, John; Durgam, Suresh; Chen, Changzheng; Chang, Cheng-Tao; Mathews, Maju; Gommoll, Carl P

2017-09-01

Treatment-emergent suicidal ideation and behavior are ongoing concerns with antidepressants. Vilazodone, currently approved for the treatment of major depressive disorder (MDD) in adults, has also been evaluated in generalized anxiety disorder (GAD). Post-hoc analyses of vilazodone trials were carried out to examine its effects on suicidal ideation and behavior in adults with MDD or GAD. Data were pooled from vilazodone trials in MDD (four studies) and GAD (three studies). The incidence of suicide-related events was analyzed on the basis of treatment-emergent adverse event reporting and Columbia-Suicide Severity Rating Scale (C-SSRS) monitoring. Treatment-emergent suicidal ideation was analyzed on the basis of a C-SSRS category shift from no suicidal ideation/behavior (C-SSRS=0) at baseline to suicide ideation (C-SSRS=1-5) during treatment. In pooled safety populations (MDD, n=2233; GAD, n=1475), suicide-related treatment-emergent adverse events occurred in less than 1% of vilazodone-treated and placebo-treated patients. Incidences of C-SSRS suicidal ideation were as follows: MDD (vilazodone=19.9%, placebo=24.7%); GAD (vilazodone=7.7%, placebo=9.4%). Shifts from no suicidal ideation/behavior at baseline to suicidal ideation during treatment were as follows: MDD (vilazodone=9.4%, placebo=10.3%); GAD (vilazodone=4.4%, placebo=6.1%). Data from placebo-controlled studies indicate little or no risk of treatment-emergent suicidal ideation or behavior with vilazodone in adults with MDD or GAD. Nevertheless, all patients should be monitored for suicidal thoughts and behaviors during antidepressant treatment.

Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO.

PubMed

Kapil, Vikas; Milsom, Alexandra B; Okorie, Michael; Maleki-Toyserkani, Sheiva; Akram, Farihah; Rehman, Farkhanda; Arghandawi, Shah; Pearl, Vanessa; Benjamin, Nigel; Loukogeorgakis, Stavros; Macallister, Raymond; Hobbs, Adrian J; Webb, Andrew J; Ahluwalia, Amrita

2010-08-01

Ingestion of dietary (inorganic) nitrate elevates circulating and tissue levels of nitrite via bioconversion in the entero-salivary circulation. In addition, nitrite is a potent vasodilator in humans, an effect thought to underlie the blood pressure-lowering effects of dietary nitrate (in the form of beetroot juice) ingestion. Whether inorganic nitrate underlies these effects and whether the effects of either naturally occurring dietary nitrate or inorganic nitrate supplementation are dose dependent remain uncertain. Using a randomized crossover study design, we show that nitrate supplementation (KNO(3) capsules: 4 versus 12 mmol [n=6] or 24 mmol of KNO(3) (1488 mg of nitrate) versus 24 mmol of KCl [n=20]) or vegetable intake (250 mL of beetroot juice [5.5 mmol nitrate] versus 250 mL of water [n=9]) causes dose-dependent elevation in plasma nitrite concentration and elevation of cGMP concentration with a consequent decrease in blood pressure in healthy volunteers. In addition, post hoc analysis demonstrates a sex difference in sensitivity to nitrate supplementation dependent on resting baseline blood pressure and plasma nitrite concentration, whereby blood pressure is decreased in male volunteers, with higher baseline blood pressure and lower plasma nitrite concentration but not in female volunteers. Our findings demonstrate dose-dependent decreases in blood pressure and vasoprotection after inorganic nitrate ingestion in the form of either supplementation or by dietary elevation. In addition, our post hoc analyses intimate sex differences in nitrate processing involving the entero-salivary circulation that are likely to be major contributing factors to the lower blood pressures and the vasoprotective phenotype of premenopausal women.

Bilateral contact ground reaction forces and contact times during plyometric drop jumping.

PubMed

Ball, Nick B; Stock, Christopher G; Scurr, Joanna C

2010-10-01

Drop jumping (DJ) is used in training programs aimed to improve lower extremity explosive power. When performing double-leg drop jumps, it is important to provide an equal stimulus to both legs to ensure balanced development of the lower legs. The aim of this study was to bilaterally analyze the ground reactions forces and temporal components of drop jumping from 3 heights. Ten recreationally active male subjects completed 3 bounce-drop jumps from 3 starting heights (0.2, 0.4, and 0.6 m). Two linked force platforms were used to record left- and right-leg peak vertical force, time to peak force, average force, ground contact time, impulse and time differential. Between-height and between-leg comparisons for each variable were made using a multivariate analysis of variance with post hoc Wilcoxon tests (p < 0.05). Results indicated that force and time variables increased as drop jump height increased (p < 0.0001). Post hoc analyses showed that at 0.2- and 0.4-m bilateral differences were present in the time to peak force, average force, and impulse. No bilateral differences for any variables were shown at 0.6-m starting height. The contact time for all jumps was <0.26 seconds. At 0.2 m, only 63% of the subjects had a starting time differential of <0.01 seconds, rising to 96.3% at 0.6 m. The results indicated that 0.6 m is the suggested drop jump height to ensure that no bilateral differences in vertical forces and temporal components occur; however, shorter contact times were found at the lower heights.

Longitudinal measures of perfluoroalkyl substances (PFAS) in serum of Gullah African Americans in South Carolina: 2003-2013.

PubMed

Gribble, Matthew O; Bartell, Scott M; Kannan, Kurunthachalam; Wu, Qian; Fair, Patricia A; Kamen, Diane L

2015-11-01

Charleston Harbor has elevated concentrations of PFAS in dolphins, but local human exposure data are limited. We sought to describe PFAS serum concentrations' temporal trends among Gullah African American residents of coastal South Carolina. Longitudinal measures of PFAS in blood serum from a Gullah clinical sample, without lupus, were examined using spaghetti plots and visit-to-visit change scores (e.g., differences in concentrations between visits) among the 68 participants with repeated measures available. We also modeled population-level trends among the 71 participants with any data using proportionate percentile models, accounting for clustering through robust standard errors. In a post-hoc analysis we examined heterogeneity of temporal trends by age through mixed-effects models for the log-transformed PFAS compounds. Population concentrations of PFOS dropped approximately 9 (95% CI: 8, 10) percent each year over 2003-2013. This was concordant with individual PFOS trajectories (median PFOS change score -21.7 ng/g wet weight, interquartile range of PFOS change scores: -32.8, -14.9) and reports for other populations over this time period. Several other compounds including PFOA, PFHxS, and PFuNDA also showed a population-level decrease. However, examination of individual trajectories suggested substantial heterogeneity. Post-hoc analyses indicated that PFAS trajectories were heterogeneous by age. Many PFAS compounds are decreasing in a sample of Gullah African Americans from coastal South Carolina. There may be age differences in the elimination kinetics of PFASs. The possible role of age as a modifier of PFAS serum trends merits further research. Copyright © 2015 Elsevier Inc. All rights reserved.

Prolonged Reduction in Shoulder Strength after Transcutaneous Electrical Nerve Stimulation Treatment of Exercise-Induced Acute Muscle Pain.

PubMed

Butera, Katie A; George, Steven Z; Borsa, Paul A; Dover, Geoffrey C

2018-03-05

Transcutaneous electrical nerve stimulation (TENS) is commonly used for reducing musculoskeletal pain to improve function. However, peripheral nerve stimulation using TENS can alter muscle motor output. Few studies examine motor outcomes following TENS in a human pain model. Therefore, this study investigated the influence of TENS sensory stimulation primarily on motor output (strength) and secondarily on pain and disability following exercise-induced delayed-onset muscle soreness (DOMS). Thirty-six participants were randomized to a TENS treatment, TENS placebo, or control group after completing a standardized DOMS protocol. Measures included shoulder strength, pain, mechanical pain sensitivity, and disability. TENS treatment and TENS placebo groups received 90 minutes of active or sham treatment 24, 48, and 72 hours post-DOMS. All participants were assessed daily. A repeated measures analysis of variance and post-hoc analysis indicated that, compared to the control group, strength remained reduced in the TENS treatment group (48 hours post-DOMS, P < 0.05) and TENS placebo group (48 hours post-DOMS, P < 0.05; 72 hours post-DOMS, P < 0.05). A mixed-linear modeling analysis was conducted to examine the strength (motor) change. Randomization group explained 5.6% of between-subject strength variance (P < 0.05). Independent of randomization group, pain explained 8.9% of within-subject strength variance and disability explained 3.3% of between-subject strength variance (both P < 0.05). While active and placebo TENS resulted in prolonged strength inhibition, the results were nonsignificant for pain. Results indicated that higher pain and higher disability were independently related to decreased strength. Regardless of the impact on pain, TENS, or even the perception of TENS, may act as a nocebo for motor output. © 2018 World Institute of Pain.

A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population.

PubMed

Li-Tsang, Cecilia W P; Lau, Joy C M; Choi, Jenny; Chan, Chetwyn C C; Jianan, Li

2006-09-01

This study aimed to determine the efficacy of silicone gel (Cica-Care) on severe post-traumatic hypertophic scars among the Chinese population. A randomized clinical trial (RCT) was conducted on 45 Chinese patients with post-traumatic hypertrophic scars. Twenty-two subjects were placed in the experimental group with silicone gel sheeting (SGS) applied 24h per day for 6 months while all subjects were taught to massage the scar daily for 15 min serving as the control intervention. Scar assessments were conducted regularly to measure the changes in thickness, pigmentation, vascularity, pliability, itchiness and pain. Two-way repeated ANOVA showed a significant difference between MT group and SGS group on scar thickness. The post hoc comparison analysis showed that the difference was significant at the post-2-month (p=0.008) and post-6-month (p<0.001) intervention. The SGS group also showed changes in pigmentation which resembled normal skin but no statistical significance was found. Pain, itchiness and pliability were also improved after intervention. This study indicated that silicone gel sheeting (Cica-Care) was effective to reduce thickness, pain, itchiness and pliability of the severe hypertrophic scar among the Chinese population. The moisturization effect of the tough and hard scar might contribute to the reduction of the skin thickness after 6 month's intervention.

Reviewing and comparing self-concept in patients undergoing hemodialysis and peritoneal dialysis

PubMed Central

Shahgholian, Nahid; Tajdari, Setareh; Nasiri, Mahmoud

2012-01-01

Background: Chronic renal disease is a health problem in today’s world. In the end-stages of renal disease patients depend upon alternative therapies including dialysis for their survival. However, dialysis causes several stressors on physical, mental and social performance of patients. The present study aimed to review and compare the self-concept in patients undergoing hemodialysis and peritoneal dialysis. Materials and Methods: This was a case-control study including two groups of patients, undergoing hemodialysis and peritoneal dialysis, who referred to Al-Zahra and Ali Asghar Hospitals, which are affiliated to Isfahan University of Medical Sciences. These groups were compared to the control group. Data were collected through completing the form of demographic characteristics and a questionnaire, written by the researcher, pertaining to the self-concept which was collected by the samples. The data were analyzed by the Software SPSS version 18. Findings: ANOVA (analysis of variance) showed that statistically there was a significant difference between mean score of self-concept in the three physical (body-image), psychological, and social self aspects in the two groups of hemodialysis and peritoneal dialysis with the control group; however, Duncan’s post-hoc analysis showed no significant difference between mean score of self-concept in the three mentioned aspects in the two groups of hemodialysis and peritoneal dialysis. Furthermore, ANOVA (analysis of variance) showed that there was no significant difference between mean score of the spiritual aspect of the self-concept in the two groups of hemodialysis and peritoneal dialysis with the control group. Duncan’s post-hoc analysis also showed no significant difference in this aspect between the two groups of hemodialysis and peritoneal dialysis. Conclusions: Patients undergoing dialysis have many psychological disorders and the type of dialysis is not of much importance in this regard; therefore, adequate education and information for clients in order to use appropriate methods of adaptation as well as appropriate social relationship, continuing social support and developing health policies seem necessary in order to prevent mental disorders and providing required services and supports for patients. PMID:23833607

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.

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.

Treatment of vaginal candidiasis for the prevention of preterm birth: a systematic review and meta-analysis.

PubMed

Roberts, Christine L; Algert, Charles S; Rickard, Kristen L; Morris, Jonathan M

2015-03-21

Recognition that ascending infection leads to preterm birth has led to a number of studies that have evaluated the treatment of vaginal infections in pregnancy to reduce preterm birth rates. However, the role of candidiasis is relatively unexplored. Our aim was to undertake a systematic review and meta-analysis to assess whether treatment of pregnant women with vulvovaginal candidiasis reduces preterm birth rates and other adverse birth outcomes. We undertook a systematic review and meta-analysis of published randomised controlled trials (RCTs) in which pregnant women were treated for vulvovaginal candidiasis (compared to placebo or no treatment) and where preterm birth was reported as an outcome. Trials were identified by searching the Cochrane Central Register of Controlled Trials, Medline and Embase databases to January 2014. Trial eligibility and outcomes were pre-specified. Two reviewers independently assessed the studies against the agreed criteria and extracted relevant data using a standard data extraction form. Meta-analysis was used to calculate pooled rate ratios (RR) and 95% confidence intervals (CI) using a fixed-effects model. There were two eligible RCTs both among women with asymptomatic candidiasis, with a total of 685 women randomised. Both trials compared treatment with usual care (no screening for, or treatment of, asymptomatic candidiasis). Data from one trial involved a post-hoc subgroup analysis (n = 586) of a larger trial of treatment of 4,429 women with asymptomatic infections in pregnancy and the other was a pilot study (n = 99). There was a significant reduction in spontaneous preterm births in treated compared with untreated women (meta-analysis RR = 0.36, 95% CI = 0.17 to 0.75). Other outcomes were reported by one or neither trial. This systematic review found two trials comparing the treatment of asymptomatic vaginal candidiasis in pregnancy for the outcome of preterm birth. Although the effect estimate suggests that treatment of asymptomatic candidiasis may reduce the risk of preterm birth, the result needs to be interpreted with caution as the primary driver for the pooled estimate comes from a post-hoc (unplanned) subgroup analysis. A prospective trial with sufficient power to answer the clinical question 'does treatment of asymptomatic candidiasis in early pregnancy prevent preterm birth' is warranted. PROSPERO CRD42014009241.

Records of pan (floodplain wetland) sedimentation as an approach for post-hoc investigation of the hydrological impacts of dam impoundment: The Pongolo river, KwaZulu-Natal.

PubMed

Heath, S K; Plater, A J

2010-07-01

River impoundment by dams has far-reaching consequences for downstream floodplains in terms of hydrology, water quality, geomorphology, ecology and ecosystem services. With the imperative of economic development, there is the danger that potential environmental impacts are not assessed adequately or monitored appropriately. Here, an investigation of sediment composition of two pans (floodplain wetlands) in the Pongolo River floodplain, KwaZulu-Natal, downstream of the Pongolapoort dam constructed in 1974, is considered as a method for post-hoc assessment of the impacts on river hydrology, sediment supply and water quality. Bumbe and Sokhunti pans have contrasting hydrological regimes in terms of their connection to the main Pongolo channel - Bumbe is a shallow ephemeral pan and Sokhunti is a deep, perennial water body. The results of X-ray fluorescence (XRF) geochemical analysis of their sediment records over a depth of >1 m show that whilst the two pans exhibit similar sediment composition and variability in their lower part, Bumbe pan exhibits a shift toward increased fine-grained mineral supply and associated nutrient influx at a depth of c. 45 cm whilst Sokhunti pan is characterised by increased biogenic productivity at a depth of c. 26 cm due to enhanced nutrient status. The underlying cause is interpreted as a shift in hydrology to a 'post-dam' flow regime of reduced flood frequencies with more regular baseline flows which reduce the average flow velocity. In addition, Sokhunti shows a greater sensitivity to soil influx during flood events due to the nature of its 'background' of autochthonous biogenic sedimentation. The timing of the overall shift in sediment composition and the dates of the mineral inwash events are not well defined, but the potential for these wetlands as sensitive recorders of dam-induced changes in floodplain hydrology, especially those with a similar setting to Sokhunti pan, is clearly demonstrated. Copyright 2010 Elsevier Ltd. All rights reserved.

Ad hoc Laser networks component technology for modular spacecraft

NASA Astrophysics Data System (ADS)

Huang, Xiujun; Shi, Dele; Ma, Zongfeng; Shen, Jingshi

2016-03-01

Distributed reconfigurable satellite is a new kind of spacecraft system, which is based on a flexible platform of modularization and standardization. Based on the module data flow analysis of the spacecraft, this paper proposes a network component of ad hoc Laser networks architecture. Low speed control network with high speed load network of Microwave-Laser communication mode, no mesh network mode, to improve the flexibility of the network. Ad hoc Laser networks component technology was developed, and carried out the related performance testing and experiment. The results showed that ad hoc Laser networks components can meet the demand of future networking between the module of spacecraft.

Ad hoc laser networks component technology for modular spacecraft

NASA Astrophysics Data System (ADS)

Huang, Xiujun; Shi, Dele; Shen, Jingshi

2017-10-01

Distributed reconfigurable satellite is a new kind of spacecraft system, which is based on a flexible platform of modularization and standardization. Based on the module data flow analysis of the spacecraft, this paper proposes a network component of ad hoc Laser networks architecture. Low speed control network with high speed load network of Microwave-Laser communication mode, no mesh network mode, to improve the flexibility of the network. Ad hoc Laser networks component technology was developed, and carried out the related performance testing and experiment. The results showed that ad hoc Laser networks components can meet the demand of future networking between the module of spacecraft.

A Study of Platelet Inhibition, Using a 'Point of Care' Platelet Function Test, following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction [PINPOINT-PPCI].

PubMed

Johnson, Thomas W; Mumford, Andrew D; Scott, Lauren J; Mundell, Stuart; Butler, Mark; Strange, Julian W; Rogers, Chris A; Reeves, Barnaby C; Baumbach, Andreas

2015-01-01

Rapid coronary recanalization following ST-elevation myocardial infarction (STEMI) requires effective anti-platelet and anti-thrombotic therapies. This study tested the impact of door to end of procedure ('door-to-end') time and baseline platelet activity on platelet inhibition within 24hours post-STEMI. 108 patients, treated with prasugrel and procedural bivalirudin, underwent Multiplate® platelet function testing at baseline, 0, 1, 2 and 24hours post-procedure. Major adverse cardiac events (MACE), bleeding and stent thrombosis (ST) were recorded. Baseline ADP activity was high (88.3U [71.8-109.0]), procedural time and consequently bivalirudin infusion duration were short (median door-to-end time 55minutes [40-70] and infusion duration 30minutes [20-42]). Baseline ADP was observed to influence all subsequent measurements of ADP activity, whereas door-to-end time only influenced ADP immediately post-procedure. High residual platelet reactivity (HRPR ADP>46.8U) was observed in 75% of patients immediately post-procedure and persisted in 24% of patients at 2hours. Five patients suffered in-hospital MACE (4.6%). Acute ST occurred in 4 patients, all were <120mins post-procedure and had HRPR. No significant bleeding was observed. In a post-hoc analysis, pre-procedural morphine use was associated with significantly higher ADP activity following intervention. Baseline platelet function, time to STEMI treatment and opiate use all significantly influence immediate post-procedural platelet activity.

Analysis on Multicast Routing Protocols for Mobile Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Xiang, Ma

As the Mobile Ad Hoc Networks technologies face a series of challenges like dynamic changes of topological structure, existence of unidirectional channel, limited wireless transmission bandwidth, the capability limitations of mobile termination and etc, therefore, the research to mobile Ad Hoc network routings inevitablely undertake a more important task than those to other networks. Multicast is a mode of communication transmission oriented to group computing, which sends the data to a group of host computers by using single source address. In a typical mobile Ad Hoc Network environment, multicast has a significant meaning. On the one hand, the users of mobile Ad Hoc Network usually need to form collaborative working groups; on the other hand, this is also an important means of fully using the broadcast performances of wireless communication and effectively using the limited wireless channel resources. This paper summarizes and comparatively analyzes the routing mechanisms of various existing multicast routing protocols according to the characteristics of mobile Ad Hoc network.

Persistent topographic quantitative EEG sequelae of chronic marihuana use: a replication study and initial discriminant function analysis.

PubMed

Struve, F A; Straumanis, J J; Patrick, G

1994-04-01

In a previous pilot study using psychiatric patients we reported that daily marihuana users had significant elevations of (1) Absolute Alpha Power, (2) Relative Alpha Power, and (3) Interhemispheric Alpha Coherence over both frontal and frontal-central areas when contrasted with subjects who did not use marihuana. We referred to this phenomenon as Hyperfrontality of Alpha. The study presented here is a successful replication of our previous findings using new samples of subjects and identical methods. Post hoc analyses based on the combined sample from both studies suggest that variables of psychiatric diagnoses and medication did not bias our results. In addition, a discriminant function analysis using quantitative EEG variables as candidate predictors generated a 95% correct THC user versus nonuser classification accuracy which received a successful jackknife replication.

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...

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…

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.…

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…

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…

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…

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…

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,…

"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...

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...

Reduction of genu recurvatum through adjustment of plantarflexion resistance of an articulated ankle-foot orthosis in individuals post stroke

PubMed Central

Kobayashi, Toshiki; Orendurff, Michael S.; Singer, Madeline L.; Gao, Fan; Daly, Wayne K.; Foreman, K. Bo

2016-01-01

Background Genu recurvatum (knee hyperextension) is a common issue for individuals post stroke. Ankle-foot orthoses are used to improve genu recurvatum, but evidence is limited concerning their effectiveness. Therefore, the aim of this study was to investigate the effect of changing the plantarflexion resistance of an articulated ankle-foot orthosis on genu recurvatum in patients post stroke. Methods Gait analysis was performed on 6 individuals post stroke with genu recurvatum using an articulated ankle-foot orthosis whose plantarflexion resistance was adjustable at four levels. Gait data were collected using a Bertec split-belt instrumented treadmill in a 3-dimensional motion analysis laboratory. Gait parameters were extracted and plotted for each subject under the four plantarflexion resistance conditions of the ankle-foot orthosis. Gait parameters included: a) peak ankle plantarflexion angle, b) peak ankle dorsiflexion moment, c) peak knee extension angle and d) peak knee flexion moment. A non-parametric Friedman test was performed followed by a post-hoc Wilcoxon Signed-Rank test for statistical analyses. Findings All the gait parameters demonstrated statistically significant differences among the four resistance conditions of the AFO. Increasing the amount of plantarflexion resistance of the ankle-foot orthosis generally reduced genu recurvatum in all subjects. However, individual analyses showed that the responses to the changes in the plantarflexion resistance of the AFO were not necessarily linear, and appear unique to each subject. Interpretations The plantarflexion resistance of an articulated AFO should be adjusted to improve genu recurvatum in patients post stroke. Future studies should investigate what clinical factors would influence the individual differences. PMID:27136122

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.

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.

Defense Acquisition and the Case of the Joint Capabilities Technology Demonstration Office: Ad Hoc Problem Solving as a Mechanism for Adaptive Change

DTIC Science & Technology

2013-04-01

Capabilities Technology Demonstration Office: Ad Hoc Problem Solving as a Mechanism for Adaptive Change Kathryn Aten and John T. Dillard Naval...Defense Acquisition and the Case of the Joint Capabilities Technology Demonstration Office: Ad Hoc Problem Solving as a Mechanism for Adaptive Change...describes the preliminary analysis and findings of our study exploring what drives successful organizational adaptation in the context of technology

Patient-reported treatment satisfaction and budget impact with rivaroxaban vs. standard therapy in elective cardioversion of atrial fibrillation: a post hoc analysis of the X-VeRT trial

PubMed Central

Hohnloser, Stefan H.; Cappato, Riccardo; Ezekowitz, Michael D.; Evers, Thomas; Sahin, Kurtulus; Kirchhof, Paulus; Meng, Isabelle Ling; van Eickels, Martin; Camm, A. John

2016-01-01

Abstract Aims We compared patient-reported treatment satisfaction and the economic impact of anticoagulation therapy with rivaroxaban vs. vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation undergoing elective cardioversion procedures. Methods and results The current study is a post hoc analysis of the prospective, multicentre X-VeRT (EXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in subjects with non-valvular aTrial fibrillation scheduled for cardioversion) trial. Patient-reported treatment satisfaction with anticoagulation therapy was assessed using the Treatment Satisfaction Questionnaire for Medication version II in seven countries (US, UK, Canada, Germany, France, Italy, and the Netherlands). An economic model was also developed to estimate the impact of postponed cardioversions for two countries (UK and Italy). This model estimated the total costs of cardioversion, taking into consideration the costs for drug therapy (including extended treatment duration due to cardioversion postponement), international normalized ratio monitoring of VKAs, the cardioversion procedure, and rescheduling the procedure. These costs were linked to the respective X-VeRT study data to estimate the total costs. Patients receiving rivaroxaban in the delayed cardioversion group had significantly higher scores for Convenience, Effectiveness, and Global satisfaction (81.74 vs. 65.78; 39.41 vs. 32.95; and 82.07 vs. 66.74, respectively; P < 0.0001). Based on the total patient population included in the treatment satisfaction substudy (n = 632) in the delayed cardioversion group in X-VeRT, the use of rivaroxaban was estimated to result in a saving of £421 and €360 per patient in UK and Italian settings, respectively. Conclusion The use of rivaroxaban in the setting of cardioversion resulted in greater patient satisfaction and cost savings, compared with that of VKA. PMID:26487668

The prognostic value of MRI in determining reinjury risk following acute hamstring injury: a systematic review.

PubMed

van Heumen, Moniek; Tol, Johannes L; de Vos, Robert-Jan; Moen, Maarten H; Weir, Adam; Orchard, John; Reurink, Gustaaf

2017-09-01

A challenge for sports physicians is to estimate the risk of a hamstring re-injury, but the current evidence for MRI variables as a risk factor is unknown. To systematically review the literature on the prognostic value of MRI findings at index injury and/or return to play for acute hamstring re-injuries. Databases of PubMed, Embase, MEDLINE, Scopus, CINAHL, Google Scholar, Web of Science, LILACS, SciELO, ScienceDirect, ProQuest, SPORTDiscus and Cochrane Library were searched until 20 June 2016. Studies evaluating MRI as a prognostic tool for determining the risk of re-injury for athletes with acute hamstring injuries were eligible for inclusion. Two authors independently screened the search results and assessed risk of bias using standardised criteria from a consensus statement. A best-evidence synthesis was used to identify the level of evidence. Post hoc analysis included correction for insufficient sample size. Of the 11 studies included, 7 had a low and 4 had a high risk of bias. No strong evidence for any MRI finding as a risk factor for hamstring re-injury was found. There was moderate evidence that intratendinous injuries were associated with increased re-injury risk. Post hoc analysis showed moderate evidence that injury to the biceps femoris was a moderate to strong risk factor for re-injury. There is currently no strong evidence for any MRI finding in predicting hamstring re-injury risk. Intratendinous injuries and biceps femoris injuries showed moderate evidence for association with a higher re-injury risk. Registration in the PROSPERO International prospective register of systematic reviews was performed prior to study initiation (registration number CRD42015024620). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effectiveness of treat-to-target strategy for LDL-cholesterol control in type 2 diabetes: post-hoc analysis of data from the MIND.IT study.

PubMed

Ardigò, Diego; Vaccaro, Olga; Cavalot, Franco; Rivellese, Albarosa Angela; Franzini, Laura; Miccoli, Roberto; Patti, Lidia; Boemi, Massimo; Trovati, Mariella; Zavaroni, Ivana

2014-04-01

The paper presents a post-hoc analysis of the intensity of dyslipidaemia care operated in the first 2 years of Multiple-Intervention-in-type-2-Diabetes.ITaly (MIND.IT) study. MIND.IT is a multicentric, randomized, two-parallel arm trial involving 1461 type 2 diabetic patients at high cardiovascular (CV) risk. The study compares the usual care (UC) of CV prevention with a multifactorial intensive care (IC) approach aiming at achieving target values for the main CV risk factors according to a step-wise treat-to-target approach. Proportion of patients on target for low-density lipoprotein cholesterol (LDL-C) was about 10% at baseline and increased significantly more with IC than UC (43 vs. 27%; p < 0.001). However, the majority (57%) of patients, in this intended intensively treated cohort, failed to achieve the proposed target. Average LDL-C decreased from 144 ± 35 to 108 ± 31 mg/dl with IC and from 142 ± 28 to 118 ± 32 with UC (p-for-interaction <0.0001). IC was associated with a significantly greater increase in statin prescription and lower withdrawal from treatment than UC (43 vs. 11% and 28 vs. 61%, respectively; both p < 0.001). However, the new treatments were characterized in both groups by the use of low starting doses (≤ 10 mg of atorvastatin, equivalent dose in more than 90% of patients) without increase in case of missed target. The application of a multifactorial treat-to-target intervention is associated with a significant improvement in LDL-C beyond usual practice. However, the change in LDL-C appears to be more related to an increased number of treated patients and a decreased treatment withdrawal than to a true treat-to-target approach.

A post hoc analysis of saxagliptin efficacy and safety in patients with type 2 diabetes stratified by UKPDS 10-year cardiovascular risk score.

PubMed

Bonora, E; Bryzinski, B; Hirshberg, B; Cook, W

2016-05-01

To assess the efficacy and safety of saxagliptin 2.5 and 5 mg/d in patients with type 2 diabetes mellitus (T2DM) and high risk of coronary heart disease (CHD) or stroke as estimated by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Post hoc analysis of data pooled from 5 previously reported phase 3, randomized, placebo-controlled, 24-week studies was conducted. Patients were stratified into subgroups by UKPDS 10-year CHD and/or stroke risk ≥20% and CHD and stroke risk <20%. End points were adjusted mean change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), 120-min postprandial glucose (PPG), and body weight and the proportion of patients achieving HbA1c <7% and ≤8% at week 24. Pooled safety data were analyzed for adverse events (AEs) and hypoglycemia. Both doses of saxagliptin reduced HbA1c, FPG, and PPG to a greater extent than placebo regardless of UKPDS risk score. The proportions of patients achieving HbA1c <7% and ≤8% were greater with saxagliptin than placebo and consistent across risk score groups. AE profile and hypoglycemia incidence were similar for saxagliptin and placebo across UKPDS risk score groups. Saxagliptin was well tolerated and improved glycemic control in patients with T2DM regardless of their CHD and stroke UKPDS risk score. Clinical trial registration numbers: Clinicaltrials.gov NCT00121641, NCT00316082, NCT00121667, NCT00313313, and NCT00295633. Copyright © 2015 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial.

PubMed

Stenberg, Erik; Szabo, Eva; Ottosson, Johan; Thorell, Anders; Näslund, Ingmar

2018-01-01

Mesenteric defect closure in laparoscopic gastric bypass surgery has been reported to reduce the risk for small bowel obstruction. Little is known, however, about the effect of mesenteric defect closure on patient-reported outcome. The aim of the present study was to see if mesenteric defect closure affects health-related quality-of-life (HRQoL) after laparoscopic gastric bypass. Patients operated at 12 centers for bariatric surgery participated in this randomized two-arm parallel study. During the operation, patients were randomized to closure of the mesenteric defects or non-closure. This study was a post-hoc analysis comparing HRQoL of the two groups before surgery, at 1 and 2 years after the operation. HRQoL was estimated using the short form 36 (SF-36-RAND) and the obesity problems (OP) scale. Between May 1, 2010, and November 14, 2011, 2507 patients were included in the study and randomly assigned to mesenteric defect closure (n = 1259) or non-closure (n = 1248). In total, 1619 patients (64.6%) reported on their HRQoL at the 2-year follow-up. Mesenteric defect closure was associated with slightly higher rating of social functioning (87 ± 22.1 vs. 85 ± 24.2, p = 0.047) and role emotional (85 ± 31.5 vs. 82 ± 35.0, p = 0.027). No difference was seen on the OP scale (open defects 22 ± 24.8 vs. closed defects 20 ± 23.8, p = 0.125). When comparing mesenteric defect closure with non-closure, there is no clinically relevant difference in HRQoL after laparoscopic gastric bypass surgery.

Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China.

PubMed

Zhou, Lei; Liu, Weibin; Li, Wei; Li, Haifeng; Zhang, Xu; Shang, Huifang; Zhang, Xu; Bu, Bitao; Deng, Hui; Fang, Qi; Li, Jimei; Zhang, Hua; Song, Zhi; Ou, Changyi; Yan, Chuanzhu; Liu, Tao; Zhou, Hongyu; Bao, Jianhong; Lu, Jiahong; Shi, Huawei; Zhao, Chongbo

2017-09-01

To determine the efficacy of low-dose, immediate-release tacrolimus in patients with myasthenia gravis (MG) with inadequate response to glucocorticoid therapy in a randomized, double-blind, placebo-controlled study. Eligible patients had inadequate response to glucocorticoids (GCs) after ⩾6 weeks of treatment with prednisone ⩾0.75 mg/kg/day or 60-100 mg/day. Patients were randomized to receive 3 mg tacrolimus or placebo daily (orally) for 24 weeks. Concomitant glucocorticoids and pyridostigmine were allowed. Patients continued GC therapy from weeks 1-4; from week 5, the dose was decreased at the discretion of the investigator. The primary efficacy outcome measure was a reduction, relative to baseline, in quantitative myasthenia gravis (QMG) score assessed using a generalized linear model; supportive analyses used alternative models. Of 138 patients screened, 83 [tacrolimus ( n = 45); placebo ( n = 38)] were enrolled and treated. The change in adjusted mean QMG score from baseline to week 24 was -4.9 for tacrolimus and -3.3 for placebo (least squares mean difference: -1.7, 95% confidence interval: -3.5, -0.1; p = 0.067). A post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group (68.2%) versus the placebo group (44.7%; p = 0.044). Adverse event profiles were similar between treatment groups. Tacrolimus 3 mg treatment for patients with MG and inadequate response to GCs did not demonstrate a statistically significant improvement in the primary endpoint versus placebo over 24 weeks; however, a post-hoc analysis demonstrated a statistically significant difference for QMG score reduction of ⩾4 points in the tacrolimus group versus the placebo group. This study was limited by the low number of patients, the absence of testing for acetylcholine receptor antibody and the absence of stratification by disease duration (which led to a disparity between the two groups). ClinicalTrials.gov identifier: NCT01325571.

Levofloxacin 750 mg QD for five days versus amoxicillin/clavulanate 875 mg/125 mg BID for ten days for treatment of acute bacterial exacerbation of chronic bronchitis: a post hoc analysis of data from severely ill patients.

PubMed

Grossman, Ronald F; Ambrusz, Mary E; Fisher, Alan C; Khashab, Mohammed M; Kahn, James B

2006-08-01

This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50% to 65% of the predicted value plus comorbidities, or > or =4 exacerbations per year. A total of 369 patients were included in the intent-to-treat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were current smokers. At the on-treatment visit, a significantly higher proportion of MA patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P < 0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).

Effectiveness of vildagliptin versus other oral antidiabetes drugs as add-on to sulphonylurea monotherapy: Post hoc analysis from the EDGE study.

PubMed

Prasanna Kumar, K M; Phadke, U; Brath, H; Gawai, A; Paldánius, P M; Mathieu, C

2016-12-01

In this post hoc analysis of the EDGE study, we assessed the effectiveness and safety of vildagliptin versus other oral antidiabetes drugs (OADs) as add-on to first-line sulphonylurea (SU) therapy in patients who did not receive metformin in a real-life setting. The primary endpoint was odds of achieving an HbA1c reduction of >0.3% without tolerability issues. Secondary endpoint was odds of achieving HbA1c <7.0% without hypoglycaemia or weight gain. Changes in HbA1c, body weight; and safety were also assessed. 2936 patients received vildagliptin and 820 received comparator OADs (any α-GI, TZD, glinide) as add-on to first-line SU therapy. Overall, the mean age, disease duration, HbA1c, and BMI at baseline were 57.1 years, 6.3 years, 8.5%, and 27.7kg/m 2 , respectively. The odds ratios for achieving primary and secondary endpoints were 1.6 (95% CI: 1.36, 1.86; p<0.0001) and 1.8 (1.45, 2.21; p<0.0001), respectively, in favour of vildagliptin. The between-treatment differences (vildagliptin vs. comparator OAD) for the mean change in HbA1c and body weight were -0.2±0.04% (p<0.0001) and -0.8±0.16kg (p<0.0001), respectively. Overall, the incidence of adverse events was low (vildagliptin, 7% vs. comparator, 8.2%) in both groups. Similar results were observed in a subset of patients enrolled from India and patients who received TZDs as a comparator OAD. Under real-life settings, vildagliptin as add-on to SU monotherapy showed better glycaemic response without tolerability issues compared with other OADs. Copyright © 2016 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

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.

The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.

PubMed

Kim, Choung-Soo; Theeuwes, Ad; Kwon, Dong Deuk; Choi, Young Deuk; Chung, Byung Ha; Lee, Hyun Moo; Lee, Kang Hyun; Lee, Sang Eun

2016-05-01

This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02-2.24) for centrally assessed rPFS, 0.77 (0.28-2.15) for OS, 0.21 (0.08-0.51) for time to chemotherapy, and 0.31 (0.17-0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97-1.10). In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population (ClinicalTrials.gov Identifier: NCT01212991).

The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients

PubMed Central

Theeuwes, Ad; Kwon, Dong Deuk; Choi, Young Deuk; Chung, Byung Ha; Lee, Hyun Moo; Lee, Kang Hyun; Lee, Sang Eun

2016-01-01

Purpose This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Results Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide-treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97–1.10). Conclusions In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population (ClinicalTrials.gov Identifier: NCT01212991). PMID:27195316

Enzalutamide in Japanese patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer: A post-hoc analysis of the placebo-controlled PREVAIL trial.

PubMed

Kimura, Go; Yonese, Junji; Fukagai, Takashi; Kamba, Tomomi; Nishimura, Kazuo; Nozawa, Masahiro; Mansbach, Hank; Theeuwes, Ad; Beer, Tomasz M; Tombal, Bertrand; Ueda, Takeshi

2016-05-01

To evaluate the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients. This was a post-hoc analysis of the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naïve patients with metastatic castration-resistant prostate cancer progressing on androgen deprivation therapy were randomized one-to-one to 160 mg/day oral enzalutamide or placebo until discontinuation on radiographic progression or skeletal-related event and initiation of subsequent antineoplastic therapy. Coprimary end-points were centrally assessed radiographic progression-free survival and overall survival. Secondary end-points were investigator-assessed radiographic progression-free survival, time to initiation of chemotherapy, time to prostate-specific antigen progression, prostate-specific antigen response (≥50% decline) and time to skeletal-related event. Of 1717 patients, 61 were enrolled in Japan (enzalutamide, n = 28; placebo, n = 33); hazard ratios (95% confidence interval) of 0.30 for centrally assessed radiographic progression-free survival (0.03-2.95), 0.59 for overall survival (0.20-1.8), 0.46 for time to chemotherapy (0.22-0.96) and 0.36 for time to prostate-specific antigen progression (0.17-0.75) showed the treatment benefit of enzalutamide over the placebo. Prostate-specific antigen responses were observed in 60.7% of enzalutamide-treated men versus 21.2% of placebo-treated men. Plasma concentrations of enzalutamide were higher in Japanese patients: the geometric mean ratio of Japanese/non-Japanese patients was 1.126 (90% confidence interval 1.018-1.245) at 13 weeks. Treatment-related adverse events grade ≥3 occurred in 3.6% of enzalutamide- and 6.1% of placebo-treated Japanese patients. Treatment effects and safety in Japanese patients were generally consistent with the overall results from PREVAIL. © 2016 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Urological Association.

Mediterranean Diet, Retinopathy, Nephropathy, and Microvascular Diabetes Complications: A Post Hoc Analysis of a Randomized Trial.

PubMed

Díaz-López, Andrés; Babio, Nancy; Martínez-González, Miguel A; Corella, Dolores; Amor, Antonio J; Fitó, Montse; Estruch, Ramon; Arós, Fernando; Gómez-Gracia, Enrique; Fiol, Miquel; Lapetra, José; Serra-Majem, Lluís; Basora, Josep; Basterra-Gortari, F Javier; Zanon-Moreno, Vicente; Muñoz, Miguel Ángel; Salas-Salvadó, Jordi

2015-11-01

To date no clinical trials have evaluated the role of dietary patterns on the incidence of microvascular diabetes complications. We hypothesized that a nutritional intervention based on the Mediterranean diet (MedDiet) would have greater protective effect on diabetic retinopathy and nephropathy than a low-fat control diet. This was a post hoc analysis of a cohort of patients with type 2 diabetes participating in the PREvención con DIeta MEDiterránea (PREDIMED) study, a multicenter randomized nutritional intervention trial conducted in a population at high cardiovascular risk. Individuals with type 2 diabetes who were free of microvascular complications at enrollment (n = 3,614, aged 55-80 years) were randomly assigned to one of three dietary interventions: MedDiet supplemented with extravirgin olive oil (MedDiet+EVOO), MedDiet supplemented with mixed nuts (MedDiet+Nuts), or a low-fat control diet. Two independent outcomes were considered: new onset of diabetic retinopathy and nephropathy. Hazard ratios (HRs) were calculated using multivariable-adjusted Cox regression. During a median follow-up of 6.0 years, we identified 74 new cases of retinopathy and 168 of nephropathy. Compared with the control diet, multivariable-adjusted HRs for diabetic retinopathy were 0.56 (95% CI 0.32-0.97) for the MedDiet+EVOO and 0.63 (0.35-1.11) for the MedDiet+Nuts. No between-group differences were found for nephropathy. When the yearly updated information on adherence to the MedDiet was considered, the HR for retinopathy in the highest versus the lowest quintile was 0.34 (0.13-0.89; P = 0.001 for trend). No significant associations were found for nephropathy. A MedDiet enriched with EVOO may protect against diabetic retinopathy but not diabetic nephropathy. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Prevalence of Chronic Kidney Disease in Turkish Adults With Obesity and Metabolic Syndrome: A Post Hoc Analysis from Chronic Renal Disease in Turkey Study.

PubMed

Arinsoy, Turgay; Deger, Serpil Muge; Ates, Kenan; Altun, Bulent; Ecder, Tevfik; Camsari, Taner; Serdengecti, Kamil; Suleymanlar, Gultekin

2016-11-01

Obesity confers an increased risk of chronic kidney disease (CKD), which is increased further by accompanying metabolic abnormalities. To investigate the relationship of the risk of CKD with obesity and metabolic syndrome (MS) in adults by means of post hoc analysis of data from the Chronic Renal Disease in Turkey (CREDIT) study. The anthropometric measurements of a total of 9,100 adult participants in the CREDIT study were included in the analyses. Subjects were classified according to the presence or absence of obesity (body mass index [BMI] > 30) and MS. Logistic regression analyses were used to estimate odds ratio for CKD. Effect modification analyses were also performed. The prevalence of obesity was 20.6% and that of MS was 31.3%. The prevalence of CKD was higher among obese subjects compared to those with a normal BMI (20.5% vs. 14%; P < .001). The odds ratio (OR) for CKD was 1.296 (95% confidence interval [CI], 1.121-1.498) for subjects who were overweight, 1.718 (95% CI, 1.444-2.044) for those with class I obesity, 1.983 (95% CI, 1.489-2.641) for those with class II obesity and 2.799 (95% CI, 1.719-4.557) for subjects with extreme obesity (P < .001 for each subgroup) compared to subjects with a normal BMI. CKD was significantly more prevalent in subjects with MS (21.9% vs. 12.3%, P < .001). The OR for CKD was higher in obese subjects with MS (adjusted OR, 1.321; 95% CI, 1.109-1.573; P = .002). The stratification of obese individuals based on their metabolic phenotype is important for prevention and treatment of CKD. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Impact of race/ethnicity on the efficacy and safety of commonly used insulin regimens: a post hoc analysis of clinical trials in type 2 diabetes mellitus.

PubMed

Davidson, Jaime A; Lacaya, Lyndon B; Jiang, Honghua; Heilmann, Cory R; Scism-Bacon, Jamie L; Gates, Jeffrey R; Jackson, Jeffrey A

2010-01-01

To explore the impact of race/ethnicity on the efficacy and safety of commonly used insulin regimens in patients with type 2 diabetes mellitus. In this post hoc analysis, pooled data from 11 multinational clinical trials involving 1455 patients with type 2 diabetes were used to compare specific insulin treatments in Latino/Hispanic, Asian, African-descent, and Caucasian patients. Insulin treatments included once daily insulin glargine or neutral protamine Hagedorn (BASAL), insulin lispro mix 75/25 twice daily (LMBID), or insulin lispro mix 50/50 three times daily (LMTID). Race/ethnicity was associated with significant outcome differences for each of the insulin regimens. BASAL therapy was associated with greater improvement in several measures of glycemic control among Latino/Hispanic patients compared with Caucasian patients (lower end point hemoglobin A1c, greater reduction in hemoglobin A1c from baseline, and a larger proportion of patients achieving hemoglobin A1c level <7%). In contrast, LMBID therapy was associated with higher end point hemoglobin A1c and a smaller decrease in hemoglobin A1c from baseline in Latino/Hispanic and Asian patients than in Caucasian patients. Furthermore, fewer Asian patients attained a hemoglobin A1c level <7% than did Caucasians patients. For LMTID therapy, hemoglobin A1c outcomes were comparable across patient groups. Fasting blood glucose and glycemic excursions varied among racial/ethnic groups for the 3 insulin regimens. Weight change was comparable among racial/ethnic groups in each insulin regimen. During treatment with LMTID, Asian patients experienced higher incidence and rate of severe hypoglycemia than Caucasian patients. Latino/Hispanic, Asian, and African-descent patients with type 2 diabetes show different metabolic responses to insulin therapy, dependent in part on insulin type and regimen intensity.

Linagliptin improves glycemic control after 1 year as add-on therapy to basal insulin in Asian patients with type 2 diabetes mellitus.

PubMed

Sheu, Wayne H-H; Park, Sung Woo; Gong, Yan; Pinnetti, Sabine; Bhattacharya, Sudipta; Patel, Sanjay; Seck, Thomas; Woerle, Hans-Juergen

2015-03-01

To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin with/without oral agents. This was a post hoc analysis of Asian patients from a global ≥52 week study in which patients on basal insulin were randomized (1:1) to double-blind treatment with linagliptin 5 mg once daily or placebo (NCT00954447). Basal insulin dose remained stable for 24 weeks, after which adjustments could be made according to the investigator's discretion to improve glycemic control. The primary endpoint was the mean change in glycated hemoglobin (HbA1c) from baseline to 24 weeks. Data were available for 154 Asian patients (80 linagliptin, 74 placebo). Baseline HbA1c (standard deviation [SD]) was 8.6 (0.9)% (70 [10] mmol/mol). The placebo-corrected mean change (standard error [SE]) in HbA1c from baseline was -0.9 (0.1)% (-10 [1] mmol/mol) (95% confidence interval [CI]: -1.2, -0.7; p<0.0001) at Week 24 and -0.9 (0.1)% (-10 [1] mmol/mol) (95% CI: -1.1, -0.6; p<0.0001) at Week 52. The frequency of adverse events (linagliptin 81.3%, placebo 91.9%) and hypoglycemia (Week 24: linagliptin 25.0%, placebo 25.7%; treatment end: linagliptin 28.8%, placebo 35.1%) was similar between groups. By Week 52, changes (SE) in mean body weight were similar in both groups (linagliptin -0.67 [0.26] kg, placebo -0.38 [0.25] kg). This study was limited by the post hoc nature of the analysis and the small number of patients in the subgroup. However, the results suggest that linagliptin significantly improves glycemic control in Asian patients with T2DM inadequately controlled by basal insulin, without increasing the risk for hypoglycemia or weight gain. ClinicalTrials identifier: NCT00954447.

Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness.

PubMed

MacIntyre, Chandini Raina; Zhang, Yi; Chughtai, Abrar Ahmad; Seale, Holly; Zhang, Daitao; Chu, Yanhui; Zhang, Haiyan; Rahman, Bayzidur; Wang, Quanyi

2016-12-30

Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. 6 major hospitals in 2 districts of Beijing, China. Cluster randomised controlled trial. 245 index cases with ILI. Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections. The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control. ACTRN12613000852752; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Asthma control using fluticasone propionate/salmeterol in Asian and non-Asian populations: a post hoc analysis of the GOAL study.

PubMed

Bousquet, Jean; Barnes, Neil; Gibbs, Michael; Gul, Nadeem; Tomkins, Susan A; Zhou, Xin; Cho, Young-Joo; Park, Hae-Sim; Busse, William; Zhong, Nanshan

2017-04-28

To analyse the efficacy of fluticasone propionate (FP) alone and combined with salmeterol (SAL) in achieving guideline-defined asthma control in Asian patients. A post hoc analysis of the GOAL study in which patients were stratified by prior-medication use into inhaled corticosteroid (ICS)-naïve (Stratum [S] 1), low-dose ICS (S2), and medium-dose ICS (S3), and randomised to receive FP/SAL or FP. Doses were stepped-up every 12 weeks until Totally Controlled asthma or maximum dose was reached (PhI) and then maintained until study end (PhII). The primary endpoint was the proportion of patients achieving Well-Controlled asthma during PhI. Additional endpoints included Total Control and adverse events. Asian and non-Asian patients were analysed separately. In Asian patients in PhI, 74% (n = 87/118) in S1 achieved Well-Controlled asthma with FP/SAL versus 74% (n = 89/121) with FP alone (p = 0.839); corresponding values were 76% (n = 81/107) versus 60% (n = 62/104; p = 0.005) in S2, and 58% (n = 59/102) versus 43% (n = 41/95; p = 0.015) in S3. More patients in all three strata achieved Totally Controlled asthma with FP/SAL versus FP alone. Control was achieved more rapidly and with lower ICS doses with FP/SAL versus FP. A high proportion of patients who achieved control during PhI maintained control during PhII. Similar trends were found in non-Asian patients. No new safety concerns were identified. A greater proportion of Asian patients (S2 and S3, for Well-Controlled; all strata, for Totally Controlled) achieved guideline-defined asthma control with FP/SAL versus FP alone. High proportions of Asian patients in S1 achieved Well-Controlled asthma in both treatment groups.

Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies.

PubMed

Draelos, Zoe Diana; Stein Gold, Linda F; Murrell, Dedee F; Hughes, Matilda H; Zane, Lee T

2016-02-01

Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals, Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD). Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents; study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0-1.5; moderate to severe pruritus, 2-3). In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment. Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.

Efficacy of montelukast for treating perennial allergic rhinitis.

PubMed

Philip, George; Williams-Herman, Debora; Patel, Piyush; Weinstein, Steven F; Alon, Achilles; Gilles, Leen; Tozzi, Carol A; Dass, S Balachandra; Reiss, Theodore F

2007-01-01

Perennial allergic rhinitis (PAR) is a chronic inflammatory nasal condition in individuals exposed year-round to allergens. This was a double-blind study of 15- to 85-year-old patients randomly allocated to montelukast, 10 mg (n=630), placebo (n=613), or the positive control cetirizine, 10 mg (n=122) for 6 weeks. The primary efficacy end point was change from baseline in Daytime Nasal Symptoms Score (DNSS; mean of congestion, rhinorrhea, sneezing, and itching scores, rated daily by patients [scale: 0=none to 3=severe]) averaged during the initial 4 weeks (primary analysis) or entire 6 weeks of treatment. Also assessed were combined post hoc results of primary end point data from this study and another similarly designed study (Patel P, et al. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis, Ann Allergy Asthma Immunol 95:551, 2005). Over 4 weeks, montelukast showed numerical improvement over placebo in DNSS (least-squares mean difference of -0.04 [95% confidence interval (CI}, -0.09, 0.01]); the difference between cetirizine and placebo was significant: -0.10 (95% CI, -0.19, -0.01). However, when averaged over 6 weeks, neither active treatment was significantly different from placebo. The Rhinoconjunctivitis Quality-of-Life score was significantly improved by montelukast (p < 0.05), but not by cetirizine, during 4 and 6 weeks. The treatment effect of montelukast, but not cetirizine, generally remained consistent through the 6 weeks of treatment. In pooled data, montelukast consistently improved DNSS versus placebo during all 6 weeks of treatment (-0.07 [95% CI, -0.10, -0.041). In conclusion, montelukast produced numerical improvement in daytime nasal symptoms and significant improvement in quality of life. In a pooled post hoc analysis, montelukast provided consistent improvement in daytime nasal symptoms over 6 weeks, supportive of an overall benefit in PAR.

Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness

PubMed Central

MacIntyre, Chandini Raina; Zhang, Yi; Chughtai, Abrar Ahmad; Seale, Holly; Zhang, Daitao; Chu, Yanhui; Zhang, Haiyan; Rahman, Bayzidur; Wang, Quanyi

2016-01-01

Rationale Medical masks are commonly used by sick individuals with influenza-like illness (ILI) to prevent spread of infections to others, but clinical efficacy data are absent. Objective Determine whether medical mask use by sick individuals with ILI protects well contacts from related respiratory infections. Setting 6 major hospitals in 2 districts of Beijing, China. Design Cluster randomised controlled trial. Participants 245 index cases with ILI. Intervention Index cases with ILI were randomly allocated to medical mask (n=123) and control arms (n=122). Since 43 index cases in the control arm also used a mask during the study period, an as-treated post hoc analysis was performed by comparing outcomes among household members of index cases who used a mask (mask group) with household members of index cases who did not use a mask (no-mask group). Main outcome measure Primary outcomes measured in household members were clinical respiratory illness, ILI and laboratory-confirmed viral respiratory infection. Results In an intention-to-treat analysis, rates of clinical respiratory illness (relative risk (RR) 0.61, 95% CI 0.18 to 2.13), ILI (RR 0.32, 95% CI 0.03 to 3.13) and laboratory-confirmed viral infections (RR 0.97, 95% CI 0.06 to 15.54) were consistently lower in the mask arm compared with control, although not statistically significant. A post hoc comparison between the mask versus no-mask groups showed a protective effect against clinical respiratory illness, but not against ILI and laboratory-confirmed viral respiratory infections. Conclusions The study indicates a potential benefit of medical masks for source control, but is limited by small sample size and low secondary attack rates. Larger trials are needed to confirm efficacy of medical masks as source control. Trial registration number ACTRN12613000852752; Results. PMID:28039289

Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis.

PubMed

LeWitt, Peter A; Verhagen Metman, Leo; Rubens, Robert; Khanna, Sarita; Kell, Sherron; Gupta, Suneel

Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in "off" time, "on" time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine). ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD. ASCEND-PD (n = 91) evaluated ER CD-LD versus CLE. In both studies, IR- and CLE-experienced patients underwent a 6-week, open-label dose-conversion period to ER CD-LD prior to randomization. For analysis, the randomized population was divided into 3 subgroups: dopaminergic agonists, rasagiline or selegiline, and amantadine. For each subgroup, changes from baseline in PD diary measures ("off" time and "on" time with and without troublesome dyskinesia), Unified Parkinson Disease Rating Scale Parts II + III scores, and adverse events were analyzed, comparing ER CD-LD with the active comparator. Concomitant dopaminergic agonist or MAO-B inhibitor use did not diminish the efficacy (improvement in "off" time and "on" time without troublesome dyskinesia) of ER CD-LD compared with IR CD-LD or CLE, whereas the improvement with concomitant amantadine failed to reach significance. Safety and tolerability were similar among the subgroups, and ER CD-LD did not increase troublesome dyskinesia. For patients on oral LD regimens and taking a dopaminergic agonist, and/or a MAO-B inhibitor, changing from an IR to an ER CD-LD formulation provides approximately an additional hour of "good" on time.

Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis

PubMed Central

LeWitt, Peter A.; Verhagen Metman, Leo; Rubens, Robert; Khanna, Sarita; Kell, Sherron; Gupta, Suneel

2018-01-01

Objectives Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in “off” time, “on” time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine). Methods ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD. ASCEND-PD (n = 91) evaluated ER CD-LD versus CLE. In both studies, IR- and CLE-experienced patients underwent a 6-week, open-label dose-conversion period to ER CD-LD prior to randomization. For analysis, the randomized population was divided into 3 subgroups: dopaminergic agonists, rasagiline or selegiline, and amantadine. For each subgroup, changes from baseline in PD diary measures (“off” time and “on” time with and without troublesome dyskinesia), Unified Parkinson Disease Rating Scale Parts II + III scores, and adverse events were analyzed, comparing ER CD-LD with the active comparator. Results and Conclusions Concomitant dopaminergic agonist or MAO-B inhibitor use did not diminish the efficacy (improvement in “off” time and “on” time without troublesome dyskinesia) of ER CD-LD compared with IR CD-LD or CLE, whereas the improvement with concomitant amantadine failed to reach significance. Safety and tolerability were similar among the subgroups, and ER CD-LD did not increase troublesome dyskinesia. For patients on oral LD regimens and taking a dopaminergic agonist, and/or a MAO-B inhibitor, changing from an IR to an ER CD-LD formulation provides approximately an additional hour of “good” on time. PMID:29432286

Molsidomine for the prevention of vasospasm-related delayed ischemic neurological deficits and delayed brain infarction and the improvement of clinical outcome after subarachnoid hemorrhage: a single-center clinical observational study.

PubMed

Ehlert, Angelika; Schmidt, Christoph; Wölfer, Johannes; Manthei, Gerd; Jacobs, Andreas H; Brüning, Roland; Heindel, Walter; Ringelstein, E Bernd; Stummer, Walter; Pluta, Ryszard M; Hesselmann, Volker

2016-01-01

OBJECT Delayed ischemic neurological deficits (DINDs) and cerebral vasospasm (CVS) are responsible fora poor outcome in patients with aneurysmal subarachnoid hemorrhage (SAH), most likely because of a decreased availability of nitric oxide (NO) in the cerebral microcirculation. In this study, the authors examined the effects of treatment with the NO donor molsidomine with regard to decreasing the incidence of spasm-related delayed brain infarctions and improving clinical outcome in patients with SAH. METHODS Seventy-four patients with spontaneous aneurysmal SAH were included in this post hoc analysis. Twenty-nine patients with SAH and proven CVS received molsidomine in addition to oral or intravenous nimodipine. Control groups consisted of 25 SAH patients with proven vasospasm and 20 SAH patients without. These patients received nimodipine therapy alone. Cranial computed tomography (CCT) before and after treatment was analyzed for CVS-related infarcts. A modified National Institutes of Health Stroke Scale (mNIHSS) and the modified Rankin Scale (mRS) were used to assess outcomes at a 3-month clinical follow-up. RESULTS Four of the 29 (13.8%) patients receiving molsidomine plus nimodipine and 22 of the 45 (48%) patients receiving nimodipine therapy alone developed vasospasm-associated brain infarcts (p < 0.01). Follow-up revealed a median mNIHSS score of 3.0 and a median mRS score of 2.5 in the molsidomine group compared with scores of 11.5 and 5.0, respectively, in the nimodipine group with CVS (p < 0.001). One patient in the molsidomine treatment group died, and 12 patients in the standard care group died (p < 0.01). CONCLUSIONS In this post hoc analysis, patients with CVS who were treated with intravenous molsidomine had a significant improvement in clinical outcome and less cerebral infarction. Molsidomine offers a promising therapeutic option in patients with severe SAH and CVS and should be assessed in a prospective study.

Effect of Baseline Exercise Capacity on Outcomes in Patients With Stable Coronary Heart Disease (A Post Hoc Analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Trial)

PubMed Central

Padala, Santosh K.; Sidhu, Mandeep S.; Hartigan, Pamela M.; Maron, David J.; Teo, Koon K.; Spertus, John A.; John Mancini, G.B.; Sedlis, Steven P.; Chaitman, Bernard R.; Heller, Gary V.; Weintraub, William S.; Boden, William E.

2017-01-01

The impact of baseline exercise capacity on clinical outcomes in patients with stable ischemic heart disease randomized to an initial strategy of optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI) in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial has not been studied. A post hoc analysis was performed in 1,052 patients of COURAGE (PCI + OMT: n = 527, OMT: n = 525) who underwent exercise treadmill testing at baseline. Patients were categorized into 2 exercise capacity groups based on metabolic equivalents (METs) achieved during baseline exercise treadmill testing (<7 METs: n = 464, ≥7 METs: n = 588) and were followed for a median of 4.6 years. The primary composite end point of death or myocardial infarction was similar in the PCI + OMT group and the OMT group for patients with exercise capacity <7 METs (19.1% vs 16.1%, p = 0.31) and ≥7 METs (13.3% vs 10.3%, p = 0.27). After adjusting for baseline covariates, the hazard ratio (99% confidence interval) for the primary end point for the PCI + OMT group versus the OMT group was 1.42 (0.90 to 2.23, p = 0.05) and for the exercise capacity subgroups of ≥7 METs and <7 METs was 0.75 (0.46 to 1.22, p = 0.13). There was no statistically significant interaction between the original treatment arm allocation (PCI + OMT vs OMT) and baseline exercise capacity. In conclusion, there was no difference in the long-term clinical outcomes in patients with exercise capacity <7 METs compared with ≥7 METs, irrespective of whether they were assigned to initial PCI. Patients with exercise capacity <7 METs did not derive a proportionately greater clinical benefit from PCI + OMT compared with those patients who received OMT alone. Published by Elsevier Inc. (Am J Cardiol 2015;116:1509–1515) PMID:26410604

Influence of complete administration of adjuvant chemotherapy cycles on overall and disease-free survival in locally advanced rectal cancer: post hoc analysis of a randomized, multicenter, non-inferiority, phase 3 trial.

PubMed

Sandra-Petrescu, Flavius; Herrle, Florian; Burkholder, Iris; Kienle, Peter; Hofheinz, Ralf-Dieter

2018-04-03

A randomized trial demonstrated that capecitabine is at least as effective as fluorouracil in the adjuvant treatment of patients with locally advanced rectal cancer. However, not all patients receive all planned cycles of chemotherapy. Therefore it is of interest how complete or partial administration of chemotherapy influences oncological outcome. A post hoc analysis of a trial with 401 randomized patients, nine being excluded because of missing data, was performed. 392 patients (197 - capecitabine, 195 - fluorouracil) could be analyzed regarding the number of administered adjuvant chemotherapy cycles. In the subgroup of 361 patients with an overall survival of at least six months, five-year overall and disease-free survival were analyzed in respect to completion (complete vs. incomplete) of chemotherapy cycles. Survival rates and curves were calculated and compared using the log-rank test. The effect of completion of chemotherapy was adjusted for relevant confounding factors. Two hundred fifty-one (64.0%) of analyzed patients received all postoperative scheduled cycles. Five-year overall survival was significantly better in these patients compared to the incomplete group (76.0 vs. 60.6%, p < 0.0001). Of 361 patients with an overall survival of at least six months, 251(69.5%) patients received all cycles. Five-year overall survival was also significantly better than in the incomplete group (76.0 vs. 66.4%, p = 0.0073). Five-year disease free survival was numerically better (64.9 vs. 58.7%, p = 0.0646; HR [not all cycles vs. all cycles] = 1.42 95% CI: [0.98, 2.07]). Cox regression models show a non-significant better OS (p = 0.061) and DFS (p = 0.083), if chemotherapy cycles were administered completely. Complete administration of chemotherapy cycles was associated with improved five-year overall and disease-free survival in patients with locally advanced rectal cancer.

Emotion experience and frailty in a sample of Italian community-dwelling older adults

PubMed Central

Mulasso, Anna; Argiolu, Laura; Roppolo, Mattia; Azucar, Danny; Rabaglietti, Emanuela

2017-01-01

Frailty increases individual vulnerability to external stressors and involves high risk for adverse geriatric outcomes. To date, few studies have addressed the role of emotion perception and its association with frailty in aged populations. This cross-sectional study aimed to explore whether a significant association between frailty and emotional experience exists in a sample of Italian community-dwelling older adults. Our sample consisted of 104 older adults (age 76±8 years; 59.6% women) living in Piedmont, Italy. Frailty was measured using the Italian version of the Tilburg Frailty Indicator (TFI), and emotion perception was measured with the Positive and Negative Affect Schedule (PANAS). The Mini–Mental State Examination was used as a screening tool for cognitive functions (people with a score ≤20 points were excluded). One-way analysis of covariance (ANCOVA), adjusted for interesting variables, and post hoc tests were performed where appropriate. According to the TFI, 57.7% of participants resulted as frail. Analysis showed a significant greater severity of frailty in the low positive affect (PA) group compared to the high PA group. Similarly, those with high negative affect (NA) showed significantly higher levels of frailty than the low NA group. As expected, significant differences for frailty were also found among the groups composed of 1) people with high PA and low NA, 2) people with low PA or high NA, and 3) people with low PA and high NA. Post hoc tests showed a greater severity of frailty in the second and in the third groups compared to the first one. Lastly, robust participants aged >75 years showed higher levels of PA than the group aged between 60 and 75 years. These findings demonstrate that both PA and NA may influence frailty, giving new insights for the evaluation and prevention of frailty in older adults. PMID:29238176

Metabolic syndrome cluster does not provide incremental prognostic information in patients with stable cardiovascular disease: A post hoc analysis of the AIM-HIGH trial.

PubMed

Lyubarova, Radmila; Robinson, Jennifer G; Miller, Michael; Simmons, Debra L; Xu, Ping; Abramson, Beth L; Elam, Marshall B; Brown, Todd M; McBride, Ruth; Fleg, Jerome L; Desvigne-Nickens, Patrice; Ayenew, Woubeshet; Boden, William E

Metabolic syndrome (MS) is a well-known risk factor for the development of cardiovascular (CV) disease; yet, controversy persists whether it adds incremental prognostic value in patients with established CV disease. This study was performed to determine if MS is associated with worse CV outcomes in patients with established CV disease treated intensively with statins. We performed a post hoc analysis of the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes trial, in which patients with established CV disease and atherogenic dyslipidemia (n = 3414) were randomly assigned to receive extended release niacin or placebo during a mean 36-month follow-up, to assess whether the presence of MS or the number of MS components contributed to CV outcomes. The composite primary end point of CV events occurred in 15.1% of patients without MS vs 13.8%, 16.9%, and 16.8% of patients with MS in the subsets with 3, 4, and 5 MS components, respectively (corresponding adjusted hazard ratios 0.9, 1.1, and 1.1 relative to patients without MS), P = .55. Comparing subgroups with 3 vs 4 or 5 MS components, there was no significant difference in either the composite primary end point or secondary end points. Patients with diabetes mellitus had higher event rates, with or without the presence of MS. The presence of MS was not associated with worse CV outcomes in the AIM-HIGH population. The rate of CV events in statin-treated Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes patients with MS was not significantly influenced by the number of MS components. Copyright © 2017 National Lipid Association. All rights reserved.

Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial.

PubMed

Kang, Jin Hyoung; Ahn, Myung-Ju; Kim, Dong-Wan; Cho, Eun Kyung; Kim, Joo-Hang; Shin, Sang Won; Wang, Xin; Kim, Jong Seok; Orlando, Mauro; Park, Keunchil

2016-04-01

We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexed-cisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status. Patients, who were ≥ 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment-emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874. Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ≥ 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFR mutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients. Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.

Cervical and Incisal Marginal Discrepancy in Ceramic Laminate Veneering Materials: A SEM Analysis.

PubMed

Ranganathan, Hemalatha; Ganapathy, Dhanraj M; Jain, Ashish R

2017-01-01

Marginal discrepancy influenced by the choice of processing material used for the ceramic laminate veneers needs to be explored further for better clinical application. This study aimed to evaluate the amount of cervical and incisal marginal discrepancy associated with different ceramic laminate veneering materials. This was an experimental, single-blinded, in vitro trial. Ten central incisors were prepared for laminate veneers with 2 mm uniform reduction and heavy chamfer finish line. Ceramic laminate veneers fabricated over the prepared teeth using four different processing materials were categorized into four groups as Group I - aluminous porcelain veneers, Group II - lithium disilicate ceramic veneers, Group III - lithium disilicate-leucite-based veneers, Group IV - zirconia-based ceramic veneers. The cervical and incisal marginal discrepancy was measured using a scanning electron microscope. ANOVA and post hoc Tukey honest significant difference (HSD) tests were used for statistical analysis. The cervical and incisal marginal discrepancy for four groups was Group I - 114.6 ± 4.3 μm, 132.5 ± 6.5 μm, Group II - 86.1 ± 6.3 μm, 105.4 ± 5.3 μm, Group III - 71.4 ± 4.4 μm, 91.3 ± 4.7 μm, and Group IV - 123.1 ± 4.1 μm, 142.0 ± 5.4 μm. ANOVA and post hoc Tukey HSD tests observed a statistically significant difference between the four test specimens with regard to cervical marginal discrepancy. The cervical and incisal marginal discrepancy scored F = 243.408, P < 0.001 and F = 180.844, P < 0.001, respectively. This study concluded veneers fabricated using leucite reinforced lithium disilicate exhibited the least marginal discrepancy followed by lithium disilicate ceramic, aluminous porcelain, and zirconia-based ceramics. The marginal discrepancy was more in the incisal region than in the cervical region in all the groups.

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.

Cardiovascular risk factor burden in Africa and the Middle East across country income categories: a post hoc analysis of the cross-sectional Africa Middle East Cardiovascular Epidemiological (ACE) study.

PubMed

Raal, Frederick J; Alsheikh-Ali, Alawi A; Omar, Mohamed I; Rashed, Wafa; Hamoui, Omar; Kane, Abdoul; Alami, Mohamed; Abreu, Paula; Mashhoud, Walid M

2018-01-01

A significant number of cardiovascular disease (CVD)-related deaths occur in developing countries. An increasing prevalence of CVD is associated with a change in the macro-economy of these countries. In this post hoc analysis, CVD risk factor (CVDRF) prevalence is evaluated across countries based on national income in the Africa and Middle East Region (AfME). Data from the Africa Middle East Cardiovascular Epidemiological (ACE) study were used; a cross-sectional study in 14 AfME countries (94 clinics) from July 2011-April 2012, which evaluated CVDRF prevalence in stable adult outpatients. World Bank definitions were used to classify countries as low-income (LI), lower-middle-income (LMI), upper-middle-income (UMI) or high-income (HI) countries. Four thousand three hundred seventy-eight subjects were recruited where 260 (6%), 1324 (30%), 1509 (35%) and 1285 (29%) were from LI, LMI, UMI, and HI countries, respectively. Of all the CVDRFs evaluated, almost two-thirds of the study population across the national income groups had abdominal obesity and dyslipidemia. Countries in the HI category were associated with a higher prevalence of diabetes (32%), obesity (44%) and smoking (16%). UMI and HI countries were associated with higher clustering of CVDRFs where at least one-third of subjects having four or more CVDRFs. Lower income countries had lower blood pressure control rates and lower percentages of outpatients achieving LDL-cholesterol targets. The burden of CVDRFs in stable outpatients is high across the national income categories in the AfME region, with HI countries showing a higher prevalence of CVDRFs. The high burden in lower income countries is associated with sub-optimal control of dyslipidemia and hypertension. Lowering the CVDRF burden would need specific public health actions in line with positive changes in the macro-economy of these countries. The ACE trial is registered under NCT01243138.

Treatment with exenatide once weekly or twice daily for 30 weeks is associated with changes in several cardiovascular risk markers

PubMed Central

Chiquette, Elaine; Toth, Peter P; Ramirez, Gilbert; Cobble, Michael; Chilton, Robert

2012-01-01

Background Dyslipidemia and type 2 diabetes are two of the most significant risk factors for the development of cardiovascular disease. Measurement of lipoprotein subclasses provides important information about derangements in lipid metabolism and helps refine cardiovascular risk assessment. Exenatide, a glucagon-like peptide 1 receptor agonist, improved glycemic control, obesity, hypertension, and dyslipidemia in patients with type 2 diabetes in clinical trials. Methods In the DURATION-1 trial, patients with type 2 diabetes were treated with exenatide once weekly or twice daily for 30 weeks. This post hoc analysis evaluated the impact of exenatide on lipoprotein subclasses in 211 DURATION-1 patients using vertical auto profile methodology and the Statistical Package for the Social Sciences general linear model adjusted for glycosylated hemoglobin (HbA1c) and weight. Results Baseline lipids and high sensitivity C-reactive protein were normal overall based on the standard lipid panel. Once-weekly exenatide reduced apolipoprotein B and the apolipoprotein B to apolipoprotein A1 ratio (P < 0.05), independent of glycemic improvement and weight loss. A significant shift in lipoprotein pattern away from small, dense low-density lipoprotein-4 cholesterol was also observed (P < 0.05). Exenatide once weekly increased high-density lipoprotein-2 cholesterol, even after adjustment for changes in HbA1c and weight (P < 0.05). Triglycerides, very low-density lipoprotein cholesterol, and high sensitivity C-reactive protein were reduced with both the once-weekly and twice-daily exenatide regimens (P < 0.05). Conclusion In this post hoc analysis, exenatide significantly improved a number of cardiovascular risk markers. Continuous exenatide exposure with exenatide once weekly elicited a greater response than did immediate-release exenatide twice daily, generally independent of glycemic improvement and weight loss. Thus, in addition to improving glycemic control, exenatide induced favorable changes in lipid and lipoprotein metabolism and decreased systemic inflammation. PMID:23166441

Patient-reported treatment satisfaction and budget impact with rivaroxaban vs. standard therapy in elective cardioversion of atrial fibrillation: a post hoc analysis of the X-VeRT trial.

PubMed

Hohnloser, Stefan H; Cappato, Riccardo; Ezekowitz, Michael D; Evers, Thomas; Sahin, Kurtulus; Kirchhof, Paulus; Meng, Isabelle Ling; van Eickels, Martin; Camm, A John

2016-02-01

We compared patient-reported treatment satisfaction and the economic impact of anticoagulation therapy with rivaroxaban vs. vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation undergoing elective cardioversion procedures. The current study is a post hoc analysis of the prospective, multicentre X-VeRT (EXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in subjects with non-valvular aTrial fibrillation scheduled for cardioversion) trial. Patient-reported treatment satisfaction with anticoagulation therapy was assessed using the Treatment Satisfaction Questionnaire for Medication version II in seven countries (US, UK, Canada, Germany, France, Italy, and the Netherlands). An economic model was also developed to estimate the impact of postponed cardioversions for two countries (UK and Italy). This model estimated the total costs of cardioversion, taking into consideration the costs for drug therapy (including extended treatment duration due to cardioversion postponement), international normalized ratio monitoring of VKAs, the cardioversion procedure, and rescheduling the procedure. These costs were linked to the respective X-VeRT study data to estimate the total costs. Patients receiving rivaroxaban in the delayed cardioversion group had significantly higher scores for Convenience, Effectiveness, and Global satisfaction (81.74 vs. 65.78; 39.41 vs. 32.95; and 82.07 vs. 66.74, respectively; P < 0.0001). Based on the total patient population included in the treatment satisfaction substudy (n = 632) in the delayed cardioversion group in X-VeRT, the use of rivaroxaban was estimated to result in a saving of £421 and €360 per patient in UK and Italian settings, respectively. The use of rivaroxaban in the setting of cardioversion resulted in greater patient satisfaction and cost savings, compared with that of VKA. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

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

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.

A Randomized Controlled Trial of an Internet Intervention for Adults with Insomnia: Effects on Comorbid Psychological and Fatigue Symptoms

PubMed Central

Thorndike, Frances P.; Ritterband, Lee M.; Gonder-Frederick, Linda A.; Lord, Holly R.; Ingersoll, Karen S.; Morin, Charles M.

2014-01-01

Objective Insomnia is frequently comorbid with other medical and psychological disorders. This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention could also reduce comorbid psychological and fatigue symptoms. Method Data from a pilot randomized controlled trial (RCT) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression, anxiety, mental health quality of life (QOL), and fatigue. Results Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants (n = 22) relative to control participants (n = 22) on all psychological symptoms, mental health QOL, and fatigue. A small post hoc subsample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs (depression, anxiety, mental health QOL, and fatigue). Conclusion Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms. PMID:24014057

A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms.

PubMed

Thorndike, Frances P; Ritterband, Lee M; Gonder-Frederick, Linda A; Lord, Holly R; Ingersoll, Karen S; Morin, Charles M

2013-10-01

Insomnia is frequently comorbid with other medical and psychological disorders. This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention could also reduce comorbid psychological and fatigue symptoms. Data from a pilot randomized controlled trial (RCT) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression, anxiety, mental health quality of life (QOL), and fatigue. Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants (n = 22) relative to control participants (n = 22) on all psychological symptoms, mental health QOL, and fatigue. A small post hoc subsample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs (depression, anxiety, mental health QOL, and fatigue). Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms. © 2013 Wiley Periodicals, Inc.

Shaping ability of nickel-titanium rotary instruments in curved root canals.

PubMed

Talati, Ali; Moradi, Saeed; Forghani, Maryam; Monajemzadeh, Ali

2013-01-01

Disinfection and subsequent obturation of the root canal space require adequate mechanical enlargement of the canals. The purpose of this in vitro study was to compare the shaping ability of Mtwo, RaCe and Medin rotary instruments during the preparation of curved root canals. Sixty mesiobuccal root canals of mandibular molars with severe curvatures between 25-35(°) and radius of 4-9 mm were randomly divided into three groups of 20 canals each. Using pre- and post-instrumentation radiographs, straightening of the canal and the apical transportation were determined with AutoCAD software. The data were analyzed using Chi square, analysis of variance, and post-hoc tests and the significance level was set at P<0.05. Mtwo instruments maintained the canal curvature significantly better than Race and Medin instruments (P<0.05). There was significant difference between the rotary instruments for iatrogenic transportation of the major foramen (P>0.05). Under the conditions of this in vitro study, Mtwo instruments seemed superior to the two other rotary instruments.

A comparison of mindfulness, nonjudgmental, and cognitive dissonance-based approaches to mirror exposure.

PubMed

Luethcke, Cynthia A; McDaniel, Leda; Becker, Carolyn Black

2011-06-01

This study compares different versions of mirror exposure (ME), a body image intervention with research support. ME protocols were adapted to maximize control and comparability, and scripted for delivery by research assistants. Female undergraduates (N=168) were randomly assigned to receive mindfulness-based (MB; n=58), nonjudgmental (NJ; n=55), or cognitive dissonance-based (CD, n=55) ME. Participants completed the Body Image Avoidance Questionnaire (BIAQ), Body Checking Questionnaire (BCQ), Satisfaction with Body Parts Scale (SBPS), Beck Depression Inventory-II (BDI-II), and Eating Disorders Examination Questionnaire (EDE-Q) at pre-treatment, post-treatment, and 1-month follow-up. Mixed models ANOVAs revealed a significant main effect of time on all measures, and no significant time by condition interaction for any measures except the SBPS. Post-hoc analysis revealed that only CD ME significantly improved SBPS outcome. Results suggest that all versions of ME reduce eating disorder risk factors, but only CD ME improves body satisfaction. Copyright © 2011 Elsevier Ltd. All rights reserved.

Psychological and autonomic effects of art making in college-aged students.

PubMed

Sandmire, David A; Rankin, Nancy E; Gorham, Sarah R; Eggleston, Daniel T; French, Cecelia A; Lodge, Emily E; Kuns, Gavin C; Grimm, David R

2016-09-01

Anxiety disorders comprise the most common category of mental illness among US young adults. Art making might be one method to help reduce anxiety, but the few studies investigating this have used only subjective measures of anxiety. This study employed both subjective (self-reported state anxiety from the State-Trait Anxiety Inventory) and objective (heart rate variability) measures to assess whether 30-minute periods of art making reduced anxiety in 47 first-year college students prior to their final examinations. Students participated in free-form painting, mandala coloring, clay modeling, and control sessions. Repeated-measures ANOVA with post hoc analysis revealed significantly greater pre- to post-session reductions in anxiety for all three types of art-making sessions than for the control session, as measured objectively. Measured subjectively, only free-form painting yielded a significant decrease in anxiety compared to the control session. Given the health benefits of anxiety reduction, further study is warranted to determine the duration of art making's anxiety-reducing effect.

Influence of Intracanal Materials in Vertical Root Fracture Pathway Detection with Cone-beam Computed Tomography.

PubMed

Dutra, Kamile Leonardi; Pachêco-Pereira, Camila; Bortoluzzi, Eduardo Antunes; Flores-Mir, Carlos; Lagravère, Manuel O; Corrêa, Márcio

2017-07-01

Investigating the vertical root fracture (VRF) pathway under different clinical scenarios may help to diagnose this condition properly. We aimed to determine the capability and intrareliability of VRF pathway detection through cone-beam computed tomographic (CBCT) imaging as well as analyze the influence of different intracanal and crown materials. VRFs were mechanically induced in 30 teeth, and 4 clinical situations were reproduced in vitro: no filling, gutta-percha, post, and metal crown. A Prexion (San Mateo, CA) 3-dimensional tomographic device was used to generate 104 CBCT scans. The VRF pathway was determined by using landmarks in the Avizo software (Version 8.1; FEI Visualization Sciences Group, Burlington, MA) by 1 observer repeated 3 times. Analysis of variance and post hoc tests were applied to compare groups. Intrareliability demonstrated an excellent agreement (intraclass correlation coefficient mean = 0.93). Descriptive analysis showed that the fracture line measurement was smaller in the post and metal crown groups than in the no-filling and gutta-percha groups. The 1-way analysis of variance test found statistically significant differences among the groups measurements. The Bonferroni correction showed statistically significant differences related to the no-filling and gutta-percha groups versus the post and metal crown groups. The VRF pathway can be accurately detected in a nonfilled tooth using limited field of view CBCT imaging. The presence of gutta-percha generated a low beam hardening artifact that did not hinder the VRF extent. The presence of an intracanal gold post made the fracture line appear smaller than it really was in the sagittal images; in the axial images, a VRF was only detected when the apical third was involved. The presence of a metal crown did not generate additional artifacts on the root surface compared to the intracanal gold post by itself. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Biotoxicity of commonly used root canal sealers: A meta-analysis.

PubMed

Kaur, Amandeep; Shah, Naseem; Logani, Ajay; Mishra, Navin

2015-01-01

The main objective of a root canal sealer is to provide a fluid tight seal. The purpose of this systematic meta-analysis was to determine the relative toxicity of commonly used root canal sealers like zinc oxide eugenol, calcium hydroxide, and resin-based sealers. An online search was conducted in peer-reviewed journals listed in PubMed, Cochrane, EBSCO, and IndMed databases between 2000 and 2012). Statistical analysis was carried out by using analysis of variance (ANOVA) followed by post-hoc comparison by Bonferroni method. The comparison between toxicity at 24 h and between 3 and 7 days was done by using paired t-test for each sealer. At 24 h, the relative biotoxicity of the three sealers reported was insignificant (P- value 0.29), but the difference in toxicity was found significant (P < 0.001) after 3 days. Calcium hydroxide sealer and zinc oxide eugenol were found to be significantly biotoxic as compared to resin-based sealers after 3 days.

Biotoxicity of commonly used root canal sealers: A meta-analysis

PubMed Central

Kaur, Amandeep; Shah, Naseem; Logani, Ajay; Mishra, Navin

2015-01-01

Introduction: The main objective of a root canal sealer is to provide a fluid tight seal. The purpose of this systematic meta-analysis was to determine the relative toxicity of commonly used root canal sealers like zinc oxide eugenol, calcium hydroxide, and resin-based sealers. Materials and Methods: An online search was conducted in peer-reviewed journals listed in PubMed, Cochrane, EBSCO, and IndMed databases between 2000 and 2012). Statistical analysis was carried out by using analysis of variance (ANOVA) followed by post-hoc comparison by Bonferroni method. The comparison between toxicity at 24 h and between 3 and 7 days was done by using paired t-test for each sealer. Results: At 24 h, the relative biotoxicity of the three sealers reported was insignificant (P- value 0.29), but the difference in toxicity was found significant (P < 0.001) after 3 days. Conclusion: Calcium hydroxide sealer and zinc oxide eugenol were found to be significantly biotoxic as compared to resin-based sealers after 3 days. PMID:25829682

Performance Analysis, Design Considerations, and Applications of Extreme-Scale In Situ Infrastructures

DOE PAGES

Ayachit, Utkarsh; Bauer, Andrew; Duque, Earl P. N.; ...

2016-11-01

A key trend facing extreme-scale computational science is the widening gap between computational and I/O rates, and the challenge that follows is how to best gain insight from simulation data when it is increasingly impractical to save it to persistent storage for subsequent visual exploration and analysis. One approach to this challenge is centered around the idea of in situ processing, where visualization and analysis processing is performed while data is still resident in memory. Our paper examines several key design and performance issues related to the idea of in situ processing at extreme scale on modern platforms: Scalability, overhead,more » performance measurement and analysis, comparison and contrast with a traditional post hoc approach, and interfacing with simulation codes. We illustrate these principles in practice with studies, conducted on large-scale HPC platforms, that include a miniapplication and multiple science application codes, one of which demonstrates in situ methods in use at greater than 1M-way concurrency.« less

Performance analysis of clustering techniques over microarray data: A case study

NASA Astrophysics Data System (ADS)

Dash, Rasmita; Misra, Bijan Bihari

2018-03-01

Handling big data is one of the major issues in the field of statistical data analysis. In such investigation cluster analysis plays a vital role to deal with the large scale data. There are many clustering techniques with different cluster analysis approach. But which approach suits a particular dataset is difficult to predict. To deal with this problem a grading approach is introduced over many clustering techniques to identify a stable technique. But the grading approach depends on the characteristic of dataset as well as on the validity indices. So a two stage grading approach is implemented. In this study the grading approach is implemented over five clustering techniques like hybrid swarm based clustering (HSC), k-means, partitioning around medoids (PAM), vector quantization (VQ) and agglomerative nesting (AGNES). The experimentation is conducted over five microarray datasets with seven validity indices. The finding of grading approach that a cluster technique is significant is also established by Nemenyi post-hoc hypothetical test.

Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain.

PubMed

Kress, H G; Koch, E D; Kosturski, H; Steup, A; Karcher, K; Dogan, C; Etropolski, M; Eerdekens, M

2016-10-01

A recent randomized-withdrawal, active- and placebo-controlled, double-blind phase 3 study showed that tapentadol prolonged release (PR) was effective and well tolerated for managing moderate to severe, chronic malignant tumour-related pain in patients who were opioid naive or dissatisfied with current treatment (Pain Physician, 2014, 17, 329-343). This post hoc, subgroup analysis evaluated the efficacy and tolerability of tapentadol PR in patients who previously received and were dissatisfied with tramadol for any reason and who had a pain intensity ≥5 (11-point numerical rating scale) before converting directly to tapentadol PR. In the original study, eligible patients had been randomized (2:1) and titrated to their optimal dose of tapentadol PR (100-250 mg bid) or morphine sulphate-controlled release (40-100 mg bid) over 2 weeks. The present report focuses on results during the titration period for a subgroup of patients randomized to tapentadol PR after having been on tramadol treatment prior to randomization in the study (n = 129). Results for this subgroup are compared with results for all 338 patients who received tapentadol PR during titration (overall tapentadol PR group). Responder rates (responders: completed titration, mean pain intensity <5 [0-10 scale] and ≤20 mg/day rescue medication during last 3 days) were slightly better for the tramadol/tapentadol PR subgroup (69.8% [90/129]) vs. the overall tapentadol PR group (63.9% [214/335]). Tolerability profiles were comparable for both groups. Results of this subgroup analysis indicate that patients with cancer pain could safely switch from prior treatment with the weak centrally acting analgesic tramadol directly to the strong centrally acting analgesic tapentadol PR, for an improved analgesic therapy for severe pain. WHAT DOES THIS STUDY ADD?: Results of this post hoc analysis show that patients who had received prior tramadol therapy could switch directly to tapentadol PR, with the majority (˜70%) experiencing improved efficacy. © 2016 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC®.

Treatment response and tolerability of frovatriptan in patients reporting short- or long-duration migraines at baseline.

PubMed

Kelman, Leslie; Harper, Samira Q; Hu, Xiaojun; Campbell, John C

2010-09-01

Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24-72 h) or short-duration (<24 h) migraines at baseline. Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a single migraine attack. Using case-report forms, physicians recorded migraine characteristics at baseline (aura, duration, frequency, severity) and with frovatriptan (duration, severity, and recurrence). Patients and physicians rated frovatriptan effectiveness and tolerability versus previous therapy; physicians recorded adverse reactions. The primary analysis was change in migraine duration with frovatriptan versus baseline. At baseline, 44.2% (7178/16 253) and 55.8% (9075/16 253) of patients reported short- and long-duration migraines, respectively; long-duration migraines were more often frequent (> or =3/months; 55.5% [4893/8811] vs. 30.6% [2132/6973]; p < 0.001; 95% CI, 23.5-26.5%), severe (61.7% [5584/9047] vs. 33.9% [2427/7156]; p < 0.001; 95% CI, 26.3-29.3%), and accompanied by aura (46.8% [4199/8977] vs. 31.3% [2215/7088]; p < 0.001; 95% CI, 14.0-17.0%). Mean (SD) onset of frovatriptan effect was <1 h; 72.3% (11 592/16 040) of patients required only one frovatriptan tablet. With frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration (p < 0.001; 95% CI, 23.5-30.2) and 76.5% of patients reporting long-duration migraines at baseline experienced short-duration migraines. Most patients (87-90%) and physicians (70-75%) rated frovatriptan more effective and tolerable than previous therapies. Patients with more severe migraine characteristics at baseline were more likely to have attacks lasting > or =24 h. When using frovatriptan, patients were 26.8-fold more likely to experience decreased versus increased headache duration. Frovatriptan might be a good option for patients with long-duration or recurrent migraine attacks. The post hoc design and analysis of a single migraine attack are possible study limitations.

Costs and health resources utilization following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain: a post hoc analysis.

PubMed

Navarro, Ana; Saldaña, María T; Pérez, Concepción; Masramón, Xavier; Rejas, Javier

2012-06-01

To analyze the changes in pain severity and associated costs resulting from resource utilization and reduced productivity in patients with gabapentin-refractory peripheral neuropathic pain who switched to pregabalin therapy in primary care settings in Spain. This is a post hoc analysis of a 12-week, multicentre, noninterventional cost-of-illness study. Patients were included in the study if they were over 18 years of age and had a diagnosis of chronic, treatment-refractory peripheral neuropathic pain. The analysis included all pregabalin-naïve patients who had previously shown an inadequate response to gabapentin and switched to pregabalin. Severity of pain before and after treatment with pregabalin, alone or as an add-on therapy, was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ) and its related visual analogue scale (VA). Healthcare resource utilization, productivity (including lost-workday equivalents [LWDE]), and related costs were assessed at baseline and after pregabalin treatment. A total of 174 patients switched to pregabalin had significant and clinically relevant reductions in pain severity (mean [SD] change on SF-MPQ VA scale, -31.9 [22.1]; P < 0.05 vs. baseline; effect size, 1.87). Reduction in pain was similar with both pregabalin monotherapy and add-on therapy. Significant reductions in healthcare resource utilization (concomitant drug use [in pregabalin add-on group], ancillary tests, and unscheduled medical visits) were observed at the end of trial. Additionally, there were substantial improvements in productivity, including a reduction in the number of LWDE following pregabalin treatment (-18.9 [26.0]; P < 0.0001). These changes correlated with substantial reductions in both direct (-652.9 ± 1622.4 €; P < 0.0001) and indirect healthcare costs (-851.6 [1259.6] €; P < 0.0001). The cost of care in patients with gabapentin-refractory peripheral neuropathic pain appeared to be significantly reduced after switching to pregabalin treatment, alone or in combination with other analgesic drugs, in a real-life setting. © 2011 The Authors. Pain Practice © 2011 World Institute of Pain.

Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program.

PubMed

Brodie, Martin J; Fakhoury, Toufic; McDonough, Belinda; Colson, Anny-Odile; Stockis, Armel; Elmoufti, Sami; Whitesides, John

2018-06-04

To assess the association, if any, between brivaracetam (BRV)-induced elevated carbamazepine-10,11-epoxide (CBZ-E) and toxicity and efficacy in patients with epilepsy. Data were pooled from three double-blind, placebo-controlled, Phase III studies of adjunctive BRV in adults with uncontrolled focal seizures (N01252/NCT00490035, N01253/NCT00464269, N01358/NCT01261325). Treatment-emergent adverse events (TEAEs) of interest (ataxia, diplopia, dizziness, nystagmus, somnolence, accidental overdose or poisoning, and toxicity), discontinuations due to TEAEs, and serious TEAEs (SAEs) were assessed in subgroups who did/did not receive carbamazepine (CBZ) at study entry (CBZ+ and CBZ-). Logistic regression analysis evaluated CBZ-E/CBZ plasma concentrations and TEAEs. SAEs suggestive of CBZ-E toxicity were summarized from the BRV safety database up to a cut-off of October 1, 2014. Percent reduction in focal seizure frequency over placebo was assessed in subgroups of CBZ-E/CBZ ratios. Data from 1558 patients were included in the pooled safety population. Of these, concomitant CBZ was received by 184/459 (40.1%) placebo-treated and 315/803 (39.2%) BRV-treated patients (≥50 mg/day). In BRV-treated patients, study completion rates were similar in the CBZ+ (92.7%) and CBZ- (88.7%) groups; incidence of TEAEs of interest was similar (CBZ+ 24.4%; CBZ- 24.2%), and did not appear affected by CBZ dosage; SAEs and discontinuations due to TEAEs were CBZ+ 1.6%; CBZ- 3.9% and 2.9%; 9.2%, respectively. Likelihood of TEAEs of interest decreased with increasing CBZ-E/CBZ ratio for BRV-treated patients: odds ratio 0.88 (95% confidence intervals 0.74, 1.03; p = 0.112). In the safety database, five SAEs suggestive of CBZ-E toxicity were identified. Efficacy outcomes did not appear to have a consistent pattern across CBZ-E/CBZ ratio subgroups. This post-hoc analysis does not support an association between CBZ-E levels and TEAEs potentially associated with CBZ-E toxicity, or with increases in efficacy. Overall, current evidence does not suggest that BRV dose adjustment is required with concomitant CBZ. Copyright © 2018 Elsevier B.V. All rights reserved.

Categorical improvements in disease severity in patients with major depressive disorder treated with vilazodone: post hoc analysis of four randomized, placebo-controlled trials.

PubMed

Durgam, Suresh; Chen, Changzheng; Gommoll, Carl P; Edwards, John; Citrome, Leslie

2016-01-01

In three 8-week studies of vilazodone 40 mg/d (NCT00285376, NCT00683592, and NCT01473394) and a 10-week study of vilazodone 20 or 40 mg/d (NCT01473381), adults with major depressive disorder (MDD) showed significantly greater improvement with vilazodone versus placebo in global disease severity as measured by mean change from baseline in Clinical Global Impression of Severity (CGI-S) score. To assess the proportion of patients achieving clinically meaningful improvement, a post hoc pooled analysis was conducted using categorical shifts in disease severity based on CGI-S scores at baseline and end of treatment (EOT). Analyses were conducted in the pooled intent-to-treat population (N=2,218). Definitions of categorical shifts included CGI-S ≥4 (moderately ill or worse) at baseline to CGI-S ≤2 (normal or borderline ill) at EOT; CGI-S ≥5 (markedly ill or worse) at baseline to CGI-S ≤2 at EOT; and CGI-S ≥6 (severely ill or worse) at baseline to CGI-S ≤3 (mildly ill or better) at EOT. At baseline, 2,217 patients were moderately ill or worse. The percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (40.0% versus 27.8%; odds ratio [OR] =1.7, P <0.001; number needed to treat [NNT] =9). In the 979 patients who were markedly ill or worse at baseline, the percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (36.8% versus 25.5%; OR =1.7, P <0.001; NNT =9). The small number of severely ill patients at baseline (n =43) provided inadequate power to detect statistically significant between-group differences, but an NNT =5 was found for improvement to mildly ill or better. Categorical shift analyses, defined using baseline and EOT CGI-S scores, showed that significantly higher proportions of patients had clinically meaningful improvements in global disease severity with vilazodone 20-40 mg/d versus placebo. This type of analysis may be useful for evaluating the effects of antidepressant treatment in adults with MDD.

Risk Factors For Bradycardia Requiring Pacemaker Implantation In Patients With Atrial Fibrillation

PubMed Central

Barrett, Tyler W.; Abraham, Robert L.; Jenkins, Cathy A.; Russ, Stephan; Storrow, Alan B.; Darbar, Dawood

2012-01-01

Symptomatic bradycardia may complicate atrial fibrillation (AF) and necessitate a permanent pacemaker. Identifying patients at increased risk for symptomatic bradycardia may reduce associated morbidities and healthcare costs. We investigated predictors for developing bradycardia requiring a permanent pacemaker among AF patients. We reviewed records of all patients treated for AF/flutter in an academic hospital’s emergency department from 8/1/2005 to 8/30/2008. We determined survival and presence of a pacemaker as of 11/1/2011. Cases were defined as patients with pacemakers placed for bradycardia after their AF diagnoses. Patients without a pacemaker who were followed at our hospital comprised the controls. We identified a priori variables for the logistic regression analysis. We fit a post-hoc model adjusting for AF type and atrioventricular nodal blocker (AVN) use. Of the 362 patients in our cohort, 119 cases had permanent pacemakers implanted for bradycardia subsequent to AF diagnosis and 243 controls were alive without a pacemaker. Median and interquartile range follow-up time was 4.5 (3.8 – 5.4) years. Odds ratios and 95% confidence intervals were determined for age at time of AF diagnosis (1.02 [1, 1.04]), female (1.58 [0.95, 2.63]), prior heart failure (2.72 [1.47, 5.01]), and African-American (0.33 [0.12, 0.94]). Post-hoc model identified permanent AF (2.99 [1.61, 5.57]) and AVN use (1.43 [0.85, 2.4]). In conclusion, among AF patients, heart failure and permanent AF each nearly triple the odds of developing bradycardia requiring a permanent pacemaker; while not statistically significant, our results suggest that women are more likely and African-Americans less likely to develop bradycardia requiring pacemaker implantation. PMID:22840846

Fully Automated Quantitative Estimation of Volumetric Breast Density from Digital Breast Tomosynthesis Images: Preliminary Results and Comparison with Digital Mammography and MR Imaging.

PubMed

Pertuz, Said; McDonald, Elizabeth S; Weinstein, Susan P; Conant, Emily F; Kontos, Despina

2016-04-01

To assess a fully automated method for volumetric breast density (VBD) estimation in digital breast tomosynthesis (DBT) and to compare the findings with those of full-field digital mammography (FFDM) and magnetic resonance (MR) imaging. Bilateral DBT images, FFDM images, and sagittal breast MR images were retrospectively collected from 68 women who underwent breast cancer screening from October 2011 to September 2012 with institutional review board-approved, HIPAA-compliant protocols. A fully automated computer algorithm was developed for quantitative estimation of VBD from DBT images. FFDM images were processed with U.S. Food and Drug Administration-cleared software, and the MR images were processed with a previously validated automated algorithm to obtain corresponding VBD estimates. Pearson correlation and analysis of variance with Tukey-Kramer post hoc correction were used to compare the multimodality VBD estimates. Estimates of VBD from DBT were significantly correlated with FFDM-based and MR imaging-based estimates with r = 0.83 (95% confidence interval [CI]: 0.74, 0.90) and r = 0.88 (95% CI: 0.82, 0.93), respectively (P < .001). The corresponding correlation between FFDM and MR imaging was r = 0.84 (95% CI: 0.76, 0.90). However, statistically significant differences after post hoc correction (α = 0.05) were found among VBD estimates from FFDM (mean ± standard deviation, 11.1% ± 7.0) relative to MR imaging (16.6% ± 11.2) and DBT (19.8% ± 16.2). Differences between VDB estimates from DBT and MR imaging were not significant (P = .26). Fully automated VBD estimates from DBT, FFDM, and MR imaging are strongly correlated but show statistically significant differences. Therefore, absolute differences in VBD between FFDM, DBT, and MR imaging should be considered in breast cancer risk assessment.

Delphi consensus on the diagnosis and management of dyslipidaemia in chronic kidney disease patients: A post hoc analysis of the DIANA study.

PubMed

Cases Amenós, Aleix; Pedro-Botet Montoya, Juan; Pascual Fuster, Vicente; Barrios Alonso, Vivencio; Pintó Sala, Xavier; Ascaso Gimilio, Juan F; Millán Nuñez-Cortés, Jesús; Serrano Cumplido, Adalberto

This post hoc study analysed the perception of the relevance of chronic kidney disease (CKD) in dyslipidaemia screening and the choice of statin among primary care physicians (PCPs) and other specialists through a Delphi questionnaire. The questionnaire included 4blocks of questions concerning dyslipidaemic patients with impaired carbohydrate metabolism. This study presents the results of the impact of CKD on screening and the choice of statin. Of the 497 experts included, 58% were PCPs and 42% were specialists (35, 7% were nephrologists). There was consensus by both PCPs and specialists, with no difference between PCPs and specialists, that CKD patients should undergo a dyslipidaemia screening and that the screening should be part of routine clinical practice. However, there was no consensus in considering the estimated glomerular filtration rate (eGFR) (although there was consensus among PCPs and nephrologists), or considering albuminuria when selecting a statin, or in determining albuminuria during follow-up after having initiated treatment with statins (although there was consensus among the nephrologists). The consensus to analyse the lipid profile in CKD patients suggests acknowledgment of the high cardiovascular risk of this condition. However, the lack of consensus in considering renal function or albuminuria, both when selecting a statin and during follow-up, suggests a limited knowledge of the differences between statins in relation to CKD. Thus, it would be advisable to develop a guideline/consensus document on the use of statins in CKD. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

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

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST)

PubMed Central

Matson, David O; Vesikari, Timo; Dennehy, Penelope; Dallas, Michael D; Goveia, Michelle G; Itzler, Robbin F; Ciarlet, Max

2014-01-01

During the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST), the period between the administration of dose 1 through 13 days after the administration of dose 3, there were more wild-type rotavirus gastroenteritis (RVGE) cases among vaccine recipients compared with placebo recipients using the protocol-specified microbiological plaque assay in the clinical-efficacy cohort, a subset of subjects where vaccine efficacy against RVGE of any severity was assessed. In this study, a rotavirus genome segment 6-based reverse transcriptase–polymerase chain reaction assay was applied post hoc to clarify the accuracy of type categorization of all these RVGE cases in vaccine recipients during the vaccination phase of REST. The assay characterized 147 (90%) of 163 re-assayed RVGE cases or rotavirus-associated health care contacts as type-determinable: either wild-type or vaccine-type rotavirus strains. In the clinical-efficacy cohort (N = 5673), 19 (18.8%) of 101 samples from RVGE cases contained wild-type rotavirus, 70 (69.3%) vaccine virus, and 12 (11.9%) were indeterminable. In the large-scale cohort (N = 68,038), 10 (34.5%) of 29 samples from RVGE-related health care contacts contained wild-type rotavirus strains, 15 (51.7%) vaccine-type rotavirus strains, and 4 (13.8%) were indeterminable. Of the 33 samples from RVGE cases in placebo recipients, all were confirmed to contain wild-type rotaviruses. Altogether, this post-hoc re-evaluation showed that the majority (75%) of type-determinable RVGE cases or health care contacts that occurred during the vaccination phase of REST in vaccine recipients were associated with vaccine-type rotavirus strains rather than wild-type rotavirus strains. PMID:25424931

Does Ultrasound-Enhanced Instruction of Musculoskeletal Anatomy Improve Physical Examination Skills of First-Year Medical Students?

PubMed

Walrod, Bryant J; Schroeder, Allison; Conroy, Mark J; Boucher, Laura C; Bockbrader, Marcia; Way, David P; McCamey, Kendra L; Hartz, Clinton A; Jonesco, Michael A; Bahner, David P

2018-01-01

Ultrasound imaging is commonly used to teach basic anatomy to medical students. The purpose of this study was to determine whether learning musculoskeletal anatomy with ultrasound improved performance on medical students' musculoskeletal physical examination skills. Twenty-seven first-year medical students were randomly assigned to 1 of 2 instructional groups: either shoulder or knee. Both groups received a lecture followed by hands-on ultrasound scanning on live human models of the assigned joint. After instruction, students were assessed on their ability to accurately palpate 4 anatomic landmarks: the acromioclavicular joint, the proximal long-head biceps tendon, and the medial and lateral joint lines of the knee. Performance scores were based on both accuracy and time. A total physical examination performance score was derived for each joint. Scores for instructional groups were compared by a 2-way analysis of variance with 1 repeated measure. Significant findings were further analyzed with post hoc tests. All students performed significantly better on the knee examination, irrespective of instructional group (F = 14.9; df = 1.25; P = .001). Moreover, the shoulder instruction group performed significantly better than the knee group on the overall assessment (t = -3.0; df = 25; P < .01). Post hoc analyses revealed that differences in group performance were due to the shoulder group's higher scores on palpation of the biceps tendon (t = -2.8; df = 25; P = .01), a soft tissue landmark. Both groups performed similarly on palpation of all other anatomic structures. The use of ultrasound appears to provide an educational advantage when learning musculoskeletal physical examination of soft tissue landmarks. © 2017 by the American Institute of Ultrasound in Medicine.

Effects of vilazodone on suicidal ideation and behavior in adults with major depressive disorder or generalized anxiety disorder: post-hoc analysis of randomized, double-blind, placebo-controlled trials

PubMed Central

Edwards, John; Durgam, Suresh; Chen, Changzheng; Chang, Cheng-Tao; Mathews, Maju; Gommoll, Carl P.

2017-01-01

Treatment-emergent suicidal ideation and behavior are ongoing concerns with antidepressants. Vilazodone, currently approved for the treatment of major depressive disorder (MDD) in adults, has also been evaluated in generalized anxiety disorder (GAD). Post-hoc analyses of vilazodone trials were carried out to examine its effects on suicidal ideation and behavior in adults with MDD or GAD. Data were pooled from vilazodone trials in MDD (four studies) and GAD (three studies). The incidence of suicide-related events was analyzed on the basis of treatment-emergent adverse event reporting and Columbia-Suicide Severity Rating Scale (C-SSRS) monitoring. Treatment-emergent suicidal ideation was analyzed on the basis of a C-SSRS category shift from no suicidal ideation/behavior (C-SSRS=0) at baseline to suicide ideation (C-SSRS=1–5) during treatment. In pooled safety populations (MDD, n=2233; GAD, n=1475), suicide-related treatment-emergent adverse events occurred in less than 1% of vilazodone-treated and placebo-treated patients. Incidences of C-SSRS suicidal ideation were as follows: MDD (vilazodone=19.9%, placebo=24.7%); GAD (vilazodone=7.7%, placebo=9.4%). Shifts from no suicidal ideation/behavior at baseline to suicidal ideation during treatment were as follows: MDD (vilazodone=9.4%, placebo=10.3%); GAD (vilazodone=4.4%, placebo=6.1%). Data from placebo-controlled studies indicate little or no risk of treatment-emergent suicidal ideation or behavior with vilazodone in adults with MDD or GAD. Nevertheless, all patients should be monitored for suicidal thoughts and behaviors during antidepressant treatment. PMID:28538024

Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL

PubMed Central

Bryce, A H; Alumkal, J J; Armstrong, A; Higano, C S; Iversen, P; Sternberg, C N; Rathkopf, D; Loriot, Y; de Bono, J; Tombal, B; Abhyankar, S; Lin, P; Krivoshik, A; Phung, D; Beer, T M

2017-01-01

Background: Advanced prostate cancer is a phenotypically diverse disease that evolves through multiple clinical courses. PSA level is the most widely used parameter for disease monitoring, but it has well-recognized limitations. Unlike in clinical trials, in practice, clinicians may rely on PSA monitoring alone to determine disease status on therapy. This approach has not been adequately tested. Methods: Chemotherapy-naive asymptomatic or mildly symptomatic men (n=872) with metastatic castration-resistant prostate cancer (mCRPC) who were treated with the androgen receptor inhibitor enzalutamide in the PREVAIL study were analyzed post hoc for rising versus nonrising PSA (empirically defined as >1.05 vs ⩽1.05 times the PSA level from 3 months earlier) at the time of radiographic progression. Clinical characteristics and disease outcomes were compared between the rising and nonrising PSA groups. Results: Of 265 PREVAIL patients with radiographic progression and evaluable PSA levels on the enzalutamide arm, nearly one-quarter had a nonrising PSA. Median progression-free survival in this cohort was 8.3 months versus 11.1 months in the rising PSA cohort (hazard ratio 1.68; 95% confidence interval 1.26–2.23); overall survival was similar between the two groups, although less than half of patients in either group were still at risk at 24 months. Baseline clinical characteristics of the two groups were similar. Conclusions: Non-rising PSA at radiographic progression is a common phenomenon in mCRPC patients treated with enzalutamide. As restaging in advanced prostate cancer patients is often guided by increases in PSA levels, our results demonstrate that disease progression on enzalutamide can occur without rising PSA levels. Therefore, a disease monitoring strategy that includes imaging not entirely reliant on serial serum PSA measurement may more accurately identify disease progression. PMID:28117385

Calcium Plus Vitamin D Supplementation and the Risk of Nonmelanoma and Melanoma Skin Cancer: Post Hoc Analyses of the Women's Health Initiative Randomized Controlled Trial

PubMed Central

Tang, Jean Y.; Fu, Teresa; LeBlanc, Erin; Manson, JoAnn E.; Feldman, David; Linos, Eleni; Vitolins, Mara Z.; Zeitouni, Nathalie C.; Larson, Joseph; Stefanick, Marcia L.

2011-01-01

Purpose In light of inverse relationships reported in observational studies of vitamin D intake and serum 25-hydroxyvitamin D levels with risk of nonmelanoma skin cancer (NMSC) and melanoma, we evaluated the effects of vitamin D combined with calcium supplementation on skin cancer in a randomized placebo-controlled trial. Methods Postmenopausal women age 50 to 79 years (N = 36,282) enrolled onto the Women's Health Initiative (WHI) calcium/vitamin D clinical trial were randomly assigned to receive 1,000 mg of elemental calcium plus 400 IU of vitamin D3 (CaD) daily or placebo for a mean follow-up period of 7.0 years. NMSC and melanoma skin cancers were ascertained by annual self-report; melanoma skin cancers underwent physician adjudication. Results Neither incident NMSC nor melanoma rates differed between treatment (hazard ratio [HR], 1.02; 95% CI, 0.95 to 1.07) and placebo groups (HR, 0.86; 95% CI, 0.64 to 1.16). In subgroup analyses, women with history of NMSC assigned to CaD had a reduced risk of melanoma versus those receiving placebo (HR, 0.43; 95% CI, 0.21 to 0.90; Pinteraction = .038), which was not observed in women without history of NMSC. Conclusion Vitamin D supplementation at a relatively low dose plus calcium did not reduce the overall incidence of NMSC or melanoma. However, in women with history of NMSC, CaD supplementation reduced melanoma risk, suggesting a potential role for calcium and vitamin D supplements in this high-risk group. Results from this post hoc subgroup analysis should be interpreted with caution but warrant additional investigation. PMID:21709199

Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan.

PubMed

Inoue, Daisuke; Muraoka, Ryoichi; Okazaki, Ryo; Nishizawa, Yoshiki; Sugimoto, Toshitsugu

2016-02-01

Many osteoporotics have comorbid diabetes mellitus (DM), hypertension (HT), and dyslipidemia (DL). However, whether such comorbidities alter response to anti-osteoporotic treatment is unknown. We did post hoc analyses of combined data from three risedronate Japanese phase III trials to determine whether the presence of DM, HT, or DL affects its efficacy and safety. Data from 885 subjects who received 48-week treatment with risedronate were collected and combined from the three phase III trials. They were divided into two groups by the presence or absence of comorbidities: DM (n = 53) versus non-DM (n = 832); HT (n = 278) versus non-HT (n = 607); and DL (n = 292) versus non-DL (n = 593). Bone mineral density (BMD), urinary type 1 collagen N-telopeptide (uNTX), and serum bone-specific alkaline phosphatase (BAP) were measured at baseline and sequentially until 48 weeks. BMD or bone markers were not different between any of the two groups. Overall, BMD was increased by 5.52%, and uNTX and BAP were decreased by 35.4 and 33.8%, respectively. Some bone markers were slightly lower in DM and DL subjects, but the responses to risedronate were not significantly different. Statin users had lower uNTX and BAP, but showed no difference in the treatment response. All the other medications had no apparent effect. Adverse event incidence was marginally higher in DL compared with non-DL (Relative risk 1.06; 95% confidence interval 1.01-1.11), but was not related to increase in any specific events. Risedronate shows consistent safety and efficacy in suppressing bone turnover and increasing BMD in osteoporosis patients with comorbid DM, HT, and/or DL.

Evaluation of Dalfampridine Extended Release 5 and 10 mg in Multiple Sclerosis

PubMed Central

Yapundich, Robert; Applebee, Angela; Bethoux, Francois; Goldman, Myla D.; Hutton, George J.; Mass, Michele; Pardo, Gabriel; Klingler, Michael; Henney, Herbert R.; Carrazana, Enrique J.

2015-01-01

Background: Dalfampridine extended-release (ER) tablets, 10 mg twice daily, have been shown to improve walking in people with multiple sclerosis. We evaluated the safety and efficacy of dalfampridine-ER 5 mg compared with 10 mg. Methods: Patients were randomized to double-blind treatment with twice-daily dalfampridine-ER tablets, 5 mg (n = 144) or 10 mg (n = 143), or placebo (n = 143) for 4 weeks. Primary efficacy endpoint was change from baseline walking speed by the Timed 25-Foot Walk 3 to 4 hours after the last dose. At 40% of sites, 2-week change from baseline walking distance was measured by the 6-Minute Walk test. Results: At 4 weeks, walking speed changes from baseline were 0.363, 0.423, and 0.478 ft/s (placebo, dalfampridine-ER 5 mg, and dalfampridine-ER 10 mg, respectively [P = NS]). Post hoc analysis of average changes between pretreatment and on-treatment showed that relative to placebo, only dalfampridine-ER 10 mg demonstrated a significant increase in walking speed (mean ± SE): 0.443 ± 0.042 ft/s versus 0.303 ± 0.038 ft/s (P = .014). Improvement in 6-Minute Walk distance was significantly greater with dalfampridine-ER 10 mg (128.6 ft, P = .014) but not with 5 mg (76.8 ft, P = .308) relative to placebo (41.7 ft). Adverse events were consistent with previous studies. No seizures were reported. Conclusions: Dalfampridine-ER 5 and 10 mg twice daily did not demonstrate efficacy on the planned endpoint. Post hoc analyses demonstrated significant increases in walking speed relative to placebo with dalfampridine-ER 10 mg. No new safety signals were observed. PMID:26052259

Cell migration, viability and tissue reaction of calcium hypochlorite based-solutions irrigants: An in vitro and in vivo study.

PubMed

Blattes, Gabriela Bess Ferraz; Mestieri, Leticia Boldrin; Böttcher, Daiana Elisabeth; Fossati, Anna Cristina Medeiros; Montagner, Francisco; Grecca, Fabiana Soares

2017-01-01

This study aimed to analyze in vitro cytotoxicity to cultured 3T3 fibroblasts and in vivo inflammatory reaction in rats by calcium hypochlorite (Ca(OCl) 2 ) solutions compared with sodium hypochlorite (NaOCl) solutions. Cultured 3T3 fibroblasts were exposed to different concentrations of (Ca(OCl) 2 ) and NaOCl solutions, and a scratch assay was performed. The viability rate was analyzed with trypan blue assay. Both solutions of 1% and 2.5% concentrations were injected into the subcutaneous tissue of 18 male Wistar rats aged 18 weeks. The inflammatory tissue reaction was evaluated at 2h, 24h, and 14days after the injections. The samples were qualitatively analyzed using a light microscope. Statistical analysis was performed with ANOVA and Tukey post hoc tests for in vitro assays and Kruskal-Wallis and Dunn post hoc tests for in vivo assays (α=0.05). In the scratch assay, Ca(OCl) 2 showed no significant difference compared with the control group (culture medium) at 24h (p<0.05). Solutions of 0.0075% and 0.005% NaOCl and Ca(OCl) 2 concentrations presented similar results compared with those in the positive control group (hydrogen peroxide) (p>0.05) in the trypan blue assay. In the in vivo assay, 1% Ca(OCl) 2 group showed a significant decrease in neutrophils at 2h and 24h (p=0.041) and 2h and 14days (p=0.017). There was no statistically significant difference for lymphocyte/plasmocyte and macrophage counts among the different concentration groups. Ca(OCl) 2 showed favorable results of viability and induced a low-level inflammatory response. Ca(OCl) 2 presented acceptable cytotoxicity and biocompatibility as an irrigant solution. Copyright © 2016 Elsevier Ltd. All rights reserved.

Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia.

PubMed

McEvoy, Joseph P; Risinger, Robert; Mykhnyak, Serhiy; Du, Yangchun; Liu, Chih-Chin; Stanford, Arielle D; Weiden, Peter J

To evaluate durability of therapeutic effect of long-term treatment with aripiprazole lauroxil in patients with schizophrenia following successful treatment of an acute psychotic episode. This post hoc analysis assessed long-term outcomes for a subgroup of patients who entered a 52-week extension study after being successfully stabilized with one of 2 doses of aripiprazole lauroxil (441 or 882 mg) in a pivotal 12-week, placebo-controlled, randomized clinical trial. Durability of therapeutic effect was measured by the proportion of patients completing the 1-year course of aripiprazole lauroxil, the trajectories of the Positive and Negative Syndrome Scale (PANSS) total and the Clinical Global Impression-Severity (CGI-S) item scores beyond the first 12 weeks, and the likelihood of remission at any follow-up point. In total, 181 patients treated with aripiprazole lauroxil entered the extension study; 73% and 66% of patients from the 441 mg and 882 mg groups, respectively, completed all 13 aripiprazole lauroxil treatments scheduled every 4 weeks over 52 weeks. Both groups continued on a positive trajectory of symptom improvements (P < .0001 for reductions in PANSS total and CGI-S scores from week 12 to end of follow-up). Most patients (74% and 68% in the aripiprazole lauroxil 441 mg and 882 mg groups, respectively) achieved remission during follow-up. These post hoc analyses of a subgroup of patients demonstrate the continued therapeutic efficacy of aripiprazole lauroxil after successful treatment of an acute episode of schizophrenia. Both the 441 mg and 882 mg groups had similar retention rates, degree of symptom improvement, and likelihood of remission. ClinicalTrials.gov identifier: NCT01469039; European Clinical Trials Database (EudraCT) numbers: 2012-003445-15 and 2012-003996-20​​​​. © Copyright 2017 Physicians Postgraduate Press, Inc.

Inter-species prediction of protein phosphorylation in the sbv IMPROVER species translation challenge

PubMed Central

Biehl, Michael; Sadowski, Peter; Bhanot, Gyan; Bilal, Erhan; Dayarian, Adel; Meyer, Pablo; Norel, Raquel; Rhrissorrakrai, Kahn; Zeller, Michael D.; Hormoz, Sahand

2015-01-01

Motivation: Animal models are widely used in biomedical research for reasons ranging from practical to ethical. An important issue is whether rodent models are predictive of human biology. This has been addressed recently in the framework of a series of challenges designed by the systems biology verification for Industrial Methodology for Process Verification in Research (sbv IMPROVER) initiative. In particular, one of the sub-challenges was devoted to the prediction of protein phosphorylation responses in human bronchial epithelial cells, exposed to a number of different chemical stimuli, given the responses in rat bronchial epithelial cells. Participating teams were asked to make inter-species predictions on the basis of available training examples, comprising transcriptomics and phosphoproteomics data. Results: Here, the two best performing teams present their data-driven approaches and computational methods. In addition, post hoc analyses of the datasets and challenge results were performed by the participants and challenge organizers. The challenge outcome indicates that successful prediction of protein phosphorylation status in human based on rat phosphorylation levels is feasible. However, within the limitations of the computational tools used, the inclusion of gene expression data does not improve the prediction quality. The post hoc analysis of time-specific measurements sheds light on the signaling pathways in both species. Availability and implementation: A detailed description of the dataset, challenge design and outcome is available at www.sbvimprover.com. The code used by team IGB is provided under http://github.com/uci-igb/improver2013. Implementations of the algorithms applied by team AMG are available at http://bhanot.biomaps.rutgers.edu/wiki/AMG-sc2-code.zip. Contact: meikelbiehl@gmail.com PMID:24994890

Marginal fit of all-ceramic crowns fabricated using two extraoral CAD/CAM systems in comparison with the conventional technique.

PubMed

Alqahtani, Fawaz

2017-01-01

The purpose of this study was to determine the effect of two extraoral computer-aided design (CAD) and computer-aided manufacturing (CAM) systems, in comparison with conventional techniques, on the marginal fit of monolithic CAD/CAM lithium disilicate ceramic crowns. This is an in vitro interventional study. The study was carried out at the Department of Prosthodontics, School of Dentistry, Prince Sattam Bin Abdul-Aziz University, Saudi Arabia, from December 2015 to April 2016. A marginal gap of 60 lithium disilicate crowns was evaluated by scanning electron microscopy. In total, 20 pressable lithium disilicate (IPS e.max Press [Ivoclar Vivadent]) ceramic crowns were fabricated using the conventional lost-wax technique as a control group. The experimental all-ceramic crowns were produced based on a scan stone model and milled using two extraoral CAD/CAM systems: the Cerec group was fabricated using the Cerec CAD/CAM system, and the Trios group was fabricated using Trios CAD and milled using Wieland Zenotec CAM. One-way analysis of variance (ANOVA) and the Scheffe post hoc test were used for statistical comparison of the groups (α=0.05). The mean (±standard deviation) of the marginal gap of each group was as follows: the Control group was 91.15 (±15.35) µm, the Cerec group was 111.07 (±6.33) µm, and the Trios group was 60.17 (±11.09) µm. One-way ANOVA and the Scheffe post hoc test showed a statistically significant difference in the marginal gap between all groups. It can be concluded from the current study that all-ceramic crowns, fabricated using the CAD/CAM system, show a marginal accuracy that is acceptable in clinical environments. The Trios CAD group displayed the smallest marginal gap.

Clobazam and Aggression-Related Adverse Events in Pediatric Patients With Lennox-Gastaut Syndrome.

PubMed

Paolicchi, Juliann M; Ross, Gail; Lee, Deborah; Drummond, Rebecca; Isojarvi, Jouko

2015-10-01

Lennox-Gastaut syndrome is an intractable epileptic encephalopathy marked by frequent drop seizures. Most patients develop moderate intellectual disability and behavioral problems, including hyperactivity, aggressiveness, insecurity, and autistic features. Treatment with benzodiazepines, including clobazam, may increase aggression/behavioral problems in patients with Lennox-Gastaut syndrome. Post hoc analyses of data from the OV-1012 trial assessed the potential for behavioral effects with clobazam treatment in pediatric (2 to 18 years) patients with Lennox-Gastaut syndrome. OV-1012 was a phase 3, randomized, double-blind, parallel-group trial comprising a 4-week baseline period, 3-week titration period, and a 12-week maintenance period. Data from 194 patients were analyzed for a history of aggression/behavioral problems, occurrence of aggression-related adverse events, and by assessment of potential drug-related effects on four behavior domains of the Child Behavior Checklist. Twenty-nine aggression-related adverse events were reported for 27 (13.9%) patients. Similar percentages of clobazam-treated patients with and without a history of aggressive behavior experienced an aggression-related adverse event (16.7% versus 15.5%, respectively). In the medium- and high-dosage clobazam groups, onset of aggression-related adverse effects occurred within the 3-week titration period with 63.2% resolving by the end of the study. Aggression-related adverse event onset and resolution were similar for the low-dosage clobazam and placebo groups. Analysis of baseline to postbaseline T scores for the behavior domains of the Child Behavior Checklist indicated no significant differences between clobazam and placebo. Post hoc analyses indicate that the overall rate of aggression with clobazam treatment was low and dosage dependent. Clobazam treatment was effective in reducing drop seizures regardless of aggression experience. Copyright © 2015 Elsevier Inc. All rights reserved.

Developmental evaluation of family functioning deficits in youths and young adults with childhood-onset bipolar disorder.

PubMed

MacPherson, Heather A; Ruggieri, Amanda L; Christensen, Rachel E; Schettini, Elana; Kim, Kerri L; Thomas, Sarah A; Dickstein, Daniel P

2018-08-01

Childhood-onset bipolar disorder (BD) is a serious condition that affects the patient and family. While research has documented familial dysfunction in individuals with BD, no studies have compared developmental differences in family functioning in youths with BD vs. adults with prospectively verified childhood-onset BD. The Family Assessment Device (FAD) was used to examine family functioning in participants with childhood-onset BD (n = 116) vs. healthy controls (HCs) (n = 108), ages 7-30 years, using multivariate analysis of covariance and multiple linear regression. Participants with BD had significantly worse family functioning in all domains (problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, general functioning) compared to HCs, regardless of age, IQ, and socioeconomic status. Post-hoc analyses suggested no influence for mood state, global functioning, comorbidity, and most medications, despite youths with BD presenting with greater severity in these areas than adults. Post-hoc tests eliminating participants taking lithium (n = 17) showed a significant diagnosis-by-age interaction: youths with BD had worse family problem solving and communication relative to HCs. Limitations include the cross-sectional design, clinical differences in youths vs. adults with BD, ambiguity in FAD instructions, participant-only report of family functioning, and lack of data on psychosocial treatments. Familial dysfunction is common in childhood-onset BD and endures into adulthood. Early identification and treatment of both individual and family impairments is crucial. Further investigation into multi-level, family-based mechanisms underlying childhood-onset BD may clarify the role family factors play in the disorder, and offer avenues for the development of novel, family-focused therapeutic strategies. Copyright © 2018 Elsevier B.V. All rights reserved.

Longitudinal measures of perfluoroalkyl substances (PFAS) in serum of Gullah African Americans in South Carolina: 2003–2013

PubMed Central

Gribble, Matthew O.; Bartell, Scott M.; Kannan, Kurunthachalam; Wu, Qian; Fair, Patricia A.; Kamen, Diane L.

2015-01-01

Background Charleston Harbor has elevated concentrations of PFAS in dolphins, but local human exposure data are limited. Objectives We sought to describe PFAS serum concentrations’ temporal trends among Gullah African American residents of coastal South Carolina. Methods Longitudinal measures of PFAS in blood serum from a Gullah clinical sample, without lupus, were examined using spaghetti plots and visit-to-visit change scores (e.g., differences in concentrations between visits) among the 68 participants with repeated measures available. We also modeled population-level trends among the 71 participants with any data using proportionate percentile models, accounting for clustering through robust standard errors. In a post-hoc analysis we examined heterogeneity of temporal trends by age through mixed-effects models for the log-transformed PFAS compounds. Results Population concentrations of PFOS dropped approximately 9 (95% CI: 8, 10) percent each year over 2003–2013. This was concordant with individual PFOS trajectories (median PFOS change score −21.7 ng/g wet weight, interquartile range of PFOS change scores: −32.8, −14.9) and reports for other populations over this time period. Several other compounds including PFOA, PFHxS, and PFuNDA also showed a population-level decrease. However, examination of individual trajectories suggested substantial heterogeneity. Post-hoc analyses indicated that PFAS trajectories were heterogeneous by age. Conclusions Many PFAS compounds are decreasing in a sample of Gullah African Americans from coastal South Carolina. There may be age differences in the elimination kinetics of PFASs. The possible role of age as a modifier of PFAS serum trends merits further research. PMID:25819541

Assessment of Maximum Aerobic Capacity and Anaerobic Threshold of Elite Ballet Dancers.

PubMed

Wyon, Matthew A; Allen, Nick; Cloak, Ross; Beck, Sarah; Davies, Paul; Clarke, Frances

2016-09-01

An athlete's cardiorespiratory profile, maximal aerobic capacity, and anaerobic threshold is affected by training regimen and competition demands. The present study aimed to ascertain whether there are company rank differences in maximal aerobic capacity and anaerobic threshold in elite classical ballet dancers. Seventy-four volunteers (M 34, F 40) were recruited from two full-time professional classical ballet companies. All participants completed a continuous incremental treadmill protocol with a 1-km/hr speed increase at the end of each 1-min stage until termination criteria had been achieved (e.g., voluntary cessation, respiratory exchange ratio <1.15, HR ±5 bpm of estimated HRmax). Peak VO2 (5-breathe smooth) was recorded and anaerobic threshold calculated using ventilatory curve and ventilatory equivalents methods. Statistical analysis reported between-subject effects for gender (F1,67=35.18, p<0.001) and rank (F1,67=8.67, p<0.001); post hoc tests reported soloists (39.5±5.15 mL/kg/min) as having significantly lower VO2 peak than artists (45.9±5.75 mL/kg/min, p<0.001) and principal dancers (48.07±3.24 mL/kg/min, p<0.001). Significant differences in anaerobic threshold were reported for age (F1,67=7.68, p=0.008) and rank (F1,67=3.56, p=0.034); post hoc tests reported artists (75.8±5.45%) having significantly lower anaerobic threshold than soloists (80.9±5.71, p<0.01) and principals (84.1±4.84%, p<0.001). The observed differences in VO2 peak and anaerobic threshold between the ranks in ballet companies are probably due to the different rehearsal and performance demands.

Association between plasma lipid parameters and APOC3 genotypes in Brazilian subjects: effect of gender, smoking and APOE genotypes.

PubMed

Fiegenbaum, Marilu; de Andrade, Fabiana Michelsen; Hutz, Mara H

2007-05-01

APOC3 polymorphisms were associated with lipid parameters and coronary artery disease in several populations but not all. Considering the multifactorial inheritance and environmental factors that underlie the determination of triglyceride (TG) and HDL-C levels, the aims of the present study were to perform association analyses of APOC3 polymorphisms and these lipids in a southern Brazilian population of European descent to investigate possible interactions with other genetic and/or environmental factors. Six hundred and seventy-three subjects participated in the study. -482C>T, -455T>C and 3238C>G polymorphisms genotyping were carried out by PCR followed by restriction enzyme digestion. In female subjects the APOC3-APOE genotype combinations had a significant effect on triglyceride levels (ANOVA, P=0.009). Post hoc analysis showed that the observed differences were between APOC3 S(*)2 carriers and S(*)1S(*)1 homozygotes in individuals with an APOE(*)3/3 genotype (Tukey HSD post hoc test, P=0.027). In APOE(*)3/(*)3 subjects, the raising effect of APOC3 S(*)2 allele on TG concentrations was more pronounced in female smokers (+59.4%) than in nonsmokers (+18.8%, P of S(*)2-smoking interaction=0.009). Among APOE(*)3/(*)3 subjects, male carriers of the less common alleles -482T and -455C had significant lower levels of HDL-C compared to homozygotes -482C/C and -455T/T (P=0.02 and P=0.006, respectively). APOC3 polymorphisms were associated with lipid variables, but the magnitude of these associations was modulated by additional genetic, biologic and/or environmental factors.

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST).

PubMed

Matson, David O; Vesikari, Timo; Dennehy, Penelope; Dallas, Michael D; Goveia, Michelle G; Itzler, Robbin F; Ciarlet, Max

2014-01-01

During the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST), the period between the administration of dose 1 through 13 days after the administration of dose 3, there were more wild-type rotavirus gastroenteritis (RVGE) cases among vaccine recipients compared with placebo recipients using the protocol-specified microbiological plaque assay in the clinical-efficacy cohort, a subset of subjects where vaccine efficacy against RVGE of any severity was assessed. In this study, a rotavirus genome segment 6-based reverse transcriptase-polymerase chain reaction assay was applied post hoc to clarify the accuracy of type categorization of all these RVGE cases in vaccine recipients during the vaccination phase of REST. The assay characterized 147 (90%) of 163 re-assayed RVGE cases or rotavirus-associated health care contacts as type-determinable: either wild-type or vaccine-type rotavirus strains. In the clinical-efficacy cohort (N = 5673), 19 (18.8%) of 101 samples from RVGE cases contained wild-type rotavirus, 70 (69.3%) vaccine virus, and 12 (11.9%) were indeterminable. In the large-scale cohort (N = 68,038), 10 (34.5%) of 29 samples from RVGE-related health care contacts contained wild-type rotavirus strains, 15 (51.7%) vaccine-type rotavirus strains, and 4 (13.8%) were indeterminable. Of the 33 samples from RVGE cases in placebo recipients, all were confirmed to contain wild-type rotaviruses. Altogether, this post-hoc re-evaluation showed that the majority (75%) of type-determinable RVGE cases or health care contacts that occurred during the vaccination phase of REST in vaccine recipients were associated with vaccine-type rotavirus strains rather than wild-type rotavirus strains.

Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL.

PubMed

Bryce, A H; Alumkal, J J; Armstrong, A; Higano, C S; Iversen, P; Sternberg, C N; Rathkopf, D; Loriot, Y; de Bono, J; Tombal, B; Abhyankar, S; Lin, P; Krivoshik, A; Phung, D; Beer, T M

2017-06-01

Advanced prostate cancer is a phenotypically diverse disease that evolves through multiple clinical courses. PSA level is the most widely used parameter for disease monitoring, but it has well-recognized limitations. Unlike in clinical trials, in practice, clinicians may rely on PSA monitoring alone to determine disease status on therapy. This approach has not been adequately tested. Chemotherapy-naive asymptomatic or mildly symptomatic men (n=872) with metastatic castration-resistant prostate cancer (mCRPC) who were treated with the androgen receptor inhibitor enzalutamide in the PREVAIL study were analyzed post hoc for rising versus nonrising PSA (empirically defined as >1.05 vs ⩽1.05 times the PSA level from 3 months earlier) at the time of radiographic progression. Clinical characteristics and disease outcomes were compared between the rising and nonrising PSA groups. Of 265 PREVAIL patients with radiographic progression and evaluable PSA levels on the enzalutamide arm, nearly one-quarter had a nonrising PSA. Median progression-free survival in this cohort was 8.3 months versus 11.1 months in the rising PSA cohort (hazard ratio 1.68; 95% confidence interval 1.26-2.23); overall survival was similar between the two groups, although less than half of patients in either group were still at risk at 24 months. Baseline clinical characteristics of the two groups were similar. Non-rising PSA at radiographic progression is a common phenomenon in mCRPC patients treated with enzalutamide. As restaging in advanced prostate cancer patients is often guided by increases in PSA levels, our results demonstrate that disease progression on enzalutamide can occur without rising PSA levels. Therefore, a disease monitoring strategy that includes imaging not entirely reliant on serial serum PSA measurement may more accurately identify disease progression.

Pitfalls in gastrointestinal permeability measurement in ICU patients with multiple organ failure using differential sugar absorption.

PubMed

Oudemans-van Straaten, Heleen M; van der Voort, Peter J; Hoek, Frans J; Bosman, Rob J; van der Spoel, Johan I; Zandstra, Durk F

2002-02-01

To assess whether gastrointestinal permeability (GIP) at intensive care unit (ICU) admission, measured by differential sugar absorption, is related to severity of disease and multiple organ failure (MOF). Post hoc, to analyse the relation between the urinary sugar recovery and renal function. Prospective observational cohort study. Eighteen-bed general ICU of a teaching hospital. Sixty-four ventilated patients admitted with MOF. GIP was assessed within 24 h using cellobiose (C), sucrose (S) and mannitol (M) absorption. Severity of disease: APACHE II and III, SAPS II and MPM II systems. Organ failure: SOFA, MODS and Goris score. The median urinary recovery of C was 0.147% (range 0.004-2.145%), of S 0.249% (0.001-3.656%) and of M 10.7% (0.6-270%). In 16 patients, M recovery was over 100% of the oral dose. They received red blood cell transfusion (RBC). In the non-transfused, the median cellobiose/mannitol (CM) ratio was 0.015 (0.0004-0.550). CM ratio was not related to severity of disease and inversely related to the SOFA score ( r=-0.30, p=0.04). Post hoc regression analysis showed that recoveries of C, S and M were positively related to urinary volume. Recoveries of C and S, but not of M, were positively related to creatinine clearance. The CM ratio corrected for diuresis, but was inversely related to creatinine clearance. Differential C, S and M absorption testing is unreliable after RBC transfusion, since bank blood contains mannitol. The excretion of C and S, but not of M, is limited by renal dysfunction. Differential sugar absorption is not reliable to test GIP in MOF patients, since non-permeability related factors act as confounders.

Six-Month Lower Limb Aerobic Exercise Improves Physical Function in Young-Old, Old-Old, and Oldest-Old Adults.

PubMed

Cho, Chaeyoon; Han, Changwan; Sung, Misun; Lee, Chaewon; Kim, Minji; Ogawa, Yoshiko; Kohzuki, Masahiro

2017-08-01

The effect of aerobic exercise on physical function and mental health in various adult age groups (young-old, 65-74; old-old, 75-84; oldest-old, ≥ 85 years) is unclear. The aim of this study was to investigate the effects of the Kohzuki Exercise Program (KEP) on physical function and mental health in these age groups. The KEP consisted of 40-min supervised sessions 3 times per week for 6 months as follows: 5 min of warm-up, 30 min of lower limb aerobic exercise, and 5 min of cool-down. A total of 50 participants (22 young-old, 20 old-old, and 8 oldest-old) who participated in the KEP completed at least 88% of the sessions. In statistical analysis, 3 (group: oldest-old, old-old, young-old) × 2 (time: baseline and after 6 months) analyses of variance were used to determine if there were significant main and interaction effects. Significant interactions were probed using the post-hoc paired t test. The Short Physical Performance Battery (SPPB) score showed significant group × time interactions after 6 months (p = 0.031). In the post-hoc test, oldest-old (p < 0.001), old-old (p < 0.001), and young-old (p < 0.01) groups had significantly better physical function after 6 months. However, none of the mental health measures showed group × time interactions at 6-month. Our results suggest that a 6-month KEP led to improved physical function in oldest-old, old-old, and young-old adults. The KEP was effective for oldest-old adults in particular. The KEP exhibits good adherence, making it suitable for a wide age range in society.

A comparative study to check fracture strength of provisional fixed partial dentures made of autopolymerizing polymethylmethacrylate resin reinforced with different materials: An in vitro study.

PubMed

Gupt, Parikshit; Nagpal, Archana; Samra, Rupandeep Kaur; Verma, Ramit; Kaur, Jasjeet; Abrol, Surbhi

2017-01-01

The purpose of the study was to evaluate the fracture strength of provisional fixed partial dentures made of autopolymerizing polymethylmethacrylate (PMMA) resin using different types of reinforcement materials to determine the best among them. Fifty samples were made (10 samples for each group) with autopolymerizing PMMA resin using reinforcement materials (stainless steel wire: looped and unlooped and glass fiber: loose and unidirectional) as 3-unit posterior bridge. The test specimens were divided into five groups depending on the reinforcing material as Group I, II, III, IV, and V; Group I: PMMA unreinforced (control group), Group II: PMMA reinforced with stainless steel wire (straight ends), Group III: PMMA reinforced with stainless steel wire (looped ends), Group IV: PMMA reinforced with unidirectional glass fibers, and Group V: PMMA reinforced with randomly distributed glass fibers. Universal testing machine was used to evaluate and compare the fracture strength of samples. Comparison of mean ultimate force and ultimate stress was done employing one-way analysis of variance and Tukey's post hoc tests. The highest and lowest mean ultimate force and mean ultimate stress were of Group IV and I, respectively. Tukey's post hoc honestly significant difference multiple comparison for mean ultimate force and stress shows the increase in strength to be statistically significant ( P < 0.05) except for the samples reinforced with randomly distributed glass fibers ( P > 0.05). Unidirectional glass fibers showed the maximum strength, which was comparable to mean values of both stainless steel wire groups. Low cost and easy technique of using stainless steel wire make it the material of choice over the unidirectional glass fiber for reinforcement in nonesthetic areas where high strength is required.

Timing considerations on the shear bond strength of orthodontic brackets after topical fluoride varnish applications

PubMed Central

Cossellu, Gianguido; Lanteri, Valentina; Butera, Andrea; Laffi, Nicola; Merlini, Alberto; Farronato, Giampietro

2017-01-01

Objectives: To assess the best temporal association between the application of a fluoride varnish on enamel and bonding procedures. Materials and Methods: Eighty mandibular bovine incisors were used. Teeth were divided into 4 groups (20 per group); Groups 1–3 were treated with fluoride varnish (Fluor Protector, Ivoclar Vivadent, Schaan, Liechtenstein), and Group 4 served as control with no pretreatment. Tooth were stored in deionized water (37°C) and subjected to thermal cycling for 400 (Group 1), 800 (Group 2), and 2500 (Group 3) cycles corresponding, respectively, to 15, 30, and 90 days in order to simulate the three different timing of bracket bonding. Shear bond strength (SBS) was measured using an Instron Universal Testing machine. Tooth surfaces were examined under a stereomicroscope at 10× magnification to assess the amount of adhesive remnant index (ARI). One-way analysis of variance (ANOVA) and Tukey's honestly significant difference post-hoc test were used for the comparison of SBS values between groups (P < 0.05). The Chi-square test was used to examine differences among ARI scores. (P < 0.05). Results: One-way ANOVA and Tukey post-hoc test showed that the SBS of different groups were significantly different and was impacted by different timing of bonding (P < 0.05). The main differences were between the control group (17.02 ± 6.38 MPa) and Group 1 (6.93 ± 4.3 MPa). The ARI scores showed that there were no significant differences between the four tested groups. Conclusions: The SBS of the brackets bonded 15 days after the application of the fluoride was set back to an optimal value. PMID:28197397

Post hoc interlaboratory comparison of single particle ICP-MS size measurements of NIST gold nanoparticle reference materials.

PubMed

Montoro Bustos, Antonio R; Petersen, Elijah J; Possolo, Antonio; Winchester, Michael R

2015-09-01

Single particle inductively coupled plasma-mass spectrometry (spICP-MS) is an emerging technique that enables simultaneous measurement of nanoparticle size and number quantification of metal-containing nanoparticles at realistic environmental exposure concentrations. Such measurements are needed to understand the potential environmental and human health risks of nanoparticles. Before spICP-MS can be considered a mature methodology, additional work is needed to standardize this technique including an assessment of the reliability and variability of size distribution measurements and the transferability of the technique among laboratories. This paper presents the first post hoc interlaboratory comparison study of the spICP-MS technique. Measurement results provided by six expert laboratories for two National Institute of Standards and Technology (NIST) gold nanoparticle reference materials (RM 8012 and RM 8013) were employed. The general agreement in particle size between spICP-MS measurements and measurements by six reference techniques demonstrates the reliability of spICP-MS and validates its sizing capability. However, the precision of the spICP-MS measurement was better for the larger 60 nm gold nanoparticles and evaluation of spICP-MS precision indicates substantial variability among laboratories, with lower variability between operators within laboratories. Global particle number concentration and Au mass concentration recovery were quantitative for RM 8013 but significantly lower and with a greater variability for RM 8012. Statistical analysis did not suggest an optimal dwell time, because this parameter did not significantly affect either the measured mean particle size or the ability to count nanoparticles. Finally, the spICP-MS data were often best fit with several single non-Gaussian distributions or mixtures of Gaussian distributions, rather than the more frequently used normal or log-normal distributions.

Impaired Decision-Making, Higher Impulsivity, and Drug Severity in Substance Dependence and Pathological Gambling.

PubMed

Krmpotich, Theodore; Mikulich-Gilbertson, Susan; Sakai, Joseph; Thompson, Laetitia; Banich, Marie T; Tanabe, Jody

2015-01-01

Substance use disorder is characterized by impaired decision making, impulsivity, and risk taking. Pathological gambling shares many of these characteristics, and having both diagnoses may be associated with greater problems than either diagnosis alone. We investigated whether among substance-dependent individuals, comorbid pathological gambling would be associated with worse decision making, greater impulsivity, risk taking, and drug severity. Ninety-six substance-dependent individuals were recruited from a residential treatment program and divided into 1 of the 2 groups depending on whether they met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for pathological gambling (SDPG, n = 26) or not (SD, n = 70). Ninety-two controls were recruited from the community. Participants completed a decision-making task (modified Iowa Gambling Task), measures of impulsivity (Barratt Impulsivity Scale and Delay Discounting), and risk taking (Balloon Analog Risk Task). Decision making was analyzed using a computational model. We tested for group differences using analysis of covariance or Kruskal-Wallis and appropriate post-hoc tests. The groups differed in decision-making parameters (P < 0.001) and self-reported impulsivity (P < 0.001). All post-hoc comparisons were significant on these measures, and indicated stepwise changes in controls, followed by SD, followed by SDPG, with SDPG performing worse on decision making and being more impulsive. Compared with SD, SDPG had greater drug severity (P < 0.001). No group differences were observed in delay discounting or risk taking. Compared with individuals with substance dependence without pathological gambling, those with both disorders demonstrated worse decision making and significantly more drug-related symptoms. When evaluating patients with substance dependence, clinicians should consider diagnostic assessments for gambling, as the co-occurrence of both disorders may impact clinical characteristics.

The effects of a single session of spinal manipulation on strength and cortical drive in athletes.

PubMed

Christiansen, Thomas Lykke; Niazi, Imran Khan; Holt, Kelly; Nedergaard, Rasmus Wiberg; Duehr, Jens; Allen, Kathryn; Marshall, Paul; Türker, Kemal S; Hartvigsen, Jan; Haavik, Heidi

2018-04-01

The primary purpose of this study was to investigate whether a single session of spinal manipulation (SM) increases strength and cortical drive in the lower limb (soleus muscle) of elite Taekwondo athletes. Soleus-evoked V-waves, H-reflex and maximum voluntary contraction (MVC) of the plantar flexors were recorded from 11 elite Taekwondo athletes using a randomized controlled crossover design. Interventions were either SM or passive movement control. Outcomes were assessed at pre-intervention and at three post-intervention time periods (immediate post, post 30 min and post 60 min). A multifactorial repeated measures ANOVA was conducted to assess within and between group differences. Time and session were used as factors. A post hoc analysis was carried out, when an interactive effect was present. Significance was set at p ≤ 0.05. SM increased MVC force [F(3,30) = 5.95, p < 0.01], and V-waves [F(3,30) = 4.25, p = 0.01] over time compared to the control intervention. Between group differences were significant for all time periods (p < 0.05) except for the post60 force measurements (p = 0.07). A single session of SM increased muscle strength and corticospinal excitability to ankle plantar flexor muscles in elite Taekwondo athletes. The increased MVC force lasted for 30 min and the corticospinal excitability increase persisted for at least 60 min.

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…

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…

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…

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…

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…

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…

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…

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…

Analysis of Web-based learning methods in emergency medicine: randomized controlled trial.

PubMed

Leszczyński, Piotr; Gotlib, Joanna; Kopański, Zbigniew; Wejnarski, Arkadiusz; Świeżewski, Stanisław; Gałązkowski, Robert

2018-04-01

In medical education, Web-based learning is increasingly used as a complement to practical classes. The objective of the study was to perform a comparative analysis of three different forms of e-learning course on emergency medicine in terms of an indicator of knowledge growth and students' satisfaction. For the purpose of the study, we developed and implemented a tool in the form of an online course: A - non-animated presentation, B - video, C - interactive video. The participants were undergraduate students of emergency medicine and nursing ( n = 106). A pre-test and a post-test were carried out, and the resulting data were analyzed using parametric tests ( t -test, ANOVA, post-hoc). Final questionnaires assessing six parameters of satisfaction were also evaluated. A significant increase in knowledge in the experimental group which used an interactive video was observed ( p = 0.04). Moreover, the number of replays of learning material was the highest in group C (2.09 ±2.48). The level of post-course satisfaction turned out to be comparable in all three groups ( p = 0.62). The study allowed the interactive course to be identified as the most effective method of distance learning among selected ones. Due to the limitations of the study, we conclude that there is a need for further studies on the effectiveness of e-learning in emergency medicine.

Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial.

PubMed

Chlebowski, Rowan T; Schwartz, Ann G; Wakelee, Heather; Anderson, Garnet L; Stefanick, Marcia L; Manson, JoAnn E; Rodabough, Rebecca J; Chien, Jason W; Wactawski-Wende, Jean; Gass, Margery; Kotchen, Jane Morley; Johnson, Karen C; O'Sullivan, Mary Jo; Ockene, Judith K; Chen, Chu; Hubbell, F Allan

2009-10-10

In the post-intervention period of the Women's Health Initiative (WHI) trial, women assigned to treatment with oestrogen plus progestin had a higher risk of cancer than did those assigned to placebo. Results also suggested that the combined hormone therapy might increase mortality from lung cancer. To assess whether such an association exists, we undertook a post-hoc analysis of lung cancers diagnosed in the trial over the entire follow-up period. The WHI study was a randomised, double-blind, placebo-controlled trial undertaken in 40 centres in the USA. 16 608 postmenopausal women aged 50-79 years with an intact uterus were randomly assigned by a computerised, stratified, permuted block algorithm to receive a once-daily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate (n=8506) or matching placebo (n=8102). We assessed incidence and mortality rates for all lung cancer, small-cell lung cancer, and non-small-cell lung cancer by use of data from treatment and post-intervention follow-up periods. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00000611. After a mean of 5.6 years (SD 1.3) of treatment and 2.4 years (0.4) of additional follow-up, 109 women in the combined hormone therapy group had been diagnosed with lung cancer compared with 85 in the placebo group (incidence per year 0.16%vs 0.13%; hazard ratio [HR] 1.23, 95% CI 0.92-1.63, p=0.16). 96 women assigned to combined therapy had non-small-cell lung cancer compared with 72 assigned to placebo (0.14%vs 0.11%; HR 1.28, 0.94-1.73, p=0.12). More women died from lung cancer in the combined hormone therapy group than in the placebo group (73 vs 40 deaths; 0.11%vs 0.06%; HR 1.71, 1.16-2.52, p=0.01), mainly as a result of a higher number of deaths from non-small-cell lung cancer in the combined therapy group (62 vs 31 deaths; 0.09%vs 0.05%; HR 1.87, 1.22-2.88, p=0.004). Incidence and mortality rates of small-cell lung cancer were similar between groups. Although treatment with oestrogen plus progestin in postmenopausal women did not increase incidence of lung cancer, it increased the number of deaths from lung cancer, in particular deaths from non-small-cell lung cancer. These findings should be incorporated into risk-benefit discussions with women considering combined hormone therapy, especially those with a high risk of lung cancer. National Heart, Lung and Blood Institute, National Institutes of Health.

Acute effect of a complex training protocol of back squats on 30-m sprint times of elite male military athletes

PubMed Central

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Serrano, Pablo Cáceres

2016-01-01

[Purpose] The aim of this study was to determine the acute effect temporal of a complex training protocol on 30 meter sprint times. A secondary objective was to evaluate the fatigue indexes of military athletes. [Subjects and Methods] Seven military athletes were the subjects of this study. The variables measured were times in 30-meter sprint, and average power and peak power of squats. The intervention session with complex training consisted of 4 sets of 5 repetitions at 30% 1RM + 4 repetitions at 60% 1RM + 3 repetitions of 30 meters with 120-second rests. For the statistical analysis repeated measures of ANOVA was used, and for the post hoc analysis, student’s t-test was used. [Results] Times in 30 meter sprints showed a significant reduction between the control set and the four experimental sets, but the average power and peak power of squats did not show significant changes. [Conclusion] The results of the study show the acute positive effect of complex training, over time, in 30-meter sprint by military athletes. This effect is due to the post activation potentiation of the lower limbs’ muscles in the 30 meters sprint. PMID:27134353

Acute effect of a complex training protocol of back squats on 30-m sprint times of elite male military athletes.

PubMed

Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Serrano, Pablo Cáceres

2016-03-01

[Purpose] The aim of this study was to determine the acute effect temporal of a complex training protocol on 30 meter sprint times. A secondary objective was to evaluate the fatigue indexes of military athletes. [Subjects and Methods] Seven military athletes were the subjects of this study. The variables measured were times in 30-meter sprint, and average power and peak power of squats. The intervention session with complex training consisted of 4 sets of 5 repetitions at 30% 1RM + 4 repetitions at 60% 1RM + 3 repetitions of 30 meters with 120-second rests. For the statistical analysis repeated measures of ANOVA was used, and for the post hoc analysis, student's t-test was used. [Results] Times in 30 meter sprints showed a significant reduction between the control set and the four experimental sets, but the average power and peak power of squats did not show significant changes. [Conclusion] The results of the study show the acute positive effect of complex training, over time, in 30-meter sprint by military athletes. This effect is due to the post activation potentiation of the lower limbs' muscles in the 30 meters sprint.

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.

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.

Nine, seven, five, or three: how many figures do we need for assessing body image?

PubMed

Ambrosi-Randić, Neala; Pokrajac-Bulian, Alessandra; Taksić, Vladimir

2005-04-01

320 Croatian female students (M=20.4 yr.) were recruited to examine the validity and reliability of figural scales using different numbers of stimuli (3, 5, 7, and 9) and different serial presentation (serial and nonserial order). A two-way analysis of variance (4 numbers x 2 orders of stimuli) was performed on ratings of current self-size and ideal size as dependent variables. Analysis indicated a significant main effect of number of stimuli. This, together with post hoc tests indicated that ratings were significantly different for a scale of three figures from scales of more figures, which in turn did not differ among themselves. Main effects of order of stimuli, as well as the interaction, were not significant. The results support the hypothesis that the optimal number of figures on a scale is seven plus (or minus) two.

Academic nursing administrators' workplace satisfaction and intent to stay.

PubMed

Emory, Jan; Lee, Peggy; Miller, Michael T; Kippenbrock, Thomas; Rosen, Chris

In nursing education, the academic administrator is critical given the multitude of challenges associated with program delivery (e.g., shortages of faculty, strict and changing regulations for program accreditation, and the sheer demand for more nurses). Unfortunately, with the focus on recruiting and retaining new novice faculty to teach students, academic nursing administrators have been overlooked in recent studies. As such, this study aims to explore the workplace satisfaction and intent to stay of academic nursing administrators by considering their relation to a variety of demographic and work related variables. A secondary data source was used from the Collaborative on Academic Careers in Higher Education (COACHE). One-way Analysis of Variance (ANOVA) with post hoc Fisher's Least Significant Difference tests and t-tests were used in the analysis. Results indicate that several modifiable work factors positively relate to both job satisfaction and intent to stay. Copyright © 2016 Elsevier Inc. All rights reserved.

Investigation of the anxiolytic effects of linalool, a lavender extract, in the male Sprague-Dawley rat.

PubMed

Cline, Michael; Taylor, John E; Flores, Jesus; Bracken, Samuel; McCall, Suzanne; Ceremuga, Thomas E

2008-02-01

The purpose of our study was to investigate the anxiolytic effects of linalool and its potential interaction with the GABAA receptor in Sprague-Dawley rats. Lavender has been used traditionally as an herbal remedy in the treatment of many medical conditions, including anxiety. Linalool is a major component of the essential oil of lavender. Forty-four rats were divided into 4 groups: control, linalool, midazolam (positive control), and flumazenil and linalool. The behavioral and the neurohormonal/physiological components of anxiety were evaluated. The behavioral component was examined by using the elevated plus maze (open arm time/total time) and the neurohormonal/physiological component by measuring serum catecholamine and corticosterone levels. Data analysis was performed using a 2-tailed Multivariate Analysis of Variance and Sheffe post-hoc test. Our data suggest that linalool does not produce anxiolysis by modulation of the GABAA receptor; however, linalool may modulate motor movements and locomotion.

Simulated annealing with probabilistic analysis for solving traveling salesman problems

NASA Astrophysics Data System (ADS)

Hong, Pei-Yee; Lim, Yai-Fung; Ramli, Razamin; Khalid, Ruzelan

2013-09-01

Simulated Annealing (SA) is a widely used meta-heuristic that was inspired from the annealing process of recrystallization of metals. Therefore, the efficiency of SA is highly affected by the annealing schedule. As a result, in this paper, we presented an empirical work to provide a comparable annealing schedule to solve symmetric traveling salesman problems (TSP). Randomized complete block design is also used in this study. The results show that different parameters do affect the efficiency of SA and thus, we propose the best found annealing schedule based on the Post Hoc test. SA was tested on seven selected benchmarked problems of symmetric TSP with the proposed annealing schedule. The performance of SA was evaluated empirically alongside with benchmark solutions and simple analysis to validate the quality of solutions. Computational results show that the proposed annealing schedule provides a good quality of solution.

Classifying post-stroke fatigue: Optimal cut-off on the Fatigue Assessment Scale.

PubMed

Cumming, Toby B; Mead, Gillian

2017-12-01

Post-stroke fatigue is common and has debilitating effects on independence and quality of life. The Fatigue Assessment Scale (FAS) is a valid screening tool for fatigue after stroke, but there is no established cut-off. We sought to identify the optimal cut-off for classifying post-stroke fatigue on the FAS. In retrospective analysis of two independent datasets (the '2015' and '2007' studies), we evaluated the predictive validity of FAS score against a case definition of fatigue (the criterion standard). Area under the curve (AUC) and sensitivity and specificity at the optimal cut-off were established in the larger 2015 dataset (n=126), and then independently validated in the 2007 dataset (n=52). In the 2015 dataset, AUC was 0.78 (95% CI 0.70-0.86), with the optimal ≥24 cut-off giving a sensitivity of 0.82 and specificity of 0.66. The 2007 dataset had an AUC of 0.83 (95% CI 0.71-0.94), and applying the ≥24 cut-off gave a sensitivity of 0.84 and specificity of 0.67. Post-hoc analysis of the 2015 dataset revealed that using only the 3 most predictive FAS items together ('FAS-3') also yielded good validity: AUC 0.81 (95% CI 0.73-0.89), with sensitivity of 0.83 and specificity of 0.75 at the optimal ≥8 cut-off. We propose ≥24 as a cut-off for classifying post-stroke fatigue on the FAS. While further validation work is needed, this is a positive step towards a coherent approach to reporting fatigue prevalence using the FAS. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of chlorhexidine and ethanol on the durability of the adhesion of the fiber post relined with resin composite to the root canal.

PubMed

Cecchin, Doglas; de Almeida, José Flávio Affonso; Gomes, Brenda P F A; Zaia, Alexandre Augusto; Ferraz, Caio Cesar Randi

2011-05-01

The aim of this study was to investigate the effects of pretreatment of gel chlorhexidine and ethanol on the bond strength and durability of the adhesion of the fiber post relined with resin composite to the root dentin. Sixty bovine incisor roots were divided into four groups: irrigation with physiologic solution (control), 5 minutes with chlorhexidine, 1 minute with ethanol, and 5 minutes with chlorhexidine followed by 1 minute with ethanol. Fiber posts relined with resin composite were cemented with RelyX ARC (3M ESPE, St Paul, MN) and a self-etching adhesive system Clearfil SE Bond (Kuraray, Kurashiki, Japan). Each group was randomly divided into three subgroups: 24 hours of water storage, 12 months of water storage, and 12 months of oil storage. All roots were sectioned transversely in the coronal, middle, and apical regions, producing 1-mm thick slices, and the push-out test was performed. Statistical analysis was performed using analysis of variance and the Tukey test for post hoc comparisons (α = 0.05). Immediate groups showed similar bond strength values with or without chlorhexidine and/or ethanol pretreatment (P > .05). A significant decrease in the bond strength in the control group was observed after 12 months of storage in water and oil (P < .05). The use of chlorhexidine- and/or ethanol-preserved bond strength in the groups stored in water and oil for 12 months (P < .05). Chlorhexidine and/or ethanol pretreatment were capable of preserving the bond strength of the fiber post relined with resin composite to root dentin for 12 months. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Influences of age, sex, and LDL-C change on cardiovascular risk reduction with pravastatin treatment in elderly Japanese patients: A post hoc analysis of data from the Pravastatin Anti-atherosclerosis Trial in the Elderly (PATE)

PubMed Central

Ouchi, Yasuyoshi; Ohashi, Yasuo; Ito, Hideki; Saito, Yasushi; Ishikawa, Toshitsugu; Akishita, Masahiro; Shibata, Taro; Nakamura, Haruo; Orimo, Hajime

2006-01-01

Background: The Pravastatin Anti-atherosclerosis Trial in the Elderly (PATE) found that the prevalence of cardiovascular events (CVEs) was significantly lower with standard-dose (10–20 mg/d) pravastatin treatment compared with low-dose (5 mg/d) pravastatin treatment in elderly (aged ⩾ 60 years) Japanese patients with hypercholesterolemia. Small differences in on-treatment total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels between the 2 dose groups in the PATE study were associated with significant differences in CVE prevalence. However, the reasons for these differences have not been determined. How sex and age differences influence the effectiveness of pravastatin also remains unclear. Objectives: The aims of this study were to determine the relationship between reduction in LDL-C level and CVE risk reduction in the PATE study and to assess the effects of sex and age on the effectiveness of pravastatin treatment (assessed using CVE risk reduction). Methods: In this post hoc analysis, Cox regression analysis was performed to study the relationship between on-treatment (pravastatin 5–20 mg/d) LDL-C level and CVE risk reduction using age, sex, smoking status, presence of diabetes mellitus and/or hypertension, history of cardiovascular disease (CVD), and high-density lipoprotein cholesterol level as adjustment factors. To explore risk reduction due to unspecified mechanisms other than LDLrC reduction, an estimated Kaplan-Meier curve from the Cox regression analysis was calculated and compared with the empirical (observed) Kaplan-Meier curve. Results: A total of 665 patients (527 women, 138 men; mean [SD] age, 72.8 [5.7] years) were enrolled in PATE and were followed up for a mean of 3.9 years (range, 3–5 years). Of those patients, 50 men and 173 women were ⩾75 years of age. Data from 619 patients were included in the present analysis. In the calculation of model-based Kaplan-Meier curves, data from an additional 32 patients were excluded from the LDL-C analysis because there were no data on pretreatment LDL levels; hence, the data from 587 patients were analyzed. A reduction in LDL-C level of 20 mg/dL was associated with an estimated CVE risk reduction of 24.7% (hazard ratio [HR] = 0.753; 95% CI, 0.625-0.907; P = 0.003). Risk was reduced by 22.2% in patients aged <75 years (HR = 0.778; 95% CI, 0.598–1.013; P = NS) and 29.9% in patients aged ⩾75 years (HR = 0.701; 95% CI, 0.526–0.934; P = 0.015). The risk reductions were 19.8% in women (HR = 0.802; 95% CI, 0.645–0.996; P = 0.046) and 35.8% in men (HR = 0.642; 95% CI, 0.453–0.911; P = 0.013). The risk reduction was 32.4% in patients without a history of CVD at enrollment (HR = 0.676; 95% CI, 0.525–0.870; P = 0.002) and 15.1% in those with a history of CVD (HR = 0.849; 95% CI, 0.630–1.143; P= NS). The estimated Kaplan-Meier curve strongly suggested that the effects of pravastatin were only partially associated with changes in LDLrC level. Conclusions: The results from this post hoc analysis suggest that pravastatin 5 to 20 mg/d might elicit CVE risk reduction by mechanisms other than cholesterol-lowering effects alone. They also suggest that pravastatin treatment might be effective in reducing the risk for CVEs in both female and male patients aged ⩾75 years. PMID:24678100

Influences of age, sex, and LDL-C change on cardiovascular risk reduction with pravastatin treatment in elderly Japanese patients: A post hoc analysis of data from the Pravastatin Anti-atherosclerosis Trial in the Elderly (PATE).

PubMed

Ouchi, Yasuyoshi; Ohashi, Yasuo; Ito, Hideki; Saito, Yasushi; Ishikawa, Toshitsugu; Akishita, Masahiro; Shibata, Taro; Nakamura, Haruo; Orimo, Hajime

2006-07-01

The Pravastatin Anti-atherosclerosis Trial in the Elderly (PATE) found that the prevalence of cardiovascular events (CVEs) was significantly lower with standard-dose (10-20 mg/d) pravastatin treatment compared with low-dose (5 mg/d) pravastatin treatment in elderly (aged ⩾ 60 years) Japanese patients with hypercholesterolemia. Small differences in on-treatment total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels between the 2 dose groups in the PATE study were associated with significant differences in CVE prevalence. However, the reasons for these differences have not been determined. How sex and age differences influence the effectiveness of pravastatin also remains unclear. The aims of this study were to determine the relationship between reduction in LDL-C level and CVE risk reduction in the PATE study and to assess the effects of sex and age on the effectiveness of pravastatin treatment (assessed using CVE risk reduction). In this post hoc analysis, Cox regression analysis was performed to study the relationship between on-treatment (pravastatin 5-20 mg/d) LDL-C level and CVE risk reduction using age, sex, smoking status, presence of diabetes mellitus and/or hypertension, history of cardiovascular disease (CVD), and high-density lipoprotein cholesterol level as adjustment factors. To explore risk reduction due to unspecified mechanisms other than LDLrC reduction, an estimated Kaplan-Meier curve from the Cox regression analysis was calculated and compared with the empirical (observed) Kaplan-Meier curve. A total of 665 patients (527 women, 138 men; mean [SD] age, 72.8 [5.7] years) were enrolled in PATE and were followed up for a mean of 3.9 years (range, 3-5 years). Of those patients, 50 men and 173 women were ⩾75 years of age. Data from 619 patients were included in the present analysis. In the calculation of model-based Kaplan-Meier curves, data from an additional 32 patients were excluded from the LDL-C analysis because there were no data on pretreatment LDL levels; hence, the data from 587 patients were analyzed. A reduction in LDL-C level of 20 mg/dL was associated with an estimated CVE risk reduction of 24.7% (hazard ratio [HR] = 0.753; 95% CI, 0.625-0.907; P = 0.003). Risk was reduced by 22.2% in patients aged <75 years (HR = 0.778; 95% CI, 0.598-1.013; P = NS) and 29.9% in patients aged ⩾75 years (HR = 0.701; 95% CI, 0.526-0.934; P = 0.015). The risk reductions were 19.8% in women (HR = 0.802; 95% CI, 0.645-0.996; P = 0.046) and 35.8% in men (HR = 0.642; 95% CI, 0.453-0.911; P = 0.013). The risk reduction was 32.4% in patients without a history of CVD at enrollment (HR = 0.676; 95% CI, 0.525-0.870; P = 0.002) and 15.1% in those with a history of CVD (HR = 0.849; 95% CI, 0.630-1.143; P= NS). The estimated Kaplan-Meier curve strongly suggested that the effects of pravastatin were only partially associated with changes in LDLrC level. The results from this post hoc analysis suggest that pravastatin 5 to 20 mg/d might elicit CVE risk reduction by mechanisms other than cholesterol-lowering effects alone. They also suggest that pravastatin treatment might be effective in reducing the risk for CVEs in both female and male patients aged ⩾75 years.

The Use of English as Ad Hoc Institutional Standard in the Belgian Asylum Interview

ERIC Educational Resources Information Center

Maryns, Katrijn

2017-01-01

In institutional settings of globalization, labelled languages are generally preferred over multilingual repertoires and mobile language resources. Drawing on linguistic-ethnographic analysis of the way English is treated as an invariable "ad hoc" idiom in the Belgian asylum interview, this article demonstrates how institutional measures…

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

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…

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…

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…

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…

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.

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.

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.

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.

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.

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.

Change in Tongue Morphology in Response to Expiratory Resistance Loading Investigated by Magnetic Resonance Imaging

PubMed Central

Yanagisawa, Yukio; Matsuo, Yoshimi; Shuntoh, Hisato; Mitamura, Masaaki; Horiuchi, Noriaki

2013-01-01

[Purpose] The purpose of this study was to investigate the effect of expiratory resistance load on the tongue area encompassing the suprahyoid and genioglossus muscles. [Subjects] The subjects were 30 healthy individuals (15 males, 15 females, mean age: 28.9 years). [Methods] Magnetic resonance imaging was used to investigate morphological changes in response to resistive expiratory pressure loading in the area encompassing the suprahyoid and genioglossus muscles. Images were taken when water pressure was sustained at 0%, 10%, 30%, and 50% of maximum resistive expiratory pressure. We then measured tongue area using image analysis software, and the morphological changes were analyzed using repeated measures analysis of variance followed by post hoc comparisons. [Results] A significant change in the tongue area was detected in both sexes upon loading. Multiple comparison analysis revealed further significant differences in tongue area as well as changes in tongue area in response to the different expiratory pressures. [Conclusion] The findings demonstrate that higher expiratory pressure facilitates greater reduction in tongue area. PMID:24259824

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

Analysis of Pervasive Mobile Ad Hoc Routing Protocols

NASA Astrophysics Data System (ADS)

Qadri, Nadia N.; Liotta, Antonio

Mobile ad hoc networks (MANETs) are a fundamental element of pervasive networks and therefore, of pervasive systems that truly support pervasive computing, where user can communicate anywhere, anytime and on-the-fly. In fact, future advances in pervasive computing rely on advancements in mobile communication, which includes both infrastructure-based wireless networks and non-infrastructure-based MANETs. MANETs introduce a new communication paradigm, which does not require a fixed infrastructure - they rely on wireless terminals for routing and transport services. Due to highly dynamic topology, absence of established infrastructure for centralized administration, bandwidth constrained wireless links, and limited resources in MANETs, it is challenging to design an efficient and reliable routing protocol. This chapter reviews the key studies carried out so far on the performance of mobile ad hoc routing protocols. We discuss performance issues and metrics required for the evaluation of ad hoc routing protocols. This leads to a survey of existing work, which captures the performance of ad hoc routing algorithms and their behaviour from different perspectives and highlights avenues for future research.

Passive and Active Analysis in DSR-Based Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Dempsey, Tae; Sahin, Gokhan; Morton, Y. T. (Jade)

Security and vulnerabilities in wireless ad hoc networks have been considered at different layers, and many attack strategies have been proposed, including denial of service (DoS) through the intelligent jamming of the most critical packet types of flows in a network. This paper investigates the effectiveness of intelligent jamming in wireless ad hoc networks using the Dynamic Source Routing (DSR) and TCP protocols and introduces an intelligent classifier to facilitate the jamming of such networks. Assuming encrypted packet headers and contents, our classifier is based solely on the observable characteristics of size, inter-arrival timing, and direction and classifies packets with up to 99.4% accuracy in our experiments. Furthermore, we investigate active analysis, which is the combination of a classifier and intelligent jammer to invoke specific responses from a victim network.

Effect of Flibanserin Treatment on Body Weight in Premenopausal and Postmenopausal Women with Hypoactive Sexual Desire Disorder: A Post Hoc Analysis.

PubMed

Kornstein, Susan G; Simon, James A; Apfel, Stuart C; Yuan, James; Barbour, Krista A; Kissling, Robert

2017-11-01

Flibanserin, a 5-HT 1A agonist and 5-HT 2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with HSDD. This analysis included three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg each bedtime (qhs) in premenopausal women, a similarly designed study in postmenopausal women, and a 52-week, open-label extension study in premenopausal women. In a pooled analysis of premenopausal women, mean baseline body mass index (BMI) was 27.0 kg/m 2 in the flibanserin group (n = 1227) and 26.8 kg/m 2 in the placebo group (n = 1238). Among patients who completed 24 weeks of treatment, least squares (LS) mean weight change was -1.4 kg in the flibanserin group (n = 1010) and -0.1 kg in the placebo group (n = 1066; p < 0.0001). Weight loss ≥5% from baseline was reported in 21.0% of patients who received flibanserin and 7.8% of patients who received placebo; weight loss ≥10% was reported in 3.8% and 2.0% of patients, respectively. In postmenopausal women, mean baseline BMI was 27.7 kg/m 2 in the flibanserin group (n = 467) and 27.3 kg/m 2 in the placebo group (n = 480). LS mean weight change at week 24 was -1.8 kg in the flibanserin group (n = 385) and -0.1 kg in the placebo group (n = 425; p < 0.0001), with weight loss ≥5% reported in 24.7% and 7.3% of patients, respectively, and weight loss ≥10% reported in 5.2% and 1.7%, respectively. In HSDD patients with >12 months (n = 880) and >18 months (n = 637) of exposure to flibanserin, mean weight change was -1.0 and -1.2 kg, respectively; 25.4% and 26.9% of patients, respectively, experienced weight loss ≥5% from baseline, and 7.8% and 8.4%, respectively, experienced weight loss ≥10%. Women treated with flibanserin for HSDD may experience weight loss.

Endovascular ultrasound for renal sympathetic denervation in patients with therapy-resistant hypertension not responding to radiofrequency renal sympathetic denervation.

PubMed

Stiermaier, Thomas; Okon, Thomas; Fengler, Karl; Mueller, Ulrike; Hoellriegel, Robert; Schuler, Gerhard; Desch, Steffen; Lurz, Philipp

2016-06-12

Recent studies have reported a considerable number of non-responders after renal sympathetic de-nervation (RSD) with radiofrequency technology. Here we report our results of repeat RSD using ultrasound in these patients. A cohort study was performed in patients who underwent ultrasound RSD after non-response to RSD with radiofrequency. Non-response was defined as mean daytime systolic blood pressure ≥140 mmHg and/or a reduction of ≤10 mmHg in ambulatory blood pressure measurement (ABPM) ≥6 months after radiofrequency denervation. ABPM was recorded at baseline, post radiofrequency RSD as well as at three and six months post ultrasound RSD. A total of 24 non-responders underwent retreatment with the ultrasound device at a mean 15.3±8.2 months after radiofrequency RSD. Ultrasound RSD was performed successfully in all patients without severe adverse events. Mean daytime systolic blood pressure changed from 161.7±14.6 mmHg at baseline to 158.5±9.5 mmHg post radiofrequency RSD and to 150.5±10.4 mmHg and 151.6±11.0 mmHg at three and six months, respectively, post ultrasound RSD (p<0.01 with repeated measures analysis of variance). The main results of post hoc testing were as follows: baseline versus post radiofrequency RSD, p=0.83; baseline versus three months post ultrasound RSD, p=0.01; and baseline versus six months post ultrasound RSD, p=0.04. Ultrasound RSD appears to be safe and an effective therapeutic approach in patients not responding to previous RSD with radiofrequency technology.

Hybrid Packet-Pheromone-Based Probabilistic Routing for Mobile Ad Hoc Networks

NASA Astrophysics Data System (ADS)

Kashkouli Nejad, Keyvan; Shawish, Ahmed; Jiang, Xiaohong; Horiguchi, Susumu

Ad-Hoc networks are collections of mobile nodes communicating using wireless media without any fixed infrastructure. Minimal configuration and quick deployment make Ad-Hoc networks suitable for emergency situations like natural disasters or military conflicts. The current Ad-Hoc networks can only support either high mobility or high transmission rate at a time because they employ static approaches in their routing schemes. However, due to the continuous expansion of the Ad-Hoc network size, node-mobility and transmission rate, the development of new adaptive and dynamic routing schemes has become crucial. In this paper we propose a new routing scheme to support high transmission rates and high node-mobility simultaneously in a big Ad-Hoc network, by combining a new proposed packet-pheromone-based approach with the Hint Based Probabilistic Protocol (HBPP) for congestion avoidance with dynamic path selection in packet forwarding process. Because of using the available feedback information, the proposed algorithm does not introduce any additional overhead. The extensive simulation-based analysis conducted in this paper indicates that the proposed algorithm offers small packet-latency and achieves a significantly higher delivery probability in comparison with the available Hint-Based Probabilistic Protocol (HBPP).

Efficacy and Safety of Roflumilast in Korean Patients with COPD

PubMed Central

Lee, Jae Seung; Hong, Yoon Ki; Park, Tae Sun; Lee, Sei Won; Oh, Yeon-Mok

2016-01-01

Purpose Roflumilast is the only oral phosphodiesterase 4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD) patients [post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted] with chronic bronchitis and a history of frequent exacerbations. This study evaluated the efficacy and safety of roflumilast in Korean patients with COPD and compared the efficacy based on the severity of airflow limitation. Materials and Methods A post-hoc subgroup analysis was performed in Korean COPD patients participating in JADE, a 12-week, double-blinded, placebo-controlled, parallel-group, phase III trial in Asia. The primary efficacy endpoint was the mean [least-squares mean adjusted for covariates (LSMean)] change in post-bronchodilator FEV1 from baseline to each post-randomization visit. Safety endpoints included adverse events (AEs) and changes in laboratory values, vital signs, and electrocardiograms. Results A total of 260 Korean COPD patients were recruited, of which 207 were randomized to roflumilast (n=102) or placebo (n=105) treatment. After 12 weeks, LSMean post-bronchodilator FEV1 increased by 43 mL for patients receiving roflumilast and decreased by 60 mL for those taking placebo. Adverse events were more common in the roflumilast group than in the placebo group; however, the types and frequency of AEs were comparable to those reported in previous studies. Conclusion Roflumilast significantly improved lung function with a tolerable safety profile in Korean COPD patients irrespective of the severity of airflow limitation. PMID:27189287

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.

Accumulation of contaminants in fish from wastewater treatment wetlands

USGS Publications Warehouse

Barber, L.B.; Keefe, S.H.; Antweiler, Ronald C.; Taylor, Howard E.; Wass, R.D.

2006-01-01

Increasing demands on water resources in arid environments make reclamation and reuse of municipal wastewater an important component of the water budget. Treatment wetlands can be an integral part of the water-reuse cycle providing both water-quality enhancement and habitat functions. When used for habitat, the bioaccumulation potential of contaminants in the wastewater is a critical consideration. Water and fish samples collected from the Tres Rios Demonstration Constructed Wetlands near Phoenix, Arizona, which uses secondary-treated wastewater to maintain an aquatic ecosystem in a desert environment, were analyzed for hydrophobic organic compounds (HOC) and trace elements. Semipermeable membrane devices (SPMD) were deployed to investigate uptake of HOC. The wetlands effectively removed HOC, and concentrations of herbicides, pesticides, and organic wastewater contaminants decreased 40-99% between inlet and outlet. Analysis of Tilapia mossambica and Gambusia affinis indicated accumulation of HOC, including p,p???-DDE and trans-nonachlor. The SPMD accumulated the HOC detected in the fish tissue as well as additional compounds. Trace-element concentrations in whole-fish tissue were highly variable, but were similar between the two species. Concentrations of HOC and trace elements varied in different fish tissue compartments, and concentrations in Tilapia liver tissue were greater than those in the whole organism or filet tissue. Bioconcentration factors for the trace elements ranged from 5 to 58 000 and for the HOC ranged from 530 to 150 000. ?? 2006 American Chemical Society.

Different effects of transcutaneous electric nerve stimulation and electroacupuncture at ST36–ST37 on the cerebral cortex

PubMed Central

Kang, Yu-Tien; Liao, Yi-Sheng; Hsieh, Ching-Liang

2015-01-01

Background The effects of transcutaneous electric nerve stimulation (TENS) and electroacupuncture (EA) on the cerebral cortex are largely unclear. The purpose of the present study was to investigate the effect of TENS and EA on the cerebral cortex by examining their effect on the median nerve-somatosensory evoked potentials (MN-SEPs). Methods Twenty volunteers were studied. The cortical and cervical spinal potentials were recorded by median nerve stimulation at the left wrist. Sham TENS, 2 Hz TENS and 2 Hz EA were applied to both ST36 and ST37. MN-SEPs were recorded during sham TENS, 2 Hz TENS and 2 Hz EA, with at least 1 week interval for each subject. One-way analysis of variance was used to determine the differences in latency and amplitude of the MN-SEPs observed in the stimulation and post-stimulation periods compared with baseline. Scheffe's post hoc correction was employed to identify pairwise differences. Results No differences in mean latency were found between the stimulation procedures during the stimulation and post-stimulation periods. 2 Hz EA but not sham TENS or 2 Hz TENS caused higher mean amplitudes in N20 and N30 during the stimulation and post-stimulation periods. Conclusions EA, but not TENS, induces changes in certain components of the signal. PMID:25432425

Genetic Moderation of Interpersonal Psychotherapy Efficacy for Low-Income Mothers with Major Depressive Disorder: Implications for Differential Susceptibility

PubMed Central

Cicchetti, Dante; Toth, Sheree L.; Handley, Elizabeth D.

2015-01-01

Genetic moderation of interpersonal psychotherapy (IPT) efficacy for economically disadvantaged women with major depressive disorder was examined. Specifically, we investigated whether genotypic variation in corticotropin releasing hormone receptor 1 (CRHR1) and the serotonin transporter gene (5-HTT) moderated effects of IPT on depressive symptoms over time. We also tested genotype moderation of IPT mechanisms social adjustment and perceived stress. Non-treatment seeking urban women at or below the poverty level with infants were recruited from the community (N = 126; M age = 25.33; SD = 4.99; 54.0% African-American, 22.2% Caucasian, and 23.8% Hispanic/biracial) and randomized to individual IPT or enhanced community standard (ECS). Results revealed that changes in depressive symptoms over time depended on both intervention group and genotypes (5-HTTLPR and CRHR1). Moreover, multiple-group path analysis indicated that IPT improved depressive symptoms, increased social adjustment and decreased perceived stress at post-treatment among women with the 0 copies of the CRHR1 TAT haplotype only. Finally, improved social adjustment at post-intervention significantly mediated the effect of IPT on reduced depressive symptoms at 8 months post-intervention for women 0 copies of the TAT haplotype only. Post-hoc analyses of 5-HTTLPR were indicative of differential susceptibility, albeit among African-American women only. PMID:25640828

Music intervention to prevent delirium among older patients admitted to a trauma intensive care unit and a trauma orthopaedic unit.

PubMed

Johnson, Kari; Fleury, Julie; McClain, Darya

2018-08-01

Evaluate music listening for delirium prevention among patients admitted to a Trauma Intensive Care and Trauma Orthopaedic Unit. The Roy Adaptation Model provided the theoretical framework focusing on modifying contextual stimuli. Randomised controlled trial, 40 patients aged 55 and older. Participants randomly assigned to receive music listening or usual care for 60 minutes, twice a day, over three days. Pre-recorded self-selected music using an iPod and headsets, with slow tempo, low pitch and simple repetitive rhythms to alter physiologic responses. Heart rate, respiratory rate, systolic and diastolic blood pressure, confusion assessment method. Repeated measures ANOVA, F(4, 134) = 4.75, p = .001, suggested statistically significant differences in heart rate pre/post music listening, and F(1, 37) = 10.44, p = .003 in systolic blood pressure pre/post music listening. Post-hoc analysis reported changes at three time periods of statistical significance; (p = .010), (p = .005) and (p = .039) and a change in systolic blood pressure pre/post music listening; (p = .001) of statistical significance. All participants screened negative for delirium. Music addresses pathophysiologic mechanisms that contribute to delirium; neurotransmitter imbalance, inflammation and acute physiologic stressors. Music to prevent delirium is one of few that provide support in a critical care setting. Copyright © 2018 Elsevier Ltd. All rights reserved.

Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate

PubMed Central

Singh, Satinder Pal; Jena, Ashok Kumar; Rattan, Vidya; Utreja, Ashok Kumar

2012-01-01

Aim: To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Materials and Methods: Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months) after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Results: Maxillary distraction resulted in significant advancement of maxilla (P<0.001). Counterclockwise rotation of the palatal plane took place after maxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Conclusions: Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable. PMID:22919221

Treatment outcome and long-term stability of skeletal changes following maxillary distraction in adult subjects of cleft lip and palate.

PubMed

Singh, Satinder Pal; Jena, Ashok Kumar; Rattan, Vidya; Utreja, Ashok Kumar

2012-04-01

To evaluate the treatment outcome and long-term stability of skeletal changes following maxillary advancement with distraction osteogenesis in adult subjects of cleft lip and palate. Total 12 North Indian adult patients in the age range of 17-34 years with cleft lip and palate underwent advancement of maxilla by distraction osteogenesis. Lateral cephalograms recorded prior to distraction, at the end of distraction, 6 months after distraction, and at least 24 months (mean 25.5 ± 1.94 months) after distraction osteogenesis were used for the evaluation of treatment outcome and long-term stability of the skeletal changes. Descriptive analysis, ANOVA, and post-hoc test were used, and P-value 0.05 was considered as a statistically significant level. Maxillary distraction resulted in significant advancement of maxilla (P<0.001). Counterclockwise rotation of the palatal plane took place after maxillary distraction. The position of the mandible and facial heights were stable during distraction. During the first 6 months of the post-distraction period, the maxilla showed relapse of approximately 30%. However, after 6 months post distraction, the relapse was very negligible. Successful advancement of maxilla was achieved by distraction osteogenesis in adult subjects with cleft lip and palate. Most of the relapse occurred during the first 6 months of post-distraction period, and after that the outcomes were stable.

Evaluation of an employer-sponsored pedometer-based physical activity program.

PubMed

Behrens, Timothy K; Domina, Lorie; Fletcher, Gena M

2007-12-01

This study evaluated a competition-based employer-sponsored physical activity program using pedometers. City employees (N approximately 2,600) formed teams in groups of 10 persons (N = 640). The groups competed against each other over a 12-wk. period with the goal of attaining 10,000 steps per day, per person. Only teams with complete data were included in the formal evaluation. A repeated-measures analysis of variance indicated significant differences in team steps by week of the program, with post hoc comparisons indicating significant differences from baseline step counts evident during Weeks 6-8 but not at the end of the program. These data confirm that competition-based physical activity programs using pedometers may not be an effective means of increasing the long-term physical activity of employees.

Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

PubMed

Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

2001-10-01

A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

Stimuli eliciting sexual arousal in males who offend adult women: an experimental study.

PubMed

Kolárský, A; Madlafousek, J; Novotná, V

1978-03-01

The sexually arousing effects of short film scenes showing a naked actress's seductive behavior were phalloplethysmographically measured in 14 sexual deviates. These were males who had offended adult women, predominantly exhibitionists. Controls were 14 normal men. Deviates responded positively to the scenes and differentiated strong and weak seduction scenes similarly to normals. Consequently, the question arises of why deviates avoid their victim's erotic cooperation and why they do not offend their regular sexual partners. Post hoc analysis of five scenes which elicited a strikingly higher response in deviates than in normals suggested that these scenes contained reduced seductive behavior but unrestrained presentation of the genitals. This finding further encourages the laboratory study of stimulus conditions for abnormal sexual arousal which occurs during the sexual offense.

Effects of Carbohydrate and Glutamine Supplementation on Oral Mucosa Immunity after Strenuous Exercise at High Altitude: A Double-Blind Randomized Trial.

PubMed

Caris, Aline Venticinque; Da Silva, Edgar Tavares; Dos Santos, Samile Amorim; Tufik, Sergio; Dos Santos, Ronaldo Vagner Thomatieli

2017-07-03

This study analyzed the effects of carbohydrate and glutamine supplementation on salivary immunity after exercise at a simulated altitude of 4500 m. Fifteen volunteers performed exercise of 70% of VO 2peak until exhaustion and were divided into three groups: hypoxia placebo, hypoxia 8% maltodextrin (200 mL/20 min), and hypoxia after six days glutamine (20 g/day) and 8% maltodextrin (200 mL/20 min). All procedures were randomized and double-blind. Saliva was collected at rest (basal), before exercise (pre-exercise), immediately after exercise (post-exercise), and two hours after exercise. Analysis of Variance (ANOVA) for repeated measures and Tukey post hoc test were performed. Statistical significance was set at p < 0.05. SaO₂% reduced when comparing baseline vs. pre-exercise, post-exercise, and after recovery for all three groups. There was also a reduction of SaO₂% in pre-exercise vs. post-exercise for the hypoxia group and an increase was observed in pre-exercise vs. recovery for both supplementation groups, and between post-exercise and for the three groups studied. There was an increase of salivary flow in post-exercise vs. recovery in Hypoxia + Carbohydrate group. Immunoglobulin A (IgA) decreased from baseline vs. post-exercise for Hypoxia + Glutamine group. Interleukin 10 (IL-10) increased from post-exercise vs. after recovery in Hypoxia + Carbohydrate group. Reduction of tumor necrosis factor alpha (TNF-α) was observed from baseline vs. post-exercise and after recovery for the Hypoxia + Carbohydrate group; a lower concentration was observed in pre-exercise vs. post-exercise and recovery. TNF-α had a reduction from baseline vs. post-exercise for both supplementation groups, and a lower secretion between baseline vs. recovery, and pre-exercise vs. post-exercise for Hypoxia + Carbohydrate group. Five hours of hypoxia and exercise did not change IgA. Carbohydrates, with greater efficiency than glutamine, induced anti-inflammatory responses.

Effects of Carbohydrate and Glutamine Supplementation on Oral Mucosa Immunity after Strenuous Exercise at High Altitude: A Double-Blind Randomized Trial

PubMed Central

Caris, Aline Venticinque; Da Silva, Edgar Tavares; Dos Santos, Samile Amorim; Tufik, Sergio

2017-01-01

This study analyzed the effects of carbohydrate and glutamine supplementation on salivary immunity after exercise at a simulated altitude of 4500 m. Fifteen volunteers performed exercise of 70% of VO2peak until exhaustion and were divided into three groups: hypoxia placebo, hypoxia 8% maltodextrin (200 mL/20 min), and hypoxia after six days glutamine (20 g/day) and 8% maltodextrin (200 mL/20 min). All procedures were randomized and double-blind. Saliva was collected at rest (basal), before exercise (pre-exercise), immediately after exercise (post-exercise), and two hours after exercise. Analysis of Variance (ANOVA) for repeated measures and Tukey post hoc test were performed. Statistical significance was set at p < 0.05. SaO2% reduced when comparing baseline vs. pre-exercise, post-exercise, and after recovery for all three groups. There was also a reduction of SaO2% in pre-exercise vs. post-exercise for the hypoxia group and an increase was observed in pre-exercise vs. recovery for both supplementation groups, and between post-exercise and for the three groups studied. There was an increase of salivary flow in post-exercise vs. recovery in Hypoxia + Carbohydrate group. Immunoglobulin A (IgA) decreased from baseline vs. post-exercise for Hypoxia + Glutamine group. Interleukin 10 (IL-10) increased from post-exercise vs. after recovery in Hypoxia + Carbohydrate group. Reduction of tumor necrosis factor alpha (TNF-α) was observed from baseline vs. post-exercise and after recovery for the Hypoxia + Carbohydrate group; a lower concentration was observed in pre-exercise vs. post-exercise and recovery. TNF-α had a reduction from baseline vs. post-exercise for both supplementation groups, and a lower secretion between baseline vs. recovery, and pre-exercise vs. post-exercise for Hypoxia + Carbohydrate group. Five hours of hypoxia and exercise did not change IgA. Carbohydrates, with greater efficiency than glutamine, induced anti-inflammatory responses. PMID:28671626

Integrating Problem-Based Learning and Simulation: Effects on Student Motivation and Life Skills.

PubMed

Roh, Young Sook; Kim, Sang Suk

2015-07-01

Previous research has suggested that a teaching strategy integrating problem-based learning and simulation may be superior to traditional lecture. The purpose of this study was to assess learner motivation and life skills before and after taking a course involving problem-based learning and simulation. The design used repeated measures with a convenience sample of 83 second-year nursing students who completed the integrated course. Data from a self-administered questionnaire measuring learner motivation and life skills were collected at pretest, post-problem-based learning, and post-simulation time points. Repeated-measures analysis of variance determined that the mean scores for total learner motivation (F=6.62, P=.003), communication (F=8.27, P<.001), problem solving (F=6.91, P=.001), and self-directed learning (F=4.45, P=.016) differed significantly between time points. Post hoc tests using the Bonferroni correction revealed that total learner motivation and total life skills significantly increased both from pretest to postsimulation and from post-problem-based learning test to postsimulation test. Subscales of learner motivation and life skills, intrinsic goal orientation, self-efficacy for learning and performance, problem-solving skills, and self-directed learning skills significantly increased both from pretest to postsimulation test and from post-problem-based learning test to post-simulation test. The results demonstrate that an integrating problem-based learning and simulation course elicits significant improvement in learner motivation and life skills. Simulation plus problem-based learning is more effective than problem-based learning alone at increasing intrinsic goal orientation, task value, self-efficacy for learning and performance, problem solving, and self-directed learning.