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.

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

PubMed

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

2014-03-06

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

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

ERIC Educational Resources Information Center

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

2016-01-01

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

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

ERIC Educational Resources Information Center

DuRapau, Theresa M.

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

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

ERIC Educational Resources Information Center

Osler, James Edward

2014-01-01

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

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

ERIC Educational Resources Information Center

Hutchinson, Susan R.

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

Post hoc analyses: after the facts.

PubMed

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

2015-01-01

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

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

PubMed

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

2016-12-01

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

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…

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.

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

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

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.

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.

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.

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

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

PubMed

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

2017-09-01

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

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

PubMed

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

2013-07-01

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

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

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

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.

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

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.

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

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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

PubMed

Kimura, Go; Ueda, Takeshi

2017-03-01

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

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

PubMed Central

Ueda, Takeshi

2017-01-01

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

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…

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,…

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.

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.

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

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.

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.

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…

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…

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…

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.

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

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).

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.

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.

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…

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…

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.

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.

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.

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.

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…

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.

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.

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

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

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.

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.

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.

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...

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…

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…

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…

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…

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

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

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.

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

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.

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.

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.

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.

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…

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…

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…

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…

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…

Pruning and Prioritising: A Case Study of a Pragmatic Method for Managing a Rapid Systematic Review with Limited Resources

ERIC Educational Resources Information Center

Harnan, Sue Elizabeth; Cooper, Katy; Jones, Sarah Lynne; Jones, Elaine

2015-01-01

Full systematic reviews are time and resource heavy. We describe a method successfully used to produce a rapid review of yoga for health and wellbeing, with limited resources, using mapping methods. Inclusion and exclusion criteria were developed a priori and refined "post hoc," with the review team blind to the study results to minimise…

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.

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.

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…

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.

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

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.

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.

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.

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…

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…

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.

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

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-...

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.

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.

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.

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.

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…

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…

Factors That Affect Age of Identification of Children with an Autism Spectrum Disorder

ERIC Educational Resources Information Center

Adelman, Chana R.; Kubiszyn, Thomas

2017-01-01

This study explored factors associated with age of identification of autism spectrum disorder (ASD). Results of a one-way ANOVA indicated differences in age of diagnosis among the four regions in the United States, F(3, 650) = 7.618, p = 0.01. Tukey's post hoc comparisons of the groups indicated that the mean age of diagnosis in the Midwest (M =…

Duodenal and ileal glucose infusions differentially alter gastrointestinal peptides, appetite response, and food intake: a tube feeding study.

PubMed

Poppitt, Sally D; Shin, Hyun Sang; McGill, Anne-Thea; Budgett, Stephanie C; Lo, Kim; Pahl, Malcolm; Duxfield, Janice; Lane, Mark; Ingram, John R

2017-09-01

Background: Activation of the ileal brake through the delivery of nutrients into the distal small intestine to promote satiety and suppress food intake provides a new target for weight loss. Evidence is limited, with support from naso-ileal lipid infusion studies. Objective: The objective of the study was to investigate whether glucose infused into the duodenum and ileum differentially alters appetite response, food intake, and secretion of satiety-related gastrointestinal peptides. Design: Fourteen healthy male participants were randomly assigned to a blinded 4-treatment crossover, with each treatment of single-day duration. On the day before the intervention (day 0), a 380-cm multilumen tube (1.75-mm diameter) with independent port access to the duodenum and ileum was inserted, and position was confirmed by X-ray. Subsequently (days 1-4), a standardized breakfast meal was followed midmorning by a 90-min infusion of isotonic glucose (15 g, 235 kJ) or saline to the duodenum or ileum. Appetite ratings were assessed with the use of visual analog scales (VASs), blood samples collected, and ad libitum energy intake (EI) measured at lunch, afternoon snack, and dinner. Results: Thirteen participants completed the 4 infusion days. There was a significant effect of nutrient infused and site (treatment × time, P < 0.05) such that glucose-to-ileum altered VAS-rated fullness, satisfaction, and thoughts of food compared with saline-to-ileum (Tukey's post hoc, P < 0.05); decreased ad libitum EI at lunch compared with glucose-to-duodenum [-22%, -988 ± 379 kJ (mean ± SEM), Tukey's post hoc, P < 0.05]; and increased glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) compared with all other treatments (Tukey's post hoc, P < 0.05). Conclusions: Macronutrient delivery to the proximal and distal small intestine elicits different outcomes. Glucose infusion to the ileum increased GLP-1 and PYY secretion, suppressed aspects of VAS-rated appetite, and decreased ad libitum EI at a subsequent meal. Although glucose to the duodenum also suppressed appetite ratings, eating behavior was not altered. This trial was registered at www.anzctr.org.au as ACTRN12612000429853. © 2017 American Society for Nutrition.

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

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

Once-monthly injection of paliperidone palmitate in patients with recently diagnosed and chronic schizophrenia: a post-hoc comparison of efficacy and safety.

PubMed

Si, Tianmei; Zhuo, Jianmin; Turkoz, Ibrahim; Mathews, Maju; Tan, Wilson; Feng, Yu

2017-12-01

The use of long-acting injectable antipsychotics in recently diagnosed schizophrenia remains less explored. We evaluated the efficacy and safety of paliperidone palmitate once-monthly (PP1M) treatment in adult patients with recently diagnosed vs. chronic schizophrenia. These post-hoc analyses included two multicenter studies. Study 1 (NCT01527305) enrolled recently diagnosed (≤5 years) and chronic (>5 years) patients; Study 2 (NCT01051531) enrolled recently diagnosed patients only. Recently diagnosed patients were further sub-grouped into ≤2 years or 2-5 years. The primary efficacy endpoint was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score. In Study 1, 41.5% patients had recent diagnosis (≤2 years: 56.8%; 2-5 years: 43.2%); 58.5% had chronic schizophrenia. In Study 2, 52.8% and 47.2% patients were grouped into ≤2 years and 2-5 years, respectively. PANSS total score showed significantly greater improvement in patients with recently diagnosed vs. chronic schizophrenia. Similar results were obtained for PANSS responder rate, improvements in PANSS, and CGI-S scores. PP1M was efficacious in both recently diagnosed and chronic schizophrenia, with the benefits being more pronounced in patients with recently diagnosed schizophrenia. This adds to growing evidence recommending long-acting antipsychotic interventions at early stages of schizophrenia.

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

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.

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.

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.

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

Influence of Skip Patterns on Item Non-Response in a Substance Use Survey of 7th to 12th Grade Students

ERIC Educational Resources Information Center

Ding, Kele; Olds, R. Scott; Thombs, Dennis L.

2009-01-01

This retrospective case study assessed the influence of item non-response error on subsequent response to questionnaire items assessing adolescent alcohol and marijuana use. Post-hoc analyses were conducted on survey results obtained from 4,371 7th to 12th grade students in Ohio in 2005. A skip pattern design in a conventional questionnaire…

Creating a Common Scale by Post-Hoc IRT Equating to Investigate the Effects of the New National Educational Policy in Japan

ERIC Educational Resources Information Center

Saida, Chisato

2017-01-01

The new national educational policy was implemented at secondary schools in 2002 in Japan. The revised Course of Study for foreign language education corresponding to the national educational policy decreased the number of English lessons per week from four to three at the junior high school level, which resulted in a 25% decrease in English…

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.

Evidence that genetic variation in the oxytocin receptor (OXTR) gene influences social cognition in ADHD.

PubMed

Park, J; Willmott, M; Vetuz, G; Toye, C; Kirley, A; Hawi, Z; Brookes, K J; Gill, M; Kent, L

2010-05-30

Some children with ADHD also have social and communication difficulties similar to those seen in children with autistic spectrum disorders and this may be due to shared genetic liability. As the oxytocin receptor (OXTR) gene has been implicated in social cognition and autistic spectrum disorders, this study investigated whether OXTR polymorphisms previously implicated in autism were associated with ADHD and whether they influenced OXTR mRNA expression in 27 normal human amygdala brain samples. The family-based association sample consisted of 450 DSM-IV diagnosed ADHD probands and their parents. Although there was no association with the ADHD phenotype, an association with social cognitive impairments in a subset of the ADHD probands (N=112) was found for SNP rs53576 (F=5.24, p=0.007) with post-hoc tests demonstrating that the AA genotype was associated with better social ability compared to the AG genotype. Additionally, significant association was also found for rs13316193 (F=3.09, p=0.05) with post-hoc tests demonstrating that the CC genotype was significantly associated with poorer social ability than the TT genotype. No significant association between genotype and OXTR mRNA expression was found. This study supports previous evidence that the OXTR gene is implicated in social cognition. Copyright 2010 Elsevier Inc. All rights reserved.

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

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.

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.

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.

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.

Influencing Anesthesia Provider Behavior Using Anesthesia Information Management System Data for Near Real-Time Alerts and Post Hoc Reports.

PubMed

Epstein, Richard H; Dexter, Franklin; Patel, Neil

2015-09-01

In this review article, we address issues related to using data from anesthesia information management systems (AIMS) to deliver near real-time alerts via AIMS workstation popups and/or alphanumeric pagers and post hoc reports via e-mail. We focus on reports and alerts for influencing the behavior of anesthesia providers (i.e., anesthesiologists, anesthesia residents, and nurse anesthetists). Multiple studies have shown that anesthesia clinical decision support (CDS) improves adherence to protocols and increases financial performance through facilitation of billing, regulatory, and compliance documentation; however, improved clinical outcomes have not been demonstrated. We inform developers and users of feedback systems about the multitude of concerns to consider during development and implementation of CDS to increase its effectiveness and to mitigate its potentially disruptive aspects. We discuss the timing and modalities used to deliver messages, implications of outlier-only versus individualized feedback, the need to consider possible unintended consequences of such feedback, regulations, sustainability, and portability among systems. We discuss statistical issues related to the appropriate evaluation of CDS efficacy. We provide a systematic review of the published literature (indexed in PubMed) of anesthesia CDS and offer 2 case studies of CDS interventions using AIMS data from our own institution illustrating the salient points. Because of the considerable expense and complexity of maintaining near real-time CDS systems, as compared with providing individual reports via e-mail after the fact, we suggest that if the same goal can be accomplished via delayed reporting versus immediate feedback, the former approach is preferable. Nevertheless, some processes require near real-time alerts to produce the desired improvement. Post hoc e-mail reporting from enterprise-wide electronic health record systems is straightforward and can be accomplished using system-independent pathways (e.g., via built-in e-mail support provided by the relational database management system). However, for some of these enterprise-wide systems, near real-time data access, necessary for CDS that generates concurrent alerts, has been challenging to implement.

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.

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.

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.

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

Translational Pharmacologic Efficacy Studies of Glial Growth Factor 2 (GGF2) in Spinal Cord Injury Models and in the Veterinary Clinical Setting

DTIC Science & Technology

2015-07-01

optimal dosage was examined using a model of rodent SCI and testing several dose levels delivered either subcutaneously (SC) or intravenously (IV...to saline treated controls. ANOVA with Dunett’s post hoc test , pɘ.05. Based on these results, the studies in year 2 compared effects of SC...ventrally and ventral- laterally . The lesion in the Acorda model was characterized by a dorsal-ventral flattening of the cord profile with a highly

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…

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...

Migraine and triggers: Post hoc ergo propter hoc?

PubMed Central

Hoffmann, Jan; Recober, Ana

2013-01-01

The influence of environmental factors on the clinical manifestation of migraine has been a matter of extensive debate over the past decades. Migraineurs commonly report foods, alcohol, meteorologic or atmospheric changes, exposure to light, sounds, or odors, as factors that trigger or aggravate their migraine attacks. In the same way, physicians frequently follow this belief in their recommendations in how migraineurs may reduce their attack frequency, especially with regard to the consumption of certain food components. Interestingly, despite being such a common belief, most of the clinical studies have shown conflicting results. The aim of the review is to critically analyze clinical and pathophysiological facts that support or refute a correlation between certain environmental stimuli and the occurrence of migraine attacks. Given the substantial discrepancy between patients' reports and objective clinical data, the methodological difficulties of investigating the link between environmental factors and migraine are highlighted. PMID:23996725

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

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

NASA Astrophysics Data System (ADS)

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

2007-05-01

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

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

NASA Astrophysics Data System (ADS)

Udphuay, Suwimon; Günther, Thomas; Everett, Mark E.; Warden, Robert R.; Briaud, Jean-Louis

2011-04-01

Pointe du Hoc overlooking the English Channel in Normandy, France was host to one of the most important military engagements of World War II but is vulnerable to cliff collapses that threaten important German fortifications including the forward observation post (OP) and Rudder's command post. The objective of this study is to apply advanced 3-D resistivity tomography towards a detailed site stability assessment with special attention to the two at-risk buildings. 3-D resistivity tomography data sets at Pointe du Hoc in the presence of extreme topography and dense cultural clutter have been successfully acquired, inverted and interpreted. A cliff stability hazard assessment scheme has been designed in which regions of high resistivity are interpreted as zones of open, dry fractures with a moderate mass movement potential. Regions of low resistivity are zones of wet, clay-filled fractures with a high mass movement potential. The OP tomography results indicate that the highest mass movement hazard appears to be associated with the marine caverns at the base of the cliff that are positioned at the point of strongest wave attack. These caverns likely occupy the future site of development of a sea arch that will threaten the OP building. The mass movement potential at the Rudder's command post area is low to moderate. The greatest risk there is associated with soil wedge failures at the top of the cliffs.

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.

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.

An evidence-based review of pregabalin for the treatment of fibromyalgia.

PubMed

Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

2018-04-16

Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

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.

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

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.

Reforming the Police in Post-Soviet States: Georgia and Kyrgyzstan

DTIC Science & Technology

2013-11-01

expected to be dedicated to their profes- sion “because it is difficult, dangerous , routine, you deal with crazy people.”43 Most servicemen return for...transnational threats such as terrorism, drug trafficking, and organized crime. Still, most of OSCE projects were ad hoc, not following any coher- ent...newsletter, please subscribe on the SSI website at www.StrategicStudiesInstitute.army.mil/newsletter. ISBN 1-58487-601-8 v FOREWORD In most Soviet successor

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

Emotion recognition ability in mothers at high and low risk for child physical abuse.

PubMed

Balge, K A; Milner, J S

2000-10-01

The study sought to determine if high-risk, compared to low-risk, mothers make more emotion recognition errors when they attempt to recognize emotions in children and adults. Thirty-two demographically matched high-risk (n = 16) and low-risk (n = 16) mothers were asked to identify different emotions expressed by children and adults. Sets of high- and low-intensity, visual and auditory emotions were presented. Mothers also completed measures of stress, depression, and ego-strength. High-risk, compared to low-risk, mothers showed a tendency to make more errors on the visual and auditory emotion recognition tasks, with a trend toward more errors on the low-intensity, visual stimuli. However, the observed trends were not significant. Only a post-hoc test of error rates across all stimuli indicated that high-risk, compared to low-risk, mothers made significantly more emotion recognition errors. Although situational stress differences were not found, high-risk mothers reported significantly higher levels of general parenting stress and depression and lower levels of ego-strength. Since only trends and a significant post hoc finding of more overall emotion recognition errors in high-risk mothers were observed, additional research is needed to determine if high-risk mothers have emotion recognition deficits that may impact parent-child interactions. As in prior research, the study found that high-risk mothers reported more parenting stress and depression and less ego-strength.

Safety and efficacy of canagliflozin in Japanese patients with type 2 diabetes mellitus: post hoc subgroup analyses according to body mass index in a 52-week open-label study.

PubMed

Inagaki, Nobuya; Goda, Maki; Yokota, Shoko; Maruyama, Nobuko; Iijima, Hiroaki

2015-01-01

The safety and efficacy of sodium glucose co-transporter 2 inhibitors in non-obese compared with obese patients with type 2 diabetes mellitus is unknown. We conducted post hoc analyses of the results of a 52-week open-label study of Japanese type 2 diabetes mellitus patients treated with 100 or 200 mg canagliflozin. Patients were divided into four subgroups according to their baseline body mass index (BMI): group I, BMI < 22 kg/m(2); group II, BMI ≥ 22 to < 25 kg/m(2); group III, BMI ≥ 25 to < 30 kg/m(2) and group IV, BMI ≥ 30 kg/m(2). The overall safety was similar among the four BMI subgroups, although there were slight differences in terms of the incidences of hypoglycemia, asymptomatic hypoglycemia, female genital infections and proportions of patients with total ketone body levels exceeding 1000 μmol/l at any time for both canagliflozin doses. Hemoglobin A1c, fasting plasma glucose and body weight decreased significantly from baseline to week 52 at both canagliflozin doses. The changes in hemoglobin A1c, and fasting plasma glucose were not significantly different among the four BMI subgroups for either dose. Canagliflozin was tolerated in patients irrespective of their BMI at the start of treatment, although some caution may be needed.

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

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.

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.

Predictors of cancer fear: the association between mass media and fear of cancer among cancer diagnosed and nondiagnosed individuals.

PubMed

Nelissen, Sara; Beullens, Kathleen; Lemal, Marijke; Van den Bulck, Jan

2015-03-01

Few studies have explored the impact of mass media on fear of cancer levels. This study investigates whether television and Internet use are associated with fear of cancer, and whether this association is different for cancer diagnosed and nondiagnosed individuals. A quantitative, standardized survey was used and administered to 2008 respondents in Flanders (Belgium), of which 621 individuals were diagnosed with cancer. For statistical analyses, hierarchical regression analyses, independent samples T-tests and post hoc mediation analyses were conducted. The results indicated that cancer diagnosed individuals differed from nondiagnosed individuals in terms of perceived cancer susceptibility, perceived cancer severity, fear of cancer, and media use. Furthermore, television exposure was directly and positively related to fear of cancer, whereas Internet use was not. The relationship between television and Internet use and fear of cancer was not different for cancer diagnosed and nondiagnosed individuals. Additional post hoc mediation analyses, however, seemed to suggest that watching more television and surfing more on the Internet could both lead to having a more negative perceived health and this was in turn associated with higher fear of cancer. To help reduce the burden of fear of cancer, cancer educators and individuals working with cancer patients need to be aware of the possible negative effects media use might have on health perception and on the levels of fear of cancer.

Patient Simulation for Assessment of Layperson Management of Opioid Overdose with Intranasal Naloxone in a Recently-Released Prisoner Cohort

PubMed Central

Kobayashi, Leo; Green, Traci C.; Bowman, Sarah E.; Ray, Madeline C.; McKenzie, Michelle S.; Rich, Josiah D.

2016-01-01

Introduction Investigators applied simulation to an experimental program that educated, trained and assessed at-risk, volunteering prisoners on opioid overdose (OD) prevention, recognition and layperson management with intranasal (IN) naloxone. Methods Consenting inmates were assessed for OD-related experience and knowledge then exposed on-site to standardized didactics and educational DVD (without simulation). Subjects were provided with IN naloxone kits at time of release and scheduled for post-release assessment. At follow-up, subjects were evaluated for their performance of layperson opioid OD resuscitative skills during video-recorded simulations. Two investigators independently scored each subject’s resuscitative actions with a 21-item checklist; post-hoc video reviews were separately completed to adjudicate subjects’ interactions for overall benefit or harm. Results One hundred and three prisoners completed the baseline assessment and study intervention then were prescribed IN naloxone kits. One-month follow-up and simulation data were available for 85 subjects (82.5% of trained recruits) who had been released and resided in the community. Subjects’ simulation checklist median score was 12.0 (IQR 11.0–15.0) out of 21 total indicated actions. Forty-four participants (51.8%) correctly administered naloxone; 16 additional subjects (18.8%) suboptimally administered naloxone. Non-indicated actions, primarily chest compressions, were observed in 49.4% of simulations. Simulated resuscitative actions by 80 subjects (94.1%) were determined post-hoc to be beneficial overall for patients overdosing on opioids. Conclusions As part of an opioid OD prevention research program for at-risk inmates, investigators applied simulation to 1-month follow-up assessments of knowledge retention and skills acquisition in post-release participants. Simulation supplemented traditional research tools for investigation of layperson OD management. PMID:28146450

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.

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.

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

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.

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.

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

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.

[Effects of radiation emitted from mobile phones on short- term heart rate variability parameters].

PubMed

Yıldız, Metin; Yılmaz, Derya; Güler, Inan; Akgüllü, Cağdaş

2012-08-01

In this study, the effects of radiation emitted from mobile phone (MP) on heart rate variability (HRV) which is accepted a non-invasive indicator of autonomic nervous system (ANS) were investigated with considering the deficiency of previous studies. A randomized controlled study has been designed and utilized with 30 young and healthy volunteers. During the experiment that had three periods, the electrocardiogram (ECG) and respiration signals were recorded and MP was attached to subjects' right ear with a bone. Ten subjects selected randomly were exposed to high -level radiation during the second period (Experimental Group 1). Ten of others were exposed during the third period with maximum level radiation (Experimental Group 2). Ten records were also made while MP was closed as a control. Short -term HRV parameters were obtained and repeated measures ANOVA and suitable post-hoc tests applied to the results. According to the results of the repeated measures ANOVA; there were no significant main effects of groups. However, there were some significant differences in measuring time periods and groups*period interactions. The post-hoc tests showed that mean R to R interval and HF power are significantly changed by maximum radiation emitted from MP. Due to the radiation emitted from MPs at maximum power, some changes may occur in HRV parameters that are associated with increased parasympathetic activity. But, the level of these changes is similar to daily activities as excitement, and stand up.

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.

Influence of Various Acidic Beverages on Tooth Erosion. Evaluation by a New Method

PubMed Central

Zimmer, Stefan; Kirchner, Georg; Bizhang, Mozhgan; Benedix, Mathias

2015-01-01

Material & Methods We have analyzed the loss of enamel and dentine after exposure to different non-alcoholic drinks with a simple new method using bovine teeth. 100 enamel and 100 dentine specimens from freshly extracted bovine incisors were randomly attributed to 10 groups (n=10 for enamel and dentine each). Prior to the start of the experiment all specimens were weighed using a precision balance. The mean initial masses (SD) were 35.8 mg (7.2) for enamel and 24.7 mg (7.0) for dentine. No statistically significant differences were found between groups for initial masses (p>0.05, ANOVA with Bonferroni post hoc test). Thereafter, all specimens of one group were simultaneously placed in 200 ml of the following fluids: Coca-Cola, Coca-Cola light, Sprite, apple juice, Red Bull, orange juice, Bonaqua Fruits (Mango-Acai), tap water, chlorinated swimming pool water, and lemon juice. Fluids were continuously ventilated at 37° C for 7 days. Thereafter the specimens were weighed again and the mean mass loss was calculated. Results The values were (enamel/dentine): Coca-Cola 7.5 mg/6.6 mg; Coca-Cola light 5.2 mg/3.5 mg, Sprite 26.1 mg/17.7 mg, apple juice 27.1 mg/15.2 mg, Red Bull 16.6 mg/17.0 mg, orange juice 24.3 mg/20.2 mg, Bonaqua Fruits (Mango-Acai) 17.8 mg/16.2 mg, tap water -0.2 mg/-0.3 mg, swimming pool water -0.3 mg/-0.2 mg, and lemon juice 32.0 mg/28.3 mg. From all drinks, Cola and Cola light showed the least erosivity (p<0.001, ANOVA with Bonferroni post hoc test) whereas lemon juice showed statistically significant higher erosivity than all other drinks except Sprite and apple juice (p<0.01, ANOVA with Bonferroni post hoc test). Conclusions In conclusion, erosivity of common non-alcoholic drinks varies widely. For example, Sprite, apple juice, and orange juice are about five times more erosive than Coca-Cola light. The findings from the present study should be taken into account in choosing a diet that provides satisfactory nutrition while minimizing tooth erosion. PMID:26035729

Influence of various acidic beverages on tooth erosion. Evaluation by a new method.

PubMed

Zimmer, Stefan; Kirchner, Georg; Bizhang, Mozhgan; Benedix, Mathias

2015-01-01

We have analyzed the loss of enamel and dentine after exposure to different non-alcoholic drinks with a simple new method using bovine teeth. 100 enamel and 100 dentine specimens from freshly extracted bovine incisors were randomly attributed to 10 groups (n=10 for enamel and dentine each). Prior to the start of the experiment all specimens were weighed using a precision balance. The mean initial masses (SD) were 35.8 mg (7.2) for enamel and 24.7 mg (7.0) for dentine. No statistically significant differences were found between groups for initial masses (p>0.05, ANOVA with Bonferroni post hoc test). Thereafter, all specimens of one group were simultaneously placed in 200 ml of the following fluids: Coca-Cola, Coca-Cola light, Sprite, apple juice, Red Bull, orange juice, Bonaqua Fruits (Mango-Acai), tap water, chlorinated swimming pool water, and lemon juice. Fluids were continuously ventilated at 37° C for 7 days. Thereafter the specimens were weighed again and the mean mass loss was calculated. The values were (enamel/dentine): Coca-Cola 7.5 mg/6.6 mg; Coca-Cola light 5.2 mg/3.5 mg, Sprite 26.1 mg/17.7 mg, apple juice 27.1 mg/15.2 mg, Red Bull 16.6 mg/17.0 mg, orange juice 24.3 mg/20.2 mg, Bonaqua Fruits (Mango-Acai) 17.8 mg/16.2 mg, tap water -0.2 mg/-0.3 mg, swimming pool water -0.3 mg/-0.2 mg, and lemon juice 32.0 mg/28.3 mg. From all drinks, Cola and Cola light showed the least erosivity (p<0.001, ANOVA with Bonferroni post hoc test) whereas lemon juice showed statistically significant higher erosivity than all other drinks except Sprite and apple juice (p<0.01, ANOVA with Bonferroni post hoc test). In conclusion, erosivity of common non-alcoholic drinks varies widely. For example, Sprite, apple juice, and orange juice are about five times more erosive than Coca-Cola light. The findings from the present study should be taken into account in choosing a diet that provides satisfactory nutrition while minimizing tooth erosion.

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.

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.

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

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.

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

Intravenous versus intramuscular cobinamide compared to intravenous saline (control) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa).

DTIC Science & Technology

2017-11-09

FWH20140070A, “Intravenous versus intramuscular // compared to intravenous saline ( control ) in the treatment of acute, survivable, hydrogen sulfide toxicity... control ) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa). 4. Principal Investigator (PI): Name Rank Date...remainder of the study. Animals were treated with IV HOC, IV Cobinamide or control (no treatment) 1 minute post apnea. There were no significant

A methodological report from the Malmö Diet and Cancer study: development and evaluation of altered routines in dietary data processing

PubMed Central

Wirfält, Elisabet; Mattisson, Irene; Johansson, Ulla; Gullberg, Bo; Wallström, Peter; Berglund, Göran

2002-01-01

Background In the Malmö Diet and Cancer study, information on dietary habits was obtained through a modified diet history method, combining a 7-day menu book for cooked meals and a diet questionnaire for foods with low day-to-day variation. Half way through the baseline data collection, a change of interview routines was implemented in order to reduce interview time. Methods Changes concentrated on portion-size estimation and recipe coding of mixed dishes reported in the menu book. All method development and tests were carefully monitored, based on experiential knowledge, and supplemented with empirical data. A post hoc evaluation study using "real world" data compared observed means of selected dietary variables before and after the alteration of routines handling dietary data, controlling for potential confounders. Results These tests suggested that simplified coding rules and standard portion-sizes could be used on a limited number of foods, without distortions of the group mean nutrient intakes, or the participants' ranking. The post hoc evaluation suggested that mean intakes of energy-adjusted fat were higher after the change in routines. The impact appeared greater in women than in men. Conclusions Future descriptive studies should consider selecting subsets assessed with either method version to avoid distortion of observed mean intakes. The impact in analytical studies may be small, because method version and diet assistant explained less than 1 percent of total variation. The distribution of cases and non-cases across method versions should be monitored. PMID:12537595

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.

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

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)

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…

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.

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

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.

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.

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.

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

PubMed Central

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

2011-01-01

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

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.

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

Nurses' attitudes towards computers: cross sectional questionnaire study.

PubMed

Brumini, Gordan; Kovic, Ivor; Zombori, Dejvid; Lulic, Ileana; Petrovecki, Mladen

2005-02-01

To estimate the attitudes of hospital nurses towards computers and the influence of gender, age, education, and computer usage on these attitudes. The study was conducted in two Croatian hospitals where integrated hospital information system is being implemented. There were 1,081 nurses surveyed by an anonymous questionnaire consisting of 8 questions about demographic data, education, and computer usage, and 30 statements on attitudes towards computers. The statements were adapted to a Likert type scale. Differences in attitudes towards computers were compared using one-way ANOVA and Tukey-b post-hoc test. The total score was 120+/-15 (mean+/-standard deviation) out of maximal 150. Nurses younger than 30 years had a higher total score than those older than 30 years (124+/-13 vs 119+/-16 for 30-39 age groups and 117+/-15 for>39 age groups, P<0.001). Nurses with a bachelor's degree (119+/-16 vs 122+/-14, P=0.002) and nurses who had attended computer science courses had a higher total score compared to the others (124+/-13 vs 118+/-16, P<0.001). Nurses using computers more than 5 hours per week had higher total score than those who used computers less than 5 hours (127+/-13 vs 124+/-12 for 1-5 h and and 119+/-14 for <1 hour per day, P<0.001, post-hoc test). Nurses in general have positive attitudes towards computers. These results are important for the planning and implementing an integrated hospital information system.

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.

Does the moment of fiber post cutting influence on the retention to root dentin?

PubMed

Borges, Marcela G; Faria-e-Silva, André L; Santos-Filho, Paulo C F; Silva, Fernanda P; Martins, Luís R M; Menezes, Murilo de Sousa

2015-01-01

Despite several advantages associated with pre-fabricated glass-fiber posts, the coronal portion of these posts must be cut to allow their use in various clinical situations. However, cutting the cemented post can generate stress on the bonding interface and affect the bond strength. The aim of this study was to investigate the effect the of fiber post cutting on the bond strength of root canals. Sixty bovine incisor roots were included in resin cylinders with simulated periodontal ligaments. Glass-fiber posts were luted using regular resin cement RelyX ARC (3M ESPE) or self-adhesive cement RelyX Unicem (3M ESPE). The posts were cut prior to cementation, immediately after luting or after building up the core (n=10). After storage for 24 h, the samples were cut and subject to push-out testing using a mechanical testing machine (EMIC DL 2000). Data were analyzed using two-way ANOVA (resin cement x moment of post cutting) and Tukey's post hoc test (α=0.05). The moment of fiber post cutting did not affect the bond strength when Unicem was used. However, the bond strength was reduced when ARC was used and when the post was cut immediately. In conclusion, the moment of fiber post cutting may affect the retention of root canal posts when a regular resin cement is used.

Glass transition temperature of hard chairside reline materials after post-polymerisation treatments.

PubMed

Urban, Vanessa M; Machado, Ana L; Alves, Marinês O; Maciel, Adeilton P; Vergani, Carlos E; Leite, Edson R

2010-09-01

This study evaluated the effect of post-polymerisation treatments on the glass transition temperature (T(g)) of five hard chairside reline materials (Duraliner II-D, Kooliner-K, New Truliner-N, Ufi Gel hard-U and Tokuso Rebase Fast-T). Specimens (10 x 10 x 1 mm) were made following the manufacturers' instructions and divided into three groups (n = 5). Control group specimens were left untreated. Specimens from the microwave group were irradiated with pre-determined power/time combinations, and specimens from the water-bath group were immersed in hot water at 55 degrees C for 10 min. Glass transition ( degrees C) was performed by differential scanning calorimetry. Data were analysed using anova, followed by post hoc Tukey's test (alpha = 0.05). Both post-polymerisation treatments promoted a significant (p < 0.05) increase in the T(g) of reline material K. Materials K, D and N showed the lowest T(g) (p < 0.05). No significant difference between T and U specimens was observed. Post-polymerisation treatments improved the glass transition of material Kooliner, with the effect being more pronounced for microwave irradiation.

FRACTURE STRENGTH OF FLARED BOVINE ROOTS RESTORED WITH DIFFERENT INTRARADICULAR POSTS

PubMed Central

Clavijo, Victor Grover Rene; Reis, José Maurício dos Santos Nunes; Kabbach, William; Silva, André Luis Faria e; de Oliveira, Osmir Batista; de Andrade, Marcelo Ferrarezi

2009-01-01

Objective: The aim of this study was to evaluate the fracture strength and failure mode of flared bovine roots restored with different intraradicular posts. Material and Methods: Fifty bovine incisors with similar dimensions were selected and their roots were flared until 1.0 mm of dentin wall remained. Next, the roots were allocated into five groups (n=10): GI-cast metal post-and-core; GII-fiber posts plus accessory fiber posts; GIII- direct anatomic post; GIV- indirect anatomic post and GV- control (specimens without intraradicular post). A polyether impression material was used to simulate the periodontal ligament. After periodontal ligament simulation, the specimens were subjected to a compressive load at a crosshead speed of 0.5 mm/min in a servo-hydraulic testing machine (MTS 810) applied at 135° to the long axis of the tooth until failure. The data (N) were subjected to ANOVA and Tukey's post-hoc test (α=0.05). Results: GI and GIV presented higher fracture strength (p<0.05) than GII. GIII presented intermediate values without statistically significant differences (p>0.05) from GI, GII and GIV. Control specimens (GV) produced the lowest fracture strength mean values (p<0.05). Despite obtaining the highest mean value, GI presented 100% of unfavorable failures. GII presented 20% of unfavorable failures. GIII, GIV and GV presented only favorable failures. Conclusions: Although further in vitro and in vivo studies are necessary, the results of this study showed that the use of direct and indirect anatomic posts in flared roots could be an alternative to cast metal post-and-core. PMID:20027429

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.

Preventive effect of a high fluoride toothpaste and arginine-carbonate toothpaste on dentinal tubules exposure followed by acid challenge: a dentine permeability evaluation

PubMed Central

2014-01-01

Background Considering the current high use of high fluoride toothpastes, the aim of the study was to quantify alterations in the root dentine permeability submitted to treatment with a high fluoride toothpaste and 8% arginine, calcium carbonate, sodium monofluorophosphate toothpaste as a preventive treatment for dentinal tubules exposure followed by acid challenge. Methods Thirty-third molars were sectioned below the cementoenamel. The root segments were connected to a hydraulic pressure apparatus to measure dentine permeability after the following sequential steps (n = 10 per group): I) Baseline; II) treatment with phosphoric acid for 30 s (maximum permeability); III) Toothbrushing (1 min) according to the experimental groups (G1- control; G2- 5000 ppm fluoride toothpaste; G3- 8% arginine-calcium carbonate toothpaste); IV) acid challenge for 5 min (orange juice). The data were converted into percentage, considering stage II as 100%. Results The results have shown a statistically significant decreasing on dentine permeability after treatment with toothpaste (Friedman test and Dunn’s post hoc test). Comparison among groups demonstrated a high increasing on dentine permeability when acid challenge was performed after toothbrushing with distilled water (control group) (Kruskal-Wallis and Dunn’s post hoc test). Conclusion The toothpaste treatment may provide sufficient resistance on dentine surface, preventing dentinal tubules exposure after acid challenge. PMID:24958423

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

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…

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…

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.…

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.…

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...

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…

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…

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.

"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...

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.

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.

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.

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.

A prospective study from south India to compare the severity of malaria caused by Plasmodium vivax, P. falciparum and dual infection.

PubMed

Mitra, Shubhanker; Abhilash, Kpp; Arora, Shalabh; Miraclin, Angel

2015-12-01

Traditionally, Plasmodium falciparum has been attributed to cause severe malaria, whereas P. vivax is considered to cause "benign" tertian malaria. Recently, there has been an increasing body of evidence challenging this conviction. However, the spectrum and degree of severity of the disease caused by P. vivax, as per World Health Organization (2012) remains unclear. Thus, in this prospective study, we aimed at comparing the severity of malaria caused by P. vivax, P. falciparum and dual infection. Adult patients presenting to Christian Medical College, Vellore from October 2012 to September 2013 with microscopically confirmed malaria were included in the study. Their clinical and laboratory parameters were recorded and analyzed. Paired t-test and chi-square with 95% CI and post-hoc analyses using the Scheffι post-hoc criterion were used to assess the statistical significance at the level of α <0.05. In total, 131 cases of malaria were identified during the study period, comprising 83 cases of P. vivax, 35 cases of P. falciparum and 13 cases of mixed vivax and falciparum infections. The spectrum and degree of hematological, hepatic, renal, metabolic, central nervous system complications of vivax malaria was not different from that of falciparum group. Thrombocytopenia and hyperbilirubinemia were the most common laboratory abnormalities identified in all the groups. This cross-sectional comparative study clearly demonstrates that clinical features, complications and case-fatality rates in vivax malaria can be as severe as in falciparum malaria. Hence, vivax malaria could not be considered benign; and appropriate preventive strategies along with antimalarial therapies should be adopted for control and elimination of this disease.

A History of the Savannah District U.S. Army Corps of Engineers

DTIC Science & Technology

1989-01-01

civil mission of the Corps changed to meet the needs of a post- industrialized society for energy , recreation, and careful regulation of the use of...34J . SA Cl<t(.R ’’’’ 00 .sUP[RVISION HIRtO LABOA AND CONTRACT IN$P(( l ION . HelION /("Cl P’ COI.lAA!. T OIUOGtNGJ , ... /It * POiIl JON, A.HOC...the Department of Energy (DOE), and the Federal Energy Regulatory Commission. This assistance usually take the form of feasibility studies or

Ad hoc vs. Non-ad hoc Percutaneous Coronary Intervention Strategies in Patients With Stable Coronary Artery Disease.

PubMed

Toyota, Toshiaki; Morimoto, Takeshi; Shiomi, Hiroki; Ando, Kenji; Ono, Koh; Shizuta, Satoshi; Kato, Takao; Saito, Naritatsu; Furukawa, Yutaka; Nakagawa, Yoshihisa; Horie, Minoru; Kimura, Takeshi

2017-03-24

Few studies have evaluated the prevalence and clinical outcomes of ad hoc percutaneous coronary intervention (PCI), performing diagnostic coronary angiography and PCI in the same session, in stable coronary artery disease (CAD) patients.Methods and Results:From the CREDO-Kyoto PCI/CABG registry cohort-2, 6,943 patients were analyzed as having stable CAD and undergoing first PCI. Ad hoc PCI and non-ad hoc PCI were performed in 1,722 (24.8%) and 5,221 (75.1%) patients, respectively. The cumulative 5-year incidence and adjusted risk for all-cause death were not significantly different between the 2 groups (15% vs. 15%, P=0.53; hazard ratio: 1.15, 95% confidence interval: 0.98-1.35, P=0.08). Ad hoc PCI relative to non-ad hoc PCI was associated with neutral risk for myocardial infarction, any coronary revascularization, and bleeding, but was associated with a trend towards lower risk for stroke (hazard ratio: 0.78, 95% confidence interval: 0.60-1.02, P=0.06). Ad hoc PCI in stable CAD patients was associated with at least comparable 5-year clinical outcomes as with non-ad hoc PCI. Considering patients' preference and the cost-saving, the ad hoc PCI strategy might be a safe and attractive option for patients with stable CAD, although the prevalence of ad hoc PCI was low in the current study population.

Stress distributions in maxillary central incisors restored with various types of post materials and designs.

PubMed

Madfa, A A; Kadir, M R Abdul; Kashani, J; Saidin, S; Sulaiman, E; Marhazlinda, J; Rahbari, R; Abdullah, B J J; Abdullah, H; Abu Kasim, N H

2014-07-01

Different dental post designs and materials affect the stability of restoration of a tooth. This study aimed to analyse and compare the stability of two shapes of dental posts (parallel-sided and tapered) made of five different materials (titanium, zirconia, carbon fibre and glass fibre) by investigating their stress transfer through the finite element (FE) method. Ten three-dimensional (3D) FE models of a maxillary central incisor restored with two different designs and five different materials were constructed. An oblique loading of 100 N was applied to each 3D model. Analyses along the centre of the post, the crown-cement/core and the post-cement/dentine interfaces were computed, and the means were calculated. One-way ANOVAs followed by post hoc tests were used to evaluate the effectiveness of the post materials and designs (p=0.05). For post designs, the tapered posts introduced significantly higher stress compared with the parallel-sided post (p<0.05), especially along the centre of the post. Of the materials, the highest level of stress was found for stainless steel, followed by zirconia, titanium, glass fibre and carbon fibre posts (p<0.05). The carbon and glass fibre posts reduced the stress distribution at the middle and apical part of the posts compared with the stainless steel, zirconia and titanium posts. The opposite results were observed at the crown-cement/core interface. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

Efficacy of Blended Preservice Training for Resource Parents

PubMed Central

White, Lee; Delaney, Richard; Pacifici, Caesar; Nelson, Carol; Whitkin, Josh; Lovejoy, Maureen; Smalley, Betsy Keefer

2017-01-01

To evaluate a new way of meeting the growing demand for training prospective resource parents, our study compared the efficacy of a blended online and in-person approach with a traditional classroom-only approach. Findings based on a sample of 111 resource parent prospects showed significantly greater gains in knowledge from pre- to posttest for the blended approach over the classroom-only approach. The blended approach also produced dramatically lower dropout rates during preservice training. Both groups made significant gains in parenting awareness from pre to post, but those gains were greater for the classroom-only approach. Post hoc analyses examined this finding more closely. Satisfaction with training was comparably high for both groups. Gains in knowledge and awareness were sustained at a 3-month follow-up assessment. PMID:28626240

Pre-study feasibility and identifying sensitivity analyses for protocol pre-specification in comparative effectiveness research.

PubMed

Girman, Cynthia J; Faries, Douglas; Ryan, Patrick; Rotelli, Matt; Belger, Mark; Binkowitz, Bruce; O'Neill, Robert

2014-05-01

The use of healthcare databases for comparative effectiveness research (CER) is increasing exponentially despite its challenges. Researchers must understand their data source and whether outcomes, exposures and confounding factors are captured sufficiently to address the research question. They must also assess whether bias and confounding can be adequately minimized. Many study design characteristics may impact on the results; however, minimal if any sensitivity analyses are typically conducted, and those performed are post hoc. We propose pre-study steps for CER feasibility assessment and to identify sensitivity analyses that might be most important to pre-specify to help ensure that CER produces valid interpretable results.

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.

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.

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

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.

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.

Novel joint selection methods can reduce sample size for rheumatoid arthritis clinical trials with ultrasound endpoints.

PubMed

Allen, John C; Thumboo, Julian; Lye, Weng Kit; Conaghan, Philip G; Chew, Li-Ching; Tan, York Kiat

2018-03-01

To determine whether novel methods of selecting joints through (i) ultrasonography (individualized-ultrasound [IUS] method), or (ii) ultrasonography and clinical examination (individualized-composite-ultrasound [ICUS] method) translate into smaller rheumatoid arthritis (RA) clinical trial sample sizes when compared to existing methods utilizing predetermined joint sites for ultrasonography. Cohen's effect size (ES) was estimated (ES^) and a 95% CI (ES^L, ES^U) calculated on a mean change in 3-month total inflammatory score for each method. Corresponding 95% CIs [nL(ES^U), nU(ES^L)] were obtained on a post hoc sample size reflecting the uncertainty in ES^. Sample size calculations were based on a one-sample t-test as the patient numbers needed to provide 80% power at α = 0.05 to reject a null hypothesis H 0 : ES = 0 versus alternative hypotheses H 1 : ES = ES^, ES = ES^L and ES = ES^U. We aimed to provide point and interval estimates on projected sample sizes for future studies reflecting the uncertainty in our study ES^S. Twenty-four treated RA patients were followed up for 3 months. Utilizing the 12-joint approach and existing methods, the post hoc sample size (95% CI) was 22 (10-245). Corresponding sample sizes using ICUS and IUS were 11 (7-40) and 11 (6-38), respectively. Utilizing a seven-joint approach, the corresponding sample sizes using ICUS and IUS methods were nine (6-24) and 11 (6-35), respectively. Our pilot study suggests that sample size for RA clinical trials with ultrasound endpoints may be reduced using the novel methods, providing justification for larger studies to confirm these observations. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

Growth of preschool children at high risk for asthma 2 years after discontinuation of fluticasone.

PubMed

Guilbert, Theresa W; Mauger, David T; Allen, David B; Zeiger, Robert S; Lemanske, Robert F; Szefler, Stanley J; Strunk, Robert C; Bacharier, Leonard B; Covar, Ronina; Sorkness, Christine A; Taussig, Lynn M; Martinez, Fernando D

2011-11-01

The effect on linear growth of daily long-term inhaled corticosteroid therapy in preschool-aged children with recurrent wheezing is controversial. We sought to determine the effect of daily inhaled corticosteroid given for 2 years on linear growth in preschool children with recurrent wheezing. Children aged 2 and 3 years with recurrent wheezing and positive modified Asthma Predictive Index scores were randomized to a 2-year treatment period of chlorofluorocarbon-delivered fluticasone propionate (176 μg/d) or masked placebo delivered through a valved chamber with a mask and then followed for 2 years off study medication. Height growth determined by means of stadiometry was compared between treatment groups. In the study cohort as a whole, the fluticasone group did not have significantly less linear growth than the placebo group (change in height from baseline difference, -0.2 cm; 95% CI, -1.1 to 0.6) 2 years after discontinuation of study treatment. In post hoc analyses children 2 years old who weighed less than 15 kg at enrollment and were treated with fluticasone had less linear growth compared with those treated with placebo (change in height from baseline difference, -1.6 cm; 95% CI, -2.8 to -0.4; P = .009). Linear growth was not significantly different in high-risk preschool-aged children with recurrent wheezing treated with 176 μg/d chlorofluorocarbon-delivered fluticasone compared with placebo 2 years after fluticasone is discontinued. However, post hoc subgroup analyses revealed that children who are younger in age and of lesser weight relative to the entire study cohort had significantly less linear growth, possibly because of a higher relative fluticasone exposure. Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. 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 ).

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 .

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.

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…

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…

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…

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…

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…

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

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.

Pullout bond strength of fiber posts luted to different depths and submitted to artificial aging.

PubMed

Macedo, V C; Souza, N A Y; Faria e Silva, A L; Cotes, C; da Silva, C; Martinelli, M; Kimpara, E T

2013-01-01

The extension of fiber post cementation often does not seem to influence the fracture resistance of restorations. This study evaluated the effects of cementation depths on the retention of fiber posts submitted to artificial aging. One hundred and sixty bovine incisors were selected to assess post retention. Following endodontic treatment, the canals were flared with diamonds burs. Postholes were prepared in lengths of 5 or 10 mm, after which fiber posts were relined with composite resin and luted with RelyX ARC or RelyX Unicem. The samples were then submitted to thermal and/or mechanical cycling before testing their pullout bond strengths. Absence of cycling was used as a control. The results of each cement were submitted to two-way and post hoc Tukey tests (α=0.05). Independent of the aging protocol, a depth of 10 mm showed higher pullout bond strength than did 5 mm, except for RelyX Unicem without cycling. For RelyX ARC, thermomechanical cycling resulted in lower values than in the absence of cycling. Mechanical cycling alone promoted the highest bond strength when the posts were luted with RelyX Unicem. The effect of artificial aging on the pullout bond strength is dependent on the type of material and the depth.

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.

A Comparison of Online, Video Synchronous, and Traditional Learning Modes for an Introductory Undergraduate Physics Course

NASA Astrophysics Data System (ADS)

Faulconer, E. K.; Griffith, J.; Wood, B.; Acharyya, S.; Roberts, D.

2018-05-01

While the equivalence between online and traditional classrooms has been well-researched, very little of this includes college-level introductory Physics. Only one study explored Physics at the whole-class level rather than specific course components such as a single lab or a homework platform. In this work, we compared the failure rate, grade distribution, and withdrawal rates in an introductory undergraduate Physics course across several learning modes including traditional face-to-face instruction, synchronous video instruction, and online classes. Statistically significant differences were found for student failure rates, grade distribution, and withdrawal rates but yielded small effect sizes. Post-hoc pair-wise test was run to determine differences between learning modes. Online students had a significantly lower failure rate than students who took the class via synchronous video classroom. While statistically significant differences were found for grade distributions, the pair-wise comparison yielded no statistically significance differences between learning modes when using the more conservative Bonferroni correction in post-hoc testing. Finally, in this study, student withdrawal rates were lowest for students who took the class in person (in-person classroom and synchronous video classroom) than online. Students that persist in an online introductory Physics class are more likely to achieve an A than in other modes. However, the withdrawal rate is higher from online Physics courses. Further research is warranted to better understand the reasons for higher withdrawal rates in online courses. Finding the root cause to help eliminate differences in student performance across learning modes should remain a high priority for education researchers and the education community as a whole.

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.

Impact of parity on ewe vaginal mechanical properties relative to the nonhuman primate and rodent.

PubMed

Knight, Katrina M; Moalli, Pamela A; Nolfi, Alexis; Palcsey, Stacy; Barone, William R; Abramowitch, Steven D

2016-08-01

Parity is the leading risk factor for the development of pelvic organ prolapse. To assess the impact of pregnancy and delivery on vaginal tissue, researchers commonly use nonhuman primate (NHP) and rodent models. The purpose of this study was to evaluate the ewe as an alternative model by investigating the impact of parity on the ewe vaginal mechanical properties and collagen structure. Mechanical properties of 15 nulliparous and parous ewe vaginas were determined via uniaxial tensile tests. Collagen content was determined by hydroxyproline assay and collagen fiber thickness was analyzed using picrosirius red staining. Outcome measures were compared using Independent samples t or Mann-Whitney U tests. ANOVA (Gabriel's pairwise post-hoc test) or the Welch Alternative for the F-ratio (Games Howell post-hoc test) was used to compare data with previously published NHP and rodent data. Vaginal tissue from the nulliparous ewe had a higher tangent modulus and tensile strength compared with the parous ewe (p < 0.025). The parous ewe vagina elongated 42 % more than the nulliparous ewe vagina (p = 0.015). No significant differences were observed in collagen structure among ewe vaginas. The tangent modulus of the nulliparous ewe vagina was not different from that of the NHP or rodent (p = 0.290). Additionally, the tangent moduli of the parous ewe and NHP vaginas did not differ (p = 0.773). Parity has a negative impact on the mechanical properties of the ewe vagina, as also observed in the NHP. The ewe may serve as an alternative model for studying parity and ultimately prolapse development.

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.

Comparison of marginal and internal adaptation of copings fabricated from three different fabrication techniques: An in vitro study.

PubMed

Arora, Aman; Yadav, Avneet; Upadhyaya, Viram; Jain, Prachi; Verma, Mrinalini

2018-01-01

The purpose of this study was to compare the marginal and internal adaptation of cobalt-chromium (Co-Cr) copings fabricated from conventional wax pattern, three-dimensional (3D)-printed resin pattern, and laser sintering technique. A total of thirty copings were made, out of which ten copings were made from 3D-printed resin pattern (Group A), ten from inlay wax pattern (Group B), and ten copings were obtained from direct metal laser sintering (DMLS) technique (Group C). All the thirty samples were seated on their respective dies and sectioned carefully using a laser jet cutter and were evaluated for marginal and internal gaps at the predetermined areas using a stereomicroscope. The values were then analyzed using one-way ANOVA test and post hoc Bonferroni test. One-way ANOVA showed lowest mean marginal discrepancy for DMLS and highest value for copings fabricated from inlay wax. The values for internal discrepancy were highest for DMLS (169.38) and lowest for 3D-printed resin pattern fabricated copings (133.87). Post hoc Bonferroni test for both marginal and internal discrepancies showed nonsignificant difference when Group A was compared to Group B ( P > 0.05) and significant when Group A was compared with Group C ( P < 0.05). Group B showed significant difference ( P < 0.05) when compared with Group C. Marginal and internal discrepancies of all the three casting techniques were within clinically acceptable values. Marginal fit of DMLS was superior as compared to other two techniques, whereas when internal fit was evaluated, conventional technique showed the best internal fit.

Comparison of the load at fracture of Turkom-Cera to Procera AllCeram and In-Ceram all-ceramic restorations.

PubMed

AL-Makramani, Bandar M A; Razak, Abdul A A; Abu-Hassan, Mohamed I

2009-08-01

This study investigated the occlusal fracture resistance of Turkom-Cerafused alumina compared to Procera AllCeram and In-Ceram all-ceramic restorations. Sixmaster dies were duplicated from the prepared maxillary first premolar tooth using nonprecious metal alloy (Wiron 99). Ten copings of 0.6 mm thickness were fabricated from each type of ceramic, for a total of thirty copings. Two master dies were used for each group, and each of them was used to lute five copings. All groups were cemented with resin luting cement Panavia F according to manufacturer's instructions and received a static load of 5 kg during cementation. After 24 hours of distilled water storage at 37 degrees C, the copings were vertically compressed using a universal testing machine at a crosshead speed of 1 mm/min. The results of the present study showed the following mean loads at fracture: Turkom-Cera (2184 +/- 164 N), In-Ceram (2042 +/- 200 N), and Procera AllCeram (1954 +/- 211 N). ANOVA and Scheffe's post hoc test showed that the mean load at fracture of Turkom-Cera was significantly different from Procera AllCeram (p < 0.05). Scheffe's post hoc test showed no significant difference between the mean load at fracture of Turkom-Cera and In-Ceram or between the mean load at fracture of In-Ceram and Procera AllCeram. Because Turkom-Cera demonstrated equal to or higher loads at fracture than currently accepted all-ceramic materials, it would seem to be acceptable for fabrication of anterior and posterior ceramic crowns.

Visual communication stimulates reproduction in Nile tilapia, Oreochromis niloticus (L.).

PubMed

Castro, A L S; Gonçalves-de-Freitas, E; Volpato, G L; Oliveira, C

2009-04-01

Reproductive fish behavior is affected by male-female interactions that stimulate physiological responses such as hormonal release and gonad development. During male-female interactions, visual and chemical communication can modulate fish reproduction. The aim of the present study was to test the effect of visual and chemical male-female interaction on the gonad development and reproductive behavior of the cichlid fish Nile tilapia, Oreochromis niloticus (L.). Fifty-six pairs were studied after being maintained for 5 days under one of the four conditions (N = 14 for each condition): 1) visual contact (V); 2) chemical contact (Ch); 3) chemical and visual contact (Ch+V); 4) no sensory contact (Iso) - males and females isolated. We compared the reproductive behavior (nesting, courtship and spawning) and gonadosomatic index (GSI) of pairs of fish under all four conditions. Visual communication enhanced the frequency of courtship in males (mean +/- SEM; V: 24.79 +/- 3.30, Ch+V: 20.74 +/- 3.09, Ch: 0.1 +/- 0.07, Iso: 4.68 +/- 1.26 events/30 min; P < 0.05, two-way ANOVA with LSD post hoc test), induced spawning in females (3 spawning in V and also 3 in Ch+V condition), and increased GSI in males (mean +/- SEM; V: 1.39 +/- 0.08, Ch+V: 1.21 +/- 0.08, Ch: 1.04 +/- 0.07, Iso: 0.82 +/- 0.07%; P < 0.05, two-way ANOVA with LSD post hoc test). Chemical communication did not affect the reproductive behavior of pairs nor did it enhance the effects of visual contact. Therefore, male-female visual communication is an effective cue, which stimulates reproduction among pairs of Nile tilapia.

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.

Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.

PubMed

Steinvil, Arie; Rogers, Toby; Torguson, Rebecca; Waksman, Ron

2016-09-12

This study aims to describe the discussions and recommendations made during the U.S. Food and Drug Administration (FDA) Circulatory System Device Panel pre-market approval application for the Absorb Bioresorbable Vascular Scaffold (BVS) System. The Absorb BVS System is a first-of-its-kind fully bioresorbable percutaneous coronary intervention technology. The absorb BVS was studied in the ABSORB III (A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions) trial, the pivotal U.S. investigational device exemption trial. Observational report of the FDA Circulatory System Device Panel pre-market approval application meeting held on March 15, 2016. The U.S. FDA Circulatory System Device Panel members reviewed the ABSROB III trial outcomes and additional post hoc analyses presented by the sponsor and the FDA. The ABSORB III trial met the primary endpoint of noninferiority of Absorb BVS compared with the control, XIENCE drug-eluting stent, for target lesion failure at 1 year. Although a higher numerical trend for adverse outcomes was reported for the Absorb BVS, there were no statistical differences between Absorb BVS and XIENCE for any safety or effectiveness components for target lesion failure or for the secondary pre-specified outcomes. Panel members raised concerns with regard to the ABSORB III results and post hoc analyses focusing mainly on the noninferiority design of the trial, the apparent safety issues of the Absorb BVS in small vessels, the mismatch of visually versus intravascular imaging assessed vessel size found in ABSORB III and its implications on the adequate device labeling, the safety of Absorb BVS in specific patient and lesion subsets, and the post-approval commitments of the sponsor. Following panel discussions and the evidence presented, the panel voted for approval of the device. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

Motivation and justification: a dual-process model of culture in action.

PubMed

Vaisey, Stephen

2009-05-01

This article presents a new model of culture in action. Although most sociologists who study culture emphasize its role in post hoc sense making, sociologists of religion and social psychologists tend to focus on the role beliefs play in motivation. The dual-process model integrates justificatory and motivational approaches by distinguishing between "discursive" and "practical" modes of culture and cognition. The author uses panel data from the National Study of Youth and Religion to illustrate the model's usefulness. Consistent with its predictions, he finds that though respondents cannot articulate clear principles of moral judgment, their choice from a list of moral-cultural scripts strongly predicts later behavior.

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.

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

Animal-assisted therapy with chronic psychiatric inpatients: equine-assisted psychotherapy and aggressive behavior.

PubMed

Nurenberg, Jeffry R; Schleifer, Steven J; Shaffer, Thomas M; Yellin, Mary; Desai, Prital J; Amin, Ruchi; Bouchard, Axel; Montalvo, Cristina

2015-01-01

Animal-assisted therapy (AAT), most frequently used with dogs, is being used increasingly as an adjunctive alternative treatment for psychiatric patients. AAT with larger animals, such as horses, may have unique benefits. In this randomized controlled study, equine and canine forms of AAT were compared with standard treatments for hospitalized psychiatric patients to determine AAT effects on violent behavior and related measures. The study included 90 patients with recent in-hospital violent behavior or highly regressed behavior. Hospitalization at the 500-bed state psychiatric hospital was two months or longer (mean 5.4 years). Participants were randomly selected to receive ten weekly group therapy sessions of standardized equine-assisted psychotherapy (EAP), canine-assisted psychotherapy (CAP), enhanced social skills psychotherapy, or regular hospital care. Participants' mean age was 44, 37% were female, 76% had diagnoses of schizophrenia or schizoaffective disorder, and 56% had been committed involuntarily for civil or forensic reasons. Violence-related incident reports filed by staff in the three months after study intake were compared with reports two months preintake. Interventions were well tolerated. Analyses revealed an intervention group effect (F=3.00, df=3 and 86, p=.035); post hoc tests showed specific benefits of EAP (p<.05). Similar AAT effects were found for the incidence of 1:1 clinical observation (F=2.70, df=3 and 86, p=.051); post hoc tests suggested benefits of CAP (p=.058) as well as EAP (p=.082). Covariance analyses indicated that staff can predict which patients are likely to benefit from EAP (p=.01). AAT, and perhaps EAP uniquely, may be an effective therapeutic modality for long-term psychiatric patients at risk of violence.

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.

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

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials

PubMed Central

Rendas-Baum, Regina; Kosinski, Mark; Singh, Amitabh; Mebus, Charles A.; Wilkinson, Bethany E.; Wallenstein, Gene V.

2017-01-01

Abstract Objectives. RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Methods. Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. Results. MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Conclusion. Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi. PMID:28460083

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).

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

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.

Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study.

PubMed

Gidal, Barry E; Wechsler, Robert T; Sankar, Raman; Montouris, Georgia D; White, H Steve; Cloyd, James C; Kane, Mary Clare; Peng, Guangbin; Tworek, David M; Shen, Vivienne; Isojarvi, Jouko

2016-10-25

To evaluate potential development of tolerance to adjunctive clobazam in patients with Lennox-Gastaut syndrome. Eligible patients enrolled in open-label extension study OV-1004, which continued until clobazam was commercially available in the United States or for a maximum of 2 years outside the United States. Enrolled patients started at 0.5 mg·kg -1 ·d -1 clobazam, not to exceed 40 mg/d. After 48 hours, dosages could be adjusted up to 2.0 mg·kg -1 ·d -1 (maximum 80 mg/d) on the basis of efficacy and tolerability. Post hoc analyses evaluated mean dosages and drop-seizure rates for the first 2 years of the open-label extension based on responder categories and baseline seizure quartiles in OV-1012. Individual patient listings were reviewed for dosage increases ≥40% and increasing seizure rates. Data from 200 patients were included. For patients free of drop seizures, there was no notable change in dosage over 24 months. For responder groups still exhibiting drop seizures, dosages were increased. Weekly drop-seizure rates for 100% and ≥75% responders demonstrated a consistent response over time. Few patients had a dosage increase ≥40% associated with an increase in seizure rates. Two-year findings suggest that the majority of patients do not develop tolerance to the antiseizure actions of clobazam. Observed dosage increases may reflect best efforts to achieve seizure freedom. It is possible that the clinical development of tolerance to clobazam has been overstated. NCT00518713 and NCT01160770. This study provides Class III evidence that the majority of patients do not develop tolerance to clobazam over 2 years of treatment. © 2016 American Academy of Neurology.

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.

Text World Theory and real world readers: From literature to life in a Belfast prison

PubMed Central

Canning, Patricia

2017-01-01

Cognitive stylistics offers a range of frameworks for understanding (amongst other things) what producers of literary texts ‘do’ with language and how they ‘do’ it. Less prevalent, however, is an understanding of the ways in which these same frameworks offer insights into what readers ‘do’ (and how they ‘do’ it). Text World Theory (Werth, 1999; Gavins, 2007; Whiteley, 2011) has proved useful for understanding how and why readers construct mental representations engendered by the act of reading. However, research on readers’ responses to literature has largely focused on an ‘idealised’ reader or an ‘experimental’ subject-reader often derived from within the academy and conducted using contrived or amended literary fiction. Moreover, the format of traditional book groups (participants read texts privately and discuss them at a later date) as well as online community forums such as Goodreads, means that such studies derive data from post-hoc, rather than real-time textual encounters and discussions. The current study is the first of its kind in analysing real-time reading contexts with real readers during a researcher-led literary project (‘read.live.learn’) in Northern Ireland’s only female prison. In doing so, the study is unique in addressing experimental and post hoc bias. Using Text World Theory, the paper considers the personal and social impact of reader engagement in the talk of the participants. As such, it has three interrelated aims: to argue for the social and personal benefits of reading stylistically rich literature in real-time reading groups; to demonstrate the efficacy of stylistics for understanding how those benefits come about, and to demonstrate the inter-disciplinary value of stylistics, particularly its potential for traversing traditional research parameters. PMID:29278261

Text World Theory and real world readers: From literature to life in a Belfast prison.

PubMed

Canning, Patricia

2017-05-01

Cognitive stylistics offers a range of frameworks for understanding (amongst other things) what producers of literary texts 'do' with language and how they 'do' it. Less prevalent, however, is an understanding of the ways in which these same frameworks offer insights into what readers 'do' (and how they 'do' it). Text World Theory (Werth, 1999; Gavins, 2007; Whiteley, 2011) has proved useful for understanding how and why readers construct mental representations engendered by the act of reading. However, research on readers' responses to literature has largely focused on an 'idealised' reader or an 'experimental' subject-reader often derived from within the academy and conducted using contrived or amended literary fiction. Moreover, the format of traditional book groups (participants read texts privately and discuss them at a later date) as well as online community forums such as Goodreads, means that such studies derive data from post-hoc, rather than real-time textual encounters and discussions. The current study is the first of its kind in analysing real-time reading contexts with real readers during a researcher-led literary project ('read.live.learn') in Northern Ireland's only female prison. In doing so, the study is unique in addressing experimental and post hoc bias. Using Text World Theory, the paper considers the personal and social impact of reader engagement in the talk of the participants. As such, it has three interrelated aims: to argue for the social and personal benefits of reading stylistically rich literature in real-time reading groups; to demonstrate the efficacy of stylistics for understanding how those benefits come about, and to demonstrate the inter-disciplinary value of stylistics, particularly its potential for traversing traditional research parameters.

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.

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.

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.

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.

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.

Role of tDCS in potentiating poststroke computerized cognitive rehabilitation: Lessons learned from a case study.

PubMed

Leo, Antonino; De Luca, Rosario; Russo, Margherita; Naro, Antonino; Bramanti, Placido; Calabrò, Rocco S

2016-01-01

Cognitive impairment after stroke is quite common and can cause important disability with a relevant impact on quality of life. Cognitive rehabilitation (CR) and related assistive technology may improve functional outcomes. A 30-year-old woman came to our research institute for an intensive CR cycle following a right parieto-temporal stroke. Because the patient was in the chronic phase, we decided to use 3 different rehabilitative protocols: (a) traditional cognitive training (TCT), (b) computerized cognitive training (CCT), and (c) CCT combined with transcranial direct stimulation (CCT plus) with a 2-week interval separating each session. Cognitive and language deficits were investigated using an ad-hoc psychometric battery at baseline (T0), post-TCT (T1), post-CCT (T2), and post-CCT plus (T3). Our patient showed the best neuropsychological improvement, with regard to attention processes and language domain, after T3. Our data showed that CCT plus should be considered a promising tool in the treatment of poststroke neuropsychological deficits.

Patient-Reported Satisfaction Following Post-bariatric Surgery: A Systematic Review.

PubMed

Barone, M; Cogliandro, A; Salzillo, R; Tambone, V; Persichetti, P

2018-06-12

The aims of our study were to identify studies that evaluated patient satisfaction following post-bariatric surgery, analyse existing questionnaires, and summarise their development, psychometric properties, and content. A multistep search was undertaken on the web-based PubMed database from the National Library of Medicine to identify studies on patient satisfaction and quality of life following post-bariatric surgery. The authors summarised all the questionnaires used in every study and categorised them as generic, surgery specific, or ad hoc, and whether they contained either validated or unvalidated measures. Our search generated a total of 1754 articles. We performed a systematic review of the 12 remaining studies, because these had sufficient data and met the inclusion criteria. All the studies identified from the literature review were assessed to determine the type of surgery used, and whether or not the questionnaire used to analyse patient satisfaction had been validated. The questionnaires were analysed by reviewers to assess adherence to the rules of the US Food and Drug Administration and the Scientific Advisory Committee of the Medical Outcomes Trust. We identified 20 individual questionnaires that included 10 generic instruments that assessed quality of life, six instruments specific for post-bariatric surgery, three instruments specific for breast surgery. In post-bariatric patients, the BODY-Q was shown to be a more objective and confident measure for evaluating the quality of life of patients following post-bariatric surgery. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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.

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.

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

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

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…

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.

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%.

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.

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.

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.

Algorithmic, LOCS and HOCS (chemistry) exam questions: performance and attitudes of college students

NASA Astrophysics Data System (ADS)

Zoller, Uri

2002-02-01

The performance of freshmen biology and physics-mathematics majors and chemistry majors as well as pre- and in-service chemistry teachers in two Israeli universities on algorithmic (ALG), lower-order cognitive skills (LOCS), and higher-order cognitive skills (HOCS) chemistry exam questions were studied. The driving force for the study was an interest in moving science and chemistry instruction from an algorithmic and factual recall orientation dominated by LOCS, to a decision-making, problem-solving and critical system thinking approach, dominated by HOCS. College students' responses to the specially designed ALG, LOCS and HOCS chemistry exam questions were scored and analysed for differences and correlation between the performance means within and across universities by the questions' category. This was followed by a combined student interview - 'speaking aloud' problem solving session for assessing the thinking processes involved in solving these types of questions and the students' attitudes towards them. The main findings were: (1) students in both universities performed consistently in each of the three categories in the order of ALG > LOCS > HOCS; their 'ideological' preference, was HOCS > algorithmic/LOCS, - referred to as 'computational questions', but their pragmatic preference was the reverse; (2) success on algorithmic/LOCS does not imply success on HOCS questions; algorithmic questions constitute a category on its own as far as students success in solving them is concerned. Our study and its results support the effort being made, worldwide, to integrate HOCS-fostering teaching and assessment strategies and, to develop HOCS-oriented science-technology-environment-society (STES)-type curricula within science and chemistry education.

Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder

PubMed Central

Cutler, Andrew J.; Saylor, Keith; Gasior, Maria; Hamdani, Mohamed; Ferreira-Cornwell, M. Celeste; Findling, Robert L.

2014-01-01

Abstract Objectives: The purpose of this study was to assess long-term improvement in quality of life (QOL) in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with lisdexamfetamine dimesylate (LDX). Methods: Adolescents with ADHD treated for ≥3 weeks in a 4 week, placebo-controlled study entered a 1 year, open-label study. After the 4 week dose optimization (30, 50, and 70 mg/day LDX) period, treatment was maintained for 48 additional weeks. Change from baseline (of prior study) to week 52/early termination (ET) (of open-label study) in ADHD Rating Scale IV (ADHD-RS-IV) assessed effectiveness, and the Youth QOL-Research Version (YQOL-R) assessed participant-perceived QOL. Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline (≥1 SD below the mean) versus all others, and for study completers versus study noncompleters. Results: These post-hoc analyses included 265 participants. Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET. Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score. At week 52/ET, study completers had greater YQOL-R improvements than did noncompleters; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters. Conclusion: Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL. PMID:24815910

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.

Resistivity tomography of Pointe du Hoc cliffs for stability assessment

NASA Astrophysics Data System (ADS)

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

2008-12-01

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

Welfare Reform and Addiction: A Priori Hypotheses, Post Hoc Explorations, and Assisted Sensemaking in Evaluating the Effects of Terminating Benefits for Chronic Substance Abusers

ERIC Educational Resources Information Center

Orwin, Robert G.; Campbell, Bernadette; Campbell, Kevin; Krupski, Antoinette

2004-01-01

The passage of the Contract with America Advancement Act terminated the Social Security Administrations Disability Insurance and Supplemental Security Income benefits for persons diagnosed with drug or alcohol addiction (also known as DA&A recipients), effective January 1, 1997. From an evaluation standpoint, the law created the opportunity…

Distinct Plasma Profile of Polar Neutral Amino Acids, Leucine, and Glutamate in Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Tirouvanziam, Rabindra; Obukhanych, Tetyana V.; Laval, Julie; Aronov, Pavel A.; Libove, Robin; Banerjee, Arpita Goswami; Parker, Karen J.; O'Hara, Ruth; Herzenberg, Leonard A.; Herzenberg, Leonore A.; Hardan, Antonio Y.

2012-01-01

The goal of this investigation was to examine plasma amino acid (AA) levels in children with Autism Spectrum Disorders (ASD, N = 27) and neuro-typically developing controls (N = 20). We observed reduced plasma levels of most polar neutral AA and leucine in children with ASD. This AA profile conferred significant post hoc power for discriminating…

Cartoon versus traditional self-study handouts for medical students: CARTOON randomized controlled trial.

PubMed

Junhasavasdikul, Detajin; Sukhato, Kanokporn; Srisangkaew, Suthan; Theera-Ampornpunt, Nawanan; Anothaisintawee, Thunyarat; Dellow, Alan

2017-08-01

The objective of this study is to compare the effectiveness of a "cartoon-style" handout with a "traditional-style" handout in a self-study assignment for preclinical medical students. Third-year medical students (n = 93) at the Faculty of Medicine Ramathibodi Hospital, Mahidol University, took a pre-learning assessment of their knowledge of intercostal chest drainage. They were then randomly allocated to receive either a "cartoon-style" or a "traditional-style" handout on the same topic. After studying these over a 2-week period, students completed a post-learning assessment and estimated their levels of reading completion. Of the 79 participants completing the post-learning test, those in the cartoon-style group achieved a score 13.8% higher than the traditional-style group (p = 0.018). A higher proportion of students in the cartoon-style group reported reading ≥75% of the handout content (70.7% versus 42.1%). In post-hoc analyses, students whose cumulative grade point averages (GPA) from previous academic assessments were in the middle and lower range achieved higher scores with the cartoon-style handout than with the traditional one. In the lower-GPA group, the use of a cartoon-style handout was independently associated with a higher score. Students given a cartoon-style handout reported reading more of the material and achieved higher post-learning test scores than students given a traditional handout.

Microplastic as a Vector for Chemicals in the Aquatic Environment: Critical Review and Model-Supported Reinterpretation of Empirical Studies.

PubMed

Koelmans, Albert A; Bakir, Adil; Burton, G Allen; Janssen, Colin R

2016-04-05

The hypothesis that 'microplastic will transfer hazardous hydrophobic organic chemicals (HOC) to marine animals' has been central to the perceived hazard and risk of plastic in the marine environment. The hypothesis is often cited and has gained momentum, turning it into paradigm status. We provide a critical evaluation of the scientific literature regarding this hypothesis. Using new calculations based on published studies, we explain the sometimes contrasting views and unify them in one interpretive framework. One explanation for the contrasting views among studies is that they test different hypotheses. When reframed in the context of the above hypothesis, the available data become consistent. We show that HOC microplastic-water partitioning can be assumed to be at equilibrium for most microplastic residing in the oceans. We calculate the fraction of total HOC sorbed by plastics to be small compared to that sorbed by other media in the ocean. We further demonstrate consistency among (a) measured HOC transfer from microplastic to organisms in the laboratory, (b) measured HOC desorption rates for polymers in artificial gut fluids (c) simulations by plastic-inclusive bioaccumulation models and (d) HOC desorption rates for polymers inferred from first principles. We conclude that overall the flux of HOCs bioaccumulated from natural prey overwhelms the flux from ingested microplastic for most habitats, which implies that microplastic ingestion is not likely to increase the exposure to and thus risks of HOCs in the marine environment.

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

PubMed Central

Alqahtani, Fawaz

2017-01-01

Objective 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. Study design This is an in vitro interventional study. Place and duration of 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. Methodology 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). Results 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. Conclusion 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. PMID:28352204

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

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.

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

PubMed

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

2018-05-21

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

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

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.

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.

Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

PubMed

Caron, Philippe J; Bevan, John S; Petersenn, Stephan; Houchard, Aude; Sert, Caroline; Webb, Susan M

2016-04-01

To evaluate the effects of lanreotide Autogel on patient-reported outcomes and association with biochemical control, using PRIMARYS data. PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly. Symptoms were assessed using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) and health-related quality of life (HRQoL) using the AcroQoL questionnaire. Correlations between PASQ and AcroQoL scores, and between PASQ/AcroQoL and growth hormone (GH)/insulin-like growth factor-1 (IGF-1) levels were also evaluated (post hoc). Acromegaly symptoms and HRQoL significantly improved from week 12 to week 48, with modest correlations at week 48 between PASQ total score (R = -0.55, p < 0.0001) and AcroQoL global and physical scores (R = -0.67, p < 0.0001). Approximately 60% of patients achieved a minimal important difference (MID; improvement >50% of baseline standard deviation) in PASQ total score and >40% achieved a MID in AcroQoL global score (post hoc). Changes in PASQ scores were similar in biochemically controlled (GH levels ≤2.5 μg/L and normal IGF-1 levels) and uncontrolled groups, while changes in global and psychological AcroQoL scores were greater in the controlled group. There was no correlation between changes in PASQ or AcroQoL scores and changes in GH or IGF-1 levels. Primary treatment with lanreotide Autogel over 1 year was associated with rapid and sustained improvements in clinical signs and symptoms and HRQoL in patients with acromegaly. Improvements in HRQoL, but not symptoms, were greater in those achieving biochemical control (ClinicalTrials.gov: NCT00690898; EudraCT: 2007-000155-34).

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.

Impact of a Water Intervention on Sugar-Sweetened Beverage Intake Substitution by Water: A Clinical Trial in Overweight and Obese Mexican Women.

PubMed

Hernández-Cordero, Sonia; Popkin, Barry M

2015-01-01

Intense marketing for sugar-sweetened beverages (SSB) along with the human innate preference for sweet taste contributes to the increase in consumption of SSB. It is important to understand the intricacies of dietary intake and global changes to the food supply to understand the complexities facing any intervention promoting water intake. We describe challenges to promote and achieve an increase in water intake and present key findings from a clinical trial examining the effects of substituting water for SSB on triglyceride levels, weight and other cardiometabolic factors in overweight/obese Mexican women. A randomized trial was conducted in Cuernavaca, Mexico selecting overweight/obese (BMI ≥25 and <39 kg/m(2)) women (18-45 years old), reporting an intake of SSB of at least 250 kcal/day. Women were randomly allocated to the water and education provision (WEP) group (n = 120) or to the education provision (EP) group (n = 120). Repeated 24 h dietary recall questionnaires, anthropometry, and fasting blood levels were collected at baseline and 3, 6, and 9 months following the intervention. There was no effect of the intervention on triglyceride concentration or on any of the studied outcomes. Post-hoc analyses according to weight at baseline show that triglyceride concentration decreased in obese women. Prevalence of metabolic syndrome after the intervention was lower in obese women from the WEP group. Water intake was increased but insufficient to achieve complete substitution of SSB, without effects on triglyceride concentration. Post-hoc analyses suggested that interventions lowered triglyceride concentration. Further studies are needed. © 2015 S. Karger AG, Basel.

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.

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.

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

PubMed

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

2018-06-09

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

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 effect of repeated preheating of dimethacrylate and silorane-based composite resins on marginal gap of class V restorations.

PubMed

Alizadeh Oskoee, Parnian; Pournaghi Azar, Fatemeh; Jafari Navimipour, Elmira; Ebrahimi Chaharom, Mohammad Esmaeel; Naser Alavi, Fereshteh; Salari, Ashkan

2017-01-01

Background. One of the problems with composite resin restorations is gap formation at resin‒tooth interface. The present study evaluated the effect of preheating cycles of silorane- and dimethacrylate-based composite resins on gap formation at the gingival margins of Class V restorations. Methods. In this in vitro study, standard Class V cavities were prepared on the buccal surfaces of 48 bovine incisors. For restorative procedure, the samples were randomly divided into 2 groups based on the type of composite resin (group 1: di-methacrylate composite [Filtek Z250]; group 2: silorane composite [Filtek P90]) and each group was randomly divided into 2 subgroups based on the composite temperature (A: room temperature; B: after 40 preheating cycles up to 55°C). Marginal gaps were measured using a stereomicroscope at ×40 and analyzed with two-way ANOVA. Inter- and intra-group comparisons were analyzed with post-hoc Tukey tests. Significance level was defined at P < 0.05. Results. The maximum and minimum gaps were detected in groups 1-A and 2-B, respectively. The effects of composite resin type, preheating and interactive effect of these variables on gap formation were significant (P<0.001). Post-hoc Tukey tests showed greater gap in dimethacrylate compared to silorane composite resins (P< 0.001). In each group, gap values were greater in composite resins at room temperature compared to composite resins after 40 preheating cycles (P<0.001). Conclusion. Gap formation at the gingival margins of Class V cavities decreased due to preheating of both composite re-sins. Preheating of silorane-based composites can result in the best marginal adaptation.

The effect of repeated preheating of dimethacrylate and silorane-based composite resins on marginal gap of class V restorations

PubMed Central

Alizadeh Oskoee, Parnian; Pournaghi Azar, Fatemeh; Jafari Navimipour, Elmira; Ebrahimi chaharom, Mohammad Esmaeel; Naser Alavi, Fereshteh; Salari, Ashkan

2017-01-01

Background. One of the problems with composite resin restorations is gap formation at resin‒tooth interface. The present study evaluated the effect of preheating cycles of silorane- and dimethacrylate-based composite resins on gap formation at the gingival margins of Class V restorations. Methods. In this in vitro study, standard Class V cavities were prepared on the buccal surfaces of 48 bovine incisors. For restorative procedure, the samples were randomly divided into 2 groups based on the type of composite resin (group 1: di-methacrylate composite [Filtek Z250]; group 2: silorane composite [Filtek P90]) and each group was randomly divided into 2 subgroups based on the composite temperature (A: room temperature; B: after 40 preheating cycles up to 55°C). Marginal gaps were measured using a stereomicroscope at ×40 and analyzed with two-way ANOVA. Inter- and intra-group comparisons were analyzed with post-hoc Tukey tests. Significance level was defined at P < 0.05. Results. The maximum and minimum gaps were detected in groups 1-A and 2-B, respectively. The effects of composite resin type, preheating and interactive effect of these variables on gap formation were significant (P<0.001). Post-hoc Tukey tests showed greater gap in dimethacrylate compared to silorane composite resins (P< 0.001). In each group, gap values were greater in composite resins at room temperature compared to composite resins after 40 preheating cycles (P<0.001). Conclusion. Gap formation at the gingival margins of Class V cavities decreased due to preheating of both composite re-sins. Preheating of silorane-based composites can result in the best marginal adaptation. PMID:28413594

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.

Added value of second biopsy target in screen-detected widespread suspicious breast calcifications.

PubMed

Falkner, Nathalie M; Hince, Dana; Porter, Gareth; Dessauvagie, Ben; Jeganathan, Sanjay; Bulsara, Max; Lo, Glen

2018-06-01

There is controversy on the optimal work-up of screen-detected widespread breast calcifications: whether to biopsy a single target or multiple targets. This study evaluates agreement between multiple biopsy targets within the same screen-detected widespread (≥25 mm) breast calcification to determine if the second biopsy adds value. Retrospective observational study of women screened in a statewide general population risk breast cancer mammographic screening program from 2009 to 2016. Screening episodes recalled for widespread calcifications where further views indicated biopsy, and two or more separate target areas were sampled within the same lesion were included. Percentage agreement and Cohen's Kappa were calculated. A total of 293317 women were screened during 761124 separate episodes with recalls for widespread calcifications in 2355 episodes. In 171 women, a second target was biopsied within the same lesion. In 149 (86%) cases, the second target biopsy result agreed with the first biopsy (κ = 0.6768). Agreement increased with increasing mammography score (85%, 86% and 92% for score 3, 4 and 5 lesions). Same day multiple biopsied lesions were three times more likely to yield concordant results compared to post-hoc second target biopsy cases. While a single target biopsy is sufficient to discriminate a benign vs. malignant diagnosis in most cases, in 14% there is added value in performing a second target biopsy. Biopsies performed prospectively are more likely to yield concordant results compared to post-hoc second target biopsy cases, suggesting a single prospective biopsy may be sufficient when results are radiological-pathological concordant; discordance still requires repeat sampling. © 2018 The Royal Australian and New Zealand College of Radiologists.

Impact of parity on ewe vaginal mechanical properties relative to the nonhuman primate and rodent

PubMed Central

Knight, Katrina M.; Moalli, Pamela A.; Nolfi, Alexis; Palcsey, Stacy; Barone, William R.

2016-01-01

Introduction and hypothesis Parity is the leading risk factor for the development of pelvic organ prolapse. To assess the impact of pregnancy and delivery on vaginal tissue, researchers commonly use nonhuman primate (NHP) and rodent models. The purpose of this study was to evaluate the ewe as an alternative model by investigating the impact of parity on the ewe vaginal mechanical properties and collagen structure. Methods Mechanical properties of 15 nulliparous and parous ewe vaginas were determined via uniaxial tensile tests. Collagen content was determined by hydroxyproline assay and collagen fiber thickness was analyzed using picrosirius red staining. Outcome measures were compared using Independent samples t or Mann–Whitney U tests. ANOVA (Gabriel’s pairwise post-hoc test) or the Welch Alternative for the F-ratio (Games Howell post-hoc test) was used to compare data with previously published NHP and rodent data. Results Vaginal tissue from the nulliparous ewe had a higher tangent modulus and tensile strength compared with the parous ewe (p < 0.025). The parous ewe vagina elongated 42 % more than the nulliparous ewe vagina (p = 0.015). No significant differences were observed in collagen structure among ewe vaginas. The tangent modulus of the nulliparous ewe vagina was not different from that of the NHP or rodent (p = 0.290). Additionally, the tangent moduli of the parous ewe and NHP vaginas did not differ (p = 0.773). Conclusions Parity has a negative impact on the mechanical properties of the ewe vagina, as also observed in the NHP. The ewe may serve as an alternative model for studying parity and ultimately prolapse development. PMID:26872644

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.

Metabolic responses to the acute ingestion of two commercially available carbonated beverages: A pilot study.

PubMed

Mendel, Ron W; Hofheins, Jennifer E

2007-09-14

The purpose of this placebo-controlled, double-blind cross-over study was to compare the effects of two commercially available soft drinks on metabolic rate. After giving informed consent, twenty healthy men and women were randomly assigned to ingest 12 ounces of Celsiustrade mark and, on a separate day, 12 ounces of Diet Coke(R). All subjects completed both trials using a randomized, counterbalanced design. Metabolic rate (via indirect calorimetry) and substrate oxidation (via respiratory exchange ratio) were measured at baseline (pre-ingestion) and at the end of each hour for 3 hours post-ingestion. Two-way ANOVA revealed a significant interaction (p < 0.001) between trials in metabolic rate. Scheffe post-hoc testing indicated that metabolic rate increased by 13.8% (+ 0.6 L/min, p < 0.001) 1 hr post, 14.4% (+0.63 L/min, p < 0.001) 2 hr post, and 8.5% (+0.37 L/min, p < 0.004) 3 hr post Celsiustrade mark ingestion. In contrast, small (~4-6%) but statistically insignificant increases in metabolic rate were noted following Diet Coke(R) ingestion. No differences in respiratory exchange ratio were noted between trials. These preliminary findings indicate Celsiustrade mark has thermogenic properties when ingested acutely. The effects of repeated, chronic ingestion of Celsiustrade mark on body composition are unknown at this time.

Metabolic responses to the acute ingestion of two commercially available carbonated beverages: A pilot study

PubMed Central

Mendel, Ron W; Hofheins, Jennifer E

2007-01-01

Background The purpose of this placebo-controlled, double-blind cross-over study was to compare the effects of two commercially available soft drinks on metabolic rate. Methods After giving informed consent, twenty healthy men and women were randomly assigned to ingest 12 ounces of Celsius™ and, on a separate day, 12 ounces of Diet Coke®. All subjects completed both trials using a randomized, counterbalanced design. Metabolic rate (via indirect calorimetry) and substrate oxidation (via respiratory exchange ratio) were measured at baseline (pre-ingestion) and at the end of each hour for 3 hours post-ingestion. Results Two-way ANOVA revealed a significant interaction (p < 0.001) between trials in metabolic rate. Scheffe post-hoc testing indicated that metabolic rate increased by 13.8% (+ 0.6 L/min, p < 0.001) 1 hr post, 14.4% (+0.63 L/min, p < 0.001) 2 hr post, and 8.5% (+0.37 L/min, p < 0.004) 3 hr post Celsius™ ingestion. In contrast, small (~4–6%) but statistically insignificant increases in metabolic rate were noted following Diet Coke® ingestion. No differences in respiratory exchange ratio were noted between trials. Conclusion These preliminary findings indicate Celsius™ has thermogenic properties when ingested acutely. The effects of repeated, chronic ingestion of Celsius™ on body composition are unknown at this time. PMID:17908290

The importance of post hoc approaches for overcoming non-response and attrition bias in population-sampled studies.

PubMed

Gray, Linsay

2016-01-01

Population-based health studies are critical resources for monitoring population health and related factors such as substance use, but reliable inference can be compromised in various ways. Non-response and attrition are major methodological problems which reduce power and can hamper the generalizability of findings if individuals who participate and who remain in a study differ systematically from those who do not. In this issue of SPPE, McCabe et al. studied participants of the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions, comparing attrition in Wave 2 across participants with different patterns of substance use at Wave 1. The implications of differential follow-up and further possibilities for addressing selective participation are discussed.

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

[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.

The effects of progressive muscle relaxation and autogenic relaxation on young soccer players' mood states.

PubMed

Hashim, Hairul Anuar; Hanafi Ahmad Yusof, Hazwani

2011-06-01

This study was designed to compare the effects of two different relaxation techniques, namely progressive muscle relaxation (PMR) and autogenic relaxation (AGR) on moods of young soccer players. sixteen adolescent athletes (mean age: 14.1 ± 1.3) received either PMR or AGR training. Using Profile of Mood States- Adolescents, their mood states were measured one week before relaxation training, before the first relaxation session, and after the twelfth relaxation session. Mixed ANOVA revealed no significant interaction effects and no significant main effects in any of the subscales. However, significant main effects for testing sessions were found for confusion, depression, fatigue, and tension subscales. Post hoc tests revealed post-intervention reductions in the confusion, depression, fatigue, and tension subscale scores. These two relaxation techniques induce equivalent mood responses and may be used to regulate young soccer players' mood states.

The Effects of Progressive Muscle Relaxation and Autogenic Relaxation on Young Soccer Players’ Mood States

PubMed Central

Hashim, Hairul Anuar; Hanafi@Ahmad Yusof, Hazwani

2011-01-01

Purpose This study was designed to compare the effects of two different relaxation techniques, namely progressive muscle relaxation (PMR) and autogenic relaxation (AGR) on moods of young soccer players. Methods Sixteen adolescent athletes (mean age: 14.1 ± 1.3) received either PMR or AGR training. Using Profile of Mood States- Adolescents, their mood states were measured one week before relaxation training, before the first relaxation session, and after the twelfth relaxation session. Results Mixed ANOVA revealed no significant interaction effects and no significant main effects in any of the subscales. However, significant main effects for testing sessions were found for confusion, depression, fatigue, and tension subscales. Post hoc tests revealed post-intervention reductions in the confusion, depression, fatigue, and tension subscale scores. Conclusion These two relaxation techniques induce equivalent mood responses and may be used to regulate young soccer players’ mood states. PMID:22375225

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.

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/

Procedural instruction in invasive bedside procedures: a systematic review and meta-analysis of effective teaching approaches.

PubMed

Huang, Grace C; McSparron, Jakob I; Balk, Ethan M; Richards, Jeremy B; Smith, C Christopher; Whelan, Julia S; Newman, Lori R; Smetana, Gerald W

2016-04-01

Optimal approaches to teaching bedside procedures are unknown. To identify effective instructional approaches in procedural training. We searched PubMed, EMBASE, Web of Science and Cochrane Library through December 2014. We included research articles that addressed procedural training among physicians or physician trainees for 12 bedside procedures. Two independent reviewers screened 9312 citations and identified 344 articles for full-text review. Two independent reviewers extracted data from full-text articles. We included measurements as classified by translational science outcomes T1 (testing settings), T2 (patient care practices) and T3 (patient/public health outcomes). Due to incomplete reporting, we post hoc classified study outcomes as 'negative' or 'positive' based on statistical significance. We performed meta-analyses of outcomes on the subset of studies sharing similar outcomes. We found 161 eligible studies (44 randomised controlled trials (RCTs), 34 non-RCTs and 83 uncontrolled trials). Simulation was the most frequently published educational mode (78%). Our post hoc classification showed that studies involving simulation, competency-based approaches and RCTs had higher frequencies of T2/T3 outcomes. Meta-analyses showed that simulation (risk ratio (RR) 1.54 vs 0.55 for studies with vs without simulation, p=0.013) and competency-based approaches (RR 3.17 vs 0.89, p<0.001) were effective forms of training. This systematic review of bedside procedural skills demonstrates that the current literature is heterogeneous and of varying quality and rigour. Evidence is strongest for the use of simulation and competency-based paradigms in teaching procedures, and these approaches should be the mainstay of programmes that train physicians to perform procedures. Further research should clarify differences among instructional methods (eg, forms of hands-on training) rather than among educational modes (eg, lecture vs simulation). 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.

Sembragiline in Moderate Alzheimer’s Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD)

PubMed Central

Nave, Stephane; Doody, Rachelle S.; Boada, Mercè; Grimmer, Timo; Savola, Juha-Matti; Delmar, Paul; Pauly-Evers, Meike; Nikolcheva, Tania; Czech, Christian; Borroni, Edilio; Ricci, Benedicte; Dukart, Juergen; Mannino, Marie; Carey, Tracie; Moran, Emma; Gilaberte, Inma; Muelhardt, Nicoletta Milani; Gerlach, Irene; Santarelli, Luca; Ostrowitzki, Susanne; Fontoura, Paulo

2017-01-01

Background: Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer’s disease (AD). Objective: To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD. Methods: In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13–20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks. Results: No differences between treated groups and placebo in adverse events or in study completion. The primary endpoint, change from baseline in ADAS-Cog11, was not met. At Week 52, the difference between sembragiline and placebo in ADAS-Cog11 change from baseline was – 0.15 (p = 0.865) and 0.90 (p = 0.312) for 1 and 5 mg groups, respectively. Relative to placebo at Week 52 (but not at prior assessment times), the 1 mg and 5 mg sembragiline groups showed differences in ADCS-ADL of 2.64 (p = 0.051) and 1.89 (p = 0.160), respectively. A treatment effect in neuropsychiatric symptoms (as assessed by the difference between sembragiline and placebo on BEHAVE-AD-FW) was also seen at Week 52 only: – 2.80 (p = 0.014; 1 mg) and – 2.64 (p = 0.019; 5 mg), respectively. A post hoc subgroup analysis revealed greater treatment effects on behavior and functioning in patients with more severe baseline behavioral symptoms (above the median). Conclusions: This study showed that sembragiline was well-tolerated in patients with moderate AD. The study missed its primary and secondary endpoints. Post hoc analyses suggested potential effect on neuropsychiatric symptoms and functioning in more behaviorally impaired study population at baseline. PMID:28550255

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.

Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study.

PubMed

Marshall, Helen; Nissen, Michael; Richmond, Peter; Shakib, Sepehr; Jiang, Qin; Cooper, David; Rill, Denise; Baber, James; Eiden, Joseph; Gruber, William C; Jansen, Kathrin U; Anderson, Annaliesa S; Zito, Edward T; Girgenti, Douglas

2016-11-01

A 2-stage, phase 1, randomized, placebo-controlled study in healthy adults to assess immunogenicity and safety of a booster dose at three dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) containing recombinant clumping factor A (ClfA) and capsular polysaccharides 5 and 8 (CP5 and CP8) conjugated to a diphtheria toxoid. Six months after initial single vaccination, in Stage 2, SA3Ag recipients were randomized (1:1) to booster vaccination or placebo, while Stage 1 placebo recipients received placebo again. Pre- and post-vaccination blood samples were analyzed. In Stage 2 (n = 345), pre-booster CP5 and CP8 titers remained high with no increase post-booster. ClfA titers remained high after initial vaccination and increased post-booster, approaching the peak response to the initial dose. Post-booster local reactions were more frequent and of greater severity than reported after the initial vaccination, particularly for the high-dose level recipients. Post hoc analysis showed no dose-response pattern and no obvious association between diphtheria toxoid titers and local reactions after initial or booster vaccination. Immune responses after the initial vaccination persisted for the 12 months studied, with little additional response after the booster dose at 6 months. Post-booster injection site reactions were more frequent and more severe but self-limiting. CLINICALTRIALS. NCT01018641. Copyright © 2016 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

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.

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.

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

Validity of a semantically cued recall procedure for the mini-mental state examination.

PubMed

Yuspeh, R L; Vanderploeg, R D; Kershaw, D A

1998-10-01

The validity of supplementing the three-item recall portion of the Mini-Mental State Examination (MMSE) with a cued recall procedure to help specify the nature of patients' memory problems was examined. Subjects were 247 individuals representing three diagnostic groups: Alzheimer's disease (AD), subcortical vascular ischemic dementia (SVaD), and normal controls. Individuals were administered a battery of neuropsychological tests, including the MMSE, as part of a comprehensive evaluation for the presence of dementia or other neurologic disorder. MMSE performance differed among groups. The three-item free recall performance also differed among groups, with post hoc analyses revealing the AD and SVaD groups were more impaired than controls but did not differ significantly from each other. Following a cued recall procedure of the MMSE three-items, groups differed, with post hoc analyses showing that AD patients failed to benefit from cues, whereas SVaD patients performed significantly better and comparable to control subjects. Significant correlations between the MMSE three-item cued recall performance and other memory measures demonstrated concurrent validity. Consistent with previous research indicating that SVaD is associated with memory encoding and retrieval deficits, whereas AD is associated with consolidation and storage problems, the present study supported the validity of the cued recall procedure of the three items on the MMSE in helping to distinguish between patients with AD and those with a vascular dementia with primarily subcortical pathology; however, despite these findings, a more extensive battery of neuropsychological measures is still recommended to consistently assess subtle diagnostic differences in these memory processes.

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

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

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.

Effect of Metformin and Flutamide on Anthropometric Indices and Laboratory Tests in Obese/Overweight PCOS Women under Hypocaloric Diet.

PubMed

Amiri, Mania; Golsorkhtabaramiri, Masoumeh; Esmaeilzadeh, Sedigheh; Ghofrani, Faeze; Bijani, Ali; Ghorbani, Leila; Delavar, Moloud Agajani

2014-10-01

This study was designed to investigate the effect of metformin and flutamide alone or in combination with anthropometric indices and laboratory tests of obese/overweight PCOS women under hypocaloric diet. This single blind clinical trial was performed on 120 PCOS women. At the beginning, hypocaloric diet was recommended for the patients. After one month while they were on the diet, the patients were randomly divided in 4 groups; metformin (500 mg, 3/day), flutamide (250 mg, 2/day), combined, metformin (500 mg, 3/day) with flutamide (250 mg, 2/day) and finally placebo group. The patients were treated for 6 months. Anthropometric indices and laboratory tests (fasting and glucose-stimulated insulin levels, lipid profile and androgens) were measured. A one-way ANOVA (Post Hoc) and paired t-test were performed to analyze data. A p ≤ 0.05 was considered statistically significant. After treatment, reduction in weight, BMI, hip circumference was significantly greater in the metformin group in comparison to other groups (p<0.05). In addition, the fasting insulin was significantly greater in metformin group and flutamide group in comparison to metformin+flutamide and placebo groups after treatment (p<0.05). Within groups, insulin level showed significant changes (before and after treatment) in metformin+flutamide group and LDL reduction was significant in flutamide group before and after treatment. Post hoc tukey and two-tailed with p≤0.05 were used to define statistical significance. Using combination of metformin and flutamide improves anthropometric indices and laboratory tests in obese/overweight PCOS women under hypocaloric diet.

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.

The effect of computer-mediated administration on self-disclosure of problems on the addiction severity index.

PubMed

Butler, Stephen F; Villapiano, Albert; Malinow, Andrew

2009-12-01

People tend to disclose more personal information when communication is mediated through the use of a computer. This study was conducted to examine the impact of this phenomenon on the way respondents answer questions during computer-mediated, self-administration of the Addiction Severity Index (ASI) called the Addiction Severity Index-Multimedia Version((R)) (ASI-MV((R))). A sample of 142 clients in substance abuse treatment was administered the ASI via an interviewer and the computerized ASI-MV((R)), three to five days apart in a counterbalanced order. Seven composite scores were compared between the two test administrations using paired t-tests. Post hoc analyses examined interviewer effects. Comparisons of composite scores for each of the domains between the face-to-face administered and computer-mediated, self-administered ASI revealed that significantly greater problem severity was reported by clients in five of the seven domains during administration of the computer-mediated, self-administered version compared to the trained interviewer version. Item analyses identified certain items as responsible for significant differences, especially those asking clients to rate need for treatment. All items that were significantly different between the two modes of administration revealed greater problem severity reported on the ASI-MV((R)) as compared to the interview administered assessment. Post hoc analyses yielded significant interviewer effects on four of the five domains where differences were observed. These data support a growing literature documenting a tendency for respondents to be more self-disclosing in a computer-mediated format over a face-to-face interview. Differences in interviewer skill in establishing rapport may account for these observations.

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.

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.).

Establishment of norms of the beta angle to assess the sagittal discrepancy for Nellore district population

PubMed Central

Prasad, Mandava; Reddy, Karnati Praveen Kumar; Talapaneni, Ashok Kumar; Chaitanya, Nellore; Bhaskar Reddy, Myla Vijay; Patil, Rajendra

2013-01-01

Background and Objectives: In orthodontic diagnosis and treatment planning, assessment of anteroposterior discrepancy is of importance to the orthodontist. Both angular and linear measurements have been incorporated into various cephalometric analyses to help the clinician diagnose anteroposterior discrepancies and establish the most appropriate treatment plan. Hence the present study is designed to establish the norms of Beta angle to assess the sagittal discrepancy for Nellore district population. Materials and Methods: The sample was screened from the old records of the Orthodontic department of Narayana Dental College and Hospital. One hundred and fifty pretreatment cephalometric radiographs (50 each of Class I, II, and III) were subdivided based on ANB, Wits appraisal, and Beta angle into skeletal Class I, II, III. The same cephalograms were again classified into skeletal Class I, II, and III based purely on Beta angle. Each group was again divided into 2 subgroups consisting of 25 male and 25 female subjects with a mean age limit between 15 and 45 years old. Results: The Newman-keuls post hoc test and ANOVA showed that the 3 groups were significantly different (P ≤ 0.001). The Newman-keuls post hoc test also found the groups to be significantly different. Conclusions: There was statistically significant difference for, the mean values and the standard deviation for Beta angle within the three skeletal patterns (Class I, Class II and Class III skeletal patterns). There was no statistically significant difference among the mean values of beta angle between Nellore district population and Caucasian norms and between male and female sex groups. PMID:24082742

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.

PROSPERA: a randomized, controlled trial evaluating rasagiline in progressive supranuclear palsy.

PubMed

Nuebling, Georg; Hensler, Mira; Paul, Sabine; Zwergal, Andreas; Crispin, Alexander; Lorenzl, Stefan

2016-08-01

To date, pharmacological treatment options for progressive supranuclear palsy (PSP), a neurodegenerative tauopathy, are limited. The MAO-B inhibitor rasagiline has shown neuroprotective effects in preclinical models of neurodegeneration. To evaluate the safety, tolerability and therapeutic effect of rasagiline on symptom progression in PSP. In this 1-year randomized, double-blind, placebo-controlled trial, 44 patients fulfilling the NINDS-PSP criteria were randomized to 1 mg/d rasagiline or placebo. The combined primary endpoint included symptom progression as measured by the PSP rating scale (PSP-RS) and the requirement of L-dopa rescue medication. Secondary endpoints included Schwab and England Activities of Daily Living (SEADL), Montgomery-Åsberg Depression Rating Scale, Mini Mental State Examination, Frontal Assessment Battery and posturographic measurements. Of the 44 patients randomized, 26 completed the trial per protocol. Rasagiline was well tolerated, with a slight increase of known side effects (hallucinations, ventricular extrasystoles). No effect on the primary endpoint (p = 0.496) was detected. Symptom progression averaged at 11.2 (rasagiline) and 10.8 (placebo) points per year (ΔPSP-RS). No difference was seen in SEADL, depression, cognitive function, frontal executive function and posturographic measurements. Post hoc analyses of PSP-RS subdomains indicate a potential beneficial effect in the "limb motor" subdomain, whereas performance appeared lower in the "mentation" and "history" subdomains in the treatment group. While rasagiline is well tolerated in PSP, a beneficial effect on overall symptom progression was not detected. Post hoc analyses suggest the implementation of more specific endpoints in future studies.

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.

Imperatives for Effective Post-Conflict Reconstruction Contracting

DTIC Science & Technology

2007-03-15

the transfer of authority from the CPA to the Interim Iraqi Government ( IIG ) in June 2004, the PMO was disestablished. All remaining DFI funds were...turned over the IIG . The Project and Contracting Office (PCO), another ad-hoc temporary organization was created and given the responsibility for...500K for division commanders with respective single transaction limits of $50K and $100K, respectively; weekly reporting; and for projects greater than

Examining statewide capacity for school health and mental health promotion: a post hoc application of a district capacity-building framework.

PubMed

Maras, Melissa A; Weston, Karen J; Blacksmith, Jennifer; Brophy, Chelsey

2015-03-01

Schools must possess a variety of capacities to effectively support comprehensive and coordinated school health promotion activities, and researchers have developed a district-level capacity-building framework specific to school health promotion. State-level school health coalitions often support such capacity-building efforts and should embed this work within a data-based, decision-making model. However, there is a lack of guidance for state school health coalitions on how they should collect and use data. This article uses a district-level capacity-building framework to interpret findings from a statewide coordinated school health needs/resource assessment in order to examine statewide capacity for school health promotion. Participants included school personnel (N = 643) from one state. Descriptive statistics were calculated for survey items, with further examination of subgroup differences among school administrators and nurses. Results were then interpreted via a post hoc application of a district-level capacity-building framework. Findings across districts revealed statewide strengths and gaps with regard to leadership and management capacities, internal and external supports, and an indicator of global capacity. Findings support the utility of using a common framework across local and state levels to align efforts and embed capacity-building activities within a data-driven, continuous improvement model. © 2014 Society for Public Health Education.

Differences in gray matter structure correlated to nationalism and patriotism

PubMed Central

Takeuchi, Hikaru; Taki, Yasuyuki; Sekiguchi, Atsushi; Nouchi, Rui; Kotozaki, Yuka; Nakagawa, Seishu; Miyauchi, Carlos Makoto; Iizuka, Kunio; Yokoyama, Ryoichi; Shinada, Takamitsu; Yamamoto, Yuki; Hanawa, Sugiko; Araki, Tsuyoshi; Hashizume, Hiroshi; Kunitoki, Keiko; Sassa, Yuko; Kawashima, Ryuta

2016-01-01

Nationalism and patriotism both entail positive evaluations of one’s nation. However, the former inherently involves derogation of other nations, whereas the latter is independent of comparisons with other nations. We used voxel-based morphometry and psychological measures and determined nationalism and patriotism’s association with gray matter density (rGMD) and their cognitive nature in healthy individuals (433 men and 344 women; age, 20.7 ± 1.9 years) using whole-brain multiple regression analyses and post hoc analyses. We found higher nationalism associated with greater rGMD in (a) areas of the posterior cingulate cortex and greater rGMD in (b) the orbitofrontal cortex, and smaller rGMD in (c) the right amygdala area. Furthermore, we found higher patriotism associated with smaller rGMD in the (d) rostrolateral prefrontal cortex. Post hoc analyses revealed the mean rGMD of the cluster (a) associated with compassion, that of (b) associated with feeling of superiority, that of (c) associated with suicide ideation, and that of (d) associated with quality of life. These results indicate that individual nationalism may be mediated by neurocognitive mechanisms in social-related areas and limbic neural mechanisms, whereas patriotism may be mediated by neurocognitive mechanisms in areas related to well-being. PMID:27418362

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.

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.

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.

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

Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson's Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE.

PubMed

Cattaneo, Carlo; Sardina, Marco; Bonizzoni, Ermino

2016-01-01

Studies 016 and SETTLE showed that safinamide was safe and effective as adjunct therapy in patients with advanced Parkinson's disease (PD) and motor fluctuations. The addition of safinamide to a stable dose of levodopa alone or with other antiparkinsonian medications significantly increased ON time with no/non-troublesome dyskinesia, decreased OFF time and improved Parkinson's symptoms. To evaluate the clinical effects of safinamide 100 mg/day on motor fluctuations and cardinal Parkinson's symptoms in specific patient subgroups using pooled data from Studies 016 and SETTLE. Both studies were double blind, placebo-controlled, randomized, phase 3 trials which enrolled patients with mid- to late-stage PD experiencing motor fluctuations while receiving optimized and stable doses of levodopa, alone or with other dopaminergic treatments. The present post-hoc analyses assessed the change from baseline in ON time (with no or non-troublesome dyskinesia) and OFF time in subgroups of patients who were receiving only levodopa at baseline, who were classified as "mild fluctuators" (daily OFF time ≤4 h), and who were receiving concomitant dopaminergic therapy, with or without amantadine, and the effects of safinamide versus placebo on individual cardinal PD symptoms during ON time. Safinamide significantly increased mean ON time (with no or non-troublesome dyskinesia) and reduced mean OFF time when used as first adjunct therapy in levodopa-treated patients and patients with mild motor fluctuations. Mean daily ON time (with no or non-troublesome dyskinesia) and OFF time were favorably changed, compared with placebo, to similar extents regardless of whether patients were receiving concomitant dopamine agonists, catechol-O-methyltransferase inhibitors and amantadine. Additionally, safinamide improved bradykinesia, rigidity, tremor and gait. Safinamide was a safe and effective first adjunct therapy in levodopa-treated patients and improved 4/5 cardinal symptoms of PD while providing benefits to mild and non-mild fluctuators and patients receiving other concomitant dopaminergic therapies.

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.

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.

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.

Human Hepatocyte Growth Factor (hHGF)-Modified Hepatic Oval Cells Improve Liver Transplant Survival

PubMed Central

Li, Li; Ran, Jiang-Hua; Li, Xue-Hua; Liu, Zhi-Heng; Liu, Gui-Jie; Gao, Yan-Chao; Zhang, Xue-Li; Sun, Hiu-Dong

2012-01-01

Despite progress in the field of immunosuppression, acute rejection is still a common postoperative complication following liver transplantation. This study aims to investigate the capacity of the human hepatocyte growth factor (hHGF) in modifying hepatic oval cells (HOCs) administered simultaneously with orthotopic liver transplantation as a means of improving graft survival. HOCs were activated and isolated using a modified 2-acetylaminofluorene/partial hepatectomy (2-AAF/PH) model in male Lewis rats. A HOC line stably expressing the HGF gene was established following stable transfection of the pBLAST2-hHGF plasmid. Our results demonstrated that hHGF-modified HOCs could efficiently differentiate into hepatocytes and bile duct epithelial cells in vitro. Administration of HOCs at the time of liver transplantation induced a wider distribution of SRY-positive donor cells in liver tissues. Administration of hHGF-HOC at the time of transplantation remarkably prolonged the median survival time and improved liver function for recipients compared to these parameters in the other treatment groups (P<0.05). Moreover, hHGF-HOC administration at the time of liver transplantation significantly suppressed elevation of interleukin-2 (IL-2), tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) levels while increasing the production of IL-10 and TGF-β1 (P<0.05). HOC or hHGF-HOC administration promoted cell proliferation, reduced cell apoptosis, and decreased liver allograft rejection rates. Furthermore, hHGF-modified HOCs more efficiently reduced acute allograft rejection (P<0.05 versus HOC transplantation only). Our results indicate that the combination of hHGF-modified HOCs with liver transplantation decreased host anti-graft immune responses resulting in a reduction of allograft rejection rates and prolonging graft survival in recipient rats. This suggests that HOC-based cell transplantation therapies can be developed as a means of treating severe liver injuries. PMID:23028627

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.

Patterns of Kidney Function Decline in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis From the HALT-PKD Trials.

PubMed

Brosnahan, Godela M; Abebe, Kaleab Z; Moore, Charity G; Rahbari-Oskoui, Frederic F; Bae, Kyongtae T; Grantham, Jared J; Schrier, Robert W; Braun, William E; Chapman, Arlene B; Flessner, Michael F; Harris, Peter C; Hogan, Marie C; Perrone, Ronald D; Miskulin, Dana C; Steinman, Theodore I; Torres, Vicente E

2018-05-01

Previous clinical studies of autosomal dominant polycystic kidney disease (ADPKD) reported that loss of kidney function usually follows a steep and relentless course. A detailed examination of individual patterns of decline in estimated glomerular filtration rate (eGFR) has not been performed. Longitudinal post hoc analysis of data collected during the Halt Progression of Polycystic Kidney Disease (HALT-PKD) trials. 494 HALT-PKD Study A participants (younger; preserved eGFR) and 435 Study B participants (older; reduced eGFR) who had more than 3 years of follow-up and 7 or more eGFR assessments. Longitudinal eGFR assessments using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation. Demographic, clinical, laboratory, and imaging features of participants. Probability of linear and nonlinear decline patterns or of stable eGFR calculated for each participant from a Bayesian model of individual eGFR trajectories. Most (62.5% in Study A and 81% in Study B) participants had a linear decline in eGFR during up to 8 years of follow-up. A proportion (22% in Study A and 13% in Study B) of progressors had a nonlinear pattern. 15.5% of participants in Study A and 6% in Study B had a prolonged (≥4.5 years) period of stable eGFRs. These individuals (Study A) had significantly smaller total kidney volumes, higher renal blood flows, lower urinary albumin excretion, and lower body mass index at baseline and study end. In Study B, participants with reduced but stable eGFRs were older than the progressors. Two-thirds of nonprogressors in both studies had PKD1 mutations, with enrichment for weak nontruncating mutations. Relatively short follow-up of a clinical trial population. Although many individuals with ADPKD have a linear decline in eGFR, prolonged intervals of stable GFRs occur in a substantial fraction. Lower body mass index was associated with more stable kidney function in early ADPKD. Copyright © 2017 National Kidney Foundation, Inc. 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.

Onset of relief of symptoms of gastroesophageal reflux disease: post hoc analysis of two previously published studies comparing pantoprazole 20 mg once daily with nizatidine or ranitidine 150 mg twice daily.

PubMed

Haag, Sebastian; Holtmann, Gerald

2010-04-01

Systematic assessments of the onset of symptom relief in the treatment of gastroesophageal reflux disease (GERD) are lacking. This work evaluated the time interval until complete symptom relief from heartburn (including both daytime and nighttime heartburn) and acid regurgitation in patients with GERD or endoscopy-negative GERD (NERD) during the first 7 days of treatment with pantoprazole, nizatidine, or ranitidine. This was a post hoc reanalysis of data from 2 previously published, multicenter, randomized, double-blind, active-controlled, parallel-group studies. Male and female patients aged >or=18 years with endoscopically proven GERD or NERD (Hetzel-Dent grade >or= [trial 1] or Savary-Miller grade 0 or 1 [trial 2]) were enrolled. Patients were required to have had reflux symptoms for the previous >or=3 months, with >or=1 symptom (ie, daytime heartburn, nighttime heartburn, or acid regurgitation) for >or=4 of the past 7 days in trial 1 or >or=1 symptom (ie, heartburn, acid eructation, or painful swallowing) of at least moderate intensity for the past 3 days in trial 2. The treatments were pantoprazole 20 mg once daily in both trials, nizatidine 150 mg BID in trial 1, or ranitidine 150 mg BID in trial 2. Presence and severity of symptoms were recorded on daily diary cards using a 4-point Likert-type scale. In total, 114 patients from trial 1 and 307 patients from trial 2 were evaluable for heartburn, and 58 patients from trial l and 271 patients from trial 2 were evaluable for acid regurgitation. In both studies, there were no significant differences in baseline characteristics between pantoprazole recipients and nizatidine or ranitidine recipients, with the exception of more men than women in trial 1 compared with trial 2 (P < 0.001). On day 2 of trial 1, 23 (39.0%) and 8 (14.5%) of pantoprazole and nizatidine recipients, respectively, experienced complete relief from heartburn (P < 0.01). The differences between groups remained statistically significant through day 7, when 28 (47.5%) and 8 (14.5 %) of pantoprazole and nizatidine recipients had no heartburn (P < 0.001). There were no differences in control of acid regurgitation over 7 days with pantoprazole compared with nizatidine or ranitidine, except at days 2 and 4 of trial 1, when significantly more patients receiving pantoprazole experienced relief from acid regurgitation than those receiving nizatidine (day 2: 60.6% [n = 20] vs 20.0% [n = 5], P < 0.01; day 4: 48.5% [n =16] vs 24.0% [n = 6], P < 0.05). In this post hoc reanalysis of data from 2 previously published clinical trials, use of pantoprazole 20 mg once daily was associated with effective early relief from heartburn and acid regurgitation among these patients with GERD and NERD; relief occurred as fast as and, in some cases, even faster than that seen with nizatidine or ranitidine.

Push-out bond strength of fiber posts to root dentin using glass ionomer and resin modified glass ionomer cements.

PubMed

Pereira, Jefferson Ricardo; Rosa, Ricardo Abreu da; Só, Marcus Vinícius Reis; Afonso, Daniele; Kuga, Milton Carlos; Honório, Heitor Marques; Valle, Accácio Lins do; Vidotti, Hugo Alberto

2014-01-01

The purpose of this study was to assess the push-out bond strength of glass fiber posts to root dentin after cementation with glass ionomer (GICs) and resinmodified glass ionomer cements (RMGICs). Fifty human maxillary canines were transversally sectioned at 15 mm from the apex. Canals were prepared with a step back technique until the application of a #55 K-file and filled. Post spaces were prepared and specimens were divided into five groups according to the cement used for post cementation: Luting & Lining Cement; Fuji II LC Improved; RelyX Luting; Ketac Cem; and Ionoseal. After cementation of the glass fiber posts, all roots were stored at 100% humidity until testing. For push-out test, 1-mm thick slices were produced. The push-out test was performed in a universal testing machine at a crosshead speed of 0.5 mm/minute and the values (MPa) were analyzed by Kolmogorov-Smirnov and Levene's tests and by two-way ANOVA and Tukey's post hoc test at a significance level of 5%. Fiber posts cemented using Luting & Lining Cement, Fuji II LC Improved, and Ketac Cem presented the highest bond strength to root dentin, followed by RelyX Luting. Ionoseal presented the lowest bond strength values (P>0.05). The post level did not influence the bond strength of fiber posts to root dentin (P=0.148). The major cause of failure was cohesive at the cement for all GICs and RMGICs. Except for Ionoseal, all cements provided satisfactory bond strength values.

Push-out bond strength of fiber posts to root dentin using glass ionomer and resin modified glass ionomer cements

PubMed Central

PEREIRA, Jefferson Ricardo; da ROSA, Ricardo Abreu; SÓ, Marcus Vinícius Reis; AFONSO, Daniele; KUGA, Milton Carlos; HONÓRIO, Heitor Marques; do VALLE, Accácio Lins; VIDOTTI, Hugo Alberto

2014-01-01

Objective The purpose of this study was to assess the push-out bond strength of glass fiber posts to root dentin after cementation with glass ionomer (GICs) and resin-modified glass ionomer cements (RMGICs). Material and Methods Fifty human maxillary canines were transversally sectioned at 15 mm from the apex. Canals were prepared with a step back technique until the application of a #55 K-file and filled. Post spaces were prepared and specimens were divided into five groups according to the cement used for post cementation: Luting & Lining Cement; Fuji II LC Improved; RelyX Luting; Ketac Cem; and Ionoseal. After cementation of the glass fiber posts, all roots were stored at 100% humidity until testing. For push-out test, 1-mm thick slices were produced. The push-out test was performed in a universal testing machine at a crosshead speed of 0.5 mm/minute and the values (MPa) were analyzed by Kolmogorov-Smirnov and Levene's tests and by two-way ANOVA and Tukey's post hoc test at a significance level of 5%. Results Fiber posts cemented using Luting & Lining Cement, Fuji II LC Improved, and Ketac Cem presented the highest bond strength to root dentin, followed by RelyX Luting. Ionoseal presented the lowest bond strength values (P>0.05). The post level did not influence the bond strength of fiber posts to root dentin (P=0.148). The major cause of failure was cohesive at the cement for all GICs and RMGICs. Conclusions Except for Ionoseal, all cements provided satisfactory bond strength values. PMID:25004052

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

The effect of consignment to broodmare sales on physiological stress measured by faecal glucocorticoid metabolites in pregnant Thoroughbred mares.

PubMed

Schulman, Martin; Becker, Annet; Ganswindt, Stefanie; Guthrie, Alan; Stout, Tom; Ganswindt, Andre

2014-01-17

Validation of a method for the minimally-invasive measurement of physiological stress will help understanding of risk factors that may contribute to stress-associated events including recrudescence of Equid herpesvirus (EHV), which is anecdotally associated with sales consignment of pregnant Thoroughbred mares. In this study we compared two similar groups of late-gestation Thoroughbred broodmares on the same farm: a consigned Sales group (N = 8) and a non-consigned Control group (N = 6). The Sales mares were separated from their paddock companions and grouped prior to their preparation for, transport to, and return from the sales venue. Both groups were monitored by sampling at regular intervals from 5 days prior to until 14 days after the sales date (D0) to measure physiological stress in terms of changes in faecal glucocorticoid metabolite (FGM) concentrations, and for event-related viral recrudescence via daily body temperature measurements and periodic nasal swabs for PCR analysis for EHV-1 and -4 DNA. In both groups, FGM levels increased post-sales before returning to pre-sales levels. Specifically, FGM concentrations in the Sales mares were significantly higher on D + 3 and D + 10 than on D-4 and D-3 (F = 12.03, P < 0.0001, Post hoc: P = 0.0003-0.0008) and in the Control group FGM concentrations were higher on D + 10 than D-4 (F = 5.52, P = 0.004, Post hoc: P = 0.005). Interestingly, mean FGM levels in Control mares were significantly higher at 4 of the 5 sampling points (t = 5.64-2.25, p = 0.0001-0.044). Only one (Sales) mare showed PCR evidence of EHV-1 shedding. Using FGM to measure physiological stress was supported by the increases observed in all mares after Sales consignment, including those not consigned to the sale. Monitoring FGM levels therefore represents an appropriate, minimally-invasive method for future studies to assess the contribution of physiological stress to EHV recrudescence in horses transported to sales or equestrian events.

The effect of consignment to broodmare Sales on physiological stress measured by faecal glucocorticoid metabolites in pregnant Thoroughbred mares

PubMed Central

2014-01-01

Background Validation of a method for the minimally-invasive measurement of physiological stress will help understanding of risk factors that may contribute to stress-associated events including recrudescence of Equid herpesvirus (EHV), which is anecdotally associated with sales consignment of pregnant Thoroughbred mares. In this study we compared two similar groups of late-gestation Thoroughbred broodmares on the same farm: a consigned Sales group (N = 8) and a non-consigned Control group (N = 6). The Sales mares were separated from their paddock companions and grouped prior to their preparation for, transport to, and return from the sales venue. Both groups were monitored by sampling at regular intervals from 5 days prior to until 14 days after the sales date (D0) to measure physiological stress in terms of changes in faecal glucocorticoid metabolite (FGM) concentrations, and for event-related viral recrudescence via daily body temperature measurements and periodic nasal swabs for PCR analysis for EHV-1 and -4 DNA. Results In both groups, FGM levels increased post-sales before returning to pre-sales levels. Specifically, FGM concentrations in the Sales mares were significantly higher on D + 3 and D + 10 than on D-4 and D-3 (F = 12.03, P < 0.0001, Post hoc: P = 0.0003 – 0.0008) and in the Control group FGM concentrations were higher on D + 10 than D-4 (F = 5.52, P = 0.004, Post hoc: P = 0.005). Interestingly, mean FGM levels in Control mares were significantly higher at 4 of the 5 sampling points (t = 5.64 – 2.25, p = 0.0001 – 0.044). Only one (Sales) mare showed PCR evidence of EHV-1 shedding. Conclusions Using FGM to measure physiological stress was supported by the increases observed in all mares after Sales consignment, including those not consigned to the sale. Monitoring FGM levels therefore represents an appropriate, minimally-invasive method for future studies to assess the contribution of physiological stress to EHV recrudescence in horses transported to sales or equestrian events. PMID:24433380

Effect of Different Endodontic Sealers on the Push-out Bond Strength of Fiber Posts.

PubMed

Forough Reyhani, Mohammad; Ghasemi, Negin; Rahimi, Saeed; Milani, Amin Salem; Omrani, Elnaz

2016-01-01

The aim of this in vitro study was to evaluate the effect of MTA-based sealer (MTA Fillapex), eugenol-based sealer (Dorifill) and an epoxy resin sealer (AH Plus) on the bond strength of fiber posts cemented with a self-etch adhesive. The root canals of 72 maxillary incisors were prepared using the step-back technique after removing/cutting off the crowns. The samples were randomly divided to 4 groups (n=18). In group 1 (the controls) gutta-percha was used without sealer. In groups 2, 3 and 4, the canals were filled with gutta-percha using AH Plus, Dorifill and MTA Fillapex sealers, respectively, by cold lateral compaction technique. After post space preparation, the fiber posts were cemented in the root canals using self-etch adhesive. Then 1-mm-thick disks were prepared from the coronal thirds of all the root canals and subjected to a push-out test. Data were analyzed using the one-way ANOVA and post hoc Tukey's tests. The maximum (4.45±0.09 MPa) and minimum (1.02±0.03 MPa) bond strength values were recorded in the control and Dorifill groups, respectively. The mean push-out bond strength values were similar for MTA Fillapex and AH Plus sealers (P>0.05). However these values were significantly higher than that of the Dorifill sealer (P<0.05). Sealer type affected the bond strength of the fiber posts and MTA Fillapex decreased the dislodgment resistant of the fiber post.

Earlier defibrotide initiation post-diagnosis of veno-occlusive disease/sinusoidal obstruction syndrome improves Day +100 survival following haematopoietic stem cell transplantation.

PubMed

Richardson, Paul G; Smith, Angela R; Triplett, Brandon M; Kernan, Nancy A; Grupp, Stephan A; Antin, Joseph H; Lehmann, Leslie; Miloslavsky, Maja; Hume, Robin; Hannah, Alison L; Nejadnik, Bijan; Soiffer, Robert J

2017-07-01

Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a progressive, potentially fatal complication of conditioning for haematopoietic stem cell transplant (HSCT). The VOD/SOS pathophysiological cascade involves endothelial-cell activation and damage, and a prothrombotic-hypofibrinolytic state. Severe VOD/SOS (typically characterized by multi-organ dysfunction) may be associated with >80% mortality. Defibrotide is approved for treating severe hepatic VOD/SOS post-HSCT in the European Union, and for hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT in the United States. Previously, defibrotide (25 mg/kg/day in 4 divided doses for a recommended ≥21 days) was available through an expanded-access treatment protocol for patients with VOD/SOS. Data from this study were examined post-hoc to determine if the timing of defibrotide initiation post-VOD/SOS diagnosis affected Day +100 survival post-HSCT. Among 573 patients, defibrotide was started on the day of VOD/SOS diagnosis in approximately 30%, and within 7 days in >90%. The relationship between Day +100 survival and treatment initiation before/after specific days post-diagnosis showed superior survival when treatment was initiated closer to VOD/SOS diagnosis with a statistically significant trend over time for better outcomes with earlier treatment initiation (P < 0·001). These results suggest that initiation of defibrotide should not be delayed after diagnosis of VOD/SOS. © 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

Neuromuscular Responses to Simulated Brazilian Jiu-Jitsu Fights

PubMed Central

da Silva, Bruno Victor Corrêa; Ide, Bernardo Neme; de Moura Simim, Mário Antônio; Marocolo, Moacir; da Mota, Gustavo Ribeiro

2014-01-01

The aim of this study was to investigate the neuromuscular performance responses following successive Brazilian Jiu-Jitsu (BJJ) fights. Twenty-three BJJ athletes (age: 26.3 ± 6.3 years; body mass: 79.4 ± 9.7 kg; body height: 1.80 ± 0.1 m) undertook 3 simulated BJJ fights (10 min duration each separated by 15 min of rest). Neuromuscular performance was measured by the bench press throw (BPT) and vertical counter movement jump (VCMJ) tests, assessed before the 1st fight (Pre) and after the last one (Post). Blood lactate (LA) was measured at Pre, 1 min Post, and 15 min Post fights. Paired t-tests were employed in order to compare the BPT and VCMJ results. One-way ANOVA with Bonferroni post hoc tests were utilized to compare LA responses. The results revealed a significant (p < 0.05) increase in VCMJ performance (40.8 ± 5.5 cm Pre vs. 42.0 ± 5.8 cm Post), but no significant changes in the BPT (814 ± 167 W Pre vs. 835 ± 213 W Post) were observed. LA concentration increased significantly (p < 0.05) at Post, both in the 1st min (10.4 ± 2.7 mmol L-1) and the 15th min (6.4 ± 2.5 mmol L-1) of recovery. We concluded that successive simulated BJJ fights demanded considerable anaerobic contribution of ATP supply, reinforcing the high-intensity intermittent nature of the sport. Nevertheless, no negative impact on acute neuromuscular performance (power) was observed. PMID:25713685

Neuromuscular responses to simulated brazilian jiu-jitsu fights.

PubMed

da Silva, Bruno Victor Corrêa; Ide, Bernardo Neme; de Moura Simim, Mário Antônio; Marocolo, Moacir; da Mota, Gustavo Ribeiro

2014-12-09

The aim of this study was to investigate the neuromuscular performance responses following successive Brazilian Jiu-Jitsu (BJJ) fights. Twenty-three BJJ athletes (age: 26.3 ± 6.3 years; body mass: 79.4 ± 9.7 kg; body height: 1.80 ± 0.1 m) undertook 3 simulated BJJ fights (10 min duration each separated by 15 min of rest). Neuromuscular performance was measured by the bench press throw (BPT) and vertical counter movement jump (VCMJ) tests, assessed before the 1st fight (Pre) and after the last one (Post). Blood lactate (LA) was measured at Pre, 1 min Post, and 15 min Post fights. Paired t-tests were employed in order to compare the BPT and VCMJ results. One-way ANOVA with Bonferroni post hoc tests were utilized to compare LA responses. The results revealed a significant (p < 0.05) increase in VCMJ performance (40.8 ± 5.5 cm Pre vs. 42.0 ± 5.8 cm Post), but no significant changes in the BPT (814 ± 167 W Pre vs. 835 ± 213 W Post) were observed. LA concentration increased significantly (p < 0.05) at Post, both in the 1st min (10.4 ± 2.7 mmol L-1) and the 15th min (6.4 ± 2.5 mmol L-1) of recovery. We concluded that successive simulated BJJ fights demanded considerable anaerobic contribution of ATP supply, reinforcing the high-intensity intermittent nature of the sport. Nevertheless, no negative impact on acute neuromuscular performance (power) was observed.

Microplastics as vectors for bioaccumulation of hydrophobic organic chemicals in the marine environment: A state-of-the-science review.

PubMed

Ziccardi, Linda M; Edgington, Aaron; Hentz, Karyn; Kulacki, Konrad J; Kane Driscoll, Susan

2016-07-01

A state-of-the-science review was conducted to examine the potential for microplastics to sorb hydrophobic organic chemicals (HOCs) from the marine environment, for aquatic organisms to take up these HOCs from the microplastics, and for this exposure to result in adverse effects to ecological and human health. Despite concentrations of HOCs associated with microplastics that can be orders of magnitude greater than surrounding seawater, the relative importance of microplastics as a route of exposure is difficult to quantify because aquatic organisms are typically exposed to HOCs from various compartments, including water, sediment, and food. Results of laboratory experiments and modeling studies indicate that HOCs can partition from microplastics to organisms or from organisms to microplastics, depending on experimental conditions. Very little information is available to evaluate ecological or human health effects from this exposure. Most of the available studies measured biomarkers that are more indicative of exposure than effects, and no studies showed effects to ecologically relevant endpoints. Therefore, evidence is weak to support the occurrence of ecologically significant adverse effects on aquatic life as a result of exposure to HOCs sorbed to microplastics or to wildlife populations and humans from secondary exposure via the food chain. More data are needed to fully understand the relative importance of exposure to HOCs from microplastics compared with other exposure pathways. Environ Toxicol Chem 2016;35:1667-1676. © 2016 SETAC. © 2016 SETAC.

Training of support afferentation in postmenopausal women.

PubMed

Bazanova, O M; Kholodina, N V; Nikolenko, E D; Payet, J

2017-12-01

We have recently shown a diminishing of the Menopause Index in old-aged women who underwent special training directed at the enhancement of support afferentation by increasing the plantar forefoot sensitivity (Bazanova et al., 2015). Based on these results we hypothesized, that purposeful training of support afferentation through stimulation of plantar graviceptors by Aikido practice will decrease excessive postural and psychoemotional tension not only in rest condition, but during cognitive and manual task performance too. Fluency of cognitive and motor task performance, EEG alpha power as an index of neuronal efficiency of cognitive control, amount of alpha power suppression as a visual activation measure and EMG power of forehead muscles as a sign of psychoemotional tension were compared in three groups of post-menopausal women: i) 8years training with forefeet support afferentation with Aikido practice (A), ii) 8years fitness training (F) and iii) no dedicated fitness training for past 8years (N). Simultaneous stabilometry, EEG, and frontal EMG recording were performed in sitting and standing up position in eyes closed and eyes open condition. Recording done at rest and while performing cognitive and finger motor tasks. We compared studied parameters between groups with one- and two-way analyses of variance (ANOVAs) with Bonferroni correction for multiple comparisons, followed by post hoc two-tailed unpaired t-tests. The fluency of tasks performance, EMG and alpha-EEG-activity displayed similar values in all groups in a sitting position. Center of pressure (CoP) sway length, velocity and energy demands for saving balance increased when standing up, more in group N than in groups F and A (all contrasts p values<0.002, η 2 >0.89). Post hoc t-tests showed increased fluency in standing in both Aikido (p<0.01) and Fitness (p<0.05) subjects in relation to untrained subjects. Increasing fluency in motor task performance was in parallel with enhancing the EEG alpha-2-power and decreasing EMG power only in A group (η 2 >0.77). Fluency in motor task and alpha EEG power decreased, but frontal EMG power increased in response to standing in untrained women (group N) and did not change in F group. Post hoc t-tests showed that EEG amount of alpha-2 power suppression in response to visual activation and frontal EMG power was lower in A than F and N groups (p<0.004) during motor task performance in the standing position. These results were interpreted as showing that training of forefoot plantar surface sensitivity in postmenopausal women decreases levels of psychoemotional tension and increases cognitive control caused by the psychomotor and postural challenges. Thus, Aikido training aimed at learning coordination between manual task performance and balance control by increasing the plantar support zones sensation decreases the cost of maintained vertical position and dependence of motor coordination on visual contribution. Copyright © 2017 Elsevier B.V. All rights reserved.

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…

Organophosphate Related Alterations in Myelin and Axonal Transport in the Living Mammalian Brain

DTIC Science & Technology

2015-10-01

examine post hoc differences when indicated. Statistical significance was assessed using an alpha level of 0.05. 3. Results 3.1. Body weights Test subjects...REPORT: Annual PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland 21702-5012 DISTRIBUTION STATEMENT: Approved...not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. 2 REPORT

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

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

PubMed

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

2011-06-01

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

Beneficial Effect of Moderate Exercise in Kidney of Rat after Chronic Consumption of Cola Drinks.

PubMed

Cao, Gabriel; González, Julián; Müller, Angélica; Ottaviano, Graciela; Ambrosio, Giuseppe; Toblli, Jorge E; Milei, José

2016-01-01

The purpose of this study was to investigate the effect of moderate intensity exercise on kidney in an animal model of high consumption of cola soft drinks. Forty-eight Wistar Kyoto rats (age: 16 weeks; weight: 350-400 g) were assigned to the following groups: WR (water runners) drank water and submitted to aerobic exercise; CR (cola runners) drank cola and submitted to aerobic exercise; WS (water sedentary) and CS (cola sedentary), not exercised groups. The aerobic exercise was performed for 5 days per week throughout the study (24 weeks) and the exercise intensity was gradually increased during the first 8 weeks until it reached 20 meters / minute for 30 minutes. Body weight, lipid profile, glycemia, plasma creatinine levels, atherogenic index of plasma (AIP) and systolic blood pressure (SBP) were determined. After 6 months all rats were sacrificed. A kidney histopathological score was obtained using a semiquantitative scale. Glomerular size and glomerulosclerosis were estimated by point-counting. The oxidative stress and pro-inflammatory status were explored by immunohistochemistry. A one way analysis of variance (ANOVA) with Tukey-Kramer post-hoc test or the Kruskal-Wallis test with Dunn's post-hoc test was used for statistics. A value of p < 0.05 was considered significant. At 6 months, an increased consumption of cola soft drink was shown in CS and CR compared with water consumers (p<0.0001). Chronic cola consumption was associated with increased plasma triglycerides, AIP, heart rate, histopathological score, glomerulosclerosis, oxidative stress and pro-inflammatory status. On the other hand, moderate exercise prevented these findings. No difference was observed in the body weight, SBP, glycemia, cholesterol and plasma creatinine levels across experimental groups. This study warns about the consequences of chronic consumption of cola drinks on lipid metabolism, especially regarding renal health. Additionally, these findings emphasize the protective role of exercise training on renal damage.

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.

Estimated medical expenditure and risk of job loss among rheumatoid arthritis patients undergoing tofacitinib treatment: post hoc analyses of two randomized clinical trials.

PubMed

Rendas-Baum, Regina; Kosinski, Mark; Singh, Amitabh; Mebus, Charles A; Wilkinson, Bethany E; Wallenstein, Gene V

2017-08-01

RA causes high disability levels and reduces health-related quality of life, triggering increased costs and risk of unemployment. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. These post hoc analyses of phase 3 data aimed to assess monthly medical expenditure (MME) and risk of job loss for tofacitinib treatment vs placebo. Data analysed were from two randomized phase 3 studies of RA patients (n = 1115) with inadequate response to MTX or TNF inhibitors (TNFi) receiving tofacitinib 5 or 10 mg twice daily, adalimumab (one study only) or placebo, in combination with MTX. Short Form 36 version 2 Health Survey physical and mental component summary scores were translated into predicted MME via an algorithm and concurrent inability to work and job loss risks at 6, 12 and 24 months, using Medical Outcomes Study data. MME reduction by month 3 was $100 greater for tofacitinib- than placebo-treated TNFi inadequate responders (P < 0.001); >20 and 6% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾16%, and risk of future job loss decreased ∼20% (P < 0.001 vs placebo). MME reduction by month 3 was $70 greater for tofacitinib- than placebo-treated MTX inadequate responders (P < 0.001); ⩾23 and 13% reductions from baseline, respectively. By month 3 of tofacitinib treatment, the odds of inability to work decreased ⩾31% and risk of future job loss decreased ⩾25% (P < 0.001 vs placebo). Tofacitinib treatment had a positive impact on estimated medical expenditure and risk of job loss for RA patients with inadequate response to MTX or TNFi. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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.

Brain-actuated gait trainer with visual and proprioceptive feedback

NASA Astrophysics Data System (ADS)

Liu, Dong; Chen, Weihai; Lee, Kyuhwa; Chavarriaga, Ricardo; Bouri, Mohamed; Pei, Zhongcai; Millán, José del R.

2017-10-01

Objective. Brain-machine interfaces (BMIs) have been proposed in closed-loop applications for neuromodulation and neurorehabilitation. This study describes the impact of different feedback modalities on the performance of an EEG-based BMI that decodes motor imagery (MI) of leg flexion and extension. Approach. We executed experiments in a lower-limb gait trainer (the legoPress) where nine able-bodied subjects participated in three consecutive sessions based on a crossover design. A random forest classifier was trained from the offline session and tested online with visual and proprioceptive feedback, respectively. Post-hoc classification was conducted to assess the impact of feedback modalities and learning effect (an improvement over time) on the simulated trial-based performance. Finally, we performed feature analysis to investigate the discriminant power and brain pattern modulations across the subjects. Main results. (i) For real-time classification, the average accuracy was 62.33 +/- 4.95 % and 63.89 +/- 6.41 % for the two online sessions. The results were significantly higher than chance level, demonstrating the feasibility to distinguish between MI of leg extension and flexion. (ii) For post-hoc classification, the performance with proprioceptive feedback (69.45 +/- 9.95 %) was significantly better than with visual feedback (62.89 +/- 9.20 %), while there was no significant learning effect. (iii) We reported individual discriminate features and brain patterns associated to each feedback modality, which exhibited differences between the two modalities although no general conclusion can be drawn. Significance. The study reported a closed-loop brain-controlled gait trainer, as a proof of concept for neurorehabilitation devices. We reported the feasibility of decoding lower-limb movement in an intuitive and natural way. As far as we know, this is the first online study discussing the role of feedback modalities in lower-limb MI decoding. Our results suggest that proprioceptive feedback has an advantage over visual feedback, which could be used to improve robot-assisted strategies for motor training and functional recovery.

Influence of different luting protocols on shear bond strength of computer aided design/computer aided manufacturing resin nanoceramic material to dentin

PubMed Central

Poggio, Claudio; Pigozzo, Marco; Ceci, Matteo; Scribante, Andrea; Beltrami, Riccardo; Chiesa, Marco

2016-01-01

Background: The purpose of this study was to evaluate the influence of three different luting protocols on shear bond strength of computer aided design/computer aided manufacturing (CAD/CAM) resin nanoceramic (RNC) material to dentin. Materials and Methods: In this in vitro study, 30 disks were milled from RNC blocks (Lava Ultimate/3M ESPE) with CAD/CAM technology. The disks were subsequently cemented to the exposed dentin of 30 recently extracted bovine permanent mandibular incisors. The specimens were randomly assigned into 3 groups of 10 teeth each. In Group 1, disks were cemented using a total-etch protocol (Scotchbond™ Universal Etchant phosphoric acid + Scotchbond Universal Adhesive + RelyX™ Ultimate conventional resin cement); in Group 2, disks were cemented using a self-etch protocol (Scotchbond Universal Adhesive + RelyX™ Ultimate conventional resin cement); in Group 3, disks were cemented using a self-adhesive protocol (RelyX™ Unicem 2 Automix self-adhesive resin cement). All cemented specimens were placed in a universal testing machine (Instron Universal Testing Machine 3343) and submitted to a shear bond strength test to check the strength of adhesion between the two substrates, dentin, and RNC disks. Specimens were stressed at a crosshead speed of 1 mm/min. Data were analyzed with analysis of variance and post-hoc Tukey's test at a level of significance of 0.05. Results: Post-hoc Tukey testing showed that the highest shear strength values (P < 0.001) were reported in Group 2. The lowest data (P < 0.001) were recorded in Group 3. Conclusion: Within the limitations of this in vitro study, conventional resin cements (coupled with etch and rinse or self-etch adhesives) showed better shear strength values compared to self-adhesive resin cements. Furthermore, conventional resin cements used together with a self-etch adhesive reported the highest values of adhesion. PMID:27076822

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.

A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension.

PubMed

Oparil, S; Abate, N; Chen, E; Creager, M A; Galet, V; Jia, G; Julius, S; Lerman, A; Lyle, P A; Pool, J; Tershakovec, A M

2008-04-01

The objective of this study was to evaluate the effects of losartan +/- hydrochlorothiazide (HCTZ) versus placebo in obese patients with systolic and diastolic hypertension. Randomized patients (n = 261) were non-diabetic with systolic blood pressure (SBP) > or = 140 and < or = 180 mmHg and diastolic BP (DBP) > or = 95 and < or = 115 mmHg, body mass index > 30 kg/m(2), and waist circumference > 40 (males)/> 35 (females) inches. Patients were randomized to placebo or a forced titration of losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/HCTZ 12.5 mg, and losartan 100 mg/HCTZ 25 mg. Primary efficacy measurements were change from baseline in SBP and DBP at 12 weeks. Secondary measurements were change from baseline in BPs at 8 and 16 weeks, percent responders at 12 and 16 weeks, and safety/tolerability. Post-hoc analyses were BP at 4 weeks and achievement of controlled BP (SBP < 140 and/or DBP < 90 mmHg) at 12 and 16 weeks. Losartan 50 mg reduced BP from 151.6/99.2 mmHg at baseline to 140.1/89.8 mmHg at week 4 (post hoc), 139.5/89.6 mmHg with losartan 100 mg at week 8 (secondary), 134.3/85.9 mmHg with losartan 100 mg/HCTZ 12.5 mg at week 12 (primary), and 132.1/84.9 mmHg with losartan 100 mg/HCTZ 50 mg at week 16 (secondary) (all p < 0.05). Rates of clinical adverse experiences were similar between treatment groups. A limitation of these analyses is the relatively rapid rate of study drug titration, which may not have allowed for the evaluation of the full treatment effect at each titration step. We conclude that losartan alone or in combination with HCTZ was generally well tolerated and effective in the treatment of elevated systolic and diastolic BP in obese patients with hypertension.

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.

Age-Related Changes in Physiological Reactivity to a Stress Task: A Near-Infrared Spectroscopy Study.

PubMed

Brugnera, A; Zarbo, C; Adorni, R; Gatti, A; Compare, A; Sakatani, K

2017-01-01

Aging is associated with changes in biological functions, such as reduced cardiovascular responses to stressful tasks. However, less is known about the influence of age on the reactivity of the prefrontal cortex (PFC) to acute stressors. Therefore, this study aimed to investigate the effects of a computerized-controlled stress task on the PFC and autonomic system activity in a sample of older and younger adults. We recruited a total of 55 healthy, right-handed persons (26 older adults with mean age 69.5, SD 5.8 years; and 29 younger adults with mean age 23.8, SD 3.3 years); groups were balanced for sex. Tasks included a control and an experimental condition: during both tasks individuals had to solve simple mental arithmetic problems. For the experimental condition, all participants were faced with a time limit that induced significant stress. Physiological indexes were collected continuously during the entire procedure using a 2-channel near infrared spectroscopy (NIRS) and an ECG monitoring system. Repeated measures ANOVA were used to assess changes in hemoglobin concentrations, and changes in both heart rate and performance outcomes. NIRS, ECG and performance data showed a significant interaction between the group and condition. Post-hoc analyses evidenced a significant increase in heart rate and Oxy-Hb concentration in the bilateral PFC between the control and experimental condition only in the younger group. Post-hoc analyses of behavioral data showed lower percentages of correct responses and higher response times in the older group. In summary, these results suggested that cardiovascular and cortical reactivity to stress tasks are a function of age. Older individuals seem to be characterized by blunted physiological reactivity, suggestive of impaired adaptive responses to acute stressors. Therefore, future studies should investigate the underlying physiological mechanisms of prefrontal and cardiovascular changes related to aging.

Influence of Different Enamel Shades and Thickness on Chroma and Value of Dentin Vita Shade: An in vitro Comparative Assessment Study.

PubMed

Hajira, Noor Saira Wajid Najma; Mehta, Deepak; Ashwini, P; Meena, N; Usha, H L

2015-04-01

The aim of the present study is to determine the influence of different enamel shades of various thickness on chroma and value of vita shade of dentin. Three enamel composite resin shades (Enamel white, grey and neutral) and one dentin shade (A 2) from A melogen Plus (Ultradent) was used. Ninety Enamel disk specimens of 0.5, 0.75 and 1 mm thickness and 10 mm in diameter for each shade and 90 dentin disk specimens of 2 mm in thickness and 10 mm in diameter was used for the study. The spectrophotometric values of the dentin shade with and without enamel specimens were recorded and the values were converted to CIEL*a*b values. Statistical analysis was done using Pearson correlation coefficients to verify the effect of thickness on Chroma and value, and the significance was evaluated by one-way ANOVA and Tukey post hoc test. Two way ANOVA and Tukey post hoc was done to verify the variation within the groups. Results revealed a significant positive correlation between thickness and chroma and a negative correlation between thickness and value. There was a statistically significant variation in between the groups. All groups produced a significant increase in chroma with increase in thickness of enamel shade upto a thickness of 0.75 mm after which the behavior of each shade was erratic. Hence, the optimum thickness would be 0.75 mm. All groups produced a significant decrease in value with increase in thickness of enamel shade. Enamel white produced the greatest reduction in value, enamel neutral the least and enamel grey demonstrated an intermediate result. There is a need to have a knowledge of the effect on chroma and value when dentin is layered with different enamel shades, it is also important to understand the effect of these enamel shades at different thicknesses to better control the color and reproduce esthetic simulating natural teeth.

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.

Brain-actuated gait trainer with visual and proprioceptive feedback.

PubMed

Liu, Dong; Chen, Weihai; Lee, Kyuhwa; Chavarriaga, Ricardo; Bouri, Mohamed; Pei, Zhongcai; Del R Millán, José

2017-10-01

Brain-machine interfaces (BMIs) have been proposed in closed-loop applications for neuromodulation and neurorehabilitation. This study describes the impact of different feedback modalities on the performance of an EEG-based BMI that decodes motor imagery (MI) of leg flexion and extension. We executed experiments in a lower-limb gait trainer (the legoPress) where nine able-bodied subjects participated in three consecutive sessions based on a crossover design. A random forest classifier was trained from the offline session and tested online with visual and proprioceptive feedback, respectively. Post-hoc classification was conducted to assess the impact of feedback modalities and learning effect (an improvement over time) on the simulated trial-based performance. Finally, we performed feature analysis to investigate the discriminant power and brain pattern modulations across the subjects. (i) For real-time classification, the average accuracy was [Formula: see text]% and [Formula: see text]% for the two online sessions. The results were significantly higher than chance level, demonstrating the feasibility to distinguish between MI of leg extension and flexion. (ii) For post-hoc classification, the performance with proprioceptive feedback ([Formula: see text]%) was significantly better than with visual feedback ([Formula: see text]%), while there was no significant learning effect. (iii) We reported individual discriminate features and brain patterns associated to each feedback modality, which exhibited differences between the two modalities although no general conclusion can be drawn. The study reported a closed-loop brain-controlled gait trainer, as a proof of concept for neurorehabilitation devices. We reported the feasibility of decoding lower-limb movement in an intuitive and natural way. As far as we know, this is the first online study discussing the role of feedback modalities in lower-limb MI decoding. Our results suggest that proprioceptive feedback has an advantage over visual feedback, which could be used to improve robot-assisted strategies for motor training and functional recovery.

Beneficial Effect of Moderate Exercise in Kidney of Rat after Chronic Consumption of Cola Drinks

PubMed Central

Cao, Gabriel; González, Julián; Müller, Angélica; Ottaviano, Graciela; Ambrosio, Giuseppe; Toblli, Jorge E.; Milei, José

2016-01-01

Aim The purpose of this study was to investigate the effect of moderate intensity exercise on kidney in an animal model of high consumption of cola soft drinks. Methods Forty-eight Wistar Kyoto rats (age: 16 weeks; weight: 350–400 g) were assigned to the following groups: WR (water runners) drank water and submitted to aerobic exercise; CR (cola runners) drank cola and submitted to aerobic exercise; WS (water sedentary) and CS (cola sedentary), not exercised groups. The aerobic exercise was performed for 5 days per week throughout the study (24 weeks) and the exercise intensity was gradually increased during the first 8 weeks until it reached 20 meters / minute for 30 minutes. Body weight, lipid profile, glycemia, plasma creatinine levels, atherogenic index of plasma (AIP) and systolic blood pressure (SBP) were determined. After 6 months all rats were sacrificed. A kidney histopathological score was obtained using a semiquantitative scale. Glomerular size and glomerulosclerosis were estimated by point-counting. The oxidative stress and pro-inflammatory status were explored by immunohistochemistry. A one way analysis of variance (ANOVA) with Tukey-Kramer post-hoc test or the Kruskal-Wallis test with Dunn’s post-hoc test was used for statistics. A value of p < 0.05 was considered significant. Results At 6 months, an increased consumption of cola soft drink was shown in CS and CR compared with water consumers (p<0.0001). Chronic cola consumption was associated with increased plasma triglycerides, AIP, heart rate, histopathological score, glomerulosclerosis, oxidative stress and pro-inflammatory status. On the other hand, moderate exercise prevented these findings. No difference was observed in the body weight, SBP, glycemia, cholesterol and plasma creatinine levels across experimental groups. Conclusions This study warns about the consequences of chronic consumption of cola drinks on lipid metabolism, especially regarding renal health. Additionally, these findings emphasize the protective role of exercise training on renal damage. PMID:27031710

Influence of different luting protocols on shear bond strength of computer aided design/computer aided manufacturing resin nanoceramic material to dentin.

PubMed

Poggio, Claudio; Pigozzo, Marco; Ceci, Matteo; Scribante, Andrea; Beltrami, Riccardo; Chiesa, Marco

2016-01-01

The purpose of this study was to evaluate the influence of three different luting protocols on shear bond strength of computer aided design/computer aided manufacturing (CAD/CAM) resin nanoceramic (RNC) material to dentin. In this in vitro study, 30 disks were milled from RNC blocks (Lava Ultimate/3M ESPE) with CAD/CAM technology. The disks were subsequently cemented to the exposed dentin of 30 recently extracted bovine permanent mandibular incisors. The specimens were randomly assigned into 3 groups of 10 teeth each. In Group 1, disks were cemented using a total-etch protocol (Scotchbond™ Universal Etchant phosphoric acid + Scotchbond Universal Adhesive + RelyX™ Ultimate conventional resin cement); in Group 2, disks were cemented using a self-etch protocol (Scotchbond Universal Adhesive + RelyX™ Ultimate conventional resin cement); in Group 3, disks were cemented using a self-adhesive protocol (RelyX™ Unicem 2 Automix self-adhesive resin cement). All cemented specimens were placed in a universal testing machine (Instron Universal Testing Machine 3343) and submitted to a shear bond strength test to check the strength of adhesion between the two substrates, dentin, and RNC disks. Specimens were stressed at a crosshead speed of 1 mm/min. Data were analyzed with analysis of variance and post-hoc Tukey's test at a level of significance of 0.05. Post-hoc Tukey testing showed that the highest shear strength values (P < 0.001) were reported in Group 2. The lowest data (P < 0.001) were recorded in Group 3. Within the limitations of this in vitro study, conventional resin cements (coupled with etch and rinse or self-etch adhesives) showed better shear strength values compared to self-adhesive resin cements. Furthermore, conventional resin cements used together with a self-etch adhesive reported the highest values of adhesion.

Fatty acid binding proteins 4 and 5 in overweight prepubertal boys: effect of nutritional counselling and supplementation with an encapsulated fruit and vegetable juice concentrate.

PubMed

Canas, Jose A; Damaso, L; Hossain, J; Balagopal, P Babu

2015-01-01

Elevated fatty acid binding proteins (FABP) may play a role in obesity and co-morbidities. The role of nutritional interventions in modulating these levels remains unclear. The aim of this post hoc study was to determine the effect of overweight (OW) on FABP4 and FABP5 in boys in relation to indices of adiposity, insulin resistance and inflammation, and to investigate the effects of a 6-month supplementation with an encapsulated fruit and vegetable juice concentrate (FVJC) plus nutritional counselling (NC) on FABP levels. A post hoc analysis of a double-blind, randomised, placebo-controlled study of children recruited from the general paediatric population was performed. A total of thirty age-matched prepubertal boys (nine lean and twenty-one OW; aged 6-10 years) were studied. Patients received NC by a registered dietitian and were randomised to FVJC or placebo capsules for 6 months. FABP4, FABP5, glucose, insulin, homeostasis model assessment-insulin resistance (HOMA-IR), glucose-induced acute insulin response (AIR), lipid-corrected β-carotene (LCβC), adiponectin, leptin, high-sensitivity C-reactive protein (hs-CRP), IL-6 and body composition by dual-energy X-ray absorptiometry were determined before and after the intervention. FABP were higher (P < 0·01) in the OW v. lean boys and correlated directly with HOMA-IR, abdominal fat mass (AFM), hs-CRP, IL-6, and LCβC (P < 0·05 for all). FABP4 was associated with adiponectin and AIR (P < 0·05). FVJC plus NC reduced FABP4, HOMA-IR and AFM (P < 0·05 for all) but not FABP5. OW boys showed elevated FABP4 and FABP5, but only FABP4 was lowered by the FVJC supplement.

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

The acute and post-discontinuation effects of a glucocorticoid receptor (GR) antagonist probe on sleep and the HPA axis in chronic insomnia: a pilot study.

PubMed

Buckley, Theresa; Duggal, Vandana; Schatzberg, Alan F

2008-06-15

Hypothalamic-pituitary-adrenal axis (HPA) hyperactivity has been reported in patients with chronic insomnia without depression. Aglucocorticoid receptor (GR) antagonist may re-regulate HPA axis activity even after discontinuation and may have clinical benefit. Ten subjects with chronic insomnia participated in a placebo controlled double-blinded prospective 30-day pilot study of the acute and post-discontinuation effects of a 5-day course of 600 mg of the glucocorticoid antagonist, mifepristone. Sleep outcome measures were polysomnogram and Insomnia Severity Index. Hormonal outcome measures were mean overnight cortisol and ACTH (23:00-07:00). We predicted sleep would improve and that overnight cortisol and ACTH would decrease at 2 weeks post-treatment discontinuation. At 2 weeks post-discontinuation, Insomnia Severity Index (ISI) decreased by 4.0 points (effect size = 0.97). Polysomnogram findings were limited. Mean cortisol (0.84 microg/dL, effect size = 0.91) and ACTH (5.50 pg/mL, effect size = 0.96) were still mildly increased (23:00 to 07:00). Post hoc analysis revealed that, the ratio of cortisol/ ACTH decreased (-0.21, effect size = 1.15) as did mean cortisol from 18:00 to 23:00 (-0.47 microg/dL, effect size = 0.56). This is the first study of a GR antagonist in chronic insomnia. Sleep improvement manifests in terms of decreased ISI post-treatment discontinuation. The decrease in cortisol in the early evening (18:00 to 23:00) in combination with the decrease in cortisol/ ACTH ratio may be an indicator of the longer-term biological mode of action of the drug.

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.

Transdermal rotigotine for the perioperative management of restless legs syndrome

PubMed Central

2012-01-01

Background Immobilisation, blood loss, sleep deficiency, and (concomitant) medications during perioperative periods might lead to acute exacerbation of symptoms in patients with the restless legs syndrome (RLS). Continuous transdermal delivery of the dopamine agonist rotigotine provides stable plasma levels over 24 h and may provide RLS patients with a feasible treatment option for perioperative situations. To assess the feasibility of use of rotigotine transdermal patch for the perioperative management of moderate to severe RLS, long-term data of an open-label extension of a rotigotine dose-finding study were retrospectively reviewed. Methods The data of all 295 patients who had entered the 5-year study were screened independently by two reviewers for the occurrence of surgical interventions during the study period. The following data were included in this post-hoc analysis: patient age, sex, surgical intervention and outcome, duration of hospital stay, rotigotine maintenance dose at the time of surgery, rotigotine dose adjustment, and continuation/discontinuation of rotigotine treatment. All parameters were analysed descriptively. No pre-specified efficacy assessments (e.g. IRLS scores) were available for the perioperative period. Results During the study period, 61 surgical interventions were reported for 52 patients (median age, 63 years; 67% female); the majority of patients (85%) had one surgical intervention. The mean rotigotine maintenance dose at time of surgery was 3.1 ± 1.1 mg/24 h. For most interventions (95%), rotigotine dosing regimens were maintained during the perioperative period. Administration was temporarily suspended in one patient and permanently discontinued in another two. The majority (96%) of the patients undergoing surgery remained in the study following the perioperative period and 30 of these patients (61%) completed the 5-year study. Conclusions Although the data were obtained from a study which was not designed to assess rotigotine use in the perioperative setting, this post-hoc analysis suggests that treatment with rotigotine transdermal patch can be maintained during the perioperative period in the majority of patients and may allow for uninterrupted alleviation of RLS symptoms. Trial Registration The 5-year rotigotine extension study is registered with ClinicalTrials.gov, identifier NCT00498186. PMID:23009552

Transdermal rotigotine for the perioperative management of restless legs syndrome.

PubMed

Högl, Birgit; Oertel, Wolfgang H; Schollmayer, Erwin; Bauer, Lars

2012-09-25

Immobilisation, blood loss, sleep deficiency, and (concomitant) medications during perioperative periods might lead to acute exacerbation of symptoms in patients with the restless legs syndrome (RLS). Continuous transdermal delivery of the dopamine agonist rotigotine provides stable plasma levels over 24 h and may provide RLS patients with a feasible treatment option for perioperative situations. To assess the feasibility of use of rotigotine transdermal patch for the perioperative management of moderate to severe RLS, long-term data of an open-label extension of a rotigotine dose-finding study were retrospectively reviewed. The data of all 295 patients who had entered the 5-year study were screened independently by two reviewers for the occurrence of surgical interventions during the study period. The following data were included in this post-hoc analysis: patient age, sex, surgical intervention and outcome, duration of hospital stay, rotigotine maintenance dose at the time of surgery, rotigotine dose adjustment, and continuation/discontinuation of rotigotine treatment. All parameters were analysed descriptively. No pre-specified efficacy assessments (e.g. IRLS scores) were available for the perioperative period. During the study period, 61 surgical interventions were reported for 52 patients (median age, 63 years; 67% female); the majority of patients (85%) had one surgical intervention. The mean rotigotine maintenance dose at time of surgery was 3.1 ± 1.1 mg/24 h. For most interventions (95%), rotigotine dosing regimens were maintained during the perioperative period. Administration was temporarily suspended in one patient and permanently discontinued in another two. The majority (96%) of the patients undergoing surgery remained in the study following the perioperative period and 30 of these patients (61%) completed the 5-year study. Although the data were obtained from a study which was not designed to assess rotigotine use in the perioperative setting, this post-hoc analysis suggests that treatment with rotigotine transdermal patch can be maintained during the perioperative period in the majority of patients and may allow for uninterrupted alleviation of RLS symptoms. The 5-year rotigotine extension study is registered with ClinicalTrials.gov, identifier NCT00498186.

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

PubMed

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

2017-04-01

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

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

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

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.

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.

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

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

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.

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.

Dynamics of biofilm formation and the interaction between Candida albicans and methicillin-susceptible (MSSA) and -resistant Staphylococcus aureus (MRSA).

PubMed

Zago, Chaiene Evelin; Silva, Sónia; Sanitá, Paula Volpato; Barbugli, Paula Aboud; Dias, Carla Maria Improta; Lordello, Virgínia Barreto; Vergani, Carlos Eduardo

2015-01-01

Polymicrobial biofilms are an understudied and a clinically relevant problem. This study evaluates the interaction between C. albicans, and methicillin- susceptible (MSSA) and resistant (MRSA) S. aureus growing in single- and dual-species biofilms. Single and dual species adhesion (90 min) and biofilms (12, 24, and 48 h) were evaluated by complementary methods: counting colony-forming units (CFU mL-1), XTT-reduction, and crystal violet staining (CV). The secretion of hydrolytic enzymes by the 48 h biofilms was also evaluated using fluorimetric kits. Scanning electron microscopy (SEM) was used to assess biofilm structure. The results from quantification assays were compared using two-way ANOVAs with Tukey post-hoc tests, while data from enzymatic activities were analyzed by one-way Welch-ANOVA followed by Games-Howell post hoc test (α = 0.05). C. albicans, MSSA and MRSA were able to adhere and to form biofilm in both single or mixed cultures. In general, all microorganisms in both growth conditions showed a gradual increase in the number of cells and metabolic activity over time, reaching peak values between 12 h and 48 h (ρ<0.05). C. albicans single- and dual-biofilms had significantly higher total biomass values (ρ<0.05) than single biofilms of bacteria. Except for single MRSA biofilms, all microorganisms in both growth conditions secreted proteinase and phospholipase-C. SEM images revealed extensive adherence of bacteria to hyphal elements of C. albicans. C. albicans, MSSA, and MRSA can co-exist in biofilms without antagonism and in an apparent synergistic effect, with bacteria cells preferentially associated to C. albicans hyphal forms.

Is Blood Eosinophil Count a Predictor of Response to Bronchodilators in Chronic Obstructive Pulmonary Disease? Results from Post Hoc Subgroup Analyses.

PubMed

Iqbal, Ahmar; Barnes, Neil C; Brooks, Jean

2015-10-01

Chronic obstructive pulmonary disease (COPD) patients with blood eosinophil (EOS) count ≥ 2% benefit from exacerbation reductions with inhaled corticosteroids (ICSs). We conducted post hoc analyses to determine if EOS count ≥ 2% is a marker for greater responsiveness to the bronchodilators umeclidinium (UMEC; long-acting muscarinic antagonist), vilanterol (VI; long-acting β2-agonist) or UMEC/VI combination. Effects of once-daily UMEC/VI 62.5/25, UMEC 62.5 and VI 25 µg versus placebo on trough forced expiratory volume in one second (FEV1), Transition Dyspnoea Index (TDI), St George's Respiratory Questionnaire (SGRQ) scores and adverse event (AE) incidences in four completed, 6-month studies were assessed by EOS subgroup. Trough FEV1 was also evaluated by ICS use and EOS subgroup. Analyses were performed using a repeated measures model. At baseline, 2437 of 4647 (52%) patients had EOS count ≥ 2%. Overall, ≈ 50% of patients used ICSs. At day 169, no notable variations were observed in trough FEV1 least squares mean differences between EOS subgroups versus placebo for UMEC/VI, UMEC and VI; results according to ICS use were similar. No differences were reported between EOS subgroups in TDI and SGRQ scores on day 168, or for incidences of AEs, serious AEs and AEs leading to withdrawal. Response to UMEC/VI, UMEC and VI in terms of trough FEV1, dyspnoea and health-related quality of life was similar for COPD patients with baseline EOS counts ≥ 2 or <2%. EOS count did not appear to predict bronchodilator response in either ICS users or non-users.

The influence of divided attention on walking turns: Effects on gait control in young adults with and without a history of low back pain.

PubMed

Smith, Jo Armour; Gordon, James; Kulig, Kornelia

2017-10-01

The cognitive control of gait is altered in individuals with low back pain, but it is unclear if this alteration persists between painful episodes. Locomotor perturbations such as walking turns may provide a sensitive measure of gait adaptation during divided attention in young adults. The purpose of this study was to investigate changes in gait during turns performed with divided attention, and to compare healthy young adults with asymptomatic individuals who have a history of recurrent low back pain (rLBP). Twenty-eight participants performed 90° ipsilateral walking turns at a controlled speed of 1.5m/s. During the divided attention condition they concurrently performed a verbal 2-back task. Step length and width, trunk-pelvis and hip excursion, inter-segmental coordination and stride-to-stride variability were quantified using motion capture. Mixed-model ANOVA were used to examine the effect of divided attention and group, and interaction effects on the selected variables. Step length variability decreased significantly with divided attention in the healthy group but not in the rLBP group (post-hoc p=0.024). Inter-segmental coordination variability was significantly decreased during divided attention (main effect of condition p <0.000). There were small but significant reductions in hip axial and sagittal motion across groups (main effect of condition p=0.044 and p=0.040 respectively), and a trend toward increased frontal motion in the rLBP group only (post-hoc p=0.048). These findings suggest that the ability to switch attentional resources during gait is altered in young adults with a history of rLBP, even between symptomatic episodes. Copyright © 2017 Elsevier B.V. All rights reserved.

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.

Effect of Metformin and Flutamide on Anthropometric Indices and Laboratory Tests in Obese/Overweight PCOS Women under Hypocaloric Diet

PubMed Central

Amiri, Mania; Golsorkhtabaramiri, Masoumeh; Esmaeilzadeh, Sedigheh; Ghofrani, Faeze; Bijani, Ali; Ghorbani, Leila; Delavar, Moloud Agajani

2014-01-01

Background This study was designed to investigate the effect of metformin and flutamide alone or in combination with anthropometric indices and laboratory tests of obese/overweight PCOS women under hypocaloric diet. Methods This single blind clinical trial was performed on 120 PCOS women. At the beginning, hypocaloric diet was recommended for the patients. After one month while they were on the diet, the patients were randomly divided in 4 groups; metformin (500 mg, 3/day), flutamide (250 mg, 2/day), combined, metformin (500 mg, 3/day) with flutamide (250 mg, 2/day) and finally placebo group. The patients were treated for 6 months. Anthropometric indices and laboratory tests (fasting and glucose-stimulated insulin levels, lipid profile and androgens) were measured. A one-way ANOVA (Post Hoc) and paired t-test were performed to analyze data. A p ≤ 0.05 was considered statistically significant. Results After treatment, reduction in weight, BMI, hip circumference was significantly greater in the metformin group in comparison to other groups (p<0.05). In addition, the fasting insulin was significantly greater in metformin group and flutamide group in comparison to metformin+flutamide and placebo groups after treatment (p<0.05). Within groups, insulin level showed significant changes (before and after treatment) in metformin+flutamide group and LDL reduction was significant in flutamide group before and after treatment. Post hoc tukey and two-tailed with p≤0.05 were used to define statistical significance. Conclusion Using combination of metformin and flutamide improves anthropometric indices and laboratory tests in obese/overweight PCOS women under hypocaloric diet. PMID:25473629

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.

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.

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.

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.

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

PubMed

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

2016-11-01

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

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.

Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone

PubMed Central

Khan, Arif; Durgam, Suresh; Tang, Xiongwen; Ruth, Adam; Mathews, Maju; Gommoll, Carl P.

2016-01-01

Objective To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). Method Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). Results The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (−1.83, P < .0001) and in psychic anxiety (−1.21, P < .0001) and somatic anxiety (−0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05). Conclusions Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items. Trial Registration ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115. PMID:27486544

Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.

PubMed

Khan, Arif; Durgam, Suresh; Tang, Xiongwen; Ruth, Adam; Mathews, Maju; Gommoll, Carl P

2016-01-01

To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (-1.83, P < .0001) and in psychic anxiety (-1.21, P < .0001) and somatic anxiety (-0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05). Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items. ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115.

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

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.

Schizophrenia and birthplace of paternal and maternal grandfather in the Jerusalem perinatal cohort prospective study.

PubMed

Harlap, S; Perrin, M C; Deutsch, L; Kleinhaus, K; Fennig, S; Nahon, D; Teitelbaum, A; Friedlander, Y; Malaspina, D

2009-06-01

Some forms of epigenetic abnormalities transmitted to offspring are manifested in differences in disease incidence that depend on parent-of-origin. To explore whether such phenomena might operate in schizophrenia spectrum disorders, we estimated the relative incidence of these conditions in relation to parent-of-origin by considering the two grandfathers' countries of birth. In a prospective cohort of 88,829 offspring, born in Jerusalem in 1964-76 we identified 637 cases through Israel's psychiatric registry. Relative risks (RR) were estimated for paternal and maternal grandfathers' countries of birth using proportional hazards methods, controlling for parents' ages, low social class and duration of marriage. After adjusting for multiple observations, we found no significant differences between descendants of maternal or paternal grandfathers born in Iraq, Iran, Turkey, Syria, Yemen, Morocco, Algeria, Tunisia, Libya/Egypt, Poland, USSR, Czechoslovakia, Germany or the USA. Those with paternal grandfathers from Romania (RR=1.9, 95% CI=1.3-2.8) or Hungary (1.6, 1.0-2.6) showed an increased incidence; however, those with maternal grandfathers from these countries experienced reduced incidence (RR=0.5, 0.3-0.8 and 0.4, 0.2-0.8). In post-hoc analyses we found that results were similar whether the comparison groups were restricted to descendants of other Europeans or included those from Western Asia and North Africa; and effects of paternal grandfathers from Romania/Hungary were more pronounced in females, while effects of maternal grandfathers from these countries were similar in males and females. These post-hoc "hypothesis-generating" findings lead one to question whether some families with ancestors in Romania or Hungary might carry a variant or mutation at a parentally imprinted locus that is altering susceptibility to schizophrenia. Such a locus, if it exists, might involve the X chromosome.

Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk

PubMed Central

Raschi, Emanuel; De Ponti, Fabrizio

2015-01-01

Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent’s management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as “signals”), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities. PMID:26167249

Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

PubMed

Raschi, Emanuel; De Ponti, Fabrizio

2015-07-08

Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

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.

Is introversion a risk factor for suicidal behaviour in depression?

PubMed

Roy, A

1998-11-01

Personality is an important determinant of suicidal behaviour. However, it has been studied little in relation to suicidal behaviour in depression. Depressed patients who had attempted suicide (N = 41) were compared with depressed patients who had never attempted suicide (N = 56) and normal controls (N = 56) for their scores on three personality questionnaires. Introversion was the only personality dimension where the post hoc test showed a different pattern between the two groups of depressed patients in their relation to controls. In particular, only depressed patients who had attempted suicide had significantly lower introversion scores than controls. The personality dimension of introversion may be a risk factor for suicidal behaviour in depression.

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

Plasticity and Activation of Spared Intraspinal Respiratory Circuits Following Spinal Cord Injury

DTIC Science & Technology

2017-12-01

ipsilateral to the C2Hx lesion. Tracheal pressures were evaluated to explore the potential of a biomechanical impact of ISMS- induced muscle contract...different from 500 µA. %P 0.05, different from 2 wk at same stimulus current. Data were evaluated using 2-way repeated-measures ANOVA with Holm...outcomes assessed. Data were evaluated using 2-way repeated-measures ANOVA with Holm-Sidak post hoc tests for individual comparisons (groups: 2

A Summative Evaluation of the Effectiveness of Classroom-Embedded, Individualistic, Computer-Based Learning for Middle School Students Placed at Academic Risk in Schools with a High Proportion of Title I Eligible Students

ERIC Educational Resources Information Center

DeLoach, Regina M.

2011-01-01

The purpose of this "post hoc," summative evaluation was to evaluate the effectiveness of classroom-embedded, individualistic, computer-based learning for middle school students placed at academic risk in schools with a high proportion of Title I eligible students. Data were mined from existing school district databases. For data (n = 393)…

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

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

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.

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.

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.

Characteristics of migraine attacks and responses to almotriptan treatment: a comparison of menstrually related and nonmenstrually related migraines.

PubMed

Diamond, Merle L; Cady, Roger K; Mao, Lian; Biondi, David M; Finlayson, Gary; Greenberg, Steven J; Wright, Pamela

2008-02-01

To compare the clinical characteristics of menstrually related migraines (MRMs) and nonmenstrually related migraines (nonMRMs) and to investigate the efficacy of almotriptan in the treatment of these migraine subtypes. These are post hoc analyses of data from the AXERT Early miGraine Intervention Study (AEGIS), a multicenter, double-blind, parallel-group trial that evaluated adults with IHS-defined migraine with and without aura. Patients were randomized 1:1 to treat 3 consecutive headaches with almotriptan 12.5 mg or matching placebo at the first sign of headache typical of their usual migraine, at any level of pain intensity but within 1 hour of onset. MRMs were defined as those occurring +/-2 days of the first day of menstrual flow. Post hoc analyses to describe headache characteristics pooled all migraine attacks experienced by patients who reported > or = 1 menses during the study regardless of assigned treatment group. The post hoc efficacy analyses included outcomes of almotriptan treatment compared with placebo treatment for all migraines in patients with a menstrual record. Of the 275 women in the AEGIS intent-to-treat population, 190 (69.1%; 97 almotriptan, 93 placebo; aged 18-54 years) reported > or = 1 menses during the trial. Of the 506 migraines reported by these patients, 95 (18.8%) occurred +/-2 days of the first day of menstrual flow and were defined as MRM. Aura was associated with 11.7% of MRM and 15.0% of nonMRM. Allodynia-associated symptoms were present with 62.8% of MRM and 57.0% of nonMRM. Prior to treatment, 19.1% of MRM were associated with normal functional ability, 68.1% with disturbed functional ability, and 12.8% required bed rest compared with 18.9%, 68.8%, and 12.3%, respectively, of nonMRM. Pretreatment pain intensity was mild in 40.0%, moderate in 47.4%, and severe in 12.6% of MRM compared with 43.6%, 47.2%, and 9.2%, respectively, of nonMRM. Almotriptan treatment efficacy outcomes for MRM vs nonMRM, respectively, were: 2-hour pain relief, 77.4% vs 68.3%; 2-hour pain free, 35.4% vs 35.9%; and sustained pain free, 22.9% vs 23.8%. Almotriptan was similarly effective in relieving migraine-associated symptoms and improving functional disability associated with both MRM and nonMRM. Prior to treatment, the presence of migraine-associated characteristics including aura, allodynia-associated symptoms, photophobia, phonophobia, and nausea were similar for both MRM and nonMRM attacks. The pretreatment levels of pain intensity and functional disability were likewise similar across the migraine subtypes. Almotriptan was equally effective in the treatment of both MRM and nonMRM attacks and was associated with an adverse event profile that was similar to placebo treatment.

Promoting healthful family meals to prevent obesity: HOME Plus, a randomized controlled trial.

PubMed

Fulkerson, Jayne A; Friend, Sarah; Flattum, Colleen; Horning, Melissa; Draxten, Michelle; Neumark-Sztainer, Dianne; Gurvich, Olga; Story, Mary; Garwick, Ann; Kubik, Martha Y

2015-12-15

Family meal frequency has been shown to be strongly associated with better dietary intake; however, associations with weight status have been mixed. Family meals-focused randomized controlled trials with weight outcomes have not been previously conducted. Therefore, this study purpose was to describe weight-related outcomes of the HOME Plus study, the first family meals-focused randomized controlled trial to prevent excess weight gain among youth. Families (n = 160 8-12-year-old children and their parents/guardians) were randomized to intervention (n = 81) or control (n = 79) groups. Data were collected at baseline (2011-2012), post-intervention (12-months post-baseline) and follow-up (21-months post-baseline). The intervention included ten monthly group sessions (nutrition education; hands-on meal and snack planning, preparation, and skill development; screen time reductions) and five motivational, goal-setting phone calls. The main outcome was child body mass index (BMI) z-score. General linear models, adjusted for baseline values and demographics, showed no significant treatment group differences in BMI z-scores at post-intervention or follow-up; however, a promising reduction in excess weight gain was observed. Post-hoc stratification by pubertal onset indicated prepubescent children in the intervention group had significantly lower BMI z-scores than their control group counterparts. The study used a strong theoretical framework, rigorous design, quality measurement and a program with high fidelity to test a family meals-focused obesity prevention intervention. It showed a modest decrease in excess weight gain. The significant intervention effect among prepubescent children suggests the intervention may be more efficacious among relatively young children, although more research with appropriately powered samples are needed to replicate this finding. This study is registered at www.clinicaltrials.gov NCT01538615. Registered 01/17/2012.

Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders.

PubMed

Humaidan, P; Chin, W; Rogoff, D; D'Hooghe, T; Longobardi, S; Hubbard, J; Schertz, J

2017-03-01

How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH (follitropin alfa plus lutropin alfa; r-hFSH/r-hLH) compare with that of r-hFSH monotherapy for controlled ovarian stimulation (COS) in patients with poor ovarian response (POR)? The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable. Although meta-analyses of clinical trials have suggested some beneficial effect on reproductive outcomes with r-hLH supplementation in patients with POR, the definitions of POR were heterogeneous and limit the comparability across studies. Phase III, single-blind, active-comparator, randomized, parallel-group clinical trial. Patients were followed for a single ART cycle. A total of 939 women were randomized (1:1) to receive either r-hFSH/r-hLH or r-hFSH. Randomization, stratified by study site and participant age, was conducted via an interactive voice response system. Women classified as having POR, based on criteria incorporating the ESHRE Bologna criteria, were down-regulated with a long GnRH agonist protocol and following successful down-regulation were randomized (1:1) to COS with r-hFSH/r-hLH or r-hFSH alone. The primary efficacy endpoint was the number of oocytes retrieved following COS. Safety endpoints included the incidence of adverse events, including ovarian hyperstimulation syndrome (OHSS). Post hoc analyses investigated safety outcomes and correlations between live birth and baseline characteristics (age and number of oocytes retrieved in previous ART treatment cycles or serum anti-Müllerian hormone (AMH)). The significance of the treatment effect was tested by generalized linear models (Poisson regression for counts and logistic regression for binary endpoints) adjusting for age and country. Of 949 subjects achieving down-regulation, 939 were randomized to r-hFSH/r-hLH (n = 477) or r-hFSH (n = 462) and received treatment. Efficacy assessment: In the intention-to-treat (ITT) population, the mean (SD) number of oocytes retrieved (primary endpoint) was 3.3 (2.71) in the r-hFSH/r-hLH group compared with 3.6 (2.82) in the r-hFSH group (between-group difference not statistically significant). The observed difference between treatment groups (r-hFSH/r-hLH and r-hFSH, respectively) for efficacy outcomes decreased over the course of pregnancy (biochemical pregnancy rate: 17.3% versus 23.9%; clinical pregnancy rate: 14.1% versus 16.8%; ongoing pregnancy rate: 11.0% versus 12.4%; and live birth rate: 10.6% versus 11.7%). An interaction (identified post hoc) between baseline characteristics related to POR and treatment effect was noted for live birth, with r-hFSH/r-hLH associated with a higher live birth rate for patients with moderate or severe POR, whereas r-hFSH was associated with a higher live birth rate for those with mild POR. A post hoc logistic regression analysis indicated that the incidence of total pregnancy outcome failure was lower in the r-hFSH/r-hLH group (6.7%) compared with the r-hFSH group (12.4%) with an odds ratio of 0.52 (95% CI 0.33, 0.82; P = 0.005). Safety assessment: The overall proportion of patients with treatment-emergent adverse events (TEAEs) occurring during or after r-hFSH/r-hLH or r-hFSH use (stimulation or post-stimulation phase) was 19.9% and 26.8%, respectively. There was no consistent pattern of TEAEs associated with either treatment. Despite using inclusion criteria for POR incorporating the ESHRE Bologna criteria, further investigation is needed to determine the impact of the heterogeneity of POR in the Bologna patient population. The observed correlation between baseline clinical characteristics related to POR and live birth rate, as well as the observed differences between groups regarding total pregnancy outcome failure were from post hoc analyses, and the study was not powered for these endpoints. In addition, the attrition rate for pregnancy outcomes in this trial may not reflect general medical practice. Furthermore, as the patient population was predominantly White these results might not be applicable to other ethnicities. In the population of women with POR investigated in this study, although the number of oocytes retrieved was similar following stimulation with either a fixed-ratio combination of r-hFSH/r-hLH or r-hFSH monotherapy, post hoc analyses showed that there was a lower rate of total pregnancy outcome failure in patients receiving r-hFSH/r-hLH, in addition to a higher live birth rate in patients with moderate and severe POR. These findings are clinically relevant and require additional investigation. The benefit:risk balance of treatment with either r-hFSH/r-hLH or r-hFSH remains positive. This study was funded by Merck KGaA, Darmstadt, Germany. P.H. has received honoraria for lectures and unrestricted research grants from Ferring, Merck KGaA and MSD. D.R. is a former employee of EMD Serono, a business of Merck KGaA, Darmstadt, Germany. J.S., J.H. and W.C. are employees of EMD Serono Research and Development Institute, a business of Merck KGaA, Darmstadt, Germany. T.D.'H. and S.L. are employees of Merck KGaA, Darmstadt, Germany. ClinicalTrials.gov identifier: NCT02047227; EudraCT Number: 2013-003817-16. ClinicalTrials.gov: 24 January 2014; EudraCT: 19 December 2013. 30 January 2014. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

Linking Satellites Via Earth "Hot Spots" and the Internet to Form Ad Hoc Constellations

NASA Technical Reports Server (NTRS)

Mandl, Dan; Frye, Stu; Grosvenor, Sandra; Ingram, Mary Ann; Langley, John; Miranda, Felix; Lee, Richard Q.; Romanofsky, Robert; Zaman, Afoz; Popovic, Zoya

2004-01-01

As more assets are placed in orbit, opportunities emerge to combine various sets of satellites in temporary constellations to perform collaborative image collections. Often, new operations concepts for a satellite or set of satellites emerge after launch. To the degree with which new space assets can be inexpensively and rapidly integrated into temporary or "ad hoc" constellations, will determine whether these new ideas will be implemented or not. On the Earth Observing 1 (EO-1) satellite, a New Millennium Program mission, a number of experiments were conducted and are being conducted to demonstrate various aspects of an architecture that, when taken as a whole, will enable progressive mission autonomy. In particular, the target architecture will use adaptive ground antenna arrays to form, as close as possible, the equivalent of wireless access points for low earth orbiting satellites. Coupled with various ground and flight software and the Internet. the architecture enables progressive mission autonomy. Thus, new collaborative sensing techniques can be implemented post-launch. This paper will outline the overall operations concept and highlight details of both the research effort being conducted in

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.

Swedish women's food habits during pregnancy up to six months post-partum: A longitudinal study.

PubMed

Wennberg, Anna Lena; Isaksson, Ulf; Sandström, Herbert; Lundqvist, Anette; Hörnell, Agneta; Hamberg, Katarina

2016-06-01

Diet influences the health of the foetus and the woman during pregnancy and later in life. It is therefore important to investigate pregnant women's food habits. The aim of this study was to describe women's food habits during pregnancy and up to six months post-partum. A Food Frequency Questionnaire (VIP-FFQ) was distributed to 163 pregnant women on five occasions during and after pregnancy. Data were analysed using Friedman's ANOVA and a Bonferroni post-hoc test. Food habits in relation to the National Food Agency's (NFA) food index. The pregnant women's diets were inadequate according to the NFA food index. A tendency towards an even poorer diet after delivery was identified, something which was related to an increased intake of discretionary food, e.g. sweets, cakes, cookies, crisps, ice cream, and decreased intake of fruit and vegetable. The alcohol consumption was low throughout. The food habits during pregnancy were inadequate compared to recommendations and these habits became unhealthier after delivery. These suggest that dietary counselling needs to be more effective and continued into the lactating period. An increased focus should be given to healthy eating from the life course perspective, not just focus on effects on the foetus and pregnancy outcomes. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

Modification of irrational ideas and test anxiety through rational stage directed hypnotherapy [RSDH].

PubMed

Boutin, G E; Tosi, D J

1983-05-01

Examined the effects of four treatment conditions on the modification of Irrational Ideas and test anxiety in female nursing students. The treatments were Rational Stage Directed Hypnotherapy, a cognitive behavioral approach that utilized hypnosis and vivid-emotive-imagery, a hypnosis-only treatment, a placebo condition, and a no-treatment control. The 48 Ss were assigned randomly to one of these treatment groups, which met for 1 hour per week for 6 consecutive weeks with in-vivo homework assignments also utilized. Statistically significant treatment effects on cognitive, affective, behavioral, and physiological measures were noted for both the RSDH and hypnosis group at the posttest and at a 2-month follow-up. Post-hoc analyses revealed the RSDH treatment group to be significantly more effective than the hypnosis only group on both the post- and follow-up tests. The placebo and control groups showed no significant effects either at post-treatment or at follow-up.

Response of PAH-degrading genes to PAH bioavailability in the overlying water, suspended sediment, and deposited sediment of the Yangtze River.

PubMed

Xia, Xinghui; Xia, Na; Lai, Yunjia; Dong, Jianwei; Zhao, Pujun; Zhu, Baotong; Li, Zhihuang; Ye, Wan; Yuan, Yue; Huang, Junxiong

2015-06-01

The degrading genes of hydrophobic organic compounds (HOCs) serve as indicators of in situ HOC degradation potential, and the existing forms and bioavailability of HOCs might influence the distribution of HOC-degrading genes in natural waters. However, little research has been conducted to study the relationship between them. In the present study, nahAc and nidA genes, which act as biomarkers for naphthalene- and pyrene-degrading bacteria, were selected as model genotypes to investigate the response of polycyclic aromatic hydrocarbon (PAH)-degrading genes to PAH bioavailability in the overlying water, suspended sediment (SPS), and deposited sediment of the Yangtze River. The freely dissolved concentration, typically used to reflect HOC bioavailability, and total dissolved, as well as sorbed concentrations of PAHs were determined. Phylogenetic analysis showed that all the PAH-ring hydroxylating dioxygenase gene sequences of Gram-negative bacteria (PAH-RHD[GN]) were closely related to nahAc, nagAc, nidA, and uncultured PAH-RHD genes. The PAH-RHD[GN] gene diversity as well as nahAc and nidA gene copy numbers decreased in the following order: deposited sediment>SPS>overlying water. The nahAc and nidA gene abundance was not significantly correlated with environmental parameters but was significantly correlated with the bioavailable existing forms of naphthalene and pyrene in the three phases. The nahAc gene copy numbers in the overlying water and deposited sediment were positively correlated with freely dissolved naphthalene concentrations in the overlying and pore water phases, respectively, and so were nidA gene copy numbers. This study suggests that the distribution and abundance of HOC-degrading bacterial population depend on the HOC bioavailability in aquatic environments. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effect of Different Endodontic Sealers on the Push-out Bond Strength of Fiber Posts

PubMed Central

Forough Reyhani, Mohammad; Ghasemi, Negin; Rahimi, Saeed; Milani, Amin Salem; Omrani, Elnaz

2016-01-01

Introduction: The aim of this in vitro study was to evaluate the effect of MTA-based sealer (MTA Fillapex), eugenol-based sealer (Dorifill) and an epoxy resin sealer (AH Plus) on the bond strength of fiber posts cemented with a self-etch adhesive. Materials and Methods: The root canals of 72 maxillary incisors were prepared using the step-back technique after removing/cutting off the crowns. The samples were randomly divided to 4 groups (n=18). In group 1 (the controls) gutta-percha was used without sealer. In groups 2, 3 and 4, the canals were filled with gutta-percha using AH Plus, Dorifill and MTA Fillapex sealers, respectively, by cold lateral compaction technique. After post space preparation, the fiber posts were cemented in the root canals using self-etch adhesive. Then 1-mm-thick disks were prepared from the coronal thirds of all the root canals and subjected to a push-out test. Data were analyzed using the one-way ANOVA and post hoc Tukey’s tests. Results: The maximum (4.45±0.09 MPa) and minimum (1.02±0.03 MPa) bond strength values were recorded in the control and Dorifill groups, respectively. The mean push-out bond strength values were similar for MTA Fillapex and AH Plus sealers (P>0.05). However these values were significantly higher than that of the Dorifill sealer (P<0.05). Conclusion: Sealer type affected the bond strength of the fiber posts and MTA Fillapex decreased the dislodgment resistant of the fiber post. PMID:27141220

Sequencing Effects of Plyometric Training Applied Before or After Regular Soccer Training on Measures of Physical Fitness in Young Players.

PubMed

Ramirez-Campillo, Rodrigo; Alvarez, Cristian; Gentil, Paulo; Loturco, Irineu; Sanchez-Sanchez, Javier; Izquierdo, Mikel; Moran, Jason; Nakamura, Fabio Y; Chaabene, Helmi; Granacher, Urs

2018-03-22

To compare the effects of short-term (i.e., 7 week) plyometric training applied before (PJT-B) or after (PJT-A) soccer practice on components of physical fitness in young soccer players, a single-blind randomized controlled trial was conducted. Post-pubertal boys aged 17.0±0.5 years were allocated to three groups: PJT-B (n=12), PJT-A (n=14), and control (CON; n=12). The outcome measures included tests to evaluate 20-m speed, standing long jump [SLJ], squat jump [SJ], countermovement jump [CMJ], and drop jump [DJ], 20-m multistage shuttle running speed [MSSRT], and Illinois change of direction speed [ICODT]. While the CON performed soccer-specific training, the PJT-A and PJT-B groups conducted the same soccer-specific sessions but replaced ∼11% of their time with plyometric training. The PJT-B group performed plyometric exercises after a warm-up program, and the PJT-A group conducted plyometric exercises ∼10 minutes after the completion of soccer training. Analyses of variance (ANOVAs) were used to detect differences between groups in all variables for pre- and post-training tests. Main effects of time (all p<.01; d=0.19-0.79) and group x time interactions (all p<.05; d=0.17-0.76) were observed for all examined variables. Post hoc analyses revealed significant increases in the PJT-B group (SLJ: 9.4%, d=1.7; CMJ: 11.2%, d=0.75; 20-m MSSRT: 9.0%, d=0.77) and the PJT-A group (SLJ: 3.1%, d=0.7; CMJ: 4.9%, d=0.27; 20-m MSSRT: 9.0%, d=0.76). Post hoc analyses also revealed significant increases in the PJT-B group (20-m speed: -7.4%, d=0.75; 20-cm DJ reactive strength index: 19.1%, d=1.4; SJ: 6.3%, d=0.44; ICODT results: -4.2%, d=1.1). In general, our study revealed that plyometric training is effective in improving measures of physical fitness in young male soccer players when combined with regular soccer training. More specifically, larger training induced effects on physical fitness were registered if plyometric training was conducted prior to soccer specific training.

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

Effects of using human patient simulator versus a CD-ROM on learning the management of patients exposed to chemical agents.

PubMed

Johnson, Don; Flagg, Amanda; Dremsa, Theresa L

2010-01-01

Very little prospective, randomized, experimental research exists on the use of simulation as a teaching method, and no studies have compared the effects of 2 strategies of using the Human Patient Simulator (HPS) and a CD-ROM on the management of patients exposed to chemical agents. A prospective, pretest-posttest experimental, mixed design (within and between) was used to determine if there were statistically significant differences between educational strategies using HPS, CD-ROM, and a control group in the care of patients exposed to chemical agents. Care was operationally defined as the score on the Management of Chemical Warfare Patients Performance (MCWPP) instrument. Participants included active duty and reserve military nurses (n=92). They were randomly assigned to one of 3 teaching groups: HPS (n=30), CD-ROM (n=31), or a control group (n=31). Analysis of variance and a Tukey post-hoc test were used to analyze the data. The means on MCWPP instrument were as follows: HPS (pretest: mean=65.13, SD ± 8.9; posttest mean=73.0, SD ± 8.6); CD-ROM (pretest: mean=67.74, SD ± 11.18, posttest mean=65.67, SD ± 10.82); control (pretest: mean=68.51 SD ± 8.5; posttest mean=62.6, SD ± 8.6). There were no significant differences between the groups on the pretest (P=.363), but there were significant differences on the posttest (P=.001). Post-hoc analyses indicated the HPS group performed better than the CD-ROM group (P=.017) and the control group (P=.000). There was no significant difference between the CD-ROM and control groups (P=.485). Based on the results of this study, the HPS is more effective than the CD-ROM in teaching nurses about the care of patients exposed to chemical agents.

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.

Effect of glide path preparation on apical extrusion of debris in root canals instrumented with three single-file systems: An ex vivo comparative study

PubMed Central

Pawar, Ajinkya M.; Pawar, Mansing; Kfir, Anda; Thakur, Bhagyashree; Mutha, Pooja; Banga, Kulwinder Singh

2017-01-01

Aim: The aim of this study was to test the effect of new protocol of glide path preparation by 20/0.04 rotary file on apical extrusion of debris when instrumenting fine curved mesial canals in mandibular molars with Self-adjusting File (SAF) and compare it to a glide path prepared by 20/0.02 hand K-file and rotary OneShape (OS) and reciprocating WaveOne (WO) file instrumentation. Materials and Methods: Sixty mandibular molars with curved mesial roots were selected and randomly divided into three groups (n = 20) for instrumentation. In two groups, glide path was prepared using 20/0.02 K-file for instrumentation by OS (size 25/0.06 taper) and WO (size 25/0.08 taper) files; in the remaining group, 20/0.04 rotary file was used for glide path preparation and instrumented by SAF (1.5 mm). The debris extruded during instrumentation was collected in preweighed Eppendorf tubes and stored in an incubator at 70°C for 5 days. Tubes containing the dry extruded debris were then weighed. One-way analysis of variance (ANOVA) was applied to the weights obtained, followed by Tukey's post hoc test for multiple comparison. Results: The mean debris (g) extruded apically was 0.000651 ± 0.000291, 0.000823 ± 0.000319, and 0.000473 ± 0.000238 for Group 1 (20/0.02 + OS), Group 2 (20/0.02 + WO), and Group 3 (20/0.04 + SAF), respectively. The groups exhibited a significant difference (P < 0.01; ANOVA). Group 3 resulted in least debris extrusion compared to Groups 1 and 2 (P < 0.01; Tukey's post hoc test). Conclusion: Glide path prepared to size 20/0.04 and SAF 1.5 mm instrumentation produce less debris in curved mesial canals of mandibular molars, compared to glide path established by 20/0.02 and instrumentation by OS and WO files. PMID:28855758

Modulation of Inflammatory and Profibrotic Signaling in a Rabbit Model of Acute Phonotrauma Using Triamcinolone

PubMed Central

Hall, Joseph E.; Suehiro, Atsushi; Branski, Ryan C.; Garrett, C. Gaelyn; Rousseau, Bernard

2015-01-01

Objective To investigate the hypothesis that prophylactic triamcinolone modulates acute vocal fold inflammatory and profibrotic signaling during acute phonotrauma. Study Design In vivo rabbit phonation model. Setting Academic medical center. Subjects and Methods Forty New Zealand white breeder rabbits were randomly assigned to 1 of 4 groups: control (no intervention), no treatment (30 minutes of raised intensity phonation), sham treatment (bilateral intralaryngeal triamcinolone acetonide injection at 0 μg/25 μL followed by 30 minutes of raised intensity phonation), or steroid treatment (bilateral intralaryngeal triamcinolone acetonide injection at 400 μg/25 μL followed by 30 minutes of raised intensity phonation). Quantitative polymerase chain reaction (qPCR) was used to investigate gene expression levels of cyclooxygenase-2 (COX-2), interleukin (IL)–1β, and transforming growth factor (TGF)–β1. Results Results revealed a significant main effect for COX-2 (P = .002). Post hoc testing revealed that rabbits receiving no treatment (15.10) had higher COX-2 gene expression than control (5.90; P <.001). There were no significant differences in COX-2 expression between treatment groups. Results revealed a significant main effect for IL-1β (P < .001). Post hoc testing revealed that rabbits receiving no treatment (14.70) had higher IL-1β gene expression than control (6.30) (P = .001). There were no significant differences in IL-1β gene expression between treatment groups. There were no significant differences in TGF-β1 gene expression (P = .525) between treatment and control groups. Conclusion Given conflicting evidence, further studies are necessary to investigate vocal fold steroid injections prior to and following the induction of phonotrauma. Prophylactic administration of triamcinolone immediately prior to acute phonotrauma resulted in no significant changes in COX-2, IL-1β, and TGF-β1 gene transcript levels. PMID:22399283

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.

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.