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Sample records for a-site randomness effect

  1. Relatively Random: Context Effects on Perceived Randomness and Predicted Outcomes

    ERIC Educational Resources Information Center

    Matthews, William J.

    2013-01-01

    This article concerns the effect of context on people's judgments about sequences of chance outcomes. In Experiment 1, participants judged whether sequences were produced by random, mechanical processes (such as a roulette wheel) or skilled human action (such as basketball shots). Sequences with lower alternation rates were judged more likely to…

  2. Effect Sizes in Cluster-Randomized Designs

    ERIC Educational Resources Information Center

    Hedges, Larry V.

    2007-01-01

    Multisite research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Researchers would like to compute effect size indexes based on the standardized mean difference to compare the results of cluster-randomized studies (and corresponding quasi-experiments) with other studies and to…

  3. Modeling Randomness in Judging Rating Scales with a Random-Effects Rating Scale Model

    ERIC Educational Resources Information Center

    Wang, Wen-Chung; Wilson, Mark; Shih, Ching-Lin

    2006-01-01

    This study presents the random-effects rating scale model (RE-RSM) which takes into account randomness in the thresholds over persons by treating them as random-effects and adding a random variable for each threshold in the rating scale model (RSM) (Andrich, 1978). The RE-RSM turns out to be a special case of the multidimensional random…

  4. The Random-Effect DINA Model

    ERIC Educational Resources Information Center

    Huang, Hung-Yu; Wang, Wen-Chung

    2014-01-01

    The DINA (deterministic input, noisy, and gate) model has been widely used in cognitive diagnosis tests and in the process of test development. The outcomes known as slip and guess are included in the DINA model function representing the responses to the items. This study aimed to extend the DINA model by using the random-effect approach to allow…

  5. First surface-based estimation of the aerosol indirect effect over a site in southeastern China

    NASA Astrophysics Data System (ADS)

    Liu, Jianjun; Li, Zhanqing

    2018-02-01

    The deployment of the U.S. Atmospheric Radiation Measurement mobile facility in Shouxian from May to December 2008 amassed the most comprehensive set of measurements of atmospheric, surface, aerosol, and cloud variables in China. This deployment provided a unique opportunity to investigate the aerosol-cloud interactions, which are most challenging and, to date, have not been examined to any great degree in China. The relationship between cloud droplet effective radius (CER) and aerosol index (AI) is very weak in summer because the cloud droplet growth is least affected by the competition for water vapor. Mean cloud liquid water path (LWP) and cloud optical depth (COD) significantly increase with increasing AI in fall. The sensitivities of CER and LWP to aerosol loading increases are not significantly different under different air mass conditions. There is a significant correlation between the changes in hourly mean AI and the changes in hourly mean CER, LWP, and COD. The aerosol first indirect effect (FIE) is estimated in terms of relative changes in both CER (FIECER) and COD (FIECOD) with changes in AI for different seasons and air masses. FIECOD and FIECER are similar in magnitude and close to the typical FIE value of ˜ 0.23, and do not change much between summer and fall or between the two different air mass conditions. Similar analyses were done using spaceborne Moderate Resolution Imaging Spectroradiometer data. The satellite-derived FIE is contrary to the FIE estimated from surface retrievals and may have large uncertainties due to some inherent limitations.

  6. A Mixed Effects Randomized Item Response Model

    ERIC Educational Resources Information Center

    Fox, J.-P.; Wyrick, Cheryl

    2008-01-01

    The randomized response technique ensures that individual item responses, denoted as true item responses, are randomized before observing them and so-called randomized item responses are observed. A relationship is specified between randomized item response data and true item response data. True item response data are modeled with a (non)linear…

  7. Assessing the effect of mine subsidence on dwarf shrub ericoid heath communities within a site of national importance

    SciTech Connect

    Humphries, R.N.; Wessemann, H.; Benyon, P.R.

    1998-12-31

    Planning consent was applied for in 1997 to extract coal from the Stanley Main seam beneath Skipwith Common, North Yorkshire in the United Kingdom. The 293ha Common is of national importance for its dwarf shrub ericoid heath communities, and has statutory protection under UK law as a Site of Special Scientific Interest (SSSI). Current planning guidance requires the effects of the mining proposals to be rigorously examined. The distribution of the heath vegetation is largely determined by the surface topography and sub-surface clay features, these determine relative site subsidence on drainage, and hence soil wetness and heath vegetation. Up tomore » date topographical, soil and vegetation surveys were undertaken. This data was used in conjunction with the mining company`s subsidence predictions to model the effects of the mining of the previous and deeper Barnsley seam, as well as the proposed extraction of the Stanley Main seam. Overall, the model predicted there would be no adverse effect of subsidence from the mining of the Barnsley seam or cumulative effects following the extraction of the Stanley Main seam on the site features which determine relative wetness and heath distribution. The prediction for the Barnsley seam was tested using past and current vegetation and soil wetness records. On a broad scale, there was no field evidence that the previous mining has resulted in a reduction in the extent of ericiod heath communities within the SSSI. On a local scale, there was some evidence for a very small effect at the one location where a potential effect was predicted. As the principal physical changes to the SSSI are induced by the previous mining of the Barnsley seam, no further effects were predicted for extracting the Stanley Main seam. The modelling approach has proved to be valuable, both technically and as a means of explaining the potential effects of mining on a nationally important nature conservation site to various interested parties, including

  8. General Framework for Effect Sizes in Cluster Randomized Experiments

    ERIC Educational Resources Information Center

    VanHoudnos, Nathan

    2016-01-01

    Cluster randomized experiments are ubiquitous in modern education research. Although a variety of modeling approaches are used to analyze these data, perhaps the most common methodology is a normal mixed effects model where some effects, such as the treatment effect, are regarded as fixed, and others, such as the effect of group random assignment…

  9. The influence of pericardial fat upon left ventricular function in obese females: evidence of a site-specific effect

    PubMed Central

    2014-01-01

    Background Although increased volume of pericardial fat has been associated with decreased cardiac function, it is unclear whether this association is mediated by systemic overall obesity or direct regional fat interactions. We hypothesized that if local effects dominate, left ventricular (LV) function would be most strongly associated with pericardial fat that surrounds the left rather than the right ventricle (RV). Methods Female obese subjects (n = 60) had cardiovascular magnetic resonance (CMR) scans to obtain measures of LV function and pericardial fat volumes. LV function was obtained using the cine steady state free precession imaging in short axis orientation. The amount of pericardial fat was determined volumetrically by the cardiac gated T1 black blood imaging and normalized to body surface area. Results In this study cohort, LV fat correlated with several LV hemodynamic measurements including cardiac output (r = -0.41, p = 0.001) and stroke volume (r = -0.26, p = 0.05), as well as diastolic functional parameters including peak-early-filling rate (r = -0.38, p = 0.01), early late filling ratio (r = -0.34, p = 0.03), and time to peak-early-filling (r = 0.34, p = 0.03). These correlations remained significant even after adjusting for the body mass index and the blood pressure. However, similar correlations became weakened or even disappeared between RV fat and LV function. LV function was not correlated with systemic plasma factors, such as C-reactive protein (CRP), B-type natriuretic peptide (BNP), Interleukin-6 (IL-6), resistin and adiponectin (all p > 0.05). Conclusions LV hemodynamic and diastolic function was associated more with LV fat as compared to RV or total pericardial fat, but not with systemic inflammatory markers or adipokines. The correlations between LV function and pericardial fat remained significant even after adjusting for systemic factors. These findings suggest a site-specific influence

  10. Estimation of the Nonlinear Random Coefficient Model when Some Random Effects Are Separable

    ERIC Educational Resources Information Center

    du Toit, Stephen H. C.; Cudeck, Robert

    2009-01-01

    A method is presented for marginal maximum likelihood estimation of the nonlinear random coefficient model when the response function has some linear parameters. This is done by writing the marginal distribution of the repeated measures as a conditional distribution of the response given the nonlinear random effects. The resulting distribution…

  11. Effect of randomness in logistic maps

    NASA Astrophysics Data System (ADS)

    Khaleque, Abdul; Sen, Parongama

    2015-01-01

    We study a random logistic map xt+1 = atxt[1 - xt] where at are bounded (q1 ≤ at ≤ q2), random variables independently drawn from a distribution. xt does not show any regular behavior in time. We find that xt shows fully ergodic behavior when the maximum allowed value of at is 4. However , averaged over different realizations reaches a fixed point. For 1 ≤ at ≤ 4, the system shows nonchaotic behavior and the Lyapunov exponent is strongly dependent on the asymmetry of the distribution from which at is drawn. Chaotic behavior is seen to occur beyond a threshold value of q1(q2) when q2(q1) is varied. The most striking result is that the random map is chaotic even when q2 is less than the threshold value 3.5699⋯ at which chaos occurs in the nonrandom map. We also employ a different method in which a different set of random variables are used for the evolution of two initially identical x values, here the chaotic regime exists for all q1 ≠ q2 values.

  12. Comparative effects of precommercial thinning, urea fertilizer, and red alder in a site II, coast Douglas-fir plantation.

    Treesearch

    Richard E. Miller; Edmund L. Obermeyer; Harry W. Anderson

    1999-01-01

    We varied the number of red alder retained with 300 Douglas-fir per acre on a high-quality site in coastal Oregon. Alder densities of 0, 20, 40, and 80 per acre were tested. Our fifth treatment eliminated nitrogen-fixing alder, but substituted nitrogen fertilizer. Treatment 6 had neither thinning nor alder control. Treatments were randomly assigned within each of three...

  13. Summer School Effects in a Randomized Field Trial

    ERIC Educational Resources Information Center

    Zvoch, Keith; Stevens, Joseph J.

    2013-01-01

    This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

  14. Random diffusion and leverage effect in financial markets.

    PubMed

    Perelló, Josep; Masoliver, Jaume

    2003-03-01

    We prove that Brownian market models with random diffusion coefficients provide an exact measure of the leverage effect [J-P. Bouchaud et al., Phys. Rev. Lett. 87, 228701 (2001)]. This empirical fact asserts that past returns are anticorrelated with future diffusion coefficient. Several models with random diffusion have been suggested but without a quantitative study of the leverage effect. Our analysis lets us to fully estimate all parameters involved and allows a deeper study of correlated random diffusion models that may have practical implications for many aspects of financial markets.

  15. Analog model for quantum gravity effects: phonons in random fluids.

    PubMed

    Krein, G; Menezes, G; Svaiter, N F

    2010-09-24

    We describe an analog model for quantum gravity effects in condensed matter physics. The situation discussed is that of phonons propagating in a fluid with a random velocity wave equation. We consider that there are random fluctuations in the reciprocal of the bulk modulus of the system and study free phonons in the presence of Gaussian colored noise with zero mean. We show that, in this model, after performing the random averages over the noise function a free conventional scalar quantum field theory describing free phonons becomes a self-interacting model.

  16. A-Site (MCe) Substitution Effects on the Structures and Properties of CaBi4Ti4O15 Ceramics

    NASA Astrophysics Data System (ADS)

    Yan, Haixue; Li, Chengen; Zhou, Jiaguang; Zhu, Weimin; He, Lianxin; Song, Yuxin

    2000-11-01

    We investigated the effect of A-site compound substitution on the structures and properties of Ca0.8(MCe)0.1Bi4Ti4O15 (M denotes Li, Na and K) ceramics. The samples were prepared by the conventional ceramic technique. Sintering characteristics of Ca0.8(MCe)0.1Bi4Ti4O15 and CaBi4Ti4O15 ceramics were discussed. X-ray powder diffraction patterns of the three modified CBT-based compounds show a single phase of bismuth oxide layer type structure with m=4. The hysteresis loops of polarization versus electric field of the four compounds were also measured. A-site compound substitution improves the piezoelectric properties and the high-temperature resistivity of these materials. A-site (LiCe) and (KCe) substitution not only improves the Curie temperature but also decreases the temperature coefficient of dielectric constant (TK\\varepsilon). Among the three modified ceramics, only the Curie temperature of Ca0.8(NaCe)0.1Bi4Ti4O15 is lower than that of CaBi4Ti4O15; however, its TK\\varepsilon is the lowest. As a result, all the three modified CBT-based ceramics were found to be excellent high-temperature piezoelectric materials.

  17. Random Effects Structure for Confirmatory Hypothesis Testing: Keep It Maximal

    ERIC Educational Resources Information Center

    Barr, Dale J.; Levy, Roger; Scheepers, Christoph; Tily, Harry J.

    2013-01-01

    Linear mixed-effects models (LMEMs) have become increasingly prominent in psycholinguistics and related areas. However, many researchers do not seem to appreciate how random effects structures affect the generalizability of an analysis. Here, we argue that researchers using LMEMs for confirmatory hypothesis testing should minimally adhere to the…

  18. Comparative effects of urea fertilizer and red alder in a site III, coast Douglas-fir plantation in the Washington Cascade Range.

    Treesearch

    Richard E. Miller; Harry W. Anderson; Marshall Murray; Rick. Leon

    2005-01-01

    Five randomly assigned treatments were used to quantify effects of adding varying numbers of red alder (Alnus rubra Bong.) or nitrogen (N) fertilization on growth of a 10-year-old conifer plantation at a medium quality site in the western Washington Cascade Range. Zero, 20, 40, and 80 alder trees per acre were retained along with about 300 conifers...

  19. Random Effects: Variance Is the Spice of Life.

    PubMed

    Jupiter, Daniel C

    Covariates in regression analyses allow us to understand how independent variables of interest impact our dependent outcome variable. Often, we consider fixed effects covariates (e.g., gender or diabetes status) for which we examine subjects at each value of the covariate. We examine both men and women and, within each gender, examine both diabetic and nondiabetic patients. Occasionally, however, we consider random effects covariates for which we do not examine subjects at every value. For example, we examine patients from only a sample of hospitals and, within each hospital, examine both diabetic and nondiabetic patients. The random sampling of hospitals is in contrast to the complete coverage of all genders. In this column I explore the differences in meaning and analysis when thinking about fixed and random effects variables. Copyright © 2016 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

  20. The effect of A-site substitution on the structure and magnetism of Sr2-xPrxFeCoO6 (x = 0, 1, 2)

    NASA Astrophysics Data System (ADS)

    Haripriya, G. R.; Chakraborty, Debamitra; Pradheesh, R.; Sankaranarayanan, V.; Sethupathi, K.

    2018-05-01

    The paper presents the variation of structure and magnetism observed with the A-site composition of the double perovskite oxide Sr2-xPrxFeCoO6 (x = 0, 1, 2). The lattice symmetry was found to be lowered from tetragonal (x = 0) to orthorhombic (x = 2). With a ratio 1:1 of Sr and Pr, a highly asymmetric monoclinic structure is observed. The magnetic behavior of the middle member (x = 1) shows resemblance with that of Sr2FeCoO6, indicating the effect of Sr in the dilution of rare earth magnetism.

  1. Random forests of interaction trees for estimating individualized treatment effects in randomized trials.

    PubMed

    Su, Xiaogang; Peña, Annette T; Liu, Lei; Levine, Richard A

    2018-04-29

    Assessing heterogeneous treatment effects is a growing interest in advancing precision medicine. Individualized treatment effects (ITEs) play a critical role in such an endeavor. Concerning experimental data collected from randomized trials, we put forward a method, termed random forests of interaction trees (RFIT), for estimating ITE on the basis of interaction trees. To this end, we propose a smooth sigmoid surrogate method, as an alternative to greedy search, to speed up tree construction. The RFIT outperforms the "separate regression" approach in estimating ITE. Furthermore, standard errors for the estimated ITE via RFIT are obtained with the infinitesimal jackknife method. We assess and illustrate the use of RFIT via both simulation and the analysis of data from an acupuncture headache trial. Copyright © 2018 John Wiley & Sons, Ltd.

  2. The blocked-random effect in pictures and words.

    PubMed

    Toglia, M P; Hinman, P J; Dayton, B S; Catalano, J F

    1997-06-01

    Picture and word recall was examined in conjunction with list organization. 60 subjects studied a list of 30 items, either words or their pictorial equivalents. The 30 words/pictures, members of five conceptual categories, each represented by six exemplars, were presented either blocked by category or in a random order. While pictures were recalled better than words and a standard blocked-random effect was observed, the interaction indicated that the recall advantage of a blocked presentation was restricted to the word lists. A similar pattern emerged for clustering. These findings are discussed in terms of limitations upon the pictorial superiority effect.

  3. A Gompertzian model with random effects to cervical cancer growth

    SciTech Connect

    Mazlan, Mazma Syahidatul Ayuni; Rosli, Norhayati

    2015-05-15

    In this paper, a Gompertzian model with random effects is introduced to describe the cervical cancer growth. The parameters values of the mathematical model are estimated via maximum likehood estimation. We apply 4-stage Runge-Kutta (SRK4) for solving the stochastic model numerically. The efficiency of mathematical model is measured by comparing the simulated result and the clinical data of the cervical cancer growth. Low values of root mean-square error (RMSE) of Gompertzian model with random effect indicate good fits.

  4. Effect of A-Site Cation Ordering on Chemical Stability, Oxygen Stoichiometry and Electrical Conductivity in Layered LaBaCo2O5+δ Double Perovskite

    PubMed Central

    Bernuy-Lopez, Carlos; Høydalsvik, Kristin; Einarsrud, Mari-Ann; Grande, Tor

    2016-01-01

    The effect of the A-site cation ordering on the chemical stability, oxygen stoichiometry and electrical conductivity in layered LaBaCo2O5+δ double perovskite was studied as a function of temperature and partial pressure of oxygen. Tetragonal A-site cation ordered layered LaBaCo2O5+δ double perovskite was obtained by annealing cubic A-site cation disordered La0.5Ba0.5CoO3-δ perovskite at 1100 °C in N2. High temperature X-ray diffraction between room temperature (RT) and 800 °C revealed that LaBaCo2O5+δ remains tetragonal during heating in oxidizing atmosphere, but goes through two phase transitions in N2 and between 450 °C and 675 °C from tetragonal P4/mmm to orthorhombic Pmmm and back to P4/mmm due to oxygen vacancy ordering followed by disordering of the oxygen vacancies. An anisotropic chemical and thermal expansion of LaBaCo2O5+δ was demonstrated. La0.5Ba0.5CoO3-δ remained cubic at the studied temperature irrespective of partial pressure of oxygen. LaBaCo2O5+δ is metastable with respect to La0.5Ba0.5CoO3-δ at oxidizing conditions inferred from the thermal evolution of the oxygen deficiency and oxidation state of Co in the two materials. The oxidation state of Co is higher in La0.5Ba0.5CoO3-δ resulting in a higher electrical conductivity relative to LaBaCo2O5+δ. The conductivity in both materials was reduced with decreasing partial pressure of oxygen pointing to a p-type semiconducting behavior. PMID:28773279

  5. Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

    ERIC Educational Resources Information Center

    Schroder, Kerstin E. E.

    2011-01-01

    Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

  6. Performance of Random Effects Model Estimators under Complex Sampling Designs

    ERIC Educational Resources Information Center

    Jia, Yue; Stokes, Lynne; Harris, Ian; Wang, Yan

    2011-01-01

    In this article, we consider estimation of parameters of random effects models from samples collected via complex multistage designs. Incorporation of sampling weights is one way to reduce estimation bias due to unequal probabilities of selection. Several weighting methods have been proposed in the literature for estimating the parameters of…

  7. Effect Sizes in Three-Level Cluster-Randomized Experiments

    ERIC Educational Resources Information Center

    Hedges, Larry V.

    2011-01-01

    Research designs involving cluster randomization are becoming increasingly important in educational and behavioral research. Many of these designs involve two levels of clustering or nesting (students within classes and classes within schools). Researchers would like to compute effect size indexes based on the standardized mean difference to…

  8. Application of Poisson random effect models for highway network screening.

    PubMed

    Jiang, Ximiao; Abdel-Aty, Mohamed; Alamili, Samer

    2014-02-01

    In recent years, Bayesian random effect models that account for the temporal and spatial correlations of crash data became popular in traffic safety research. This study employs random effect Poisson Log-Normal models for crash risk hotspot identification. Both the temporal and spatial correlations of crash data were considered. Potential for Safety Improvement (PSI) were adopted as a measure of the crash risk. Using the fatal and injury crashes that occurred on urban 4-lane divided arterials from 2006 to 2009 in the Central Florida area, the random effect approaches were compared to the traditional Empirical Bayesian (EB) method and the conventional Bayesian Poisson Log-Normal model. A series of method examination tests were conducted to evaluate the performance of different approaches. These tests include the previously developed site consistence test, method consistence test, total rank difference test, and the modified total score test, as well as the newly proposed total safety performance measure difference test. Results show that the Bayesian Poisson model accounting for both temporal and spatial random effects (PTSRE) outperforms the model that with only temporal random effect, and both are superior to the conventional Poisson Log-Normal model (PLN) and the EB model in the fitting of crash data. Additionally, the method evaluation tests indicate that the PTSRE model is significantly superior to the PLN model and the EB model in consistently identifying hotspots during successive time periods. The results suggest that the PTSRE model is a superior alternative for road site crash risk hotspot identification. Copyright © 2013 Elsevier Ltd. All rights reserved.

  9. A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.

    PubMed

    Elul, Batya; Lahuerta, Maria; Abacassamo, Fatima; Lamb, Matthew R; Ahoua, Laurence; McNairy, Margaret L; Tomo, Maria; Horowitz, Deborah; Sutton, Roberta; Mussa, Antonio; Gurr, Danielle; Jani, Ilesh

    2014-10-15

    Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real

  10. Neighborhood Effects in a Behavioral Randomized Controlled Trial

    PubMed Central

    Pruitt, Sandi L.; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2015-01-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5,628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient’s CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. PMID:25456014

  11. Parallel Mitogenome Sequencing Alleviates Random Rooting Effect in Phylogeography.

    PubMed

    Hirase, Shotaro; Takeshima, Hirohiko; Nishida, Mutsumi; Iwasaki, Wataru

    2016-04-28

    Reliably rooted phylogenetic trees play irreplaceable roles in clarifying diversification in the patterns of species and populations. However, such trees are often unavailable in phylogeographic studies, particularly when the focus is on rapidly expanded populations that exhibit star-like trees. A fundamental bottleneck is known as the random rooting effect, where a distant outgroup tends to root an unrooted tree "randomly." We investigated whether parallel mitochondrial genome (mitogenome) sequencing alleviates this effect in phylogeography using a case study on the Sea of Japan lineage of the intertidal goby Chaenogobius annularis Eighty-three C. annularis individuals were collected and their mitogenomes were determined by high-throughput and low-cost parallel sequencing. Phylogenetic analysis of these mitogenome sequences was conducted to root the Sea of Japan lineage, which has a star-like phylogeny and had not been reliably rooted. The topologies of the bootstrap trees were investigated to determine whether the use of mitogenomes alleviated the random rooting effect. The mitogenome data successfully rooted the Sea of Japan lineage by alleviating the effect, which hindered phylogenetic analysis that used specific gene sequences. The reliable rooting of the lineage led to the discovery of a novel, northern lineage that expanded during an interglacial period with high bootstrap support. Furthermore, the finding of this lineage suggested the existence of additional glacial refugia and provided a new recent calibration point that revised the divergence time estimation between the Sea of Japan and Pacific Ocean lineages. This study illustrates the effectiveness of parallel mitogenome sequencing for solving the random rooting problem in phylogeographic studies. © The Author 2016. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  12. Magnet/Hall-Effect Random-Access Memory

    NASA Technical Reports Server (NTRS)

    Wu, Jiin-Chuan; Stadler, Henry L.; Katti, Romney R.

    1991-01-01

    In proposed magnet/Hall-effect random-access memory (MHRAM), bits of data stored magnetically in Perm-alloy (or equivalent)-film memory elements and read out by using Hall-effect sensors to detect magnetization. Value of each bit represented by polarity of magnetization. Retains data for indefinite time or until data rewritten. Speed of Hall-effect sensors in MHRAM results in readout times of about 100 nanoseconds. Other characteristics include high immunity to ionizing radiation and storage densities of order 10(Sup6)bits/cm(Sup 2) or more.

  13. Effects of Check and Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

    2014-01-01

    Objectives: This study examined the effects of Check & Connect (C&C) on the attendance, behavior, and academic outcomes of at-risk youth in a field-based effectiveness trial. Method: A multisite randomized block design was used, wherein 260 primarily Hispanic (89%) and economically disadvantaged (74%) students were randomized to treatment…

  14. Radiation Effects of Commercial Resistive Random Access Memories

    NASA Technical Reports Server (NTRS)

    Chen, Dakai; LaBel, Kenneth A.; Berg, Melanie; Wilcox, Edward; Kim, Hak; Phan, Anthony; Figueiredo, Marco; Buchner, Stephen; Khachatrian, Ani; Roche, Nicolas

    2014-01-01

    We present results for the single-event effect response of commercial production-level resistive random access memories. We found that the resistive memory arrays are immune to heavy ion-induced upsets. However, the devices were susceptible to single-event functional interrupts, due to upsets from the control circuits. The intrinsic radiation tolerant nature of resistive memory makes the technology an attractive consideration for future space applications.

  15. Analyzing degradation data with a random effects spline regression model

    SciTech Connect

    Fugate, Michael Lynn; Hamada, Michael Scott; Weaver, Brian Phillip

    This study proposes using a random effects spline regression model to analyze degradation data. Spline regression avoids having to specify a parametric function for the true degradation of an item. A distribution for the spline regression coefficients captures the variation of the true degradation curves from item to item. We illustrate the proposed methodology with a real example using a Bayesian approach. The Bayesian approach allows prediction of degradation of a population over time and estimation of reliability is easy to perform.

  16. Analyzing degradation data with a random effects spline regression model

    DOE PAGES

    Fugate, Michael Lynn; Hamada, Michael Scott; Weaver, Brian Phillip

    2017-03-17

    This study proposes using a random effects spline regression model to analyze degradation data. Spline regression avoids having to specify a parametric function for the true degradation of an item. A distribution for the spline regression coefficients captures the variation of the true degradation curves from item to item. We illustrate the proposed methodology with a real example using a Bayesian approach. The Bayesian approach allows prediction of degradation of a population over time and estimation of reliability is easy to perform.

  17. Estimating overall exposure effects for the clustered and censored outcome using random effect Tobit regression models.

    PubMed

    Wang, Wei; Griswold, Michael E

    2016-11-30

    The random effect Tobit model is a regression model that accommodates both left- and/or right-censoring and within-cluster dependence of the outcome variable. Regression coefficients of random effect Tobit models have conditional interpretations on a constructed latent dependent variable and do not provide inference of overall exposure effects on the original outcome scale. Marginalized random effects model (MREM) permits likelihood-based estimation of marginal mean parameters for the clustered data. For random effect Tobit models, we extend the MREM to marginalize over both the random effects and the normal space and boundary components of the censored response to estimate overall exposure effects at population level. We also extend the 'Average Predicted Value' method to estimate the model-predicted marginal means for each person under different exposure status in a designated reference group by integrating over the random effects and then use the calculated difference to assess the overall exposure effect. The maximum likelihood estimation is proposed utilizing a quasi-Newton optimization algorithm with Gauss-Hermite quadrature to approximate the integration of the random effects. We use these methods to carefully analyze two real datasets. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  18. Effective Perron-Frobenius eigenvalue for a correlated random map

    NASA Astrophysics Data System (ADS)

    Pool, Roman R.; Cáceres, Manuel O.

    2010-09-01

    We investigate the evolution of random positive linear maps with various type of disorder by analytic perturbation and direct simulation. Our theoretical result indicates that the statistics of a random linear map can be successfully described for long time by the mean-value vector state. The growth rate can be characterized by an effective Perron-Frobenius eigenvalue that strongly depends on the type of correlation between the elements of the projection matrix. We apply this approach to an age-structured population dynamics model. We show that the asymptotic mean-value vector state characterizes the population growth rate when the age-structured model has random vital parameters. In this case our approach reveals the nontrivial dependence of the effective growth rate with cross correlations. The problem was reduced to the calculation of the smallest positive root of a secular polynomial, which can be obtained by perturbations in terms of Green’s function diagrammatic technique built with noncommutative cumulants for arbitrary n -point correlations.

  19. Effects of lidocaine on random skin flap survival in rats.

    PubMed

    Cao, Bin; Wang, Liren; Lin, Dingsheng; Cai, Leyi; Gao, Weiyang

    2015-01-01

    Use of a random skin flap is common for repairing wounds and for reconstruction. Lidocaine is a traditional local anesthetic that blocks sodium channels and has positive effects on ischemia-reperfusion injury. To investigate the effects of lidocaine on random skin flap survival in rats. McFarlane flaps were established in 20 rats divided into 2 groups. Lidocaine was injected in the lidocaine group, and the same concentration of saline was injected in the control group. The survival area of the flaps was measured on Day 7. Levels of inflammation were evaluated by hematoxylin and eosin (H&E)-stained slices, and superoxide dismutase and malonyldialdehyde contents were examined. The mean survival area of the flaps in the lidocaine group was significantly larger than that in the control group. Superoxide dismutase activity increased significantly in the lidocaine group compared with that in the control group. Malonyldialdehyde level in the lidocaine group was significantly lower than that in the control group. The H&E-stained slices showed that inflammation was clearly inhibited in the lidocaine group. Lidocaine improved the survival of random skin flaps.

  20. A random wave model for the Aharonov-Bohm effect

    NASA Astrophysics Data System (ADS)

    Houston, Alexander J. H.; Gradhand, Martin; Dennis, Mark R.

    2017-05-01

    We study an ensemble of random waves subject to the Aharonov-Bohm effect. The introduction of a point with a magnetic flux of arbitrary strength into a random wave ensemble gives a family of wavefunctions whose distribution of vortices (complex zeros) is responsible for the topological phase associated with the Aharonov-Bohm effect. Analytical expressions are found for the vortex number and topological charge densities as functions of distance from the flux point. Comparison is made with the distribution of vortices in the isotropic random wave model. The results indicate that as the flux approaches half-integer values, a vortex with the same sign as the fractional part of the flux is attracted to the flux point, merging with it in the limit of half-integer flux. We construct a statistical model of the neighbourhood of the flux point to study how this vortex-flux merger occurs in more detail. Other features of the Aharonov-Bohm vortex distribution are also explored.

  1. Transport properties of random media: A new effective medium theory

    SciTech Connect

    Busch, K.; Soukoulis, C.M.

    We present a new method for efficient, accurate calculations of transport properties of random media. It is based on the principle that the wave energy density should be uniform when averaged over length scales larger than the size of the scatterers. This scheme captures the effects of resonant scattering of the individual scatterer exactly, as well as the multiple scattering in a mean-field sense. It has been successfully applied to both ``scalar`` and ``vector`` classical wave calculations. Results for the energy transport velocity are in agreement with experiment. This approach is of general use and can be easily extended tomore » treat different types of wave propagation in random media. {copyright} {ital 1995} {ital The} {ital American} {ital Physical} {ital Society}.« less

  2. Twice random, once mixed: applying mixed models to simultaneously analyze random effects of language and participants.

    PubMed

    Janssen, Dirk P

    2012-03-01

    Psychologists, psycholinguists, and other researchers using language stimuli have been struggling for more than 30 years with the problem of how to analyze experimental data that contain two crossed random effects (items and participants). The classical analysis of variance does not apply; alternatives have been proposed but have failed to catch on, and a statistically unsatisfactory procedure of using two approximations (known as F(1) and F(2)) has become the standard. A simple and elegant solution using mixed model analysis has been available for 15 years, and recent improvements in statistical software have made mixed models analysis widely available. The aim of this article is to increase the use of mixed models by giving a concise practical introduction and by giving clear directions for undertaking the analysis in the most popular statistical packages. The article also introduces the DJMIXED: add-on package for SPSS, which makes entering the models and reporting their results as straightforward as possible.

  3. Neighborhood effects in a behavioral randomized controlled trial.

    PubMed

    Pruitt, Sandi L; Leonard, Tammy; Murdoch, James; Hughes, Amy; McQueen, Amy; Gupta, Samir

    2014-11-01

    Randomized controlled trials (RCTs) of interventions intended to modify health behaviors may be influenced by neighborhood effects which can impede unbiased estimation of intervention effects. Examining a RCT designed to increase colorectal cancer (CRC) screening (N=5628), we found statistically significant neighborhood effects: average CRC test use among neighboring study participants was significantly and positively associated with individual patient's CRC test use. This potentially important spatially-varying covariate has not previously been considered in a RCT. Our results suggest that future RCTs of health behavior interventions should assess potential social interactions between participants, which may cause intervention arm contamination and may bias effect size estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. A-SITE-AND/OR B-SITE-MODIFIED PBZRTIO3 MATERIALS AND (PB, SR, CA, BA, MG) (ZR, TI,NB, TA)O3 FILMS HAVING UTILITY IN FERROELECTRIC RANDOM ACCESS MEMORIES AND HIGH PERFORMANCE THIN FILM MICROACTUATORS

    NASA Technical Reports Server (NTRS)

    Bilodeau, Steven (Inventor); Baum, Thomas H. (Inventor); Roeder, Jeffrey F. (Inventor); Chen, Ing-Shin (Inventor)

    2004-01-01

    A modified PbZrTiO.sub.3 perovskite crystal material thin film, wherein the PbZrTiO.sub.3 perovskite crystal material includes crystal lattice A-sites and B-sites at least one of which is modified by the presence of a substituent selected from the group consisting of (i) A-site substituents consisting of Sr, Ca, Ba and Mg, and (ii) B-site substituents selected from the group consisting of Nb and Ta. The perovskite crystal thin film material may be formed by liquid delivery MOCVD from metalorganic precursors of the metal components of the thin film, to form PZT and PSZT, and other piezoelectric and ferroelectric thin film materials. The thin films of the invention have utility in non-volatile ferroelectric memory devices (NV-FeRAMs), and in microelectromechanical systems (MEMS) as sensor and/or actuator elements, e.g., high speed digital system actuators requiring low input power levels.

  5. Static and dynamic optical properties of La 1-xSr xFeO 3-δ: The effects of A-site and oxygen stoichiometry

    DOE PAGES

    Sergey Y. Smolin; Sfeir, Matthew Y.; Scafetta, Mark D.; ...

    2015-12-09

    Perovskite oxides are a promising material class for photovoltaic and photocatalytic applications due to their visible band gaps, nanosecond recombination lifetimes, and great chemical diversity. However, there is limited understanding of the link between composition and static and dynamic optical properties, despite the critical role these properties play in the design of light-harvesting devices. To clarify these relationships, we systemically studied the optoelectronic properties in La 1-xSr xFeO 3-δ epitaxial films, uncovering the effects of A-site cation substitution and oxygen stoichiometry. Variable-angle spectroscopic ellipsometry was used to measure static optical properties, revealing a linear increase in absorption coefficient at 1.25more » eV and a red-shifting of the optical absorption edge with increasing Sr fraction. The absorption spectra can be similarly tuned through the introduction of oxygen vacancies, indicating the critical role that nominal Fe valence plays in optical absorption. Dynamic optoelectronic properties were studied with ultrafast transient reflectance spectroscopy, revealing similar nanosecond photoexcited carrier lifetimes for oxygen deficient and stoichiometric films with the same nominal Fe valence. Furthermore, these results demonstrate that while the static optical absorption is strongly dependent on nominal Fe valence tuned through cation or anion stoichiometry, oxygen vacancies do not appear to play a significantly detrimental role in the recombination kinetics.« less

  6. Effective band structure of random III-V alloys

    NASA Astrophysics Data System (ADS)

    Popescu, Voicu; Zunger, Alex

    2010-03-01

    Random substitutional alloys have no long range order (LRO) or translational symmetry so rigorously speaking they have no E(k) band structure or manifestations thereof. Yet, many experiments on alloys are interpreted using the language of band theory, e.g. inferring Van Hove singularities, band dispersion and effective masses. Many standard alloy theories (VCA- or CPA-based) have the LRO imposed on the alloy Hamiltonian, assuming only on-site disorder, so they can not be used to judge the extent of LRO that really exists. We adopt the opposite way, by using large (thousand atom) randomly generated supercells in which chemically identical alloy atoms are allowed to have different local environments (a polymorphous representation). This then drives site-dependent atomic relaxation as well as potential fluctuations. The eigenstates from such supercells are then mapped onto the Brillouin zone (BZ) of the primitive cell, producing effective band dispersion. Results for (In,Ga)X show band-like behaviour only near the centre and faces of the BZ but rapidly lose such characteristics away from γ or for higher bands. We further analyse the effects of stoichiometry variation, internal relaxation, and short-range order on the alloy band structure.

  7. Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

    PubMed

    Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

    2017-01-01

    Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing

  8. A mediator effect size in randomized clinical trials.

    PubMed

    Kraemer, Helena Chmura

    2014-12-01

    To understand the process by which a treatment (T) achieves an effect on outcome (O) and thus to improve the effect of T on O, it is vital to detect mediators, to compare the impact of different mediators, and to develop hypotheses about the causal factors (all mediators) linking T and O. An index is needed to facilitate interpretation of the potential clinical importance of a mediator (M) of choice of T on treatment O in randomized clinical trials (RCTs). Ideally such a mediator effect size should (1) be invariant under any rescaling of M and O consistent with the model used, and (2) reflect the difference between the overall observed effect of T on O and what the maximal effect of T on O could be were the association between T and M broken. A mediator effect size is derived first for the traditional linear model, and then more generally for any categorical (ordered or non-ordered) potential mediator. Issues such as the problem of multiple treatments, outcomes and mediators, and of causal inferences, and the correspondence between this approach and earlier ones, are discussed. Illustrations are given of the application of the approach. Copyright © 2014 John Wiley & Sons, Ltd.

  9. Generated effect modifiers (GEM’s) in randomized clinical trials

    PubMed Central

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R. Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an “effect modifier”. Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. PMID:27465235

  10. Generated effect modifiers (GEM's) in randomized clinical trials.

    PubMed

    Petkova, Eva; Tarpey, Thaddeus; Su, Zhe; Ogden, R Todd

    2017-01-01

    In a randomized clinical trial (RCT), it is often of interest not only to estimate the effect of various treatments on the outcome, but also to determine whether any patient characteristic has a different relationship with the outcome, depending on treatment. In regression models for the outcome, if there is a non-zero interaction between treatment and a predictor, that predictor is called an "effect modifier". Identification of such effect modifiers is crucial as we move towards precision medicine, that is, optimizing individual treatment assignment based on patient measurements assessed when presenting for treatment. In most settings, there will be several baseline predictor variables that could potentially modify the treatment effects. This article proposes optimal methods of constructing a composite variable (defined as a linear combination of pre-treatment patient characteristics) in order to generate an effect modifier in an RCT setting. Several criteria are considered for generating effect modifiers and their performance is studied via simulations. An example from a RCT is provided for illustration. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. The Effectiveness of Propolis on Gingivitis: A Randomized Controlled Trial

    PubMed Central

    Paulino, Niraldo; Nör, Jacques E.; Moreira, Alexandre

    2014-01-01

    Abstract Background: A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Methods: Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days −14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). Results: The 38 persons who completed the study (age 13–22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Conclusions: Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period. PMID:25380344

  12. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    PubMed

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  13. Randomization at the level of primary care practice: use of pre-intervention data and random effects models.

    PubMed

    Nixon, R M; Duffy, S W; Fender, G R; Day, N E; Prevost, T C

    2001-06-30

    The Anglia menorrhagia education study tests the effectiveness of an education package for the treatment of menorrhagia given to doctors at a primary care level. General practices were randomized to receive or not receive the package. It is hoped that this intervention will reduce the proportion of women suffering from menorrhagia that are referred to hospital. Data are available on the treatment and referral of women in the practices in the education and control groups, both pre- and post-intervention. We define and demonstrate a random effects logistic regression model that includes pre-intervention data for calculating the effectiveness of the intervention. Copyright 2001 John Wiley & Sons, Ltd.

  14. Effect of packing method on the randomness of disc packings

    NASA Astrophysics Data System (ADS)

    Zhang, Z. P.; Yu, A. B.; Oakeshott, R. B. S.

    1996-06-01

    The randomness of disc packings, generated by random sequential adsorption (RSA), random packing under gravity (RPG) and Mason packing (MP) which gives a packing density close to that of the RSA packing, has been analysed, based on the Delaunay tessellation, and is evaluated at two levels, i.e. the randomness at individual subunit level which relates to the construction of a triangle from a given edge length distribution and the randomness at network level which relates to the connection between triangles from a given triangle frequency distribution. The Delaunay tessellation itself is also analysed and its almost perfect randomness at the two levels is demonstrated, which verifies the proposed approach and provides a random reference system for the present analysis. It is found that (i) the construction of a triangle subunit is not random for the RSA, MP and RPG packings, with the degree of randomness decreasing from the RSA to MP and then to RPG packing; (ii) the connection of triangular subunits in the network is almost perfectly random for the RSA packing, acceptable for the MP packing and not good for the RPG packing. Packing method is an important factor governing the randomness of disc packings.

  15. Effects of professional oral health care on elderly: randomized trial.

    PubMed

    Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

    2014-11-01

    To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P < 0.05). Moreover, DPI significantly improved in the intervention group (Intervention, 57% [8/14]; Control, 13% [2/16]: Fisher's, two-tailed, P < 0.05). The improvement in DPI extended for 3 months after intervention. None of side effects were reported. The short-term professional oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. Placebo Effects and the Common Cold: A Randomized Controlled Trial

    PubMed Central

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

    2011-01-01

    blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, −4.47 to −0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (−97.0, 95% CI, −249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions. PMID:21747102

  17. Effects of vinpocetine on random skin flap survival in rats.

    PubMed

    Xiao-Xiao, Tao; Sen-Min, Wu; Ding-Sheng, Lin

    2013-07-01

    The effect of vinpocetine on flap survival, vascular endothelial growth factor (VEGF) expression, and superoxide dismutase (SOD) and malondialdehyde (MDA) contents were evaluated in this study. The McFarlane flap model was established in 20 rats and evaluated within two groups. Postoperative celiac injection was given for 7 days in the two groups: vinpocetine was applied in Group 1, and the same volume of saline was applied in Group 2. Flap necrosis was measured on day 7 by cellophane in all groups. VEGF expression was determined using immunohistochemical methods on tissue samples taken after 7 days of injections. SOD and MDA contents were examined according to the Kit (reagent instructions). Vinpocetine significantly reduced necrosis area in Group 1 (p < 0.05). VEGF expression and SOD contents were significantly increased in Group 1 compared with Group 2 (p < 0.01), whereas MDA level was reduced (p < 0.05). This experimental study demonstrates that vinpocetine improves survival of random skin flaps, promotes neovascularization, and increases VEGF expression. Meanwhile, vinpocetine has a protective effect against ischemia-reperfusion injury by improving SOD vitality and decreasing MDA value. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  18. Random Walks and Effective Optical Depth in Relativistic Flow

    NASA Astrophysics Data System (ADS)

    Shibata, Sanshiro; Tominaga, Nozomu; Tanaka, Masaomi

    2014-05-01

    We investigate the random walk process in relativistic flow. In the relativistic flow, photon propagation is concentrated in the direction of the flow velocity due to the relativistic beaming effect. We show that in the pure scattering case, the number of scatterings is proportional to the size parameter ξ ≡ L/l 0 if the flow velocity β ≡ v/c satisfies β/Γ Gt ξ-1, while it is proportional to ξ2 if β/Γ Lt ξ-1, where L and l 0 are the size of the system in the observer frame and the mean free path in the comoving frame, respectively. We also examine the photon propagation in the scattering and absorptive medium. We find that if the optical depth for absorption τa is considerably smaller than the optical depth for scattering τs (τa/τs Lt 1) and the flow velocity satisfies \\beta \\gg \\sqrt{2\\tau _a/\\tau _s}, then the effective optical depth is approximated by τ* ~= τa(1 + β)/β. Furthermore, we perform Monte Carlo simulations of radiative transfer and compare the results with the analytic expression for the number of scatterings. The analytic expression is consistent with the results of the numerical simulations. The expression derived in this study can be used to estimate the photon production site in relativistic phenomena, e.g., gamma-ray burst and active galactic nuclei.

  19. The Effectiveness of Mandatory-Random Student Drug Testing

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric

    2011-01-01

    One approach some U.S. schools now use to combat high rates of adolescent substance use is school-based mandatory-random student drug testing (MRSDT). Under MRSDT, students and their parents sign consent forms agreeing to the students' participation in random drug testing as a condition of participating in athletics and other school-sponsored…

  20. Simulation of the Effects of Random Measurement Errors

    ERIC Educational Resources Information Center

    Kinsella, I. A.; Hannaidh, P. B. O.

    1978-01-01

    Describes a simulation method for measurement of errors that requires calculators and tables of random digits. Each student simulates the random behaviour of the component variables in the function and by combining the results of all students, the outline of the sampling distribution of the function can be obtained. (GA)

  1. Effective dynamics of a random walker on a heterogeneous ring: Exact results

    NASA Astrophysics Data System (ADS)

    Masharian, S. R.

    2018-07-01

    In this paper, by considering a biased random walker hopping on a one-dimensional lattice with a ring geometry, we investigate the fluctuations of the speed of the random walker. We assume that the lattice is heterogeneous i.e. the hopping rate of the random walker between the first and the last lattice sites is different from the hopping rate of the random walker between the other links of the lattice. Assuming that the average speed of the random walker in the steady-state is v∗, we have been able to find the unconditional effective dynamics of the random walker where the absolute value of the average speed of the random walker is -v∗. Using a perturbative method in the large system-size limit, we have also been able to show that the effective hopping rates of the random walker near the defective link are highly site-dependent.

  2. The Effective Conductivity of Random Suspensions of Spherical Particles

    NASA Astrophysics Data System (ADS)

    Bonnecaze, R. T.; Brady, J. F.

    1991-03-01

    The effective conductivity of an infinite, random, mono-disperse, hard-sphere suspension is reported for particle to matrix conductivity ratios of ∞ , 10 and 0.01 for sphere volume fractions, c, up to 0.6. The conductivities are computed with a method previously described by the authors, which includes both far- and near-field interactions, and the particle configurations are generated via a Monte Carlo method. The results are consistent with the previous theoretical work of D. J. Jeffrey to O(c2) and the bounds computed by S. Torquato and F. Lado. It is also found that the Clausius-Mosotti equation is reasonably accurate for conductivity ratios of 10 or less all the way up to 60% (by volume). The calculated conductivities compare very well with those of experiments. In addition, percolation-like numerical experiments are performed on periodically replicated cubic lattices of N nearly touching spheres with an infinite particle to matrix conductivity ratio where the conductivity is computed as spheres are removed one by one from the lattice. Under suitable normalization of the conductivity and volume fraction, it is found that the initial volume fraction must be extremely close to maximum packing in order to observe a percolation transition, indicating that the near-field effects must be very large relative to far-field effects. These percolation transitions occur at the accepted values for simple (SC), bodycentred (BCC) and face-centred (FCC) cubic lattices. Also, the vulnerability of the lattices computed here are exactly those of previous investigators. Due to limited data above the percolation threshold, we could not correlate the conductivity with a power law near the threshold; however, it can be correlated with a power law for large normalized volume fractions. In this case the exponents are found to be 1.70, 1.75 and 1.79 for SC, BCC and FCC lattices respectively.

  3. Persistent random walk of cells involving anomalous effects and random death

    NASA Astrophysics Data System (ADS)

    Fedotov, Sergei; Tan, Abby; Zubarev, Andrey

    2015-04-01

    The purpose of this paper is to implement a random death process into a persistent random walk model which produces sub-ballistic superdiffusion (Lévy walk). We develop a stochastic two-velocity jump model of cell motility for which the switching rate depends upon the time which the cell has spent moving in one direction. It is assumed that the switching rate is a decreasing function of residence (running) time. This assumption leads to the power law for the velocity switching time distribution. This describes the anomalous persistence of cell motility: the longer the cell moves in one direction, the smaller the switching probability to another direction becomes. We derive master equations for the cell densities with the generalized switching terms involving the tempered fractional material derivatives. We show that the random death of cells has an important implication for the transport process through tempering of the superdiffusive process. In the long-time limit we write stationary master equations in terms of exponentially truncated fractional derivatives in which the rate of death plays the role of tempering of a Lévy jump distribution. We find the upper and lower bounds for the stationary profiles corresponding to the ballistic transport and diffusion with the death-rate-dependent diffusion coefficient. Monte Carlo simulations confirm these bounds.

  4. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    PubMed

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; p<0.05) and -2.84 mmHg (CI, -5.33 to -0.33 mmHg; p<0.05), respectively, after the 8-week intervention. The corresponding net change in renin activity was -1.17 ng/mL/h for the nattokinase group compared with the control group (p<0.05). In conclusion, nattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  5. Bayesian Hierarchical Random Effects Models in Forensic Science.

    PubMed

    Aitken, Colin G G

    2018-01-01

    Statistical modeling of the evaluation of evidence with the use of the likelihood ratio has a long history. It dates from the Dreyfus case at the end of the nineteenth century through the work at Bletchley Park in the Second World War to the present day. The development received a significant boost in 1977 with a seminal work by Dennis Lindley which introduced a Bayesian hierarchical random effects model for the evaluation of evidence with an example of refractive index measurements on fragments of glass. Many models have been developed since then. The methods have now been sufficiently well-developed and have become so widespread that it is timely to try and provide a software package to assist in their implementation. With that in mind, a project (SAILR: Software for the Analysis and Implementation of Likelihood Ratios) was funded by the European Network of Forensic Science Institutes through their Monopoly programme to develop a software package for use by forensic scientists world-wide that would assist in the statistical analysis and implementation of the approach based on likelihood ratios. It is the purpose of this document to provide a short review of a small part of this history. The review also provides a background, or landscape, for the development of some of the models within the SAILR package and references to SAILR as made as appropriate.

  6. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    PubMed

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  7. Effects of trimetazidine in nonischemic heart failure: a randomized study.

    PubMed

    Winter, José Luis; Castro, Pablo F; Quintana, Juan Carlos; Altamirano, Rodrigo; Enriquez, Andres; Verdejo, Hugo E; Jalil, Jorge E; Mellado, Rosemarie; Concepción, Roberto; Sepúlveda, Pablo; Rossel, Victor; Sepúlveda, Luis; Chiong, Mario; García, Lorena; Lavandero, Sergio

    2014-03-01

    Heart failure (HF) is associated with changes in myocardial metabolism that lead to impairment of contractile function. Trimetazidine (TMZ) modulates cardiac energetic efficiency and improves outcomes in ischemic heart disease. We evaluated the effects of TMZ on left ventricular ejection fraction (LVEF), cardiac metabolism, exercise capacity, O2 uptake, and quality of life in patients with nonischemic HF. Sixty patients with stable nonischemic HF under optimal medical therapy were included in this randomized double-blind study. Patients were randomized to TMZ (35 mg orally twice a day) or placebo for 6 months. LVEF, 6-minute walk test (6MWT), maximum O2 uptake in cardiopulmonary exercise test, different markers of metabolism, oxidative stress, and endothelial function, and quality of life were assessed at baseline and after TMZ treatment. Left ventricular peak glucose uptake was evaluated with the use of the maximum standardized uptake value (SUV) by 18-fluorodeoxyglucose positron emission tomography ((18)FDG-PET). Etiology was idiopathic in 85% and hypertensive in 15%. Both groups were similar in age, functional class, LVEF, and levels of N-terminal pro-B-type natriuretic peptide at baseline. After 6 months of TMZ treatment, no changes were observed in LVEF (31 ± 10% vs 34 ± 8%; P = .8), 6MWT (443 ± 25 m vs 506 ± 79 m; P = .03), maximum O2 uptake (19.1 ± 5.0 mL kg(-1) min(-1) vs 23.0 ± 7.2 mL kg(-1) min(-1); P = .11), functional class (percentages of patients in functional classes I/II/III/IV 10/3753/0 vs 7/40/50/3; P = .14), or quality of life (32 ± 26 points vs 24 ± 18 points; P = .25) in TMZ versus placebo, respectively. In the subgroup of patients evaluated with (18)FDG-PET, no significant differences were observed in SUV between both groups (7.0 ± 3.6 vs 8.2 ± 3.4 respectively; P = .47). In patients with nonischemic HF, the addition of TMZ to optimal medical treatment does not result in significant changes of LVEF, exercise capacity, O2 uptake, or

  8. Effects of clear aligners on sleep bruxism: randomized controlled trial.

    PubMed

    Castroflorio, T; Bargellini, A; Lucchese, A; Manuelli, M; Casasco, F; Cugliari, G; Cioffi, I; Deregibus, A

    2018-01-01

    The possible effects on sleep bruxism (SB) of clear aligners in orthodontics are unknown. This study was conducted to analyze the effects of clear aligners on SB. Sixty subjects needing orthodontic treatment and affected by SB (33 m, 27 f, 20±;5 years) were enrolled in the study and randomly assigned to one of the following three groups: 20 were given clear aligners (CAT) (12 m, 8 f, 19±5 years), 20 occlusal splint (MOS) (9 m, 11 f, 22±5 years) and 20 a placebo splint (PMS) (12 m, 8 f, 24±3 years). All groups were followed for 6 consecutive months and monitored for SB with a portable electromyographic-electrocardiographic (EMG-ECG) device (Bruxoff®, OT Bioelettronica, Torino, Italy). MOS subjects reduced masseter contractions after 6 months of treatment (t3) (MD=-29.11, std. error 11.74, p=0.017) but increased phasic contractions related to SB after 3 months of treatment (t2) (MD=4.73, std. error 2.36, p=0.048) and tonic contractions related to SB during all the six months of treatment (t1, t2, t3) when compared to PMS. CAT subjects increased phasic contractions related to SB during the first (t1) (MD=3.94, std. error 2.27, p=0.04) and the third month (t2) of treatment (MD=4.62, std. error 2.36, p=0.046) when compared to PMS. No significant differences were found for SB index at any time for all the three groups. Although MOS and CAT affected EMG signals during sleep time differently, they did not influence the overall SB index.

  9. Hip-Hop to Health Jr. Randomized Effectiveness Trial

    PubMed Central

    Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.

    2015-01-01

    Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively

  10. Effects of Check & Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

    2014-01-01

    The present study evaluates the effectiveness of Check & Connect (C&C) in a randomly assigned sample of students who were all receiving Communities in Schools (CIS) services. The research questions for the study include: Are there differences in attendance, academics, and behavior for CIS students who also receive C&C compared to…

  11. Random effects coefficient of determination for mixed and meta-analysis models.

    PubMed

    Demidenko, Eugene; Sargent, James; Onega, Tracy

    2012-01-01

    The key feature of a mixed model is the presence of random effects. We have developed a coefficient, called the random effects coefficient of determination, [Formula: see text], that estimates the proportion of the conditional variance of the dependent variable explained by random effects. This coefficient takes values from 0 to 1 and indicates how strong the random effects are. The difference from the earlier suggested fixed effects coefficient of determination is emphasized. If [Formula: see text] is close to 0, there is weak support for random effects in the model because the reduction of the variance of the dependent variable due to random effects is small; consequently, random effects may be ignored and the model simplifies to standard linear regression. The value of [Formula: see text] apart from 0 indicates the evidence of the variance reduction in support of the mixed model. If random effects coefficient of determination is close to 1 the variance of random effects is very large and random effects turn into free fixed effects-the model can be estimated using the dummy variable approach. We derive explicit formulas for [Formula: see text] in three special cases: the random intercept model, the growth curve model, and meta-analysis model. Theoretical results are illustrated with three mixed model examples: (1) travel time to the nearest cancer center for women with breast cancer in the U.S., (2) cumulative time watching alcohol related scenes in movies among young U.S. teens, as a risk factor for early drinking onset, and (3) the classic example of the meta-analysis model for combination of 13 studies on tuberculosis vaccine.

  12. The electronic structure of RbTiOPO4 and the effects of the A-site cation substitution in KTiOPO4-family crystals

    NASA Astrophysics Data System (ADS)

    Atuchin, V. V.; Kesler, V. G.; Meng, Guangsi; Lin, Z. S.

    2012-10-01

    The electronic structure of RbTiOPO4 has been investigated with x-ray photoemission spectroscopy. Detailed photoemission spectra of the element core levels have been recorded under excitation by nonmonochromatic Al Kα radiation (1486.6 eV). The chemical bonding parameters are compared to those reported for complex titanates and phosphates. The band structures of KTiOPO4, RbTiOPO4, K0.535R0.465TiOPO4 and TlTiOPO4 have been calculated by ab initio methods and compared to available experimental results. It is found that the band structure of KTP-type phosphate crystals is weakly dependent on the nature of the A-site (A=K, Rb, Tl) element.

  13. Random effects coefficient of determination for mixed and meta-analysis models

    PubMed Central

    Demidenko, Eugene; Sargent, James; Onega, Tracy

    2011-01-01

    The key feature of a mixed model is the presence of random effects. We have developed a coefficient, called the random effects coefficient of determination, Rr2, that estimates the proportion of the conditional variance of the dependent variable explained by random effects. This coefficient takes values from 0 to 1 and indicates how strong the random effects are. The difference from the earlier suggested fixed effects coefficient of determination is emphasized. If Rr2 is close to 0, there is weak support for random effects in the model because the reduction of the variance of the dependent variable due to random effects is small; consequently, random effects may be ignored and the model simplifies to standard linear regression. The value of Rr2 apart from 0 indicates the evidence of the variance reduction in support of the mixed model. If random effects coefficient of determination is close to 1 the variance of random effects is very large and random effects turn into free fixed effects—the model can be estimated using the dummy variable approach. We derive explicit formulas for Rr2 in three special cases: the random intercept model, the growth curve model, and meta-analysis model. Theoretical results are illustrated with three mixed model examples: (1) travel time to the nearest cancer center for women with breast cancer in the U.S., (2) cumulative time watching alcohol related scenes in movies among young U.S. teens, as a risk factor for early drinking onset, and (3) the classic example of the meta-analysis model for combination of 13 studies on tuberculosis vaccine. PMID:23750070

  14. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

    PubMed

    Platt, Richard; Takvorian, Samuel U; Septimus, Edward; Hickok, Jason; Moody, Julia; Perlin, Jonathan; Jernigan, John A; Kleinman, Ken; Huang, Susan S

    2010-06-01

    The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. All admissions to adult ICUs. The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. Recruitment of hospitals is complete. Data collection will end in Summer 2011. This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

  15. Effect of A-site La and Ba doping on threshold field and characteristic temperatures of PbSc0.5Ta0.5O3 relaxor studied by acoustic emission

    NASA Astrophysics Data System (ADS)

    Dul'kin, E.; Mihailova, B.; Gospodinov, M.; Roth, M.

    2012-09-01

    The structural transitions in Pb1-xLaxSc(1+x)/2Ta(1-x)/2O3, x = 0.08 (PLST) relaxor crystals were studied by means of acoustic emission (AE) under an external electric field (E) and compared with those observed in pure PbSc0.5Ta0.5O3 (PST) and Pb0.78Ba0.22Sc0.5Ta0.5O3 (PBST) [E. Dul'kin et al., EPL 94, 57002 (2011)]. Similar to both the PST and PBST compounds, in zero field PLST exhibits AE corresponding to a para-to-antiferroelectric incommensurate phase transition at Tn = 276 K, lying in the vicinity of dielectric temperature maximum (Tm). This AE signal exhibits a nontrivial behavior when applying E resembling the electric-field-dependence of Tn previously observed for both the PST and PBST, namely, Tn initially decreases with the increase of E, attains a minimum at a threshold field Eth = 0.5 kV/cm, accompanied by a pronounced maximum of the AE count rate Ṅ = 12 s-1, and then starts increasing as E enhances. The similarities and difference between PST, PLST, and PBST with respect to Tn, Eth, and Ṅ are discussed from the viewpoint of three mechanisms: (i) chemically induced random local electric field due to the extra charge on the A-site ion, (ii) disturbance of the system of stereochemically active lone-pair electrons of Pb2+ by the isotropic outermost electron shell of substituting ion, and (iii) change in the tolerance factor and elastic field to the larger ionic radius of the substituting A-site ion due to the different radius of the substituting ion. The first two mechanisms influence the actual values of Tn and Eth, whereas the latter is shown to affect the normalized Ṅ, indicating the fractions undergoing a field-induced crossover from a modulated antiferroelectric to a ferroelectric state. Creation of secondary random electric field, caused by doping-induced A-site-O ionic chemical bonding, is discussed.

  16. The Effectiveness of Mandatory-Random Student Drug Testing. NCEE 2010-4025

    ERIC Educational Resources Information Center

    James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric

    2010-01-01

    To help assess the effects of school-based random drug testing programs, the U.S. Department of Education's Institute of Education Sciences (IES) contracted with RMC Research Corporation and Mathematica Policy Research to conduct an experimental evaluation of the Mandatory-Random Student Drug Testing (MRSDT) programs in 36 high schools within…

  17. The prompted optional randomization trial: a new design for comparative effectiveness research.

    PubMed

    Flory, James; Karlawish, Jason

    2012-12-01

    Randomized controlled trials are the gold standard for medical evidence because randomization provides the best-known protection against confounding of results. Randomization has practical and ethical problems that limit the number of trials that can be conducted, however. A different method for collecting clinical data retains the statistically useful properties of randomization without incurring its practical and ethical challenges. A computerized prompt introduces a random element into clinical decision-making that can be instantly overridden if it conflicts with optimal patient care. This creates a weak form of randomization that still eliminates the effect of all confounders, can be carried out without disturbing routine clinical care, and arguably will not require research-grade informed consent.

  18. Evaluation of some random effects methodology applicable to bird ringing data

    USGS Publications Warehouse

    Burnham, K.P.; White, Gary C.

    2002-01-01

    Existing models for ring recovery and recapture data analysis treat temporal variations in annual survival probability (S) as fixed effects. Often there is no explainable structure to the temporal variation in S1,..., Sk; random effects can then be a useful model: Si = E(S) + ??i. Here, the temporal variation in survival probability is treated as random with average value E(??2) = ??2. This random effects model can now be fit in program MARK. Resultant inferences include point and interval estimation for process variation, ??2, estimation of E(S) and var (E??(S)) where the latter includes a component for ??2 as well as the traditional component for v??ar(S??\\S??). Furthermore, the random effects model leads to shrinkage estimates, Si, as improved (in mean square error) estimators of Si compared to the MLE, S??i, from the unrestricted time-effects model. Appropriate confidence intervals based on the Si are also provided. In addition, AIC has been generalized to random effects models. This paper presents results of a Monte Carlo evaluation of inference performance under the simple random effects model. Examined by simulation, under the simple one group Cormack-Jolly-Seber (CJS) model, are issues such as bias of ??s2, confidence interval coverage on ??2, coverage and mean square error comparisons for inference about Si based on shrinkage versus maximum likelihood estimators, and performance of AIC model selection over three models: Si ??? S (no effects), Si = E(S) + ??i (random effects), and S1,..., Sk (fixed effects). For the cases simulated, the random effects methods performed well and were uniformly better than fixed effects MLE for the Si.

  19. Complex networks: Effect of subtle changes in nature of randomness

    NASA Astrophysics Data System (ADS)

    Goswami, Sanchari; Biswas, Soham; Sen, Parongama

    2011-03-01

    In two different classes of network models, namely, the Watts Strogatz type and the Euclidean type, subtle changes have been introduced in the randomness. In the Watts Strogatz type network, rewiring has been done in different ways and although the qualitative results remain the same, finite differences in the exponents are observed. In the Euclidean type networks, where at least one finite phase transition occurs, two models differing in a similar way have been considered. The results show a possible shift in one of the phase transition points but no change in the values of the exponents. The WS and Euclidean type models are equivalent for extreme values of the parameters; we compare their behaviour for intermediate values.

  20. Zero-inflated count models for longitudinal measurements with heterogeneous random effects.

    PubMed

    Zhu, Huirong; Luo, Sheng; DeSantis, Stacia M

    2017-08-01

    Longitudinal zero-inflated count data arise frequently in substance use research when assessing the effects of behavioral and pharmacological interventions. Zero-inflated count models (e.g. zero-inflated Poisson or zero-inflated negative binomial) with random effects have been developed to analyze this type of data. In random effects zero-inflated count models, the random effects covariance matrix is typically assumed to be homogeneous (constant across subjects). However, in many situations this matrix may be heterogeneous (differ by measured covariates). In this paper, we extend zero-inflated count models to account for random effects heterogeneity by modeling their variance as a function of covariates. We show via simulation that ignoring intervention and covariate-specific heterogeneity can produce biased estimates of covariate and random effect estimates. Moreover, those biased estimates can be rectified by correctly modeling the random effects covariance structure. The methodological development is motivated by and applied to the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study, the largest clinical trial of alcohol dependence performed in United States with 1383 individuals.

  1. Conceptualizing and Testing Random Indirect Effects and Moderated Mediation in Multilevel Models: New Procedures and Recommendations

    ERIC Educational Resources Information Center

    Bauer, Daniel J.; Preacher, Kristopher J.; Gil, Karen M.

    2006-01-01

    The authors propose new procedures for evaluating direct, indirect, and total effects in multilevel models when all relevant variables are measured at Level 1 and all effects are random. Formulas are provided for the mean and variance of the indirect and total effects and for the sampling variances of the average indirect and total effects.…

  2. Psychological Effects of Automated External Defibrillator Training A randomized trial

    PubMed Central

    Meischke, Hendrika; Diehr, Paula; Phelps, Randi; Damon, Susan; Rea, Tom

    2011-01-01

    Objectives The objective of this study was to test if an Automated External Defibrillator (AED) training program would positively affect the mental health of family members of high risk patients. Methods 305 ischemic heart disease patients and their family members were randomized to one of four AED training programs: two video-based training programs and two face-to-face training programs that emphasized self-efficacy and perceived control. Patients and family members were surveyed at baseline, 3 and 9 months post ischemic event on demographic characteristics, measures of quality of life (SF=36) , self-efficacy and perceived control. For this study, family members were the focus rather than the patients. Results Regression analyses showed that family members in the face-to-face training programs did not score better on any of the mental health status variables than family members who participated in the other training programs but for an increase in self-efficacy beliefs at 3 months post training. Conclusion The findings suggest that a specifically designed AED training program emphasizing self-efficacy and perceived control beliefs is not likely to enhance family member mental health. PMID:21411144

  3. A random effects meta-analysis model with Box-Cox transformation.

    PubMed

    Yamaguchi, Yusuke; Maruo, Kazushi; Partlett, Christopher; Riley, Richard D

    2017-07-19

    In a random effects meta-analysis model, true treatment effects for each study are routinely assumed to follow a normal distribution. However, normality is a restrictive assumption and the misspecification of the random effects distribution may result in a misleading estimate of overall mean for the treatment effect, an inappropriate quantification of heterogeneity across studies and a wrongly symmetric prediction interval. We focus on problems caused by an inappropriate normality assumption of the random effects distribution, and propose a novel random effects meta-analysis model where a Box-Cox transformation is applied to the observed treatment effect estimates. The proposed model aims to normalise an overall distribution of observed treatment effect estimates, which is sum of the within-study sampling distributions and the random effects distribution. When sampling distributions are approximately normal, non-normality in the overall distribution will be mainly due to the random effects distribution, especially when the between-study variation is large relative to the within-study variation. The Box-Cox transformation addresses this flexibly according to the observed departure from normality. We use a Bayesian approach for estimating parameters in the proposed model, and suggest summarising the meta-analysis results by an overall median, an interquartile range and a prediction interval. The model can be applied for any kind of variables once the treatment effect estimate is defined from the variable. A simulation study suggested that when the overall distribution of treatment effect estimates are skewed, the overall mean and conventional I 2 from the normal random effects model could be inappropriate summaries, and the proposed model helped reduce this issue. We illustrated the proposed model using two examples, which revealed some important differences on summary results, heterogeneity measures and prediction intervals from the normal random effects model. The

  4. Teacher Effects in Early Grades: Evidence from a Randomized Study

    ERIC Educational Resources Information Center

    Konstantopoulos, Spyros

    2011-01-01

    Background/Context: One important question to educational research is whether teachers can influence student achievement over time. This question is related to the durability of teacher effects on student achievement in successive grades. The research evidence about teacher effects on student achievement has been somewhat mixed. Some education…

  5. Standardized Effect Size Measures for Mediation Analysis in Cluster-Randomized Trials

    ERIC Educational Resources Information Center

    Stapleton, Laura M.; Pituch, Keenan A.; Dion, Eric

    2015-01-01

    This article presents 3 standardized effect size measures to use when sharing results of an analysis of mediation of treatment effects for cluster-randomized trials. The authors discuss 3 examples of mediation analysis (upper-level mediation, cross-level mediation, and cross-level mediation with a contextual effect) with demonstration of the…

  6. Rippled graphene in an in-plane magnetic field: effects of a random vector potential.

    PubMed

    Lundeberg, Mark B; Folk, Joshua A

    2010-10-01

    We report measurements of the effects of a random vector potential generated by applying an in-plane magnetic field to a graphene flake. Magnetic flux through the ripples cause orbital effects: Phase-coherent weak localization is suppressed, while quasirandom Lorentz forces lead to anisotropic magnetoresistance. Distinct signatures of these two effects enable the ripple size to be characterized.

  7. Asymptotic Effect of Misspecification in the Random Part of the Multilevel Model

    ERIC Educational Resources Information Center

    Berkhof, Johannes; Kampen, Jarl Kennard

    2004-01-01

    The authors examine the asymptotic effect of omitting a random coefficient in the multilevel model and derive expressions for the change in (a) the variance components estimator and (b) the estimated variance of the fixed effects estimator. They apply the method of moments, which yields a closed form expression for the omission effect. In…

  8. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    PubMed

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

  9. Effects of low-level radioactive-waste disposal on water chemistry in the unsaturated zone at a site near Sheffield, Illinois, 1982-84

    USGS Publications Warehouse

    Peters, C.A.; Striegl, Robert G.; Mills, P.C.; Healy, R.W.

    1992-01-01

    A 1982-84 field study defined the chemistry of water collected from the unsaturated zone at a low-level radioactive-waste disposal site near Sheffield, Bureau County, Ill. Chemical data were evaluated to determine the principal, naturally occurring geochemical reactions in the unsaturated zone and to evaluate waste-induced effects on pore-water chemistry. Samples of precipitation, unsaturated-zone pore water, and saturated-zone water were analyzed for specific conductance, pH, alkalinity, major cations and anions, dissolved organic carbon, gross alpha and beta radiation, and tritium. Little change in concentration of most major constituents in the unsaturated-zone water was observed with respect to depth or distance from disposal trenches. Tritium and dissolved organic carbon concentrations were, however, dependent on proximity to trenches. The primary reactions, both on-site and off-site, were carbonate and clay dissolution, cation exchange, and the oxidation of pyrite. The major difference between on-site and off-site inorganic water chemistry resulted from the removal of the Roxana Silt and the Radnor Till Member of the Glasford Formation from on-site. Off-site, the Roxana Silt contributed substantial quantities of sodium to solution from montmorillonite dissolution and associated cation-exchange reactions. The Radnor Till Member provided exchange surfaces for magnesium. Precipitation at the site had an ionic composition of calcium zinc sulfate and an average pH of 4.6. Within 0.3 meter of the land surface, infiltrating rainwater or snowmelt changed to an ionic composition of calcium sulfate off-site and calcium bicarbonate on-site and had an average pH of 7.9; below that depth, pH averaged 7.5 and the ionic composition generally was calcium magnesium bicarbonate. Alkalinity and specific conductance differed primarily according to composition of geologic materials. Tritium concentrations ranged from 0.2 (detection limit) to 1,380 nanocuries per liter. The

  10. Effects of low-level radioactive-waste disposal on water chemistry in the unsaturated zone at a site near Sheffield, Illinois, 1982-84

    USGS Publications Warehouse

    Peters, C.A.; Striegl, Robert G.; Mills, P.C.; Healy, R.W.

    1992-01-01

    A 1982-84 field study defined the chemistry of water collected from the unsaturated zone at a low-level radioactive-waste disposal site near Sheffield, Bureau County, Illinois. Chemical data were evaluated to determine the principal naturally occurring geochemical reactions in the unsaturated zone and to evaluate waste-induced effects on pore-water chemistry. Samples of precipitation, unsaturated-zone pore water, and saturated-zone water were analyzed for specific conductance, pH, alkalinity, major cations and anions, dissolved organic carbon, gross alpha and beta radiation, and tritium. Little change in concentration of most major constituents in the unsaturated-zone water was observed with respect to depth or distance from disposal trenches. Tritium and dissolved organic carbon concentrations were, however, dependent on proximity to trenches. The primary reactions, both on- site and off-site, were carbonate and clay dissolution, cation exchange, and the oxidation of pyrite. The major difference between on-site and off-site inorganic water chemistry resulted from the removal of the Roxana Silt and the Radnor Till Member of the Glasford Formation from on-site. Off-site, the Roxana Silt contributed substantial quantities of sodium to solution from montmorillonite dissolution and associated cation-exchange reactions. The Radnor Till Member provided exchange surfaces for magnesium. Precipitation at the site had an ionic composition of calcium zinc sulfate and an average pH of 4.6. Within 0.3 meter of the land surface, infiltrating rain water or snowmelt changed to an ionic canposition of calcium sulfate off-site and calcium bicarbonate on-site and had an average pH of 7.9; below that depth, pH averaged 7.5 and the ionic composition generally was calcium magnesium bicarbonate. Alkalinity and specific conductance differed primarily according to composition of geologic materials. Tritium concentrations ranged from 0.2 (detection limit) to 1,380 nanocuries per liter. The

  11. Effect of the degree of disorder on electronic and optical properties in random superlattices

    NASA Technical Reports Server (NTRS)

    Wang, E. G.; Su, W. P.; Ting, C. S.

    1994-01-01

    A three-dimensional tight-binding calculation is developed and used to study disorder effects in a realistic random superlattice. With increasing disorder, a tendency of possible indirect-direct band-gap transition is suggested. Direct evidence of mobility edges between localized and extended states in three-dimensional random systems is given. As system disorder increases, the optical absorption intensities increase dramatically from five to forty-five times stronger than the ordered (GaAs)(sub 1)/(AlAs)(sub 1) superlattice. It is believed that the degree of disorder significantly affects electronic and optical properties of GaAs/AlAs random superlattices.

  12. Quantum random walks on congested lattices and the effect of dephasing.

    PubMed

    Motes, Keith R; Gilchrist, Alexei; Rohde, Peter P

    2016-01-27

    We consider quantum random walks on congested lattices and contrast them to classical random walks. Congestion is modelled on lattices that contain static defects which reverse the walker's direction. We implement a dephasing process after each step which allows us to smoothly interpolate between classical and quantum random walks as well as study the effect of dephasing on the quantum walk. Our key results show that a quantum walker escapes a finite boundary dramatically faster than a classical walker and that this advantage remains in the presence of heavily congested lattices.

  13. Quantum random walks on congested lattices and the effect of dephasing

    PubMed Central

    Motes, Keith R.; Gilchrist, Alexei; Rohde, Peter P.

    2016-01-01

    We consider quantum random walks on congested lattices and contrast them to classical random walks. Congestion is modelled on lattices that contain static defects which reverse the walker’s direction. We implement a dephasing process after each step which allows us to smoothly interpolate between classical and quantum random walks as well as study the effect of dephasing on the quantum walk. Our key results show that a quantum walker escapes a finite boundary dramatically faster than a classical walker and that this advantage remains in the presence of heavily congested lattices. PMID:26812924

  14. Effect of randomness on multi-frequency aeroelastic responses resolved by Unsteady Adaptive Stochastic Finite Elements

    NASA Astrophysics Data System (ADS)

    Witteveen, Jeroen A. S.; Bijl, Hester

    2009-10-01

    The Unsteady Adaptive Stochastic Finite Elements (UASFE) method resolves the effect of randomness in numerical simulations of single-mode aeroelastic responses with a constant accuracy in time for a constant number of samples. In this paper, the UASFE framework is extended to multi-frequency responses and continuous structures by employing a wavelet decomposition pre-processing step to decompose the sampled multi-frequency signals into single-frequency components. The effect of the randomness on the multi-frequency response is then obtained by summing the results of the UASFE interpolation at constant phase for the different frequency components. Results for multi-frequency responses and continuous structures show a three orders of magnitude reduction of computational costs compared to crude Monte Carlo simulations in a harmonically forced oscillator, a flutter panel problem, and the three-dimensional transonic AGARD 445.6 wing aeroelastic benchmark subject to random fields and random parameters with various probability distributions.

  15. Effects of Cooperative Writing with Embedded Multimedia: A Randomized Experiment

    ERIC Educational Resources Information Center

    Madden, Nancy A.; Slavin, Robert E.; Logan, Michele

    2011-01-01

    The present study represented an effort to improve on the outcomes of the Puma (2006) study by creating a writing process program that provided students with compelling video models of effective writing practices in small writing teams. In this method, called Writing Wings with Media (WWM), students worked in 4-member, heterogeneous writing groups…

  16. Estimating safety effects of pavement management factors utilizing Bayesian random effect models.

    PubMed

    Jiang, Ximiao; Huang, Baoshan; Zaretzki, Russell L; Richards, Stephen; Yan, Xuedong

    2013-01-01

    Previous studies of pavement management factors that relate to the occurrence of traffic-related crashes are rare. Traditional research has mostly employed summary statistics of bidirectional pavement quality measurements in extended longitudinal road segments over a long time period, which may cause a loss of important information and result in biased parameter estimates. The research presented in this article focuses on crash risk of roadways with overall fair to good pavement quality. Real-time and location-specific data were employed to estimate the effects of pavement management factors on the occurrence of crashes. This research is based on the crash data and corresponding pavement quality data for the Tennessee state route highways from 2004 to 2009. The potential temporal and spatial correlations among observations caused by unobserved factors were considered. Overall 6 models were built accounting for no correlation, temporal correlation only, and both the temporal and spatial correlations. These models included Poisson, negative binomial (NB), one random effect Poisson and negative binomial (OREP, ORENB), and two random effect Poisson and negative binomial (TREP, TRENB) models. The Bayesian method was employed to construct these models. The inference is based on the posterior distribution from the Markov chain Monte Carlo (MCMC) simulation. These models were compared using the deviance information criterion. Analysis of the posterior distribution of parameter coefficients indicates that the pavement management factors indexed by Present Serviceability Index (PSI) and Pavement Distress Index (PDI) had significant impacts on the occurrence of crashes, whereas the variable rutting depth was not significant. Among other factors, lane width, median width, type of terrain, and posted speed limit were significant in affecting crash frequency. The findings of this study indicate that a reduction in pavement roughness would reduce the likelihood of traffic

  17. Heterogeneous Suppression of Sequential Effects in Random Sequence Generation, but Not in Operant Learning.

    PubMed

    Shteingart, Hanan; Loewenstein, Yonatan

    2016-01-01

    There is a long history of experiments in which participants are instructed to generate a long sequence of binary random numbers. The scope of this line of research has shifted over the years from identifying the basic psychological principles and/or the heuristics that lead to deviations from randomness, to one of predicting future choices. In this paper, we used generalized linear regression and the framework of Reinforcement Learning in order to address both points. In particular, we used logistic regression analysis in order to characterize the temporal sequence of participants' choices. Surprisingly, a population analysis indicated that the contribution of the most recent trial has only a weak effect on behavior, compared to more preceding trials, a result that seems irreconcilable with standard sequential effects that decay monotonously with the delay. However, when considering each participant separately, we found that the magnitudes of the sequential effect are a monotonous decreasing function of the delay, yet these individual sequential effects are largely averaged out in a population analysis because of heterogeneity. The substantial behavioral heterogeneity in this task is further demonstrated quantitatively by considering the predictive power of the model. We show that a heterogeneous model of sequential dependencies captures the structure available in random sequence generation. Finally, we show that the results of the logistic regression analysis can be interpreted in the framework of reinforcement learning, allowing us to compare the sequential effects in the random sequence generation task to those in an operant learning task. We show that in contrast to the random sequence generation task, sequential effects in operant learning are far more homogenous across the population. These results suggest that in the random sequence generation task, different participants adopt different cognitive strategies to suppress sequential dependencies when

  18. Application of random effects to the study of resource selection by animals

    USGS Publications Warehouse

    Gillies, C.S.; Hebblewhite, M.; Nielsen, S.E.; Krawchuk, M.A.; Aldridge, Cameron L.; Frair, J.L.; Saher, D.J.; Stevens, C.E.; Jerde, C.L.

    2006-01-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence.2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability.3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed.4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects.5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection.6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  19. Application of random effects to the study of resource selection by animals.

    PubMed

    Gillies, Cameron S; Hebblewhite, Mark; Nielsen, Scott E; Krawchuk, Meg A; Aldridge, Cameron L; Frair, Jacqueline L; Saher, D Joanne; Stevens, Cameron E; Jerde, Christopher L

    2006-07-01

    1. Resource selection estimated by logistic regression is used increasingly in studies to identify critical resources for animal populations and to predict species occurrence. 2. Most frequently, individual animals are monitored and pooled to estimate population-level effects without regard to group or individual-level variation. Pooling assumes that both observations and their errors are independent, and resource selection is constant given individual variation in resource availability. 3. Although researchers have identified ways to minimize autocorrelation, variation between individuals caused by differences in selection or available resources, including functional responses in resource selection, have not been well addressed. 4. Here we review random-effects models and their application to resource selection modelling to overcome these common limitations. We present a simple case study of an analysis of resource selection by grizzly bears in the foothills of the Canadian Rocky Mountains with and without random effects. 5. Both categorical and continuous variables in the grizzly bear model differed in interpretation, both in statistical significance and coefficient sign, depending on how a random effect was included. We used a simulation approach to clarify the application of random effects under three common situations for telemetry studies: (a) discrepancies in sample sizes among individuals; (b) differences among individuals in selection where availability is constant; and (c) differences in availability with and without a functional response in resource selection. 6. We found that random intercepts accounted for unbalanced sample designs, and models with random intercepts and coefficients improved model fit given the variation in selection among individuals and functional responses in selection. Our empirical example and simulations demonstrate how including random effects in resource selection models can aid interpretation and address difficult assumptions

  20. A spatial error model with continuous random effects and an application to growth convergence

    NASA Astrophysics Data System (ADS)

    Laurini, Márcio Poletti

    2017-10-01

    We propose a spatial error model with continuous random effects based on Matérn covariance functions and apply this model for the analysis of income convergence processes (β -convergence). The use of a model with continuous random effects permits a clearer visualization and interpretation of the spatial dependency patterns, avoids the problems of defining neighborhoods in spatial econometrics models, and allows projecting the spatial effects for every possible location in the continuous space, circumventing the existing aggregations in discrete lattice representations. We apply this model approach to analyze the economic growth of Brazilian municipalities between 1991 and 2010 using unconditional and conditional formulations and a spatiotemporal model of convergence. The results indicate that the estimated spatial random effects are consistent with the existence of income convergence clubs for Brazilian municipalities in this period.

  1. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    ERIC Educational Resources Information Center

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  2. The Impact of Five Missing Data Treatments on a Cross-Classified Random Effects Model

    ERIC Educational Resources Information Center

    Hoelzle, Braden R.

    2012-01-01

    The present study compared the performance of five missing data treatment methods within a Cross-Classified Random Effects Model environment under various levels and patterns of missing data given a specified sample size. Prior research has shown the varying effect of missing data treatment options within the context of numerous statistical…

  3. Random-Effects Models for Meta-Analytic Structural Equation Modeling: Review, Issues, and Illustrations

    ERIC Educational Resources Information Center

    Cheung, Mike W.-L.; Cheung, Shu Fai

    2016-01-01

    Meta-analytic structural equation modeling (MASEM) combines the techniques of meta-analysis and structural equation modeling for the purpose of synthesizing correlation or covariance matrices and fitting structural equation models on the pooled correlation or covariance matrix. Both fixed-effects and random-effects models can be defined in MASEM.…

  4. A Randomized Effectiveness Trial of Brief Parent Training: Six-Month Follow-Up

    ERIC Educational Resources Information Center

    Kjøbli, John; Bjørnebekk, Gunnar

    2013-01-01

    Objective: To examine the follow-up effectiveness of brief parent training (BPT) for children with emerging or existing conduct problems. Method: With the use of a randomized controlled trial and parent and teacher reports, this study examined the effectiveness of BPT compared to regular services 6 months after the end of the intervention.…

  5. Effect of texture randomization on the slip and interfacial robustness in turbulent flows over superhydrophobic surfaces

    NASA Astrophysics Data System (ADS)

    Seo, Jongmin; Mani, Ali

    2018-04-01

    Superhydrophobic surfaces demonstrate promising potential for skin friction reduction in naval and hydrodynamic applications. Recent developments of superhydrophobic surfaces aiming for scalable applications use random distribution of roughness, such as spray coating and etched process. However, most previous analyses of the interaction between flows and superhydrophobic surfaces studied periodic geometries that are economically feasible only in laboratory-scale experiments. In order to assess the drag reduction effectiveness as well as interfacial robustness of superhydrophobic surfaces with randomly distributed textures, we conduct direct numerical simulations of turbulent flows over randomly patterned interfaces considering a range of texture widths w+≈4 -26 , and solid fractions ϕs=11 %-25 % . Slip and no-slip boundary conditions are implemented in a pattern, modeling the presence of gas-liquid interfaces and solid elements. Our results indicate that slip of randomly distributed textures under turbulent flows is about 30 % less than those of surfaces with aligned features of the same size. In the small texture size limit w+≈4 , the slip length of the randomly distributed textures in turbulent flows is well described by a previously introduced Stokes flow solution of randomly distributed shear-free holes. By comparing DNS results for patterned slip and no-slip boundary against the corresponding homogenized slip length boundary conditions, we show that turbulent flows over randomly distributed posts can be represented by an isotropic slip length in streamwise and spanwise direction. The average pressure fluctuation on a gas pocket is similar to that of the aligned features with the same texture size and gas fraction, but the maximum interface deformation at the leading edge of the roughness element is about twice as large when the textures are randomly distributed. The presented analyses provide insights on implications of texture randomness on drag

  6. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    PubMed Central

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

  7. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

    PubMed

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

    2014-01-01

    This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

  8. Effect of Polydispersity on Diffusion in Random Obstacle Matrices

    NASA Astrophysics Data System (ADS)

    Cho, Hyun Woo; Kwon, Gyemin; Sung, Bong June; Yethiraj, Arun

    2012-10-01

    The dynamics of tracers in disordered matrices is of interest in a number of diverse areas of physics such as the biophysics of crowding in cells and cell membranes, and the diffusion of fluids in porous media. To a good approximation the matrices can be modeled as a collection of spatially frozen particles. In this Letter, we consider the effect of polydispersity (in size) of the matrix particles on the dynamics of tracers. We study a two dimensional system of hard disks diffusing in a sea of hard disk obstacles, for different values of the polydispersity of the matrix. We find that for a given average size and area fraction, the diffusion of tracers is very sensitive to the polydispersity. We calculate the pore percolation threshold using Apollonius diagrams. The diffusion constant, D, follows a scaling relation D˜(ϕc-ϕm)μ-β for all values of the polydispersity, where ϕm is the area fraction and ϕc is the value of ϕm at the percolation threshold.

  9. Effect of polydispersity on diffusion in random obstacle matrices.

    PubMed

    Cho, Hyun Woo; Kwon, Gyemin; Sung, Bong June; Yethiraj, Arun

    2012-10-12

    The dynamics of tracers in disordered matrices is of interest in a number of diverse areas of physics such as the biophysics of crowding in cells and cell membranes, and the diffusion of fluids in porous media. To a good approximation the matrices can be modeled as a collection of spatially frozen particles. In this Letter, we consider the effect of polydispersity (in size) of the matrix particles on the dynamics of tracers. We study a two dimensional system of hard disks diffusing in a sea of hard disk obstacles, for different values of the polydispersity of the matrix. We find that for a given average size and area fraction, the diffusion of tracers is very sensitive to the polydispersity. We calculate the pore percolation threshold using Apollonius diagrams. The diffusion constant, D, follows a scaling relation D~(φ(c)-φ(m))(μ-β) for all values of the polydispersity, where φ(m) is the area fraction and φ(c) is the value of φ(m) at the percolation threshold.

  10. Lossless Astronomical Image Compression and the Effects of Random Noise

    NASA Technical Reports Server (NTRS)

    Pence, William

    2009-01-01

    In this paper we compare a variety of modern image compression methods on a large sample of astronomical images. We begin by demonstrating from first principles how the amount of noise in the image pixel values sets a theoretical upper limit on the lossless compression ratio of the image. We derive simple procedures for measuring the amount of noise in an image and for quantitatively predicting how much compression will be possible. We then compare the traditional technique of using the GZIP utility to externally compress the image, with a newer technique of dividing the image into tiles, and then compressing and storing each tile in a FITS binary table structure. This tiled-image compression technique offers a choice of other compression algorithms besides GZIP, some of which are much better suited to compressing astronomical images. Our tests on a large sample of images show that the Rice algorithm provides the best combination of speed and compression efficiency. In particular, Rice typically produces 1.5 times greater compression and provides much faster compression speed than GZIP. Floating point images generally contain too much noise to be effectively compressed with any lossless algorithm. We have developed a compression technique which discards some of the useless noise bits by quantizing the pixel values as scaled integers. The integer images can then be compressed by a factor of 4 or more. Our image compression and uncompression utilities (called fpack and funpack) that were used in this study are publicly available from the HEASARC web site.Users may run these stand-alone programs to compress and uncompress their own images.

  11. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

    PubMed

    Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

    2013-05-01

    This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

  12. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes.

    PubMed

    Li, Baoyue; Lingsma, Hester F; Steyerberg, Ewout W; Lesaffre, Emmanuel

    2011-05-23

    Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model

  13. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes

    PubMed Central

    2011-01-01

    Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability

  14. Charge disproportionation of mixed-valent Cr triggered by Bi lone-pair effect in the A -site-ordered perovskite BiC u3C r4O12

    NASA Astrophysics Data System (ADS)

    Etter, Martin; Isobe, Masahiko; Sakurai, Hiroya; Yaresko, Alexander; Dinnebier, Robert E.; Takagi, Hidenori

    2018-05-01

    A new A -site-ordered perovskite BiC u3C r4O12 is synthesized under a high pressure of 7.7 GPa. A phase transition from a paramagnetic metal to a ferrimagnetic metal is observed at Tc=190 K accompanied with a structural change from cubic to monoclinic. Structural analysis of the low-temperature monoclinic phase reveals that this transition represents a charge disproportionation of C r3.75 + into C r4 + and C r3.5 + . We argue that the asymmetric displacement of Bi caused by a lone-pair effect triggers the formation of a dimeric Cr4+2O5 unit and leads to an ordering of C r4 + and C r3.5 + below the transition.

  15. Network meta-analysis of disconnected networks: How dangerous are random baseline treatment effects?

    PubMed

    Béliveau, Audrey; Goring, Sarah; Platt, Robert W; Gustafson, Paul

    2017-12-01

    In network meta-analysis, the use of fixed baseline treatment effects (a priori independent) in a contrast-based approach is regularly preferred to the use of random baseline treatment effects (a priori dependent). That is because, often, there is not a need to model baseline treatment effects, which carry the risk of model misspecification. However, in disconnected networks, fixed baseline treatment effects do not work (unless extra assumptions are made), as there is not enough information in the data to update the prior distribution on the contrasts between disconnected treatments. In this paper, we investigate to what extent the use of random baseline treatment effects is dangerous in disconnected networks. We take 2 publicly available datasets of connected networks and disconnect them in multiple ways. We then compare the results of treatment comparisons obtained from a Bayesian contrast-based analysis of each disconnected network using random normally distributed and exchangeable baseline treatment effects to those obtained from a Bayesian contrast-based analysis of their initial connected network using fixed baseline treatment effects. For the 2 datasets considered, we found that the use of random baseline treatment effects in disconnected networks was appropriate. Because those datasets were not cherry-picked, there should be other disconnected networks that would benefit from being analyzed using random baseline treatment effects. However, there is also a risk for the normality and exchangeability assumption to be inappropriate in other datasets even though we have not observed this situation in our case study. We provide code, so other datasets can be investigated. Copyright © 2017 John Wiley & Sons, Ltd.

  16. Predicting longitudinal trajectories of health probabilities with random-effects multinomial logit regression.

    PubMed

    Liu, Xian; Engel, Charles C

    2012-12-20

    Researchers often encounter longitudinal health data characterized with three or more ordinal or nominal categories. Random-effects multinomial logit models are generally applied to account for potential lack of independence inherent in such clustered data. When parameter estimates are used to describe longitudinal processes, however, random effects, both between and within individuals, need to be retransformed for correctly predicting outcome probabilities. This study attempts to go beyond existing work by developing a retransformation method that derives longitudinal growth trajectories of unbiased health probabilities. We estimated variances of the predicted probabilities by using the delta method. Additionally, we transformed the covariates' regression coefficients on the multinomial logit function, not substantively meaningful, to the conditional effects on the predicted probabilities. The empirical illustration uses the longitudinal data from the Asset and Health Dynamics among the Oldest Old. Our analysis compared three sets of the predicted probabilities of three health states at six time points, obtained from, respectively, the retransformation method, the best linear unbiased prediction, and the fixed-effects approach. The results demonstrate that neglect of retransforming random errors in the random-effects multinomial logit model results in severely biased longitudinal trajectories of health probabilities as well as overestimated effects of covariates on the probabilities. Copyright © 2012 John Wiley & Sons, Ltd.

  17. Random forests as cumulative effects models: A case study of lakes and rivers in Muskoka, Canada.

    PubMed

    Jones, F Chris; Plewes, Rachel; Murison, Lorna; MacDougall, Mark J; Sinclair, Sarah; Davies, Christie; Bailey, John L; Richardson, Murray; Gunn, John

    2017-10-01

    Cumulative effects assessment (CEA) - a type of environmental appraisal - lacks effective methods for modeling cumulative effects, evaluating indicators of ecosystem condition, and exploring the likely outcomes of development scenarios. Random forests are an extension of classification and regression trees, which model response variables by recursive partitioning. Random forests were used to model a series of candidate ecological indicators that described lakes and rivers from a case study watershed (The Muskoka River Watershed, Canada). Suitability of the candidate indicators for use in cumulative effects assessment and watershed monitoring was assessed according to how well they could be predicted from natural habitat features and how sensitive they were to human land-use. The best models explained 75% of the variation in a multivariate descriptor of lake benthic-macroinvertebrate community structure, and 76% of the variation in the conductivity of river water. Similar results were obtained by cross-validation. Several candidate indicators detected a simulated doubling of urban land-use in their catchments, and a few were able to detect a simulated doubling of agricultural land-use. The paper demonstrates that random forests can be used to describe the combined and singular effects of multiple stressors and natural environmental factors, and furthermore, that random forests can be used to evaluate the performance of monitoring indicators. The numerical methods presented are applicable to any ecosystem and indicator type, and therefore represent a step forward for CEA. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  18. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages.

    PubMed

    Kim, Yoonsang; Choi, Young-Ku; Emery, Sherry

    2013-08-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods' performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages-SAS GLIMMIX Laplace and SuperMix Gaussian quadrature-perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes.

  19. Logistic Regression with Multiple Random Effects: A Simulation Study of Estimation Methods and Statistical Packages

    PubMed Central

    Kim, Yoonsang; Emery, Sherry

    2013-01-01

    Several statistical packages are capable of estimating generalized linear mixed models and these packages provide one or more of three estimation methods: penalized quasi-likelihood, Laplace, and Gauss-Hermite. Many studies have investigated these methods’ performance for the mixed-effects logistic regression model. However, the authors focused on models with one or two random effects and assumed a simple covariance structure between them, which may not be realistic. When there are multiple correlated random effects in a model, the computation becomes intensive, and often an algorithm fails to converge. Moreover, in our analysis of smoking status and exposure to anti-tobacco advertisements, we have observed that when a model included multiple random effects, parameter estimates varied considerably from one statistical package to another even when using the same estimation method. This article presents a comprehensive review of the advantages and disadvantages of each estimation method. In addition, we compare the performances of the three methods across statistical packages via simulation, which involves two- and three-level logistic regression models with at least three correlated random effects. We apply our findings to a real dataset. Our results suggest that two packages—SAS GLIMMIX Laplace and SuperMix Gaussian quadrature—perform well in terms of accuracy, precision, convergence rates, and computing speed. We also discuss the strengths and weaknesses of the two packages in regard to sample sizes. PMID:24288415

  20. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

    PubMed

    Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

    2016-08-31

    In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

  1. The effect of atomoxetine on random and directed exploration in humans.

    PubMed

    Warren, Christopher M; Wilson, Robert C; van der Wee, Nic J; Giltay, Eric J; van Noorden, Martijn S; Cohen, Jonathan D; Nieuwenhuis, Sander

    2017-01-01

    The adaptive regulation of the trade-off between pursuing a known reward (exploitation) and sampling lesser-known options in search of something better (exploration) is critical for optimal performance. Theory and recent empirical work suggest that humans use at least two strategies for solving this dilemma: a directed strategy in which choices are explicitly biased toward information seeking, and a random strategy in which decision noise leads to exploration by chance. Here we examined the hypothesis that random exploration is governed by the neuromodulatory locus coeruleus-norepinephrine system. We administered atomoxetine, a norepinephrine transporter blocker that increases extracellular levels of norepinephrine throughout the cortex, to 22 healthy human participants in a double-blind crossover design. We examined the effect of treatment on performance in a gambling task designed to produce distinct measures of directed exploration and random exploration. In line with our hypothesis we found an effect of atomoxetine on random, but not directed exploration. However, contrary to expectation, atomoxetine reduced rather than increased random exploration. We offer three potential explanations of our findings, involving the non-linear relationship between tonic NE and cognitive performance, the interaction of atomoxetine with other neuromodulators, and the possibility that atomoxetine affected phasic norepinephrine activity more so than tonic norepinephrine activity.

  2. Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

    PubMed Central

    Harrison, R; Dey, P; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R; Logue, J P; Leidecker, V; Hopwood, P

    2001-01-01

    In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11139305

  3. The Effect of Teacher-Family Communication on Student Engagement: Evidence from a Randomized Field Experiment

    ERIC Educational Resources Information Center

    Kraft, Matthew A.; Dougherty, Shaun M.

    2013-01-01

    In this study, we evaluate the efficacy of teacher communication with parents and students as a means of increasing student engagement. We estimate the causal effect of teacher communication by conducting a randomized field experiment in which sixth- and ninth-grade students were assigned to receive a daily phone call home and a text/written…

  4. A Randomized Effectiveness Trial of Brief Cognitive-Behavioral Therapy for Depressed Adolescents Receiving Antidepressant Medication

    ERIC Educational Resources Information Center

    Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie

    2005-01-01

    Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…

  5. Effects of Aerobic Exercise on Overweight Children's Cognitive Functioning: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Davis, Catherine L.; Tomporowski, Phillip D.; Boyle, Colleen A.; Waller, Jennifer L.; Miller, Patricia H.; Naglieri, Jack A.; Gregoski, Mathew

    2007-01-01

    The study tested the effect of aerobic exercise training on executive function in overweight children. Ninety-four sedentary, overweight but otherwise healthy children (mean age = 9.2 years, body mass index [greater than or equal to] 85th percentile) were randomized to a low-dose (20 min/day exercise), high-dose (40 min/day exercise), or control…

  6. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  7. The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial.

    PubMed

    Holt, Jane; Lord, Jonathan; Acharya, Umesh; White, Adrian; O'Neill, Nyree; Shaw, Steve; Barton, Andy

    2009-06-01

    To determine whether foot reflexology, a complementary therapy, has an effect greater than sham reflexology on induction of ovulation. Sham-controlled randomized trial with patients and statistician blinded. Infertility clinic in Plymouth, United Kingdom. Forty-eight women attending the clinic with anovulation. Women were randomized to receive eight sessions of either genuine foot reflexology or sham reflexology with gentle massage over 10 weeks. The primary outcome was ovulation detected by serum progesterone level of >30 nmol/L during the study period. Twenty-six patients were randomized to genuine reflexology and 22 to sham (one randomized patient was withdrawn). Patients remained blinded throughout the trial. The rate of ovulation during true reflexology was 11 out of 26 (42%), and during sham reflexology it was 10 out of 22 (46%). Pregnancy rates were 4 out of 26 in the true group and 2 out of 22 in the control group. Because of recruitment difficulties, the required sample size of 104 women was not achieved. Patient blinding of reflexology studies is feasible. Although this study was too small to reach a definitive conclusion on the specific effect of foot reflexology, the results suggest that any effect on ovulation would not be clinically relevant. Sham reflexology may have a beneficial general effect, which this study was not designed to detect.

  8. Educational Effects of the Tools of the Mind Curriculum: A Randomized Trial

    ERIC Educational Resources Information Center

    Barnett, W.Steven; Jung, Kwanghee; Yarosz, Donald J.; Thomas, Jessica; Hornbeck, Amy; Stechuk, Robert; Burns, Susan

    2008-01-01

    The effectiveness of the "Tools of the Mind (Tools)" curriculum in improving the education of 3- and 4-year-old children was evaluated by means of a randomized trial. The "Tools" curriculum, based on the work of Vygotsky, focuses on the development of self-regulation at the same time as teaching literacy and mathematics skills…

  9. Cure fraction model with random effects for regional variation in cancer survival.

    PubMed

    Seppä, Karri; Hakulinen, Timo; Kim, Hyon-Jung; Läärä, Esa

    2010-11-30

    Assessing regional differences in the survival of cancer patients is important but difficult when separate regions are small or sparsely populated. In this paper, we apply a mixture cure fraction model with random effects to cause-specific survival data of female breast cancer patients collected by the population-based Finnish Cancer Registry. Two sets of random effects were used to capture the regional variation in the cure fraction and in the survival of the non-cured patients, respectively. This hierarchical model was implemented in a Bayesian framework using a Metropolis-within-Gibbs algorithm. To avoid poor mixing of the Markov chain, when the variance of either set of random effects was close to zero, posterior simulations were based on a parameter-expanded model with tailor-made proposal distributions in Metropolis steps. The random effects allowed the fitting of the cure fraction model to the sparse regional data and the estimation of the regional variation in 10-year cause-specific breast cancer survival with a parsimonious number of parameters. Before 1986, the capital of Finland clearly stood out from the rest, but since then all the 21 hospital districts have achieved approximately the same level of survival. Copyright © 2010 John Wiley & Sons, Ltd.

  10. An Evaluation of Information Criteria Use for Correct Cross-Classified Random Effects Model Selection

    ERIC Educational Resources Information Center

    Beretvas, S. Natasha; Murphy, Daniel L.

    2013-01-01

    The authors assessed correct model identification rates of Akaike's information criterion (AIC), corrected criterion (AICC), consistent AIC (CAIC), Hannon and Quinn's information criterion (HQIC), and Bayesian information criterion (BIC) for selecting among cross-classified random effects models. Performance of default values for the 5…

  11. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  12. Motivational Interviewing as a Supervision Strategy in Probation: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Walters, Scott T.; Vader, Amanda M.; Nguyen, Norma; Harris, T. Robert; Eells, Jennifer

    2010-01-01

    Motivational interviewing (MI) has been recommended as a supervision style in probation. This project examined the effectiveness of an MI training curriculum on probation officer MI skill and subsequent probationer outcome. Twenty probation officers were randomized to receive MI training, or to a waiting list control, while an additional group of…

  13. Firm-Related Training Tracks: A Random Effects Ordered Probit Model

    ERIC Educational Resources Information Center

    Groot, Wim; van den Brink, Henriette Maassen

    2003-01-01

    A random effects ordered response model of training is estimated to analyze the existence of training tracks and time varying coefficients in training frequency. Two waves of a Dutch panel survey of workers are used covering the period 1992-1996. The amount of training received by workers increased during the period 1994-1996 compared to…

  14. Exploring Mechanisms of Effective Teacher Coaching: A Tale of Two Cohorts From a Randomized Experiment

    ERIC Educational Resources Information Center

    Blazar, David; Kraft, Matthew A.

    2015-01-01

    Although previous research has shown that teacher coaching can improve teaching practices and student achievement, little is known about specific features of effective coaching programs. We estimate the impact of MATCH Teacher Coaching (MTC) on a range of teacher practices using a blocked randomized trial and explore how changes in the coaching…

  15. Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

    ERIC Educational Resources Information Center

    Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

    2009-01-01

    International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118…

  16. The Effectiveness of Two Grammar Treatment Procedures for Children with SLI: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Smith-Lock, Karen M.; Leitão, Suze; Prior, Polly; Nickels, Lyndsey

    2015-01-01

    Purpose: This study compared the effectiveness of two grammar treatment procedures for children with specific language impairment. Method: A double-blind superiority trial with cluster randomization was used to compare a cueing procedure, designed to elicit a correct production following an initial error, to a recasting procedure, which required…

  17. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    ERIC Educational Resources Information Center

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  18. A Randomized Trial of Longitudinal Effects of Low-Intensity Responsivity Education/Prelinguistic Milieu Teaching

    ERIC Educational Resources Information Center

    Warren, Steven F.; Fey, Marc E.; Finestack, Lizbeth, H.; Brady, Nancy C.; Bredin-Oja, Shelley L.; Fleming, Kandace K.

    2008-01-01

    Purpose: To evaluate the longitudinal effects of a 6-month course of responsivity education (RE)/prelinguistic milieu teaching (PMT) for young children with developmental delay. Method: Fifty-one children, age 24-33 months, with fewer than 10 expressive words were randomly assigned to early-treatment/no-treatment groups. All treatment was added as…

  19. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  20. Revisiting Fixed- and Random-Effects Models: Some Considerations for Policy-Relevant Education Research

    ERIC Educational Resources Information Center

    Clarke, Paul; Crawford, Claire; Steele, Fiona; Vignoles, Anna

    2015-01-01

    The use of fixed (FE) and random effects (RE) in two-level hierarchical linear regression is discussed in the context of education research. We compare the robustness of FE models with the modelling flexibility and potential efficiency of those from RE models. We argue that the two should be seen as complementary approaches. We then compare both…

  1. The Effects of Student Coaching: An Evaluation of a Randomized Experiment in Student Advising

    ERIC Educational Resources Information Center

    Bettinger, Eric P.; Baker, Rachel B.

    2014-01-01

    College graduation rates often lag behind college attendance rates. One theory as to why students do not complete college is that they lack key information about how to be successful or fail to act on the information that they have. We present evidence from a randomized experiment which tests the effectiveness of individualized student coaching.…

  2. Effectiveness of Stepped Care for Chronic Fatigue Syndrome: A Randomized Noninferiority Trial

    ERIC Educational Resources Information Center

    Tummers, Marcia; Knoop, Hans; Bleijenberg, Gijs

    2010-01-01

    Objective: In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period.…

  3. Full Bayes Poisson gamma, Poisson lognormal, and zero inflated random effects models: Comparing the precision of crash frequency estimates.

    PubMed

    Aguero-Valverde, Jonathan

    2013-01-01

    In recent years, complex statistical modeling approaches have being proposed to handle the unobserved heterogeneity and the excess of zeros frequently found in crash data, including random effects and zero inflated models. This research compares random effects, zero inflated, and zero inflated random effects models using a full Bayes hierarchical approach. The models are compared not just in terms of goodness-of-fit measures but also in terms of precision of posterior crash frequency estimates since the precision of these estimates is vital for ranking of sites for engineering improvement. Fixed-over-time random effects models are also compared to independent-over-time random effects models. For the crash dataset being analyzed, it was found that once the random effects are included in the zero inflated models, the probability of being in the zero state is drastically reduced, and the zero inflated models degenerate to their non zero inflated counterparts. Also by fixing the random effects over time the fit of the models and the precision of the crash frequency estimates are significantly increased. It was found that the rankings of the fixed-over-time random effects models are very consistent among them. In addition, the results show that by fixing the random effects over time, the standard errors of the crash frequency estimates are significantly reduced for the majority of the segments on the top of the ranking. Copyright © 2012 Elsevier Ltd. All rights reserved.

  4. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

    PubMed

    Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-03-21

    To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group

  5. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

    PubMed Central

    Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-01-01

    Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with

  6. Peer Effects in the Workplace: Evidence from Random Groupings in Professional Golf Tournaments

    PubMed Central

    Guryan, Jonathan; Kroft, Kory; Notowidigdo, Matthew J.

    2010-01-01

    This paper uses random assignment in professional golf tournaments to test for peer effects in the workplace. We find no evidence that playing partners’ ability affects performance, contrary to recent evidence on peer effects in the workplace from laboratory experiments, grocery scanners, and soft-fruit pickers. In our preferred specification we can rule out peer effects larger than 0.043 strokes for a one stroke increase in playing partners’ ability. Our results complement existing studies on workplace peer effects and are useful in explaining how social effects vary across labor markets, across individuals, and with the form of incentives faced. PMID:20454555

  7. The estimation of branching curves in the presence of subject-specific random effects.

    PubMed

    Elmi, Angelo; Ratcliffe, Sarah J; Guo, Wensheng

    2014-12-20

    Branching curves are a technique for modeling curves that change trajectory at a change (branching) point. Currently, the estimation framework is limited to independent data, and smoothing splines are used for estimation. This article aims to extend the branching curve framework to the longitudinal data setting where the branching point varies by subject. If the branching point is modeled as a random effect, then the longitudinal branching curve framework is a semiparametric nonlinear mixed effects model. Given existing issues with using random effects within a smoothing spline, we express the model as a B-spline based semiparametric nonlinear mixed effects model. Simple, clever smoothness constraints are enforced on the B-splines at the change point. The method is applied to Women's Health data where we model the shape of the labor curve (cervical dilation measured longitudinally) before and after treatment with oxytocin (a labor stimulant). Copyright © 2014 John Wiley & Sons, Ltd.

  8. An approximate generalized linear model with random effects for informative missing data.

    PubMed

    Follmann, D; Wu, M

    1995-03-01

    This paper develops a class of models to deal with missing data from longitudinal studies. We assume that separate models for the primary response and missingness (e.g., number of missed visits) are linked by a common random parameter. Such models have been developed in the econometrics (Heckman, 1979, Econometrica 47, 153-161) and biostatistics (Wu and Carroll, 1988, Biometrics 44, 175-188) literature for a Gaussian primary response. We allow the primary response, conditional on the random parameter, to follow a generalized linear model and approximate the generalized linear model by conditioning on the data that describes missingness. The resultant approximation is a mixed generalized linear model with possibly heterogeneous random effects. An example is given to illustrate the approximate approach, and simulations are performed to critique the adequacy of the approximation for repeated binary data.

  9. The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

    PubMed

    Kawafha, Mariam M; Tawalbeh, Loai Issa

    2015-04-01

    The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

  10. Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial.

    PubMed

    Blikman, Lyan Jm; van Meeteren, Jetty; Twisk, Jos Wr; de Laat, Fred Aj; de Groot, Vincent; Beckerman, Heleen; Stam, Henk J; Bussmann, Johannes Bj

    2017-10-01

    Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA). Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

  11. Estimation of treatment efficacy with complier average causal effects (CACE) in a randomized stepped wedge trial.

    PubMed

    Gruber, Joshua S; Arnold, Benjamin F; Reygadas, Fermin; Hubbard, Alan E; Colford, John M

    2014-05-01

    Complier average causal effects (CACE) estimate the impact of an intervention among treatment compliers in randomized trials. Methods used to estimate CACE have been outlined for parallel-arm trials (e.g., using an instrumental variables (IV) estimator) but not for other randomized study designs. Here, we propose a method for estimating CACE in randomized stepped wedge trials, where experimental units cross over from control conditions to intervention conditions in a randomized sequence. We illustrate the approach with a cluster-randomized drinking water trial conducted in rural Mexico from 2009 to 2011. Additionally, we evaluated the plausibility of assumptions required to estimate CACE using the IV approach, which are testable in stepped wedge trials but not in parallel-arm trials. We observed small increases in the magnitude of CACE risk differences compared with intention-to-treat estimates for drinking water contamination (risk difference (RD) = -22% (95% confidence interval (CI): -33, -11) vs. RD = -19% (95% CI: -26, -12)) and diarrhea (RD = -0.8% (95% CI: -2.1, 0.4) vs. RD = -0.1% (95% CI: -1.1, 0.9)). Assumptions required for IV analysis were probably violated. Stepped wedge trials allow investigators to estimate CACE with an approach that avoids the stronger assumptions required for CACE estimation in parallel-arm trials. Inclusion of CACE estimates in stepped wedge trials with imperfect compliance could enhance reporting and interpretation of the results of such trials.

  12. Effectiveness of the clinical teaching associate model to improve clinical learning outcomes: a randomized controlled trial.

    PubMed

    Parchebafieh, Samaneh; Gholizadeh, Leila; Lakdizaji, Sima; Ghiasvandiyan, Shahrzad; Davoodi, Arefeh

    2014-01-01

    This study examined the effectiveness of the clinical teaching associate (CTA) model to improve clinical learning outcomes in nursing students. Students were randomly allocated to either the CTA (n = 28) or traditional training group (n = 32), and their clinical knowledge, skills, and satisfaction with the learning experience were assessed and compared. The results showed that the CTA model was equally effective in improving clinical knowledge, skills, and satisfaction of nursing students.

  13. A randomized comparison of three chest compression techniques and associated hemodynamic effect during infant CPR: A randomized manikin study.

    PubMed

    Smereka, Jacek; Szarpak, Lukasz; Rodríguez-Núñez, Antonio; Ladny, Jerzy R; Leung, Steve; Ruetzler, Kurt

    2017-10-01

    Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation. High-quality cardio-pulmonary resuscitation (CPR) is essential, but is poorly performed, even by highly skilled healthcare providers. The recently described two-thumb chest compression technique (nTTT) consists of the two thumbs directed at the angle of 90° to the chest while having the fingers fist-clenched. This technique might facilitate adequate chest-compression depth, chest-compression rate and rate of full chest-pressure relief. 42 paramedics from the national Emergency Medical Service of Poland performed three single-rescuer CPR sessions for 10 minutes each. Each session was randomly assigned to the conventional two-thumb (TTHT), the conventional two-finger (TFT) or the nTTT. The manikin used for this study was connected with an arterial blood pressure measurement device and blood measurements were documented on a 10-seconds cycle. The nTTT provided significant higher systolic (82 vs. 30 vs. 41 mmHg). A statistically significant difference was noticed between nTTT and TFT (p<.001), nTTT and TTHT (p<0.001), TFT and TTHT (p=0.003). The median diastolic preassure using nTTT was 16 mmHg compared with 9 mmHg for TFT (p<0.001), and 9.5 mmHg for TTHT (p<0.001). Mean arterial pressure using distinct methods varied and amounted to 40 vs. 22. vs. 26 mmHg (nTTT vs. TFT vs. TTHT, respectively). A statistically significant difference was noticed between nTTT and TFT (p<0.001), nTTT and TTEHT (p<0.001), and TFT and TTHT (p<0.001). The highest median pulse pressure was obtained by the nTTT 67.5 mmHg. Pulse pressure was 31.5 mmHg in the TTHT and 24 mmHg in the TFT. The difference between TFT and TTHT (p=0.025), TFT and nTTT (p<0.001), as well as between TTHT and nTTT (p<0.001) were statistically significant. The new nTTT technique generated higher arterial blood pressures compared to established chest compression techniques using an infant manikin

  14. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  15. A simple method for assessing occupational exposure via the one-way random effects model.

    PubMed

    Krishnamoorthy, K; Mathew, Thomas; Peng, Jie

    2016-11-01

    A one-way random effects model is postulated for the log-transformed shift-long personal exposure measurements, where the random effect in the model represents an effect due to the worker. Simple closed-form confidence intervals are proposed for the relevant parameters of interest using the method of variance estimates recovery (MOVER). The performance of the confidence bounds is evaluated and compared with those based on the generalized confidence interval approach. Comparison studies indicate that the proposed MOVER confidence bounds are better than the generalized confidence bounds for the overall mean exposure and an upper percentile of the exposure distribution. The proposed methods are illustrated using a few examples involving industrial hygiene data.

  16. An Evaluation of the Effectiveness of Recruitment Methods: The Staying Well after Depression Randomized Controlled Trial

    PubMed Central

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J. Mark G.

    2014-01-01

    Background Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited and trials often fail to report sufficient details about the recruitment sources and resources utilised. Purpose We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. Methods We describe eight recruitment methods utilised and two further sources not initiated by the research team and examine their efficacy in terms of (i) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial, (ii) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants, and (iii) comparison of sociodemographic characteristics of individuals recruited from different sources. Results Poster advertising, web-based advertising and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. Limitations It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other

  17. An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial.

    PubMed

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G

    2014-04-01

    Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in

  18. Quantifying the impact of fixed effects modeling of clusters in multiple imputation for cluster randomized trials

    PubMed Central

    Andridge, Rebecca. R.

    2011-01-01

    In cluster randomized trials (CRTs), identifiable clusters rather than individuals are randomized to study groups. Resulting data often consist of a small number of clusters with correlated observations within a treatment group. Missing data often present a problem in the analysis of such trials, and multiple imputation (MI) has been used to create complete data sets, enabling subsequent analysis with well-established analysis methods for CRTs. We discuss strategies for accounting for clustering when multiply imputing a missing continuous outcome, focusing on estimation of the variance of group means as used in an adjusted t-test or ANOVA. These analysis procedures are congenial to (can be derived from) a mixed effects imputation model; however, this imputation procedure is not yet available in commercial statistical software. An alternative approach that is readily available and has been used in recent studies is to include fixed effects for cluster, but the impact of using this convenient method has not been studied. We show that under this imputation model the MI variance estimator is positively biased and that smaller ICCs lead to larger overestimation of the MI variance. Analytical expressions for the bias of the variance estimator are derived in the case of data missing completely at random (MCAR), and cases in which data are missing at random (MAR) are illustrated through simulation. Finally, various imputation methods are applied to data from the Detroit Middle School Asthma Project, a recent school-based CRT, and differences in inference are compared. PMID:21259309

  19. Effect of Random Thermal Spikes on Stirling Convertor Heater Head Reliability

    NASA Technical Reports Server (NTRS)

    Shah, Ashwin R.; Korovaichuk, Igor; Halford, Gary R.

    2004-01-01

    Onboard radioisotope power systems being developed to support future NASA exploration missions require reliable design lifetimes of up to 14 yr and beyond. The structurally critical heater head of the high-efficiency developmental Stirling power convertor has undergone extensive computational analysis of operating temperatures (up to 650 C), stresses, and creep resistance of the thin-walled Inconel 718 bill of material. Additionally, assessment of the effect of uncertainties in the creep behavior of the thin-walled heater head, the variation in the manufactured thickness, variation in control temperature, and variation in pressure on the durability and reliability were performed. However, it is possible for the heater head to experience rare incidences of random temperature spikes (excursions) of short duration. These incidences could occur randomly with random magnitude and duration during the desired mission life. These rare incidences could affect the creep strain rate and therefore the life. The paper accounts for these uncertainties and includes the effect of such rare incidences, random in nature, on the reliability. The sensitivities of variables affecting the reliability are quantified and guidelines developed to improve the reliability are outlined. Furthermore, the quantified reliability is being verified with test data from the accelerated benchmark tests being conducted at the NASA Glenn Research Center.

  20. Random species loss underestimates dilution effects of host diversity on foliar fungal diseases under fertilization.

    PubMed

    Liu, Xiang; Chen, Fei; Lyu, Shengman; Sun, Dexin; Zhou, Shurong

    2018-02-01

    With increasing attention being paid to the consequences of global biodiversity losses, several recent studies have demonstrated that realistic species losses can have larger impacts than random species losses on community productivity and resilience. However, little is known about the effects of the order in which species are lost on biodiversity-disease relationships. Using a multiyear nitrogen addition and artificial warming experiment in natural assemblages of alpine meadow vegetation on the Qinghai-Tibetan Plateau, we inferred the sequence of plant species losses under fertilization/warming. Then the sequence of species losses under fertilization/warming was used to simulate the species loss orders (both realistic and random) in an adjacently novel removal experiment manipulating plot-level plant diversity. We explicitly compared the effect sizes of random versus realistic species losses simulated from fertilization/warming on plant foliar fungal diseases. We found that realistic species losses simulated from fertilization had greater effects than random losses on fungal diseases, and that species identity drove the diversity-disease relationship. Moreover, the plant species most prone to foliar fungal diseases were also the least vulnerable to extinction under fertilization, demonstrating the importance of protecting low competence species (the ability to maintain and transmit fungal infections was low) to impede the spread of infectious disease. In contrast, there was no difference between random and realistic species loss scenarios simulated from experimental warming (or the combination of warming and fertilization) on the diversity-disease relationship, indicating that the functional consequences of species losses may vary under different drivers.

  1. The Expected Sample Variance of Uncorrelated Random Variables with a Common Mean and Some Applications in Unbalanced Random Effects Models

    ERIC Educational Resources Information Center

    Vardeman, Stephen B.; Wendelberger, Joanne R.

    2005-01-01

    There is a little-known but very simple generalization of the standard result that for uncorrelated random variables with common mean [mu] and variance [sigma][superscript 2], the expected value of the sample variance is [sigma][superscript 2]. The generalization justifies the use of the usual standard error of the sample mean in possibly…

  2. A note on variance estimation in random effects meta-regression.

    PubMed

    Sidik, Kurex; Jonkman, Jeffrey N

    2005-01-01

    For random effects meta-regression inference, variance estimation for the parameter estimates is discussed. Because estimated weights are used for meta-regression analysis in practice, the assumed or estimated covariance matrix used in meta-regression is not strictly correct, due to possible errors in estimating the weights. Therefore, this note investigates the use of a robust variance estimation approach for obtaining variances of the parameter estimates in random effects meta-regression inference. This method treats the assumed covariance matrix of the effect measure variables as a working covariance matrix. Using an example of meta-analysis data from clinical trials of a vaccine, the robust variance estimation approach is illustrated in comparison with two other methods of variance estimation. A simulation study is presented, comparing the three methods of variance estimation in terms of bias and coverage probability. We find that, despite the seeming suitability of the robust estimator for random effects meta-regression, the improved variance estimator of Knapp and Hartung (2003) yields the best performance among the three estimators, and thus may provide the best protection against errors in the estimated weights.

  3. The conditional power of randomization tests for single-case effect sizes in designs with randomized treatment order: A Monte Carlo simulation study.

    PubMed

    Michiels, Bart; Heyvaert, Mieke; Onghena, Patrick

    2018-04-01

    The conditional power (CP) of the randomization test (RT) was investigated in a simulation study in which three different single-case effect size (ES) measures were used as the test statistics: the mean difference (MD), the percentage of nonoverlapping data (PND), and the nonoverlap of all pairs (NAP). Furthermore, we studied the effect of the experimental design on the RT's CP for three different single-case designs with rapid treatment alternation: the completely randomized design (CRD), the randomized block design (RBD), and the restricted randomized alternation design (RRAD). As a third goal, we evaluated the CP of the RT for three types of simulated data: data generated from a standard normal distribution, data generated from a uniform distribution, and data generated from a first-order autoregressive Gaussian process. The results showed that the MD and NAP perform very similarly in terms of CP, whereas the PND performs substantially worse. Furthermore, the RRAD yielded marginally higher power in the RT, followed by the CRD and then the RBD. Finally, the power of the RT was almost unaffected by the type of the simulated data. On the basis of the results of the simulation study, we recommend at least 20 measurement occasions for single-case designs with a randomized treatment order that are to be evaluated with an RT using a 5% significance level. Furthermore, we do not recommend use of the PND, because of its low power in the RT.

  4. Design of healthy hearts in the heartland (H3): A practice-randomized, comparative effectiveness study.

    PubMed

    Ciolino, Jody D; Jackson, Kathryn L; Liss, David T; Brown, Tiffany; Walunas, Theresa L; Murakami, Linda; Chung, Isabel; Persell, Stephen D; Kho, Abel N

    2018-06-02

    The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand the ability of small primary care practices to improve "ABCS" clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed to assess feasibility of implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) quality improvement (QI) strategies to improve ABCS at practices in Illinois, Indiana, and Wisconsin. We describe the design and randomization of the H3 study. We conducted a two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness study in 226 primary care practices across four "waves" of randomization with a 12-month intervention period, followed by a six-month sustainability period. Randomization controlled imbalance in nine baseline variables through a modified constrained algorithm. Among others, we used initial, unverified estimates of baseline ABCS values. We randomized 112 and 114 practices to POC and POC + PM arms, respectively. Randomization ensured baseline comparability for all nine key variables, including the ABCS measures indicating proportion of patients at the practice level meeting each quality measure. Median(Inner Quartile Range) values were A: 0.78(0.66-0.86) in POC arm vs. 0.77(0.63-0.86) in POC + PM arm, B: 0.64(0.53-0.73) vs. 0.64(0.53-0.75), C: 0.78(0.63-0.86) vs. 0.75(0.64-0.81), S: 0.80(0.65-0.81) vs. 0.79(0.61-0.91). Surrogate estimates for the true ABCS at baseline coupled with the unique randomization logic achieved adequate baseline balance on these outcomes. Similar practice- or cluster-randomized trials may consider adaptations of this design. Final analyses on 12- and 18-month ABCS outcomes for the H3 study are forthcoming. This trial is registered on ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284; https://clinicaltrials.gov/ct2/show/NCT02598284?term

  5. The effects of motivation feedback in patients with severe mental illness: a cluster randomized controlled trial

    PubMed Central

    Jochems, Eline C; van der Feltz-Cornelis, Christina M; van Dam, Arno; Duivenvoorden, Hugo J; Mulder, Cornelis L

    2015-01-01

    Objective To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968). Participants: adult outpatients with a primary diagnosis of a psychotic disorder or a personality disorder and their clinicians, treated in 12 community mental health teams (the clusters) of two mental health institutions in the Netherlands. Interventions: monthly motivation feedback (MF) generated by clinicians additional to treatment as usual (TAU) and TAU by the community mental health teams. Primary outcome: treatment engagement at patient level, assessed at 12 months by clinicians. Randomization: teams were allocated to MF or TAU by a computerized randomization program that randomized each team to a single treatment by blocks of varying size. All participants within these teams received similar treatment. Clinicians and patients were not blind to treatment allocation at the 12-month assessment. Results The 294 randomized patients (148 MF, 146 TAU) and 57 clinicians (29 MF, 28 TAU) of 12 teams (6 MF, 6 TAU) were analyzed according to the intention-to-treat principle. No statistically significant differences between treatment groups on treatment engagement were found (adjusted mean difference =0.1, 95% confidence interval =−2.2 to 2.3, P=0.96, d=0). Preplanned ancillary analyses showed statistically significant interaction effects between treatment group and primary diagnosis on treatment motivation and quality of life (secondary outcomes), which were beneficial for patients with a primary diagnosis of a personality disorder but not for those with a psychotic disorder. There were no reports of adverse events. Conclusion The current findings imply that monitoring and discussing the patient’s motivation is insufficient to improve motivation and treatment engagement, and

  6. A comparison of methods for estimating the random effects distribution of a linear mixed model.

    PubMed

    Ghidey, Wendimagegn; Lesaffre, Emmanuel; Verbeke, Geert

    2010-12-01

    This article reviews various recently suggested approaches to estimate the random effects distribution in a linear mixed model, i.e. (1) the smoothing by roughening approach of Shen and Louis,(1) (2) the semi-non-parametric approach of Zhang and Davidian,(2) (3) the heterogeneity model of Verbeke and Lesaffre( 3) and (4) a flexible approach of Ghidey et al. (4) These four approaches are compared via an extensive simulation study. We conclude that for the considered cases, the approach of Ghidey et al. (4) often shows to have the smallest integrated mean squared error for estimating the random effects distribution. An analysis of a longitudinal dental data set illustrates the performance of the methods in a practical example.

  7. Effects of exercises on Bell's palsy: systematic review of randomized controlled trials.

    PubMed

    Cardoso, Jefferson Rosa; Teixeira, Elsie Cobra; Moreira, Michelle Damasceno; Fávero, Francis Meire; Fontes, Sissy Veloso; Bulle de Oliveira, Acary Souza

    2008-06-01

    This study examined the effects of facial exercises associated either with mirror or electromyogram (EMG) biofeedback with respect to complications of delayed recovery in Bell's palsy. Patients with unilateral idiopathic facial palsy were included in this review. Facial exercises associated with mirror and/or EMG biofeedback as treatment. Report of facial symmetry, synkinesis, lip mobility, and physical and social aspects. Four studies of 132 met the eligibility criteria. The studies described mime therapy versus control (n = 50), mirror biofeedback exercise versus control (n = 27), "small" mirror movements versus conventional neuromuscular retraining (n = 10), and EMG biofeedback + mirror training versus mirror training alone. The treatment length varied from 1 to 12 months. Because of the small number of randomized controlled trials, it was not possible to analyze if the exercises, associated either with mirror or EMG biofeedback, were effective. In summary, the available evidence from randomized controlled trials is not yet strong enough to become integrated into clinical practice.

  8. Recruitment of healthy participants for studies on risks for alcoholism: effectiveness of random digit dialling.

    PubMed

    Sorocco, Kristen H; Vincent, Andrea S; Collins, Frank L; Johnson, Christine A; Lovallo, William R

    2006-01-01

    To compare the effectiveness of two strategies for recruiting healthy research volunteers. Demographic characteristics and recruitment costs of participants who completed a laboratory study examining risk factors for alcoholism recruited through random digit dialling (N = 11) and community advertisements (N = 102) were compared. Advertisement yielded a more representative sample [76% Caucasian, less well educated (M = 15.2 years, SEM = 0.2; P < 0.05), more equally divided by family history of alcoholism (43% FH- and 57% FH+), and lower in SES (M = 42.8, SEM = 1.3; P < 0.05)] and was more cost effective (72 dollars vs 2272 dollars per participant) than random digit dialling. Findings are relevant to alcohol researchers trying to determine the recruitment strategy that will yield the most representative sample at the lowest cost.

  9. A theoretical approach to quantify the effect of random cracks on rock deformation in uniaxial compression

    NASA Astrophysics Data System (ADS)

    Zhou, Shuwei; Xia, Caichu; Zhou, Yu

    2018-06-01

    Cracks have a significant effect on the uniaxial compression of rocks. Thus, a theoretically analytical approach was proposed to assess the effects of randomly distributed cracks on the effective Young’s modulus during the uniaxial compression of rocks. Each stage of the rock failure during uniaxial compression was analyzed and classified. The analytical approach for the effective Young’s modulus of a rock with only a single crack was derived while considering the three crack states under stress, namely, opening, closure-sliding, and closure-nonsliding. The rock was then assumed to have many cracks with randomly distributed direction, and the effect of crack shape and number during each stage of the uniaxial compression on the effective Young’s modulus was considered. Thus, the approach for the effective Young’s modulus was used to obtain the whole stress-strain process of uniaxial compression. Afterward, the proposed approach was employed to analyze the effects of related parameters on the whole stress-stain curve. The proposed approach was eventually compared with some existing rock tests to validate its applicability and feasibility. The proposed approach has clear physical meaning and shows favorable agreement with the rock test results.

  10. A-site ordered quadruple perovskite oxides

    NASA Astrophysics Data System (ADS)

    Youwen, Long

    2016-07-01

    The A-site ordered perovskite oxides with chemical formula display many intriguing physical properties due to the introduction of transition metals at both A‧ and B sites. Here, research on the recently discovered intermetallic charge transfer occurring between A‧-site Cu and B-site Fe ions in LaCu3Fe4O12 and its analogues is reviewed, along with work on the magnetoelectric multiferroicity observed in LaMn3Cr4O12 with cubic perovskite structure. The Cu-Fe intermetallic charge transfer leads to a first-order isostructural phase transition accompanied by drastic variations in magnetism and electrical transport properties. The LaMn3Cr4O12 is a novel spin-driven multiferroic system with strong magnetoelectric coupling effects. The compound is the first example of cubic perovskite multiferroics to be found. It opens up a new arena for studying unexpected multiferroic mechanisms. Project supported by the National Basic Research Program of China (Grant No. 2014CB921500), the Strategic Priority Research Program of the Chinese Academy of Sciences (Grant No. XDB07030300), and the National Natural Science Foundation of China (Grant No. 11574378).

  11. Cultivating teacher mindfulness: Effects of a randomized controlled trial on work, home, and sleep outcomes.

    PubMed

    Crain, Tori L; Schonert-Reichl, Kimberly A; Roeser, Robert W

    2017-04-01

    The effects of randomization to a workplace mindfulness training (WMT) or a waitlist control condition on teachers' well-being (moods and satisfaction at work and home), quantity of sleep, quality of sleep, and sleepiness during the day were examined in 2 randomized, waitlist controlled trials (RCTs). The combined sample of the 2 RCTs, conducted in Canada and the United States, included 113 elementary and secondary school teachers (89% female). Measures were collected at baseline, postprogram, and 3-month follow-up; teachers were randomly assigned to condition after baseline assessment. Results showed that teachers randomized to WMT reported less frequent bad moods at work and home, greater satisfaction at work and home, more sleep on weekday nights, better quality sleep, and decreased insomnia symptoms and daytime sleepiness. Training-related group differences in mindfulness and rumination on work at home at postprogram partially mediated the reductions in negative moods at home and increases in sleep quality at follow-up. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  12. Reliability of Space-Shuttle Pressure Vessels with Random Batch Effects

    NASA Technical Reports Server (NTRS)

    Feiveson, Alan H.; Kulkarni, Pandurang M.

    2000-01-01

    In this article we revisit the problem of estimating the joint reliability against failure by stress rupture of a group of fiber-wrapped pressure vessels used on Space-Shuttle missions. The available test data were obtained from an experiment conducted at the U.S. Department of Energy Lawrence Livermore Laboratory (LLL) in which scaled-down vessels were subjected to life testing at four accelerated levels of pressure. We estimate the reliability assuming that both the Shuttle and LLL vessels were chosen at random in a two-stage process from an infinite population with spools of fiber as the primary sampling unit. Two main objectives of this work are: (1) to obtain practical estimates of reliability taking into account random spool effects and (2) to obtain a realistic assessment of estimation accuracy under the random model. Here, reliability is calculated in terms of a 'system' of 22 fiber-wrapped pressure vessels, taking into account typical pressures and exposure times experienced by Shuttle vessels. Comparisons are made with previous studies. The main conclusion of this study is that, although point estimates of reliability are still in the 'comfort zone,' it is advisable to plan for replacement of the pressure vessels well before the expected Lifetime of 100 missions per Shuttle Orbiter. Under a random-spool model, there is simply not enough information in the LLL data to provide reasonable assurance that such replacement would not be necessary.

  13. Behavioral effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    PubMed

    Bink, Marleen; van Nieuwenhuizen, Chijs; Popma, Arne; Bongers, Ilja L; van Boxtel, Geert J M

    2015-09-01

    Neurofeedback has been proposed as a potentially effective intervention for reducing Attention Deficit Hyperactivity Disorder (ADHD) symptoms. However, it remains unclear whether neurofeedback is of additional value to treatment as usual (TAU) for adolescents with clinical ADHD symptoms. Using a multicenter parallel-randomized controlled trial design, adolescents with ADHD symptoms were randomized to receive either a combination of TAU and neurofeedback (NFB + TAU, n = 45) or TAU-only (n = 26). Randomization was computer generated and stratified for age group (ages 12 through 16, 16 through 20, 20 through 24). Neurofeedback treatment consisted of approximately 37 sessions of theta/sensorimotor rhythm (SMR)-training on the vertex (Cz). Primary behavioral outcome measures included the ADHD-rating scale, Youth Self Report, and Child Behavior Checklist all assessed pre- and post-intervention. Behavioral problems decreased equally for both groups with medium to large effect sizes, range of partial η2 = 0.08-0.31, p < 0.05. Hence, the combination of NFB + TAU was not more effective than TAU-only on the behavioral outcome measures. In addition, reported adverse effects were similar for both groups. On behavioral outcome measures, the combination of neurofeedback and TAU was as effective as TAU-only for adolescents with ADHD symptoms. Considering the absence of additional behavioral effects in the current study, in combination with the limited knowledge of specific treatment effects, it is questionable whether theta/SMR neurofeedback for adolescents with ADHD and comorbid disorders in clinical practice should be used. Further research is warranted to investigate possible working mechanisms and (long-term) specific treatment effects of neurofeedback.

  14. Clustering of time-course gene expression profiles using normal mixture models with autoregressive random effects

    PubMed Central

    2012-01-01

    Background Time-course gene expression data such as yeast cell cycle data may be periodically expressed. To cluster such data, currently used Fourier series approximations of periodic gene expressions have been found not to be sufficiently adequate to model the complexity of the time-course data, partly due to their ignoring the dependence between the expression measurements over time and the correlation among gene expression profiles. We further investigate the advantages and limitations of available models in the literature and propose a new mixture model with autoregressive random effects of the first order for the clustering of time-course gene-expression profiles. Some simulations and real examples are given to demonstrate the usefulness of the proposed models. Results We illustrate the applicability of our new model using synthetic and real time-course datasets. We show that our model outperforms existing models to provide more reliable and robust clustering of time-course data. Our model provides superior results when genetic profiles are correlated. It also gives comparable results when the correlation between the gene profiles is weak. In the applications to real time-course data, relevant clusters of coregulated genes are obtained, which are supported by gene-function annotation databases. Conclusions Our new model under our extension of the EMMIX-WIRE procedure is more reliable and robust for clustering time-course data because it adopts a random effects model that allows for the correlation among observations at different time points. It postulates gene-specific random effects with an autocorrelation variance structure that models coregulation within the clusters. The developed R package is flexible in its specification of the random effects through user-input parameters that enables improved modelling and consequent clustering of time-course data. PMID:23151154

  15. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    PubMed

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  16. Confidence intervals for single-case effect size measures based on randomization test inversion.

    PubMed

    Michiels, Bart; Heyvaert, Mieke; Meulders, Ann; Onghena, Patrick

    2017-02-01

    In the current paper, we present a method to construct nonparametric confidence intervals (CIs) for single-case effect size measures in the context of various single-case designs. We use the relationship between a two-sided statistical hypothesis test at significance level α and a 100 (1 - α) % two-sided CI to construct CIs for any effect size measure θ that contain all point null hypothesis θ values that cannot be rejected by the hypothesis test at significance level α. This method of hypothesis test inversion (HTI) can be employed using a randomization test as the statistical hypothesis test in order to construct a nonparametric CI for θ. We will refer to this procedure as randomization test inversion (RTI). We illustrate RTI in a situation in which θ is the unstandardized and the standardized difference in means between two treatments in a completely randomized single-case design. Additionally, we demonstrate how RTI can be extended to other types of single-case designs. Finally, we discuss a few challenges for RTI as well as possibilities when using the method with other effect size measures, such as rank-based nonoverlap indices. Supplementary to this paper, we provide easy-to-use R code, which allows the user to construct nonparametric CIs according to the proposed method.

  17. Gravitational microlensing - The effect of random motion of individual stars in the lensing galaxy

    NASA Technical Reports Server (NTRS)

    Kundic, Tomislav; Wambsganss, Joachim

    1993-01-01

    We investigate the influence of random motion of individual stars in the lensing galaxy on the light curve of a gravitationally lensed background quasar. We compare this with the effects of the transverse motion of the galaxy. We find that three-dimensional random motion of stars with a velocity dispersion sigma in each dimension is more effective in producing 'peaks' in a microlensed light curve by a factor a about 1.3 than motion of the galaxy with a transverse velocity v(t) = sigma. This effectiveness parameter a seems to depend only weakly on the surface mass density. With an assumed transverse velocity of v(t) = 600 km/s of the galaxy lensing the QSO 2237+0305 and a measured velocity dispersion of sigma = 215 km/s, the expected rate of maxima in the light curves calculated for bulk motion alone has to be increased by about 10 percent due to the random motion of stars. As a consequence, the average time interval Delta t between two high-magnification events is smaller than the time interval Delta(t) bulk, calculated for bulk motion alone, Delta t about 0.9 Delta(t) bulk.

  18. Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

    PubMed Central

    Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

    2012-01-01

    Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

  19. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention.

    PubMed

    Fox, Caroline S; Gurary, Ellen B; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

    2016-04-27

    A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30-day page views. Whether insufficient social media intensity contributed to these results is uncertain. Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journal's accounts. To increase social media intensity, a larger base of followers was built using advertising and organic growth, and posts were presented in triplicate and boosted on Facebook and retweeted on Twitter. The primary outcome was 30-day page views. Stopping rules were established at the point that 50% of the manuscripts were randomized and had 30-day follow-up to compare groups on 30-day page views. The trial was stopped for futility on September 26, 2015. Overall, 74 manuscripts were randomized to receive social media exposure, and 78 manuscripts were randomized to the control arm. The intervention and control arms were similar based on article type (P=0.85), geographic location of the corresponding author (P=0.33), and whether the manuscript had an editorial (P=0.80). Median number of 30-day page views was 499.5 in the social media arm and 450.5 in the control arm; there was no evidence of a treatment effect (P=0.38). There were no statistically significant interactions of treatment by manuscript type (P=0.86), by corresponding author (P=0.35), by trimester of publication date (P=0.34), or by editorial status (P=0.79). A more intensive social media strategy did not result in increased 30-day page views of original research. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  20. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    PubMed

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  1. Effect of pravastatin on survival in patients with advanced hepatocellular carcinoma. A randomized controlled trial

    PubMed Central

    Kawata, S; Yamasaki, E; Nagase, T; Inui, Y; Ito, N; Matsuda, Y; Inada, M; Tamura, S; Noda, S; Imai, Y; Matsuzawa, Y

    2001-01-01

    Chemotherapy is not effective for hepatocellular carcinoma (HCC). HMG-CoA redutase inhibitors have cytostatic activity for cancer cells, but their clinical usefulness is unknown. To investigate whether pravastatin, a potent HMG-CoA reductase inhibitor, prolongs survival in patients with advanced HCC, this randomized controlled trial was conducted between February 1990 and February 1998 at Osaka University Hospital. 91 consecutive patients <71 years old (mean age 62) with unresectable HCC were enroled in this study. 8 patients were withdrawn because of progressive liver dysfunction; 83 patients were randomized to standard treatment with or without pravastatin. All patients underwent transcatheter arterial embolization (TAE) followed by oral 5-FU 200 mg−1d for 2 months. Patients were then randomly assigned to control (n = 42) and pravastatin (n = 41) groups. Pravastatin was administered at a daily dose of 40 mg. The effect of pravastatin on tumour growth was assessed by ultrasonography. Primary endpoint was death due to progression of HCC. The duration of pravastatin administration was 16.5 ± 9.8 months (mean ± SD). No patients in either group were lost to follow-up. Median survival was 18 months in the pravastatin group versus 9 months in controls (P = 0.006). The Cox proportional hazards model showed that pravastatin was a significant factor contributing to survival. Pravastatin prolonged the survival of patients with advanced HCC, suggesting its value for adjuvant treatment. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11286466

  2. Effects of prenatal yoga on women's stress and immune function across pregnancy: A randomized controlled trial.

    PubMed

    Chen, Pao-Ju; Yang, Luke; Chou, Cheng-Chen; Li, Chia-Chi; Chang, Yu-Cune; Liaw, Jen-Jiuan

    2017-04-01

    The effects of prenatal yoga on biological indicators have not been widely studied. Thus, we compared changes in stress and immunity salivary biomarkers from 16 to 36 weeks' gestation between women receiving prenatal yoga and those receiving routine prenatal care. For this longitudinal, prospective, randomized controlled trial, we recruited 94 healthy pregnant women at 16 weeks' gestation through convenience sampling from a prenatal clinic in Taipei. Participants were randomly assigned to intervention (n=48) or control (n=46) groups using Clinstat block randomization. The 20-week intervention comprised two weekly 70-min yoga sessions led by a midwife certified as a yoga instructor; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A levels were collected before and after yoga every 4 weeks from 16 to 36 weeks' gestation. The intervention group had lower salivary cortisol (p<0.001) and higher immunoglobulin A (p<0.001) levels immediately after yoga than the control group. Specifically, the intervention group had significantly higher long-term salivary immunoglobulin A levels than the control group (p=0.018), and infants born to women in the intervention group weighed more than those born to the control group (p<0.001). Prenatal yoga significantly reduced pregnant women's stress and enhanced their immune function. Clinicians should learn the mechanisms of yoga and its effects on pregnant women. Our findings can guide clinicians to help pregnant women alleviate their stress and enhance their immune function. Copyright © 2017. Published by Elsevier Ltd.

  3. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

    PubMed

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-11-30

    Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

  4. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    PubMed Central

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

  5. Effects of absorption on multiple scattering by random particulate media: exact results.

    PubMed

    Mishchenko, Michael I; Liu, Li; Hovenier, Joop W

    2007-10-01

    We employ the numerically exact superposition T-matrix method to perform extensive computations of elec nottromagnetic scattering by a volume of discrete random medium densely filled with increasingly absorbing as well as non-absorbing particles. Our numerical data demonstrate that increasing absorption diminishes and nearly extinguishes certain optical effects such as depolarization and coherent backscattering and increases the angular width of coherent backscattering patterns. This result corroborates the multiple-scattering origin of such effects and further demonstrates the heuristic value of the concept of multiple scattering even in application to densely packed particulate media.

  6. The effect of parent education program for preschool children with developmental disabilities: A randomized controlled trial.

    PubMed

    Leung, Cynthia; Chan, Stanley; Lam, Tiney; Yau, Sharon; Tsang, Sandra

    2016-09-01

    This study aimed to evaluate the efficacy of a parent education program, the Happy Parenting program, for Chinese preschool children with developmental disabilities. This study adopted randomized controlled trial design without blinding. Participants were randomized into intervention group (n=62) who were offered the Happy Parenting program delivered by educational psychologists and trainee educational psychologists, and a control group (n=57) who were offered a parent talk after the intervention group had completed treatment. Parent participants were requested to complete questionnaires on their children's behavior, their parenting stress, and discipline strategies. Analysis was by intention-to-treat. The results indicated significant decrease in child problem behaviors, parenting stress and dysfunctional discipline strategies in the intervention group at post-intervention. This study provided promising evidence on the effectiveness of a parent education program, the Happy Parenting program, for Chinese preschool children with developmental disabilities. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. Random crystal field effect on the magnetic and hysteresis behaviors of a spin-1 cylindrical nanowire

    NASA Astrophysics Data System (ADS)

    Zaim, N.; Zaim, A.; Kerouad, M.

    2017-02-01

    In this work, the magnetic behavior of the cylindrical nanowire, consisting of a ferromagnetic core of spin-1 atoms surrounded by a ferromagnetic shell of spin-1 atoms is studied in the presence of a random crystal field interaction. Based on Metropolis algorithm, the Monte Carlo simulation has been used to investigate the effects of the concentration of the random crystal field p, the crystal field D and the shell exchange interaction Js on the phase diagrams and the hysteresis behavior of the system. Some characteristic behaviors have been found, such as the first and second-order phase transitions joined by tricritical point for appropriate values of the system parameters, triple and isolated critical points can be also found. Depending on the Hamiltonian parameters, single, double and para hysteresis regions are explicitly determined.

  8. Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

    PubMed

    Howie, Amanda J; Malouff, John M

    2014-01-01

    Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

  9. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    PubMed

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Effectivity of artrihpi irrigation for diabetic ulcer healing: A randomized controlled trial

    NASA Astrophysics Data System (ADS)

    Gayatri, Dewi; Asmorohadi, Aries; Dahlia, Debie

    2018-02-01

    The healing process of diabetic ulcer is often impeded by inflammation, infection, and decreased immune state. High pressure irrigation (10-15 psi) may be used to control the infection level. This research was designed to identify the effectiveness of artrihpi irrigation device towards diabetic ulcers in public hospitals in the Central Java. This research is a randomized control trial with cross over design. Sixty four subjects were selected using block randomization technique, and were divided into control and intervention group. The intervention was given in 6 days along with wound healing evaluation in every 3 days. The results demonstrated that there was a significant difference decrease scoring healing after treatment, even though the difference scoring healing between both groups was not statistically significant. However, it means difference was found that in the intervention artrihpi the wound healing was better than the spuit. These results illustrates the artrihpi may be solution of using high pressure irrigation to help healing process diabetic ulcers.

  11. Random crystal field effects on the integer and half-integer mixed-spin system

    NASA Astrophysics Data System (ADS)

    Yigit, Ali; Albayrak, Erhan

    2018-05-01

    In this work, we have focused on the random crystal field effects on the phase diagrams of the mixed spin-1 and spin-5/2 Ising system obtained by utilizing the exact recursion relations (ERR) on the Bethe lattice (BL). The distribution function P(Di) = pδ [Di - D(1 + α) ] +(1 - p) δ [Di - D(1 - α) ] is used to randomize the crystal field.The phase diagrams are found to exhibit second- and first-order phase transitions depending on the values of α, D and p. It is also observed that the model displays tricritical point, isolated point, critical end point and three compensation temperatures for suitable values of the system parameters.

  12. Effective degrees of freedom of a random walk on a fractal

    NASA Astrophysics Data System (ADS)

    Balankin, Alexander S.

    2015-12-01

    We argue that a non-Markovian random walk on a fractal can be treated as a Markovian process in a fractional dimensional space with a suitable metric. This allows us to define the fractional dimensional space allied to the fractal as the ν -dimensional space Fν equipped with the metric induced by the fractal topology. The relation between the number of effective spatial degrees of freedom of walkers on the fractal (ν ) and fractal dimensionalities is deduced. The intrinsic time of random walk in Fν is inferred. The Laplacian operator in Fν is constructed. This allows us to map physical problems on fractals into the corresponding problems in Fν. In this way, essential features of physics on fractals are revealed. Particularly, subdiffusion on path-connected fractals is elucidated. The Coulomb potential of a point charge on a fractal embedded in the Euclidean space is derived. Intriguing attributes of some types of fractals are highlighted.

  13. Aerobic exercise effects upon cognition in Mild Cognitive Impairment: A systematic review of randomized controlled trials.

    PubMed

    Cammisuli, D M; Innocenti, A; Franzoni, F; Pruneti, C

    2017-07-01

    Several studies have shown that physical activity has positive effects on cognition in healthy older adults without cognitive complains but lesser is known about the effectiveness of aerobic exercise in patients suffering from Mild Cognitive Impairment (MCI). The aim of the present study was to systematically review the evidence from randomized controlled trials (RCTs) about the effects of aerobic exercise upon cognition in MCI patients. To this end, PubMed, Cochrane and Web of Science databases were analytically searched for RCTs including aerobic exercise interventions for MCI patients. There is evidence that aerobic exercise improves cognition in MCI patients. Overall research reported moderate effects for global cognition, logical memory, inhibitory control and divided attention. Due to methodological limitations of the investigated studies, findings should be interpreted with caution. Standardized training protocols, larger scale interventions and follow-ups may also provide better insight into the preventive effects of aerobic exercise on cognitive deterioration in MCI and its conversion into dementia.

  14. Effects of mindfulness meditation on chronic pain: a randomized controlled trial.

    PubMed

    la Cour, Peter; Petersen, Marian

    2015-04-01

    This randomized controlled clinical trial investigated the effects of mindfulness meditation on chronic pain. A total of 109 patients with nonspecific chronic pain were randomized to either a standardized mindfulness meditation program (mindfulness-based stress reduction [MBSR]) or to a wait list control. Pain, physical function, mental function, pain acceptance, and health-related quality of life were measured. The SF36 vitality scale was chosen as the primary outcome measure; the primary end point was after completing the MBSR course. Within a 2.5-year period, 43 of the 109 randomized patients completed the mindfulness program, while 47 remained in the control group. Data were compared at three time points: at baseline, after completion of the course/waiting period, and at the 6-month follow-up. Significant effect (Cohen's d = 0.39) was found on the primary outcome measure, the SF36 vitality scale. On the secondary variables, significant medium to large size effects (Cohen's d = 0.37-0.71) were found for lower general anxiety and depression, better mental quality of life (psychological well-being), feeling in control of the pain, and higher pain acceptance. Small (nonsignificant) effect sizes were found for pain measures. There were no significant differences in the measures just after the intervention vs the 6-month follow-up. A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions in patients with long-lasting chronic pain. © 2014 American Academy of Pain Medicine.

  15. The Effect of Random Error on Diagnostic Accuracy Illustrated with the Anthropometric Diagnosis of Malnutrition

    PubMed Central

    2016-01-01

    Background It is often thought that random measurement error has a minor effect upon the results of an epidemiological survey. Theoretically, errors of measurement should always increase the spread of a distribution. Defining an illness by having a measurement outside an established healthy range will lead to an inflated prevalence of that condition if there are measurement errors. Methods and results A Monte Carlo simulation was conducted of anthropometric assessment of children with malnutrition. Random errors of increasing magnitude were imposed upon the populations and showed that there was an increase in the standard deviation with each of the errors that became exponentially greater with the magnitude of the error. The potential magnitude of the resulting error of reported prevalence of malnutrition were compared with published international data and found to be of sufficient magnitude to make a number of surveys and the numerous reports and analyses that used these data unreliable. Conclusions The effect of random error in public health surveys and the data upon which diagnostic cut-off points are derived to define “health” has been underestimated. Even quite modest random errors can more than double the reported prevalence of conditions such as malnutrition. Increasing sample size does not address this problem, and may even result in less accurate estimates. More attention needs to be paid to the selection, calibration and maintenance of instruments, measurer selection, training & supervision, routine estimation of the likely magnitude of errors using standardization tests, use of statistical likelihood of error to exclude data from analysis and full reporting of these procedures in order to judge the reliability of survey reports. PMID:28030627

  16. Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

    PubMed

    Hendren, Samantha; Griggs, Jennifer J; Epstein, Ronald; Humiston, Sharon; Jean-Pierre, Pascal; Winters, Paul; Sanders, Mechelle; Loader, Starlene; Fiscella, Kevin

    2012-10-01

    Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation. 2012 AACR

  17. The effect of statins on erectile dysfunction: a meta-analysis of randomized trials.

    PubMed

    Kostis, John B; Dobrzynski, Jeanne M

    2014-07-01

    Erectile dysfunction (ED) is common in older men, especially those with comorbidities such as diabetes and atherosclerotic disease, conditions where statins are frequently prescribed. To examine the effect of statin therapy on ED using the five-item version of the International Inventory of Erectile Function (IIEF). We performed a random-effects meta-analysis of studies identified by a systematic search of MEDLINE, Web of Knowledge, the Cochrane Database, and ClinicalTrials.gov. Examination of the 186 retrieved citations resulted in the selection of 11 randomized trials for inclusion in the meta-analysis. Change in the IIEF score. IIEF increased by 3.4 points (95% CI 1.7-5.0, P = 0.0001) with statins compared to control. This effect remained statistically significant after multiple sensitivity analyses, including analysis for publication bias, a cumulative meta-analysis, and 11 repeated analyses with each study omitted sequentially. The increase in IIEF with statins was approximately one-third to one-half of that previously reported with phosphodiesterase-5 inhibitors and larger than the effect of lifestyle modification. Metaregression showed an increase in benefit with decreasing lipophilicity. The average age of participants and the degree of LDL cholesterol lowering did not alter the effect on IIEF. Statins cause a clinically relevant improvement of erectile function as measured by the five-item version of the IIEF. © 2014 International Society for Sexual Medicine.

  18. A Randomized Control Intervention Investigating the Effects of Acute Exercise on Emotional Regulation.

    PubMed

    Edwards, Meghan K; Rhodes, Ryan E; Loprinzi, Paul D

    2017-09-01

    Exercise may help to cope with hectic or demanding events after a stressful situation occurs. Limited research has evaluated whether exercise, prior to a stressor, helps to facilitate subsequent emotional regulation. This pilot study addresses this novel paradigm. We employed a randomized controlled trial evaluating the effects of acute exercise on emotional regulation. Participants were randomly assigned to stretch (control group, N = 10), walk (N = 9), or jog (N = 8) for 15-minutes, after which they were exposed to a film clip intended to elicit a negative emotional response. Participants' emotions were monitored before and during exercise, as well as after the film clip. Emotional responses were evaluated using the Exercise Induced Feeling Inventory and Affective Circumplex Scale. A group x time splitplot interaction effect was significant for anger (p = .046) and anxiousness (p = .038). Follow-up analyses showed that only the stretching group (p = .048) had a significantly increased anger score from baseline to post-film clip, suggesting a protective emotional effect from walking and jogging. Exercise was effective in regulating anger and anxiousness after a stressful event. These findings provide evidence for potential preventive effects of exercise in facilitating emotional regulation.

  19. Sequential change detection and monitoring of temporal trends in random-effects meta-analysis.

    PubMed

    Dogo, Samson Henry; Clark, Allan; Kulinskaya, Elena

    2017-06-01

    Temporal changes in magnitude of effect sizes reported in many areas of research are a threat to the credibility of the results and conclusions of meta-analysis. Numerous sequential methods for meta-analysis have been proposed to detect changes and monitor trends in effect sizes so that meta-analysis can be updated when necessary and interpreted based on the time it was conducted. The difficulties of sequential meta-analysis under the random-effects model are caused by dependencies in increments introduced by the estimation of the heterogeneity parameter τ 2 . In this paper, we propose the use of a retrospective cumulative sum (CUSUM)-type test with bootstrap critical values. This method allows retrospective analysis of the past trajectory of cumulative effects in random-effects meta-analysis and its visualization on a chart similar to CUSUM chart. Simulation results show that the new method demonstrates good control of Type I error regardless of the number or size of the studies and the amount of heterogeneity. Application of the new method is illustrated on two examples of medical meta-analyses. © 2016 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd. © 2016 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd.

  20. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

    ERIC Educational Resources Information Center

    Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-01-01

    Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

  1. A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

    ERIC Educational Resources Information Center

    Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

    2017-01-01

    Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

  2. Mediating Parent Learning to Promote Social Communication for Toddlers with Autism: Effects from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Schertz, Hannah H.; Odom, Samuel L.; Baggett, Kathleen M.; Sideris, John H.

    2018-01-01

    A randomized controlled trial was conducted to evaluate effects of the Joint Attention Mediated Learning (JAML) intervention. Toddlers with autism spectrum disorders (ASD) aged 16-30 months (n = 144) were randomized to intervention and community control conditions. Parents, who participated in 32 weekly home-based sessions, followed a mediated…

  3. The Effects of School Gardens on Children's Science Knowledge: A Randomized Controlled Trial of Low-Income Elementary Schools

    ERIC Educational Resources Information Center

    Wells, Nancy M.; Myers, Beth M.; Todd, Lauren E.; Barale, Karen; Gaolach, Brad; Ferenz, Gretchen; Aitken, Martha; Henderson, Charles R.; Tse, Caroline; Pattison, Karen Ostlie; Taylor, Cayla; Connerly, Laura; Carson, Janet B.; Gensemer, Alexandra Z.; Franz, Nancy K.; Falk, Elizabeth

    2015-01-01

    This randomized controlled trial or "true experiment" examines the effects of a school garden intervention on the science knowledge of elementary school children. Schools were randomly assigned to a group that received the garden intervention (n?=?25) or to a waitlist control group that received the garden intervention at the end of the…

  4. Utility and Cost-Effectiveness of Motivational Messaging to Increase Survey Response in Physicians: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Chan, Randolph C. H.; Mak, Winnie W. S.; Pang, Ingrid H. Y.; Wong, Samuel Y. S.; Tang, Wai Kwong; Lau, Joseph T. F.; Woo, Jean; Lee, Diana T. F.; Cheung, Fanny M.

    2018-01-01

    The present study examined whether, when, and how motivational messaging can boost the response rate of postal surveys for physicians based on Higgin's regulatory focus theory, accounting for its cost-effectiveness. A three-arm, blinded, randomized controlled design was used. A total of 3,270 doctors were randomly selected from the registration…

  5. Cognitive-Behavioral Treatment for Panic Disorder with Agoraphobia: A Randomized, Controlled Trial and Cost-Effectiveness Analysis

    ERIC Educational Resources Information Center

    Roberge, Pasquale; Marchand, Andre; Reinharz, Daniel; Savard, Pierre

    2008-01-01

    A randomized, controlled trial was conducted to examine the cost-effectiveness of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants were randomly assigned to standard (n = 33), group (n = 35), and brief (n = 32) treatment conditions. Results show significant clinical and statistical improvement…

  6. The Ecological Effects of Universal and Selective Violence Prevention Programs for Middle School Students: A Randomized Trial

    ERIC Educational Resources Information Center

    Simon, Thomas R.; Ikeda, Robin M.; Smith, Emilie Phillips; Reese, Le'Roy E.; Rabiner, David L.; Miller, Shari; Winn, Donna-Marie; Dodge, Kenneth A.; Asher, Steven R.; Horne, Arthur M.; Orpinas, Pamela; Martin, Roy; Quinn, William H.; Tolan, Patrick H.; Gorman-Smith, Deborah; Henry, David B.; Gay, Franklin N.; Schoeny, Michael; Farrell, Albert D.; Meyer, Aleta L.; Sullivan, Terri N.; Allison, Kevin W.

    2009-01-01

    This study reports the findings of a multisite randomized trial evaluating the separate and combined effects of 2 school-based approaches to reduce violence among early adolescents. A total of 37 schools at 4 sites were randomized to 4 conditions: (1) a universal intervention that involved implementing a student curriculum and teacher training…

  7. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    ERIC Educational Resources Information Center

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  8. The Effect of Interference on Temporal Order Memory for Random and Fixed Sequences in Nondemented Older Adults

    ERIC Educational Resources Information Center

    Tolentino, Jerlyn C.; Pirogovsky, Eva; Luu, Trinh; Toner, Chelsea K.; Gilbert, Paul E.

    2012-01-01

    Two experiments tested the effect of temporal interference on order memory for fixed and random sequences in young adults and nondemented older adults. The results demonstrate that temporal order memory for fixed and random sequences is impaired in nondemented older adults, particularly when temporal interference is high. However, temporal order…

  9. Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

    ERIC Educational Resources Information Center

    Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

    2017-01-01

    A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

  10. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    PubMed

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  11. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial

    PubMed Central

    Xu, Sha-bei; Huang, Bo; Zhang, Chen-yan; Du, Peng; Yuan, Qi; Bi, Gui-juan; Zhang, Gui-bin; Xie, Min-jie; Luo, Xiang; Huang, Guang-ying; Wang, Wei

    2013-01-01

    Background: The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. Methods: We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization. Results: After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23–7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29–13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33–37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04–1.09). Interpretation: Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. Trial registration: Clinicaltrials.gov no. NCT00685789. PMID:23439629

  12. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial.

    PubMed

    Xu, Sha-bei; Huang, Bo; Zhang, Chen-yan; Du, Peng; Yuan, Qi; Bi, Gui-juan; Zhang, Gui-bin; Xie, Min-jie; Luo, Xiang; Huang, Guang-ying; Wang, Wei

    2013-04-02

    The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization. After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23-7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29-13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33-37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04-1.09). Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. Clinicaltrials.gov no. NCT00685789.

  13. Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial.

    PubMed

    Michalsen, Andreas; Bock, Silke; Lüdtke, Rainer; Rampp, Thomas; Baecker, Marcus; Bachmann, Jürgen; Langhorst, Jost; Musial, Frauke; Dobos, Gustav J

    2009-06-01

    We investigated the effectiveness of cupping, a traditional method of treating musculoskeletal pain, in patients with carpal tunnel syndrome (CTS) in an open randomized trial. n = 52 outpatients (58.5 +/- 8.0 years) with neurologically confirmed CTS were randomly assigned to either a verum (n = 26) or a control group (n = 26). Verum patients were treated with a single application of wet cupping, and control patients with a single local application of heat within the region overlying the trapezius muscle. Patients were followed up on day 7 after treatment. The primary outcome, severity of CTS symptoms (VAS), was reduced from 61.5 +/- 20.5 to 24.6 +/- 22.7 mm at day 7 in the cupping group and from 67.1 +/- 20.2 to 51.7 +/- 23.9 mm in the control group [group difference -24.5mm (95%CI -36.1; -2.9, P < .001)]. Significant treatment effects were also found for the Levine CTS-score (-.6 pts: 95%CI -.9; -.2, P = .002), neck pain (-12.6mm; 95%CI -18.8; -6.4, P < .001), functional disability (DASH-Score) (-11.1 pts; 95%CI -17.1; -5.1, P < .001), and physical quality of life (.3; 95%CI .0; .3, P = .048). The treatment was safe and well tolerated. We conclude that cupping therapy may be effective in relieving the pain and other symptoms related to CTS. The efficacy of cupping in the long-term management of CTS and related mechanisms remains to be clarified. The results of a randomized trial on the clinical effects of traditional cupping therapy in patients with carpal tunnel syndrome are presented. Cupping of segmentally related shoulder zones appears to alleviate the symptoms of carpal tunnel syndrome.

  14. Effect of A-site deficiency in LaMn{sub 0.9}Co{sub 0.1}O{sub 3} perovskites on their catalytic performance for soot combustion

    SciTech Connect

    Dinamarca, Robinson; Garcia, Ximena; Jimenez, Romel

    Highlights: • A-site defective perovskites increases the oxidation state of the B-cation. • Not always non-stoichiometric perovskites exhibit higher catalytic activity in soot combustion. • The highly symmetric cubic crystalline structure diminishes the redox properties of perovskites. - Abstract: The influence of lanthanum stoichiometry in Ag-doped (La{sub 1-x}Ag{sub x}Mn{sub 0.9}Co{sub 0.1}O{sub 3}) and A-site deficient (La{sub 1-x}Mn{sub 0.9}Co{sub 0.1}O{sub 3-δ}) perovskites with x equal to 10, 20 and 30 at.% has been investigated in catalysts for soot combustion. The catalysts were prepared by the amorphous citrate method and characterized by XRD, nitrogen adsorption, XPS, O{sub 2}-TPD and TPR. The formationmore » of a rhombohedral excess-oxygen perovskite for Ag-doped and a cubic perovskite structure for an A-site deficient series is confirmed. The efficient catalytic performance of the larger Ag-doped perovskite structure is attributed to the rhombohedral crystalline structure, Ag{sub 2}O segregated phases and the redox pair Mn{sup 4+}/Mn{sup 3+}. A poor catalytic activity for soot combustion was observed with A-site deficient perovskites, despite the increase in the redox pair Mn{sup 4+}/Mn{sup 3+}, which is attributed to the cubic crystalline structure.« less

  15. Is EEG-biofeedback an effective treatment in autism spectrum disorders? A randomized controlled trial.

    PubMed

    Kouijzer, Mirjam E J; van Schie, Hein T; Gerrits, Berrie J L; Buitelaar, Jan K; de Moor, Jan M H

    2013-03-01

    EEG-biofeedback has been reported to reduce symptoms of autism spectrum disorders (ASD) in several studies. However, these studies did not control for nonspecific effects of EEG-biofeedback and did not distinguish between participants who succeeded in influencing their own EEG activity and participants who did not. To overcome these methodological shortcomings, this study evaluated the effects of EEG-biofeedback in ASD in a randomized pretest-posttest control group design with blinded active comparator and six months follow-up. Thirty-eight participants were randomly allocated to the EEG-biofeedback, skin conductance (SC)-biofeedback or waiting list group. EEG- and SC-biofeedback sessions were similar and participants were blinded to the type of feedback they received. Assessments pre-treatment, post-treatment, and after 6 months included parent ratings of symptoms of ASD, executive function tasks, and 19-channel EEG recordings. Fifty-four percent of the participants significantly reduced delta and/or theta power during EEG-biofeedback sessions and were identified as EEG-regulators. In these EEG-regulators, no statistically significant reductions of symptoms of ASD were observed, but they showed significant improvement in cognitive flexibility as compared to participants who managed to regulate SC. EEG-biofeedback seems to be an applicable tool to regulate EEG activity and has specific effects on cognitive flexibility, but it did not result in significant reductions in symptoms of ASD. An important finding was that no nonspecific effects of EEG-biofeedback were demonstrated.

  16. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. (c) 2015 APA, all rights reserved).

  17. Clinical effects of probiotics containing Bacillus species on gingivitis: a pilot randomized controlled trial.

    PubMed

    Alkaya, B; Laleman, I; Keceli, S; Ozcelik, O; Cenk Haytac, M; Teughels, W

    2017-06-01

    Lactobacillus spp. and bifidobacteria are the most frequently used probiotics in oral health research. However, although probiotic effects have been suggested for other genera, such as bacilli, no trials are available to describe the effect of bacilli probiotics on gingivitis in humans. The aim of the present study was to evaluate the clinical effects of a bacilli-containing toothpaste, a mouthrinse and a toothbrush cleaner versus a placebo in patients with generalized gingivitis. In this double-blind placebo-controlled randomized clinical trial, nonsmoking, systemically healthy patients with generalized gingivitis were included. They used a placebo or an experimental probiotic Bacillus subtilis-, Bacillus megaterium- and Bacillus pumulus-containing toothpaste, mouthrinse and toothbrush cleaner for 8 wk. Primary outcome measures of interest were plaque and gingivitis index, and the secondary outcome measures were pocket probing depth and bleeding on probing. Twenty male and 20 female patients were randomized over the two groups. All participants could be included in the final analysis. Although plaque and gingivitis indices were significantly reduced after 8 wk, no intergroup differences could be found at any time point. Also, for the secondary outcome measure, intragroup but no intergroup differences could be detected. No harm or unintended effects were reported by the patients after using the study products. This study did not show any statistically significant differences between a placebo and a bacilli-containing toothpaste, mouthrinse and toothbrush cleaner on gingivitis parameters. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Technology diffusion in hospitals: a log odds random effects regression model.

    PubMed

    Blank, Jos L T; Valdmanis, Vivian G

    2015-01-01

    This study identifies the factors that affect the diffusion of hospital innovations. We apply a log odds random effects regression model on hospital micro data. We introduce the concept of clustering innovations and the application of a log odds random effects regression model to describe the diffusion of technologies. We distinguish a number of determinants, such as service, physician, and environmental, financial and organizational characteristics of the 60 Dutch hospitals in our sample. On the basis of this data set on Dutch general hospitals over the period 1995-2002, we conclude that there is a relation between a number of determinants and the diffusion of innovations underlining conclusions from earlier research. Positive effects were found on the basis of the size of the hospitals, competition and a hospital's commitment to innovation. It appears that if a policy is developed to further diffuse innovations, the external effects of demand and market competition need to be examined, which would de facto lead to an efficient use of technology. For the individual hospital, instituting an innovations office appears to be the most prudent course of action. © 2013 The Authors. International Journal of Health Planning and Management published by John Wiley & Sons, Ltd.

  19. Random-effects meta-analysis: the number of studies matters.

    PubMed

    Guolo, Annamaria; Varin, Cristiano

    2017-06-01

    This paper investigates the impact of the number of studies on meta-analysis and meta-regression within the random-effects model framework. It is frequently neglected that inference in random-effects models requires a substantial number of studies included in meta-analysis to guarantee reliable conclusions. Several authors warn about the risk of inaccurate results of the traditional DerSimonian and Laird approach especially in the common case of meta-analysis involving a limited number of studies. This paper presents a selection of likelihood and non-likelihood methods for inference in meta-analysis proposed to overcome the limitations of the DerSimonian and Laird procedure, with a focus on the effect of the number of studies. The applicability and the performance of the methods are investigated in terms of Type I error rates and empirical power to detect effects, according to scenarios of practical interest. Simulation studies and applications to real meta-analyses highlight that it is not possible to identify an approach uniformly superior to alternatives. The overall recommendation is to avoid the DerSimonian and Laird method when the number of meta-analysis studies is modest and prefer a more comprehensive procedure that compares alternative inferential approaches. R code for meta-analysis according to all of the inferential methods examined in the paper is provided.

  20. Differential Peer Effects, Student Achievement, and Student Absenteeism: Evidence From a Large-Scale Randomized Experiment.

    PubMed

    Eren, Ozkan

    2017-04-01

    Using data from a well-executed randomized experiment, I examine the effects of gender composition and peer achievement on high school students' outcomes in disadvantaged neighborhoods. Results show that having a higher proportion of female peers in the classroom improves girls' math test scores only in less-advanced courses. For male students, the estimated gender peer effects are positive but less precisely estimated. I also find no effect of average classroom achievement on female math test scores. Males, on the other hand, seem to benefit from a higher-achieving classroom. I propose mechanisms relating to lower gender stereotype influences and gender-specific attitudes toward competition as potential explanations for peer effects findings. Finally, having a higher proportion of female students in the classroom decreases student absenteeism among male students but has no impact on female attendance.

  1. Rigorous control conditions diminish treatment effects in weight loss randomized controlled trials

    PubMed Central

    Dawson, John A.; Kaiser, Kathryn A.; Affuso, Olivia; Cutter, Gary R.; Allison, David B.

    2015-01-01

    Background It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG) randomized controlled trials (RCTs). Subjects/Methods We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework is used in order to model and understand the relationship between treatment effects and control group outcomes. Results Under the informed model, an increase in control group WL of one kilogram corresponds with an expected shrinkage of the treatment effect by 0.309 kg [95% CI (−0.480, −0.138), p = 0.00081]; this result is robust against violations of the model assumptions. Conclusions We find that control conditions with large weight losses diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies. PMID:26449419

  2. Multilevel covariance regression with correlated random effects in the mean and variance structure.

    PubMed

    Quintero, Adrian; Lesaffre, Emmanuel

    2017-09-01

    Multivariate regression methods generally assume a constant covariance matrix for the observations. In case a heteroscedastic model is needed, the parametric and nonparametric covariance regression approaches can be restrictive in the literature. We propose a multilevel regression model for the mean and covariance structure, including random intercepts in both components and allowing for correlation between them. The implied conditional covariance function can be different across clusters as a result of the random effect in the variance structure. In addition, allowing for correlation between the random intercepts in the mean and covariance makes the model convenient for skewedly distributed responses. Furthermore, it permits us to analyse directly the relation between the mean response level and the variability in each cluster. Parameter estimation is carried out via Gibbs sampling. We compare the performance of our model to other covariance modelling approaches in a simulation study. Finally, the proposed model is applied to the RN4CAST dataset to identify the variables that impact burnout of nurses in Belgium. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  3. Effect of intradermal human recombinant copper-zinc superoxide dismutase on random pattern flaps in rats.

    PubMed

    Schein, Ophir; Westreich, Melvyn; Shalom, Avshalom

    2013-09-01

    Studies have focused on enhancing flap viability using superoxide dismutase (SOD), but only a few used SOD from human origin, and most gave the compound systemically. We evaluated the ability of SOD to improve random skin flap survival using human recombinant copper-zinc superoxide dismutase (Hr-CuZnSOD) in variable doses, injected intradermally into the flap. Seventy male Sprague Dawley rats were randomly assigned into 4 groups. Cephalic random pattern flaps were elevated on their backs and intradermal injections of different dosages of Hr-CuZnSOD were given 15 minutes before surgery. Flap survival was evaluated by fluorescein fluorescence. Analysis of variance (ANOVA) and t test statistical analyses were performed. Flap survival in all treated groups was significantly better than in the controls. The beneficial effect of HR-CuZnSOD on flap survival is attained when it is given intradermally into the flap tissue. Theoretically, Hr-CuZnSOD delivered with local anesthetics used in flap elevation may be a valuable clinical tool. Copyright © 2012 Wiley Periodicals, Inc.

  4. The Effects of Inhalation Aromatherapy on Anxiety in Patients With Myocardial Infarction: A Randomized Clinical Trial

    PubMed Central

    Najafi, Zahra; Taghadosi, Mohsen; Sharifi, Khadijeh; Farrokhian, Alireza; Tagharrobi, Zahra

    2014-01-01

    Background: Anxiety is an important mental health problem in patients with cardiac disease. Anxiety reduces patients’ quality of life and increases the risk of different cardiac complications. Objectives: The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infarction. Patients and Methods: This was a randomized clinical trial conduced on 68 patients with myocardial infarction hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in 2013. By using the block randomization technique, patients were randomly assigned to experimental (33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days) and control (35 patients receiving routine care of study setting including no aromatherapy) groups. At the beginning of study and twenty minutes after each aromatherapy session, anxiety state of patients was assessed using the Spielberger’s State Anxiety Inventory. Data was analyzed using SPSS v. 16.0. We used Chi-square, Fisher’s exact, independent-samples T-test and repeated measures analysis of variance to analyze the study data. Results: The study groups did not differ significantly regarding baseline anxiety mean and demographic characteristics. However, after the administration of aromatherapy, anxiety mean in the experimental group was significantly lower than the control group. Conclusions: Inhalation aromatherapy with lavender aroma can reduce anxiety in patients with myocardial infarction. Consequently, healthcare providers, particularly nurses, can use this strategy to improve postmyocardial infarction anxiety management. PMID:25389481

  5. Effect of random errors in planar PIV data on pressure estimation in vortex dominated flows

    NASA Astrophysics Data System (ADS)

    McClure, Jeffrey; Yarusevych, Serhiy

    2015-11-01

    The sensitivity of pressure estimation techniques from Particle Image Velocimetry (PIV) measurements to random errors in measured velocity data is investigated using the flow over a circular cylinder as a test case. Direct numerical simulations are performed for ReD = 100, 300 and 1575, spanning laminar, transitional, and turbulent wake regimes, respectively. A range of random errors typical for PIV measurements is applied to synthetic PIV data extracted from numerical results. A parametric study is then performed using a number of common pressure estimation techniques. Optimal temporal and spatial resolutions are derived based on the sensitivity of the estimated pressure fields to the simulated random error in velocity measurements, and the results are compared to an optimization model derived from error propagation theory. It is shown that the reductions in spatial and temporal scales at higher Reynolds numbers leads to notable changes in the optimal pressure evaluation parameters. The effect of smaller scale wake structures is also quantified. The errors in the estimated pressure fields are shown to depend significantly on the pressure estimation technique employed. The results are used to provide recommendations for the use of pressure and force estimation techniques from experimental PIV measurements in vortex dominated laminar and turbulent wake flows.

  6. Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial.

    PubMed

    Udsen, Flemming Witt; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars Holger

    2014-05-21

    Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone. The present study is known as 'TeleCare North' in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight). There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial. Clinicaltrials.gov, http://NCT01984840, November 14, 2013.

  7. Two new methods to fit models for network meta-analysis with random inconsistency effects.

    PubMed

    Law, Martin; Jackson, Dan; Turner, Rebecca; Rhodes, Kirsty; Viechtbauer, Wolfgang

    2016-07-28

    Meta-analysis is a valuable tool for combining evidence from multiple studies. Network meta-analysis is becoming more widely used as a means to compare multiple treatments in the same analysis. However, a network meta-analysis may exhibit inconsistency, whereby the treatment effect estimates do not agree across all trial designs, even after taking between-study heterogeneity into account. We propose two new estimation methods for network meta-analysis models with random inconsistency effects. The model we consider is an extension of the conventional random-effects model for meta-analysis to the network meta-analysis setting and allows for potential inconsistency using random inconsistency effects. Our first new estimation method uses a Bayesian framework with empirically-based prior distributions for both the heterogeneity and the inconsistency variances. We fit the model using importance sampling and thereby avoid some of the difficulties that might be associated with using Markov Chain Monte Carlo (MCMC). However, we confirm the accuracy of our importance sampling method by comparing the results to those obtained using MCMC as the gold standard. The second new estimation method we describe uses a likelihood-based approach, implemented in the metafor package, which can be used to obtain (restricted) maximum-likelihood estimates of the model parameters and profile likelihood confidence intervals of the variance components. We illustrate the application of the methods using two contrasting examples. The first uses all-cause mortality as an outcome, and shows little evidence of between-study heterogeneity or inconsistency. The second uses "ear discharge" as an outcome, and exhibits substantial between-study heterogeneity and inconsistency. Both new estimation methods give results similar to those obtained using MCMC. The extent of heterogeneity and inconsistency should be assessed and reported in any network meta-analysis. Our two new methods can be used to fit

  8. The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

    PubMed Central

    Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

    2014-01-01

    Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who

  9. The effectiveness of lifestyle triple P in the Netherlands: a randomized controlled trial.

    PubMed

    Gerards, Sanne M P L; Dagnelie, Pieter C; Gubbels, Jessica S; van Buuren, Stef; Hamers, Femke J M; Jansen, Maria W J; van der Goot, Odilia H M; de Vries, Nanne K; Sanders, Matthew R; Kremers, Stef P J

    2015-01-01

    Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4-8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children's body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children's dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. No intervention effects were found on children's body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children's soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent's report of children's time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Although the Lifestyle Triple P intervention showed positive effects on some parent reported child

  10. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial.

    PubMed

    Bekelis, Kimon; Calnan, Daniel; Simmons, Nathan; MacKenzie, Todd A; Kakoulides, George

    2017-06-01

    To investigate the effect of exposure to a virtual reality (VR) environment preoperatively on patient-reported outcomes for surgical operations. There is a scarcity of well-developed quality improvement initiatives targeting patient satisfaction. We performed a randomized controlled trial of patients undergoing cranial and spinal operations in a tertiary referral center. Patients underwent a 1:1 randomization to an immersive preoperative VR experience or standard preoperative experience stratified on type of operation. The primary outcome measures were the Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) score and the Amsterdam Preoperative Anxiety and Information (APAIS) score, as markers of the patient's experience during the surgical encounter. During the study period, a total of 127 patients (mean age 55.3 years, 41.9% females) underwent randomization. The average EVAN-G score was 84.3 (standard deviation, SD, 6.4) after VR, and 64.3 (SD, 11.7) after standard preoperative experience (difference, 20.0; 95% confidence interval, CI, 16.6-23.3). Exposure to an immersive VR experience also led to higher APAIS score (difference, 29.9; 95% CI, 24.5-35.2). In addition, VR led to lower preoperative VAS stress score (difference, -41.7; 95% CI, -33.1 to -50.2), and higher preoperative VAS preparedness (difference, 32.4; 95% CI, 24.9-39.8), and VAS satisfaction (difference, 33.2; 95% CI, 25.4-41.0) scores. No association was identified with VAS stress score (difference, -1.6; 95% CI, -13.4 to 10.2). In a randomized controlled trial, we demonstrated that patients exposed to preoperative VR had increased satisfaction during the surgical encounter. Harnessing the power of this technology, hospitals can create an immersive environment that minimizes stress, and enhances the perioperative experience.

  11. The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

    PubMed

    Eldabe, Sam; Thomson, Simon; Duarte, Rui; Brookes, Morag; deBelder, Mark; Raphael, Jon; Davies, Ed; Taylor, Rod

    2016-01-01

    Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial. © 2015 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of

  12. Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial.

    PubMed

    Cao, Yan; Yin, Xuan; Soto-Aguilar, Francisca; Liu, Yiping; Yin, Ping; Wu, Junyi; Zhu, Bochang; Li, Wentao; Lao, Lixing; Xu, Shifen

    2016-11-16

    The incidence, mortality, and prevalence of stroke are high in China. Stroke is commonly associated with insomnia; both insomnia and stroke have been effectively treated with acupuncture for a long time. The aim of this proposed trial is to assess the therapeutic effect of acupuncture on insomnia following stroke. This proposed study is a single-center, single-blinded (patient-assessor-blinded), parallel-group randomized controlled trial. We will randomly assign 60 participants with insomnia following stroke into two groups in a 1:1 ratio. The intervention group will undergo traditional acupuncture that achieves the De-qi sensation, and the control group will receive sham acupuncture without needle insertion. The same acupoints (DU20, DU24, EX-HN3, EX-HN22, HT7, and SP6) will be used in both groups. Treatments will be given to all participants three times a week for the subsequent 4 weeks. The primary outcome will be the Pittsburgh Sleep Quality Index. The secondary outcomes will be: the Insomnia Severity Index; sleep efficacy, sleep awakenings, and total sleep time recorded via actigraphy; the National Institutes of Health Stroke Scale; the Stroke-Specific Quality of Life score; the Hospital Anxiety and Depression Scale. The use of estazolam will be permitted and regulated under certain conditions. Outcomes will be assessed at baseline, 2 weeks after treatment commencement, 4 weeks after treatment commencement, and at the 8-week follow-up. This proposed study will contribute to expanding knowledge about acupuncture treatment for insomnia following stroke. This will be a high-quality randomized controlled trial with strict methodology and few design deficits. It will investigate the effectiveness of acupuncture as an alternative treatment for insomnia following stroke. Chinese Clinical Trial Registry identifier: ChiCTR-IIC-16008382 . Registered on 28 April 2016.

  13. Postural stability effects of random vibration at the feet of construction workers in simulated elevation.

    PubMed

    Simeonov, P; Hsiao, H; Powers, J; Ammons, D; Kau, T; Amendola, A

    2011-07-01

    The risk of falls from height on a construction site increases under conditions which degrade workers' postural control. At elevation, workers depend heavily on sensory information from their feet to maintain balance. The study tested two hypotheses: "sensory enhancement"--sub-sensory (undetectable) random mechanical vibrations at the plantar surface of the feet can improve worker's balance at elevation; and "sensory suppression"--supra-sensory (detectable) random mechanical vibrations can have a degrading effect on balance in the same experimental settings. Six young (age 20-35) and six aging (age 45-60) construction workers were tested while standing in standard and semi-tandem postures on instrumented gel insoles. The insoles applied sub- or supra-sensory levels of random mechanical vibrations to the feet. The tests were conducted in a surround-screen virtual reality system, which simulated a narrow plank at elevation on a construction site. Upper body kinematics was assessed with a motion-measurement system. Postural stability effects were evaluated by conventional and statistical mechanics sway measures, as well as trunk angular displacement parameters. Analysis of variance did not confirm the "sensory enhancement" hypothesis, but provided evidence for the "sensory suppression" hypothesis. The supra-sensory vibration had a destabilizing effect, which was considerably stronger in the semi-tandem posture and affected most of the sway variables. Sensory suppression associated with elevated vibration levels on a construction site may increase the danger of losing balance. Construction workers at elevation, e.g., on a beam or narrow plank might be at increased risk of fall if they can detect vibrations under their feet. To reduce the possibility of losing balance, mechanical vibration to supporting structures used as walking/working surfaces should be minimized when performing construction tasks at elevation. Published by Elsevier Ltd.

  14. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial.

    PubMed

    Ajimsha, M S; Binsu, D; Chithra, S

    2014-06-01

    Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population. To investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST). Randomized, controlled, double blinded trial. Nonprofit research foundation clinic in India. Sixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow-up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 (P<0.001). Patients in the MFR and control groups reported a 72.4% and 7.4% reduction, respectively, in their pain and functional disability in week 4 compared with that in week 1, which persisted as 60.6% in the follow-up at week 12 in the MFR group compared to the baseline. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (P<0.05). This study provides evidence that MFR is more effective than a control intervention for PHP. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Role of Statistical Random-Effects Linear Models in Personalized Medicine

    PubMed Central

    Diaz, Francisco J; Yeh, Hung-Wen; de Leon, Jose

    2012-01-01

    Some empirical studies and recent developments in pharmacokinetic theory suggest that statistical random-effects linear models are valuable tools that allow describing simultaneously patient populations as a whole and patients as individuals. This remarkable characteristic indicates that these models may be useful in the development of personalized medicine, which aims at finding treatment regimes that are appropriate for particular patients, not just appropriate for the average patient. In fact, published developments show that random-effects linear models may provide a solid theoretical framework for drug dosage individualization in chronic diseases. In particular, individualized dosages computed with these models by means of an empirical Bayesian approach may produce better results than dosages computed with some methods routinely used in therapeutic drug monitoring. This is further supported by published empirical and theoretical findings that show that random effects linear models may provide accurate representations of phase III and IV steady-state pharmacokinetic data, and may be useful for dosage computations. These models have applications in the design of clinical algorithms for drug dosage individualization in chronic diseases; in the computation of dose correction factors; computation of the minimum number of blood samples from a patient that are necessary for calculating an optimal individualized drug dosage in therapeutic drug monitoring; measure of the clinical importance of clinical, demographic, environmental or genetic covariates; study of drug-drug interactions in clinical settings; the implementation of computational tools for web-site-based evidence farming; design of pharmacogenomic studies; and in the development of a pharmacological theory of dosage individualization. PMID:23467392

  16. Role of Statistical Random-Effects Linear Models in Personalized Medicine.

    PubMed

    Diaz, Francisco J; Yeh, Hung-Wen; de Leon, Jose

    2012-03-01

    Some empirical studies and recent developments in pharmacokinetic theory suggest that statistical random-effects linear models are valuable tools that allow describing simultaneously patient populations as a whole and patients as individuals. This remarkable characteristic indicates that these models may be useful in the development of personalized medicine, which aims at finding treatment regimes that are appropriate for particular patients, not just appropriate for the average patient. In fact, published developments show that random-effects linear models may provide a solid theoretical framework for drug dosage individualization in chronic diseases. In particular, individualized dosages computed with these models by means of an empirical Bayesian approach may produce better results than dosages computed with some methods routinely used in therapeutic drug monitoring. This is further supported by published empirical and theoretical findings that show that random effects linear models may provide accurate representations of phase III and IV steady-state pharmacokinetic data, and may be useful for dosage computations. These models have applications in the design of clinical algorithms for drug dosage individualization in chronic diseases; in the computation of dose correction factors; computation of the minimum number of blood samples from a patient that are necessary for calculating an optimal individualized drug dosage in therapeutic drug monitoring; measure of the clinical importance of clinical, demographic, environmental or genetic covariates; study of drug-drug interactions in clinical settings; the implementation of computational tools for web-site-based evidence farming; design of pharmacogenomic studies; and in the development of a pharmacological theory of dosage individualization.

  17. Coordinate based random effect size meta-analysis of neuroimaging studies.

    PubMed

    Tench, C R; Tanasescu, Radu; Constantinescu, C S; Auer, D P; Cottam, W J

    2017-06-01

    Low power in neuroimaging studies can make them difficult to interpret, and Coordinate based meta-analysis (CBMA) may go some way to mitigating this issue. CBMA has been used in many analyses to detect where published functional MRI or voxel-based morphometry studies testing similar hypotheses report significant summary results (coordinates) consistently. Only the reported coordinates and possibly t statistics are analysed, and statistical significance of clusters is determined by coordinate density. Here a method of performing coordinate based random effect size meta-analysis and meta-regression is introduced. The algorithm (ClusterZ) analyses both coordinates and reported t statistic or Z score, standardised by the number of subjects. Statistical significance is determined not by coordinate density, but by a random effects meta-analyses of reported effects performed cluster-wise using standard statistical methods and taking account of censoring inherent in the published summary results. Type 1 error control is achieved using the false cluster discovery rate (FCDR), which is based on the false discovery rate. This controls both the family wise error rate under the null hypothesis that coordinates are randomly drawn from a standard stereotaxic space, and the proportion of significant clusters that are expected under the null. Such control is necessary to avoid propagating and even amplifying the very issues motivating the meta-analysis in the first place. ClusterZ is demonstrated on both numerically simulated data and on real data from reports of grey matter loss in multiple sclerosis (MS) and syndromes suggestive of MS, and of painful stimulus in healthy controls. The software implementation is available to download and use freely. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Business as a Site of Language Contact.

    ERIC Educational Resources Information Center

    Harris, Sandra; Bargiela-Chiappini, Francesca

    2003-01-01

    Discusses the field of language for business. Argues for redressing the balance of research into business as a site of language contact in favor of less well-represented languages and cultures through indigenous discourse studies, and notes the increasing frequency and importance of work involving Asian languages. (Author/VWL)

  19. Coherent light scattering of heterogeneous randomly rough films and effective medium in the theory of electromagnetic wave multiple scattering

    SciTech Connect

    Berginc, G

    2013-11-30

    We have developed a general formalism based on Green's functions to calculate the coherent electromagnetic field scattered by a random medium with rough boundaries. The approximate expression derived makes it possible to determine the effective permittivity, which is generalised for a layer of an inhomogeneous random medium with different types of particles and bounded with randomly rough interfaces. This effective permittivity describes the coherent propagation of an electromagnetic wave in a random medium with randomly rough boundaries. We have obtained an expression, which contains the Maxwell – Garnett formula at the low-frequency limit, and the Keller formula; the latter hasmore » been proved to be in good agreement with experiments for particles whose dimensions are larger than a wavelength. (coherent light scattering)« less

  20. Effectiveness and Cost-Effectiveness of Different Weekly Frequencies of Pilates for Chronic Low Back Pain: Randomized Controlled Trial.

    PubMed

    Miyamoto, Gisela Cristiane; Moura, Katherinne Ferro; Franco, Yuri Rafael dos Santos; Oliveira, Naiane Teixeira Bastos de; Amaral, Diego Diulgeroglo Vicco; Branco, Amanda Nery Castelo; Silva, Maria Liliane da; Lin, Christine; Cabral, Cristina Maria Nunes

    2016-03-01

    The Pilates method has been recommended to patients with low back pain, but the evidence on effectiveness is inconclusive. In addition, there is still no evidence for the cost-effectiveness of this method or for the ideal number of sessions to achieve the highest effectiveness. The aim of this study will be to investigate the effectiveness and cost-effectiveness of the Pilates method with different weekly frequencies in the treatment of patients with nonspecific low back pain. This is a randomized controlled trial with blinded assessor. This study will be conducted at a physical therapy clinic in São Paulo, Brazil. Two hundred ninety-six patients with nonspecific low back pain between the ages of 18 and 80 years will be assessed and randomly allocated to 4 groups (n=74 patients per group). All groups will receive an educational booklet. The booklet group will not receive additional exercises. Pilates group 1 will follow a Pilates-based program once a week, Pilates group 2 will follow the same program twice a week, and Pilates group 3 will follow the same program 3 times a week. The intervention will last 6 weeks. A blinded assessor will evaluate pain, quality-adjusted life-years, general and specific disability, kinesiophobia, pain catastrophizing, and global perceived effect 6 weeks, 6 months, and 12 months after randomization. Therapists and patients will not be blinded. This will be the first study to investigate different weekly frequencies of treatment sessions for nonspecific low back pain. The results of this study will contribute to a better definition of treatment programs for this population. © 2016 American Physical Therapy Association.

  1. Effects of simvastatin and oral contraceptive agent on polycystic ovary syndrome: prospective, randomized, crossover trial.

    PubMed

    Banaszewska, Beata; Pawelczyk, Leszek; Spaczynski, Robert Z; Dziura, James; Duleba, Antoni J

    2007-02-01

    Polycystic ovary syndrome (PCOS) is associated with hyperandrogenism and cardiovascular risks including dyslipidemia and systemic inflammation. In vitro, statins decrease proliferation and steroidogenesis of ovarian theca-interstitial cells. The study objective was to compare effects of two treatments of PCOS: simvastatin plus oral contraceptive pill (OCP) vs. OCP alone. In a prospective, crossover trial, 48 women with PCOS were randomized to either simvastatin plus OCP for 12 wk followed by OCP alone for an additional 12 wk, or to OCP alone for 12 wk and, subsequently, simvastatin plus OCP for an additional 12 wk. Evaluations were performed at baseline, after 12 wk (crossover), and after 24 wk. Data were analyzed using a random effects model. The study was conducted in an academic medical center. Serum total testosterone was the primary outcome measure. Total testosterone decreased by 38% after Statin + OCP, whereas OCP alone led to a 26% decrease; the statin-attributable effect was significant (P < 0.004). Free testosterone declined by 58% after Statin + OCP, significantly more than the 35% decline after OCP alone (P = 0.006). Hirsutism decreased by 8.1% after Statin + OCP, a greater effect than the 4.7% decrease after OCP alone (P = 0.02). Statin decreased LH, but not FSH or prolactin. Statin + OCP decreased total and low-density lipoprotein cholesterol by 7.5% and 20%, respectively. OCP alone led to a 5% increase of total cholesterol without effect on low-density lipoprotein cholesterol. Statin prevented OCP induced increase of triglycerides. C-reactive protein decreased by 45% after Statin + OCP, a significantly different effect (P = 0.006) than a 6% increase after OCP alone. Soluble vascular cell adhesion molecule 1 decreased by 18% after Statin + OCP, a greater decline than the 10% decrease after OCP alone (P = 0.01). Simvastatin improved endocrine/clinical aspects of PCOS and had beneficial effects on lipid profile and markers of systemic inflammation.

  2. Walking Aids Moderate Exercise Effects on Gait Speed in People With Dementia: A Randomized Controlled Trial.

    PubMed

    Toots, Annika; Littbrand, Håkan; Holmberg, Henrik; Nordström, Peter; Lundin-Olsson, Lillemor; Gustafson, Yngve; Rosendahl, Erik

    2017-03-01

    To investigate the effects of exercise on gait speed, when tested using walking aids and without, and whether effects differed according to amount of support in the test. A cluster-randomized controlled trial. The Umeå Dementia and Exercise (UMDEX) study was set in 16 nursing homes in Umeå, Sweden. One hundred forty-one women and 45 men (mean age 85 years) with dementia, of whom 145 (78%) habitually used walking aids. Participants were randomized to the high-intensity functional exercise program or a seated attention control activity. Blinded assessors measured 4-m usual gait speed with walking aids if any gait speed (GS), and without walking aids and with minimum amount of support, at baseline, 4 months (on intervention completion), and 7 months. Linear mixed models showed no between-group effect in either gait speed test at 4 or 7 months. In interaction analyses exercise effects differed significantly between participants who walked unsupported compared with when walking aids or minimum support was used. Positive between-group exercise effects on gait speed (m/s) were found in subgroups that walked unsupported at 4 and 7 months (GS: 0.07, P = .009 and 0.13, P < .001; and GS test without walking aids: 0.05, P = .011 and 0.07, P = .029, respectively). In people with dementia living in nursing homes exercise had positive effects on gait when tested unsupported compared with when walking aids or minimum support was used. The study suggests that the use of walking aids in gait speed tests may conceal exercise effects. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  3. A call for randomized controlled cost-effectiveness analysis of percutaneous transluminal coronary angioplasty.

    PubMed

    Holly, N

    1988-01-01

    A rapidly evolving technology, percutaneous transluminal coronary angioplasty, is increasingly favored over bypass surgery for treating some types of coronary stenosis because of its less traumatic invasion, better recovery response, and lower initial cost. However, substantially higher failure rates in initial procedures offset PTCA's savings to an unknown extent and cloud analysis of its overall impact. Lack of randomized clinical data precludes valid cost-effectiveness comparison of the technologies at this time. Criteria for establishing valid data and evaluations of currently available data are described in this paper.

  4. Effect of flashlight guidance on manual ventilation performance in cardiopulmonary resuscitation: A randomized controlled simulation study.

    PubMed

    Kim, Ji Hoon; Beom, Jin Ho; You, Je Sung; Cho, Junho; Min, In Kyung; Chung, Hyun Soo

    2018-01-01

    Several auditory-based feedback devices have been developed to improve the quality of ventilation performance during cardiopulmonary resuscitation (CPR), but their effectiveness has not been proven in actual CPR situations. In the present study, we investigated the effectiveness of visual flashlight guidance in maintaining high-quality ventilation performance. We conducted a simulation-based, randomized, parallel trial including 121 senior medical students. All participants were randomized to perform ventilation during 2 minutes of CPR with or without flashlight guidance. For each participant, we measured mean ventilation rate as a primary outcome and ventilation volume, inspiration velocity, and ventilation interval as secondary outcomes using a computerized device system. Mean ventilation rate did not significantly differ between flashlight guidance and control groups (P = 0.159), but participants in the flashlight guidance group exhibited significantly less variation in ventilation rate than participants in the control group (P<0.001). Ventilation interval was also more regular among participants in the flashlight guidance group. Our results demonstrate that flashlight guidance is effective in maintaining a constant ventilation rate and interval. If confirmed by further studies in clinical practice, flashlight guidance could be expected to improve the quality of ventilation performed during CPR.

  5. Bayesian hierarchical models for cost-effectiveness analyses that use data from cluster randomized trials.

    PubMed

    Grieve, Richard; Nixon, Richard; Thompson, Simon G

    2010-01-01

    Cost-effectiveness analyses (CEA) may be undertaken alongside cluster randomized trials (CRTs) where randomization is at the level of the cluster (for example, the hospital or primary care provider) rather than the individual. Costs (and outcomes) within clusters may be correlated so that the assumption made by standard bivariate regression models, that observations are independent, is incorrect. This study develops a flexible modeling framework to acknowledge the clustering in CEA that use CRTs. The authors extend previous Bayesian bivariate models for CEA of multicenter trials to recognize the specific form of clustering in CRTs. They develop new Bayesian hierarchical models (BHMs) that allow mean costs and outcomes, and also variances, to differ across clusters. They illustrate how each model can be applied using data from a large (1732 cases, 70 primary care providers) CRT evaluating alternative interventions for reducing postnatal depression. The analyses compare cost-effectiveness estimates from BHMs with standard bivariate regression models that ignore the data hierarchy. The BHMs show high levels of cost heterogeneity across clusters (intracluster correlation coefficient, 0.17). Compared with standard regression models, the BHMs yield substantially increased uncertainty surrounding the cost-effectiveness estimates, and altered point estimates. The authors conclude that ignoring clustering can lead to incorrect inferences. The BHMs that they present offer a flexible modeling framework that can be applied more generally to CEA that use CRTs.

  6. Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial.

    PubMed

    Amini, E; Rafiei, P; Zarei, K; Gohari, M; Hamidi, M

    2013-01-01

    Music is considered a subset of developmental supportive care. It may act as a suitable auditory stimulant in preterm infants. Also, it may reduce stress responses in autonomic, motor and state systems. To assess and compare the influence of lullaby and classical music on physiologic parameters. This is a randomized clinical trial with cross-over design. A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days. Each infant was exposed to three phases: lullaby music, classical music, and no music (control) for two days each. The sequence of these phases was assigned randomly to each subject. Babies were continuously monitored for heart rate, respiratory rate, and oxygen saturation and changes between phases were analyzed. Lullaby reduced heart rate (p < 0.001) and respiratory rate (p = 0.004). These effects extended in the period after the exposure (p < .001 and p = 0.001, respectively). Classical music reduced heart rate (p = 0.018). The effects of classical music disappeared once the music stopped. Oxygen saturation did not change during intervention. Music can affect vital signs of preterm infants; this effect can possibly be related to the reduction of stress during hospitalization. The implications of these findings on clinical and developmental outcomes need further study.

  7. Clinical Effects of Dry Needling Among Asymptomatic Individuals With Hamstring Tightness: A Randomized Controlled Trial.

    PubMed

    Geist, Kathleen; Bradley, Claire; Hofman, Alan; Koester, Rob; Roche, Fenella; Shields, Annalise; Frierson, Elizabeth; Rossi, Ainsley; Johanson, Marie

    2017-11-01

    Randomized controlled trial. The aim of this study was to determine the effects of dry needling on hamstring extensibility and functional performance tests among asymptomatic individuals with hamstring muscle tightness. Dry needling has been shown to increase range of motion in the upper quarter and may have similar effects in the lower quarter. 27 subjects with hamstring extensibility deficits were randomly assigned to side of treatment (dominant or nondominant) and group (blunt needling or dry needling). The first session included measurement of hamstring extensibility and performance on 4 unilateral hop tests, instruction in home hamstring stretching exercises and needling distal to the ischial tuberosity and midbellies of the medial and lateral hamstrings. A second session, 3-5 days following the first session, included outcome measures and a second needling intervention, and a third session, 4-6 weeks following the first session, included outcome measures only. A 2 × 3 × 2 ANOVA was used to statistically analyze the data. Hamstring extensibility showed a significant side × time interaction (P < .05). The single hop for distance, timed 6-meter hop, and the crossover hop test had a significant main effect of time (P < .05). The triple hop for distance showed a significant side × time × group interaction (P < .05). It does not appear dry needling results in increased extensibility beyond that of stretching alone in asymptomatic individuals. Our study findings suggest that dry needling may improve certain dimensions of functional performance, although no clear conclusion can be made. Intervention, level 2b.

  8. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

    PubMed Central

    Zywiak, William H.; Edwards, Steven M.; Tidey, Jennifer W.; Swift, Robert M.; Kenna, George A.

    2014-01-01

    Rationale There is presently no approved single treatment for dual alcohol and nicotine dependencies. Objective This pilot study investigated baclofen effects in alcoholic smokers. Methods This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. Results Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. Conclusions This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies. PMID:24973894

  9. Effective pore-scale dispersion upscaling with a correlated continuous time random walk approach

    NASA Astrophysics Data System (ADS)

    Le Borgne, T.; Bolster, D.; Dentz, M.; de Anna, P.; Tartakovsky, A.

    2011-12-01

    We investigate the upscaling of dispersion from a pore-scale analysis of Lagrangian velocities. A key challenge in the upscaling procedure is to relate the temporal evolution of spreading to the pore-scale velocity field properties. We test the hypothesis that one can represent Lagrangian velocities at the pore scale as a Markov process in space. The resulting effective transport model is a continuous time random walk (CTRW) characterized by a correlated random time increment, here denoted as correlated CTRW. We consider a simplified sinusoidal wavy channel model as well as a more complex heterogeneous pore space. For both systems, the predictions of the correlated CTRW model, with parameters defined from the velocity field properties (both distribution and correlation), are found to be in good agreement with results from direct pore-scale simulations over preasymptotic and asymptotic times. In this framework, the nontrivial dependence of dispersion on the pore boundary fluctuations is shown to be related to the competition between distribution and correlation effects. In particular, explicit inclusion of spatial velocity correlation in the effective CTRW model is found to be important to represent incomplete mixing in the pore throats.

  10. Effects of dehydroepiandrosterone supplementation during stressful military training: a randomized, controlled, double-blind field study.

    PubMed

    Taylor, Marcus K; Padilla, Genieleah A; Stanfill, Katherine E; Markham, Amanda E; Khosravi, Jasmine Y; Ward, Michael D Dial; Koehler, Matthew M

    2012-01-01

    Dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEAS) are anabolic prehormones involved in the synthesis of testosterone. Both have been shown to exert neuroprotective effects during stress. In this randomized, controlled, double-blind field study, we examined the effects of a 12-day DHEA regimen on stress indices in military men undergoing survival training. Forty-eight men were randomized to either a DHEA treatment group or placebo control group. The treatment group received 50 mg of oral DHEA supplementation daily for 5 days during classroom training followed by 7 days of 75 mg during stressful field operations. Control subjects received identical placebo pills. Salivary assays (DHEA[S], testosterone, and cortisol) were conducted at four time points: distal pre-stress (T1), proximal pre-stress (T2), mock-captivity stress (T3), and 24 h recovery (T4). Subjective distress was also assessed at T1, T3, and T4. As expected, DHEA treatment resulted in higher salivary concentrations of DHEA and DHEAS during daily living, mock-captivity stress, and recovery. Similar patterns were observed for salivary markers of anabolic balance: DHEA/cortisol, DHEAS/cortisol, and testosterone/cortisol concentration ratios. Despite notable time effects, no group differences emerged for subjective distress. A brief, low dose DHEA regimen yielded large increases in salivary DHEA(S) concentrations and enhanced anabolic balance throughout sustained military stress. These physiological changes did not extrapolate to subjective distress.

  11. Unexpected Effects of a System-Distributed Mobile Application in Maternity Care: A Randomized Controlled Trial.

    PubMed

    Ledford, Christy J W; Womack, Jasmyne J; Rider, Heather A; Seehusen, Angela B; Conner, Stephen J; Lauters, Rebecca A; Hodge, Joshua A

    2018-06-01

    As pregnant mothers increasingly engage in shared decision making regarding prenatal decisions, such as induction of labor, the patient's level of activation may influence pregnancy outcomes. One potential tool to increase patient activation in the clinical setting is mobile applications. However, research is limited in comparing mobile apps with other modalities of patient education and engagement tools. This study was designed to test the effectiveness of a mobile app as a replacement for a spiral notebook guide as a patient education and engagement tool in the prenatal clinical setting. This randomized controlled trial was conducted in the Women's Health Clinic and Family Health Clinic of three hospitals. Repeated-measures analysis of covariance was used to test intervention effects in the study sample of 205 patients. Mothers used a mobile app interface to more frequently record information about their pregnancy; however, across time, mothers using a mobile app reported a significant decrease in patient activation. The unexpected negative effects in the group of patients randomized to the mobile app prompt these authors to recommend that health systems pause before distributing their own version of mobile apps that may decrease patient activation. Mobile apps can be inherently empowering and engaging, but how a system encourages their use may ultimately determine their adoption and success.

  12. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial.

    PubMed

    Gür, Gözde; Ayhan, Cigdem; Yakut, Yavuz

    2017-06-01

    Core stabilization training is used to improve postural balance in musculoskeletal problems. The purpose of this study was to investigate the effectiveness of stabilization training in adolescent idiopathic scoliosis. A randomized controlled trial, pretest-posttest design. In total, 25 subjects with adolescent idiopathic scoliosis were randomly divided into two groups: stabilization group ( n = 12) and control group ( n = 13). The stabilization group received core stabilization in addition to traditional rehabilitation, and the control group received traditional rehabilitation for 10 weeks. Assessment included Cobb's angle on radiograph, apical vertebral rotation in Adam's test, trunk asymmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Trunk Appearance Perception Scale), and quality of life (Scoliosis Research Society-22 questionnaire). Inter-group comparisons showed significantly greater improvements in the mean change in lumbar apical vertebral rotation degree and the pain domain of Scoliosis Research Society-22 in the stabilization group than those in the control group ( p < 0.05). No significant differences were observed for other measurements between the groups; however, trends toward greater improvement were observed in the stabilization group. Core stabilization training in addition to traditional exercises was more effective than traditional exercises alone in the correction of vertebral rotation and reduction of pain in adolescent idiopathic scoliosis. Clinical relevance Stabilization exercises are more effective in reducing rotation deformity and pain than traditional exercises in the conservative rehabilitation of adolescent idiopathic scoliosis. These improvements suggest that stabilization training should be added to rehabilitation programs in adolescent idiopathic scoliosis.

  13. Antioxidant effects of curcuminoids in patients with type 2 diabetes mellitus: a randomized controlled trial.

    PubMed

    Panahi, Yunes; Khalili, Nahid; Sahebi, Ebrahim; Namazi, Soha; Karimian, Maryam Saberi; Majeed, Muhammed; Sahebkar, Amirhossein

    2017-02-01

    Oxidative stress has a key role in the pathogenesis of type II diabetes mellitus (T2DM) and its vascular complications. Antioxidant therapy has been suggested as a potential approach to blunt T2DM development and progression. The aim of this study was to assess the effects of supplementation with curcuminoids, which are natural polyphenolics from turmeric, on oxidative indices in diabetic individuals. In this randomized double-blind placebo-controlled trial, 118 subjects with T2DM were randomized to curcuminoids (1000 mg/day co-administered with piperine 10 mg/day) or matching placebo for a period of 8 weeks. Serum total antioxidant capacity, superoxide dismutase (SOD) activities and malondialdehyde (MDA) concentrations were measured at baseline and after the supplementation period. Curcuminoids supplementation caused a significant elevation in serum total antioxidant capacity (TAC) (p < 0.001) and SOD activities (p < 0.001), while serum MDA levels were significantly reduced compared with the placebo group (p < 0.001). These results remained statistically significant after adjustment for potential confounders (baseline differences in body mass index and fasting serum insulin). The present results support an antioxidant effect of curcuminoids supplementation in patients with T2DM, and call for future studies to assess the impact of these antioxidant effects on the occurrence of diabetic complications and cardiovascular endpoints.

  14. Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial.

    PubMed

    Alipour, Zahra; Eskandari, Narges; Ahmari Tehran, Hoda; Eshagh Hossaini, Seyed Kamal; Sangi, Sareh

    2013-08-01

    Despite persuasive theories about the beneficial effects of music and singing in developmental care for premature infants, few small studies are available in this regard. We conducted this study to investigate the physiological and behavioral responses of premature infants to recorded lullaby music and silence. In a randomized controlled trial, 90 premature infants in the neonatal care unit of a hospital in Qom (Iran) were randomly allocated to intervention (lullaby and silence) or control groups. Lullaby music was played via headphones at a volume of 50-60 dB. In the silence group, headphones were placed on the infants' ears while no music was played. The three groups were surveyed for physiological responses including oxygen saturation, respiratory and heart rates, and behavioral states every five minutes before, during, and after the intervention. The three groups were not significantly different in terms of mean values of respiratory and heart rates, oxygen saturation, and behavioral states of infants. Similarly, no significant within group differences in respiratory and heart rates, oxygen saturation, and behavioral states were observed at different times. Our findings did not support the beneficial effects of music for premature infants. However, music is a noninvasive, non-pharmaceutical, and relatively low-cost intervention that can be implemented at infants' bedside. Thus further research is warranted to determine whether the effects noted in previous studies can be consistently replicated in diverse settings and with diverse groups of preterm infants. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Effect of guided relaxation and imagery on falls self-efficacy: a randomized controlled trial.

    PubMed

    Kim, Bang Hyun; Newton, Roberta A; Sachs, Michael L; Glutting, Joseph J; Glanz, Karen

    2012-06-01

    To examine the effects of guided relaxation and imagery (GRI) on improvement in falls self-efficacy in older adults who report having a fear of falling. Randomized, controlled trial with allocation to GRI or guided relaxation with music of choice. General community. Ninety-one men and women aged 60 to 92. Participants were randomized to listen to a GRI audio compact disk (intervention group) or a guided relaxation audio compact disk and music of choice (control group) twice a week for 6 weeks for 10 minutes per session. Primary outcome measure was the Short Falls Efficacy Scale-International (FES-I). Secondary outcome measures were the Leisure Time Exercise Questionnaire (LTEQ) and the Timed Up and Go (TUG) mobility test. GRI participants reported greater improvements on the Short FES-I (P = .002) and LTEQ (P = .001) scores and shorter time on the TUG (P = .002) than the guided relaxation and music-of-choice group. GRI was more effective at increasing falls self-efficacy and self-reported leisure time exercise and reducing times on a simple mobility test than was guided relaxation with music of choice. GRI is an effective, simple, low-cost tool for older adults to improve falls self-efficacy and leisure time exercise behaviors. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

  16. Effect of botulinum toxin A and nitroglycerin on random skin flap survival in rats.

    PubMed

    Ghanbarzadeh, Kourosh; Tabatabaie, Omid Reza; Salehifar, Ebrahim; Amanlou, Massoud; Khorasani, Ghasemali

    2016-01-01

    A suitable pharmacological substitute for the well-established surgical delay technique for random skin flaps to increase viability has been elusive. To evaluate the effects of nitroglycerin and botulinum toxin type A on random flap survival in a rat model. The present controlled experimental study was performed in the four groups of rats. One week after intervention in each group, the flap was raised and kept in situ, and flap necrosis was evaluated through follow-up. Group 1 received intradermal botulinum toxin type A (BTX-A) and topical nitroglycerin 2%; group 2 received BTX-A and topical Vaseline (Unilever, USA); group 3 received topical nitroglycerin and intradermal normal saline; and group 4 received topical Vaseline and intradermal normal saline. BTX-A reduced the area of necrosis compared with control (24% versus 56% respectively; P<0.001). Nitroglycerin application was associated with a trend toward improved flap viability (42% versus 56%; P=0.059). The combination of topical nitroglycerin and BTX-A, compared with Vaseline and BTX-A, was associated with decreased flap necrosis (16.1% versus 24%, respectively), although it was not statistically significant (P=0.45). BTX-A was effective in reducing distal flap necrosis. The effect of BTX-A was significantly more pronounced than nitroglycerin ointment.

  17. The effect of different types of music on patients' preoperative anxiety: A randomized controlled trial.

    PubMed

    Uğraş, Gülay Altun; Yıldırım, Güven; Yüksel, Serpil; Öztürkçü, Yusuf; Kuzdere, Mustafa; Öztekin, Seher Deniz

    2018-05-01

    The purpose of this study was to determine effect of three different types of music on patients' preoperative anxiety. This randomized controlled trial included 180 patients who were randomly divided into four groups. While the control group didn't listen to music, the experimental groups respectively listened to natural sounds, Classical Turkish or Western Music for 30 min. The State Anxiety Inventory (STAI-S), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and cortisol levels were checked. The post-music STAI-S, SBP, DBP, HR and cortisol levels of the patients in music groups were significantly lower than pre-music time. All types of music decreased STAI-S, SBP, and cortisol levels; additionally natural sounds reduced DBP; Classical Turkish Music also decreased DBP, and HR. All types of music had an effect on reducing patients' preoperative anxiety, and listening to Classical Turkish Music was particularly the most effective one. Copyright © 2018 Elsevier Ltd. All rights reserved.

  18. Effectiveness of Mindfulness-Based Stress Reduction Bibliotherapy: A Preliminary Randomized Controlled Trial.

    PubMed

    Hazlett-Stevens, Holly; Oren, Yelena

    2017-06-01

    This randomized controlled investigation examined the effectiveness of a self-help bibliotherapy format of the evidence-based mindfulness-based stress reduction (MBSR) intervention. College students seeking stress reduction were randomly assigned to a 10-week MBSR bibliotherapy intervention group (n = 47) or a no-treatment control group (n = 45). Self-report measures were collected at baseline and postintervention. A total of 25 bibliotherapy and 43 control group participants provided final data following the intervention period. Compared to the control group, bibliotherapy participants reported increased mindfulness following the intervention. Significant decreases on measures of depression, anxiety, stress, perceived stress, and anxiety sensitivity also were reported postintervention as well as increased quality of life in physical health, psychological, and environmental domains. No statistically significant group effects were found for social relationships quality of life domain, worry, and experiential avoidance measures. This MBSR workbook may provide an acceptable and effective alternative for motivated individuals seeking to reduce stress, at least for a select group of individuals who are willing and able to sustain participation in the intervention. © 2016 Wiley Periodicals, Inc.

  19. Effect of tranexamic acid on gross hematuria: A pilot randomized clinical trial study.

    PubMed

    Moharamzadeh, Payman; Ojaghihaghighi, Seyedhossein; Amjadi, Mohsen; Rahmani, Farzad; Farjamnia, Arezoo

    2017-12-01

    Local forms of the tranexamic acid have been effective in treating many haemorrhagic cases. So that the aim of the current study is to assess the effectiveness of local tranexamic acid in controlling painless hematuria in patients referred to the emergency department. This is a randomized, double-blind clinical trial study, which was conducted on 50 patients with complaints of painless lower urinary tract bleeding during June 2014 and August 2015. The patients were randomly divided into two groups of 25 people each, one group receiving tranexamic acid and the other given a placebo. During bladder irrigation, local tranexamic acid and the placebo were injected into the bladder via Foley catheter. Patients were examined over 24h in terms of the amount of normal saline serum used for irrigation, level of hemoglobin, and blood in urine. In this study it was observed that consumption of tranexamic acid significantly decreased the volume of used serum for bladder irrigation (P=0.041) and the microscopic status of urine decreased significantly in terms of the hematuria after 24h (P=0.026). However, the rate of packed cell transfusion and drop in hemoglobin levels showed no significant difference in both groups of patients (P˃0.05). The results of this study showed that tranexamic acid could significantly reduce the volume of required serum for bladder irrigation to clear urine, but it had no significant effect on the drop in serum hemoglobin levels. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Effectiveness of horticultural therapy: a systematic review of randomized controlled trials.

    PubMed

    Kamioka, Hiroharu; Tsutani, Kiichiro; Yamada, Minoru; Park, Hyuntae; Okuizumi, Hiroyasu; Honda, Takuya; Okada, Shinpei; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Handa, Shuichi; Mutoh, Yoshiteru

    2014-10-01

    To summarize the evidence from randomized controlled trials (RCTs) on the effects of horticultural therapy (HT). Studies were eligible if they were RCTs. Studies included one treatment group in which HT was applied. We searched the following databases from 1990 up to August 20, 2013: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi-Web, GHL, WPRIM, and PsyclNFO. We also searched all Cochrane Database and Campbell Systematic Reviews up to September 20, 2013. Four studies met all inclusion criteria. The language of all eligible publications was English and Korean. Target diseases and/or symptoms were dementia, severe mental illness such as schizophrenia, bipolar disorder, and major depression, frail elderly in nursing home, and hemiplegic patients after stroke. These studies showed significant effectiveness in one or more outcomes for mental health and behavior. However, our review especially detected omissions of the following descriptions: method used to generate randomization, concealment, blinding, and intention-to-treat analysis. In addition, the results of this study suggested that the RCTs conducted have been of relatively low quality. Although there was insufficient evidence in the studies of HT due to poor methodological and reporting quality and heterogeneity, HT may be an effective treatment for mental and behavioral disorders such as dementia, schizophrenia, depression, and terminal-care for cancer. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

    PubMed Central

    Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

    2010-01-01

    International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118 international students at an urban, American university. Interventions were conducted at the start of a semester, and assessments were conducted at baseline and the end of the semester. Group assertiveness training was rated positively by students and led to lower negative affect, whereas expressive writing was less well received and led to higher homesickness and fear, but also higher positive affect. The combined intervention had no effects, perhaps because the two components negated each other. It is concluded that group assertiveness training improves emotional adjustment of international students, but expressive writing has mixed effects and needs further development and study. PMID:20357910

  2. Antihypertensive effect of Iranian Crataegus curvisepala Lind.: a randomized, double-blind study.

    PubMed

    Asgary, S; Naderi, G H; Sadeghi, M; Kelishadi, R; Amiri, M

    2004-01-01

    The aim of the present study was to investigate the potential antihypertensive effects of extracts of the flavonoid-rich Iranian flower, Crataegus curvisepala Lind., a member of the Rosaceae family. The hydroalcoholic extract of the leaves and flowers were studied in a double-blind, placebo-controlled clinical trial to determine its effects. A total of 92 men and women with primary mild hypertension, aged 40-60 years, were selected and divided randomly into two groups, receiving either hydroalcoholic extract of C. curvisepala Lind. or placebo three times daily for more than 4 months. Blood pressure (BP) was measured each month. Statistical analysis was carried out using Student's t-test. The results obtained showed a significant decrease in both systolic and diastolic BP after 3 months (p < 0.05). C. curvisepala has a time-dependent antihypertensive effect.

  3. Randomized Controlled Trial for Behavioral Smoking and Weight Control Treatment: Effect of Concurrent versus Sequential Intervention

    PubMed Central

    Spring, Bonnie; Doran, Neal; Pagoto, Sherry; Schneider, Kristin; Pingitore, Regina; Hedeker, Don

    2014-01-01

    Prospects for changing multiple health behaviors conjointly remain controversial. We compared effects on tobacco abstinence and weight gain of adding diet and exercise concurrently or after smoking treatment. Female regular smokers (n=315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit at week 5, and were followed for 9 months after the quit date. Weight management was added to the first 8 weeks for Early Diet (ED), the final 8 weeks for Late Diet (LD), and omitted for Control. Both Diet groups tended to show greater bio-verified abstinence than Control although differences were nonsignificant. Compared to Control, ED initially suppressed weight gain but lost that effect over time, whereas LD initially lacked but gradually acquired a weight suppression effect that stabilized [p = .004]. Behavioral weight control did not undermine smoking cessation and slowed the rate of weight gain when initiated after the smoking quit date, supporting a sequential approach to multiple behavior change. PMID:15482037

  4. The Clinical Effectiveness and Cost-Effectiveness of Lamotrigine in Borderline Personality Disorder: A Randomized Placebo-Controlled Trial.

    PubMed

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Cunningham, Gillian; Dale, Oliver; Ganguli, Poushali; Lawrence-Smith, Geoff; Leeson, Verity; Lemonsky, Fenella; Lykomitrou, Georgia; Montgomery, Alan A; Morriss, Richard; Munjiza, Jasna; Paton, Carol; Skorodzien, Iwona; Singh, Vineet; Tan, Wei; Tyrer, Peter; Reilly, Joseph G

    2018-04-06

    The authors examined whether lamotrigine is a clinically effective and cost-effective treatment for people with borderline personality disorder. This was a multicenter, double-blind, placebo-controlled randomized trial. Between July 2013 and November 2016, the authors recruited 276 people age 18 or over who met diagnostic criteria for borderline personality disorder. Individuals with coexisting bipolar affective disorder or psychosis, those already taking a mood stabilizer, and women at risk of pregnancy were excluded. A web-based randomization service was used to allocate participants randomly in a 1:1 ratio to receive either an inert placebo or up to 400 mg/day of lamotrigine. The primary outcome measure was score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at 52 weeks. Secondary outcome measures included depressive symptoms, deliberate self-harm, social functioning, health-related quality of life, resource use and costs, side effects of treatment, and adverse events. A total of 195 (70.6%) participants were followed up at 52 weeks, at which point 49 (36%) of those in the lamotrigine group and 58 (42%) of those in the placebo group were taking study medication. The mean ZAN-BPD score was 11.3 (SD=6.6) among those in the lamotrigine group and 11.5 (SD=7.7) among those in the placebo group (adjusted difference in means=0.1, 95% CI=-1.8, 2.0). There was no evidence of any differences in secondary outcomes. Costs of direct care were similar in the two groups. The results suggest that treating people with borderline personality disorder with lamotrigine is not a clinically effective or cost-effective use of resources.

  5. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial.

    PubMed

    Neufingerl, Nicole; Zebregs, Yvonne E M P; Schuring, Ewoud A H; Trautwein, Elke A

    2013-06-01

    Evidence from clinical studies has suggested that cocoa may increase high-density lipoprotein (HDL)-cholesterol concentrations. However, it is unclear whether this effect is attributable to flavonoids or theobromine, both of which are major cocoa components. We investigated whether pure theobromine increases serum HDL cholesterol and whether there is an interaction effect between theobromine and cocoa. The study had a 2-center, double-blind, randomized, placebo-controlled, full factorial parallel design. After a 2-wk run-in period, 152 healthy men and women (aged 40-70 y) were randomly allocated to consume one 200-mL drink/d for 4 wk that contained 1) cocoa, which naturally provided 150 mg theobromine and 325 mg flavonoids [cocoa intervention (CC)], 2) 850 mg pure theobromine [theobromine intervention (TB)], 3) cocoa and added theobromine, which provided 1000 mg theobromine and 325 mg flavonoids [theobromine and cocoa intervention (TB+CC)], or 4) neither cocoa nor theobromine (placebo). Blood lipids and apolipoproteins were measured at the start and end of interventions. In a 2-factor analysis, there was a significant main effect of the TB (P < 0.0001) but not CC (P = 0.1288) on HDL cholesterol but no significant interaction (P = 0.3735). The TB increased HDL-cholesterol concentrations by 0.16 mmol/L (P < 0.0001). Furthermore, there was a significant main effect of the TB on increasing apolipoprotein A-I (P < 0.0001) and decreasing apolipoprotein B and LDL-cholesterol concentrations (P < 0.02). Theobromine independently increased serum HDL-cholesterol concentrations by 0.16 mmol/L. The lack of significant cocoa and interaction effects suggested that theobromine may be the main ingredient responsible for the HDL cholesterol-raising effect. This trial was registered at clinicaltrials.gov as NCT01481389.

  6. Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial.

    PubMed

    Brewer, Noel T; Hall, Marissa G; Noar, Seth M; Parada, Humberto; Stein-Seroussi, Al; Bach, Laura E; Hanley, Sean; Ribisl, Kurt M

    2016-07-01

    Pictorial warnings on cigarette packs draw attention and increase quit intentions, but their effect on smoking behavior remains uncertain. To assess the effect of adding pictorial warnings to the front and back of cigarette packs. This 4-week between-participant randomized clinical trial was carried out in California and North Carolina. We recruited a convenience sample of adult cigarette smokers from the general population beginning September 2014 through August 2015. Of 2149 smokers who enrolled, 88% completed the trial. No participants withdrew owing to adverse events. We randomly assigned participants to receive on their cigarette packs for 4 weeks either text-only warnings (one of the Surgeon General's warnings currently in use in the United States on the side of the cigarette packs) or pictorial warnings (one of the Family Smoking Prevention and Tobacco Control Act's required text warnings and pictures that showed harms of smoking on the top half of the front and back of the cigarette packs). The primary trial outcome was attempting to quit smoking during the study. We hypothesized that smokers randomized to receive pictorial warnings would be more likely to report a quit attempt during the study than smokers randomized to receive a text-only Surgeon General's warning. Of the 2149 participants who began the trial (1039 men, 1060 women, and 34 transgender people; mean [SD] age, 39.7 [13.4] years for text-only warning, 39.8 [13.7] for pictorial warnings), 1901 completed it. In intent-to-treat analyses (n = 2149), smokers whose packs had pictorial warnings were more likely than those whose packs had text-only warnings to attempt to quit smoking during the 4-week trial (40% vs 34%; odds ratio [OR], 1.29; 95% CI, 1.09-1.54). The findings did not differ across any demographic groups. Having quit smoking for at least the 7 days prior to the end of the trial was more common among smokers who received pictorial than those who received text-only warnings (5.7% vs 3

  7. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial

    PubMed Central

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V.; Dhananjaya, Kiran Murthy

    2014-01-01

    Background: Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70–80% of prisoners have been identified as current smokers. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Materials and Methods: A randomized controlled trial was planned among male prisoners in Central Jail, Bangalore city. There were 1600 convicted prisoners. A self-administered questionnaire was given to the prisoners to assess their smoking behavior by which prevalence of tobacco smoking was found. Exactly 1352 tobacco users were studied. Among them, there were 1252 smokers. Based on inclusion criteria and informed consent given by the prisoners, a sample of 600 was chosen for the study by systematic random sampling. Among the 600 prisoners, 300 were randomly selected for the study group and 300 for the control group. Results: Prevalence of tobacco smoking among the prisoners was 92.60%. In the present study, after smoking cessation intervention, 17% showed no change in smoking, 21.66% reduced smoking, 16% stopped smoking, and 45.33% relapsed (P < 0.0001) at the end of 6-month follow-up in the study group. Conclusion: Tobacco use was high among the prisoners. Tobacco reduction is possible in the prison even if the living conditions are not favorable. Relatively high rate of relapse in our study indicates that some policies should be adopted to improve smokers’ information on consequences of tobacco on health and motivational intervention should be added to prisoners. PMID:25558450

  8. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial.

    PubMed

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V; Dhananjaya, Kiran Murthy

    2014-12-01

    Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70-80% of prisoners have been identified as current smokers. To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. A randomized controlled trial was planned among male prisoners in Central Jail, Bangalore city. There were 1600 convicted prisoners. A self-administered questionnaire was given to the prisoners to assess their smoking behavior by which prevalence of tobacco smoking was found. Exactly 1352 tobacco users were studied. Among them, there were 1252 smokers. Based on inclusion criteria and informed consent given by the prisoners, a sample of 600 was chosen for the study by systematic random sampling. Among the 600 prisoners, 300 were randomly selected for the study group and 300 for the control group. Prevalence of tobacco smoking among the prisoners was 92.60%. In the present study, after smoking cessation intervention, 17% showed no change in smoking, 21.66% reduced smoking, 16% stopped smoking, and 45.33% relapsed (P < 0.0001) at the end of 6-month follow-up in the study group. Tobacco use was high among the prisoners. Tobacco reduction is possible in the prison even if the living conditions are not favorable. Relatively high rate of relapse in our study indicates that some policies should be adopted to improve smokers' information on consequences of tobacco on health and motivational intervention should be added to prisoners.

  9. The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

    PubMed

    Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

    2013-11-01

    In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

  10. The effectiveness of xylitol in a school-based cluster-randomized clinical trial.

    PubMed

    Lee, Wonik; Spiekerman, Charles; Heima, Masahiro; Eggertsson, Hafsteinn; Ferretti, Gerald; Milgrom, Peter; Nelson, Suchitra

    2015-01-01

    The purpose of this double-blind, cluster-randomized clinical trial was to examine the effects of xylitol gummy bear snacks on dental caries progression in primary and permanent teeth of inner-city school children. A total of 562 children aged 5-6 years were recruited from five elementary schools in East Cleveland, Ohio. Children were randomized by classroom to receive xylitol (7.8 g/day) or placebo (inulin fiber 20 g/day) gummy bears. Gummy bears were given three times per day for the 9-month kindergarten year within a supervised school environment. Children in both groups also received oral health education, toothbrush and fluoridated toothpaste, topical fluoride varnish treatment and dental sealants. The numbers of new decayed, missing, and filled surfaces for primary teeth (dmfs) and permanent teeth (DMFS) from baseline to the middle of 2nd grade (exit exam) were compared between the treatment (xylitol/placebo) groups using an optimally-weighted permutation test for cluster-randomized data. The mean new d(3-6)mfs at the exit exam was 5.0 ± 7.6 and 4.0 ± 6.5 for the xylitol and placebo group, respectively. Similarly, the mean new D(3-6)MFS was 0.38 ± 0.88 and 0.48 ± 1.39 for the xylitol and placebo group, respectively. The adjusted mean difference between the two groups was not statistically significant: new d(3-6)mfs: mean 0.4, 95% CI -0.25, 0.8), and new D(3-6)MFS: mean 0.16, 95% CI -0.16, 0.43. Xylitol consumption did not have additional benefit beyond other preventive measures. Caries progression in the permanent teeth of both groups was minimal, suggesting that other simultaneous prevention modalities may have masked the possible beneficial effects of xylitol in this trial. © 2014 S. Karger AG, Basel.

  11. Randomized Evaluation of the Effectiveness of a Structured Educational Program for Patients With Essential Hypertension.

    PubMed

    Perl, Sabine; Niederl, Ella; Kos, Cornelia; Mrak, Peter; Ederer, Herbert; Rakovac, Ivo; Beck, Peter; Kraler, Elisabeth; Stoff, Ingrid; Klima, Gert; Pieske, Burkert M; Pieber, Thomas R; Zweiker, Robert

    2016-07-01

    Adherence to medication and lifestyle interventions are essential keys for the management of hypertension. In this respect, a structured educational program for hypertensive patients has got remarkable merits (herz.leben). In order to determine the isolated effect of participation in the educational program, neglecting the possible impact of more intense care, this prospective multicenter randomized controlled study was designed (NCT00453037). A total of 256 patients in 13 centers were enrolled and randomly assigned to 2 groups (G). G-I (n = 137) underwent the educational program immediately (T-0), G-II (n = 119) after 6 months (T-6). Follow-up visits were done after 6 (T-6) and 12 (T-12) months. Primary endpoint was a difference in office blood pressure (BP) at T-6, when only G-I had undergone the educational program. Patients' baseline characteristics were comparable. At T-6, systolic office and home BP were significantly lower in G-I compared to G-II: office BP systolic 139 (134-150) mm Hg vs. 150 (135-165) mm Hg (P < 0.01); diastolic 80 (76-85) mm Hg vs. 84 (75-90) mm Hg (ns); home BP systolic 133 (130-140) mm Hg vs. 142 (132-150) mm Hg (P < 0.01); diastolic 80 (75-85) mm Hg vs. 80 (76-89) mm Hg (ns)). At T-12, when all patients had undergone the educational program differences in BP disappeared. The results of this multicenter randomized controlled study provide significant evidence for benefit by participation in a structured educational program. Positive effects seem to be mediated by better adherence and life style changes due to higher levels of information and patient empowerment. Therefore, educational strategies should be considered as standard of care for hypertensive patients. © American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. Effects of structured patient education in adults with atopic dermatitis: Multicenter randomized controlled trial.

    PubMed

    Heratizadeh, Annice; Werfel, Thomas; Wollenberg, Andreas; Abraham, Susanne; Plank-Habibi, Sibylle; Schnopp, Christina; Sticherling, Michael; Apfelbacher, Christian; Biedermann, Tilo; Breuer, Kristine; Fell, Isabel; Fölster-Holst, Regina; Heine, Guido; Grimm, Jennifer; Hennighausen, Lars; Kugler, Claudia; Reese, Imke; Ring, Johannes; Schäkel, Knut; Schmitt, Jochen; Seikowski, Kurt; von Stebut, Esther; Wagner, Nicola; Waßmann-Otto, Anja; Wienke-Graul, Ute; Weisshaar, Elke; Worm, Margitta; Gieler, Uwe; Kupfer, Joerg

    2017-09-01

    Atopic dermatitis (AD) is a chronic relapsing skin disease prevalent in 1% to 3% of adults in Western industrialized countries. We sought to investigate the effectiveness of educational training in an outpatient setting on coping with the disease, quality of life, symptoms, and severity in adults with AD. In this German prospective, randomized controlled multicenter study, adult patients with moderate-to-severe AD were educated by referring to a comprehensive 12-hour training manual consented by a multiprofessional study group from different centers (Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene [ARNE]). Patients were randomly allocated to the intervention or waiting control groups. Study visits were performed at baseline and after 1 year (1 year of follow-up). Primary outcomes were defined as a decrease in (1) "catastrophizing cognitions" with respect to itching (Juckreiz-Kognitions-Fragebogen questionnaire), (2) "social anxiety" (Marburger Hautfragebogen questionnaire), (3) subjective burden by symptoms of the disease (Skindex-29 questionnaire), and (4) improvement of disease signs and symptoms assessed by using the SCORAD index at 1 year of follow-up. Data were analyzed on an intention-to-treat basis. At 1 year of follow-up, patients from the intervention group (n = 168) showed a significantly better improvement compared with the waiting group (n = 147) in the following defined primary study outcomes: coping behavior with respect to itching (P < .001), quality of life assessed by using the Skindex-29 questionnaire (P < .001), and the SCORAD index (P < .001). This is the first randomized, controlled multicenter study on patient education in adult AD. The ARNE training program shows significant beneficial effects on a variety of psychosocial parameters, as well as AD severity. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  13. Neurocognitive effects of neurofeedback in adolescents with ADHD: a randomized controlled trial.

    PubMed

    Bink, Marleen; van Nieuwenhuizen, Chijs; Popma, Arne; Bongers, Ilja L; van Boxtel, Geert J M

    2014-05-01

    Neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder (ADHD), mainly attention problems. However, the additional influence of neurofeedback over treatment as usual (TAU) on neurocognitive functioning for adolescents with ADHD remains unclear. By using a multicenter parallel randomized controlled trial (RCT) design, male adolescents with a DSM-IV-TR diagnosis of ADHD (mean age = 16.1 years; range, 12-24) were randomized to receive either a combination of TAU and neurofeedback (n = 45) or TAU (n = 26). Randomization was computer generated and stratified by age group (ages 12 through 15, 16 through 20, and 21 through 24 years). The neurofeedback intervention consisted of approximately 37 sessions over a period of 25 weeks of theta/sensorimotor rhythm training on the vertex (Cz). Primary neurocognitive outcomes included performance parameters derived from the D2 Test of Attention, the Digit Span backward, the Stroop Color-Word Test and the Tower of London, all assessed preintervention and postintervention. Data were collected between December 2009 and July 2012. At postintervention, outcomes of attention and/or motor speed were improved, with faster processing times for both intervention conditions and with medium to large effect sizes (range, ηp2 = .08-.54; P values < .023). In both groups, no improvements for higher executive functions were observed. Results might partly resemble practice effects. Although neurocognitive outcomes improved in all adolescents receiving treatment for ADHD, no additional value for neurofeedback over TAU was observed. Hence, this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to TAU for adolescents with ADHD symptoms. Trialregister.nl identifier: 1759. © Copyright 2014 Physicians Postgraduate Press, Inc.

  14. Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

    PubMed

    Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

    2014-02-01

    Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

  15. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    NASA Astrophysics Data System (ADS)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  16. Effects of oral vitamin E on treatment of atopic dermatitis: A randomized controlled trial.

    PubMed

    Jaffary, Fariba; Faghihi, Gita; Mokhtarian, Arghavan; Hosseini, Sayed Mohsen

    2015-11-01

    The pathogenesis of atopic dermatitis (AD) remains to be determined; recently a possible change in the immune system with production of immunoglobulins is proposed. As vitamin E is a potent antioxidant, with the ability to decrease the serum levels of immunoglobulin E (IgE) in atopic patients, we aimed to evaluate the effect of oral vitamin E on treatment of AD. This randomized, double-blind, placebo-controlled trial comprised seventy participants with mild-to-moderate AD, based on the Hanifin and Rajka diagnostic criteria. The patients were randomly selected from teaching skin clinics in Isfahan, Iran. They were randomly assigned to two groups of equal number, receiving vitamin E (400 IU/day) and placebo for four 4 months. Each month, the extent, severity, and subjective symptoms including itch and sleeplessness were measured by SCORAD index. Three months after the end of intervention, the recurrence rate was assessed. The improvement in all symptoms, except sleeplessness, was significantly higher in the group receiving vitamin E than in controls (-1.5 vs. 0.218 in itching, -10.85 vs. -3.54 in extent of lesion, and -11.12 vs. -3.89 in SCORAD index, respectively, P < 0.05). Three months after the end of intervention, the recurrence rate of AD was evaluated. Recurrence rate between all 42 individuals, who remained in the study, was 18.6%. Recurrence ratio of the group receiving vitamin E compared to the placebo group was 1.17, without significant differences between the two groups (P > 0.05). This study suggests that vitamin E can improve the symptoms and the quality of life in patients with AD. As vitamin E has no side effects with a dosage of 400 IU/day, it can be recommended for the treatment of AD.

  17. Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

    PubMed

    Zaragoza, M; Sallés, M; Gomez, J; Bayas, J M; Trilla, A

    1999-06-01

    The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

  18. Biases in Estimating Treatment Effects Due to Attrition in Randomized Controlled Trials and Cluster Randomized Controlled Trials: A Simulation Study

    ERIC Educational Resources Information Center

    Dong, Nianbo; Lipsey, Mark W.

    2011-01-01

    Attrition occurs when study participants who were assigned to the treatment and control conditions do not provide outcome data and thus do not contribute to the estimation of the treatment effects. It is very common in experimental studies in education as illustrated, for instance, in a meta-analysis studying "the effects of attrition on baseline…

  19. A-site- and/or B-site-modified PbZrTiO3 materials and (Pb, Sr, Ca, Ba, Mg) (Zr, Ti, Nb, Ta)O3 films having utility in ferroelectric random access memories and high performance thin film microactuators

    NASA Technical Reports Server (NTRS)

    Bilodeau, Steven (Inventor); Baum, Thomas H. (Inventor); Roeder, Jeffrey F. (Inventor); Chen, Ing-Shin (Inventor)

    2001-01-01

    A modified PbZrTiO.sub.3 perovskite crystal material thin film, wherein the PbZrTiO.sub.3 perovskite crystal material includes crystal lattice A-sites and B-sites at least one of which is modified by the presence of a substituent selected from the group consisting of (i) A-site substituents consisting of Sr, Ca, Ba and Mg, and (ii) B-site substituents selected from the group consisting of Nb and Ta. The perovskite crystal thin film material may be formed by liquid delivery MOCVD from metalorganic precursors of the metal components of the thin film, to form PZT and PSZT, and other piezoelectric and ferroelectric thin film materials. The thin films of the invention have utility in non-volatile ferroelectric memory devices (NV-FeRAMs), and in microelectromechanical systems (MEMS) as sensor and/or actuator elements, e.g., high speed digital system actuators requiring low input power levels.

  20. Integrating Tobacco Treatment into Cancer Care: Study Protocol for a Randomized Controlled Comparative Effectiveness Trial

    PubMed Central

    Park, Elyse R.; Ostroff, Jamie S.; Perez, Giselle K.; Hyland, Kelly A.; Rigotti, Nancy A.; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R.; Levy, Douglas E.; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O’Brien, Maureen; de León-Sanchez, Suhana; Will Whitlock, C.

    2016-01-01

    Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. PMID:27444428

  1. Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials.

    PubMed

    Fernández-San-Martín, Maria Isabel; Masa-Font, Roser; Palacios-Soler, Laura; Sancho-Gómez, Pilar; Calbó-Caldentey, Cristina; Flores-Mateo, Gemma

    2010-06-01

    Insomnia is an often seen primary health care problem. Valerian might be an alternative treatment with fewer secondary effects. The aim of this study is to evaluate its effectiveness on insomnia through a meta-analysis of published literature. Search for randomized clinical trials (RCTs) of Valerian preparations compared with a placebo on Medline, the Cochrane Library, Embase and Biosis. sleep-quality improvement (SQ, yes/no), sleep-quality improvement quantified through visual analogical scales (SQS) and the latency time (LT) in minutes until getting to sleep. Three meta-analyses were carried out using inverse-variance weighted random effects models. Heterogeneity was determined with the Q-statistic and was explored through a sub-groups analysis. Publication bias was evaluated using the funnel plot. Eighteen RCTs were selected; eight had a score of 5 on Jadad's scale. The mean differences in LT between the Valerian and placebo treatment groups was 0.70 min (95% CI, -3.44 to 4.83); the standardized mean differences between the groups measured with SQS was -0.02 (95% CI, -0.35 to 0.31); treatment with Valerian showed a relative risk of SQ of 1.37 (95% CI, 1.05-1.78) compared with the placebo group. There was heterogeneity in the three meta-analyses, but it diminished in the sub groups analysis. No publication bias was detected. The qualitative dichotomous results suggest that valerian would be effective for a subjective improvement of insomnia, although its effectiveness has not been demonstrated with quantitative or objective measurements. We recommend future investigations oriented toward improving insomnia with other more promising treatments. Copyright 2010 Elsevier B.V. All rights reserved.

  2. Physical effects of Anma therapy (Japanese massage) for gynecologic cancer survivors: A randomized controlled trial.

    PubMed

    Donoyama, Nozomi; Satoh, Toyomi; Hamano, Tetsutaro; Ohkoshi, Norio; Onuki, Mamiko

    2016-09-01

    Cancer survivors often have physical and psychological complaints after standard cancer treatment. We conducted a randomized control trial to evaluate the physical and psychological/emotional effects of Anma therapy (Japanese massage, AMT) in gynecologic cancer survivors. The primary objective was to verify the effects of 8 consecutive weeks of weekly AMT. The secondary objective was to confirm the immediate effects of single-session AMT. We report here results of the physical effects of AMT. Forty participants were randomly allocated to an AMT group that received one 40-min AMT session per week for 8weeks and a no-AMT group. The primary endpoint was severity of subjective physical complaints assessed using a visual analogue scale (VAS). Secondary endpoints were urine and saliva analyses and psychological/emotional questionnaire scores. In the primary analysis, least-squares means (LSM) estimates of VAS score improvement over the 8weeks were -21.5 (95% confidence interval [CI], -30.1 to -12.8, P=0.0017) in the AMT group (n=20) and 0.8 (95%CI, -7.7 to 9.2, P=0.89) in the no-AMT group (n=20). The difference in the LSM estimates between the groups was -22.2 (95%CI, -34.4 to -10.1, P=0.0007). There were significant differences in VAS score and urinary epinephrine between before and after the intervention session, demonstrating the superiority of AMT. A single AMT session reduces the severity of subjective physical complaints and might inhibit the sympathetic nervous system in gynecologic cancer survivors. Receiving weekly AMT sessions for eight weeks effectively continues to reduce the severity of subjective physical complaints. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Moderators of intervention effects on parenting practices in a randomized controlled trial in early childhood.

    PubMed

    Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller

    2014-01-01

    The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.

  4. Moderators of Intervention Effects on Parenting Practices in a Randomized Controlled Trial in Early Childhood

    PubMed Central

    Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L.; Dawson-McClure, Spring; Palamar, Joseph J.; Brotman, Laurie Miller

    2013-01-01

    Objective The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family), moderated the effects of early family preventive intervention on parenting among high-risk families. Method Ninety-two preschool-age children (Mean age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Results Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Conclusions Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact in families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-centered, group-based intervention is promising for strengthening parenting among the highest risk families. PMID:24063291

  5. The Effect of Music Therapy in Patients with Huntington's Disease: A Randomized Controlled Trial.

    PubMed

    van Bruggen-Rufi, Monique C H; Vink, Annemieke C; Wolterbeek, Ron; Achterberg, Wilco P; Roos, Raymund A C

    2017-01-01

    Music therapy may have beneficial effects on improving communication and expressive skills in patients with Huntington's disease (HD). Most studies are, however, small observational studies and methodologically limited. Therefore we conducted a multi-center randomized controlled trial. To determine the efficacy of music therapy in comparison with recreational therapy in improving quality of life of patients with advanced Huntington's disease by means of improving communication. Sixty-three HD-patients with a Total Functional Capacity (TFC) score of ≤7, admitted to four long-term care facilities in The Netherlands, were randomized to receive either group music therapy or group recreational therapy in 16 weekly sessions. They were assessed at baseline, after 8, 16 and 28 weeks using the Behaviour Observation Scale for Huntington (BOSH) and the Problem Behaviour Assessment-short version (PBA-s). A linear mixed model with repeated measures was used to compare the scores between the two groups. Group music therapy offered once weekly for 16 weeks to patients with Huntington's disease had no additional beneficial effect on communication or behavior compared to group recreational therapy. This was the first study to assess the effect of group music therapy on HD patients in the advanced stages of the disease. The beneficial effects of music therapy, recorded in many, mainly qualitative case reports and studies, could not be confirmed with the design (i.e. group therapy vs individual therapy) and outcome measures that have been used in the present study. A comprehensive process-evaluation alongside the present effect evaluation is therefore performed.

  6. Effectiveness of a decision-training aid on referral prioritization capacity: a randomized controlled trial.

    PubMed

    Harries, Priscilla; Tomlinson, Christopher; Notley, Elizabeth; Davies, Miranda; Gilhooly, Kenneth

    2012-01-01

    In the community mental health field, occupational therapy students lack the capacity to prioritize referrals effectively. The purpose of this study was to test the effectiveness of a clinical decision-training aid on referral prioritization capacity. A double-blind, parallel-group, randomized controlled trial was conducted using a judgment analysis approach. Each participant used the World Wide Web to prioritize referral sets at baseline, immediate posttest, and 2-wk follow-up. The intervention group was provided with training after baseline testing; control group was purely given instructions to continue with the task. One hundred sixty-five students were randomly allocated to intervention (n = 87) or control (n = 81). Intervention. Written and graphical descriptions were given of an expert consensus standard explaining how referral information should be used to prioritize referrals. Participants' prioritization ratings were correlated with the experts' ratings of the same referrals at each stage of testing, as well as to examine the effect on mean group scores, regression weights, and the lens model indices. At baseline, no differences were found between control and intervention on rating capacity or demographic characteristics. Comparison of the difference in mean correlation baseline scores of the control and intervention group compared with immediate posttest showed a statistically significant result that was maintained at 2-wk follow-up. The effect size was classified as large. At immediate posttest and follow-up, the intervention group improved rating capacity, whereas the control group's capacity remained poor. The results of this study indicate that the decision-training aid has a positive effect on referral prioritization capacity. This freely available, Web-based decision-training aid will be a valuable adjunct to the education of these novice health professionals internationally.

  7. Effects of Horticulture on Frail and Prefrail Nursing Home Residents: A Randomized Controlled Trial.

    PubMed

    Lai, Claudia K Y; Kwan, Rick Y C; Lo, Shirley K L; Fung, Connie Y Y; Lau, Jordan K H; Tse, Mimi M Y

    2018-05-24

    Frail nursing home residents face multiple health challenges as a result of their frail status. The aim of this study was to examine the effects of HT on the psychosocial well-being of frail and prefrail nursing home residents. Randomized controlled trial. Nursing homes. One hundred eleven participants were randomly allocated into the intervention [horticultural therapy (HT)] and control (social activities) conditions. HT group participants attended a weekly 60-minute session for 8 consecutive weeks. Control group activities were social in nature, without any horticulture components. The outcome measures include happiness, depressive symptoms, self-efficacy, well-being, social network, and social engagement. The time points of measurement were at baseline (T 0 ), immediately postintervention (T 1 ), and 12 weeks postintervention (T 2 ). A modified intention-to-treat approach was adopted. A multivariate general estimating equation was used to analyze the data. Forty-six and 50 participants received at least 1 session of the intervention and control condition protocol, respectively. A significant interaction effect between group and time was observed only on the happiness scale (β = 1.457, P = .036), but not on other outcome variables. In a follow-up cluster analysis of those who received HT, a greater effect on subjective happiness (mean difference = 6.23, P < .001) was observed for participants who were happier at baseline. HT was found to be effective in promoting subjective happiness for frail and prefrail nursing home residents. Its favorable effect suggests that HT should be used to promote the psychosocial well-being of those who are frail. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  8. The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study.

    PubMed

    Kim, Eunjung; Cain, Kevin C; Webster-Stratton, Carolyn

    2008-09-01

    Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.

  9. Effectiveness of oncogenetics training on general practitioners' consultation skills: a randomized controlled trial

    PubMed Central

    Houwink, Elisa J.F.; Muijtjens, Arno M.M.; van Teeffelen, Sarah R.; Henneman, Lidewij; Rethans, Jan Joost; van der Jagt, Liesbeth E.J.; van Luijk, Scheltus J.; Dinant, Geert Jan; van der Vleuten, Cees; Cornel, Martina C.

    2014-01-01

    Purpose: General practitioners are increasingly called upon to deliver genetic services and could play a key role in translating potentially life-saving advancements in oncogenetic technologies to patient care. If general practitioners are to make an effective contribution in this area, their genetics competencies need to be upgraded. The aim of this study was to investigate whether oncogenetics training for general practitioners improves their genetic consultation skills. Methods: In this pragmatic, blinded, randomized controlled trial, the intervention consisted of a 4-h training (December 2011 and April 2012), covering oncogenetic consultation skills (family history, familial risk assessment, and efficient referral), attitude (medical ethical issues), and clinical knowledge required in primary-care consultations. Outcomes were measured using observation checklists by unannounced standardized patients and self-reported questionnaires. Results: Of 88 randomized general practitioners who initially agreed to participate, 56 completed all measurements. Key consultation skills significantly and substantially improved; regression coefficients after intervention were equivalent to 0.34 and 0.28 at 3-month follow-up, indicating a moderate effect size. Satisfaction and perceived applicability of newly learned skills were highly scored. Conclusion: The general practitioner–specific training proved to be a feasible, satisfactory, and clinically applicable method to improve oncogenetics consultation skills and could be used as an educational framework to inform future training activities with the ultimate aim of improving medical care. PMID:23722870

  10. Effect of postnatal home visits on maternal/infant outcomes in Syria: a randomized controlled trial.

    PubMed

    Bashour, Hyam N; Kharouf, Mayada H; Abdulsalam, Asma A; El Asmar, Khalil; Tabbaa, Mohammed A; Cheikha, Salah A

    2008-01-01

    Early postpartum home visiting is universal in many Western countries. Studies from developing countries on the effects of home visits are rare. In Syria, where the postpartum period is rather ignored, this study aimed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities; infant morbidity; uptake of postpartum care; use of contraceptive methods; and on selected neonatal health practices. A randomized controlled trial was carried out in Damascus. Three groups of new mothers were randomly allocated to receive either 4 postnatal home visits (A), one visit (B), or no visit (C). A total of 876 women were allocated and followed up. Registered midwives with special training made a one or a series of home visits providing information, educating, and supporting women. A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants (28.5% and 30%, respectively) as compared with Group C (20%), who received no visits. There were no reported differences between groups in other outcomes. While postpartum home visits significantly increased exclusive breastfeeding, other outcomes did not change. Further studies framed in a nonbiomedical context are needed. Other innovative approaches to improve postnatal care in Syria are needed.

  11. Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial.

    PubMed

    Briken, S; Gold, S M; Patra, S; Vettorazzi, E; Harbs, D; Tallner, A; Ketels, G; Schulz, K H; Heesen, C

    2014-03-01

    Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis (MS). Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans. It may, therefore, be particularly useful for MS patients with pronounced neurodegeneration. To investigate the potential of standardized exercise as a therapeutic intervention for progressive MS, in a randomized-controlled pilot trial. Patients with progressive MS and moderate disability (Expanded Disability Status Scale (EDSS) of 4-6) were randomized to one of three exercise interventions (arm ergometry, rowing, bicycle ergometry) for 8-10 weeks or a waitlist control group. We analyzed the drop-out rate as a measure of feasibility. The primary endpoint of the study was aerobic fitness. Secondary endpoints were walking ability, cognitive function as measured by a neuropsychological test battery, depression and fatigue. A total of 42 patients completed the trial (10.6% drop-out rate). Significant improvements were seen in aerobic fitness. In addition, exercise improved walking ability, depressive symptoms, fatigue and several domains of cognitive function. This study indicated that aerobic training is feasible and could be beneficial for patients with progressive MS. Larger exercise studies are needed to confirm the effect on cognition. ISRCTN (trial number 76467492) http://isrctn.org.

  12. Analgesic Effect of Intraperitoneal Bupivacaine Hydrochloride After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial.

    PubMed

    Alamdari, Nasser Malekpour; Bakhtiyari, Mahmood; Gholizadeh, Barmak; Shariati, Catrine

    2018-03-01

    The indications for sleeve gastrectomy as a primary procedure for the surgical treatment of morbid obesity have increased worldwide. Pain is the most common complaint for patients on the first day after laparoscopic sleeve gastrectomy. There are various methods for decreasing pain after laparoscopic sleeve gastrectomy such as the use of intraperitoneal bupivacaine hydrochloride. This clinical trial was an attempt to discover the effects of intraperitoneal bupivacaine hydrochloride on alleviating postoperative pain after laparoscopic sleeve gastrectomy. In general, 120 patients meeting the inclusion criteria were enrolled. Patients were randomly allocated into two interventions and control groups using a balanced block randomization technique. One group received intraperitoneal bupivacaine hydrochloride (30 cm 3 ), and the other group served as the control one and did not receive bupivacaine hydrochloride. Diclofenac suppository and paracetamol injection were administered to both groups for postoperative pain management. The mean subjective postoperative pain score was significantly decreased in patients who received intraperitoneal bupivacaine hydrochloride within the first 24 h after the surgery; thus, the instillation of bupivacaine hydrochloride was beneficial in managing postoperative pain. The intraoperative peritoneal irrigation of bupivacaine hydrochloride (30 cm 3 , 0.25%) in sleeve gastrectomy patients was safe and effective in reducing postoperative pain, nausea, and vomiting (IRCT2016120329181N4).

  13. Network sampling coverage II: The effect of non-random missing data on network measurement

    PubMed Central

    Smith, Jeffrey A.; Moody, James; Morgan, Jonathan

    2016-01-01

    Missing data is an important, but often ignored, aspect of a network study. Measurement validity is affected by missing data, but the level of bias can be difficult to gauge. Here, we describe the effect of missing data on network measurement across widely different circumstances. In Part I of this study (Smith and Moody, 2013), we explored the effect of measurement bias due to randomly missing nodes. Here, we drop the assumption that data are missing at random: what happens to estimates of key network statistics when central nodes are more/less likely to be missing? We answer this question using a wide range of empirical networks and network measures. We find that bias is worse when more central nodes are missing. With respect to network measures, Bonacich centrality is highly sensitive to the loss of central nodes, while closeness centrality is not; distance and bicomponent size are more affected than triad summary measures and behavioral homophily is more robust than degree-homophily. With respect to types of networks, larger, directed networks tend to be more robust, but the relation is weak. We end the paper with a practical application, showing how researchers can use our results (translated into a publically available java application) to gauge the bias in their own data. PMID:27867254

  14. Network sampling coverage II: The effect of non-random missing data on network measurement.

    PubMed

    Smith, Jeffrey A; Moody, James; Morgan, Jonathan

    2017-01-01

    Missing data is an important, but often ignored, aspect of a network study. Measurement validity is affected by missing data, but the level of bias can be difficult to gauge. Here, we describe the effect of missing data on network measurement across widely different circumstances. In Part I of this study (Smith and Moody, 2013), we explored the effect of measurement bias due to randomly missing nodes. Here, we drop the assumption that data are missing at random: what happens to estimates of key network statistics when central nodes are more/less likely to be missing? We answer this question using a wide range of empirical networks and network measures. We find that bias is worse when more central nodes are missing. With respect to network measures, Bonacich centrality is highly sensitive to the loss of central nodes, while closeness centrality is not; distance and bicomponent size are more affected than triad summary measures and behavioral homophily is more robust than degree-homophily. With respect to types of networks, larger, directed networks tend to be more robust, but the relation is weak. We end the paper with a practical application, showing how researchers can use our results (translated into a publically available java application) to gauge the bias in their own data.

  15. Effect of motivational interviewing on rates of early childhood caries: a randomized trial.

    PubMed

    Harrison, Rosamund; Benton, Tonya; Everson-Stewart, Siobhan; Weinstein, Phil

    2007-01-01

    The purposes of this randomized controlled trial were to: (1) test motivational interviewing (MI) to prevent early childhood caries; and (2) use Poisson regression for data analysis. A total of 240 South Asian children 6 to 18 months old were enrolled and randomly assigned to either the MI or control condition. Children had a dental exam, and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention. Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression. Hazard ratios were produced. Analyses included all participants whenever possible. Poisson regression supported a protective effect of MI (hazard ratio [HR]=0.54 (95%CI=035-0.84)-that is, the M/ group had about a 46% lower rate of dmfs at 2 years than did control children. Similar treatment effect estimates were obtained from models that included, as alternative outcomes, ds, dms, and dmfs, including "white spot lesions." Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had: (1) prechewed their food; (2) been raised in a rural environment; and (3) a higher family income (P<.05). A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries.

  16. Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic.

    PubMed

    Schmidt, Norman B; Raines, Amanda M; Allan, Nicholas P; Zvolensky, Michael J

    2016-02-01

    Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Crash Frequency Analysis Using Hurdle Models with Random Effects Considering Short-Term Panel Data

    PubMed Central

    Chen, Feng; Ma, Xiaoxiang; Chen, Suren; Yang, Lin

    2016-01-01

    Random effect panel data hurdle models are established to research the daily crash frequency on a mountainous section of highway I-70 in Colorado. Road Weather Information System (RWIS) real-time traffic and weather and road surface conditions are merged into the models incorporating road characteristics. The random effect hurdle negative binomial (REHNB) model is developed to study the daily crash frequency along with three other competing models. The proposed model considers the serial correlation of observations, the unbalanced panel-data structure, and dominating zeroes. Based on several statistical tests, the REHNB model is identified as the most appropriate one among four candidate models for a typical mountainous highway. The results show that: (1) the presence of over-dispersion in the short-term crash frequency data is due to both excess zeros and unobserved heterogeneity in the crash data; and (2) the REHNB model is suitable for this type of data. Moreover, time-varying variables including weather conditions, road surface conditions and traffic conditions are found to play importation roles in crash frequency. Besides the methodological advancements, the proposed technology bears great potential for engineering applications to develop short-term crash frequency models by utilizing detailed data from field monitoring data such as RWIS, which is becoming more accessible around the world. PMID:27792209

  18. Taking immunosuppressive medications effectively (TIMELink): a pilot randomized controlled trial in adult kidney transplant recipients.

    PubMed

    Russell, Cynthia; Conn, Vicki; Ashbaugh, Catherine; Madsen, Richard; Wakefield, Mark; Webb, Andrew; Coffey, Deanna; Peace, Leanne

    2011-01-01

    Immunosuppressive medication non-adherence is one of the most prevalent but preventable causes of poor outcomes in adult renal transplant recipients, yet there is a paucity of studies testing interventions in this area. Using a randomized controlled trial design, 30 adult renal transplant recipients were screened for medication non-adherence using electronic monitoring. Fifteen non-adherent participants were randomized to receive either a continuous self-improvement intervention or attention control management. The six-month continuous self-improvement intervention involved the participant and clinical nurse specialist collaboratively identifying the person's life routines, important people, and possible solutions to enhance medication taking. The participant then received individual monthly medication taking feedback delivered via a graphic printout of daily medication taking generated from electronic monitoring. The mean medication adherence score for the continuous self-improvement intervention group (n = 8) was statistically significantly higher than the attention control group's (n = 5) mean medication adherence score (p = 0.03). The continuous self-improvement intervention effect size (Cohen's d) was large at 1.4. Participants' perceptions of the intervention were highly favorable. The continuous self-improvement intervention shows promise as an effective and feasible approach to improve medication adherence in adult renal transplant recipients. A fully-powered study with a diverse sample is needed to confirm these preliminary findings. © 2010 John Wiley & Sons A/S.

  19. Evaluation of the effects of a diabetes educational program: a randomized clinical trial.

    PubMed

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-02-05

    Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). The educational program model developed was effective to improve the glycemic control of the intervention group participants.

  20. Evaluation of the effects of a diabetes educational program: a randomized clinical trial

    PubMed Central

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-01-01

    ABSTRACT OBJECTIVE Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. METHODS This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. RESULTS After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p < 0.05). However, the mean HbA1c level at T3, T6 and T9 times were significantly lower among the people in the intervention group (p < 0.05). CONCLUSIONS The educational program model developed was effective to improve the glycemic control of the intervention group participants. PMID:29412378

  1. Anxiety sensitivity risk reduction in smokers: A randomized control trial examining effects on panic

    PubMed Central

    Schmidt, Norman B.; Raines, Amanda M.; Allan, Nicholas P.; Zvolensky, Michael J.

    2016-01-01

    Empirical evidence has identified several risk factors for panic psychopathology, including smoking and anxiety sensitivity (AS; the fear of anxiety-related sensations). Smokers with elevated AS are therefore a particularly vulnerable population for panic. Yet, there is little knowledge about how to reduce risk of panic among high AS smokers. The present study prospectively evaluated panic outcomes within the context of a controlled randomized risk reduction program for smokers. Participants (N = 526) included current smokers who all received a state-of-the-art smoking cessation intervention with approximately half randomized to the AS reduction intervention termed Panic-smoking Program (PSP). The primary hypotheses focus on examining the effects of a PSP on panic symptoms in the context of this vulnerable population. Consistent with prediction, there was a significant effect of treatment condition on AS, such that individuals in the PSP condition, compared to those in the control condition, demonstrated greater decreases in AS throughout treatment and the follow-up period. In addition, PSP treatment resulted in lower rates of panic-related symptomatology. Moreover, mediation analyses indicated that reductions in AS resulted in lower panic symptoms. The present study provides the first empirical evidence that brief, targeted psychoeducational interventions can mitigate panic risk among smokers. PMID:26752327

  2. Generalized essential energy space random walks to more effectively accelerate solute sampling in aqueous environment

    NASA Astrophysics Data System (ADS)

    Lv, Chao; Zheng, Lianqing; Yang, Wei

    2012-01-01

    Molecular dynamics sampling can be enhanced via the promoting of potential energy fluctuations, for instance, based on a Hamiltonian modified with the addition of a potential-energy-dependent biasing term. To overcome the diffusion sampling issue, which reveals the fact that enlargement of event-irrelevant energy fluctuations may abolish sampling efficiency, the essential energy space random walk (EESRW) approach was proposed earlier. To more effectively accelerate the sampling of solute conformations in aqueous environment, in the current work, we generalized the EESRW method to a two-dimension-EESRW (2D-EESRW) strategy. Specifically, the essential internal energy component of a focused region and the essential interaction energy component between the focused region and the environmental region are employed to define the two-dimensional essential energy space. This proposal is motivated by the general observation that in different conformational events, the two essential energy components have distinctive interplays. Model studies on the alanine dipeptide and the aspartate-arginine peptide demonstrate sampling improvement over the original one-dimension-EESRW strategy; with the same biasing level, the present generalization allows more effective acceleration of the sampling of conformational transitions in aqueous solution. The 2D-EESRW generalization is readily extended to higher dimension schemes and employed in more advanced enhanced-sampling schemes, such as the recent orthogonal space random walk method.

  3. Effect of a stress management program on subjects with neck pain: A pilot randomized controlled trial.

    PubMed

    Metikaridis, T Damianos; Hadjipavlou, Alexander; Artemiadis, Artemios; Chrousos, George; Darviri, Christina

    2016-05-20

    Studies have shown that stress is implicated in the cause of neck pain (NP). The purpose of this study is to examine the effect of a simple, zero cost stress management program on patients suffering from NP. This study is a parallel-type randomized clinical study. People suffering from chronic non-specific NP were chosen randomly to participate in an eight week duration program of stress management (N= 28) (including diaphragmatic breathing, progressive muscle relaxation) or in a no intervention control condition (N= 25). Self-report measures were used for the evaluation of various variables at the beginning and at the end of the eight-week monitoring period. Descriptive and inferential statistic methods were used for the statistical analysis. At the end of the monitoring period, the intervention group showed a statistically significant reduction of stress and anxiety (p= 0.03, p= 0.01), report of stress related symptoms (p= 0.003), percentage of disability due to NP (p= 0.000) and NP intensity (p= 0.002). At the same time, daily routine satisfaction levels were elevated (p= 0.019). No statistically significant difference was observed in cortisol measurements. Stress management has positive effects on NP patients.

  4. Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

    PubMed

    Pradeep, A R; Agarwal, Esha; Naik, Savitha B

    2012-06-01

    Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

  5. Effects of Yoga on Heart Rate Variability and Depressive Symptoms in Women: A Randomized Controlled Trial.

    PubMed

    Chu, I-Hua; Wu, Wen-Lan; Lin, I-Mei; Chang, Yu-Kai; Lin, Yuh-Jen; Yang, Pin-Chen

    2017-04-01

    The purpose of the study was to investigate the effects of a 12-week yoga program on heart rate variability (HRV) and depressive symptoms in depressed women. This was a randomized controlled trial. Twenty-six sedentary women scoring ≥14 on the Beck Depression Inventory-II were randomized to either the yoga or the control group. The yoga group completed a 12-week yoga program, which took place twice a week for 60 min per session and consisted of breathing exercises, yoga pose practice, and supine meditation/relaxation. The control group was instructed not to engage in any yoga practice and to maintain their usual level of physical activity during the course of the study. Participants' HRV, depressive symptoms, and perceived stress were assessed at baseline and post-test. The yoga group had a significant increase in high-frequency HRV and decreases in low-frequency HRV and low frequency/high frequency ratio after the intervention. The yoga group also reported significantly reduced depressive symptoms and perceived stress. No change was found in the control group. A 12-week yoga program was effective in increasing parasympathetic tone and reducing depressive symptoms and perceived stress in women with elevated depressive symptoms. Regular yoga practice may be recommended for women to cope with their depressive symptoms and stress and to improve their HRV.

  6. The effect of random or sequential presentation of targets during robot-assisted therapy on children.

    PubMed

    Ladenheim, Barbara; Altenburger, Peter; Cardinal, Ryan; Monterroso, Linda; Dierks, Tracy; Mast, Joelle; Krebs, Hermano Igo

    2013-01-01

    Robot assisted upper extremity therapy has been shown to be effective in adult stroke patients and in children with cerebral palsy (CP) and other acquired brain injuries (ABI). The patient's active involvement is a factor in its efficacy. However, this demands focused attention during training sessions, which can be a challenge for children. To compare results of training requiring two different levels of focused attention. Differences in short term performance and retention of gains as a function of training protocol as measured by the Fugl-Meyer (FM) were predicted. Thirty-one children with CP or ABI were randomly divided into two groups. All received 16 one hour sessions of robot-assisted therapy (twice a week for 8 weeks) where they moved a robot handle to direct a cursor on the screen toward designated targets. One group had targets presented sequentially in clockwise fashion, the other presented in random order. Thus, one group could anticipate the position of each target, the other could not. Both groups showed significant functional improvement after therapy, but no significant difference between groups was observed. Assist-as-needed robotic training is effective in children with CP or ABI with small non-significant differences attributed to attentional demand.

  7. The effects of mirror therapy on the gait of subacute stroke patients: a randomized controlled trial.

    PubMed

    Ji, Sang Gu; Kim, Myoung Kwon

    2015-04-01

    To investigate the effect of mirror therapy on the gait of patients with subacute stroke. Randomized controlled experimental study. Outpatient rehabilitation hospital. Thirty-four patients with stroke were randomly assigned to two groups: a mirror therapy group (experimental) and a control group. The stroke patients in the experimental group underwent comprehensive rehabilitation therapy and mirror therapy for the lower limbs. The stroke patients in the control group underwent sham therapy and comprehensive rehabilitation therapy. Participants in both groups received therapy five days per week for four weeks. Temporospatial gait characteristics, such as single stance, stance phase, step length, stride, swing phase, velocity, and cadence, were assessed before and after the four weeks therapy period. A significant difference was observed in post-training gains for the single stance (10.32 SD 4.14 vs. 6.54 SD 3.23), step length (8.47 SD 4.12 vs. 4.83 SD 2.14), and stride length (17.03 SD 6.57 vs 10.54 SD 4.34) between the experimental group and the control group (p < 0.05). However, there were no significant differences between two groups on stance phase, swing phase, velocity, cadence, and step width (P > 0.05). We conclude that mirror therapy may be beneficial in improving the effects of stroke on gait ability. © The Author(s) 2014.

  8. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    PubMed

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P < 0.001) at both short and long follow-ups. Deep dry needling and passive stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  9. Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial.

    PubMed

    Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H

    2016-04-01

    To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  10. Effects of acupressure on progress of labor and cesarean section rate: randomized clinical trial

    PubMed Central

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2015-01-01

    OBJECTIVE To analyze the effects of acupressure at the SP6 point on labor duration and cesarean section rates in parturients served in a public maternity hospital. METHODS This controlled, randomized, double-blind, pragmatic clinical trial involved 156 participants with gestational age ≥ 37 weeks, cervical dilation ≥ 4 cm, and ≥ 2 contractions in 10 min. The women were randomly divided into an acupressure, placebo, or control group at a university hospital in an inland city in the state of Sao Paulo, Brazil, in 2013. Acupressure was applied to the SP6 point during contractions for 20 min. RESULTS The average labor duration was significantly different between the SP6 acupressure group [221.5 min (SD = 162.4)] versus placebo [397.9 min (SD = 265.6)] and versus control [381.9 min (SD = 358.3)] (p = 0.0047); however, the groups were similar regarding the cesarean section rates (p = 0.2526) and Apgar scores in the first minute (p = 0.9542) and the fifth minute (p = 0.7218) of life of the neonate. CONCLUSIONS The SP6 acupressure point proved to be a complementary measure to induce labor and may shorten the labor duration without causing adverse effects to the mother or the newborn. However, it did not affect the cesarean section rate. PMID:25741644

  11. The Effects of Bougie Diameters on Tissue Oxygen Levels After Sleeve Gastrectomy: A Randomized Experimental Trial

    PubMed

    Konca, Can; Yılmaz, Ali Abbas; Çelik, Süleyman Utku; Kayılıoğlu, Selami Ilgaz; Paşaoğlu, Özge Tuğçe; Ceylan, Halil Arda; Genç, Volkan

    2018-05-29

    Staple-line leak is the most frightening complication of laparoscopic sleeve gastrectomy and several predisposing factors such as using improper staple sizes regardless of gastric wall thickness, narrower bougie diameter and ischemia of the staple line are asserted. To evaluate the effects of different bougie diameters on tissue oxygen partial pressure at the esophagogastric junction after sleeve gastrectomy. A randomized and controlled animal experiment with 1:1:1:1 allocation ratio. Thirty-two male Wistar Albino rats were randomly divided into 4 groups of 8 each. While 12-Fr bougies were used in groups 1 and 3, 8-Fr bougies were used in groups 2 and 4. Fibrin sealant application was also carried out around the gastrectomy line after sleeve gastrectomy in groups 3 and 4. Burst pressure of gastrectomy line, tissue oxygen partial pressure and hydroxyproline levels at the esophagogastric junction were measured and compared among groups. Mortality was detected in 2 out of 32 rats (6.25%) and one of them was in group 2 and the cause of this mortality was gastric leak. Gastric leak was detected in 2 out of 32 rats (6.25%). There was no significant difference in terms of burst pressures, tissue oxygen partial pressure and tissue hydroxyproline levels among the 4 groups. The use of narrower bougie along with fibrin sealant has not had a negative effect on tissue perfusion and wound healing.

  12. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials

    PubMed Central

    Kim, Sang-Dol

    2016-01-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  13. 1% hydrocortisone ointment is an effective treatment of pruritus ani: a pilot randomized controlled crossover trial.

    PubMed

    Al-Ghnaniem, R; Short, K; Pullen, A; Fuller, L C; Rennie, J A; Leather, A J M

    2007-12-01

    Pruritus ani (PA) is a common condition which is difficult to treat in the absence of obvious predisposing factors. There is paucity of evidence-based guidelines on the treatment of this condition. We examined whether 1% hydrocortisone ointment is an effective treatment for PA. A pilot randomized, double-blind, placebo-controlled, crossover trial was carried out. Eleven patients consented to take part in the trial and ten completed the study. After a 2-week run-in period, patients with primary PA were randomly allocated to receive 1% hydrocortisone ointment or placebo for 2 weeks followed by the opposite treatment for a further 2-week period. There was a washout period of 2 weeks between treatments. The primary outcome measure was reduction in itch using a visual analogue score (VAS). The secondary outcome measures were improvement in quality of life measured using a validated questionnaire (Dermatology Life Quality Index, DLQI) and improvement in clinical appearance of the perianal skin using the Eczema Area and Severity Index (EASI) score. Treatment with 1% hydrocortisone ointment resulted in a 68% reduction in VAS compared with placebo (P=0.019), a 75% reduction in DLQI score (P=0.067), and 81% reduction in EASI score (P=0.01). A short course of mild steroid ointment is an effective treatment for PA.

  14. Sample size calculation in cost-effectiveness cluster randomized trials: optimal and maximin approaches.

    PubMed

    Manju, Md Abu; Candel, Math J J M; Berger, Martijn P F

    2014-07-10

    In this paper, the optimal sample sizes at the cluster and person levels for each of two treatment arms are obtained for cluster randomized trials where the cost-effectiveness of treatments on a continuous scale is studied. The optimal sample sizes maximize the efficiency or power for a given budget or minimize the budget for a given efficiency or power. Optimal sample sizes require information on the intra-cluster correlations (ICCs) for effects and costs, the correlations between costs and effects at individual and cluster levels, the ratio of the variance of effects translated into costs to the variance of the costs (the variance ratio), sampling and measuring costs, and the budget. When planning, a study information on the model parameters usually is not available. To overcome this local optimality problem, the current paper also presents maximin sample sizes. The maximin sample sizes turn out to be rather robust against misspecifying the correlation between costs and effects at the cluster and individual levels but may lose much efficiency when misspecifying the variance ratio. The robustness of the maximin sample sizes against misspecifying the ICCs depends on the variance ratio. The maximin sample sizes are robust under misspecification of the ICC for costs for realistic values of the variance ratio greater than one but not robust under misspecification of the ICC for effects. Finally, we show how to calculate optimal or maximin sample sizes that yield sufficient power for a test on the cost-effectiveness of an intervention.

  15. Performance of time-varying predictors in multilevel models under an assumption of fixed or random effects.

    PubMed

    Baird, Rachel; Maxwell, Scott E

    2016-06-01

    Time-varying predictors in multilevel models are a useful tool for longitudinal research, whether they are the research variable of interest or they are controlling for variance to allow greater power for other variables. However, standard recommendations to fix the effect of time-varying predictors may make an assumption that is unlikely to hold in reality and may influence results. A simulation study illustrates that treating the time-varying predictor as fixed may allow analyses to converge, but the analyses have poor coverage of the true fixed effect when the time-varying predictor has a random effect in reality. A second simulation study shows that treating the time-varying predictor as random may have poor convergence, except when allowing negative variance estimates. Although negative variance estimates are uninterpretable, results of the simulation show that estimates of the fixed effect of the time-varying predictor are as accurate for these cases as for cases with positive variance estimates, and that treating the time-varying predictor as random and allowing negative variance estimates performs well whether the time-varying predictor is fixed or random in reality. Because of the difficulty of interpreting negative variance estimates, 2 procedures are suggested for selection between fixed-effect and random-effect models: comparing between fixed-effect and constrained random-effect models with a likelihood ratio test or fitting a fixed-effect model when an unconstrained random-effect model produces negative variance estimates. The performance of these 2 procedures is compared. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  16. Effect of tailoring in an internet-based intervention for smoking cessation: randomized controlled trial.

    PubMed

    Wangberg, Silje C; Nilsen, Olav; Antypas, Konstantinos; Gram, Inger Torhild

    2011-12-15

    Studies suggest that tailored materials are superior to nontailored materials in supporting health behavioral change. Several trials on tailored Internet-based interventions for smoking cessation have shown good effects. There have, however, been few attempts to isolate the effect of the tailoring component of an Internet-based intervention for smoking cessation and to compare it with the effectiveness of the other components. The study aim was to isolate the effect of tailored emails in an Internet-based intervention for smoking cessation by comparing two versions of the intervention, with and without tailored content. We conducted a two-arm, randomized controlled trial of the open and free Norwegian 12-month follow-up, fully automated Internet-based intervention for smoking cessation, slutta.no. We collected information online on demographics, smoking, self-efficacy, use of the website, and participant evaluation at enrollment and subsequently at 1, 3, and 12 months. Altogether, 2298 self-selected participants aged 16 years or older registered at the website between August 15, 2006 and December 7, 2007 and were randomly assigned to either a multicomponent, nontailored Internet-based intervention for smoking cessation (control) or a version of the same Internet-based intervention with tailored content delivered on the website and via email. Of the randomly assigned participants, 116 (of 419, response rate = 27.7%) in the intervention group and 128 (of 428, response rate = 29.9%) in the control group had participated over the 12 months and responded at the end of follow-up. The 7-day intention-to-treat abstinence rate at 1 month was 15.2% (149/982) among those receiving the tailored intervention, compared with 9.4% (94/999) among those who received the nontailored intervention (P < .001). The corresponding figures at 3 months were 13.5% (122/902) and 9.4% (84/896, P =.006) and at 12 months were 11.2% (47/419) and 11.7% (50/428, P = .91). Likewise, the intervention

  17. Effects of interpretive nutrition labels on consumer food purchases: the Starlight randomized controlled trial.

    PubMed

    Ni Mhurchu, Cliona; Volkova, Ekaterina; Jiang, Yannan; Eyles, Helen; Michie, Jo; Neal, Bruce; Blakely, Tony; Swinburn, Boyd; Rayner, Mike

    2017-03-01

    Background: Nutrition labeling is a prominent policy to promote healthy eating. Objective: We aimed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases. Design: In this parallel-group randomized controlled trial, we enrolled household shoppers across New Zealand who owned smartphones and were aged ≥18 y. Eligible participants were randomly assigned (1:1:1) to receive either traffic light labels (TLLs), Health Star Rating labels (HSRs), or a control [nutrition information panel (NIP)]. Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens. The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period, which was measured by using the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC). Results: Between October 2014 and November 2015, 1357 eligible shoppers were randomly assigned to TLL ( n = 459), HSR ( n = 443), or NIP ( n = 455) labels. Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was -0.20 (95% CI: -0.94, 0.54; P = 0.60). The corresponding difference for HSR compared with NIP was -0.60 (95% CI: -1.35, 0.15; P = 0.12). In an exploratory per-protocol analysis of participants who used the labeling intervention more often than average ( n = 423, 31%), those who were assigned to TLL and HSR had significantly better NPSC scores [TLL compared with NIP: -1.33 (95% CI: -2.63, -0.04; P = 0.04); HSR compared with NIP: -1.70 (95% CI: -2.97, -0.43; P = 0.01)]. Shoppers who were randomly assigned to HSR and TLL also found the labels significantly more useful and easy to understand than the NIP (all P values <0.001). Conclusions: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases. However, shoppers who used

  18. Quantification of Randomly-methylated-{beta}-cyclodextrin effect on liposome: An ESR study

    SciTech Connect

    Grammenos, A., E-mail: A.Grammenos@ulg.ac.be; Bahri, M.A.; Guelluy, P.H.

    2009-12-04

    In the present work, the effect of Randomly-methylated-{beta}-cyclodextrin (Rameb) on the microviscosity of dimyristoyl-L-{alpha} phosphatidylcholine (DMPC) bilayer was investigated using the electron spin resonance (ESR) technique. The ability of Rameb to extract membrane cholesterol was demonstrated. For the first time, the percentage of cholesterol extracted by Rameb from cholesterol doped DMPC bilayer was monitored and quantified throughout a wide Rameb concentration range. The effect of cholesterol on the inner part of the membrane was also investigated using 16-doxyl stearic acid spin label (16-DSA). 16-DSA seems to explore two different membrane domains and report their respective microviscosities. ESR experiments also establishmore » that the presence of 30% of cholesterol in DMPC liposomes suppresses the jump in membrane fluidity at lipids phase-transition temperature (23.9 {sup o}C).« less

  19. Effective-medium theory of elastic waves in random networks of rods.

    PubMed

    Katz, J I; Hoffman, J J; Conradi, M S; Miller, J G

    2012-06-01

    We formulate an effective medium (mean field) theory of a material consisting of randomly distributed nodes connected by straight slender rods, hinged at the nodes. Defining wavelength-dependent effective elastic moduli, we calculate both the static moduli and the dispersion relations of ultrasonic longitudinal and transverse elastic waves. At finite wave vector k the waves are dispersive, with phase and group velocities decreasing with increasing wave vector. These results are directly applicable to networks with empty pore space. They also describe the solid matrix in two-component (Biot) theories of fluid-filled porous media. We suggest the possibility of low density materials with higher ratios of stiffness and strength to density than those of foams, aerogels, or trabecular bone.

  20. Methods for Synthesizing Findings on Moderation Effects Across Multiple Randomized Trials

    PubMed Central

    Brown, C Hendricks; Sloboda, Zili; Faggiano, Fabrizio; Teasdale, Brent; Keller, Ferdinand; Burkhart, Gregor; Vigna-Taglianti, Federica; Howe, George; Masyn, Katherine; Wang, Wei; Muthén, Bengt; Stephens, Peggy; Grey, Scott; Perrino, Tatiana

    2011-01-01

    This paper presents new methods for synthesizing results from subgroup and moderation analyses across different randomized trials. We demonstrate that such a synthesis generally results in additional power to detect significant moderation findings above what one would find in a single trial. Three general methods for conducting synthesis analyses are discussed, with two methods, integrative data analysis, and parallel analyses, sharing a large advantage over traditional methods available in meta-analysis. We present a broad class of analytic models to examine moderation effects across trials that can be used to assess their overall effect and explain sources of heterogeneity, and present ways to disentangle differences across trials due to individual differences, contextual level differences, intervention, and trial design. PMID:21360061

  1. Methods for synthesizing findings on moderation effects across multiple randomized trials.

    PubMed

    Brown, C Hendricks; Sloboda, Zili; Faggiano, Fabrizio; Teasdale, Brent; Keller, Ferdinand; Burkhart, Gregor; Vigna-Taglianti, Federica; Howe, George; Masyn, Katherine; Wang, Wei; Muthén, Bengt; Stephens, Peggy; Grey, Scott; Perrino, Tatiana

    2013-04-01

    This paper presents new methods for synthesizing results from subgroup and moderation analyses across different randomized trials. We demonstrate that such a synthesis generally results in additional power to detect significant moderation findings above what one would find in a single trial. Three general methods for conducting synthesis analyses are discussed, with two methods, integrative data analysis and parallel analyses, sharing a large advantage over traditional methods available in meta-analysis. We present a broad class of analytic models to examine moderation effects across trials that can be used to assess their overall effect and explain sources of heterogeneity, and present ways to disentangle differences across trials due to individual differences, contextual level differences, intervention, and trial design.

  2. Random safety auditing, root cause analysis, failure mode and effects analysis.

    PubMed

    Ursprung, Robert; Gray, James

    2010-03-01

    Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.

  3. Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials.

    PubMed

    Yu, Changhe; Ji, Kangshou; Cao, Huijuan; Wang, Ying; Jin, Hwang Hye; Zhang, Zhe; Yang, Guanlin

    2015-03-28

    The purpose of this systematic review is to assess the effectiveness of acupuncture for angina pectoris. Eleven electronic databases were searched until January 2013. The study included randomized controlled trials that the effectiveness of acupuncture alone was compared to anti-angina medicines (in addition to conventional treatment) and the effectiveness of a combination of acupuncture plus anti-angina medicines was compared to anti-angina medicines alone. The trial selection, data extraction, quality assessment and data analytic procedures outlined in the 2011 Cochrane Handbook were involved. The study included 25 randomized controlled trials (involving 2,058 patients) that met our inclusion criteria. The pooled results showed that the number of patients with ineffectiveness of angina relief was less in the combined acupuncture-anti-angina treatment group than in the anti-angina medicines alone group (RR 0.33, 95% CI 0.23-0.47, p < 0.00001, I2 = 0%). Similarly, compared to the anti-angina medicines alone group, fewer patients in the combined treatment group showed no ECG improvement (RR 0.50, 95% CI 0.40-0.62, p < 0.00001, I2 = 0%). However, no differences were observed between acupuncture treatment alone and anti-angina medicines alone for both outcome measures. Only four trials mentioned adverse effects. One trial found no significant difference between acupuncture and Chinese medicine, and three reported no adverse events. The quality of the trials was found to be low. The findings showed very low evidence to support the use of acupuncture for improving angina symptoms and ECG of angina patients. However, the quality of the trials included in this study was low. Large and rigorously designed trials are needed to confirm the potential benefit and adverse events of acupuncture.

  4. Effect of led photobiomodulation on analgesia during labor: Study protocol for a randomized clinical trial.

    PubMed

    Traverzim, Maria Aparecida Dos Santos; Makabe, Sergio; Silva, Daniela Fátima Teixeira; Pavani, Christiane; Bussadori, Sandra Kalil; Fernandes, Kristianne Santos Porta; Motta, Lara Jansiski

    2018-06-01

    Labor pain is one of the most intense pains experienced by women, which leads to an increase in the number of women opting to undergo a cesarean delivery. Pharmacological and nonpharmacological analgesia methods are used to control labor pain. Epidural analgesia is the most commonly used pharmacological analgesia method. However, it may have side effects on the fetus and the mother. Light-emitting diode (LED) photobiomodulation is an effective and noninvasive alternative to pharmacological methods. To evaluate the effects of LED photobiomodulation on analgesia during labor. In total, 60 women in labor admitted to a public maternity hospital will be selected for a randomized controlled trial. The participants will be randomized into 2 groups: intervention group [analgesia with LED therapy (n = 30)] and control group [analgesia with bath therapy (n = 30)]. The perception of pain will be assessed using the visual analogue scale (VAS), with a score from 0 to 10 at baseline, that is, before the intervention. In both the groups, the procedures will last 10 minutes and will be performed at 3 time points during labor: during cervical dilation of 4 to 5 cm, 6 to 7 cm, and 8 to 9 cm. At all 3 time points, pain perception will be evaluated using VAS shortly after the intervention. In addition, the evaluation of membrane characteristics (intact or damaged), heart rate, uterine dynamics, and cardiotocography will be performed at all time points. The use of LED photobiomodulation will have an analgesic effect superior to that of the bath therapy.

  5. The effect of financial incentives on chlamydia testing rates: Evidence from a randomized experiment☆

    PubMed Central

    Dolan, Paul; Rudisill, Caroline

    2014-01-01

    Financial incentives have been used in a variety of settings to motivate behaviors that might not otherwise be undertaken. They have been highlighted as particularly useful in settings that require a single behavior, such as appointment attendance or vaccination. They also have differential effects based on socioeconomic status in some applications (e.g. smoking). To further investigate these claims, we tested the effect of providing different types of non-cash financial incentives on the return rates of chlamydia specimen samples amongst 16–24 year-olds in England. In 2011 and 2012, we ran a two-stage randomized experiment involving 2988 young people (1489 in Round 1 and 1499 in Round 2) who requested a chlamydia screening kit from Freetest.me, an online and text screening service run by Preventx Limited. Participants were randomized to control, or one of five types of financial incentives in Round 1 or one of four financial incentives in Round 2. We tested the effect of five types of incentives on specimen sample return; reward vouchers of differing values, charity donation, participation in a lottery, choices between a lottery and a voucher and including vouchers of differing values in the test kit prior to specimen return. Financial incentives of any type, did not make a significant difference in the likelihood of specimen return. The more deprived individuals were, as calculated using Index of Multiple Deprivation (IMD), the less likely they were to return a sample. The extent to which incentive structures influenced sample return was not moderated by IMD score. Non-cash financial incentives for chlamydia testing do not seem to affect the specimen return rate in a chlamydia screening program where test kits are requested online, mailed to requestors and returned by mail. They also do not appear more or less effective in influencing test return depending on deprivation level. PMID:24373390

  6. Effects of Vitex agnus and Flaxseed on cyclic mastalgia: A randomized controlled trial.

    PubMed

    Mirghafourvand, Mojgan; Mohammad-Alizadeh-Charandabi, Sakineh; Ahmadpour, Parivash; Javadzadeh, Yousef

    2016-02-01

    Evidence on the effect of Vitex agnus and Flaxseed on cyclical mastalgia is not enough. This study aimed to assess the efficacy of V. agnus and Flaxseed on cyclical mastalgia. This randomized controlled trial was conducted on 159 women referred to health centers of Tabriz, Iran. Subjects were allocated into three groups (n=53 per group) using block randomization. Group I received 25g daily Flaxseed powder and placebo of V. agnus; group II received daily 3.2-4.8mg V. agnus tablet and placebo of Flaxseed and control group received both placebo. Nominal day breast pain was applied at baseline, first, and second month after the intervention. Data was analyzed using general linear model. There was no statistical significant difference between the three groups in terms of socio-demographic characteristics and baseline values. The breast pain improved significantly in both intervention groups during the first and second month after intervention. Mean NDBP score was significantly lower than that in the control group at the first month after the intervention in the Flaxseed [adjusted mean difference: -3.1 (95% CI: -4.2 to -2.0)] and V. agnus groups [-3.3 (-4.3 to -2.2)] and the second month after the intervention in Flaxseed [-7.0 (-8.1 to -5.9)] and V. agnus groups [-6.4 (-7.5 to -5.3)]. Flaxseed and V. agnus are effective in short-term period in decreasing cyclical mastalgia. However, further studies are needed to examine the long-term effectiveness and sustainability of the effects after stopping the treatment in order to decide whether these alternative treatments are suitable to treat mastalgia or not. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. Effect of Turkish classical music on blood pressure: a randomized controlled trial in hypertensive elderly patients.

    PubMed

    Bekiroğlu, Tansel; Ovayolu, Nimet; Ergün, Yusuf; Ekerbiçer, Hasan Çetin

    2013-06-01

    Existing studies suggest that music therapy can have favorable effects on hypertension and anxiety. We therefore set out to investigate the effect of Turkish classical music. To investigate whether Turkish classical music has positive effects on blood pressures and anxiety levels in elderly patients. This was a randomized controlled trial performed on 60 hypertensive patients living in a local elderly home in Adana, Turkey. Following the completion of a socio-demographic form for each patient, Hamilton anxiety scale was applied. Thereafter, the subjects were randomly divided into two equal-size groups and were allowed to either listen to Turkish classical music (music therapy group) or have a resting period (control group) for 25 min. The primary and secondary outcome measures were blood pressure and Hamilton anxiety scale scores, respectively. The mean reduction in systolic blood pressure was 13.00 mmHg in the music therapy group and 6.50 mmHg in the control group. The baseline adjusted between treatment group difference was not statistically significant (95% CI 6.80-9.36). The median reductions in diastolic blood pressures were 10 mmHg both in the music therapy and control groups. The between treatment group difference was not statistically significant (Mann-Whitney U test, P = 0.839). The mean reduction in HAMA-A was 1.63 in the music therapy group and 0.77 in the control group. The baseline adjusted between treatment group difference was not statistically significant (95% CI 0.82-1.92). The study demonstrated that both Turkish classical music and resting alone have positive effects on blood pressure in patients with hypertension. Copyright © 2013 Elsevier Ltd. All rights reserved.

  8. Effects of yoga, strength training and advice on back pain: a randomized controlled trial.

    PubMed

    Brämberg, Elisabeth Björk; Bergström, Gunnar; Jensen, Irene; Hagberg, Jan; Kwak, Lydia

    2017-03-29

    Among the working population, non-specific low-back pain and neck pain are one of the most common reasons for sickness absenteeism. The aim was to evaluate the effects of an early intervention of yoga - compared with strength training or evidence-based advice - on sickness absenteeism, sickness presenteeism, back and neck pain and disability among a working population. A randomized controlled trial was conducted on 159 participants with predominantly (90%) chronic back and neck pain. After screening, the participants were randomized to kundalini yoga, strength training or evidence-based advice. Primary outcome was sickness absenteeism. Secondary outcomes were sickness presenteeism, back and neck pain and disability. Self-reported questionnaires and SMS text messages were completed at baseline, 6 weeks, 6 and 12 months. The results did not indicate that kundalini yoga and strength training had any statistically significant effects on the primary outcome compared with evidence-based advice. An interaction effect was found between adherence to recommendations and sickness absenteeism, indicating larger significant effects among the adherers to kundalini yoga versus evidence-based advice: RR = 0.47 (CI 0.30; 0.74, p = 0.001), strength training versus evidence-based advice: RR = 0.60 (CI 0.38; 0.96, p = 0.032). Some significant differences were also found for the secondary outcomes to the advantage of kundalini yoga and strength training. Guided exercise in the forms of kundalini yoga or strength training does not reduce sickness absenteeism more than evidence-based advice alone. However, secondary analyses reveal that among those who pursue kundalini yoga or strength training at least two times a week, a significantly reduction in sickness absenteeism was found. Methods to increase adherence to treatment recommendations should be further developed and applied in exercise interventions. Clinicaltrials.gov NCT01653782, date of registration: June, 28

  9. Rifaximin has minor effects on bacterial composition, inflammation, and bacterial translocation in cirrhosis: A randomized trial.

    PubMed

    Kimer, Nina; Pedersen, Julie S; Tavenier, Juliette; Christensen, Jeffrey E; Busk, Troels M; Hobolth, Lise; Krag, Aleksander; Al-Soud, Waleed Abu; Mortensen, Martin S; Sørensen, Søren J; Møller, Søren; Bendtsen, Flemming

    2018-01-01

    Decompensated cirrhosis is characterized by disturbed hemodynamics, immune dysfunction, and high risk of infections. Translocation of viable bacteria and bacterial products from the gut to the blood is considered a key driver in this process. Intestinal decontamination with rifaximin may reduce bacterial translocation (BT) and decrease inflammation. A randomized, placebo-controlled trial investigated the effects of rifaximin on inflammation and BT in decompensated cirrhosis. Fifty-four out-patients with cirrhosis and ascites were randomized, mean age 56 years (± 8.4), and model for end-stage liver disease score 12 (± 3.9). Patients received rifaximin 550-mg BD (n = 36) or placebo BD (n = 18). Blood and fecal (n = 15) sampling were conducted at baseline and after 4 weeks. Bacterial DNA in blood was determined by real-time qPCR 16S rRNA gene quantification. Bacterial composition in feces was analyzed by 16S rRNA gene sequencing. Circulating markers of inflammation, including tumor necrosis factor alpha, interleukins 6, 10, and 18, stromal cell-derived factor 1-α, transforming growth factor β-1, and high sensitivity C-reactive protein, were unaltered by rifaximin treatment. Rifaximin altered abundance of bacterial taxa in blood marginally, only a decrease in Pseudomonadales was observed. In feces, rifaximin decreased bacterial richness, but effect on particular species was not observed. Subgroup analyses on patients with severely disturbed hemodynamics (n = 34) or activated lipopolysaccharide binding protein (n = 37) revealed no effect of rifaximin. Four weeks of treatment with rifaximin had no impact on the inflammatory state and only minor effects on BT and intestinal bacterial composition in stable, decompensated cirrhosis (NCT01769040). © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  10. Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

    PubMed

    Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

    2017-11-01

    Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO 2 max (control) or 70% VO 2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO 2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

  11. The effect of financial incentives on chlamydia testing rates: evidence from a randomized experiment.

    PubMed

    Dolan, Paul; Rudisill, Caroline

    2014-03-01

    Financial incentives have been used in a variety of settings to motivate behaviors that might not otherwise be undertaken. They have been highlighted as particularly useful in settings that require a single behavior, such as appointment attendance or vaccination. They also have differential effects based on socioeconomic status in some applications (e.g. smoking). To further investigate these claims, we tested the effect of providing different types of non-cash financial incentives on the return rates of chlamydia specimen samples amongst 16-24 year-olds in England. In 2011 and 2012, we ran a two-stage randomized experiment involving 2988 young people (1489 in Round 1 and 1499 in Round 2) who requested a chlamydia screening kit from Freetest.me, an online and text screening service run by Preventx Limited. Participants were randomized to control, or one of five types of financial incentives in Round 1 or one of four financial incentives in Round 2. We tested the effect of five types of incentives on specimen sample return; reward vouchers of differing values, charity donation, participation in a lottery, choices between a lottery and a voucher and including vouchers of differing values in the test kit prior to specimen return. Financial incentives of any type, did not make a significant difference in the likelihood of specimen return. The more deprived individuals were, as calculated using Index of Multiple Deprivation (IMD), the less likely they were to return a sample. The extent to which incentive structures influenced sample return was not moderated by IMD score. Non-cash financial incentives for chlamydia testing do not seem to affect the specimen return rate in a chlamydia screening program where test kits are requested online, mailed to requestors and returned by mail. They also do not appear more or less effective in influencing test return depending on deprivation level. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  12. Effectiveness of an Energy Management Training Course on Employee Well-Being: A Randomized Controlled Trial.

    PubMed

    Das, Sai Krupa; Mason, Shawn T; Vail, Taylor A; Rogers, Gail V; Livingston, Kara A; Whelan, Jillian G; Chin, Meghan K; Blanchard, Caroline M; Turgiss, Jennifer L; Roberts, Susan B

    2018-01-01

    Programs focused on employee well-being have gained momentum in recent years, but few have been rigorously evaluated. This study evaluates the effectiveness of an intervention designed to enhance vitality and purpose in life by assessing changes in employee quality of life (QoL) and health-related behaviors. A worksite-based randomized controlled trial. Twelve eligible worksites (8 randomized to the intervention group [IG] and 4 to the wait-listed control group [CG]). Employees (n = 240) at the randomized worksites. A 2.5-day group-based behavioral intervention. Rand Medical Outcomes Survey (MOS) 36-item Short-Form (SF-36) vitality and QoL measures, Ryff Purpose in Life Scale, Center for Epidemiologic Studies questionnaire for depression, MOS sleep, body weight, physical activity, diet quality, and blood measures for glucose and lipids (which were used to calculate a cardiometabolic risk score) obtained at baseline and 6 months. General linear mixed models were used to compare least squares means or prevalence differences in outcomes between IG and CG participants. As compared to CG, IG had a significantly higher mean 6-month change on the SF-36 vitality scale ( P = .003) and scored in the highest categories for 5 of the remaining 7 SF-36 domains: general health ( P = .014), mental health ( P = .027), absence of role limitations due to physical problems ( P = .026), and social functioning ( P = .007). The IG also had greater improvements in purpose in life ( P < .001) and sleep quality (index I, P = .024; index II, P = .021). No statistically significant changes were observed for weight, diet, physical activity, or cardiometabolic risk factors. An intensive 2.5-day intervention showed improvement in employee QoL and well-being over 6 months.

  13. Protocol for digital intervention for effective health promotion of small children-A cluster randomized trial.

    PubMed

    Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

    2018-03-08

    This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a 4-month follow-up. The data are being collected from 200 families with a 4-year-old child. Cluster randomization is being performed at the municipality level. Municipalities (N = 4) located in Southwest Finland, comprising child health clinics (N = 15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a 4-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. © 2018 John Wiley & Sons Ltd.

  14. Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial

    PubMed Central

    Salehi, Zeinab; Roayaei, Mahnaz

    2015-01-01

    Background: Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. Methods: This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Results: Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after − before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after − before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). Conclusions: The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy. PMID:26682028

  15. Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial.

    PubMed

    Geller, Elizabeth J; Dumond, Julie B; Bowling, J Michael; Khandelwal, Christine M; Wu, Jennifer M; Busby-Whitehead, Jan; Kaufer, Daniel I

    This study aimed to investigate the effect of trospium chloride on cognitive function in postmenopausal women treated for overactive bladder (OAB). Randomized double-blind placebo-controlled trial conducted from April 2013 to April 2015. Women aged 50 years or older seeking treatment for OAB were randomized to either trospium chloride XR 60 mg daily or placebo. Baseline cognitive function was assessed via Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam, Mini Mental Status X, Digit Span, Trails A, Trails B, and Epworth Sleepiness Scale. Cognitive function was reassessed at week 1 and week 4. A priori power analysis determined that 21 subjects were needed per group. Although 59 women were enrolled and randomized (28 trospium and 31 placebo), 45 completed assessment (21 trospium and 24 placebo). Mean age was 68 years, 78% were white, and 44% had previously taken OAB medication. For the primary outcome, there was no difference in HVLT-R total score between trospium and placebo groups at week 4 (P = 0.29). There were also no differences based on the other cognitive tests. There was a correlation between age and the following week-4 tests: HVLT-R total score (r = -0.3, P = 0.02), HVLT-R total recall subscale (r = -0.4, P = 0.007), Trails A (r = 0.4, P = 0.002), and Trails B (r = 0.4, P = 0.004). A linear regression model found that HVLT-R total score decreased by 0.372 points for each increased year of age. In women aged 50 years and older, there were no changes in cognitive function between those taking trospium and placebo. Cognitive function was correlated with age.

  16. Effect of Vitamin E on Oxaliplatin-induced Peripheral Neuropathy Prevention: A Randomized Controlled Trial.

    PubMed

    Salehi, Zeinab; Roayaei, Mahnaz

    2015-01-01

    Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy-induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin-based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin-induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study. Thirty-two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after - before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference [after - before] of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001). The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin-induced peripheral neuropathy.

  17. Effect of pumping pressure on onset of lactation after caesarean section: A randomized controlled study.

    PubMed

    Zhang, Feng; Yang, Yahui; Bai, Ting; Sun, Lele; Sun, Mingzhu; Shi, Xueling; Zhu, Meng; Ge, Meijuan; Xia, Haiou

    2018-01-01

    Caesarean section is associated with weaker newborn suction pressure. This nonblinded, randomized trial explored the effect of suction pressures generating by a breast pump on mothers' onset of lactation and milk supply after caesarean section. A high pressure group (-150 mmHg), a low pressure group (-100 mmHg), and a control group (none) were generated under computer random assignment with concealed allocation in 2 tertiary hospitals. The breast pumping began within 2 hr after caesarean operation (6 times a day and 30 min per time) until onset of lactation. The primary outcomes were the timing of onset of lactation, milk supply, and mother's satisfaction in lactation, using both intention-to-treat and per-protocol analyses. The secondary endpoints were the pumping-related pain, nipple injury, and maternal fatigue. All 164 women randomized were included in analysis. The breast pumping at -150 mmHg optimally advanced the timing of the onset of lactation and increased daytime milk supply. The pumping also appeared to boost mothers' confidence in lactation. The results in the per-protocol population (n = 148) were consistent with those of intention-to-treat population (n = 164). However, the pumping aggravated maternal nipple pain and fatigue, though there was no statistical significance. The findings suggest that a higher pumping pressure within the range of normal vaginally born infant suction could promote onset of lactation and milk supply among mothers giving birth by caesarean section. The pumping could also enhance mothers' confidence in breastfeeding. © 2017 John Wiley & Sons Ltd.

  18. Effects of hormone therapy on brain structure: A randomized controlled trial.

    PubMed

    Kantarci, Kejal; Tosakulwong, Nirubol; Lesnick, Timothy G; Zuk, Samantha M; Gunter, Jeffrey L; Gleason, Carey E; Wharton, Whitney; Dowling, N Maritza; Vemuri, Prashanthi; Senjem, Matthew L; Shuster, Lynne T; Bailey, Kent R; Rocca, Walter A; Jack, Clifford R; Asthana, Sanjay; Miller, Virginia M

    2016-08-30

    To investigate the effects of hormone therapy on brain structure in a randomized, double-blinded, placebo-controlled trial in recently postmenopausal women. Participants (aged 42-56 years, within 5-36 months past menopause) in the Kronos Early Estrogen Prevention Study were randomized to (1) 0.45 mg/d oral conjugated equine estrogens (CEE), (2) 50 μg/d transdermal 17β-estradiol, or (3) placebo pills and patch for 48 months. Oral progesterone (200 mg/d) was given to active treatment groups for 12 days each month. MRI and cognitive testing were performed in a subset of participants at baseline, and at 18, 36, and 48 months of randomization (n = 95). Changes in whole brain, ventricular, and white matter hyperintensity volumes, and in global cognitive function, were measured. Higher rates of ventricular expansion were observed in both the CEE and the 17β-estradiol groups compared to placebo; however, the difference was significant only in the CEE group (p = 0.01). Rates of ventricular expansion correlated with rates of decrease in brain volume (r = -0.58; p ≤ 0.001) and with rates of increase in white matter hyperintensity volume (r = 0.27; p = 0.01) after adjusting for age. The changes were not different between the CEE and 17β-estradiol groups for any of the MRI measures. The change in global cognitive function was not different across the groups. Ventricular volumes increased to a greater extent in recently menopausal women who received CEE compared to placebo but without changes in cognitive performance. Because the sample size was small and the follow-up limited to 4 years, the findings should be interpreted with caution and need confirmation. This study provides Class I evidence that brain ventricular volume increased to a greater extent in recently menopausal women who received oral CEE compared to placebo. © 2016 American Academy of Neurology.

  19. Likelihood-Based Random-Effect Meta-Analysis of Binary Events.

    PubMed

    Amatya, Anup; Bhaumik, Dulal K; Normand, Sharon-Lise; Greenhouse, Joel; Kaizar, Eloise; Neelon, Brian; Gibbons, Robert D

    2015-01-01

    Meta-analysis has been used extensively for evaluation of efficacy and safety of medical interventions. Its advantages and utilities are well known. However, recent studies have raised questions about the accuracy of the commonly used moment-based meta-analytic methods in general and for rare binary outcomes in particular. The issue is further complicated for studies with heterogeneous effect sizes. Likelihood-based mixed-effects modeling provides an alternative to moment-based methods such as inverse-variance weighted fixed- and random-effects estimators. In this article, we compare and contrast different mixed-effect modeling strategies in the context of meta-analysis. Their performance in estimation and testing of overall effect and heterogeneity are evaluated when combining results from studies with a binary outcome. Models that allow heterogeneity in both baseline rate and treatment effect across studies have low type I and type II error rates, and their estimates are the least biased among the models considered.

  20. Testing concordance of instrumental variable effects in generalized linear models with application to Mendelian randomization

    PubMed Central

    Dai, James Y.; Chan, Kwun Chuen Gary; Hsu, Li

    2014-01-01

    Instrumental variable regression is one way to overcome unmeasured confounding and estimate causal effect in observational studies. Built on structural mean models, there has been considerale work recently developed for consistent estimation of causal relative risk and causal odds ratio. Such models can sometimes suffer from identification issues for weak instruments. This hampered the applicability of Mendelian randomization analysis in genetic epidemiology. When there are multiple genetic variants available as instrumental variables, and causal effect is defined in a generalized linear model in the presence of unmeasured confounders, we propose to test concordance between instrumental variable effects on the intermediate exposure and instrumental variable effects on the disease outcome, as a means to test the causal effect. We show that a class of generalized least squares estimators provide valid and consistent tests of causality. For causal effect of a continuous exposure on a dichotomous outcome in logistic models, the proposed estimators are shown to be asymptotically conservative. When the disease outcome is rare, such estimators are consistent due to the log-linear approximation of the logistic function. Optimality of such estimators relative to the well-known two-stage least squares estimator and the double-logistic structural mean model is further discussed. PMID:24863158

  1. A systematic appraisal of allegiance effect in randomized controlled trials of psychotherapy.

    PubMed

    Dragioti, Elena; Dimoliatis, Ioannis; Fountoulakis, Konstantinos N; Evangelou, Evangelos

    2015-01-01

    Experimenter's allegiance (EA) refers to a personal confidence of the superiority of a specific psychotherapy treatment. This factor has been linked with larger treatment effects in favor of the preferred treatment. However, various studies have displayed contradictory results between EA and the pattern of treatment effects. Using a systematic approach followed by meta-analysis, we aimed to evaluate the impact of an allegiance effect on the results of psychotherapeutic studies. We considered the meta-analyses of randomized controlled trials (RCTs) of different types of psychotherapies in the Cochrane Database of Systematic Reviews. Eligible articles included meta-analyses of RCTs with at least one study showing evidence of EA (i.e., allegiant study). Effect sizes in allegiant RCTs were compared with non-allegiant using random and fixed models and a summary relative odds ratio (ROR) were calculated. Heterogeneity was quantified with the I (2) metric. A total of 30 meta-analyses including 240 RCTs were analyzed. The summary ROR was 1.31 [(95 % confidence interval (CI: 1.03-1.66) P = 0.30, I (2) = 53 %] indicating larger effects when allegiance exists. The impact of allegiance did not differ significantly (P > 0.05) when we compared psychiatric versus medical outcomes. Allegiance effect was significant for all forms of psychotherapy except for cognitive behavioral therapy. Moreover, the impact of allegiance was significant only when the treatment integrity of delivered psychotherapy was not assessed. Allegiance effect was even stronger where the experimenter was also both the developer of the preferred treatment and supervised or trained the therapists. No significant differences were found between allegiant and non-allegiant studies in terms of overall quality of studies. Experimenter's allegiance influences the effect sizes of psychotherapy RCTs and can be considered non-financial conflict of interest introducing a form of optimism bias, especially since

  2. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke: A Randomized Clinical Trial.

    PubMed

    Fransen, Puck S S; Berkhemer, Olvert A; Lingsma, Hester F; Beumer, Debbie; van den Berg, Lucie A; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama À Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van den Berg, J S Peter; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van Oostenbrugge, Robert J; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2016-02-01

    Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. To evaluate the influence of time from stroke onset to the start of treatment and from stroke onset to reperfusion on the effect of IAT. The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) was a multicenter, randomized clinical open-label trial of IAT vs no IAT in 500 patients. The time to the start of treatment was defined as the time from onset of symptoms to groin puncture (TOG). The time from onset of treatment to reperfusion (TOR) was defined as the time to reopening the vessel occlusion or the end of the procedure in cases for which reperfusion was not achieved. Data were collected from December 3, 2010, to June 3, 2014, and analyzed (intention to treat) from July 1, 2014, to September 19, 2015. Main outcome was the modified Rankin Scale (mRS) score for functional outcome (range, 0 [no symptoms] to 6 [death]). Multiple ordinal logistic regression analysis estimated the effect of treatment and tested for the interaction of time to randomization, TOG, and TOR with treatment. The effect of treatment as a risk difference on reaching independence (mRS score, 0-2) was computed as a function of TOG and TOR. Calculations were adjusted for age, National Institutes of Health Stroke Scale score, previous stroke, atrial fibrillation, diabetes mellitus, and intracranial arterial terminus occlusion. Among 500 patients (58% male; median age, 67 years), the median TOG was 260 (interquartile range [IQR], 210-311) minutes; median TOR, 340 (IQR, 274-395) minutes. An interaction between TOR and treatment (P = .04) existed, but not between TOG and treatment (P = .26). The adjusted risk difference (95% CI) was 25.9% (8.3%-44.4%) when reperfusion was reached

  3. Effect of exercise type on smoking cessation: a meta-analysis of randomized controlled trials.

    PubMed

    Klinsophon, Thaniya; Thaveeratitham, Premtip; Sitthipornvorakul, Ekalak; Janwantanakul, Prawit

    2017-09-06

    Exercise is one choice of additional treatment for smoking cessation by relieving nicotine withdrawal symptoms and smoking craving. The possible mechanism of the effect of exercise on relieving nicotine withdrawal symptoms and smoking craving is including affect, biological, and cognitive hypotheses. Evidence suggests that different types of exercise have different effects on these mechanisms. Therefore, type of exercise might have effect on smoking cessation. The purpose of this study is to systematically review randomized controlled trials to gain insight into which types of exercise are effective for smoking cessation. Publications were systemically searched up to November 2016 in several databases (PubMed, ScienceDirect, PEDro, Web of Science, Scopus and Cochrane Library), using the following keywords: "physical activity", "exercise", "smoking", "tobacco" and "cigarette". The methodological quality was assessed independently by two authors. Meta-analysis was conducted to examine the effectiveness of the type of exercise on smoking cessation. The quality of the evidence was assessed and rated according to the GRADE approach. 20 articles on 19 studies were judged to meet the selection criteria (seven low-risk of bias RCTs and 12 high-risk of bias RCTs). The findings revealed low quality evidence for the effectiveness of yoga for smoking cessation at the end of the treatment. The evidence found for no effect of aerobic exercise, resisted exercise, and a combined aerobic and resisted exercise program on smoking cessation was of low to moderate quality. Furthermore, very low to low quality evidence was found for no effect of physical activity on smoking cessation. There was no effect of aerobic exercise, resisted exercise, physical activity and combined aerobic and resisted exercise on smoking cessation. There was a positive effect on smoking cessation at the end of treatment in the program where yoga plus cognitive-behavioral therapy (CBT) was used. However, which

  4. Iterative usage of fixed and random effect models for powerful and efficient genome-wide association studies

    USDA-ARS?s Scientific Manuscript database

    False positives in a Genome-Wide Association Study (GWAS) can be effectively controlled by a fixed effect and random effect Mixed Linear Model (MLM) that incorporates population structure and kinship among individuals to adjust association tests on markers; however, the adjustment also compromises t...

  5. Validating Components of Teacher Effectiveness: A Random Assignment Study of Value-Added, Observation, and Survey Scores

    ERIC Educational Resources Information Center

    Bacher-Hicks, Andrew; Chin, Mark; Kane, Thomas J.; Staiger, Douglas O.

    2015-01-01

    Policy changes from the past decade have resulted in a growing interest in identifying effective teachers and their characteristics. This study is the third study to use data from a randomized experiment to test the validity of measures of teacher effectiveness. The authors collected effectiveness measures across three school years from three…

  6. The Effectiveness of Lifestyle Triple P in the Netherlands: A Randomized Controlled Trial

    PubMed Central

    Gerards, Sanne M. P. L.; Dagnelie, Pieter C.; Gubbels, Jessica S.; van Buuren, Stef; Hamers, Femke J. M.; Jansen, Maria W. J.; van der Goot, Odilia H. M.; de Vries, Nanne K.; Sanders, Matthew R.; Kremers, Stef P. J.

    2015-01-01

    Introduction Lifestyle Triple P is a general parenting intervention which focuses on preventing further excessive weight gain in overweight and obese children. The objective of the current study was to assess the effectiveness of the Lifestyle Triple P intervention in the Netherlands. Method We used a parallel randomized controlled design to test the effectiveness of the intervention. In total, 86 child-parent triads (children 4–8 years old, overweight or obese) were recruited and randomly assigned (allocation ratio 1:1) to the Lifestyle Triple P intervention or the control condition. Parents in the intervention condition received a 14-week intervention consisting of ten 90-minute group sessions and four individual telephone sessions. Primary outcome measure was the children’s body composition (BMI z-scores, waist circumference and skinfolds). The research assistant who performed the measurements was blinded for group assignment. Secondary outcome measures were the children’s dietary behavior and physical activity level, parenting practices, parental feeding style, parenting style, and parental self-efficacy. Outcome measures were assessed at baseline and 4 months (short-term) and 12 months (long-term) after baseline. Multilevel multiple regression analyses were conducted to determine the effect of the intervention on primary and secondary outcome measures. Results No intervention effects were found on children’s body composition. Analyses of secondary outcomes showed positive short-term intervention effects on children’s soft-drink consumption and parental responsibility regarding physical activity, encouragement to eat, psychological control, and efficacy and satisfaction with parenting. Longer-term intervention effects were found on parent’s report of children’s time spent on sedentary behavior and playing outside, parental monitoring food intake, and responsibility regarding nutrition. Conclusion Although the Lifestyle Triple P intervention showed

  7. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial.

    PubMed

    Lin, Haotian; Chen, Weirong; Luo, Lixia; Congdon, Nathan; Zhang, Xinyu; Zhong, Xiaojian; Liu, Zhaochuan; Chen, Wan; Wu, Changrui; Zheng, Danying; Deng, Daming; Ye, Shaobi; Lin, Zhuoling; Zou, Xia; Liu, Yizhi

    2012-12-01

    Regular follow-up is essential to successful management of childhood cataract. We sought to assess whether a mobile phone short message service (SMS) for parents of children with cataract could improve follow-up adherence and the proportion of procedures performed in timely fashion. Randomized, controlled trial. This trial is registered with ClinicalTrials.gov, NCT01417819. We included 258 parent-child pairs involved in the Childhood Cataract Program of the Chinese Ministry of Health. Participants were randomized (1:1) to a mobile phone SMS intervention or standard follow-up appointments. All participants were scheduled to attend ≥ 4 follow-up appointments according to the protocol. Parents in the intervention group received SMS automated reminders before scheduled appointments. The control group parents did not receive SMSs or any alternative reminder of scheduled appointments. Regular ocular examinations and analyses were performed by investigators masked to group allocation; however, study participants and the manager in charge of randomization and sending SMSs were not masked. Number of follow-up appointments attended, additional surgeries, laser treatments, changes in eyeglasses prescription, and occurrence of secondary ocular hypertension. Among parent-child participants, 135 were randomly assigned to the SMS intervention and 123 to standard appointments. Attendance rates for the SMS group (first visit, 97.8%; second, 91.9%; third, 92.6%; fourth, 83%) were significantly higher than those for the control group (first visit, 87.8%; second, 69.9%; third, 56.9%; fourth, 33.3%). The increase in attendance rate for total number of follow-up visits with SMS reminders was 47.2% (relative risk [RR] for attendance, 1.47; 95% confidence interval [CI], 1.16-1.78; P = 0.003). The number needed to remind (NNR) to gain 1 additional visit by 1 child was 3 (95% CI, 1.8-4.2). A total of 247 clinical interventions were carried out in the SMS group and 134 in the control group

  8. The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial.

    PubMed

    Walsh, Michael; Manns, Braden J; Klarenbach, Scott; Tonelli, Marcello; Hemmelgarn, Brenda; Culleton, Bruce

    2010-04-01

    Hyperphosphatemia is common among patients receiving dialysis and is associated with increased mortality. Nocturnal hemodialysis (NHD) is a long, slow dialytic modality that may improve hyperphosphatemia and disorders of mineral metabolism. We performed a randomized-controlled trial of NHD compared with conventional hemodialysis (CvHD); in this paper, we report detailed results of mineral metabolism outcomes. Prevalent patients were randomized to receive NHD 5 to 6 nights per week for 6to 10 hours per night or to continue CvHD thrice weekly for 6 months. Oral phosphate binders and vitamin D analogs were adjusted to maintain phosphate, calcium and parathyroid hormone (PTH) levels within recommended targets. Compared with CvHD patients, patients in the NHD group had a significant decrease in serum phosphate over the course of the study (0.49 mmol/L, 95% confidence interval 0.24-0.74; P=0.002) despite a significant reduction in the use of phosphate binders. Sixty-one percent of patients in the NHD group compared with 20% in the CvHD group had a decline in intact PTH (P=0.003). Nocturnal hemodialysis lowers serum phosphate, calcium-phosphate product and requirement for phosphate binders. The effects of NHD on PTH are variable. The impact of these changes on long-term cardiovascular and bone-related outcomes requires further investigation.

  9. Effect of testosterone supplementation on sexual functioning in aging men: a 6-month randomized controlled trial.

    PubMed

    Emmelot-Vonk, M H; Verhaar, H J J; Nakhai-Pour, H R; Grobbee, D E; van der Schouw, Y T

    2009-01-01

    Serum testosterone levels decline significantly with aging and this has been associated with reduced sexual function. We have conducted a double-blind, randomized, placebo-controlled trial to investigate the effect of testosterone supplementation on sexual function in 237 elderly men with a testosterone level <13.7 nmol l(-1). Participants were randomly assigned to receive oral testosterone undecanoate or a placebo for 6 months. A total of 207 men completed the study. After treatment, there were no differences in scores on sexual function between the groups. Subanalysis showed that although a baseline testosterone level in the lowest tertile was associated with significantly lower scores for sexual fantasies, desire of sexual contact and frequency of sexual contact, supplementation of testosterone did not result in improvement on any of these items in this group. In conclusion, the findings do not support the view that testosterone undecanoate supplementation for 6 months to elderly men with low-normal testosterone concentrations favorably affects sexual function.

  10. A Randomized, Controlled Trial of Emotional Disclosure in Rheumatoid Arthritis: Can Clinician Assistance Enhance the Effects?

    PubMed Central

    Keefe, Francis J.; Anderson, Timothy; Lumley, Mark; Caldwell, David; Stainbrook, David; Mckee, Daphne; Waters, Sandra J.; Connelly, Mark; Affleck, Glenn; Pope, Mary Susan; Weiss, Marianne; Riordan, Paul A.; Uhlin, Brian D.

    2008-01-01

    Emotional disclosure by writing or talking about stressful life experiences improves health status in non-clinical populations, but its success in clinical populations, particularly rheumatoid arthritis (RA), has been mixed. In this randomized, controlled trial, we attempted to increase the efficacy of emotional disclosure by having a trained clinician help patients emotionally disclose and process stressful experiences. We randomized 98 adults with RA to one of four conditions: a) private verbal emotional disclosure; b) clinician-assisted verbal emotional disclosure; c) arthritis information control (all of which engaged in four, 30-minute laboratory sessions); or d) no-treatment, standard care only control group. Outcome measures (pain, disability, affect, stress) were assessed at baseline, 2 months following treatment (2-month follow-up), and at 5-month, and 15-month follow-ups. A manipulation check demonstrated that, as expected, both types of emotional disclosure led to immediate (post-session) increases in negative affect compared with arthritis information. Outcome analyses at all three follow-ups revealed no clear pattern of effects for either clinician-assisted or private emotional disclosure compared with the two control groups. There were some benefits in terms of a reduction in pain behavior with private disclosure versus clinician-assisted disclosure at the 2 month follow-up, but no other significant between group differences. We conclude that verbal emotional disclosure about stressful experiences, whether conducted privately or assisted by a clinician, has little or no benefit for people with RA. PMID:17923329

  11. Does occasional cannabis use impact anxiety and depression treatment outcomes?: Results from a randomized effectiveness trial.

    PubMed

    Bricker, Jonathan B; Russo, Joan; Stein, Murray B; Sherbourne, Cathy; Craske, Michelle; Schraufnagel, Trevor J; Roy-Byrne, Peter

    2007-01-01

    This study investigated the extent to which occasional cannabis use moderated anxiety and depression outcomes in the Collaborative Care for Anxiety and Panic (CCAP) study, a combined cognitive-behavioral therapy (CBT) and pharmacotherapy randomized effectiveness trial. Participants were 232 adults from six university-based primary care outpatient clinics in three West Coast cities randomized to receive either the CCAP intervention or the usual care condition. Results showed significant (P<.01) evidence of an interaction between treatment group (CCAP vs. usual care) and cannabis use status (monthly vs. less than monthly) for depressive symptoms, but not for panic disorder or social phobia symptoms (all P>.05). Monthly cannabis users' depressive symptoms improved in the CCAP intervention just as much as those who used cannabis less than monthly, whereas monthly users receiving usual care had significantly more depressive symptoms than those using less than monthly. A combined CBT and medication treatment intervention may be a promising approach for the treatment of depression among occasional cannabis users. (c) 2006 Wiley-Liss, Inc.

  12. Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial.

    PubMed

    Chan, Hui Yu; Ho, Roger Chun-Man; Mahendran, Rathi; Ng, Kheng Siang; Tam, Wilson Wai-San; Rawtaer, Iris; Tan, Chay Hoon; Larbi, Anis; Feng, Lei; Sia, Angelia; Ng, Maxel Kian-Wee; Gan, Goh Lee; Kua, Ee Heok

    2017-08-29

    Due to a rapidly ageing population in the world, it is increasingly pertinent to promote successful ageing strategies which are cost-effective, easily accessible, and more likely to be acceptable to the elderly. Past research associates exposure to natural environments and horticultural therapy (HT) with positive psychological, social and physical health benefits. This Randomized Controlled Trial (RCT) is designed to evaluate the efficacy of HT in promoting Asian elderly' mental health, cognitive functioning and physical health. 70 elderly participants aged 60 to 85 years old will be randomized to participate in either the active horticultural therapy group or be in the waitlist control. Sessions will be weekly for 12 weeks, and monthly for 3 months. Mental health will be assessed through self-reports of depressive and anxiety symptomatology, life satisfaction, social connectedness and psychological well-being, collaborated with immunological markers. Outcome measures of cognitive functioning and physical health include neuropsychological tests of cognitive function and basic health screening. Outcomes will be assessed at baseline, 3 months and 6 months post-intervention. This RCT comprehensively investigates the efficacy of a non-invasive intervention, HT, in enhancing mental health, cognitive functioning and physical health. The results have tremendous potential for supporting future successful ageing programs and applicability to larger populations. ClinicalTrials.gov NCT02495194 . Trial registration date: July 13, 2015. Retrospectively registered.

  13. A Randomized Controlled Trial Examining the Effects of Reflexology on Children With Functional Constipation.

    PubMed

    Canbulat Sahiner, Nejla; Demirgoz Bal, Meltem

    Functional constipation is a common problem in Turkey that affects up to 10% of children. Reflexologists claim that reflexology can be beneficial in the treatment of constipation. The aim of this randomized controlled study was to determine the effectiveness of reflexology in treating functional constipation in children. Thirty-seven children who were referred to a pediatrician with functional constipation as defined by the Rome III criteria were recruited to the study. After the physician's diagnosis, two groups (intervention/control) were created. The intervention and control groups comprised 17 and 20 children, respectively. Each child in the intervention group was given a foot massage for 10 minutes five times a week, and toilet/diet/motivation training was given to their parents. The test period lasted for 4 weeks. Toilet/diet/motivation training was undertaken for 30 minutes once per week (for a total of 4 weeks) in an interactive manner. The parents of children in the control group received equivalent toilet/diet/motivation training only. No significant differences in terms of feces frequency and feces consistency were noted between the intervention and control groups (p > .05). This study sample showed that only toilet/diet/motivation training had potential benefit for treating functional constipation in children. Further larger randomized trials are required to establish whether there are benefits to foot message in the treatment of functional constipation in children.

  14. The Effect of Eye Patching on Clear Corneal Incision Architecture in Phacoemulsification: A Randomized Controlled Trial.

    PubMed

    Ho, Fui Li; Salowi, Mohamad Aziz; Bastion, Mae-Lynn Catherine

    2017-01-01

    To investigate the effects of postoperative eye patching on clear corneal incision architecture in phacoemulsification. A single-center, randomized controlled trial. A total of 132 patients with uncomplicated phacoemulsification were randomly allocated to the intervention or control group. The intervention group received postoperative eye patching for approximately 18 hours, whereas the control group received eye shield. The clear corneal incision architecture was examined postoperatively at 2 hours, 1 day, and 7 days after surgery using optical coherence tomography. Epithelial gaping was significantly reduced on postoperative day 1 in the intervention group (52.4%) compared with control (74.2%) (P = 0.01). No differences were found for other architectural defects. Descemet membrane detachment was associated with lower intraocular pressure on postoperative day 7 (P = 0.02). Presence of underlying diabetes mellitus did not seem to influence architectural defects. Postoperative eye patching facilitated epithelial healing and reduced the occurrence of epithelial gaping on postoperative day 1. It may play a role in protecting and improving corneal wounds during the critical immediate postoperative period. Copyright 2017 Asia-Pacific Academy of Ophthalmology.

  15. Effects of zinc and magnesium supplements on postpartum depression and anxiety: A randomized controlled clinical trial.

    PubMed

    Fard, Fatemeh Edalati; Mirghafourvand, Mojgan; Mohammad-Alizadeh Charandabi, Sakineh; Farshbaf-Khalili, Azizeh; Javadzadeh, Yousef; Asgharian, Hanieh

    2017-10-01

    Postpartum anxiety and depression are prevalent disorders. The authors of this study aimed to determine the effects of zinc and magnesium supplements on depressive symptoms and anxiety in postpartum women referred to three governmental, educational hospitals in Tabriz, Iran during 2014-2015. In this triple-blind, randomized, controlled clinical trial, the participants were randomly assigned to the zinc sulfate, magnesium sulfate, and placebo groups (n = 33 per group). The intervention groups received a 27-mg zinc sulfate tablet or 320-mg magnesium sulfate tablet per day for 8 weeks, whereas the control group received a placebo tablet each day during the same period. The Edinburgh Postnatal Depression Scale and the Spielberger State-Trait Anxiety Inventory were completed before and 8 weeks after the intervention. Blood samples were drawn from each participant to determine serum levels of zinc and magnesium before intervention at 48 hours after delivery. Also, a 24-hour dietary questionnaire was used during the first and last 3 days of the intervention. Adjusting for baseline scores as well as zinc and magnesium serum levels, no significant difference was observed between groups 8 weeks after delivery in mean scores of depressive symptoms (p = .553), state anxiety (p = .995), and trait anxiety (p = .234). This study concluded magnesium and zinc did not reduce postpartum anxiety and depressive symptoms.

  16. Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial

    PubMed Central

    Rocca, Corinne H.; Kohn, Julia E.; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J. Joseph; Darney, Philip D.; Harper, Cynthia C.

    2016-01-01

    Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011–2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. PMID:26794168

  17. Prophylactic effect of artemether on human schistosomiasis mansoni among Egyptian children: A randomized controlled trial.

    PubMed

    Elmorshedy, Hala; Tanner, Marcel; Bergquist, Robert N; Sharaf, Soraya; Barakat, Rashida

    2016-06-01

    A double-blind, randomized controlled trial was conducted in an endemic focus for Schistosoma mansoni in Kafr El-Sheikh Governorate, Northern Nile Delta, Egypt, to evaluate the prophylactic effect of artemether (ART) given in conjunction with praziquantel (PZQ). The study encompassed 913 primary school children randomly assigned to two treatment groups PZQ/ART and PZQ/ART-placebo. At baseline, both groups received 40 mg/kg body weight of PZQ twice four weeks apart, after which one group received 6 mg/kg body weight of ART every 3 weeks in 5 cycles during the transmission season and the other group received ART-placebo. At the end of the study, prevalence of infection among the PZQ/ART was approximately half that of the PZQ/ART-placebo group, i.e. 6.7% versus 11.6%, and incidence of new infections for the PZQ/ART was 2.7% versus 6.5% for the PZQ/ART-placebo. In conclusion, PZQ/ART combined therapy might be considered as an adjunct measure against human schistosomiasis, by specifically reducing transmission and therefore contribute to disease elimination. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Effect of two laser photobiomodulation application protocols on the viability of random skin flap in rats

    NASA Astrophysics Data System (ADS)

    Martignago, C. C. S. M.; Tim, C. R.; Assis, L.; Neve, L. M. G.; Bossini, P. S.; Renno, A. C.; Avó, L. R. S.; Liebano, R. E.; Parizotto, N. A.

    2018-02-01

    Objective: to identify the best low intensity laser photobiomodulation application site to increase the viability of the cutaneous flap in rats. Methods: 18 male rats (Rattus norvegicus: var. Albinus, Rodentia Mammalia) were randomly distributed into 3 groups (n = 6). Group I (GI) was submitted to simulated laser photobiomodulation, group II (GII) was submitted to the laser photobiomodulation at three points in the flap cranial base, and group III (GIII) was submitted to laser photobiomodulation at twelve points distributed along the flap. All groups were irradiated with an Indium, Galium, Aluminum and Phosphorus diode laser (InGaAlP), 660 nm, with power of 50 mW, total energy of 12 J in continuous emission mode. The treatment started immediately after performing the cranial base random skin flap (dimension of 10X4 cm2 ) and reapplied every 24 hours, with a total of 5 applications. The animals were euthanized after the evaluation of the percentage of necrosis area and the material was collected for histological analysis on the 7th postoperative day. Results: GII animals presented a statistically significant decrease for the necrosis area when compared to the other groups, and a statistically significant increase in the quantification of collagen when compared to the control. We did not observe a statistical difference between the TGFβ and FGF expression in the different groups evaluated. Conclusion: the application of laser photobiomodulation at three points of the flap cranial base was more effective than at twelve points regarding the reduction of necrosis area.

  19. Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial.

    PubMed

    Thompson, Kirsten M J; Rocca, Corinne H; Kohn, Julia E; Goodman, Suzan; Stern, Lisa; Blum, Maya; Speidel, J Joseph; Darney, Philip D; Harper, Cynthia C

    2016-03-01

    We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013). Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500: 802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR = 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Public funding and provider training substantially improve LARC access.

  20. Effects of Periodontal Therapy on Rate of Preterm Delivery A Randomized Controlled Trial

    PubMed Central

    Offenbacher, Steven; Beck, James D.; Jared, Heather L.; Mauriello, Sally M.; Mendoza, Luisto C.; Couper, David J.; Stewart, Dawn D.; Murtha, Amy P.; Cochran, David L.; Dudley, Donald J.; Reddy, Michael S.; Geurs, Nicolaas C.; Hauth, John C.

    2010-01-01

    OBJECTIVE To test the effects of maternal periodontal disease treatment on the incidence of preterm birth (delivery before 37 weeks of gestation). METHODS The Maternal Oral Therapy to Reduce Obstetric Risk Study was a randomized, treatment-masked, controlled clinical trial of pregnant women with periodontal disease who were receiving standard obstetric care. Participants were assigned to either a periodontal treatment arm, consisting of scaling and root planing early in the second trimester, or a delayed treatment arm that provided periodontal care after delivery. Pregnancy and maternal periodontal status were followed to delivery and neonatal outcomes until discharge. The primary outcome (gestational age less than 37 weeks) and the secondary outcome (gestational age less than 35 weeks) were analyzed using a χ2 test of equality of two proportions. RESULTS The study randomized 1,806 patients at three performance sites and completed 1,760 evaluable patients. At baseline, there were no differences comparing the treatment and control arms for any of the periodontal or obstetric measures. The rate of preterm delivery for the treatment group was 13.1% and 11.5% for the control group (P=.316). There were no significant differences when comparing women in the treatment group with those in the control group with regard to the adverse event rate or the major obstetric and neonatal outcomes. CONCLUSION Periodontal therapy did not reduce the incidence of preterm delivery. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, www.clinicaltrials.gov, NCT00097656. LEVEL OF EVIDENCE I PMID:19701034

  1. Effects of pushing techniques during the second stage of labor: A randomized controlled trial.

    PubMed

    Koyucu, Refika Genç; Demirci, Nurdan

    2017-10-01

    Spontaneous pushing is a method that is used in the management of the second stage of labor and suggested to be more physiological for the mother and infant. The present study aims to evaluate the effects of pushing techniques on the mother and newborn. This randomized prospective study was performed between June 2013-March 2014 in a tertiary maternity clinic in Istanbul. 80 low risk, nulliparous cases were randomized to pushing groups. Valsalva pushing group was told to hold their breath while pushing. No visual-verbal instructions were given to spontaneous pushing group and they were encouraged to push without preventing respiration. Demographic data, second stage period, perineal laceration rates, fetal heart rate patterns, presence of meconium stained amniotic liquid, newborn APGAR scores, POP-Q examination and Q-tip test results were evaluated in these cases. The second stage of labor was significantly longer with spontaneous pushing. Decrease in Hb levels in valsalva pushing group was determined to be higher than spontaneous pushing group. An increased urethral mobility was observed in valsalva pushing group. Although the duration of the second stage of labor was longer compared to valsalva pushing technique, women were able to give birth without requiring any verbal or visual instruction, without exceeding the limit value of two hours and without affecting fetal wellness and neonatal results. Copyright © 2017. Published by Elsevier B.V.

  2. The Promoting Effective Advance Care for Elders (PEACE) randomized pilot study: theoretical framework and study design.

    PubMed

    Allen, Kyle R; Hazelett, Susan E; Radwany, Steven; Ertle, Denise; Fosnight, Susan M; Moore, Pamela S

    2012-04-01

    Practice guidelines are available for hospice and palliative medicine specialists and geriatricians. However, these guidelines do not adequately address the needs of patients who straddle the 2 specialties: homebound chronically ill patients. The purpose of this article is to describe the theoretical basis for the Promoting Effective Advance Care for Elders (PEACE) randomized pilot study. PEACE is an ongoing 2-group randomized pilot study (n=80) to test an in-home interdisciplinary care management intervention that combines palliative care approaches to symptom management, psychosocial and emotional support, and advance care planning with geriatric medicine approaches to optimizing function and addressing polypharmacy. The population comprises new enrollees into PASSPORT, Ohio's community-based, long-term care Medicaid waiver program. All PASSPORT enrollees have geriatric/palliative care crossover needs because they are nursing home eligible. The intervention is based on Wagner's Chronic Care Model and includes comprehensive interdisciplinary care management for these low-income frail elders with chronic illnesses, uses evidence-based protocols, emphasizes patient activation, and integrates with community-based long-term care and other community agencies. Our model, with its standardized, evidence-based medical and psychosocial intervention protocols, will transport easily to other sites that are interested in optimizing outcomes for community-based, chronically ill older adults. © Mary Ann Liebert, Inc.

  3. Effect of random vacancies on the electronic properties of graphene and T graphene: a theoretical approach

    NASA Astrophysics Data System (ADS)

    Sadhukhan, B.; Nayak, A.; Mookerjee, A.

    2017-12-01

    In this communication we present together four distinct techniques for the study of electronic structure of solids: the tight-binding linear muffin-tin orbitals, the real space and augmented space recursions and the modified exchange-correlation. Using this we investigate the effect of random vacancies on the electronic properties of the carbon hexagonal allotrope, graphene, and the non-hexagonal allotrope, planar T graphene. We have inserted random vacancies at different concentrations, to simulate disorder in pristine graphene and planar T graphene sheets. The resulting disorder, both on-site (diagonal disorder) as well as in the hopping integrals (off-diagonal disorder), introduces sharp peaks in the vicinity of the Dirac point built up from localized states for both hexagonal and non-hexagonal structures. These peaks become resonances with increasing vacancy concentration. We find that in presence of vacancies, graphene-like linear dispersion appears in planar T graphene and the cross points form a loop in the first Brillouin zone similar to buckled T graphene that originates from π and π* bands without regular hexagonal symmetry. We also calculate the single-particle relaxation time, τ (ěc {q}) of ěc {q} labeled quantum electronic states which originates from scattering due to presence of vacancies, causing quantum level broadening.

  4. Effects of music therapy on intravitreal injections: a randomized clinical trial.

    PubMed

    Chen, Xuejing; Seth, Rajeev K; Rao, Veena S; Huang, John J; Adelman, Ron A

    2012-08-01

    To investigate the effects of music therapy on anxiety, perceived pain, and satisfaction in patients undergoing intravitreal injections in the outpatient setting. This is a randomized clinical trial. Seventy-three patients were recruited from the retina clinic at 1 institution and randomized into a music therapy (n=37) or control (n=36) group. Prior to injection, patients completed the state portion of the Spielberger State Trait Anxiety Inventory (STAI-S). The music therapy group listened to classical music through computer speakers while waiting for and during the injection. The control group underwent the injection in the same setting without music. Afterward, all patients completed another STAI-S and a satisfaction and pain questionnaire. The main outcome measures were objective anxiety derived from STAI-S scores and subjective pain and anxiety from the post procedure questionnaire. The music therapy group had a greater decrease in anxiety than the control group (P=0.0480). Overall, 73% of all patients requested music for future injections (P=0.0001). The music therapy group (84%) requested music in future injections more frequently than the control group (61%) (P=0.0377). Both groups reported similar levels of pain (P=0.5879). Classical music before and during intravitreal injections decreases anxiety in patients without decreasing pain. Most patients desire to have music during future injections. Music therapy is a low-cost, easy, safe intervention that reduces anxiety during intravitreal injections in the outpatient setting.

  5. Effect of biomagnetic therapy versus physiotherapy for treatment of knee osteoarthritis: a randomized controlled trial.

    PubMed

    Gremion, Gerald; Gaillard, David; Leyvraz, Pierre-Francois; Jolles, Brigitte M

    2009-11-01

    To assess the effectiveness of pulsed signal therapy in the treatment of knee osteoarthritis (Kellgren II or III). A randomized, double-blind controlled clinical trial. The first 95 patients sent to the clinic with knee osteo-arthritis were selected and randomized into treatment with pulsed signal therapy or conventional physiotherapy. Assessment included recording of usual demographic data, pertinent history, baseline medication and radiographs. Clinical evaluation was made at baseline, 6 weeks and 6 months after the end of treatment by the same blinded doctor. At each follow-up time, the patient was asked to complete a visual analogue pain scale and a Lequesne score. The doctor recorded the degree of pain on motion and the ability to move the affected knee. Both treatments resulted in significant improvements in pain and physical function. A statistical difference was observed only for activities of daily living, where the physiotherapy was more efficient (p<0.03). The cost of treatment with pulsed signal therapy was significantly higher, double the treatment cost of conventional physiotherapy. Like physiotherapy, pulsed signal therapy has improved the clinical state of treated patients but with no significant statistical difference. Pulsed signal therapy is, however, more expensive.

  6. Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial

    PubMed Central

    Deepeshwar, Singh; Tanwar, Monika; Kavuri, Vijaya; Budhi, Rana B.

    2018-01-01

    Objective: To investigate the effect of integrated approach of yoga therapy (IAYT) intervention in individual with knee Osteoarthritis. Design: Randomized controlled clincial trail. Participants: Sixty-six individual prediagnosed with knee osteoarthritis aged between 30 and 75 years were randomized into two groups, i.e., Yoga (n = 31) and Control (n = 35). Yoga group received IAYT intervention for 1 week at yoga center of S-VYASA whereas Control group maintained their normal lifestyle. Outcome measures: The Falls Efficacy Scale (FES), Handgrip Strength test (left hand LHGS and right hand RHGS), Timed Up and Go Test (TUG), Sit-to-Stand (STS), and right & left extension and flexion were measured on day 1 and day 7. Results: There were a significant reduction in TUG (p < 0.001), Right (p < 0.001), and Left Flexion (p < 0.001) whereas significant improvements in LHGS (p < 0.01), and right extension (p < 0.05) & left extension (p < 0.001) from baseline in Yoga group. Conclusion: IAYT practice showed an improvement in TUG, STS, HGS, and Goniometer test, which suggest improved muscular strength, flexibility, and functional mobility. CTRI Registration Number: http://ctri.nic.in/Clinicaltrials, identifier CTRI/2017/10/010141. PMID:29867604

  7. Effect of NICU Department Orientation Program on Mother’s Anxiety: a Randomized Clinical Trial

    PubMed Central

    Valizadeh, Leila; Hosseini, Mohammad Bager; Heydarpoor Damanabad, Zhilla; Rahkar Farshi, Mahni; Asgari Jafarabadi, Mohammad; Ranjbar Kochaksaraie, Fatemeh

    2016-01-01

    Introduction: Neonatal intensive care unit induces the high level of anxiety for mothers. The aim of this study was to evaluate the effectiveness of NICU orientation program on the anxiety of mothers who had preterm newborns hospitalized in NICU. Methods: This study was a randomized clinical trial (three parallel groups). Participants included 99 mothers with preterm newborns hospitalized in NICU of Al- Zahra hospital, affiliated to Tabriz University of Medical Sciences in 2015. Mothers were randomly assigned to one of three groups (film, booklet, and control). Mothers completed the State- Trait Anxiety Inventory before entering to the NICU, and then mothers in the experiment groups became familiar with the NICU environment through watching a film or reading booklet. After the first NICU visit, all mothers completed the STAI and Cattell's Anxiety Questionnaires. Data were analyzed using SPSS ver. 13 software. Results: There was no significant difference between three groups regarding state- trait anxiety before the intervention. After the first NICU visit, a significant reduction in maternal state anxiety was seen in the both experiment groups. There was no statistical significant difference regarding trait anxiety. Data obtained from Cattell's anxiety questionnaire after intervention, showed significant difference in state anxiety between groups. Conclusion: Employing film and booklet orientation strategy after preterm delivery can reduce the mother’s anxiety and beneficent for the mother, baby, family and health care system. PMID:27752486

  8. Fractional CO2 laser is an effective therapeutic modality for xanthelasma palpebrarum: a randomized clinical trial.

    PubMed

    Esmat, Samia M; Elramly, Amany Z; Abdel Halim, Dalia M; Gawdat, Heba I; Taha, Hanaa I

    2014-12-01

    Xanthelasma palpebrarum (XP) is a common cosmetic concern. Although there is a wide range of therapeutic modalities for XP, there is no general consensus on the optimal treatment for such condition. Compare the efficacy and safety of super pulsed (SP) and fractional CO2 lasers in the treatment of XP. This prospective randomized comparative clinical study included 20 adult patients with bilateral and symmetrical XP lesions. Xanthelasma palpebrarum lesions were randomly assigned to treatment by either single session of ablative SP CO2 laser or 3 to 5 sessions of ablative fractional CO2 laser with monthly intervals. All patients were assessed using digital photography and optical coherence tomography images. Xanthelasma palpebrarum lesions on both sides were successfully removed with significant improvement in size, color, and thickness. Although lesions treated by SP CO2 laser showed significantly better improvement regarding color and thickness of the lesions, downtime and patient satisfaction were significantly better for lesions treated with fractional CO2 laser. Scarring and recurrence were significantly higher in lesions treated by SP CO2 laser. Ablative fractional CO2 laser is an effective and safe therapeutic option for XP with significantly shorter downtime and higher patient satisfaction compared with SP CO2 laser.

  9. Therapeutic effects of flurbiprofen axetil on mesenteric traction syndrome: randomized clinical trial.

    PubMed

    Takahashi, Hidemasa; Shida, Dai; Tagawa, Kyoko; Iwamoto, Ryo; Arita, Makoto; Arai, Hiroyuki; Suzuki, Takeo

    2017-08-11

    This study aimed to reveal the appropriate timing for the intravenous administration of flurbiprofen axetil for preventing mesenteric traction syndrome (MTS), caused by prostacyclin release. In this prospective, randomized, clinical study, forty-five patients who were undergoing elective surgery for colorectal cancer via laparotomy were enrolled. Patients were randomly divided into 3 groups: a preoperative group (n = 16) receiving flurbiprofen axetil directly before surgery; a post-MTS group (n = 14) receiving following MTS onset; and a control group (n = 15) who were not administered flurbiprofen axetil. 6-keto-PGF1α, a stable metabolite of prostacyclin, levels were measured and mean blood pressures were recorded. In the preoperative group, 6-keto-PGF1α levels did not increase, blood pressure levels did not decrease, and no facial flushing was observed. In both the post-MTS and control groups, 6-keto-PGF1α levels increased markedly after mesenteric traction and blood pressure decreased significantly. The post-MTS group exhibited a faster decreasing trend in 6-keto-PGF1α levels and quick restore of the mean blood pressure, and the use of vasopressors and phenylephrine were lower than that in the control group. Even therapeutic administration of flurbiprofen axetil after the onset of MTS has also effects on MTS by suppressing prostacyclin production. Clinical trial number: UMIN000009111 . (Registered 14 October 2012).

  10. Effect of Escitalopram on Hot Flash Interference: A Randomized, Controlled Trial

    PubMed Central

    Carpenter, Janet S.; Guthrie, Katherine A.; Larson, Joseph C.; Freeman, Ellen W.; Joffe, Hadine; Reed, Susan D.; Ensrud, Kristine E.; LaCroix, Andrea Z.

    2012-01-01

    Objectives To estimate the effect of escitalopram 10–20 mg/day versus placebo for reducing hot flash interference in daily life and understand correlates and predictors of reductions in hot flash interference, a key measure of quality of life. Design Multi-site, randomized, double-blind, placebo-controlled clinical trial. Patients 205 midlife women (46% African-American) who met criteria participated. Setting MsFLASH clinical sites in Boston, Indianapolis, Oakland, and Philadelphia. Intervention After baseline, women were randomized to 1 pill of escitalopram 10 mg/day (n=104) or placebo (n=101) with follow-up at 4- and 8-weeks. At week 4, those not achieving 50% fewer hot flashes were increased to 2 pills daily (20 mg/day or 2 placebo pills). Main outcome measures The Hot Flash Related Daily Interference Scale; Correlates were variables from hot flash diaries; Predictors were baseline demographics, clinical variables, depression, anxiety, sleep quality, and hot flashes. Results Compared to placebo, escitalopram significantly reduced hot flash interference by 6.0 points at week 4 and 3.4 points at week 8 more than placebo (p=0.012). Reductions in hot flash interference correlated with changes in hot flash diary variables. However, baseline variables did not significantly predict reductions in hot flash interference. Conclusions Escitalopram 10–20mg/day for 8 weeks improves women’s quality of life and this benefit did not vary by demographic, clinical, mood, sleep, or hot flash variables. PMID:22480818

  11. Effective degrees of freedom of a random walk on a fractal.

    PubMed

    Balankin, Alexander S

    2015-12-01

    We argue that a non-Markovian random walk on a fractal can be treated as a Markovian process in a fractional dimensional space with a suitable metric. This allows us to define the fractional dimensional space allied to the fractal as the ν-dimensional space F(ν) equipped with the metric induced by the fractal topology. The relation between the number of effective spatial degrees of freedom of walkers on the fractal (ν) and fractal dimensionalities is deduced. The intrinsic time of random walk in F(ν) is inferred. The Laplacian operator in F(ν) is constructed. This allows us to map physical problems on fractals into the corresponding problems in F(ν). In this way, essential features of physics on fractals are revealed. Particularly, subdiffusion on path-connected fractals is elucidated. The Coulomb potential of a point charge on a fractal embedded in the Euclidean space is derived. Intriguing attributes of some types of fractals are highlighted.

  12. Effects of random tooth profile errors on the dynamic behaviors of planetary gears

    NASA Astrophysics Data System (ADS)

    Xun, Chao; Long, Xinhua; Hua, Hongxing

    2018-02-01

    In this paper, a nonlinear random model is built to describe the dynamics of planetary gear trains (PGTs), in which the time-varying mesh stiffness, tooth profile modification (TPM), tooth contact loss, and random tooth profile error are considered. A stochastic method based on the method of multiple scales (MMS) is extended to analyze the statistical property of the dynamic performance of PGTs. By the proposed multiple-scales based stochastic method, the distributions of the dynamic transmission errors (DTEs) are investigated, and the lower and upper bounds are determined based on the 3σ principle. Monte Carlo method is employed to verify the proposed method. Results indicate that the proposed method can be used to determine the distribution of the DTE of PGTs high efficiently and allow a link between the manufacturing precision and the dynamical response. In addition, the effects of tooth profile modification on the distributions of vibration amplitudes and the probability of tooth contact loss with different manufacturing tooth profile errors are studied. The results show that the manufacturing precision affects the distribution of dynamic transmission errors dramatically and appropriate TPMs are helpful to decrease the nominal value and the deviation of the vibration amplitudes.

  13. The effect of additional ankle and midfoot mobilizations on plantar fasciitis: a randomized controlled trial.

    PubMed

    Shashua, Anat; Flechter, Shlomo; Avidan, Liat; Ofir, Dani; Melayev, Alex; Kalichman, Leonid

    2015-04-01

    A single-blind randomized controlled trial. To evaluate the efficacy of ankle and midfoot mobilization on pain and function of patients with plantar fasciitis (PF). Plantar fasciitis is a degenerative process of the plantar fascia, with a lifetime prevalence of approximately 10%. Limited ankle dorsiflexion is a common finding and apparently acts as a contributing factor to the development of PF. Fifty patients with PF, aged 23 to 73 years, were randomly assigned to either the intervention or control group. Both groups received 8 treatments, twice a week, consisting of stretching exercises and ultrasound. In addition, the intervention group received mobilization of the ankle and midfoot joints. Dorsiflexion range of motion was measured at the beginning and at the end of treatment. The results were evaluated by 3 outcomes: the numeric pain-rating scale, Lower Extremity Functional Scale, and algometry. No significant difference was found between groups in any of the outcomes. Both groups showed a significant difference in the numeric pain-rating scale and Lower Extremity Functional Scale. Both groups significantly improved in dorsiflexion range of motion, with no difference between groups. The addition of ankle and foot joint mobilization aimed at improving dorsiflexion range of motion is not more effective than stretching and ultrasound alone in treating PF. The association between limited ankle dorsiflexion and PF is most probably due to soft tissue limitations, not the joints. Trial registered at ClinicalTrials.gov (registration number NCT01439932). Therapy, level 1b.

  14. Effect of magnetic helicity upon rectilinear propagation of charged particles in random magnetic fields

    NASA Technical Reports Server (NTRS)

    Earl, James A.

    1992-01-01

    When charged particles spiral along a large constant magnetic field, their trajectories are scattered by any random field components that are superposed on the guiding field. If the random field configuration embodies helicity, the scattering is asymmetrical with respect to a plane perpendicular to the guiding field, for particles moving into the forward hemisphere are scattered at different rates from those moving into the backward hemisphere. This asymmetry gives rise to new terms in the transport equations that describe propagation of charged particles. Helicity has virtually no impact on qualitative features of the diffusive mode of propagation. However, characteristic velocities of the coherent modes that appear after a highly anisotropic injection exhibit an asymmetry related to helicity. Explicit formulas, which embody the effects of helicity, are given for the anisotropies, the coefficient diffusion, and the coherent velocities. Predictions derived from these expressions are in good agreement with Monte Carlo simulations of particle transport, but the simulations reveal certain phenomena whose explanation calls for further analytical work.

  15. Effects of Ginger on Serum Lipids and Lipoproteins in Peritoneal Dialysis Patients: A Randomized Controlled Trial.

    PubMed

    Tabibi, Hadi; Imani, Hossein; Atabak, Shahnaz; Najafi, Iraj; Hedayati, Mehdi; Rahmani, Leila

    2016-01-01

    ♦ In peritoneal dialysis (PD) patients, one of the major risk factors for cardiovascular disease is lipid abnormalities. This study was designed to investigate the effects of ginger supplementation on serum lipids and lipoproteins in PD patients. ♦ In this randomized, double-blind, placebo-controlled trial, 36 PD patients were randomly assigned to either the ginger or the placebo group. The patients in the ginger group received 1,000 mg ginger daily for 10 weeks, while the placebo group received corresponding placebos. At baseline and at the end of week 10, 7 mL of blood were obtained from each patient after a 12- to 14-hour fast, and serum concentrations of triglyceride, total cholesterol, low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and lipoprotein (a) [Lp (a)] were measured. ♦ Serum triglyceride concentration decreased significantly up to 15% in the ginger group at the end of week 10 compared with baseline (p < 0.01), and the reduction was significant in comparison with the placebo group (p < 0.05). There were no significant differences between the 2 groups in mean changes of serum total cholesterol, LDL-C, HDL-C, and Lp (a). ♦ This study indicates that daily administration of 1,000 mg ginger reduces serum triglyceride concentration, which is a risk factor for cardiovascular disease, in PD patients. Copyright © 2016 International Society for Peritoneal Dialysis.

  16. Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial.

    PubMed

    Chen, Jiao; Feng, Shuwei; Zeng, Jiuzhi; Wu, Xi; Yang, Mingxiao; Tang, Hongzhi; Fan, Huaying; Yang, Jie; Liang, Fanrong

    2016-05-21

    Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome. This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial. The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome. Chinese Clinical Trial Registry, ChiCTR-IOR-15007358

  17. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial.

    PubMed

    McGinnis, Kate; Murray, Eileen; Cherven, Brooke; McCracken, Courtney; Travers, Curtis

    2016-12-01

    Applied mechanical vibration in pediatric and adult populations has been shown to be an effective analgesic for acute and chronic pain, including needle pain. Studies among the neonatal population are lacking. According to the Gate Control Theory, it is expected that applied mechanical vibration will have a summative effect with standard nonpharmacologic pain control strategies, reducing behavioral and physiologic pain responses to heel lancing. To determine the safety and efficacy of mechanical vibration for relief of heel lance pain among neonates. In this parallel design randomized controlled trial, eligible enrolled term or term-corrected neonates (n = 56) in a level IV neonatal intensive care unit were randomized to receive either sucrose and swaddling or sucrose, swaddling, and vibration for heel lance analgesia. Vibration was applied using a handheld battery-powered vibrator (Norco MiniVibrator, Hz = 92) to the lateral aspect of the lower leg along the sural dermatome throughout the heel lance procedure. Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores, heart rate, and oxygen saturations were collected at defined intervals surrounding heel lancing. Infants in the vibration group (n = 30) had significantly lower N-PASS scores and more stable heart rates during heel stick (P = .006, P = .037) and 2 minutes after heel lance (P = .002, P = .016) than those in the nonvibration group. There were no adverse behavioral or physiologic responses to applied vibration in the sample. Applied mechanical vibration is a safe and effective method for managing heel lance pain. This pilot study suggests that mechanical vibration warrants further exploration as a nonpharmacologic pain management tool among the neonatal population.

  18. Effect of facet joint injection versus systemic steroids in low back pain: a randomized controlled trial.

    PubMed

    Ribeiro, Luiza Helena; Furtado, Rita Nely Vilar; Konai, Monique Sayuri; Andreo, Ana Beatriz; Rosenfeld, Andre; Natour, Jamil

    2013-11-01

    Randomized clinical trial. To compare the effectiveness of facet joint injection versus systemic steroid in patients with a diagnosis of facet joint syndrome. The term facet joint syndrome has been used to define back pain originating from the facet joints. Treatment is mainly conservative, although interventions, including intra-articular injections and medial branch nerve blocks are used to manage facet-mediated pain. Several studies have evaluated the effectiveness of these interventions. Results of facet joint injection, however, are conflicting. Sixty subjects with a diagnosis of facet joint syndrome were enrolled in the study. They were randomized into experimental and control groups. The experimental group was administered with intra-articular injection of 6 lumbar facet joints with triamcinolone hexacetonide; the control group was administered with triamcinolone acetonide intramuscular injection of 6 lumbar paravertebral points. Visits were taken at baseline and at 1, 4, 12, and 24 weeks after interventions. Outcome measures were used: pain visual analogue scale, pain visual analogue scale during extension of the spine, Likert scale, improvement percentage scale, Roland-Morris, 36-Item Short Form Health Survey, and accountability of medications taken.Homogeneity was tested using the Student t, Pearson χ, and Mann-Whitney tests. Analysis of variance was used to analyze differences in the groups over time and the Student t test to analyze differences between groups at each time evaluation. The groups were similar at baseline. Comparisons between the groups showed, in analysis of variance analysis, an improvement in the experimental group regarding diclofenac intake and quality of life, in the "role physical" profile, assessed by 36-Item Short Form Health Survey.In the analysis at each time point, an improvement in the experimental group was also found in the Roland-Morris questionnaire, in the improvement percentage scale and in the response to treatment

  19. Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial.

    PubMed

    Kleckner, Ian R; Kamen, Charles; Gewandter, Jennifer S; Mohile, Nimish A; Heckler, Charles E; Culakova, Eva; Fung, Chunkit; Janelsins, Michelle C; Asare, Matthew; Lin, Po-Ju; Reddy, Pavan S; Giguere, Jeffrey; Berenberg, Jeffrey; Kesler, Shelli R; Mustian, Karen M

    2018-04-01

    Over half of all cancer patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy experience chemotherapy-induced peripheral neuropathy (CIPN), which includes numbness, tingling, pain, cold sensitivity, and motor impairment in the hands and feet. CIPN is a dose-limiting toxicity, potentially increasing mortality. There are no FDA-approved drugs to treat CIPN, and behavioral interventions such as exercise are promising yet understudied. This secondary analysis of our nationwide phase III randomized controlled trial of exercise for fatigue examines (1) effects of exercise on CIPN symptoms, (2) factors that predict CIPN symptoms, and (3) factors that moderate effects of exercise on CIPN symptoms. Cancer patients (N = 355, 56 ± 11 years, 93% female, 79% breast cancer) receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy were randomized to chemotherapy or chemotherapy plus Exercise for Cancer Patients (EXCAP©®). EXCAP is a standardized, individualized, moderate-intensity, home-based, six-week progressive walking and resistance exercise program. Patients reported CIPN symptoms of numbness and tingling and hot/coldness in hands/feet (0-10 scales) pre- and post-intervention. We explored baseline neuropathy, sex, age, body mass index, cancer stage, and cancer type as possible factors associated with CIPN symptoms and exercise effectiveness. Exercise reduced CIPN symptoms of hot/coldness in hands/feet (-0.46 units, p = 0.045) and numbness and tingling (- 0.42 units, p = 0.061) compared to the control. Exercise reduced CIPN symptoms more for patients who were older (p = 0.086), male (p = 0.028), or had breast cancer (p = 0.076). Exercise appears to reduce CIPN symptoms in patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy. Clinicians should consider prescribing exercise for these patients. Clinical Trials.gov , # NCT00924651, http://www.clinicaltrials.gov .

  20. Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study

    PubMed Central

    Chandler, Melanie; Locke, Dona EC; Fields, Julie; Phatak, Vaishali; Crook, Julia; Hanna, Sherrie; Lunde, Angela; Morris, Miranda; Graff-Radford, Michelle; Hughes, Christine A; Lepore, Susan; Cuc, Andrea; Caselli, Maria; Hurst, Duane; Wethe, Jennifer; Francone, Andrea; Eilertsen, Jeanne; Lucas, Pauline; Hoffman Snyder, Charlene; Kuang, LeeAnn; Becker, Marigrace; Dean, Pamela; Diehl, Nancy; Lofquist, Marvin; Vanderhook, Shirley; Myles, Diana; Cochran, Denise

    2017-01-01

    Background Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. Trial Registration  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv) PMID

  1. Metabolic and hormonal effects of caffeine: randomized, double-blind, placebo-controlled crossover trial.

    PubMed

    MacKenzie, Todd; Comi, Richard; Sluss, Patrick; Keisari, Ronit; Manwar, Simone; Kim, Janice; Larson, Robin; Baron, John A

    2007-12-01

    In short-term studies, caffeine has been shown to increase insulin levels, reduce insulin sensitivity, and increase cortisol levels. However, epidemiological studies have indicated that long-term consumption of beverages containing caffeine such as coffee and green tea is associated with a reduced risk of type 2 diabetes mellitus. There is a paucity of randomized studies addressing the metabolic and hormonal effects of consuming caffeine over periods of more than 1 day. We evaluated the effect of oral intake of 200 mg of caffeine taken twice a day for 7 days on glucose metabolism, as well as on serum cortisol, dehydroepiandrosterone (DHEA), and androstenedione, and on nighttime salivary melatonin. A double-blind, randomized, placebo-controlled crossover study with periods of 7 days and washouts of 5 days comparing caffeine with placebo capsules was conducted. Participants were 16 healthy adults aged 18 to 22 years with a history of caffeine consumption. Blood samples from each subject were assayed for glucose, insulin, serum cortisol, DHEA, and androstenedione on the eighth day of each period after an overnight fast. Nighttime salivary melatonin was also measured. Insulin levels were significantly higher (by 1.80 microU/mL; 95% confidence interval, 0.33-3.28) after caffeine intake than after placebo. The homeostasis model assessment index of insulin sensitivity was reduced by 35% (95% confidence interval, 7%-62%) by caffeine. There were no differences in glucose, DHEA, androstenedione, and melatonin between treatment periods. This study provides evidence that daily caffeine intake reduces insulin sensitivity; the effect persists for at least a week and is evident up to 12 hours after administration.

  2. Effect of oxygen therapy on myocardial salvage in ST elevation myocardial infarction: the randomized SOCCER trial.

    PubMed

    Khoshnood, Ardavan; Carlsson, Marcus; Akbarzadeh, Mahin; Bhiladvala, Pallonji; Roijer, Anders; Nordlund, David; Höglund, Peter; Zughaft, David; Todorova, Lizbet; Mokhtari, Arash; Arheden, Håkan; Erlinge, David; Ekelund, Ulf

    2018-04-01

    Recent studies suggest that administration of O2 in patients with acute myocardial infarction may have negative effects. With the use of cardiac MRI (CMR), we evaluated the effects of supplemental O2 in patients with ST elevation myocardial infarction (STEMI) accepted for acute percutaneous coronary intervention (PCI). This study was a randomized-controlled trial conducted at two university hospitals in Sweden. Normoxic STEMI patients were randomized in the ambulance to either supplemental O2 (10 l/min) or room air until the conclusion of the PCI. CMR was performed 2-6 days after the inclusion. The primary endpoint was the myocardial salvage index assessed by CMR. The secondary endpoints included infarct size and myocardium at risk. At inclusion, the O2 (n=46) and air (n=49) patient groups had similar patient characteristics. There were no significant differences in myocardial salvage index [53.9±25.1 vs. 49.3±24.0%; 95% confidence interval (CI): -5.4 to 14.6], myocardium at risk (31.9±10.0% of the left ventricle in the O2 group vs. 30.0±11.8% in the air group; 95% CI: -2.6 to 6.3), or infarct size (15.6±10.4% of the left ventricle vs. 16.0±11.0%; 95% CI: -4.7 to 4.1). In STEMI patients undergoing acute PCI, we found no effect of high-flow oxygen compared with room air on the size of ischemia before PCI, myocardial salvage, or the resulting infarct size. These results support the safety of withholding supplemental oxygen in normoxic STEMI patients.

  3. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial.

    PubMed

    Cully, Jeffrey A; Breland, Jessica Y; Robertson, Suzanne; Utech, Anne E; Hundt, Natalie; Kunik, Mark E; Petersen, Nancy J; Masozera, Nicholas; Rao, Radha; Naik, Aanand D

    2014-04-28

    Depression and diabetes cause significant burden for patients and the healthcare system and, when co-occurring, result in poorer self-care behaviors and worse glycemic control than for either condition alone. However, the clinical management of these comorbid conditions is complicated by a host of patient, provider, and system-level barriers that are especially problematic for patients in rural locations. Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions. Presently, there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices. This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment (HOPE) intervention, which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas. A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm. Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6- and 12-month follow-up. The trial has two primary goals: 1) to examine the effectiveness of the intervention on both physical (diabetes) and emotional health (depression) outcomes and 2) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting. This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home. Behavioral Activation Therapy for Rural Veterans

  4. Effective treatment of hypoglycemia in children with type 1 diabetes: a randomized controlled clinical trial.

    PubMed

    McTavish, Lindsay; Wiltshire, Esko

    2011-06-01

    To determine the most effective of four oral treatments for hypoglycemia in children with type 1 diabetes using a weight-based protocol during diabetes camp. During diabetes camp treatment of hypoglycemia was randomized to one of the four treatments, randomly assigned for each episode using a sealed envelope: glucose tablets, jellybeans, orange juice, and sugar mints (Mentos dragees®). An equivalent carbohydrate dose was calculated for each patient for each treatment (0.3 g carbohydrate/kg) and provided to camp leaders. Glucose was measured at 0, 2, 5, 10, and 15 min and symptoms recorded. A total of 191 episodes of hypoglycemia were recorded in 39 children (1-12 episodes per child), with 2 episodes excluded because of protocol violations. Fifty-two episodes were treated with glucose tablets, 45 with jellybeans, 44 with juice, and 48 with sugar mints. Change in glucose at 10 (p = 0.034) and 15 min (p = 0.005) and glucose at 15 min (p = 0.026) were significantly different between treatment groups - jellybeans produced the lowest and slowest response. Glucose tablets did not differ significantly from juice or Mentos dragees. There was a trend for repeat treatment to be required more often with a single treatment 'dose' of jellybeans (p = 0.058). Symptoms occurred in 112 episodes, with a median time to symptom resolution of 12 min (interquartile range (IQR) 8-15 min). Jellybeans are less effective treatment for hypoglycemia than the other three treatments. Glucose tablets, Mentos dragees® and orange juice are of similar efficacy. Treatment with 0.3 g/kg of carbohydrate (excluding jellybeans) effectively resolved hypoglycemia in most children, with 15 min often required to normalize blood glucose. © 2011 John Wiley & Sons A/S.

  5. Paule‐Mandel estimators for network meta‐analysis with random inconsistency effects

    PubMed Central

    Veroniki, Areti Angeliki; Law, Martin; Tricco, Andrea C.; Baker, Rose

    2017-01-01

    Network meta‐analysis is used to simultaneously compare multiple treatments in a single analysis. However, network meta‐analyses may exhibit inconsistency, where direct and different forms of indirect evidence are not in agreement with each other, even after allowing for between‐study heterogeneity. Models for network meta‐analysis with random inconsistency effects have the dual aim of allowing for inconsistencies and estimating average treatment effects across the whole network. To date, two classical estimation methods for fitting this type of model have been developed: a method of moments that extends DerSimonian and Laird's univariate method and maximum likelihood estimation. However, the Paule and Mandel estimator is another recommended classical estimation method for univariate meta‐analysis. In this paper, we extend the Paule and Mandel method so that it can be used to fit models for network meta‐analysis with random inconsistency effects. We apply all three estimation methods to a variety of examples that have been used previously and we also examine a challenging new dataset that is highly heterogenous. We perform a simulation study based on this new example. We find that the proposed Paule and Mandel method performs satisfactorily and generally better than the previously proposed method of moments because it provides more accurate inferences. Furthermore, the Paule and Mandel method possesses some advantages over likelihood‐based methods because it is both semiparametric and requires no convergence diagnostics. Although restricted maximum likelihood estimation remains the gold standard, the proposed methodology is a fully viable alternative to this and other estimation methods. PMID:28585257

  6. Effect of a life review program for Chinese patients with advanced cancer: a randomized controlled trial.

    PubMed

    Xiao, Huimin; Kwong, Enid; Pang, Samantha; Mok, Esther

    2013-01-01

    Empirical data suggest that life review is an effective psychospiritual intervention. However, it has not been applied to Chinese patients with advanced cancer, and its effects on this population remain unknown. The aim of the study was to determine the effect of a life review program on quality of life among Chinese patients with advanced cancer. In this prospective randomized controlled trial, a total of 80 patients were randomly assigned to the life review program group and the control group. The 3-weekly life review program included reviewing a life and formulating a life review booklet. Outcome data were assessed by a collector who was blinded to group assignment before and immediately after the program and at a 3-week follow-up. Significantly better scores in overall quality of life, support, negative emotions, sense of alienation, existential distress, and value of life were found in the life review group immediately after the program and at the 3-week follow-up. This study provides additional data on the potential role of a life review in improving quality of life, particularly psychospiritual well being; it also indicates that the life review program could enable Chinese patients with advanced cancer to express their views on life and death. The life review program offers advanced cancer patients an opportunity to integrate their whole life experiences and discuss end-of-life issues, which lays the ground for further active intervention in their psychospiritual distress. The program could be integrated into daily home care to enhance the psychospiritual well-being of Chinese patients with advanced cancer.

  7. Effects of a randomized intervention to improve workplace social capital in community health centers in China.

    PubMed

    Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

    2014-01-01

    To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. This study was conducted in 20 community health centers of similar size in Jinan of China during 2012-2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings.

  8. Effects of Exercise on Cognitive Function in Older People with Dementia: A Randomized Controlled Trial.

    PubMed

    Toots, Annika; Littbrand, Håkan; Boström, Gustaf; Hörnsten, Carl; Holmberg, Henrik; Lundin-Olsson, Lillemor; Lindelöf, Nina; Nordström, Peter; Gustafson, Yngve; Rosendahl, Erik

    2017-01-01

    Although physical exercise has been suggested to influence cognitive function, previous exercise studies show inconsistent results in people with dementia. To investigate effects of exercise on cognitive function in people with dementia. The Umeå Dementia and Exercise (UMDEX) study, a cluster-randomized controlled trial, was set in 16 nursing homes in Umeå, Sweden. One hundred-and-forty-one women and 45 men with dementia; mean age of 85 y and mean Mini-Mental State Examination (MMSE) score of 15, were randomized to a High-Intensity Functional Exercise program or a seated attention control activity. Blinded assessors measured global cognitive function using the MMSE and the Alzheimer's disease Assessment Scale - Cognitive subscale (ADAS-Cog), and executive function using Verbal fluency (VF) at baseline and 4 months (directly after intervention completion), and MMSE and VF at 7 months. Linear mixed models showed no between-group effects in mean difference from baseline (95% confidence intervals, CI) at 4 months in MMSE (-0.27; 95% CI -1.4 to 0.87, p = 0.644), ADAS-Cog (-1.04, 95% CI -4 to 1.92, p = 0.491), or VF (-0.53, 95% CI -1.42 to 0.35, p = 0.241) or at 7 months in MMSE (-1.15, 95% CI -2.32 to 0.03, p = 0.056) or VF (-0.18, 95% CI -1.09 to 0.74, p = 0.707). A 4-month, high-intensity functional exercise program had no superior effects on global cognition or executive function in people with dementia living in nursing homes when compared with an attention control activity.

  9. Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial.

    PubMed

    Andrews, Jeannette O; Mueller, Martina; Dooley, Mary; Newman, Susan D; Magwood, Gayenell S; Tingen, Martha S

    2016-09-01

    To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Effects of a Randomized Intervention to Improve Workplace Social Capital in Community Health Centers in China

    PubMed Central

    Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

    2014-01-01

    Objective To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. Methods This study was conducted in 20 community health centers of similar size in Jinan of China during 2012–2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. Results No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. Conclusions The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings. PMID:25503627

  11. Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial.

    PubMed

    Conklin, Heather M; Lawford, Joanne; Jasper, Bruce W; Morris, E Brannon; Howard, Scott C; Ogg, Susan W; Wu, Shengjie; Xiong, Xiaoping; Khan, Raja B

    2009-07-01

    To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels. Childhood cancer survivors (N = 103) identified as having attention and learning problems completed a randomized, double-blind, 3-week, home-crossover trial of placebo, low-dose methylphenidate (0.3 mg/kg; 10 mg twice daily maximum) and moderate-dose methylphenidate (0.6 mg/kg; 20 mg twice daily maximum). Caregivers completed the Barkley Side Effects Rating Scale (SERS) at baseline and each week during the medication trial. Siblings of cancer survivors (N = 49) were recruited as a healthy comparison group. There was a significantly higher number and severity of symptoms endorsed on the SERS when patients were taking moderate dose compared with placebo or low dose, but not low dose compared with placebo. The number of side effects endorsed on the SERS was significantly lower during all 3 home-crossover weeks (placebo, low dose, moderate dose) when compared with baseline symptom scores. The severity of side effects was also significantly lower, compared with baseline screening, during placebo and low-dose weeks but not moderate-dose weeks. Both the number and severity of symptoms endorsed at baseline were significantly higher for patients compared with siblings. Female gender and lower IQ were associated with higher adverse effect levels. Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

  12. Effects of PMTO in Foster Families with Children with Behavior Problems: A Randomized Controlled Trial.

    PubMed

    Maaskant, Anne M; van Rooij, Floor B; Overbeek, Geertjan J; Oort, Frans J; Arntz, Maureen; Hermanns, Jo M A

    2017-01-01

    The present randomized controlled trial examined the effectiveness of Parent Management Training Oregon for foster parents with foster children (aged 4-12) with severe externalizing behavior problems in long-term foster care arrangements. Foster children's behavior problems are challenging for foster parents and increase the risk of placement breakdown. There is little evidence for the effectiveness of established interventions to improve child and parent functioning in foster families. The goal of Parent Management Training Oregon, a relatively long and intensive (6-9 months, with weekly sessions) parent management training, is to reduce children's problem behavior through improvement of parenting practices. We specifically investigated whether Parent Management Training Oregon is effective to reduce foster parenting stress. A significant effect of Parent Management Training Oregon, compared to Care as Usual was expected on reduced parenting stress improved parenting practices, and on reduced child behavior problems. Multi-informant (foster mothers, foster fathers, and teachers) data were used from 86 foster families (46 Parent Management Training Oregon, 40 Care as Usual) using a pre-posttest design. Multilevel analyses based on the intention to treat principle (retention rate 73 %) showed that Parent Management Training Oregon, compared to Care as Usual, reduced general levels of parenting stress as well as child related stress and parent-related stress (small to medium effect sizes). The clinical significance of this effect was, however, limited. Compared to a decrease in the Care as Usual group, Parent Management Training Oregon helped foster mothers to maintain parental warmth (small effect size). There were no other effects of Parent Management Training Oregon on self-reported parenting behaviors. Child behavior problems were reduced in both conditions, indicating no additive effects of Parent Management Training Oregon to Care as Usual on child

  13. Effect of Aloe vera mouthwash on periodontal health: triple blind randomized control trial.

    PubMed

    Karim, Bushra; Bhaskar, Dara John; Agali, Chandan; Gupta, Devanand; Gupta, Rajendra Kumar; Jain, Ankita; Kanwar, Alpana

    2014-03-01

    With the increasing incidence of periodontal diseases and development of antibiotic resistance, the global need for alternative treatment modalities, safe, effective, and economical products is the need of time. Aloe vera is a medicinal plant which has the greater medicinal value and enormous properties for curing and preventing oral diseases disease. The aim of the study was to access the effect of Aloe vera mouthwash on the dental plaque and gingivitis and comparing it with the bench mark control chlorhexidine and placebo. 345 healthy subjects were randomly allocated in 3 groups to the test group (n=115) - mouthwash containing Aloe vera, Control group (n=115) -chlorhexidene group, Distilled water - Placebo (n=115) . Plaque Index (PI) and Gingival Index (GI) were assessed at days 0, 15 and 30. Subjects were asked to rinse their mouth with the stated mouthwash, twice a day, during a 30-day period. Our result showed that Aloe vera mouthrinse is equally effective in reducing periodontal indices as Chlorhexidine. The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to placebo group. There was a significant reduction on plaque and gingivitis in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them (p>0.05). Aloe vera mouthwash showed no side effects as seen with chlorhexidine. The results of the present study indicate that Aloe vera may prove to be an effective mouthwash owing to its ability in reducing periodontal indices.

  14. Effect of the Sonas Programme on Communication in People with Dementia: A Randomized Controlled Trial

    PubMed Central

    Strøm, Benedicte Sørensen; Engedal, Knut; Benth, Jurate Saltyte; Grov, Ellen-Karine

    2017-01-01

    Background Strategies to improve communication in people with dementia are warranted. We examined the effect of the Sonas programme on communication ability in persons with moderate to severe dementia. Methods A 24-week 3-armed (Sonas, reading, and control group) randomized controlled trial including 120 nursing home residents with dementia was conducted; 105 completed the follow-up assessments. The main outcome was change in communication abilities measured by the Holden Communication Scale (HCS). Results We found no overall significant effect of the Sonas programme with regard to communication ability as measured by the HCS. However, an effect between the Sonas group and the reading group and between the Sonas group and the control group from T0 to T1 and T2 was found, as well as a significant improvement in communication in the Sonas group. Among people with severe dementia, the Sonas group scored significantly better on the HCS compared to the reading group after 12 weeks, but not after 24 weeks. Conclusion This study failed to document an overall effect of the Sonas programme on communication; however, the findings indicate that the Sonas programme has a significant effect on communication among those with severe dementia. PMID:28553314

  15. Treatment selection in a randomized clinical trial via covariate-specific treatment effect curves.

    PubMed

    Ma, Yunbei; Zhou, Xiao-Hua

    2017-02-01

    For time-to-event data in a randomized clinical trial, we proposed two new methods for selecting an optimal treatment for a patient based on the covariate-specific treatment effect curve, which is used to represent the clinical utility of a predictive biomarker. To select an optimal treatment for a patient with a specific biomarker value, we proposed pointwise confidence intervals for each covariate-specific treatment effect curve and the difference between covariate-specific treatment effect curves of two treatments. Furthermore, to select an optimal treatment for a future biomarker-defined subpopulation of patients, we proposed confidence bands for each covariate-specific treatment effect curve and the difference between each pair of covariate-specific treatment effect curve over a fixed interval of biomarker values. We constructed the confidence bands based on a resampling technique. We also conducted simulation studies to evaluate finite-sample properties of the proposed estimation methods. Finally, we illustrated the application of the proposed method in a real-world data set.

  16. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial.

    PubMed

    Meyer, Björn; Berger, Thomas; Caspar, Franz; Beevers, Christopher G; Andersson, Gerhard; Weiss, Mario

    2009-05-11

    Depression is associated with immense suffering and costs, and many patients receive inadequate care, often because of the limited availability of treatment. Web-based treatments may play an increasingly important role in closing this gap between demand and supply. We developed the integrative, Web-based program Deprexis, which covers therapeutic approaches such as behavioral activation, cognitive restructuring, mindfulness/acceptance exercises, and social skills training. To evaluate the effectiveness of the Web-based intervention in a randomized controlled trial. There were 396 adults recruited via Internet depression forums in Germany, and they were randomly assigned in an 80:20 weighted randomization sequence to either 9 weeks of immediate-program-access as an add-on to treatment-as-usual (N = 320), or to a 9-week delayed-access plus treatment-as-usual condition (N = 76). At pre- and post-treatment and 6-month follow-up, we measured depression (Beck Depression Inventory) as the primary outcome measure and social functioning (Work and Social Adjustment Scale) as the secondary outcome measure. Complete analyses and intention-to-treat analyses were performed. Of 396 participants, 216 (55%) completed the post-measurement 9 weeks later. Available case analyses revealed a significant reduction in depression severity (BDI), Cohen's d = .64 (CI 95% = 0.33 - 0.94), and significant improvement in social functioning (WSA), Cohen's d = .64, 95% (CI 95% = 0.33 - 0.95). These improvements were maintained at 6-month follow-up. Intention-to-treat analyses confirmed significant effects on depression and social functioning improvements (BDI: Cohen's d = .30, CI 95% = 0.05 - 0.55; WSA: Cohen's d = .36, CI 95% = 0.10 - 0.61). Moreover, a much higher percentage of patients in the intervention group experienced a significant reduction of depression symptoms (BDI: odds ratio [OR] = 6.8, CI 95% = 2.90 - 18.19) and recovered more often (OR = 17.3, 95% CI 2.3 - 130). More than 80% of

  17. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial.

    PubMed

    Wedam, Erich F; Bigelow, George E; Johnson, Rolley E; Nuzzo, Paul A; Haigney, Mark C P

    2007-12-10

    Levomethadyl acetate, methadone hydrochloride, and buprenorphine hydrochloride are equally effective treatments for opioid dependence. Each blocks the human ether-a-go-go-related gene (hERG)-associated channel in vitro and represents a risk for QT prolongation. To compare the effects of 3 known hERG-associated channel blockers on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid-addicted subjects. We analyzed 12-lead electrocardiograms collected at baseline and every 4 weeks from 165 opioid-addicted participants in a 17-week randomized double-blind clinical trial of equally effective doses of levomethadyl, methadone, and buprenorphine at a major referral center. Analyses were limited to the 154 patients with a normal baseline QTc = (QT/ radical R-R) who had at least 1 subsequent in-treatment electrocardiogram. Patients were randomized to receive treatment with levomethadyl, methadone, or buprenorphine (hereinafter, levomethadyl, methadone, and buprenorphine groups, respectively). The prespecified end points were a QTc greater than 470 milliseconds in men (or >490 milliseconds in women), or an increase from baseline in QTc greater than 60 milliseconds. Baseline QTc was similar in the 3 groups. The levomethadyl and methadone groups were significantly more likely to manifest a QTc greater than 470 or 490 milliseconds (28% for the levomethadyl group vs 23% for the methadone group vs 0% for the buprenorphine group; P < .001) or an increase from baseline in QTc greater than 60 milliseconds (21% of the levomethadyl group [odds ratio, 15.8; 95% confidence interval, 3.7-67.1] and 12% of the methadone group [odds ratio, 8.4; 95% confidence interval, 1.9-36.4]) compared with the buprenorphine group (2% of subjects; P < .001). In subjects whose dosage of levomethadyl or methadone remained fixed over at least 8 weeks, the QTc continued to increase progressively over time (P = .08 for the levomethadyl group, P = .01 for the methadone group

  18. Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial.

    PubMed

    Rosenheck, Robert; Perlick, Deborah; Bingham, Stephen; Liu-Mares, Wen; Collins, Joseph; Warren, Stuart; Leslie, Douglas; Allan, Edward; Campbell, E Cabrina; Caroff, Stanley; Corwin, June; Davis, Lori; Douyon, Richard; Dunn, Lawrence; Evans, Denise; Frecska, Ede; Grabowski, John; Graeber, David; Herz, Lawrence; Kwon, Kong; Lawson, William; Mena, Felicitas; Sheikh, Javaid; Smelson, David; Smith-Gamble, Valerie

    2003-11-26

    Although olanzapine has been widely adopted as a treatment of choice for schizophrenia, its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a standard antipsychotic drug. To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia. Double-blind, randomized controlled trial with randomization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers. Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of schizophrenia or schizoaffective disorder, serious symptoms, and serious dysfunction for the previous 2 years. Fifty-nine percent fully completed and 36% partially completed follow-up assessments. Patients were randomly assigned to receive flexibly dosed olanzapine, 5 to 20 mg/d, with prophylactic benztropine, 1 to 4 mg/d (n = 159); or haloperidol, 5 to 20 mg/d (n = 150), for 12 months. Standardized measures of symptoms, quality of life, neurocognitive status, and adverse effects of medication. Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole (ie, consumption of all resources on behalf of these patients). There were no significant differences between groups in study retention; positive, negative, or total symptoms of schizophrenia; quality of life; or extrapyramidal symptoms. Olanzapine was associated with reduced akathisia in the intention-to-treat analysis (P<.001) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug. Small but significant advantages were also observed on measures of memory and motor function. Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs, ranging from 3000

  19. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

    PubMed

    Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

    2014-09-23

    To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity <6/12 in either eye without glasses correctable to >6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and

  20. A case study of the effects of random errors in rawinsonde data on computations of ageostrophic winds

    NASA Technical Reports Server (NTRS)

    Moore, J. T.

    1985-01-01

    Data input for the AVE-SESAME I experiment are utilized to describe the effects of random errors in rawinsonde data on the computation of ageostrophic winds. Computer-generated random errors for wind direction and speed and temperature are introduced into the station soundings at 25 mb intervals from which isentropic data sets are created. Except for the isallobaric and the local wind tendency, all winds are computed for Apr. 10, 1979 at 2000 GMT. Divergence fields reveal that the isallobaric and inertial-geostrophic-advective divergences are less affected by rawinsonde random errors than the divergence of the local wind tendency or inertial-advective winds.

  1. Effects of BMI, Fat Mass, and Lean Mass on Asthma in Childhood: A Mendelian Randomization Study

    PubMed Central

    Granell, Raquel; Henderson, A. John; Evans, David M.; Smith, George Davey; Ness, Andrew R.; Lewis, Sarah; Palmer, Tom M.; Sterne, Jonathan A. C.

    2014-01-01

    Background Observational studies have reported associations between body mass index (BMI) and asthma, but confounding and reverse causality remain plausible explanations. We aim to investigate evidence for a causal effect of BMI on asthma using a Mendelian randomization approach. Methods and Findings We used Mendelian randomization to investigate causal effects of BMI, fat mass, and lean mass on current asthma at age 7½ y in the Avon Longitudinal Study of Parents and Children (ALSPAC). A weighted allele score based on 32 independent BMI-related single nucleotide polymorphisms (SNPs) was derived from external data, and associations with BMI, fat mass, lean mass, and asthma were estimated. We derived instrumental variable (IV) estimates of causal risk ratios (RRs). 4,835 children had available data on BMI-associated SNPs, asthma, and BMI. The weighted allele score was strongly associated with BMI, fat mass, and lean mass (all p-values<0.001) and with childhood asthma (RR 2.56, 95% CI 1.38–4.76 per unit score, p = 0.003). The estimated causal RR for the effect of BMI on asthma was 1.55 (95% CI 1.16–2.07) per kg/m2, p = 0.003. This effect appeared stronger for non-atopic (1.90, 95% CI 1.19–3.03) than for atopic asthma (1.37, 95% CI 0.89–2.11) though there was little evidence of heterogeneity (p = 0.31). The estimated causal RRs for the effects of fat mass and lean mass on asthma were 1.41 (95% CI 1.11–1.79) per 0.5 kg and 2.25 (95% CI 1.23–4.11) per kg, respectively. The possibility of genetic pleiotropy could not be discounted completely; however, additional IV analyses using FTO variant rs1558902 and the other BMI-related SNPs separately provided similar causal effects with wider confidence intervals. Loss of follow-up was unlikely to bias the estimated effects. Conclusions Higher BMI increases the risk of asthma in mid-childhood. Higher BMI may have contributed to the increase in asthma risk toward the end of the 20th century. Please see

  2. Strong coupling electrostatics for randomly charged surfaces: antifragility and effective interactions.

    PubMed

    Ghodrat, Malihe; Naji, Ali; Komaie-Moghaddam, Haniyeh; Podgornik, Rudolf

    2015-05-07

    We study the effective interaction mediated by strongly coupled Coulomb fluids between dielectric surfaces carrying quenched, random monopolar charges with equal mean and variance, both when the Coulomb fluid consists only of mobile multivalent counterions and when it consists of an asymmetric ionic mixture containing multivalent and monovalent (salt) ions in equilibrium with an aqueous bulk reservoir. We analyze the consequences that follow from the interplay between surface charge disorder, dielectric and salt image effects, and the strong electrostatic coupling that results from multivalent counterions on the distribution of these ions and the effective interaction pressure they mediate between the surfaces. In a dielectrically homogeneous system, we show that the multivalent counterions are attracted towards the surfaces with a singular, disorder-induced potential that diverges logarithmically on approach to the surfaces, creating a singular but integrable counterion density profile that exhibits an algebraic divergence at the surfaces with an exponent that depends on the surface charge (disorder) variance. This effect drives the system towards a state of lower thermal 'disorder', one that can be described by a renormalized temperature, exhibiting thus a remarkable antifragility. In the presence of an interfacial dielectric discontinuity, the singular behavior of counterion density at the surfaces is removed but multivalent counterions are still accumulated much more strongly close to randomly charged surfaces as compared with uniformly charged ones. The interaction pressure acting on the surfaces displays in general a highly non-monotonic behavior as a function of the inter-surface separation with a prominent regime of attraction at small to intermediate separations. This attraction is caused directly by the combined effects from charge disorder and strong coupling electrostatics of multivalent counterions, which dominate the surface-surface repulsion due to

  3. Effects of physical exercise interventions in frail older adults: a systematic review of randomized controlled trials.

    PubMed

    de Labra, Carmen; Guimaraes-Pinheiro, Christyanne; Maseda, Ana; Lorenzo, Trinidad; Millán-Calenti, José C

    2015-12-02

    Low physical activity has been shown to be one of the most common components of frailty, and interventions have been considered to prevent or reverse this syndrome. The purpose of this systematic review of randomized, controlled trials is to examine the exercise interventions to manage frailty in older people. The PubMed, Web of Science, and Cochrane Central Register of Controlled Trials databases were searched using specific keywords and Medical Subject Headings for randomized, controlled trials published during the period of 2003-2015, which enrolled frail older adults in an exercise intervention program. Studies where frailty had been defined were included in the review. A narrative synthesis approach was performed to examine the results. The Physiotherapy Evidence Database (PEDro scale) was used to assess the methodological quality of the selected studies. Of 507 articles, nine papers met the inclusion criteria. Of these, six included multi-component exercise interventions (aerobic and resistance training not coexisting in the intervention), one included physical comprehensive training, and two included exercises based on strength training. All nine of these trials included a control group receiving no treatment, maintaining their habitual lifestyle or using a home-based low level exercise program. Five investigated the effects of exercise on falls, and among them, three found a positive impact of exercise interventions on this parameter. Six trials reported the effects of exercise training on several aspects of mobility, and among them, four showed enhancements in several measurements of this outcome. Three trials focused on the effects of exercise intervention on balance performance, and one demonstrated enhanced balance. Four trials investigated functional ability, and two showed positive results after the intervention. Seven trials investigated the effects of exercise intervention on muscle strength, and five of them reported increases; three trials

  4. Cost Effectiveness of Interventions to Promote Screening for Colorectal Cancer: A Randomized Trial

    PubMed Central

    Misra, Swati; Chan, Wenyaw; Chang, Yu-Chia; Bartholomew, L. Kay; Greisinger, Anthony; McQueen, Amy; Vernon, Sally W.

    2011-01-01

    Objectives Screening for colorectal cancer is considered cost effective, but is underutilized in the U.S. Information on the efficiency of "tailored interventions" to promote colorectal cancer screening in primary care settings is limited. The paper reports the results of a cost effectiveness analysis that compared a survey-only control group to a Centers for Disease Control (CDC) web-based intervention (screen for life) and to a tailored interactive computer-based intervention. Methods A randomized controlled trial of people 50 and over, was conducted to test the interventions. The sample was 1224 partcipants 50-70 years of age, recruited from Kelsey-Seybold Clinic, a large multi-specialty clinic in Houston, Texas. Screening status was obtained by medical chart review after a 12-month follow-up period. An "intention to treat" analysis and micro costing from the patient and provider perspectives were used to estimate the costs and effects. Analysis of statistical uncertainty was conducted using nonparametric bootstrapping. Results The estimated cost of implementing the web-based intervention was $40 per person and the cost of the tailored intervention was $45 per person. The additional cost per person screened for the web-based intervention compared to no intervention was $2602 and the tailored intervention was no more effective than the web-based strategy. Conclusions The tailored intervention was less cost-effective than the web-based intervention for colorectal cancer screening promotion. The web-based intervention was less cost-effective than previous studies of in-reach colorectal cancer screening promotion. Researchers need to continue developing and evaluating the effectiveness and cost-effectiveness of interventions to increase colorectal cancer screening. PMID:21617335

  5. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    PubMed Central

    2012-01-01

    Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve

  6. Quantifying Adventitious Error in a Covariance Structure as a Random Effect

    PubMed Central

    Wu, Hao; Browne, Michael W.

    2017-01-01

    We present an approach to quantifying errors in covariance structures in which adventitious error, identified as the process underlying the discrepancy between the population and the structured model, is explicitly modeled as a random effect with a distribution, and the dispersion parameter of this distribution to be estimated gives a measure of misspecification. Analytical properties of the resultant procedure are investigated and the measure of misspecification is found to be related to the RMSEA. An algorithm is developed for numerical implementation of the procedure. The consistency and asymptotic sampling distributions of the estimators are established under a new asymptotic paradigm and an assumption weaker than the standard Pitman drift assumption. Simulations validate the asymptotic sampling distributions and demonstrate the importance of accounting for the variations in the parameter estimates due to adventitious error. Two examples are also given as illustrations. PMID:25813463

  7. Effect of inhibitory firing pattern on coherence resonance in random neural networks

    NASA Astrophysics Data System (ADS)

    Yu, Haitao; Zhang, Lianghao; Guo, Xinmeng; Wang, Jiang; Cao, Yibin; Liu, Jing

    2018-01-01

    The effect of inhibitory firing patterns on coherence resonance (CR) in random neuronal network is systematically studied. Spiking and bursting are two main types of firing pattern considered in this work. Numerical results show that, irrespective of the inhibitory firing patterns, the regularity of network is maximized by an optimal intensity of external noise, indicating the occurrence of coherence resonance. Moreover, the firing pattern of inhibitory neuron indeed has a significant influence on coherence resonance, but the efficacy is determined by network property. In the network with strong coupling strength but weak inhibition, bursting neurons largely increase the amplitude of resonance, while they can decrease the noise intensity that induced coherence resonance within the neural system of strong inhibition. Different temporal windows of inhibition induced by different inhibitory neurons may account for the above observations. The network structure also plays a constructive role in the coherence resonance. There exists an optimal network topology to maximize the regularity of the neural systems.

  8. Effects of random aspects of cutting tool wear on surface roughness and tool life

    NASA Astrophysics Data System (ADS)

    Nabil, Ben Fredj; Mabrouk, Mohamed

    2006-10-01

    The effects of random aspects of cutting tool flank wear on surface roughness and on tool lifetime, when turning the AISI 1045 carbon steel, were studied in this investigation. It was found that standard deviations corresponding to tool flank wear and to the surface roughness increase exponentially with cutting time. Under cutting conditions that correspond to finishing operations, no significant differences were found between the calculated values of the capability index C p at the steady-state region of the tool flank wear, using the best-fit method or the Box-Cox transformation, or by making the assumption that the surface roughness data are normally distributed. Hence, a method to establish cutting tool lifetime could be established that simultaneously respects the desired average of surface roughness and the required capability index.

  9. Effectiveness of Self-Hypnosis on the Relief of Experimental Dental Pain: A Randomized Trial.

    PubMed

    Wolf, Thomas Gerhard; Wolf, Dominik; Below, Dagna; d'Hoedt, Bernd; Willershausen, Brita; Daubländer, Monika

    2016-01-01

    This randomized, controlled clinical trial evaluates the effectiveness of self-hypnosis on pain perception. Pain thresholds were measured, and a targeted, standardized pain stimulus was created by electrical stimulation of the dental pulp of an upper anterior tooth. Pain stimulus was rated by a visual analogue scale (VAS). The pain threshold under self-hypnosis was higher (57.1 ± 17.1) than without hypnotic intervention (39.5 ± 11.8) (p < .001). Pain was rated lower on the VAS with self-hypnosis (4.0 ± 3.8) than in the basal condition without self-hypnosis (7.1 ± 2.7) (p < .001). Self-hypnosis can be used in clinical practice as an adjunct to the gold standard of local anesthesia for pain management, as well as an alternative in individual cases.

  10. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study.

    PubMed

    Bauer, Brent A; Cutshall, Susanne M; Wentworth, Laura J; Engen, Deborah; Messner, Penny K; Wood, Christina M; Brekke, Karen M; Kelly, Ryan F; Sundt, Thoralf M

    2010-05-01

    Integrative therapies such as massage have gained support as interventions that improve the overall patient experience during hospitalization. Cardiac surgery patients undergo long procedures and commonly have postoperative back and shoulder pain, anxiety, and tension. Given the promising effects of massage therapy for alleviation of pain, tension, and anxiety, we studied the efficacy and feasibility of massage therapy delivered in the postoperative cardiovascular surgery setting. Patients were randomized to receive a massage or to have quiet relaxation time (control). In total, 113 patients completed the study (massage, n=62; control, n=51). Patients receiving massage therapy had significantly decreased pain, anxiety, and tension. Patients were highly satisfied with the intervention, and no major barriers to implementing massage therapy were identified. Massage therapy may be an important component of the healing experience for patients after cardiovascular surgery. Copyright 2009 Elsevier Ltd. All rights reserved.

  11. Activated aging dynamics and effective trap model description in the random energy model

    NASA Astrophysics Data System (ADS)

    Baity-Jesi, M.; Biroli, G.; Cammarota, C.

    2018-01-01

    We study the out-of-equilibrium aging dynamics of the random energy model (REM) ruled by a single spin-flip Metropolis dynamics. We focus on the dynamical evolution taking place on time-scales diverging with the system size. Our aim is to show to what extent the activated dynamics displayed by the REM can be described in terms of an effective trap model. We identify two time regimes: the first one corresponds to the process of escaping from a basin in the energy landscape and to the subsequent exploration of high energy configurations, whereas the second one corresponds to the evolution from a deep basin to the other. By combining numerical simulations with analytical arguments we show why the trap model description does not hold in the former but becomes exact in the second.

  12. Cost-effectiveness analysis of a randomized trial comparing care models for chronic kidney disease.

    PubMed

    Hopkins, Robert B; Garg, Amit X; Levin, Adeera; Molzahn, Anita; Rigatto, Claudio; Singer, Joel; Soltys, George; Soroka, Steven; Parfrey, Patrick S; Barrett, Brendan J; Goeree, Ron

    2011-06-01

    Potential cost and effectiveness of a nephrologist/nurse-based multifaceted intervention for stage 3 to 4 chronic kidney disease are not known. This study examines the cost-effectiveness of a chronic disease management model for chronic kidney disease. Cost and cost-effectiveness were prospectively gathered alongside a multicenter trial. The Canadian Prevention of Renal and Cardiovascular Endpoints Trial (CanPREVENT) randomized 236 patients to receive usual care (controls) and another 238 patients to multifaceted nurse/nephrologist-supported care that targeted factors associated with development of kidney and cardiovascular disease (intervention). Cost and outcomes over 2 years were examined to determine the incremental cost-effectiveness of the intervention. Base-case analysis included disease-related costs, and sensitivity analysis included all costs. Consideration of all costs produced statistically significant differences. A lower number of days in hospital explained most of the cost difference. For both base-case and sensitivity analyses with all costs included, the intervention group required fewer resources and had higher quality of life. The direction of the results was unchanged to inclusion of various types of costs, consideration of payer or societal perspective, changes to the discount rate, and levels of GFR. The nephrologist/nurse-based multifaceted intervention represents good value for money because it reduces costs without reducing quality of life for patients with chronic kidney disease.

  13. The effectiveness of critical time intervention for abused women leaving women's shelters: a randomized controlled trial.

    PubMed

    Lako, Danielle A M; Beijersbergen, Mariëlle D; Jonker, Irene E; de Vet, Renée; Herman, Daniel B; van Hemert, Albert M; Wolf, Judith R L M

    2018-05-01

    To examine the effectiveness of critical time intervention (CTI)-an evidence-based intervention-for abused women transitioning from women's shelters to community living. A randomized controlled trial was conducted in nine women's shelters across the Netherlands. 136 women were assigned to CTI (n = 70) or care-as-usual (n = 66). Data were analyzed using intention-to-treat three-level mixed-effects models. Women in the CTI group had significant fewer symptoms of post-traumatic stress (secondary outcome) (adjusted mean difference - 7.27, 95% CI - 14.31 to - 0.22) and a significant fourfold reduction in unmet care needs (intermediate outcome) (95% CI 0.06-0.94) compared to women in the care-as-usual group. No differences were found for quality of life (primary outcome), re-abuse, symptoms of depression, psychological distress, self-esteem (secondary outcomes), family support, and social support (intermediate outcomes). This study shows that CTI is effective in a population of abused women in terms of a reduction of post-traumatic stress symptoms and unmet care needs. Because follow-up ended after the prescribed intervention period, further research is needed to determine the full long-term effects of CTI in this population.

  14. Open, randomized trial of the effects of aripiprazole versus risperidone on social cognition in schizophrenia.

    PubMed

    Maat, Arija; Cahn, Wiepke; Gijsman, Harm J; Hovens, Johannes E; Kahn, René S; Aleman, André

    2014-04-01

    To date, only few studies have examined the impact of medication on social cognition and none have examined the effects of aripiprazole in this respect. The goal of this 8-week, randomized, multicenter, open-label study was to examine the effects of aripiprazole and risperidone on social cognition and neurocognition in individuals with schizophrenia. Eighty schizophrenia patients (DSM-IV-TR) aged 16-50 years were administered multiple computerized measures of social cognition and neurocognition including reaction times at baseline and the end of week 8. Social functioning was mapped with the Social Functioning scale and Quality of Life scale. The study ran from June 2005 to March 2011. Scores on social cognitive and neurocognitive tests improved with both treatments, as did reaction time. There were few differences between the two antipsychotics on (social) cognitive test-scores. The aripiprazole group performed better (more correct items) on symbol substitution (P=.003). Aripiprazole was also superior to risperidone on reaction time for emotional working memory and working memory (P=.006 and P=.023, respectively). Improvements on these tests were correlated with social functioning. In conclusion, aripiprazole and risperidone showed a similar impact on social cognitive test-scores. However, aripiprazole treatment produced a greater effect on patients' processing speed compared to risperidone, with these improvements being associated with concurrent improvements in social functioning. Further research on the long-term effects of aripiprazole on cognition is warranted. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  15. Effects of wet-cupping on blood pressure in hypertensive patients: a randomized controlled trial.

    PubMed

    Aleyeidi, Nouran A; Aseri, Khaled S; Matbouli, Shadia M; Sulaiamani, Albaraa A; Kobeisy, Sumayyah A

    2015-11-01

    Although cupping remains a popular treatment modality worldwide, its efficacy for most diseases, including hypertension, has not been scientifically evaluated. We aimed to determine the efficacy of wet-cupping for high blood pressure, and the incidence of the procedure's side effects in the intervention group. This is a randomized controlled trial conducted in the General Practice Department at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, between May 2013 and February 2014. There were two groups (40 participants each): intervention group undergoing wet-cupping (hijama) in addition to conventional hypertension treatment, and a control group undergoing only conventional hypertension treatment. Three wet-cupping sessions were performed every other day. The mean systolic and diastolic blood pressures were measured using a validated automatic sphygmomanometer. The follow-up period was 8 weeks. Wet-cupping provided an immediate reduction of systolic blood pressure. After 4 weeks of follow-up, the mean systolic blood pressure in the intervention group was 8.4 mmHg less than in the control group (P=0.046). After 8 weeks, there were no significant differences in blood pressures between the intervention and control groups. In this study, wet-cupping did not result in any serious side effects. Wet-cupping therapy is effective for reducing systolic blood pressure in hypertensive patients for up to 4 weeks, without serious side effects. Wet-cupping should be considered as a complementary hypertension treatment, and further studies are needed. ClinicalTrials.gov Identifier NCT01987583.

  16. Effect of Amalaki rasayana on DNA damage and repair in randomized aged human individuals.

    PubMed

    Vishwanatha, Udupi; Guruprasad, Kanive P; Gopinath, Puthiya M; Acharya, Raviraj V; Prasanna, Bokkasa V; Nayak, Jayakrishna; Ganesh, Rajeshwari; Rao, Jayalaxmi; Shree, Rashmi; Anchan, Suchitra; Raghu, Kothanahalli S; Joshi, Manjunath B; Paladhi, Puspendu; Varier, Panniampilly M; Muraleedharan, Kollath; Muraleedharan, Thrikovil S; Satyamoorthy, Kapaettu

    2016-09-15

    Preparations from Phyllanthus emblica called Amalaki rasayana is used in the Indian traditional medicinal system of Ayurveda for healthy living in elderly. The biological effects and its mechanisms are not fully understood. Since the diminishing DNA repair is the hallmark of ageing, we tested the influence of Amalaki rasayana on recognized DNA repair activities in healthy aged individuals. Amalaki rasayana was prepared fresh and healthy aged randomized human volunteers were administrated with either rasayana or placebo for 45 days strictly as per the traditional text. The DNA repair was analyzed in peripheral blood mononuclear cells before and after rasayana administration and after 45 days post-rasayana treatment regimen. UVC-induced DNA strand break repair (DSBR) based on extent of DNA unwinding by fluorometric analysis, nucleotide excision repair (NER) by flow cytometry and constitutive base excision repair (BER) by gap filling method were analyzed. Amalaki rasayana administration stably maintained/enhanced the DSBR in aged individuals. There were no adverse side effects. Further, subjects with different body mass index showed differential DNA strand break repair capacity. No change in unscheduled DNA synthesis during NER and BER was observed between the groups. Intake of Amalaki rasayana by aged individuals showed stable maintenance of DNA strand break repair without toxic effects. However, there was no change in nucleotide and base excision repair activities. Results warrant further studies on the effects of Amalaki rasayana on DSBR activities. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials.

    PubMed

    Kamioka, Hiroharu; Okada, Shinpei; Tsutani, Kiichiro; Park, Hyuntae; Okuizumi, Hiroyasu; Handa, Shuichi; Oshio, Takuya; Park, Sang-Jun; Kitayuguchi, Jun; Abe, Takafumi; Honda, Takuya; Mutoh, Yoshiteru

    2014-04-01

    The objectives of this review were to summarize the evidence from randomized controlled trials (RCTs) on the effects of animal-assisted therapy (AAT). Studies were eligible if they were RCTs. Studies included one treatment group in which AAT was applied. We searched the following databases from 1990 up to October 31, 2012: MEDLINE via PubMed, CINAHL, Web of Science, Ichushi Web, GHL, WPRIM, and PsycINFO. We also searched all Cochrane Database up to October 31, 2012. Eleven RCTs were identified, and seven studies were about "Mental and behavioral disorders". Types of animal intervention were dog, cat, dolphin, bird, cow, rabbit, ferret, and guinea pig. The RCTs conducted have been of relatively low quality. We could not perform meta-analysis because of heterogeneity. In a study environment limited to the people who like animals, AAT may be an effective treatment for mental and behavioral disorders such as depression, schizophrenia, and alcohol/drug addictions, and is based on a holistic approach through interaction with animals in nature. To most effectively assess the potential benefits for AAT, it will be important for further research to utilize and describe (1) RCT methodology when appropriate, (2) reasons for non-participation, (3) intervention dose, (4) adverse effects and withdrawals, and (5) cost. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Effects of Localized Cold Therapy on Pain in Postoperative Spinal Fusion Patients: A Randomized Control Trial.

    PubMed

    Quinlan, Patricia; Davis, Jack; Fields, Kara; Madamba, Pia; Colman, Lisa; Tinca, Daniela; Cannon Drake, Regina

    Cold therapy used in the sports medicine settings has been found to be effective in reducing postoperative pain; however, there are limited studies that examine the effect of cold therapy on postoperative pain in patients with posterior lumbar spinal fusion. The purpose of this study was to determine the effects of cold on postoperative spine pain and add to the body of knowledge specific to practical application of cold therapy in the spine surgery setting. Researchers used a two-group randomized control design to evaluate the effects of local cold therapy on postoperative pain and analgesia use after lumbar spinal fusion surgery. The primary outcome was postoperative pain. Secondary outcomes included analgesia use and perceived benefit of cold therapy. The intervention (cold) group had a marginally greater reduction in mean Numerical Rating Scale score across all 12 pain checks (M ± SD = -1.1 ± 0.8 points reduction vs. -1.0 ± 0.8 points reduction, p = .589). On average, the intervention group used less morphine equivalents (M ± SD = 12.6 ± 31.5 vs. 23.7 ± 40.0) than the control group across pain checks seven to 12 (p = .042). This study provides additional evidence to support the use of cold therapy as an adjuvant pain management strategy to optimize pain control and reduce opioid consumption following spine fusion surgical procedures.

  19. Single versus double embryo transfer: cost-effectiveness analysis alongside a randomized clinical trial.

    PubMed

    Fiddelers, Audrey A A; van Montfoort, Aafke P A; Dirksen, Carmen D; Dumoulin, John C M; Land, Jolande A; Dunselman, Gerard A J; Janssen, J Marij; Severens, Johan L; Evers, Johannes L H

    2006-08-01

    Twin pregnancies after IVF are still frequent and are considered high-risk pregnancies leading to high costs. Transferring one embryo can reduce the twin pregnancy rate. We compared cost-effectiveness of one fresh cycle elective single embryo transfer (eSET) versus one fresh cycle double embryo transfer (DET) in an unselected patient population. Patients starting their first IVF cycle were randomized between eSET and DET. Societal costs per couple were determined empirically, from hormonal stimulation up to 42 weeks after embryo transfer. An incremental cost-effectiveness ratio (ICER) was calculated, representing additional costs per successful pregnancy. Successful pregnancy rates were 20.8% for eSET and 39.6% for DET. Societal costs per couple were significantly lower after eSET (7334 euro) compared with DET (10,924 euro). The ICER of DET compared with eSET was 19,096 euro, meaning that each additional successful pregnancy in the DET group will cost 19,096 euro extra. One cycle eSET was less expensive, but also less effective compared to one cycle DET. It depends on the society's willingness to pay for one extra successful pregnancy, whether one cycle DET is preferred from a cost-effectiveness point of view.

  20. Effects of Pilates method in elderly people: Systematic review of randomized controlled trials.

    PubMed

    de Oliveira Francisco, Cristina; de Almeida Fagundes, Alessandra; Gorges, Bruna

    2015-07-01

    The Pilates method has been widely used in physical training and rehabilitation. Evidence regarding the effectiveness of this method in elderly people is limited. Six randomized controlled trials studies involving the use of the Pilates method for elderly people, published prior to December 2013, were selected from the databases PubMed, MEDLINE, Embase, Cochrane, Scielo and PEDro. Three articles suggested that Pilates produced improvements in balance. Two studies evaluated the adherence to Pilates programs. One study assessed Pilates' influence on cardio-metabolic parameters and another study evaluated changes in body composition. Strong evidence was found regarding beneficial effects of Pilates over static and dynamic balance in women. Nevertheless, evidence of balance improvement in both genders, changes in body composition in woman and adherence to Pilates programs were limited. Effects on cardio-metabolic parameters due to Pilates training presented inconclusive results. Pilates may be a useful tool in rehabilitation and prevention programs but more high quality studies are necessary to establish all the effects on elderly populations. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. A prospective randomized study of the effectiveness of aromatherapy for relief of postoperative nausea and vomiting.

    PubMed

    Hodge, Nancy S; McCarthy, Mary S; Pierce, Roslyn M

    2014-02-01

    Postoperative nausea and vomiting (PONV) is a major concern for patients having surgery under general anesthesia as it causes subjective distress along with increased complications and delays in discharge from the hospital. Aromatherapy represents a complementary and alternative therapy for the management of PONV. The objective of this study was to compare the effectiveness of aromatherapy (QueaseEase, Soothing Scents, Inc, Enterprise, AL) versus an unscented inhalant in relieving PONV. One hundred twenty-one patients with postoperative nausea were randomized into a treatment group receiving an aromatic inhaler and a control group receiving a placebo inhaler to evaluate the effectiveness of aromatherapy. Initial and follow-up nausea assessment scores in both treatment and placebo groups decreased significantly (P < .01), and there was a significant difference between the two groups (P = .03). Perceived effectiveness of aromatherapy was significantly higher in the treatment group (P < .001). Aromatherapy was favorably received by most patients and represents an effective treatment option for postoperative nausea. Published by Elsevier Inc.

  2. A randomized clinical trial of the effectiveness of premarital intervention: moderators of divorce outcomes.

    PubMed

    Markman, Howard J; Rhoades, Galena K; Stanley, Scott M; Peterson, Kristina M

    2013-02-01

    This study examined the effects of premarital relationship intervention on divorce during the first 8 years of first marriage. Religious organizations were randomly assigned to have couples marrying through them complete the Prevention and Relationship Education Program (PREP) or their naturally occurring premarital services. Results indicated no differences in overall divorce rates between naturally occurring services (n = 44), PREP delivered by clergy at religious organizations (n = 66), or PREP delivered by professionals at a university (n = 83). Three moderators were also tested. Measured premaritally and before intervention, the level of negativity of couples' interactions moderated effects. Specifically, couples observed to have higher levels of negative communication in a video task were more likely to divorce if they received PREP than if they received naturally occurring services; couples with lower levels of premarital negative communication were more likely to remain married if they received PREP. A history of physical aggression in the current relationship before marriage and before intervention showed a similar pattern as a moderator, but the effect was only marginally significant. Family-of-origin background (parental divorce and/or aggression) was not a significant moderator of prevention effects across the two kinds of services. Implications for defining risk, considering divorce as a positive versus negative outcome, the practice of premarital relationship education, and social policy are discussed. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  3. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.

    PubMed

    Liu, Zhishun; Liu, Yan; Xu, Huanfang; He, Liyun; Chen, Yuelai; Fu, Lixin; Li, Ning; Lu, Yonghui; Su, Tongsheng; Sun, Jianhua; Wang, Jie; Yue, Zenghui; Zhang, Wei; Zhao, Jiping; Zhou, Zhongyu; Wu, Jiani; Zhou, Kehua; Ai, Yanke; Zhou, Jing; Pang, Ran; Wang, Yang; Qin, Zongshi; Yan, Shiyan; Li, Hongjiao; Luo, Lin; Liu, Baoyan

    2017-06-27

    Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group

  4. A randomized control trial evaluating the educational effectiveness of a rapid HIV posttest counseling video.

    PubMed

    Calderon, Yvette; Leider, Jason; Hailpern, Susan; Haughey, Marianne; Ghosh, Reena; Lombardi, Pamela; Bijur, Polly; Bauman, Laurie

    2009-04-01

    Many of the individuals most at risk for HIV infection (i.e., minority populations, women, adolescents) are also the most marginalized by our health care system. Lacking primary care providers, they rely on the Emergency Department (ED) for their health care needs and education. In this prospective randomized controlled trial, we compared the educational effectiveness of a 15-minute posttest counseling video with the normal practice of a session with an HIV counselor. The study population was composed of ambulatory patients recruited for rapid HIV testing in the ED. The RAs (research assistants) recruited a convenience sample of stable patients presenting to the walk-in section of an inner-city adult ED for rapid HIV testing. Eligible patients for this study included patients who consented for the rapid HIV test and completed measures on condom intention and condom use self-efficacy. Before receiving their results, participants who consented to be in this study were randomized to either a 15-minute HIV posttest educational video available in English/Spanish or to a posttest educational session with an HIV counselor. Afterwards, both groups completed an assessment tool concerning HIV prevention and transmission. Of the 128 participants, 61 and 67 patients were randomized to the video and counselor groups, respectively. The groups were similar with respect to gender, ethnicity and experience with prior HIV testing. Mean knowledge scores were higher in the video group (76.20% vs. 69.3%; 90% CI for the difference, 2.8, 11.2). As the lower bound of the CI for the difference was higher than the lower equivalence boundary (-5%), we infer that the video was at least as effective as the counselor educational session. The use of an educational counseling video is a valid alternative for providing posttest education and prevention information during the waiting period associated with the 20-minute HIV rapid test. Without disruption in clinical flow, both testing and education

  5. Fitting parametric random effects models in very large data sets with application to VHA national data

    PubMed Central

    2012-01-01

    Background With the current focus on personalized medicine, patient/subject level inference is often of key interest in translational research. As a result, random effects models (REM) are becoming popular for patient level inference. However, for very large data sets that are characterized by large sample size, it can be difficult to fit REM using commonly available statistical software such as SAS since they require inordinate amounts of computer time and memory allocations beyond what are available preventing model convergence. For example, in a retrospective cohort study of over 800,000 Veterans with type 2 diabetes with longitudinal data over 5 years, fitting REM via generalized linear mixed modeling using currently available standard procedures in SAS (e.g. PROC GLIMMIX) was very difficult and same problems exist in Stata’s gllamm or R’s lme packages. Thus, this study proposes and assesses the performance of a meta regression approach and makes comparison with methods based on sampling of the full data. Data We use both simulated and real data from a national cohort of Veterans with type 2 diabetes (n=890,394) which was created by linking multiple patient and administrative files resulting in a cohort with longitudinal data collected over 5 years. Methods and results The outcome of interest was mean annual HbA1c measured over a 5 years period. Using this outcome, we compared parameter estimates from the proposed random effects meta regression (REMR) with estimates based on simple random sampling and VISN (Veterans Integrated Service Networks) based stratified sampling of the full data. Our results indicate that REMR provides parameter estimates that are less likely to be biased with tighter confidence intervals when the VISN level estimates are homogenous. Conclusion When the interest is to fit REM in repeated measures data with very large sample size, REMR can be used as a good alternative. It leads to reasonable inference for both Gaussian and non

  6. Effect of electroacupuncture in postanesthetic shivering during regional anesthesia: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Shivering during regional anesthesia is a common complication and is related to a decrease in the patient’s core body temperature. Previous studies have shown that acupuncture on specific acupoints can preserve core body temperature. The present study evaluated the effect of electroacupuncture in preventing the shivering caused by regional anesthesia. Methods This prospective and randomized controlled study analyzed the data from 80 patients undergoing urological surgery, who were classified as ASA I or II. Spinal anesthesia was performed in all patients using 15 mg of bupivacaine. The patients were randomly allocated to receive either placebo acupuncture (Group P, n = 40) or electroacupuncture (Group A, n = 40) for 30 min before administration of spinal anesthesia. Shivering score was recorded at 5 min intervals, with 0 representing no shivering and 4 representing the most severe shivering possible. Heart rate, blood pressure, and tympanic temperature were recorded before the intrathecal injection, and again every 5 min thereafter until 30 min. Results After spinal anesthesia, the decrease in tympanic temperature was less for Group A patients than Group P, with the difference being statistically significant. After 15 min, 13 patients in Group P attained a shivering score of 3 or more, compared with 3 patients in Group A. Significantly more patients in Group P attained a shivering score of at least 1. Conclusions The prophylactic use of electroacupuncture might maintain core body temperature, and may effectively prevent the shivering that commonly develops during regional anesthesia. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000096853. PMID:23181618

  7. The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial.

    PubMed

    Scott, John R; Krishnan, Rohin; Rotenberg, Brian W; Sowerby, Leigh J

    2017-11-25

    Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. Colloidal silver (CS), a widely used naturopathic agent, has recently shown anti-biofilm properties both in vitro and within a rhinosinusitis animal model. To date, no trials involving humans have been published in world literature. The purpose of this study was to assess the efficacy of CS as a topical nasal spray in patients with refractory CRSsP. A prospective cohort study was conducted using a convenience sample of 20 randomized patients with crossover methodology, comparing nasal sprays with CS versus saline. Patients sprayed twice daily for six weeks with the first intervention and then switched to the second for the next six weeks, with measurements made at baseline and each time point. Primary outcomes were changes in SNOT-22 and Lund-Kennedy (LK) endoscopic scores. All analysis was non-parametric and was conducted using STATA 14. Twenty-two patients were enrolled in the study with 20 completing the entire protocol. Mean 6-week change in SNOT-22 scores were -2.8 and 1.0 for saline and CS, respectively (p = 0.373). Similarly, mean 6-week change in LK scores were -1.4 and -1.1 for saline and CS, respectively (p = 0.794). Significant period effects were observed with the SNOT-22 score between the randomized groups. No participants experienced negative health effects directly attributable to the administration of intranasal CS. Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP. NCT02403479 . Registered on March 1, 2015.

  8. Effects of electro-acupuncture on personality traits in depression: a randomized controlled study.

    PubMed

    Wang, Wei-dong; Lu, Xue-yu; Ng, Siu-man; Hong, Lan; Zhao, Yang; Lin, Ying-na; Wang, Fang

    2013-10-01

    To explore the personality-adjusting effect of electro-acupuncture treatment for depression and compared this treatment with paroxetine treatment. A non-blinded, randomized controlled trial was adopted. Sixty depressed patients, who met trial criteria, were randomly assigned to the treatment and the control groups. In the treatment group, electro-acupuncture treatment was used, and paroxetine treatment was used in the control group. During the 24-week study period, 12 patients dropped out and 48 patients completed the study. The Minnesota Multiple Personality Inventory (MMPI) was adopted as the evaluation tool. At the same time, the Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS) and Montgomery-Asberg Depression Rating Scale (MADRS) were used to evaluate the psychological state. Evaluations were done before and after treatment. After treatment, patients' psychological state improved significantly in both groups (P<0.01). For the treatment group, within-group comparison between baseline and after 24 weeks of treatment showed that severity of depression had significantly decreased (P<0.01). MADRS and SDS scores decreased significantly (P<0.05) and MMPI subscale scores for hypochondriasis, depression, psychopathic deviate, psychasthenia, social introversion and fake decreased significantly (P<0.05). For the control group, severity of depression also decreased significantly. MADRS and SDS scores decreased significantly (P<0.05); and MMPI subscale scores for hypochondriasis, depression, hysteria, paranoia, and psychasthenia decreased significantly (P<0.05). Between-group comparison demonstrated that for the MMPI subscales paranoia and social introversion, the decrease of score was greater in the treatment group than in the control group (P<0.05). However, there were no other significant differences between the control group and the treatment group. Electro-acupuncture is effective for treating depression and affects personality traits.

  9. Placebo effect of medication cost in Parkinson disease: a randomized double-blind study.

    PubMed

    Espay, Alberto J; Norris, Matthew M; Eliassen, James C; Dwivedi, Alok; Smith, Matthew S; Banks, Christi; Allendorfer, Jane B; Lang, Anthony E; Fleck, David E; Linke, Michael J; Szaflarski, Jerzy P

    2015-02-24

    To examine the effect of cost, a traditionally "inactive" trait of intervention, as contributor to the response to therapeutic interventions. We conducted a prospective double-blind study in 12 patients with moderate to severe Parkinson disease and motor fluctuations (mean age 62.4 ± 7.9 years; mean disease duration 11 ± 6 years) who were randomized to a "cheap" or "expensive" subcutaneous "novel injectable dopamine agonist" placebo (normal saline). Patients were crossed over to the alternate arm approximately 4 hours later. Blinded motor assessments in the "practically defined off" state, before and after each intervention, included the Unified Parkinson's Disease Rating Scale motor subscale, the Purdue Pegboard Test, and a tapping task. Measurements of brain activity were performed using a feedback-based visual-motor associative learning functional MRI task. Order effect was examined using stratified analysis. Although both placebos improved motor function, benefit was greater when patients were randomized first to expensive placebo, with a magnitude halfway between that of cheap placebo and levodopa. Brain activation was greater upon first-given cheap but not upon first-given expensive placebo or by levodopa. Regardless of order of administration, only cheap placebo increased activation in the left lateral sensorimotor cortex and other regions. Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to, albeit less than, levodopa. Perceptions of cost are capable of altering the placebo response in clinical studies. This study provides Class III evidence that perception of cost is capable of influencing motor function and brain activation in Parkinson disease. © 2015 American Academy of Neurology.

  10. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial.

    PubMed

    Arguisuelas, María D; Lisón, Juan Francisco; Sánchez-Zuriaga, Daniel; Martínez-Hurtado, Isabel; Doménech-Fernández, Julio

    2017-05-01

    Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate myofascial release (MFR) protocol on pain, disability, and fear-avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty-four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain Questionnaire (SF-MPQ) and visual analog scale (VAS), disability measured with Roland Morris Questionnaire, and fear-avoidance beliefs measured with Fear-Avoidance Beliefs Questionnaire. Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% confidence interval [CI]: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the Fear-Avoidance Beliefs Questionnaire score also displayed a significant decrease in the MFR group (P < 0.05) as compared to sham MFR. MFR therapy produced a significant improvement in both pain and disability. Because the minimal clinically important differences in pain and disability are, however, included in the 95% CI, we cannot know whether this improvement is clinically relevant. 2.

  11. The effect of deworming on early childhood development in Peru: A randomized controlled trial.

    PubMed

    Joseph, Serene A; Casapía, Martín; Lazarte, Fabiola; Rahme, Elham; Pezo, Lidsky; Blouin, Brittany; Gyorkos, Theresa W

    2015-12-01

    There is a knowledge gap on the effect of early childhood deworming on development in low- and middle-income countries. This evidence is important in the critical window of growth and development before two years of age. A randomized controlled trial of the benefit, and optimal timing and frequency, of deworming on development was conducted in Iquitos, Peru. Children were enrolled during routine 12-month growth and development visits and randomly allocated to: (1) deworming at the 12-month visit and placebo at the 18-month visit; (2) placebo at the 12-month visit and deworming at the 18-month visit; (3) deworming at the 12 and 18-month visits; or (4) placebo at the 12 and 18-month visits. The Bayley Scales of Infant Development III was used to assess cognitive, language and motor skills at the 12 and 24-month visits. One-way ANOVA analyses used an intention-to-treat approach. Between September 2011 and June 2012, 1760 children were enrolled. Attendance at the 24-month visit was 88.8% ( n =1563). Raw scores on all subtests increased over 12 months; however, cognitive and expressive language scaled scores decreased. There was no statistically significant benefit of deworming, or effect of timing or frequency, on any of the development scores. Baseline height and weight and maternal education were associated with development scores at 24 months. After 12 months of follow-up, an overall benefit of deworming on cognition, language or fine motor development was not detected. Additional integrated child and maternal interventions should be considered to prevent developmental deficits in this critical period.

  12. The effectiveness of massage therapy in the treatment of infantile colic symptoms: A randomized controlled trial.

    PubMed

    Sheidaei, Ali; Abadi, Alireza; Zayeri, Farid; Nahidi, Fatemeh; Gazerani, Nafiseh; Mansouri, Anita

    2016-01-01

    Infantile colic, cry-fuss and sleep problems are transient in the initial months of life, but they contribute to maternal depression, parenting stress and family mental health problems. In this randomized clinical trial, we aimed to explore the efficacy of massage therapy compared to rocking in reducing infantile colic symptoms including duration and number of cries, sleep duration and severity of infant colic. This was a single blind RCT study with a one-week follow-up. One hundred colicky infants aged younger than 12 weeks old were randomly assigned into massage and rocking groups. Infants in the massage group received a massage for 15-20 minutes once during a day and once at night before sleeping for a week. In the control group, mothers rocked their infants gently for 5-25 minutes when the symptoms of colic appeared. Parents recorded the details of the colic symptoms in a diary every day. A GEE approach was applied to explore the effect of the intervention. Efficiency of massage therapy was significantly higher than rocking. At the end of the study, the mean number of daily cries was 4.26±1.40 in the massage and 6.9±2.14 the rocking groups (p<0.01). The mean of the severity score was 1.39±0.19 less in the massage group (p<0.01). Moreover, the mean differences of massage and rocking groups were -0.82±0.20 hour (p<0.01) and 0.72±0.35 (p= 0.04) in the duration of cries and duration of sleep, respectively. Massaging significantly improved colic symptoms during a one-week intervention for all outcomes. In addition, significant differences were found between the intervention and control groups in favor of massaging. Therefore, massage therapy is more effective than rocking for treating infant colic symptoms.

  13. Effect of Membrane Permeability on Inflammation and Arterial Stiffness: A Randomized Trial

    PubMed Central

    Cheng, Yuk Lun; Leung, Chi Bon; Szeto, Cheuk Chun; Chow, Kai Ming; Kwan, Bonnie Ching-Ha; Ng, Esther Siu-Chun; Fok, Queenie Wing-Yi; Poon, Yuet Ling; Yu, Alex Wai-Yin

    2010-01-01

    Background and objectives: Both larger molecule removal and dialyzer biocompatibility have been implicated in the high-flux hemodialysis (HD)-associated favorable outcome. In an attempt to delineate the effect of membrane permeability, we performed a randomized, crossover study to compare the inflammatory biomarkers, lipid profile, and aortic pulse wave velocity (PWV) of two dialyzers that are composed of identical membranes but with different flux characteristics. Design, setting, participants, & measurements: Stable patients who had anuria and were on low-flux polysulfone membrane were randomly allocated either to HD with high-flux polyamide membrane (group A; 22 patients) or to HD with low-flux polyamide membrane (group B; 24 patients) for 24 weeks, then they were started on 24 weeks of the alternative HD treatment. Apart from the dialyzer, the dialysis prescription remained unchanged. Results: Nineteen patients from group A and 23 patients from group B completed the study. Predialysis β2-microglobulin levels decreased significantly when using the high-flux polyamide membrane. No difference between membranes was observed for serum albumin, high-sensitivity C-reactive protein, fibrinogen, IL-6, triglycerides, HDL cholesterol, LDL cholesterol, and lipoprotein(a) during the study. A significant increase in aortic PWV, a marker of aortic stiffness, was noted after patients switched from high-flux to low-flux polyamide membranes. Similarly, the rate of change in aortic PWV was significantly decreased with the use of the high-flux polyamide membrane. Conclusions: Our findings suggest that dialysis with polyamide membranes with different flux characteristics did not modify the inflammatory indices and lipid profile in stable HD patients; however, a seemingly beneficial effect on aortic stiffness was noted for patients who were maintained on high-flux polyamide membrane. PMID:20203165

  14. Prebiotic effect of an infant formula supplemented with galacto-oligosaccharides: randomized multicenter trial.

    PubMed

    Giovannini, Marcello; Verduci, Elvira; Gregori, Dario; Ballali, Simonetta; Soldi, Sara; Ghisleni, Diana; Riva, Enrica

    2014-01-01

    The objective of the study was to investigate the effects of a galacto-oligosaccharides (GOS)-supplemented formula on the intestinal microbiota in healthy term infants, with a specific consideration for gastrointestinal symptoms as colic, stool frequency and consistency, regurgitation. This was a randomized, double-blind, controlled, parallel-group clinical trial performed simultaneously by 6 centers in Italy. Three groups were considered: breastfed, formula-fed, and GOS-supplemented formula-fed infants. Formula-fed infants were randomized to receive either the control or the study formula and consume the assigned formula exclusively until the introduction of complementary feeding. The nutritional composition of the 2 formulas were identical, apart from the supplemented GOS (0.4 g/100 mL) in the study formula. Four different types of bacteria were evaluated in order to assess the efficacy of GOS-supplemented formula on infants: Bifidobacterium, Lactobacillus, and Clostridium, Escherichia coli. A total of 199 breastfed infants and 163 formula-fed infants were recruited. When considering stool frequency and consistency, GOS-supplemented formula presented normal and soft stools in the majority of episodes (89%). In the supplemented group the incidence of colic was lower with respect to the control group. A significantly lower count of Clostridium and a higher count of Bifidobacterium were found when comparing study formula and control formula in infants with colic. In children with colic the ratio between Clostridium count and Bifidobacterium and Lactobacillus count was in favor of the latter two when considering the GOS-supplemented formula group with respect to the control one. The prebiotic-supplemented formula mimicked the effect of human milk in promoting Bifidobacterium and Lactobacillus growth and in inhibiting Clostridium growth, resulting in a significantly lower presence of colic.

  15. Effect of probiotic chewing tablets on early childhood caries--a randomized controlled trial.

    PubMed

    Hedayati-Hajikand, Trifa; Lundberg, Ulrika; Eldh, Catarina; Twetman, Svante

    2015-09-24

    To evaluate the effect of probiotic chewing tablets on early childhood caries development in preschool children living in a low socioeconomic multicultural area. The investigation employed a randomized double-blind placebo-controlled design. The study group consisted of 138 healthy 2-3-year-old children that were consecutively recruited after informed parental consent. After enrollment, they were randomized to a test or a placebo group. The parents of the test group were instructed to give their child one chewing tablet per day containing three strains of live probiotic bacteria (ProBiora3) and the placebo group got identical tablets without bacteria. The duration was one year and the prevalence and increment of initial and manifest caries lesions was examined at baseline and follow-up. All parents were thoroughly instructed to brush the teeth of their off-springs twice daily with fluoride toothpaste. The groups were balanced at baseline and the attrition rate was 20%. Around 2/3 of the children in both groups reported an acceptable compliance. The caries increment (Δds) was significantly lower in the test group when compared with the placebo group, 0.2 vs. 0.8 (p < 0.05). The risk reduction was 0.47 (95% CI 0.24-0.98) and the number needed to treat close to five. No differences were displayed between the groups concerning presence of visible plaque or bleeding-on-brushing. No side effects were reported. The results suggested that early childhood caries development could be reduced through administration of these probiotic chewing tablets as adjunct to daily use of fluoride toothpaste in preschool children. Further studies on a possible dose-response relationship seem justified ClinicalTrials.gov Identifier: NCT01720771 . First received: October 31, 2012.

  16. The effect of hormone therapy on plasma homocysteine levels: a randomized clinical trial.

    PubMed

    Tutuncu, Levent; Ergur, Ali Rustu; Mungen, Ercument; Gun, Ismet; Ertekin, Aktug; Yergok, Yusuf Ziya

    2005-03-01

    An elevated plasma homocysteine level is a risk factor for cardiovascular diseases. Hormone therapy (HT) may reduce fasting plasma homocysteine levels. We studied 80 postmenopausal women to determine the effect of medroxyprogesterone acetate (MPA) combined with conjugated equine estrogens (CEE) on fasting plasma homocysteine levels. In a randomized, double blind, prospective, placebo-controlled study, we randomly assigned 80 healthy postmenopausal women between CEE 0.625 mg/d combined with MPA 2.5 mg/d (n = 20), CEE 0.625 mg/d combined with MPA 5 mg/d (n = 20), unopposed CEE 0.625 mg/d (n = 20), and placebo (n = 20) all given for a duration of 6 months. Fasting plasma homocysteine levels were measured before and at the end of the treatment. Before treatment, plasma homocysteine concentrations were similar in all groups. After 6 months of unopposed CEE, the mean fasting plasma homocysteine levels decreased by 19.02% when compared with baseline levels (P < 0.05). The mean fasting plasma homocysteine concentrations decreased by 17.63% and 19.56% from baseline in both the CEE plus MPA 2.5 mg/d and CEE plus MPA 5 mg/d groups, respectively (P < 0.05 for each group). In contrast, plasma homocysteine levels increased by 11.66% in the placebo group. The homocysteine lowering effect did not differ significantly among the three groups of women receiving unopposed CEE alone and CEE plus MPA at two different doses. Six months of estrogen therapy (ET) and combined estrogen-progestogen therapy (EPT) significantly lower fasting plasma homocysteine levels in healthy postmenopausal women with equal efficacy.

  17. Effects of Natural Sounds on Pain: A Randomized Controlled Trial with Patients Receiving Mechanical Ventilation Support.

    PubMed

    Saadatmand, Vahid; Rejeh, Nahid; Heravi-Karimooi, Majideh; Tadrisi, Sayed Davood; Vaismoradi, Mojtaba; Jordan, Sue

    2015-08-01

    Nonpharmacologic pain management in patients receiving mechanical ventilation support in critical care units is under investigated. Natural sounds may help reduce the potentially harmful effects of anxiety and pain in hospitalized patients. The aim of this study was to examine the effect of pleasant, natural sounds on self-reported pain in patients receiving mechanical ventilation support, using a pragmatic parallel-arm, randomized controlled trial. The study was conducted in a general adult intensive care unit of a high-turnover teaching hospital, in Tehran, Iran. Between October 2011 and June 2012, we recruited 60 patients receiving mechanical ventilation support to the intervention (n = 30) and control arms (n = 30) of a pragmatic parallel-group, randomized controlled trial. Participants in both arms wore headphones for 90 minutes. Those in the intervention arm heard pleasant, natural sounds, whereas those in the control arm heard nothing. Outcome measures included the self-reported visual analog scale for pain at baseline; 30, 60, and 90 minutes into the intervention; and 30 minutes post-intervention. All patients approached agreed to participate. The trial arms were similar at baseline. Pain scores in the intervention arm fell and were significantly lower than in the control arm at each time point (p < .05). Administration of pleasant, natural sounds via headphones is a simple, safe, nonpharmacologic nursing intervention that may be used to allay pain for up to 120 minutes in patients receiving mechanical ventilation support. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  18. Effects of Coriandrum sativum Syrup on Migraine: A Randomized, Triple-Blind, Placebo-Controlled Trial

    PubMed Central

    Delavar Kasmaei, Hosein; Ghorbanifar, Zahra; Zayeri, Farid; Minaei, Bagher; Kamali, Seyed Hamid; Rezaeizadeh, Hossein; Amin, Gholamreza; Ghobadi, Ali; Mirzaei, Zohreh

    2016-01-01

    Background: Migraine is one of the most common and debilitating neurological problems. Although numerous preventive drugs are used to treat migraine, their complications are unavoidable. Application of herbal medicine, especially well-known medicinal plants, to treatment of chronic diseases, like migraine, could be effective. Coriandrum sativum L. (C. sativum) fruit is one of the most commonly prescribed herbs in Persian medicine, which has been used to treat headache. Objectives: This study was designed to evaluate the effects of C. sativum syrup on duration, severity and frequency of migraine. Patients and Methods: A total of 68 migraineurs, who had the eligibility criteria, according to international headache society diagnostic criteria, were randomly assigned to intervention group (n = 34) or control group (n = 34). In addition to 500 mg of sodium valproate per day, in intervention group, they received 15 mL of Coriander fruit syrup and 15 mL of placebo syrup, in control group, three times a day, during a month. The subjects were followed for clinical efficacy at weeks 1, 2, 3 and 4. The number of migraine attacks per week, as well as the duration and severity of attacks, were evaluated. Results: Of 68 patients randomized, 66 were included in analysis. The generalized estimating equations analysis showed that the Coriander fruit syrup decreased duration, severity and frequency of migraine, in the intervention group (P < 0.001). To be more precise, the mean migraine duration, severity and frequency, in the intervention group, were 5.7 hours, 3.65 units and about 50% less than control group, respectively. Conclusions: Results of this study showed that C. sativum fruit is efficient in reduction of the duration and frequency of migraine attacks and in diminishing pain degree. PMID:26889386

  19. Effect of Manual Lymphatic Drainage After Total Knee Arthroplasty: A Randomized Controlled Trial.

    PubMed

    Pichonnaz, Claude; Bassin, Jean-Philippe; Lécureux, Estelle; Christe, Guillaume; Currat, Damien; Aminian, Kamiar; Jolles, Brigitte M

    2016-05-01

    To evaluate the effects of manual lymphatic drainage (MLD) on knee swelling and the assumed consequences of swelling after total knee arthroplasty (TKA). Randomized controlled trial. Primary care hospital. Two groups of 30 patients were randomized before TKA surgery (N=60; 65% women [39]; mean age, 70.7±8.8y; weight, 77.8±11.3kg; size, 1.64±0.08m; body mass index, 29.9±4.1kg/m(2)). Participants received either 5 MLD treatments or a placebo, added to rehabilitation, in between the second day and the seventh day after surgery. Swelling was measured by blinded evaluators before surgery and at second day, seventh day, and 3 months using bioimpedance spectroscopy and volume measurement. Secondary outcomes were active and passive range of motion, pain, knee function, and gait parameters. At seventh day and 3 months, no outcome was significantly different between groups, except for the knee passive flexion contracture at 3 months, which was lower and less frequent in the MLD group (-2.6°; 95% confidence interval, -5.0° to -0.21°; P=.04; absolute risk reduction, 26.6%; 95% confidence interval, 0.9%-52.3%; number needed to treat, 4). The mean pain level decreased between 5.8 and 8.2mm on the visual analog scale immediately after MLD, which was significant after 4 of 5 MLD treatments. MLD treatments applied immediately after TKA surgery did not reduce swelling. It reduced pain immediately after the treatment. Further studies should investigate whether the positive effect of MLD on knee extension is replicable. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  20. Effect of Maintenance Therapy with Isoxsuprine in the Prevention of Preterm Labor: Randomized controlled trial

    PubMed Central

    Alavi, Azin; Rajaee, Minoo; Amirian, Malihe; Mahboobi, Hamidreza; Jahanshahi, Keramat Allah; Faghihi, Armaghan

    2015-01-01

    Background: Isoxsuprine (Vasodilan) is a beta-adrenergic that directly affects the vascular smooth muscle and results in peripheral vascular dilation. Isoxsuprine relaxes the uterine smooth muscles and is used for treatment of pre-term labor and dysmenorrhea. Isoxsuprine is used extensively in hospitals and private clinics in Iran; however, few studies have reported its safety and efficacy in the prevention of pre-term labor. Objective: The aim of this study was to assess the effect of maintenance therapy with oral isoxsuprine for the prevention of pre-term labor. Methods: We undertook a blinded prospective randomized trial of 70 women with singleton pregnancies who presented in pre-term labor between 26 to 34 weeks of gestation. After arresting the contractions with intravenous magnesium sulfate, the patients were randomized into two groups, with the treatment group receiving oral isoxsuprine until 34 weeks of gestation. Response to treatment was assessed by the progression of the pregnancies in both groups. The data were analyzed using SPSS software. Results: Our results showed that 14 (40%) of the patients in the case group and 12 (34.29%) of patients in the control group had pre-term births, and there was no significant difference between the two groups (P=0.621). Also four women (11.43%) in the case group and five women (14.29%) in the control group delivered before 34 weeks (P=0.721). Conclusion: Oral isoxsuprine was not effective as a maintenance treatment in preventing pre-term births or in delaying delivery until after 34 weeks. Larger studies are needed to identify the best treatment for pre-term labor. PMID:26396726

  1. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial.

    PubMed

    Vollstädt-Klein, Sabine; Loeber, Sabine; Kirsch, Martina; Bach, Patrick; Richter, Anne; Bühler, Mira; von der Goltz, Christoph; Hermann, Derik; Mann, Karl; Kiefer, Falk

    2011-06-01

    In alcohol-dependent patients, alcohol-associated cues elicit brain activation in mesocorticolimbic networks involved in relapse mechanisms. Cue-exposure based extinction training (CET) has been shown to be efficacious in the treatment of alcoholism; however, it has remained unexplored whether CET mediates its therapeutic effects via changes of activity in mesolimbic networks in response to alcohol cues. In this study, we assessed CET treatment effects on cue-induced responses using functional magnetic resonance imaging (fMRI). In a randomized controlled trial, abstinent alcohol-dependent patients were randomly assigned to a CET group (n = 15) or a control group (n = 15). All patients underwent an extended detoxification treatment comprising medically supervised detoxification, health education, and supportive therapy. The CET patients additionally received nine CET sessions over 3 weeks, exposing the patient to his/her preferred alcoholic beverage. Cue-induced fMRI activation to alcohol cues was measured at pretreatment and posttreatment. Compared with pretreatment, fMRI cue-reactivity reduction was greater in the CET relative to the control group, especially in the anterior cingulate gyrus and the insula, as well as limbic and frontal regions. Before treatment, increased cue-induced fMRI activation was found in limbic and reward-related brain regions and in visual areas. After treatment, the CET group showed less activation than the control group in the left ventral striatum. The study provides first evidence that an exposure-based psychotherapeutic intervention in the treatment of alcoholism impacts on brain areas relevant for addiction memory and attentional focus to alcohol-associated cues and affects mesocorticolimbic reward pathways suggested to be pathophysiologically involved in addiction. Copyright © 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  2. Physical and psychologic effects of aromatherapy inhalation on pregnant women: a randomized controlled trial.

    PubMed

    Igarashi, Toshiko

    2013-10-01

    Stress reduction care is important for pregnant women to decrease obstetric complications and children's health problems after birth. The aim of this study is to clarify the physical and psychologic effects of inhalation aromatherapy on pregnant women. Essential oils with high linalool and linalyl acetate content that may be used during pregnancy were selected and among these, and the one preferred by the participant was used. This was a prospective, randomized, controlled trial. This trial was performed at a gynecology outpatient department in a hospital in Kyoto, Japan. The study included pregnant women in week 28 of a single pregnancy with a normal course. Participants were randomly assigned into an aromatherapy group and a control group. They were seated in the resting, seated position for 10 minutes. During the latter 5 minutes of each 10-minute session, aromatherapy inhalation was performed for the aromatherapy group. Before and after the intervention, the Profile of Mood States (POMS) was measured. During the trial, the heart-rate fluctuations were measured for the autonomic nervous system regulation. A total of 13 pregnant women participated in the trial. Seven (7) participants were assigned to the aromatherapy group and 6 participants to the control group. The results of the POMS were such that based on an intragroup comparison, significant differences were observed in the Tension-Anxiety score (p<0.05) and the Anger-Hostility score (p<0.05), and the respective improvements observed were due to aromatherapy. The results of the autonomic nervous system regulation were such that based on an intragroup comparison within the aromatherapy group, the parasympathetic nerve activity increased significantly (p<0.05). Aromatherapy inhalation using essential oils containing linalyl acetate and linalool was found to be effective for the POMS and parasympathetic nerve activity, based on an intragroup comparison. However, based on a comparison between the groups, no

  3. Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

    PubMed

    Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

    2014-01-01

    Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

  4. Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial.

    PubMed

    Dirkmann, Daniel; Groeben, Harald; Farhan, Hassan; Stahl, David L; Eikermann, Matthias

    2015-01-01

    This multi-centre, prospective, randomized, double-blind, placebo-controlled study was designed to test the hypotheses that parecoxib improves patients' postoperative analgesia without increasing surgical blood loss following radical open prostatectomy. 105 patients (64 ± 7 years old) were randomized to receive either parecoxib or placebo with concurrent morphine patient controlled analgesia. Cumulative opioid consumption (primary objective) and the overall benefit of analgesia score (OBAS), the modified brief pain inventory short form (m-BPI-sf), the opioid-related symptom distress scale (OR-SDS), and perioperative blood loss (secondary objectives) were assessed. In each group 48 patients received the study medication for 48 hours postoperatively. Parecoxib significantly reduced cumulative opioid consumption by 24% (43 ± 24.1 mg versus 57 ± 28 mg, mean ± SD, p=0.02), translating into improved benefit of analgesia (OBAS: 2(0/4) versus 3(1/5.25), p=0.01), pain severity (m-BPI-sf: 1(1/2) versus 2(2/3), p < 0.01) and pain interference (m-BPI-sf: 1(0/1) versus 1(1/3), p=0.001), as well as reduced opioid-related side effects (OR-SDS score: 0.3(0.075/0.51) versus 0.4(0.2/0.83), p=0.03). Blood loss was significantly higher at 24 hours following surgery in the parecoxib group (4.3 g⋅dL(-1) (3.6/4.9) versus (3.2 g⋅dL(-1) (2.4/4.95), p=0.02). Following major abdominal surgery, parecoxib significantly improves patients' perceived analgesia. Parecoxib may however increase perioperative blood loss. Further trials are needed to evaluate the effects of selective cyclooxygenase-2 inhibitors on blood loss. ClinicalTrials.gov Identifier: NCT00346268.

  5. Electrophysiological effects of desflurane in children with Wolff-Parkinson-White syndrome: a randomized crossover study.

    PubMed

    Hino, H; Oda, Y; Yoshida, Y; Suzuki, T; Shimada, M; Nishikawa, K

    2018-02-01

    We hypothesized that, compared with propofol, desflurane prolongs the antegrade accessory pathway effective refractory period (APERP) in children undergoing radiofrequency catheter ablation for Wolff-Parkinson-White (WPW) syndrome. In this randomized crossover study, children aged 4.1-16.1 years undergoing radiofrequency catheter ablation for WPW syndrome were randomly divided into four groups according to the concentration of desflurane and anesthetics used in the first and the second electrophysiological studies (EPS). After induction of general anesthesia with propofol and tracheal intubation, they received one of the following regimens: 0.5 minimum alveolar concentration (MAC) desflurane (first EPS) and propofol (second EPS) (Des0.5-Prop group, n = 8); propofol (first EPS) and 0.5 MAC desflurane (second EPS) (Prop-Des0.5 group, n = 9); 1 MAC desflurane (first EPS) and propofol (second EPS) (Des1.0-Prop group, n = 10); propofol (first EPS) and 1 MAC desflurane (second EPS) (Prop-Des1.0 group, n = 9). Radiofrequency catheter ablation was performed upon completion of EPS. Sample size was determined to detect a difference in the APERP. Desflurane at 1.0 MAC significantly prolonged the APERP compared with propofol, but did not affect the sinoatrial conduction time, atrio-His interval or atrioventricular node effective refractory period. Supraventricular tachycardia was induced in all children receiving propofol, but not induced in 1 and 4 children receiving 0.5 MAC and 1.0 MAC desflurane, respectively. Desflurane enhances the refractoriness and may block the electrical conduction of the atrioventricular accessory pathway, and is therefore not suitable for use in children undergoing radiofrequency catheter ablation for WPW syndrome. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  6. Financial Incentives for Promoting Colorectal Cancer Screening: A Randomized, Comparative Effectiveness Trial.

    PubMed

    Gupta, Samir; Miller, Stacie; Koch, Mark; Berry, Emily; Anderson, Paula; Pruitt, Sandi L; Borton, Eric; Hughes, Amy E; Carter, Elizabeth; Hernandez, Sylvia; Pozos, Helen; Halm, Ethan A; Gneezy, Ayelet; Lieberman, Alicea J; Sugg Skinner, Celette; Argenbright, Keith; Balasubramanian, Bijal

    2016-11-01

    Offering financial incentives to promote or "nudge" participation in cancer screening programs, particularly among vulnerable populations who traditionally have lower rates of screening, has been suggested as a strategy to enhance screening uptake. However, effectiveness of such practices has not been established. Our aim was to determine whether offering small financial incentives would increase colorectal cancer (CRC) screening completion in a low-income, uninsured population. We conducted a randomized, comparative effectiveness trial among primary care patients, aged 50-64 years, not up-to-date with CRC screening served by a large, safety net health system in Fort Worth, Texas. Patients were randomly assigned to mailed fecal immunochemical test (FIT) outreach (n=6,565), outreach plus a $5 incentive (n=1,000), or outreach plus a $10 incentive (n=1,000). Outreach included reminder phone calls and navigation to promote diagnostic colonoscopy completion for patients with abnormal FIT. Primary outcome was FIT completion within 1 year, assessed using an intent-to-screen analysis. FIT completion was 36.9% with vs. 36.2% without any financial incentive (P=0.60) and was also not statistically different for the $10 incentive (34.6%, P=0.32 vs. no incentive) or $5 incentive (39.2%, P=0.07 vs. no incentive) groups. Results did not differ substantially when stratified by age, sex, race/ethnicity, or neighborhood poverty rate. Median time to FIT return also did not differ across groups. Financial incentives, in the amount of $5 or $10 offered in exchange for responding to mailed invitation to complete FIT, do not impact CRC screening completion.

  7. Periodontal Therapy Effects on Nitrite Related to Oral Bacteria: A 6-Month Randomized Clinical Trial.

    PubMed

    Cortelli, Sheila C; Costa, Fernando O; Rodrigues, Edson; Cota, Luis O M; Cortelli, Jose R

    2015-08-01

    Nitrite is a biologic factor relevant to oral and systemic homeostasis. Through an oral bacteria reduction process, it was suggested that periodontal therapy and chlorhexidine (CHX) rinse could affect nitrite levels, leading to negative effects, such as an increase in blood pressure. This 6-month randomized clinical trial evaluated the effects of periodontal therapeutic protocols on salivary nitrite and its relation to subgingival bacteria. One hundred patients with periodontitis were allocated randomly to debridement procedures in four weekly sections (quadrant scaling [QS]) or within 24 hours (full-mouth scaling [FMS]) in conjunction with a 60-day CHX (QS + CHX and FMS + CHX), placebo (QS + placebo and FMS + placebo), or no mouthrinse (QS + none and FMS + none) use. Real-time polymerase chain reaction determined total bacterial, Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Streptococcus oralis, and Actinomyces naeslundii levels. Salivary nitrite concentration was determined with Griess reagent. Data were analyzed statistically at baseline and 3 and 6 months by analysis of variance, Kruskal-Wallis, Mann-Whitney U, and Spearman correlation tests (P <0.05). Nitrite concentrations did not tend to change over time. Regarding CHX use, there was a negative correlation between nitrite and total bacterial load at 6 months (FMS + CHX) and one positive correlation between P. gingivalis and nitrite at baseline (QS + CHX). Independently of rinse type, in the FMS group, nitrite correlated negatively with several microbial parameters and also with a higher percentage of deep periodontal pockets. The relationship between nitrite and bacterial levels appears weak. Short-term scaling exhibited a greater influence on nitrite concentrations then long-term CHX use.

  8. Psychophysiological effects of massage-myofascial release after exercise: a randomized sham-control study.

    PubMed

    Arroyo-Morales, Manuel; Olea, Nicolas; Martínez, Marin Manuel; Hidalgo-Lozano, Amparo; Ruiz-Rodríguez, Concepción; Díaz-Rodríguez, Lourdes

    2008-12-01

    The aim of this study was to evaluate the effect of massage on neuromuscular recruitment, mood state, and mechanical nociceptive threshold (MNT) after high-intensity exercise. This was a prospective randomized clinical trial using between-groups design. The study was conducted at a university-based sports medicine clinic. Sixty-two (62) healthy active students age 18-26 participated. Participants, randomized into two groups, performed three 30-second Wingate tests and immediately received whole-body massage-myofascial induction or placebo (sham ultrasound/magnetotherapy) treatment. The duration (40 minutes), position, and therapist were the same for both treatments. Dependent variables were surface electromyography (sEMG) of quadriceps, profile of mood states (POMS) and mechanical nociceptive threshold (MNT) of trapezius and masseter muscles. These data were assessed at baseline and after exercise and recovery periods. Generalized estimating equations models were performed on dependent variables to assess differences between groups. Significant differences were found in effects of treatment on sEMG of Vastus Medialis (VM) (p = 0.02) and vigor subscale (p = 0.04). After the recovery period, there was a significant decrease in electromyographic (EMG) activity of VM (p = 0.02) in the myofascial-release group versus a nonsignificant increase in the placebo group (p = 0.32), and a decrease in vigor (p < 0.01) in the massage group versus no change in the placebo group (p = 0.86). Massage reduces EMG amplitude and vigor when applied as a passive recovery technique after a high-intensity exercise protocol. Massage may induce a transient loss of muscle strength or a change in the muscle fiber tension-length relationship, influenced by alterations of muscle function and a psychological state of relaxation.

  9. Effects of Fluoxetine on Neural Functional Prognosis after Ischemic Stroke: A Randomized Controlled Study in China.

    PubMed

    He, Yi-Tao; Tang, Bing-Shan; Cai, Zhi-Li; Zeng, Si-Ling; Jiang, Xin; Guo, Yi

    2016-04-01

    We investigated the effects of fluoxetine on the short-term and long-term neural functional prognoses after ischemic stroke. In this prospective randomized controlled single-blind clinical study in China, eligible patients afflicted with ischemic stroke were randomized into control and treatment groups. Patients in the treatment group received fluoxetine in addition to the basic therapies in the control group over a period of 90 days. The follow-up period was 180 days. We evaluated the effects of fluoxetine on the National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score after ischemic stroke through single- and multiple-factor analysis. The mean NIHSS score on day 180 after treatment was significantly lower in the treatment group than in the control group (P = .009). The mean BI scores on days 90 and 180 were significantly higher in the treatment group (P = .026) than in the control group (P = .011). The improvements in the NIHSS and BI scores on days 90 and 180 compared with baseline in the treatment group were all significantly greater than that in the control group (P = .033, P = .013, P = .013, P = .019, respectively). Treatment with fluoxetine was an independent factor affecting the NIHSS and BI scores on day 180 after treatment. Treatment with fluoxetine for 90 days after ischemic stroke can improve the long-term neural functional outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  10. Cost-effectiveness of Occupational Therapy in Older People: Systematic Review of Randomized Controlled Trials.

    PubMed

    Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Yamauchi, Keita

    2016-06-01

    A systematic review of the cost-effectiveness of occupational therapy for older people was conducted. MEDLINE, CINAHL, Web of Science, PsycINFO, Cochrane Library, OT seeker and unpublished trials registers were searched. Reference lists of all potentially eligible studies were searched with no language restrictions. We included trial-based full economic evaluations that considered both costs and outcomes in occupational therapy for older people compared with standard care (i.e. other therapy) or no intervention. We reviewed each trial for methodological quality using the Cochrane risk of bias tool and assessed the quality of economic evaluations using a Drummond checklist. In the results of this review, we included five eligible studies (1-5) that were randomized controlled trials with high-quality economic evaluation. Two studies were full economic evaluations of interventions for fall prevention (1 and 2); two studies were full economic evaluations of preventive occupational therapy interventions (3 and 4; one was a comparison of an occupational therapy group with a social work group); one study was a full economic evaluation of occupational therapy for individuals with dementia (5). Two of the studies (one was preventive occupational therapy [3] and the other was occupational therapy for dementia [5]) found a significant effect and confirmed the cost-effectiveness of occupational therapy for older people compared with the control group. These studies found that occupational therapy for older people was clinically effective and cost-effective in comparison with standard care or other therapies. With reference to their clinical implication, these intervention studies (using a client-centred approach) suggested potentially cost-effective means to motivate clients to maintain their own health. However, this review has limitations because of the high heterogeneity of the reviewed studies on full economic evaluations of occupational therapy for older people. Future

  11. The effects of gait retraining in runners with patellofemoral pain: A randomized trial.

    PubMed

    Roper, Jenevieve L; Harding, Elizabeth M; Doerfler, Deborah; Dexter, James G; Kravitz, Len; Dufek, Janet S; Mermier, Christine M

    2016-06-01

    Running popularity has increased resulting in a concomitant increase in running-related injuries with patellofemoral pain most commonly reported. The purpose of this study was to determine whether gait retraining by modifying footstrike patterns from rearfoot strike to forefoot strike reduces patellofemoral pain and improves associated biomechanical measures, and whether the modification influences risk of ankle injuries. Sixteen subjects (n=16) were randomly placed in the control (n=8) or experimental (n=8) group. The experimental group performed eight gait retraining running sessions over two weeks where footstrike pattern was switched from rearfoot strike to forefoot strike, while the control group performed running sessions with no intervention. Variables were recorded pre-, post-, and one-month post-running trials. Knee pain was significantly reduced post-retraining (P<0.05; effect size=0.294) and one-month follow-up (P<0.05; effect size=0.294). Knee abduction was significantly improved post-retraining (P<0.05; effect size=0.291) and one-month follow-up (P<0.05; effect size=0.291). Ankle flexion was significantly different post-retraining (P<0.05; effect size=0.547), as well as ankle range of motion post-retraining (P<0.05; effect size=0.425) and one-month follow-up (P<0.05; effect size=0.425). Findings suggest running with a forefoot strike pattern leads to reduced knee pain, and should be considered a possible strategy for management of patellofemoral pain in recreational runners. This trial is registered at the US National Institutes of Health (clinicaltrials.gov) #NCT02567123. Published by Elsevier Ltd.

  12. Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.

    PubMed

    Fridriksdottir, N; Gunnarsdottir, S; Zoëga, S; Ingadottir, B; Hafsteinsdottir, E J G

    2018-02-01

    Symptom management is of high priority in cancer care. Information and communication technology allows interventions to be provided through the internet to enhance the delivery of care. This study aimed to review the effects of web-based interventions on cancer patients' symptoms. MEDLINE, PSychINFO, PubMed, CINAHL, and Cochrane databases were systematically searched. Included were randomized controlled trials (RCTs), pilot RCTs, or quasi-experimental (QE) studies focusing on web-based interventions in adult cancer patients with at least one outcome primary or secondary, in terms of symptoms, treatment side effects, or distress. Data were analyzed study by study. Twenty studies were identified. All web interventions included information, 16 included self-management support, 14 included self-monitoring, 13 included feedback/tailored information, 12 used communication with health-care professionals, and eight used communication with other patients. Overall, 13 studies reported positive symptom outcomes. Psychological distress was reported in eight studies with positive intervention effects in three. Symptoms of anxiety/depression were reported in ten studies with positive intervention effects in five. Somatic symptom severity was reported in ten studies with intervention effects found in six, and symptom distress was reported in six studies with intervention effects found in all. This review shows the promising potential of web-based interventions for cancer symptom management, although it was limited by considerable heterogeneity in the interventions tested and targeted outcomes. The multidimensional nature of symptoms was partly addressed; only one study was guided by a comprehensive theoretical model of cancer symptom management. It can only be speculated which web elements are important for effective symptom outcomes. Further testing is needed for web-based cancer symptom management.

  13. [Immediate analgesic effect of wrist-ankle acupuncture for acute lumbago: a randomized controlled trial].

    PubMed

    Su, Jiang-tao; Zhou, Qing-hui; Li, Rui; Zhang, Jie; Li, Wei-hong; Wang, Qiong

    2010-08-01

    To assess the immediate analgesic effect of wrist-ankle acupuncture on acute lumbago and the relationship between the analgesic effect and the expectation of patients. A randomized, single-blind, sham-controlled trial was designed. Sixty cases of acute lumbago were randomly divided into two groups, 30 cases in each one. In observation group, wrist-ankle acupuncture was adopted to the Lower 5 and Lower 6 bilaterally, no requirement of Deqi (arrival of qi). In control group, sham acupuncture was adopted. The treatment was applied once in either group, with the needles retained for 30 min. The Short-form McGill Pain Questionnaire (SF-MPQ) and the Modified-Modified Schober (MMS) test were used to assess the motion related pain and the situation of spinal flexion in 3 min before treatment and 5 min, 10 min, 15 min, during treatment and 30 min (needle removed), respectively. The Expectation and Treatment Credibility Scale (ETCS) was applied to analyze the relationship between the expectation of patients and the analgesic effect. The adverse reaction was recorded. There were no statistically significant differences in SF-MPQ, MMS and ETCS before treatment between two groups (all P>0.05). In 5 min after needles insertion, the scores of the items in SF-MPQ in observation group were lower than those in control group (P<0.05, P<0.01). In 10 min after needles insertion, the scores of SF-MPQ in observation group were lower than those in control group and the scores of MMS were higher than those in control group (P<0.05). In 15 min after needles insertion, except the sensory pain rating index, the scores of the rest items in SF-MPQ in observation group were all lower than those in control group (P<0.05, P<0.01). In 30 min (needles removed), the scores of affective pain rating index of SF-MPQ and Visual Analogue Scale (VAS) in observation group were lower than those in control group (P<0.05, P<0.01). The expectation before treatment was negatively correlated with VAS scores in 5

  14. Metabolic signatures of adiposity in young adults: Mendelian randomization analysis and effects of weight change.

    PubMed

    Würtz, Peter; Wang, Qin; Kangas, Antti J; Richmond, Rebecca C; Skarp, Joni; Tiainen, Mika; Tynkkynen, Tuulia; Soininen, Pasi; Havulinna, Aki S; Kaakinen, Marika; Viikari, Jorma S; Savolainen, Markku J; Kähönen, Mika; Lehtimäki, Terho; Männistö, Satu; Blankenberg, Stefan; Zeller, Tanja; Laitinen, Jaana; Pouta, Anneli; Mäntyselkä, Pekka; Vanhala, Mauno; Elliott, Paul; Pietiläinen, Kirsi H; Ripatti, Samuli; Salomaa, Veikko; Raitakari, Olli T; Järvelin, Marjo-Riitta; Smith, George Davey; Ala-Korpela, Mika

    2014-12-01

    Increased adiposity is linked with higher risk for cardiometabolic diseases. We aimed to determine to what extent elevated body mass index (BMI) within the normal weight range has causal effects on the detailed systemic metabolite profile in early adulthood. We used Mendelian randomization to estimate causal effects of BMI on 82 metabolic measures in 12,664 adolescents and young adults from four population-based cohorts in Finland (mean age 26 y, range 16-39 y; 51% women; mean ± standard deviation BMI 24 ± 4 kg/m(2)). Circulating metabolites were quantified by high-throughput nuclear magnetic resonance metabolomics and biochemical assays. In cross-sectional analyses, elevated BMI was adversely associated with cardiometabolic risk markers throughout the systemic metabolite profile, including lipoprotein subclasses, fatty acid composition, amino acids, inflammatory markers, and various hormones (p<0.0005 for 68 measures). Metabolite associations with BMI were generally stronger for men than for women (median 136%, interquartile range 125%-183%). A gene score for predisposition to elevated BMI, composed of 32 established genetic correlates, was used as the instrument to assess causality. Causal effects of elevated BMI closely matched observational estimates (correspondence 87% ± 3%; R(2)= 0.89), suggesting causative influences of adiposity on the levels of numerous metabolites (p<0.0005 for 24 measures), including lipoprotein lipid subclasses and particle size, branched-chain and aromatic amino acids, and inflammation-related glycoprotein acetyls. Causal analyses of certain metabolites and potential sex differences warrant stronger statistical power. Metabolite changes associated with change in BMI during 6 y of follow-up were examined for 1,488 individuals. Change in BMI was accompanied by widespread metabolite changes, which had an association pattern similar to that of the cross-sectional observations, yet with greater metabolic effects (correspondence 160% ± 2

  15. Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial.

    PubMed

    Pitkälä, Kaisu H; Pöysti, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Savikko, Niina; Kautiainen, Hannu; Strandberg, Timo E

    2013-05-27

    Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease (AD). To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services. A randomized controlled trial. A total of 210 home-dwelling patients with AD living with their spousal caregiver. The 3 trial arms included (1) group-based exercise (GE; 4-hour sessions with approximately 1-hour training) and (2) tailored home-based exercise (HE; 1-hour training), both twice a week for 1 year, and (3) a control group (CG) receiving the usual community care. The Functional Independence Measure (FIM), the Short Physical Performance Battery, and information on the use and costs of social and health care services. All groups deteriorated in functioning during the year after randomization, but deterioration was significantly