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Sample records for randomly oriented cluster

  1. The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice.

    Science.gov (United States)

    Shawyer, Frances; Enticott, Joanne C; Brophy, Lisa; Bruxner, Annie; Fossey, Ellie; Inder, Brett; Julian, John; Kakuma, Ritsuko; Weller, Penelope; Wilson-Evered, Elisabeth; Edan, Vrinda; Slade, Mike; Meadows, Graham N

    2017-05-08

    Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder

  2. Cluster randomization and political philosophy.

    Science.gov (United States)

    Chwang, Eric

    2012-11-01

    In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

  3. Random matrix improved subspace clustering

    KAUST Repository

    Couillet, Romain

    2017-03-06

    This article introduces a spectral method for statistical subspace clustering. The method is built upon standard kernel spectral clustering techniques, however carefully tuned by theoretical understanding arising from random matrix findings. We show in particular that our method provides high clustering performance while standard kernel choices provably fail. An application to user grouping based on vector channel observations in the context of massive MIMO wireless communication networks is provided.

  4. Single-cluster dynamics for the random-cluster model

    NARCIS (Netherlands)

    Deng, Y.; Qian, X.; Blöte, H.W.J.

    We formulate a single-cluster Monte Carlo algorithm for the simulation of the random-cluster model. This algorithm is a generalization of the Wolff single-cluster method for the q-state Potts model to noninteger values q>1. Its results for static quantities are in a satisfactory agreement with those

  5. Single-cluster dynamics for the random-cluster model

    NARCIS (Netherlands)

    Deng, Y.; Qian, X.; Blöte, H.W.J.

    2009-01-01

    We formulate a single-cluster Monte Carlo algorithm for the simulation of the random-cluster model. This algorithm is a generalization of the Wolff single-cluster method for the q-state Potts model to noninteger values q>1. Its results for static quantities are in a satisfactory agreement with those

  6. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  7. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  8. Fast Constrained Spectral Clustering and Cluster Ensemble with Random Projection

    Directory of Open Access Journals (Sweden)

    Wenfen Liu

    2017-01-01

    Full Text Available Constrained spectral clustering (CSC method can greatly improve the clustering accuracy with the incorporation of constraint information into spectral clustering and thus has been paid academic attention widely. In this paper, we propose a fast CSC algorithm via encoding landmark-based graph construction into a new CSC model and applying random sampling to decrease the data size after spectral embedding. Compared with the original model, the new algorithm has the similar results with the increase of its model size asymptotically; compared with the most efficient CSC algorithm known, the new algorithm runs faster and has a wider range of suitable data sets. Meanwhile, a scalable semisupervised cluster ensemble algorithm is also proposed via the combination of our fast CSC algorithm and dimensionality reduction with random projection in the process of spectral ensemble clustering. We demonstrate by presenting theoretical analysis and empirical results that the new cluster ensemble algorithm has advantages in terms of efficiency and effectiveness. Furthermore, the approximate preservation of random projection in clustering accuracy proved in the stage of consensus clustering is also suitable for the weighted k-means clustering and thus gives the theoretical guarantee to this special kind of k-means clustering where each point has its corresponding weight.

  9. Orientational and Translational Ordering of Sub-Monolayer Films of Passivated Multiply-Twinned Gold Clusters

    Energy Technology Data Exchange (ETDEWEB)

    WELLNER,A.; NELLIST,P.D.; PALMER,R.E.; AINDOW,M.; WILCOXON,JESS P.

    2000-07-18

    The influence of the substrate on the translational and orientational ordering in sub-monolayer films of passivated multiply-twinned gold clusters has been investigated using high resolution and dark field transmission electron microscopy. Although clear differences were observed in the degree of translational ordering on amorphous carbon and etched silicon substrates, there was no corresponding variation in the crystallographic orientation of the nanocrystal cores. The results demonstrate that the orientation of passivated clusters with multiply-twinned cores is effectively random with respect to both the superlattice and the substrate.

  10. Cluster randomized trials for pharmacy practice research.

    Science.gov (United States)

    Gums, Tyler; Carter, Barry; Foster, Eric

    2016-06-01

    Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity.

  11. Oriented Spatial Box Plot, a New Pattern for Points Clusters

    OpenAIRE

    Etienne, Laurent; Devogele, Thomas; McArdle, Gavin

    2014-01-01

    Nowadays, an abundance of sensors are used to collect very large datasets containing spatial points which can be mined and analyzed to extract meaningful patterns and information. This article examines patterns which describe the dispersion of 2D data around a central tendency. Several state of the art patterns for point cluster analysis are presented and critiqued before a new pattern, the Oriented Spatial Box Plot, is defined. The Oriented Spatial Box Plot extends the clas...

  12. Fast Constrained Spectral Clustering and Cluster Ensemble with Random Projection

    National Research Council Canada - National Science Library

    Wenfen Liu; Mao Ye; Jianghong Wei; Xuexian Hu

    2017-01-01

    Constrained spectral clustering (CSC) method can greatly improve the clustering accuracy with the incorporation of constraint information into spectral clustering and thus has been paid academic attention widely...

  13. Pseudo cluster randomization: balancing the disadvantages of cluster and individual randomization

    NARCIS (Netherlands)

    Melis, R.J.F.; Teerenstra, S.; Olde Rikkert, M.G.M.; Borm, G.F.

    2011-01-01

    While designing a trial to evaluate a complex intervention, one may be confronted with the dilemma that randomization at the level of the individual patient risks contamination bias, whereas cluster randomization risks incomparability of study arms and recruitment problems. Literature provides only

  14. Bridges in the random-cluster model

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    Eren Metin Elçi

    2016-02-01

    Full Text Available The random-cluster model, a correlated bond percolation model, unifies a range of important models of statistical mechanics in one description, including independent bond percolation, the Potts model and uniform spanning trees. By introducing a classification of edges based on their relevance to the connectivity we study the stability of clusters in this model. We prove several exact relations for general graphs that allow us to derive unambiguously the finite-size scaling behavior of the density of bridges and non-bridges. For percolation, we are also able to characterize the point for which clusters become maximally fragile and show that it is connected to the concept of the bridge load. Combining our exact treatment with further results from conformal field theory, we uncover a surprising behavior of the (normalized variance of the number of (non-bridges, showing that it diverges in two dimensions below the value 4cos2⁡(π/3=0.2315891⋯ of the cluster coupling q. Finally, we show that a partial or complete pruning of bridges from clusters enables estimates of the backbone fractal dimension that are much less encumbered by finite-size corrections than more conventional approaches.

  15. Statistical Estimation and Clustering of Group-invariant Orientation Parameters

    CERN Document Server

    Chen, Yu-Hui; Newstadt, Gregory; DeGraef, Marc; Simmons, Jeffrey; Hero, Alfred

    2015-01-01

    We treat the problem of estimation of orientation parameters whose values are invariant to transformations from a spherical symmetry group. Previous work has shown that any such group-invariant distribution must satisfy a restricted finite mixture representation, which allows the orientation parameter to be estimated using an Expectation Maximization (EM) maximum likelihood (ML) estimation algorithm. In this paper, we introduce two parametric models for this spherical symmetry group estimation problem: 1) the hyperbolic Von Mises Fisher (VMF) mixture distribution and 2) the Watson mixture distribution. We also introduce a new EM-ML algorithm for clustering samples that come from mixtures of group-invariant distributions with different parameters. We apply the models to the problem of mean crystal orientation estimation under the spherically symmetric group associated with the crystal form, e.g., cubic or octahedral or hexahedral. Simulations and experiments establish the advantages of the extended EM-VMF and ...

  16. Maximin Optimal Designs for Cluster Randomized Trials

    Science.gov (United States)

    Wu, Sheng; Wong, Weng Kee; Crespi, Catherine M.

    2017-01-01

    Summary We consider design issues for cluster randomized trials (CRTs) with a binary outcome where both unit costs and intraclass correlation coefficients (ICCs) in the two arms may be unequal. We first propose a design that maximizes cost efficiency (CE), defined as the ratio of the precision of the efficacy measure to the study cost. Because such designs can be highly sensitive to the unknown ICCs and the anticipated success rates in the two arms, a local strategy based on a single set of best guesses for the ICCs and success rates can be risky. To mitigate this issue, we propose a maximin optimal design that permits ranges of values to be specified for the success rate and the ICC in each arm. We derive maximin optimal designs for three common measures of the efficacy of the intervention, risk difference, relative risk and odds ratio, and study their properties. Using a real cancer control and prevention trial example, we ascertain the efficiency of the widely used balanced design relative to the maximin optimal design and show that the former can be quite inefficient and less robust to mis-specifications of the ICCs and the success rates in the two arms. PMID:28182835

  17. Phase transitions for information diffusion in random clustered networks

    Science.gov (United States)

    Lim, Sungsu; Shin, Joongbo; Kwak, Namju; Jung, Kyomin

    2016-09-01

    We study the conditions for the phase transitions of information diffusion in complex networks. Using the random clustered network model, a generalisation of the Chung-Lu random network model incorporating clustering, we examine the effect of clustering under the Susceptible-Infected-Recovered (SIR) epidemic diffusion model with heterogeneous contact rates. For this purpose, we exploit the branching process to analyse information diffusion in random unclustered networks with arbitrary contact rates, and provide novel iterative algorithms for estimating the conditions and sizes of global cascades, respectively. Showing that a random clustered network can be mapped into a factor graph, which is a locally tree-like structure, we successfully extend our analysis to random clustered networks with heterogeneous contact rates. We then identify the conditions for phase transitions of information diffusion using our method. Interestingly, for various contact rates, we prove that random clustered networks with higher clustering coefficients have strictly lower phase transition points for any given degree sequence. Finally, we confirm our analytical results with numerical simulations of both synthetically-generated and real-world networks.

  18. Robustness and Optimal Design Issues for Cluster Randomized Trials

    NARCIS (Netherlands)

    Korendijk, E.|info:eu-repo/dai/nl/072035463

    2012-01-01

    Cluster randomized trials (CRT), in which whole clusters instead of individuals are assigned to conditions, are not uncommon in the social, behavioral, educational, medical and organizational sciences. Though the assignment of individuals to treatment conditions is more efficient, this may not

  19. Scattering from randomly oriented scatterers with strong permittivity fluctuations

    Science.gov (United States)

    Yueh, S. H.; Kong, J. A.; Shin, R. T.

    1990-01-01

    Strong permittivity fluctuation theory is used to solve the problem of scattering from a medium composed of completely randomly oriented scatterers under a low frequency limit. Gaussian statistics are not assumed for the renormalized scattering sources. Numerical results on effective permittivity are illustrated for oblate and prolate spheroidal scatterers and compared with the results for spherical scatterers. The results are consistent with discrete scatterer theory. The effective permittivity of a random medium embedded with nonspherical scatterers shows a higher imaginary part than the spherical scatterer case with equal correlation volume. Under the distorted Born approximation, the polarimetric covariance matrix for the backscattered electric field is calculated for half-space randomly oriented scatterers. The nonspherical geometry of the scatterers shows significant effects on the cross-polarized backscattering returns, and the correlation coefficient between HH and VV returns. The polarimetric backscattering coefficients can provide useful information in distinguishing the geometry of scatterers.

  20. Methods for sample size determination in cluster randomized trials.

    Science.gov (United States)

    Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

    2015-06-01

    The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.

  1. Personalized PageRank Clustering: A graph clustering algorithm based on random walks

    Science.gov (United States)

    A. Tabrizi, Shayan; Shakery, Azadeh; Asadpour, Masoud; Abbasi, Maziar; Tavallaie, Mohammad Ali

    2013-11-01

    Graph clustering has been an essential part in many methods and thus its accuracy has a significant effect on many applications. In addition, exponential growth of real-world graphs such as social networks, biological networks and electrical circuits demands clustering algorithms with nearly-linear time and space complexity. In this paper we propose Personalized PageRank Clustering (PPC) that employs the inherent cluster exploratory property of random walks to reveal the clusters of a given graph. We combine random walks and modularity to precisely and efficiently reveal the clusters of a graph. PPC is a top-down algorithm so it can reveal inherent clusters of a graph more accurately than other nearly-linear approaches that are mainly bottom-up. It also gives a hierarchy of clusters that is useful in many applications. PPC has a linear time and space complexity and has been superior to most of the available clustering algorithms on many datasets. Furthermore, its top-down approach makes it a flexible solution for clustering problems with different requirements.

  2. The effect of cluster size variability on statistical power in cluster-randomized trials.

    Directory of Open Access Journals (Sweden)

    Stephen A Lauer

    Full Text Available The frequency of cluster-randomized trials (CRTs in peer-reviewed literature has increased exponentially over the past two decades. CRTs are a valuable tool for studying interventions that cannot be effectively implemented or randomized at the individual level. However, some aspects of the design and analysis of data from CRTs are more complex than those for individually randomized controlled trials. One of the key components to designing a successful CRT is calculating the proper sample size (i.e. number of clusters needed to attain an acceptable level of statistical power. In order to do this, a researcher must make assumptions about the value of several variables, including a fixed mean cluster size. In practice, cluster size can often vary dramatically. Few studies account for the effect of cluster size variation when assessing the statistical power for a given trial. We conducted a simulation study to investigate how the statistical power of CRTs changes with variable cluster sizes. In general, we observed that increases in cluster size variability lead to a decrease in power.

  3. Localization and orientation of heavy-atom cluster compounds in protein crystals using molecular replacement

    OpenAIRE

    Dahms, Sven O.; Kuester, Miriam; Streb, Carsten; Roth, Christian; Str?ter, Norbert; Than, Manuel E

    2013-01-01

    Heavy-atom clusters (HA clusters) containing a large number of specifically arranged electron-dense scatterers are especially useful for experimental phase determination of large complex structures, weakly diffracting crystals or structures with large unit cells. Often, the determination of the exact orientation of the HA cluster and hence of the individual heavy-atom positions proves to be the critical step in successful phasing and subsequent structure solution. Here, it is demonstrated tha...

  4. Exploring biological network structure with clustered random networks

    Directory of Open Access Journals (Sweden)

    Bansal Shweta

    2009-12-01

    Full Text Available Abstract Background Complex biological systems are often modeled as networks of interacting units. Networks of biochemical interactions among proteins, epidemiological contacts among hosts, and trophic interactions in ecosystems, to name a few, have provided useful insights into the dynamical processes that shape and traverse these systems. The degrees of nodes (numbers of interactions and the extent of clustering (the tendency for a set of three nodes to be interconnected are two of many well-studied network properties that can fundamentally shape a system. Disentangling the interdependent effects of the various network properties, however, can be difficult. Simple network models can help us quantify the structure of empirical networked systems and understand the impact of various topological properties on dynamics. Results Here we develop and implement a new Markov chain simulation algorithm to generate simple, connected random graphs that have a specified degree sequence and level of clustering, but are random in all other respects. The implementation of the algorithm (ClustRNet: Clustered Random Networks provides the generation of random graphs optimized according to a local or global, and relative or absolute measure of clustering. We compare our algorithm to other similar methods and show that ours more successfully produces desired network characteristics. Finding appropriate null models is crucial in bioinformatics research, and is often difficult, particularly for biological networks. As we demonstrate, the networks generated by ClustRNet can serve as random controls when investigating the impacts of complex network features beyond the byproduct of degree and clustering in empirical networks. Conclusion ClustRNet generates ensembles of graphs of specified edge structure and clustering. These graphs allow for systematic study of the impacts of connectivity and redundancies on network function and dynamics. This process is a key step in

  5. Exploring biological network structure with clustered random networks.

    Science.gov (United States)

    Bansal, Shweta; Khandelwal, Shashank; Meyers, Lauren Ancel

    2009-12-09

    Complex biological systems are often modeled as networks of interacting units. Networks of biochemical interactions among proteins, epidemiological contacts among hosts, and trophic interactions in ecosystems, to name a few, have provided useful insights into the dynamical processes that shape and traverse these systems. The degrees of nodes (numbers of interactions) and the extent of clustering (the tendency for a set of three nodes to be interconnected) are two of many well-studied network properties that can fundamentally shape a system. Disentangling the interdependent effects of the various network properties, however, can be difficult. Simple network models can help us quantify the structure of empirical networked systems and understand the impact of various topological properties on dynamics. Here we develop and implement a new Markov chain simulation algorithm to generate simple, connected random graphs that have a specified degree sequence and level of clustering, but are random in all other respects. The implementation of the algorithm (ClustRNet: Clustered Random Networks) provides the generation of random graphs optimized according to a local or global, and relative or absolute measure of clustering. We compare our algorithm to other similar methods and show that ours more successfully produces desired network characteristics.Finding appropriate null models is crucial in bioinformatics research, and is often difficult, particularly for biological networks. As we demonstrate, the networks generated by ClustRNet can serve as random controls when investigating the impacts of complex network features beyond the byproduct of degree and clustering in empirical networks. ClustRNet generates ensembles of graphs of specified edge structure and clustering. These graphs allow for systematic study of the impacts of connectivity and redundancies on network function and dynamics. This process is a key step in unraveling the functional consequences of the structural

  6. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  7. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  8. Connectivity properties of the random-cluster model

    Science.gov (United States)

    Weigel, Martin; Metin Elci, Eren; Fytas, Nikolaos G.

    2016-02-01

    We investigate the connectivity properties of the random-cluster model mediated by bridge bonds that, if removed, lead to the generation of new connected components. We study numerically the density of bridges and the fragmentation kernel, i.e., the relative sizes of the generated fragments, and find that these quantities follow a scaling description. The corresponding scaling exponents are related to well known equilibrium critical exponents of the model. Using the Russo-Margulis formalism, we derive an exact relation between the expected density of bridges and the number of active edges. The same approach allows us to study the fluctuations in the numbers of bridges, thereby uncovering a new singularity in the random- cluster model as q clusters connected by bridges and candidate-bridges play a pivotal role. We discuss several different implementations of the necessary connectivity algorithms and assess their relative performance.

  9. Fluctuations of orientational order and clustering in a two-dimensional colloidal system under quenched disorder

    Science.gov (United States)

    Horn, Tobias; Deutschländer, Sven; Löwen, Hartmut; Maret, Georg; Keim, Peter

    2013-12-01

    Using both video microscopy of superparamagnetic colloidal particles confined in two dimensions and corresponding computer simulations of repulsive parallel dipoles, we study the formation of fluctuating orientational clusters and topological defects in the context of the KTHNY-like melting scenario under quenched disorder. We analyze cluster densities, average cluster sizes, and the population of noncluster particles, as well as the development of defects, as a function of the system temperature and disorder strength. In addition, the probability distribution of clustering and orientational order is presented. We find that the well-known disorder-induced widening of the hexatic phase can be traced back to the distinct development characteristics of clusters and defects along the melting transitions from the solid phase to the hexatic phase to the isotropic fluid.

  10. Localization and orientation of heavy-atom cluster compounds in protein crystals using molecular replacement.

    Science.gov (United States)

    Dahms, Sven O; Kuester, Miriam; Streb, Carsten; Roth, Christian; Sträter, Norbert; Than, Manuel E

    2013-02-01

    Heavy-atom clusters (HA clusters) containing a large number of specifically arranged electron-dense scatterers are especially useful for experimental phase determination of large complex structures, weakly diffracting crystals or structures with large unit cells. Often, the determination of the exact orientation of the HA cluster and hence of the individual heavy-atom positions proves to be the critical step in successful phasing and subsequent structure solution. Here, it is demonstrated that molecular replacement (MR) with either anomalous or isomorphous differences is a useful strategy for the correct placement of HA cluster compounds. The polyoxometallate cluster hexasodium α-metatungstate (HMT) was applied in phasing the structure of death receptor 6. Even though the HA cluster is bound in alternate partially occupied orientations and is located at a special position, its correct localization and orientation could be determined at resolutions as low as 4.9 Å. The broad applicability of this approach was demonstrated for five different derivative crystals that included the compounds tantalum tetradecabromide and trisodium phosphotungstate in addition to HMT. The correct placement of the HA cluster depends on the length of the intramolecular vectors chosen for MR, such that both a larger cluster size and the optimal choice of the wavelength used for anomalous data collection strongly affect the outcome.

  11. Clustered continuous-time random walks: diffusion and relaxation consequences.

    Science.gov (United States)

    Weron, Karina; Stanislavsky, Aleksander; Jurlewicz, Agnieszka; Meerschaert, Mark M; Scheffler, Hans-Peter

    2012-06-08

    We present a class of continuous-time random walks (CTRWs), in which random jumps are separated by random waiting times. The novel feature of these CTRWs is that the jumps are clustered. This introduces a coupled effect, with longer waiting times separating larger jump clusters. We show that the CTRW scaling limits are time-changed processes. Their densities solve two different fractional diffusion equations, depending on whether the waiting time is coupled to the preceding jump, or the following one. These fractional diffusion equations can be used to model all types of experimentally observed two power-law relaxation patterns. The parameters of the scaling limit process determine the power-law exponents and loss peak frequencies.

  12. Failure process in heterogeneous materials with randomly oriented fibers

    Science.gov (United States)

    Sbiaai, H.; Hader, A.; Bakir, R.; Achik, I.; Tarras, I.; Boughaleb, Y.

    2017-06-01

    Our aim in this study is to investigate the failure process in heterogeneous materials with randomly oriented fibers. In our proposed system, the fiber bundle model assumes that all the fibers are randomly oriented in all directions relative to the vertical one. Our calculations are performed in the framework of the local load-sharing rule, which states that the applied load of a broken fiber is redistributed only to its neighboring ones. The results show that this system presents a greater resistance than the classical one where the fibers are arranged parallel to the applied load. We found that the density of the broken fibers exhibited a power law and was linearly correlated with the applied load and temperature. However, the results show that the failure process of the considered system is characterized by an avalanche phenomenon with two different regimes. We also studied the crossover behavior of lifetime of the materials versus both applied load and temperature. We compared these results with those obtained from the classical model.

  13. Ethical issues posed by cluster randomized trials in health research

    Directory of Open Access Journals (Sweden)

    Donner Allan

    2011-04-01

    Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

  14. Localization and orientation of heavy-atom cluster compounds in protein crystals using molecular replacement

    Energy Technology Data Exchange (ETDEWEB)

    Dahms, Sven O., E-mail: sdahms@fli-leibniz.de; Kuester, Miriam [Leibniz Institute for Age Research – Fritz Lipmann Institute (FLI), Beutenbergstrasse 11, D-07745 Jena (Germany); Streb, Carsten [Friedrich-Alexander-University Erlangen-Nürnberg, Egerlandstrasse 1, D-91058 Erlangen (Germany); Roth, Christian; Sträter, Norbert [Universität Leipzig, D-04103 Leipzig (Germany); Than, Manuel E., E-mail: sdahms@fli-leibniz.de [Leibniz Institute for Age Research – Fritz Lipmann Institute (FLI), Beutenbergstrasse 11, D-07745 Jena (Germany)

    2013-02-01

    A new approach is presented that allows the efficient localization and orientation of heavy-atom cluster compounds used in experimental phasing by a molecular replacement procedure. This permits the calculation of meaningful phases up to the highest resolution of the diffraction data. Heavy-atom clusters (HA clusters) containing a large number of specifically arranged electron-dense scatterers are especially useful for experimental phase determination of large complex structures, weakly diffracting crystals or structures with large unit cells. Often, the determination of the exact orientation of the HA cluster and hence of the individual heavy-atom positions proves to be the critical step in successful phasing and subsequent structure solution. Here, it is demonstrated that molecular replacement (MR) with either anomalous or isomorphous differences is a useful strategy for the correct placement of HA cluster compounds. The polyoxometallate cluster hexasodium α-metatungstate (HMT) was applied in phasing the structure of death receptor 6. Even though the HA cluster is bound in alternate partially occupied orientations and is located at a special position, its correct localization and orientation could be determined at resolutions as low as 4.9 Å. The broad applicability of this approach was demonstrated for five different derivative crystals that included the compounds tantalum tetradecabromide and trisodium phosphotungstate in addition to HMT. The correct placement of the HA cluster depends on the length of the intramolecular vectors chosen for MR, such that both a larger cluster size and the optimal choice of the wavelength used for anomalous data collection strongly affect the outcome.

  15. Design and Analysis Considerations for Cluster Randomized Controlled Trials That Have a Small Number of Clusters.

    Science.gov (United States)

    Deke, John

    2016-10-25

    Cluster randomized controlled trials (CRCTs) often require a large number of clusters in order to detect small effects with high probability. However, there are contexts where it may be possible to design a CRCT with a much smaller number of clusters (10 or fewer) and still detect meaningful effects. The objective is to offer recommendations for best practices in design and analysis for small CRCTs. I use simulations to examine alternative design and analysis approaches. Specifically, I examine (1) which analytic approaches control Type I errors at the desired rate, (2) which design and analytic approaches yield the most power, (3) what is the design effect of spurious correlations, and (4) examples of specific scenarios under which impacts of different sizes can be detected with high probability. I find that (1) mixed effects modeling and using Ordinary Least Squares (OLS) on data aggregated to the cluster level both control the Type I error rate, (2) randomization within blocks is always recommended, but how best to account for blocking through covariate adjustment depends on whether the precision gains offset the degrees of freedom loss, (3) power calculations can be accurate when design effects from small sample, spurious correlations are taken into account, and (4) it is very difficult to detect small effects with just four clusters, but with six or more clusters, there are realistic circumstances under which small effects can be detected with high probability. © The Author(s) 2016.

  16. Market-Oriented Projects: Analysis in an Information Technology Cluster

    Directory of Open Access Journals (Sweden)

    José Edson Lara

    2014-09-01

    Full Text Available This article introduces and analyzes the result of research addressing the business performance of the Local Productive Arrangement of Information Technology RMBH-MG. The theoretical model of reference for the quantitative research was the Market Orientation, or Markor scale, proposed by Kohli, Jaworski (1993. 83 entrepreneurs, out of a total of 142 of the sector, as well as 04 leading business entities were investigated. The study shows that the technical support in the development of micro and small enterprises provided by SEBRAE generated better level of satisfaction in the construct "generation of intelligence" and the "reply to", in relation to "construct" dissemination of intelligence ". The construct "response to the market of the companies met" presented higher performance than the construct "dissemination of technological information". The project as a whole was well rated by entrepreneurs. Nomologicamente the theoretical model explains satisfactorily the project performance.

  17. Two different approaches to the affective profiles model: median splits (variable-oriented) and cluster analysis (person-oriented)

    Science.gov (United States)

    MacDonald, Shane; Archer, Trevor

    2015-01-01

    Background. The notion of the affective system as being composed of two dimensions led Archer and colleagues to the development of the affective profiles model. The model consists of four different profiles based on combinations of individuals’ experience of high/low positive and negative affect: self-fulfilling, low affective, high affective, and self-destructive. During the past 10 years, an increasing number of studies have used this person-centered model as the backdrop for the investigation of between and within individual differences in ill-being and well-being. The most common approach to this profiling is by dividing individuals’ scores of self-reported affect using the median of the population as reference for high/low splits. However, scores just-above and just-below the median might become high and low by arbitrariness, not by reality. Thus, it is plausible to criticize the validity of this variable-oriented approach. Our aim was to compare the median splits approach with a person-oriented approach, namely, cluster analysis. Method. The participants (N = 2, 225) were recruited through Amazons’ Mechanical Turk and asked to self-report affect using the Positive Affect Negative Affect Schedule. We compared the profiles’ homogeneity and Silhouette coefficients to discern differences in homogeneity and heterogeneity between approaches. We also conducted exact cell-wise analyses matching the profiles from both approaches and matching profiles and gender to investigate profiling agreement with respect to affectivity levels and affectivity and gender. All analyses were conducted using the ROPstat software. Results. The cluster approach (weighted average of cluster homogeneity coefficients = 0.62, Silhouette coefficients = 0.68) generated profiles with greater homogeneity and more distinctive from each other compared to the median splits approach (weighted average of cluster homogeneity coefficients = 0.75, Silhouette coefficients = 0.59). Most of the

  18. Nonparametric resampling of random walks for spectral network clustering

    Science.gov (United States)

    Fallani, Fabrizio De Vico; Nicosia, Vincenzo; Latora, Vito; Chavez, Mario

    2014-01-01

    Parametric resampling schemes have been recently introduced in complex network analysis with the aim of assessing the statistical significance of graph clustering and the robustness of community partitions. We propose here a method to replicate structural features of complex networks based on the non-parametric resampling of the transition matrix associated with an unbiased random walk on the graph. We test this bootstrapping technique on synthetic and real-world modular networks and we show that the ensemble of replicates obtained through resampling can be used to improve the performance of standard spectral algorithms for community detection.

  19. Nonparametric resampling of random walks for spectral network clustering.

    Science.gov (United States)

    De Vico Fallani, Fabrizio; Nicosia, Vincenzo; Latora, Vito; Chavez, Mario

    2014-01-01

    Parametric resampling schemes have been recently introduced in complex network analysis with the aim of assessing the statistical significance of graph clustering and the robustness of community partitions. We propose here a method to replicate structural features of complex networks based on the non-parametric resampling of the transition matrix associated with an unbiased random walk on the graph. We test this bootstrapping technique on synthetic and real-world modular networks and we show that the ensemble of replicates obtained through resampling can be used to improve the performance of standard spectral algorithms for community detection.

  20. Orientation of non-spherical protonated water clusters revealed by infrared absorption dichroism.

    Science.gov (United States)

    Daldrop, Jan O; Saita, Mattia; Heyden, Matthias; Lorenz-Fonfria, Victor A; Heberle, Joachim; Netz, Roland R

    2018-01-22

    Infrared continuum bands that extend over a broad frequency range are a key spectral signature of protonated water clusters. They are observed for many membrane proteins that contain internal water molecules, but their microscopic mechanism has remained unclear. Here we compute infrared spectra for protonated and unprotonated water chains, discs, and droplets from ab initio molecular dynamics simulations. The continuum bands of the protonated clusters exhibit significant anisotropy for chains and discs, with increased absorption along the direction of maximal cluster extension. We show that the continuum band arises from the nuclei motion near the excess charge, with a long-ranged amplification due to the electronic polarizability. Our experimental, polarization-resolved light-dark difference spectrum of the light-driven proton pump bacteriorhodopsin exhibits a pronounced dichroic continuum band. Our results suggest that the protonated water cluster responsible for the continuum band of bacteriorhodopsin is oriented perpendicularly to the membrane normal.

  1. A Random Walk Approach to Query Informative Constraints for Clustering.

    Science.gov (United States)

    Abin, Ahmad Ali

    2017-08-09

    This paper presents a random walk approach to the problem of querying informative constraints for clustering. The proposed method is based on the properties of the commute time, that is the expected time taken for a random walk to travel between two nodes and return, on the adjacency graph of data. Commute time has the nice property of that, the more short paths connect two given nodes in a graph, the more similar those nodes are. Since computing the commute time takes the Laplacian eigenspectrum into account, we use this property in a recursive fashion to query informative constraints for clustering. At each recursion, the proposed method constructs the adjacency graph of data and utilizes the spectral properties of the commute time matrix to bipartition the adjacency graph. Thereafter, the proposed method benefits from the commute times distance on graph to query informative constraints between partitions. This process iterates for each partition until the stop condition becomes true. Experiments on real-world data show the efficiency of the proposed method for constraints selection.

  2. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  3. Orientational distributions of contact clusters in proteins closely resemble those of an icosahedron.

    Science.gov (United States)

    Feng, Yaping; Jernigan, Robert L; Kloczkowski, Andrzej

    2008-11-15

    The orientational geometry of residue packing in proteins was studied in the past by superimposing clusters of neighboring residues with several simple lattices (Bagci et al., Proteins 2003;53:56-67; Raghunathan et al., Protein Sci 1997;6:2072-2083). In this work, instead of a lattice we use the regular polyhedron, the icosahedron, as the model to describe the orientational distribution of contacts in clusters derived from a high-resolution protein dataset (522 protein structures with high resolution icosahedron is 0.91, which is a significant improvement in comparison with the value 0.82 for the order parameter with the face-centered cubic (fcc) lattice. Close packing tendencies and patterns of residue packing in proteins are considered in detail and a theoretical description of these packing regularities is proposed.

  4. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  5. Calculating sample sizes for cluster randomized trials: we can keep it simple and efficient !

    NARCIS (Netherlands)

    van Breukelen, Gerard J.P.; Candel, Math J.J.M.

    2012-01-01

    Objective: Simple guidelines for efficient sample sizes in cluster randomized trials with unknown intraclass correlation and varying cluster sizes. Methods: A simple equation is given for the optimal number of clusters and sample size per cluster. Here, optimal means maximizing power for a given

  6. Design of a cluster-randomized minority recruitment trial: RECRUIT.

    Science.gov (United States)

    Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

    2017-06-01

    Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or

  7. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    evaluated in the eligible trials. RESULTS: Thirty-five eligible trials were identified. The majority of them were conducted in Asia, used community as randomization unit, and had less than 10,000 participants. To minimize confounding, 23 of the 35 trials had stratified, blocked, or paired the clusters...... before they were randomized, while 17 had adjusted for confounding in the analysis. Ten of the 35 trials did not account for clustering in sample size calculations, and seven did not account for the cluster-randomized design in the analysis. The number of cluster-randomized trials increased over time......To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...

  8. Understanding Statistical Power in Cluster Randomized Trials: Challenges Posed by Differences in Notation and Terminology

    Science.gov (United States)

    Spybrook, Jessaca; Hedges, Larry; Borenstein, Michael

    2014-01-01

    Research designs in which clusters are the unit of randomization are quite common in the social sciences. Given the multilevel nature of these studies, the power analyses for these studies are more complex than in a simple individually randomized trial. Tools are now available to help researchers conduct power analyses for cluster randomized…

  9. Robotic virtual reality simulation plus standard robotic orientation versus standard robotic orientation alone: a randomized controlled trial.

    Science.gov (United States)

    Vaccaro, Christine M; Crisp, Catrina C; Fellner, Angela N; Jackson, Christopher; Kleeman, Steven D; Pavelka, James

    2013-01-01

    The objective of this study was to compare the effect of virtual reality simulation training plus robotic orientation versus robotic orientation alone on performance of surgical tasks using an inanimate model. Surgical resident physicians were enrolled in this assessor-blinded randomized controlled trial. Residents were randomized to receive either (1) robotic virtual reality simulation training plus standard robotic orientation or (2) standard robotic orientation alone. Performance of surgical tasks was assessed at baseline and after the intervention. Nine of 33 modules from the da Vinci Skills Simulator were chosen. Experts in robotic surgery evaluated each resident's videotaped performance of the inanimate model using the Global Rating Scale (GRS) and Objective Structured Assessment of Technical Skills-modified for robotic-assisted surgery (rOSATS). Nine resident physicians were enrolled in the simulation group and 9 in the control group. As a whole, participants improved their total time, time to incision, and suture time from baseline to repeat testing on the inanimate model (P = 0.001, 0.003, virtual reality simulation improve surgical skills on an inanimate model, although this may be a function of the initial "practice" on the inanimate model and repeat testing of a known task. However, robotic virtual reality simulation training increases GRS pass rates consistent with improved robotic technical skills learned in a virtual reality environment.

  10. Orientation of the tetranuclear manganese cluster and tyrosine Z in the O(2)-evolving complex of photosystem II: An EPR study of the S(2)Y(Z)(*) state in oriented acetate-inhibited photosystem II membranes.

    Science.gov (United States)

    Lakshmi, K V; Eaton, S S; Eaton, G R; Brudvig, G W

    1999-09-28

    Inhibitory treatment by acetate, followed by illumination and rapid freezing, is known to trap the S(2)Y(Z)(*) state of the O(2)-evolving complex (OEC) in photosystem II (PS II). An EPR spectrum of this state exhibits broad split signals due to the interaction of the tyrosyl radical, Y(Z)(*), with the S = 1/2 S(2) state of the Mn(4) cluster. We present a novel approach to analyze S(2)Y(Z)(*) spectra of one-dimensionally (1-D) oriented acetate-inhibited PS II membranes to determine the magnitude and relative orientation of the S(2)Y(Z)(*) dipolar vector within the membrane. Although there exists a vast body of EPR data on isolated spins in oriented membrane sheets, the present study is the first of its kind on dipolar-coupled electron spin pairs in such systems. We demonstrate the feasibility of the technique and establish a rigorous treatment to account for the disorder present in partially oriented 1-D membrane preparations. We find that (i) the point-dipole distance between Y(Z)(*) and the Mn(4) cluster is 7.9 +/- 0.2 A, (ii) the angle between the interspin vector and the thylakoid membrane normal is 75 degrees, (iii) the g(z)()-axis of the Mn(4) cluster is 70 degrees away from the membrane normal and 35 degrees away from the interspin vector, and (iv) the exchange interaction between the two spins is -275 x 10(-)(4) cm(-)(1), which is antiferromagnetic. Due to the sensitivity of EPR line shapes of oriented spin-coupled pairs to the interspin distance, the present study imposes a tighter constraint on the Y(Z)-Mn(4) point-dipole distance than obtained from randomly oriented samples. The geometric constraints obtained from the 1-D oriented sample are combined with published models of the structure of Mn-depleted PS II to propose a location of the Mn(4) cluster. A structure in which Y(Z) is hydrogen bonded to a manganese-bound hydroxide ligand is consistent with available data and favors maximal orbital overlap between the two redox center that would facilitate

  11. Ferromagnetic clusters induced by a nonmagnetic random disorder in diluted magnetic semiconductors

    Energy Technology Data Exchange (ETDEWEB)

    Bui, Dinh-Hoi [Institute of Research and Development, Duy Tan University, K7/25 Quang Trung, Danang (Viet Nam); Physics Department, Hue University’s College of Education, 34 Le Loi, Hue (Viet Nam); Phan, Van-Nham, E-mail: phanvannham@dtu.edu.vn [Institute of Research and Development, Duy Tan University, K7/25 Quang Trung, Danang (Viet Nam)

    2016-12-15

    In this work, we analyze the nonmagnetic random disorder leading to a formation of ferromagnetic clusters in diluted magnetic semiconductors. The nonmagnetic random disorder arises from randomness in the host lattice. Including the disorder to the Kondo lattice model with random distribution of magnetic dopants, the ferromagnetic–paramagnetic transition in the system is investigated in the framework of dynamical mean-field theory. At a certain low temperature one finds a fraction of ferromagnetic sites transiting to the paramagnetic state. Enlarging the nonmagnetic random disorder strength, the paramagnetic regimes expand resulting in the formation of the ferromagnetic clusters.

  12. Cluster randomized trials utilizing primary care electronic health records : methodological issues in design, conduct, and analysis (eCRT Study)

    NARCIS (Netherlands)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-01-01

    BACKGROUND: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical

  13. Building pathway clusters from Random Forests classification using class votes

    Directory of Open Access Journals (Sweden)

    Zhao Hongyu

    2008-02-01

    Full Text Available Abstract Background Recent years have seen the development of various pathway-based methods for the analysis of microarray gene expression data. These approaches have the potential to bring biological insights into microarray studies. A variety of methods have been proposed to construct networks using gene expression data. Because individual pathways do not act in isolation, it is important to understand how different pathways coordinate to perform cellular functions. However, there are no published methods describing how to build pathway clusters that are closely related to traits of interest. Results We propose to build pathway clusters from pathway-based classification methods. The proposed methods allow researchers to identify clusters of pathways sharing similar functions. These pathways may or may not share genes. As an illustration, our approach is applied to three human breast cancer microarray data sets. We found that our methods yielded consistent and interpretable results for these three data sets. We further investigated one of the pathway clusters found using PubMatrix. We found that informative genes in the pathway clusters do have more publications with keywords, like estrogen receptor, compared with informative genes in other top pathways. In addition, using the shortest path analysis in GeneGo's MetaCore and Human Protein Reference Database, we were able to identify the links which connect the pathways without shared genes within the pathway cluster. Conclusion Our proposed pathway clustering methods allow bioinformaticians and biologists to investigate how informative genes within pathways are related to each other and understand possible crosstalk between pathways in a cluster. Therefore, building pathway clusters may lead to a better understanding of molecular mechanisms affecting a trait of interest, and help generate further biological hypotheses from gene expression data.

  14. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

    Science.gov (United States)

    Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

    2015-06-01

    Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings. © The Author(s) 2015.

  15. Analysis of cost data in a cluster-randomized, controlled trial: comparison of methods

    DEFF Research Database (Denmark)

    Sokolowski, Ineta; Ørnbøl, Eva; Rosendal, Marianne

    is commonly used for skewed distributions. For health care data, however, we need to recover the total cost in a given patient population. Thus, we focus, on making inferences on population means. Furthermore, a problem of clustered data is added as data related to patients in primary care are organized...... in clusters of general practices.   There have been suggestions to apply different methods, e.g., the non-parametric bootstrap, to highly skewed data from pragmatic randomized trials without clusters, but there is very little information about how to analyse skewed data from cluster-randomized trials. Many......  We consider health care data from a cluster-randomized intervention study in primary care to test whether the average health care costs among study patients differ between the two groups. The problems of analysing cost data are that most data are severely skewed. Median instead of mean...

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

    NARCIS (Netherlands)

    Jochems, E.C.; van der Feltz-Cornelis, C.M.; van Dam, A.; Duivenvoorden, H.J.; Mulder, C.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).

  17. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Engers, AJ; Wensing, M.; van Tulder, M.; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN.: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES.: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence

  18. Magnetic field alignment of randomly oriented, high aspect ratio silicon microwires into vertically oriented arrays.

    Science.gov (United States)

    Beardslee, Joseph A; Sadtler, Bryce; Lewis, Nathan S

    2012-11-27

    External magnetic fields have been used to vertically align ensembles of silicon microwires coated with ferromagnetic nickel films. X-ray diffraction and image analysis techniques were used to quantify the degree of vertical orientation of the microwires. The degree of vertical alignment and the minimum field strength required for alignment were evaluated as a function of the wire length, coating thickness, magnetic history, and substrate surface properties. Nearly 100% of 100 μm long, 2 μm diameter, Si microwires that had been coated with 300 nm of Ni could be vertically aligned by a 300 G magnetic field. For wires ranging from 40 to 60 μm in length, as the length of the wire increased, a higher degree of alignment was observed at lower field strengths, consistent with an increase in the available magnetic torque. Microwires that had been exposed to a magnetic sweep up to 300 G remained magnetized and, therefore, aligned more readily during subsequent magnetic field alignment sweeps. Alignment of the Ni-coated Si microwires occurred at lower field strengths on hydrophilic Si substrates than on hydrophobic Si substrates. The magnetic field alignment approach provides a pathway for the directed assembly of solution-grown semiconductor wires into vertical arrays, with potential applications in solar cells as well as in other electronic devices that utilize nano- and microscale components as active elements.

  19. Prediction models for clustered data: comparison of a random intercept and standard regression model.

    Science.gov (United States)

    Bouwmeester, Walter; Twisk, Jos W R; Kappen, Teus H; van Klei, Wilton A; Moons, Karel G M; Vergouwe, Yvonne

    2013-02-15

    When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. The models with random intercept discriminate better than the standard model only

  20. A Coupled Hidden Markov Random Field Model for Simultaneous Face Clustering and Tracking in Videos

    KAUST Repository

    Wu, Baoyuan

    2016-10-25

    Face clustering and face tracking are two areas of active research in automatic facial video processing. They, however, have long been studied separately, despite the inherent link between them. In this paper, we propose to perform simultaneous face clustering and face tracking from real world videos. The motivation for the proposed research is that face clustering and face tracking can provide useful information and constraints to each other, thus can bootstrap and improve the performances of each other. To this end, we introduce a Coupled Hidden Markov Random Field (CHMRF) to simultaneously model face clustering, face tracking, and their interactions. We provide an effective algorithm based on constrained clustering and optimal tracking for the joint optimization of cluster labels and face tracking. We demonstrate significant improvements over state-of-the-art results in face clustering and tracking on several videos.

  1. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Dreyhaupt, Jens

    2017-05-01

    Full Text Available An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”. Compared with studies with individual randomization, studies with cluster randomization normally require (significantly larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies.Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  2. Pseudo cluster randomization dealt with selection bias and contamination in clinical trials

    NARCIS (Netherlands)

    Teerenstra, S.; Melis, R.J.F.; Peer, P.G.M.; Borm, G.F.

    2006-01-01

    BACKGROUND AND OBJECTIVES: When contamination is present, randomization on a patient level leads to dilution of the treatment effect. The usual solution is to randomize on a cluster level, but at the cost of efficiency and more importantly, this may introduce selection bias. Furthermore, it may slow

  3. cluster randomIzed trIal of the uptake of a take-home Infant dose of ...

    African Journals Online (AJOL)

    2010-07-07

    Jul 7, 2010 ... cluster randomIzed trIal of the uptake of a take-home Infant dose of nevIrapIne In kenya. H. W. ReynOldS, O. GACHunO, J. kAyITA, m. A. HAyS and J. RAkWAR, abstract. Objective: to test whether a single take home dose of infant nevirapine increased infant uptake without decreasing institutional deliveries.

  4. Generalized Mittag-Leffler relaxation: clustering-jump continuous-time random walk approach.

    Science.gov (United States)

    Jurlewicz, Agnieszka; Weron, Karina; Teuerle, Marek

    2008-07-01

    A stochastic generalization of renormalization-group transformation for continuous-time random walk processes is proposed. The renormalization consists in replacing the jump events from a randomly sized cluster by a single renormalized (i.e., overall) jump. The clustering of the jumps, followed by the corresponding transformation of the interjump time intervals, yields a new class of coupled continuous-time random walks which, applied to modeling of relaxation, lead to the general power-law properties usually fitted with the empirical Havriliak-Negami function.

  5. Developing leadership capacity for guideline use: a pilot cluster randomized control trial.

    Science.gov (United States)

    Gifford, Wendy A; Davies, Barbara L; Graham, Ian D; Tourangeau, Ann; Woodend, A Kirsten; Lefebre, Nancy

    2013-02-01

    The importance of leadership to influence nurses' use of clinical guidelines has been well documented. However, little is known about how to develop and evaluate leadership interventions for guideline use. The purpose of this study was to pilot a leadership intervention designed to influence nurses' use of guideline recommendations when caring for patients with diabetic foot ulcers in home care nursing. This paper reports on the feasibility of implementing the study protocol, the trial findings related to nursing process outcomes, and leadership behaviors. A mixed methods pilot study was conducted with a post-only cluster randomized controlled trial and descriptive qualitative interviews. Four units were randomized to control or experimental groups. Clinical and management leadership teams participated in a 12-week leadership intervention (workshop, teleconferences). Participants received summarized chart audit data, identified goals for change, and created a team leadership action. Criteria to assess feasibility of the protocol included: design, intervention, measures, and data collection procedures. For the trial, chart audits compared differences in nursing process outcomes. 8-item nursing assessments score. Secondary outcome: 5-item score of nursing care based on goals for change identified by intervention participants. Qualitative interviews described leadership behaviors that influenced guideline use. Conducting this pilot showed some aspects of the study protocol were feasible, while others require further development. Trial findings observed no significant difference in the primary outcome. A significant increase was observed in the 5-item score chosen by intervention participants (p = 0.02). In the experimental group more relations-oriented leadership behaviors, audit and feedback and reminders were described as leadership strategies. Findings suggest that a leadership intervention has the potential to influence nurses' use of guideline recommendations

  6. Clustering, randomness, and regularity in cloud fields. 4: Stratocumulus cloud fields

    Science.gov (United States)

    Lee, J.; Chou, J.; Weger, R. C.; Welch, R. M.

    1994-01-01

    To complete the analysis of the spatial distribution of boundary layer cloudiness, the present study focuses on nine stratocumulus Landsat scenes. The results indicate many similarities between stratocumulus and cumulus spatial distributions. Most notably, at full spatial resolution all scenes exhibit a decidedly clustered distribution. The strength of the clustering signal decreases with increasing cloud size; the clusters themselves consist of a few clouds (less than 10), occupy a small percentage of the cloud field area (less than 5%), contain between 20% and 60% of the cloud field population, and are randomly located within the scene. In contrast, stratocumulus in almost every respect are more strongly clustered than are cumulus cloud fields. For instance, stratocumulus clusters contain more clouds per cluster, occupy a larger percentage of the total area, and have a larger percentage of clouds participating in clusters than the corresponding cumulus examples. To investigate clustering at intermediate spatial scales, the local dimensionality statistic is introduced. Results obtained from this statistic provide the first direct evidence for regularity among large (more than 900 m in diameter) clouds in stratocumulus and cumulus cloud fields, in support of the inhibition hypothesis of Ramirez and Bras (1990). Also, the size compensated point-to-cloud cumulative distribution function statistic is found to be necessary to obtain a consistent description of stratocumulus cloud distributions. A hypothesis regarding the underlying physical mechanisms responsible for cloud clustering is presented. It is suggested that cloud clusters often arise from 4 to 10 triggering events localized within regions less than 2 km in diameter and randomly distributed within the cloud field. As the size of the cloud surpasses the scale of the triggering region, the clustering signal weakens and the larger cloud locations become more random.

  7. Cluster Oriented Spatio Temporal Multidimensional Data Visualization of Earthquakes in Indonesia

    Directory of Open Access Journals (Sweden)

    Mohammad Nur Shodiq

    2016-03-01

    Full Text Available Spatio temporal data clustering is challenge task. The result of clustering data are utilized to investigate the seismic parameters. Seismic parameters are used to describe the characteristics of earthquake behavior. One of the effective technique to study multidimensional spatio temporal data is visualization. But, visualization of multidimensional data is complicated problem. Because, this analysis consists of observed data cluster and seismic parameters. In this paper, we propose a visualization system, called as IES (Indonesia Earthquake System, for cluster analysis, spatio temporal analysis, and visualize the multidimensional data of seismic parameters. We analyze the cluster analysis by using automatic clustering, that consists of get optimal number of cluster and Hierarchical K-means clustering. We explore the visual cluster and multidimensional data in low dimensional space visualization. We made experiment with observed data, that consists of seismic data around Indonesian archipelago during 2004 to 2014. Keywords: Clustering, visualization, multidimensional data, seismic parameters.

  8. Functional Principal Component Analysis and Randomized Sparse Clustering Algorithm for Medical Image Analysis

    Science.gov (United States)

    Lin, Nan; Jiang, Junhai; Guo, Shicheng; Xiong, Momiao

    2015-01-01

    Due to the advancement in sensor technology, the growing large medical image data have the ability to visualize the anatomical changes in biological tissues. As a consequence, the medical images have the potential to enhance the diagnosis of disease, the prediction of clinical outcomes and the characterization of disease progression. But in the meantime, the growing data dimensions pose great methodological and computational challenges for the representation and selection of features in image cluster analysis. To address these challenges, we first extend the functional principal component analysis (FPCA) from one dimension to two dimensions to fully capture the space variation of image the signals. The image signals contain a large number of redundant features which provide no additional information for clustering analysis. The widely used methods for removing the irrelevant features are sparse clustering algorithms using a lasso-type penalty to select the features. However, the accuracy of clustering using a lasso-type penalty depends on the selection of the penalty parameters and the threshold value. In practice, they are difficult to determine. Recently, randomized algorithms have received a great deal of attentions in big data analysis. This paper presents a randomized algorithm for accurate feature selection in image clustering analysis. The proposed method is applied to both the liver and kidney cancer histology image data from the TCGA database. The results demonstrate that the randomized feature selection method coupled with functional principal component analysis substantially outperforms the current sparse clustering algorithms in image cluster analysis. PMID:26196383

  9. Functional Principal Component Analysis and Randomized Sparse Clustering Algorithm for Medical Image Analysis.

    Directory of Open Access Journals (Sweden)

    Nan Lin

    Full Text Available Due to the advancement in sensor technology, the growing large medical image data have the ability to visualize the anatomical changes in biological tissues. As a consequence, the medical images have the potential to enhance the diagnosis of disease, the prediction of clinical outcomes and the characterization of disease progression. But in the meantime, the growing data dimensions pose great methodological and computational challenges for the representation and selection of features in image cluster analysis. To address these challenges, we first extend the functional principal component analysis (FPCA from one dimension to two dimensions to fully capture the space variation of image the signals. The image signals contain a large number of redundant features which provide no additional information for clustering analysis. The widely used methods for removing the irrelevant features are sparse clustering algorithms using a lasso-type penalty to select the features. However, the accuracy of clustering using a lasso-type penalty depends on the selection of the penalty parameters and the threshold value. In practice, they are difficult to determine. Recently, randomized algorithms have received a great deal of attentions in big data analysis. This paper presents a randomized algorithm for accurate feature selection in image clustering analysis. The proposed method is applied to both the liver and kidney cancer histology image data from the TCGA database. The results demonstrate that the randomized feature selection method coupled with functional principal component analysis substantially outperforms the current sparse clustering algorithms in image cluster analysis.

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

    Science.gov (United States)

    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.

  11. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  12. Quenched Large Deviations for Simple Random Walks on Percolation Clusters Including Long-Range Correlations

    Science.gov (United States)

    Berger, Noam; Mukherjee, Chiranjib; Okamura, Kazuki

    2017-12-01

    We prove a quenched large deviation principle (LDP) for a simple random walk on a supercritical percolation cluster (SRWPC) on {Z^d} ({d ≥ 2} ). The models under interest include classical Bernoulli bond and site percolation as well as models that exhibit long range correlations, like the random cluster model, the random interlacement and the vacant set of random interlacements (for {d ≥ 3} ) and the level sets of the Gaussian free field ({d≥ 3} ). Inspired by the methods developed by Kosygina et al. (Commun Pure Appl Math 59:1489-1521, 2006) for proving quenched LDP for elliptic diffusions with a random drift, and by Yilmaz (Commun Pure Appl Math 62(8):1033-1075, 2009) and Rosenbluth (Quenched large deviations for multidimensional random walks in a random environment: a variational formula. Ph.D. thesis, NYU, arXiv:0804.1444v1) for similar results regarding elliptic random walks in random environment, we take the point of view of the moving particle and prove a large deviation principle for the quenched distribution of the pair empirical measures of the environment Markov chain in the non-elliptic case of SRWPC. Via a contraction principle, this reduces easily to a quenched LDP for the distribution of the mean velocity of the random walk and both rate functions admit explicit variational formulas. The main difficulty in our set up lies in the inherent non-ellipticity as well as the lack of translation-invariance stemming from conditioning on the fact that the origin belongs to the infinite cluster. We develop a unifying approach for proving quenched large deviations for SRWPC based on exploiting coercivity properties of the relative entropies in the context of convex variational analysis, combined with input from ergodic theory and invoking geometric properties of the supercritical percolation cluster.

  13. Microwave single-scattering properties of randomly oriented soft-ice hydrometeors

    Directory of Open Access Journals (Sweden)

    D. Casella

    2008-11-01

    Full Text Available Large ice hydrometeors are usually present in intense convective clouds and may significantly affect the upwelling radiances that are measured by satellite-borne microwave radiometers – especially, at millimeter-wavelength frequencies. Thus, interpretation of these measurements (e.g., for precipitation retrieval requires knowledge of the single scattering properties of ice particles. On the other hand, shape and internal structure of these particles (especially, the larger ones is very complex and variable, and therefore it is necessary to resort to simplifying assumptions in order to compute their single-scattering parameters.

    In this study, we use the discrete dipole approximation (DDA to compute the absorption and scattering efficiencies and the asymmetry factor of two kinds of quasi-spherical and non-homogeneous soft-ice particles in the frequency range 50–183 GHz. Particles of the first kind are modeled as quasi-spherical ice particles having randomly distributed spherical air inclusions. Particles of the second kind are modeled as random aggregates of ice spheres having random radii. In both cases, particle densities and dimensions are coherent with the snow hydrometeor category that is utilized by the University of Wisconsin – Non-hydrostatic Modeling System (UW-NMS cloud-mesoscale model. Then, we compare our single-scattering results for randomly-oriented soft-ice hydrometeors with corresponding ones that make use of: a effective-medium equivalent spheres, b solid-ice equivalent spheres, and c randomly-oriented aggregates of ice cylinders. Finally, we extend to our particles the scattering formulas that have been developed by other authors for randomly-oriented aggregates of ice cylinders.

  14. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

    OpenAIRE

    Osrin, D.; Azad, K.; Fernandez, A.; Manandhar, D. S.; Mwansambo, C. W.; Tripathy, P.; Costello, A. M.

    2009-01-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common ...

  15. Graded index and randomly oriented core-shell silicon nanowires for broadband and wide angle antireflection

    Directory of Open Access Journals (Sweden)

    P. Pignalosa

    2011-09-01

    Full Text Available Antireflection with broadband and wide angle properties is important for a wide range of applications on photovoltaic cells and display. The SiOx shell layer provides a natural antireflection from air to the Si core absorption layer. In this work, we have demonstrated the random core-shell silicon nanowires with both broadband (from 400nm to 900nm and wide angle (from normal incidence to 60º antireflection characteristics within AM1.5 solar spectrum. The graded index structure from the randomly oriented core-shell (Air/SiOx/Si nanowires may provide a potential avenue to realize a broadband and wide angle antireflection layer.

  16. Clustering statistics, roughness feedbacks, and randomness in experimental step-pool morphodynamics

    Science.gov (United States)

    Johnson, Joel P. L.

    2017-04-01

    Step pools are a common bed morphology in boulder-rich gravel streams, but predicting how mountainous landscapes will respond to environmental perturbations such as climate-related hydrological changes requires a better understanding of channel morphodynamics and factors that influence bed stability. Flume experiments exploring bed stabilization demonstrate feedbacks among surface roughness, coarse grain clustering, and surface grain size. Clustering is quantified by using a novel normalization of Ripley's K statistic designed for use in power law functions. At 95% confidence, many but not all beds stabilized with coarse grains becoming more clustered than complete spatial randomness. The clustering statistic predicts hydraulic roughness better than D84 does (the diameter at which 84% of grains are smaller), suggesting that the spatial organization of the bed can be a stronger control than grain size on flow hydraulics. Initial conditions affect the degree of clustering at stability, indicating sensitivity to history.

  17. When is informed consent required in cluster randomized trials in health research?

    Science.gov (United States)

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it

  18. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

    OpenAIRE

    McCarren M; Twedt EL; Mansuri FM; Nelson PR; Peek BT

    2014-01-01

    Madeline McCarren,1 Elaine L Twedt,1 Faizmohamed M Mansuri,2 Philip R Nelson,3 Brian T Peek3 1Pharmacy Benefits Management Services, Department of Veterans Affairs, Hines, IL, 2Wilkes-Barre VA Medical Center, Wilkes-Barre, PA, 3Charles George VA Medical Center, Asheville, NC, USA Purpose: Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters...

  19. Clustering Single-Cell Expression Data Using Random Forest Graphs.

    Science.gov (United States)

    Pouyan, Maziyar Baran; Nourani, Mehrdad

    2017-07-01

    Complex tissues such as brain and bone marrow are made up of multiple cell types. As the study of biological tissue structure progresses, the role of cell-type-specific research becomes increasingly important. Novel sequencing technology such as single-cell cytometry provides researchers access to valuable biological data. Applying machine-learning techniques to these high-throughput datasets provides deep insights into the cellular landscape of the tissue where those cells are a part of. In this paper, we propose the use of random-forest-based single-cell profiling, a new machine-learning-based technique, to profile different cell types of intricate tissues using single-cell cytometry data. Our technique utilizes random forests to capture cell marker dependences and model the cellular populations using the cell network concept. This cellular network helps us discover what cell types are in the tissue. Our experimental results on public-domain datasets indicate promising performance and accuracy of our technique in extracting cell populations of complex tissues.

  20. What is the role and authority of gatekeepers in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Gallo Antonio

    2012-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers. Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the

  1. Effectiveness of the Comprehensive Approach to Rehabilitation (CARe) methodology: design of a cluster randomized controlled trial.

    Science.gov (United States)

    Bitter, Neis A; Roeg, Diana P K; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

    2015-07-22

    There is an increasing amount of evidence for the effectiveness of rehabilitation interventions for people with severe mental illness (SMI). In the Netherlands, a rehabilitation methodology that is well known and often applied is the Comprehensive Approach to Rehabilitation (CARe) methodology. The overall goal of the CARe methodology is to improve the client's quality of life by supporting the client in realizing his/her goals and wishes, handling his/her vulnerability and improving the quality of his/her social environment. The methodology is strongly influenced by the concept of 'personal recovery' and the 'strengths case management model'. No controlled effect studies have been conducted hitherto regarding the CARe methodology. This study is a two-armed cluster randomized controlled trial (RCT) that will be executed in teams from three organizations for sheltered and supported housing, which provide services to people with long-term severe mental illness. Teams in the intervention group will receive the multiple-day CARe methodology training from a specialized institute and start working according the CARe Methodology guideline. Teams in the control group will continue working in their usual way. Standardized questionnaires will be completed at baseline (T0), and 10 (T1) and 20 months (T2) post baseline. Primary outcomes are recovery, social functioning and quality of life. The model fidelity of the CARe methodology will be assessed at T1 and T2. This study is the first controlled effect study on the CARe methodology and one of the few RCTs on a broad rehabilitation method or strength-based approach. This study is relevant because mental health care organizations have become increasingly interested in recovery and rehabilitation-oriented care. The trial registration number is ISRCTN77355880 .

  2. Improvement of hypertension management by structured physician education and feedback system: cluster randomized trial.

    Science.gov (United States)

    Lüders, Stefan; Schrader, Joachim; Schmieder, Roland E; Smolka, Wenefrieda; Wegscheider, Karl; Bestehorn, Kurt

    2010-06-01

    We aimed to assess whether hypertension management with a structured physician information program and a feedback system leads to improved blood pressure (BP) control and cardiovascular outcomes. Cluster randomized (3 : 1), open, monitored, multicenter trial in Germany. Primary care-based physicians in the information group (IG) received detailed training on hypertension guidelines, feedback on target-level attainment, and a reminder to intensify treatment after each patient visit, whereas the observation/control group (CG) did not receive any such measures. A three-level mixed model was developed. Time-independent level differences between groups, group-independent changes, and nonparallel group-specific changes over time were tested. A total of 15 041 (78.1%) hypertensive patients were in the IG and 4213 (21.9%) in the CG. By 1-year follow-up, 82.9% of patients in the IG and 81.5% in the CG remained in the study. The guideline-oriented BP target was attained by 56.8% in the IG and 52.5% in the CG (+4.3%, P = 0.03), whereas the individual BP target was attained by 57.0% in the IG and 51% in the CG (P = NS). BP control in the IG was achieved 2 months earlier on average. Clinical inertia, defined as the absence of medication changes, despite noncontrol of BP, occurred significantly less often in the IG group. One-year cardiovascular outcomes did not differ between groups. The delivery of systematic information in connection with a feedback system reduces clinical inertia and improves guideline adherence. Although compared with earlier studies, the hypertension control rates obtained are higher, there is still considerable room for improvement.

  3. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations

    OpenAIRE

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2016-01-01

    Cluster-level dynamic treatment regimens can be used to guide sequential, intervention or treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level DTR, the intervention or treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including based on aggregate measures of the individuals or patients that comprise it. Cluster-randomized sequentia...

  4. Solvent minimization induces preferential orientation and crystal clustering in serial micro-crystallography on micro-meshes, in situ plates and on a movable crystal conveyor belt.

    Science.gov (United States)

    Soares, Alexei S; Mullen, Jeffrey D; Parekh, Ruchi M; McCarthy, Grace S; Roessler, Christian G; Jackimowicz, Rick; Skinner, John M; Orville, Allen M; Allaire, Marc; Sweet, Robert M

    2014-11-01

    X-ray diffraction data were obtained at the National Synchrotron Light Source from insulin and lysozyme crystals that were densely deposited on three types of surfaces suitable for serial micro-crystallography: MiTeGen MicroMeshes™, Greiner Bio-One Ltd in situ micro-plates, and a moving kapton crystal conveyor belt that is used to deliver crystals directly into the X-ray beam. 6° wedges of data were taken from ∼100 crystals mounted on each material, and these individual data sets were merged to form nine complete data sets (six from insulin crystals and three from lysozyme crystals). Insulin crystals have a parallelepiped habit with an extended flat face that preferentially aligned with the mounting surfaces, impacting the data collection strategy and the design of the serial crystallography apparatus. Lysozyme crystals had a cuboidal habit and showed no preferential orientation. Preferential orientation occluded regions of reciprocal space when the X-ray beam was incident normal to the data-collection medium surface, requiring a second pass of data collection with the apparatus inclined away from the orthogonal. In addition, crystals measuring less than 20 µm were observed to clump together into clusters of crystals. Clustering required that the X-ray beam be adjusted to match the crystal size to prevent overlapping diffraction patterns. No additional problems were encountered with the serial crystallography strategy of combining small randomly oriented wedges of data from a large number of specimens. High-quality data able to support a realistic molecular replacement solution were readily obtained from both crystal types using all three serial crystallography strategies.

  5. Cluster Randomized Trail of the uptake of a take-home Infant dose ...

    African Journals Online (AJOL)

    Objective: To test whether a single take home dose of infant nevirapine increased infant uptake without decreasing institutional deliveries. Design: Cluster randomized post-test only study with control group. Setting: Ten hospitals in urban areas of Coast, Rift Valley, and Western provinces, Kenya. Participants: Pregnant ...

  6. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records

    NARCIS (Netherlands)

    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C

    BACKGROUND AND PURPOSE: The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using

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

    NARCIS (Netherlands)

    E.C. Jochems (Eline); C.M. van der Feltz-Cornelis (Christina); A. van Dam (Arno); H.J. Duivenvoorden (Hugo); C.L. Mulder (Niels)

    2015-01-01

    textabstractObjective: 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).

  8. Efficacy of a Universal Parent Training Program (HOPE-20): Cluster Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Kwan, H. W.

    2017-01-01

    Objective: This study examined the efficacy of Hands-On Parent Empowerment-20 (HOPE-20) program. Methods: Eligible participants were parents residing in Hong Kong with target children aged 2 years attending nursery schools. Cluster randomized control trial was adopted, with 10 schools (110 participants) assigned to intervention group and 8 schools…

  9. Design and protocol of the weight loss lottery : A cluster randomized trial

    NARCIS (Netherlands)

    van der Swaluw, K.; Lambooij, M.; Mathijssen, J.J.P.; Schipper, M.; Zeelenberg, M.; Polder, J.J.; Prast, H.M.

    2016-01-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based

  10. Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias.

    NARCIS (Netherlands)

    Borm, G.F.; Melis, R.J.F.; Teerenstra, S.; Peer, P.G.M.

    2005-01-01

    In some clinical trials, treatment allocation on a patient level is not feasible, and whole groups or clusters of patients are allocated to the same treatment. If, for example, a clinical trial is investigating the efficacy of various patient coaching methods and randomization is done on a patient

  11. Power for Detecting Treatment by Moderator Effects in Two- and Three-Level Cluster Randomized Trials

    Science.gov (United States)

    Spybrook, Jessaca; Kelcey, Benjamin; Dong, Nianbo

    2016-01-01

    Recently, there has been an increase in the number of cluster randomized trials (CRTs) to evaluate the impact of educational programs and interventions. These studies are often powered for the main effect of treatment to address the "what works" question. However, program effects may vary by individual characteristics or by context,…

  12. Heuristic methods using variable neighborhood random local search for the clustered traveling salesman problem

    Directory of Open Access Journals (Sweden)

    Mário Mestria

    2014-11-01

    Full Text Available In this paper, we propose new heuristic methods for solver the Clustered Traveling Salesman Problem (CTSP. The CTSP is a generalization of the Traveling Salesman Problem (TSP in which the set of vertices is partitioned into disjoint clusters and objective is to find a minimum cost Hamiltonian cycle such that the vertices of each cluster are visited contiguously. We develop two Variable Neighborhood Random Descent with Iterated Local for solver the CTSP. The heuristic methods proposed were tested in types of instances with data at different level of granularity for the number of vertices and clusters. The computational results showed that the heuristic methods outperform recent existing methods in the literature and they are competitive with an exact algorithm using the Parallel CPLEX software.

  13. Bayesian Clustering Using Hidden Markov Random Fields in Spatial Population Genetics

    Science.gov (United States)

    François, Olivier; Ancelet, Sophie; Guillot, Gilles

    2006-01-01

    We introduce a new Bayesian clustering algorithm for studying population structure using individually geo-referenced multilocus data sets. The algorithm is based on the concept of hidden Markov random field, which models the spatial dependencies at the cluster membership level. We argue that (i) a Markov chain Monte Carlo procedure can implement the algorithm efficiently, (ii) it can detect significant geographical discontinuities in allele frequencies and regulate the number of clusters, (iii) it can check whether the clusters obtained without the use of spatial priors are robust to the hypothesis of discontinuous geographical variation in allele frequencies, and (iv) it can reduce the number of loci required to obtain accurate assignments. We illustrate and discuss the implementation issues with the Scandinavian brown bear and the human CEPH diversity panel data set. PMID:16888334

  14. Parameter Estimation in Stratified Cluster Sampling under Randomized Response Models for Sensitive Question Survey.

    Science.gov (United States)

    Pu, Xiangke; Gao, Ge; Fan, Yubo; Wang, Mian

    2016-01-01

    Randomized response is a research method to get accurate answers to sensitive questions in structured sample survey. Simple random sampling is widely used in surveys of sensitive questions but hard to apply on large targeted populations. On the other side, more sophisticated sampling regimes and corresponding formulas are seldom employed to sensitive question surveys. In this work, we developed a series of formulas for parameter estimation in cluster sampling and stratified cluster sampling under two kinds of randomized response models by using classic sampling theories and total probability formulas. The performances of the sampling methods and formulas in the survey of premarital sex and cheating on exams at Soochow University were also provided. The reliability of the survey methods and formulas for sensitive question survey was found to be high.

  15. Parameter Estimation in Stratified Cluster Sampling under Randomized Response Models for Sensitive Question Survey.

    Directory of Open Access Journals (Sweden)

    Xiangke Pu

    Full Text Available Randomized response is a research method to get accurate answers to sensitive questions in structured sample survey. Simple random sampling is widely used in surveys of sensitive questions but hard to apply on large targeted populations. On the other side, more sophisticated sampling regimes and corresponding formulas are seldom employed to sensitive question surveys. In this work, we developed a series of formulas for parameter estimation in cluster sampling and stratified cluster sampling under two kinds of randomized response models by using classic sampling theories and total probability formulas. The performances of the sampling methods and formulas in the survey of premarital sex and cheating on exams at Soochow University were also provided. The reliability of the survey methods and formulas for sensitive question survey was found to be high.

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

    Science.gov (United States)

    Wang, Wei; Griswold, Michael E.

    2016-01-01

    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. PMID:27449636

  17. Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Vlemmix, F.; Rosman, A.N.; Rijnders, M.E.; Beuckens, A.; Opmeer, B.C.; Mol, B.W.J.; Kok, M.; Fleuren, M.A.H.

    2015-01-01

    Onjective: To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Design: Cluster randomized controlled trial.Setting: Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the

  18. Cellular compatibility of RGD-modified chitosan nanofibers with aligned or random orientation

    Energy Technology Data Exchange (ETDEWEB)

    Wang Yanyan; Lue Lanxin; Feng Zhangqi; Xiao Zhongdang; Huang Ningping, E-mail: nphuang@seu.edu.c, E-mail: zdxiao@seu.edu.c [State Key Laboratory of Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096 (China)

    2010-10-01

    Aligned and randomly oriented chitosan nanofibers were prepared by electrospinning. The fibers were modified with the RGD cell-adhesive peptide through a heterobifunctional crosslinker containing a segment of poly(ethylene glycol) (PEG). PEG rendered the surface hydrophilic and provided flexible spacers, allowing the preservation of the bioactivity of further captured RGD peptides. NIH 3T3 cells were used to test the cellular compatibility of these chitosan nanofibrous scaffolds. Cell morphology and viability were investigated by SEM, fluorescent staining and cell counting. The results indicate that RGD-modified surfaces significantly improve the cellular compatibility of chitosan nanofibers and suggest a good candidate as a scaffold employed in tissue engineering.

  19. A review of R-packages for random-intercept probit regression in small clusters

    Directory of Open Access Journals (Sweden)

    Haeike Josephy

    2016-10-01

    Full Text Available Generalized Linear Mixed Models (GLMMs are widely used to model clustered categorical outcomes. To tackle the intractable integration over the random effects distributions, several approximation approaches have been developed for likelihood-based inference. As these seldom yield satisfactory results when analyzing binary outcomes from small clusters, estimation within the Structural Equation Modeling (SEM framework is proposed as an alternative. We compare the performance of R-packages for random-intercept probit regression relying on: the Laplace approximation, adaptive Gaussian quadrature (AGQ, penalized quasi-likelihood, an MCMC-implementation, and integrated nested Laplace approximation within the GLMM-framework, and a robust diagonally weighted least squares estimation within the SEM-framework. In terms of bias for the fixed and random effect estimators, SEM usually performs best for cluster size two, while AGQ prevails in terms of precision (mainly because of SEM's robust standard errors. As the cluster size increases, however, AGQ becomes the best choice for both bias and precision.

  20. Use of clustering analysis in randomized controlled trials in orthopaedic surgery.

    Science.gov (United States)

    Oltean, Hanna; Gagnier, Joel J

    2015-03-08

    The effects of clustering in randomized controlled trials (RCTs) and the resulting potential violation of assumptions of independence are now well recognized. When patients in a single study are treated by several therapists, there is good reason to suspect that the variation in outcome will be smaller for patients treated in the same group than for patients treated in different groups. This potential correlation of outcomes results in a loss of independence of observations. The purpose of this study is to examine the current use of clustering analysis in RCTs published in the top five journals of orthopaedic surgery. RCTs published from 2006 to 2010 in the top five journals of orthopaedic surgery, as determined by 5-year impact factor, that included multiple therapists and/or centers were included. Identified articles were assessed for accounting for the effects of clustering of therapists and/or centers in randomization or analysis. Logistic regression used both univariate and multivariate models, with use of clustering analysis as the outcome. Multivariate models were constructed using stepwise deletion. An alpha level of 0.10 was considered significant. A total of 271 articles classified as RCTs were identified from the five journals included in the study. Thirty-two articles were excluded due to inclusion of nonhuman subjects. Of the remaining 239 articles, 186 were found to include multiple centers and/or therapists. The prevalence of use of clustering analysis was 21.5%. Fewer than half of the studies reported inclusion of a statistician, epidemiologist or clinical trials methodologist on the team. In multivariate modeling, adjusting for clustering was associated with a 6.7 times higher odds of inclusion of any type of specialist on the team (P = 0.08). Likewise, trials that accounted for clustering had 3.3 times the odds of including an epidemiologist/clinical trials methodologist than those that did not account for clustering (P = 0.04). Including

  1. High-flow oxygen for treatment of cluster headache: a randomized trial.

    Science.gov (United States)

    Cohen, Anna S; Burns, Brian; Goadsby, Peter J

    2009-12-09

    Cluster headache is an excruciatingly painful primary headache syndrome, with attacks of unilateral pain and cranial autonomic symptoms. The current licensed treatment for acute attacks is subcutaneous sumatriptan. To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache. A double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged 18-70 years) with cluster headache as defined by the International Headache Society. Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately. Patients were randomized to the order in which they received the active treatment or placebo. Patients were recruited and followed up between 2002 and 2007 at the National Hospital for Neurology and Neurosurgery, London, England. Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start of an attack of cluster headache or high-flow air placebo delivered alternately for 4 attacks. The primary end point was to render the patient pain free, or in the absence of a diary to have adequate relief, at 15 minutes. Secondary end points included rendering the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for rescue medication 15 minutes after treatment, overall response to the treatment and overall functional disability, and effect on associated symptoms. Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache were available for the analysis. For the primary end point the difference between oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence interval, 14%-26%; for 148 attacks) was significant (Wald test, chi(5)(2) = 66.7, P Treatment of patients with cluster headache at symptom onset using inhaled high-flow oxygen compared with placebo was more likely to result in being pain-free at 15 minutes. isrctn.org Identifier: ISRCTN94092997.

  2. Precision of systematic and random sampling in clustered populations: habitat patches and aggregating organisms.

    Science.gov (United States)

    McGarvey, Richard; Burch, Paul; Matthews, Janet M

    2016-01-01

    Natural populations of plants and animals spatially cluster because (1) suitable habitat is patchy, and (2) within suitable habitat, individuals aggregate further into clusters of higher density. We compare the precision of random and systematic field sampling survey designs under these two processes of species clustering. Second, we evaluate the performance of 13 estimators for the variance of the sample mean from a systematic survey. Replicated simulated surveys, as counts from 100 transects, allocated either randomly or systematically within the study region, were used to estimate population density in six spatial point populations including habitat patches and Matérn circular clustered aggregations of organisms, together and in combination. The standard one-start aligned systematic survey design, a uniform 10 x 10 grid of transects, was much more precise. Variances of the 10 000 replicated systematic survey mean densities were one-third to one-fifth of those from randomly allocated transects, implying transect sample sizes giving equivalent precision by random survey would need to be three to five times larger. Organisms being restricted to patches of habitat was alone sufficient to yield this precision advantage for the systematic design. But this improved precision for systematic sampling in clustered populations is underestimated by standard variance estimators used to compute confidence intervals. True variance for the survey sample mean was computed from the variance of 10 000 simulated survey mean estimates. Testing 10 published and three newly proposed variance estimators, the two variance estimators (v) that corrected for inter-transect correlation (ν₈ and ν(W)) were the most accurate and also the most precise in clustered populations. These greatly outperformed the two "post-stratification" variance estimators (ν₂ and ν₃) that are now more commonly applied in systematic surveys. Similar variance estimator performance rankings were found with

  3. Public attitudes toward child undervaccination: A randomized experiment on evaluations, stigmatizing orientations, and support for policies.

    Science.gov (United States)

    Carpiano, Richard M; Fitz, Nicholas S

    2017-07-01

    Child undervaccination is a complex public health problem and a contentious social and political issue. Efforts to increase vaccination coverage require understanding how the public evaluates different reasons for child undervaccination, which may influence attitudes, stigmatizing behaviors, and support for vaccination policies. We conducted a vignette experiment with a United States national online sample (n = 1469) to investigate how and why different undervaccination actions shape evaluations (blame, anger, sympathy, differentness, credibility, dangerousness), stigmatizing orientations (social distance, discrimination), and support for particular policies (e.g., research funding, belief exemptions, fines). Each participant was randomly assigned to read one of four vignettes that described a mother who either refused vaccines, delayed vaccines, encountered social barriers to obtaining vaccines, or was up-to-date on vaccines for her child. Compared to the up-to-date condition, each undervaccination action predicted significantly more negative evaluations and stigmatizing orientations. Vaccine refusal was the most negatively appraised. Differences in social distance and discrimination were explained by negative evaluations about the parent. These evaluations and orientations predicted support for a range of policies. Negative parental evaluations were associated with increased support for more severe policies. We discuss the implications of these findings for addressing undervaccination and informing health scholarship on stigma. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Vibration Analysis of Randomly Oriented Carbon Nanotube Based on FGM Beam Using Timoshenko Theory

    Directory of Open Access Journals (Sweden)

    Mohammad Amin Rashidifar

    2015-02-01

    Full Text Available The carbon nanotube (CNT reinforced functionally graded materials (FGM are expected to be the new generation materials having wide range of unexplored potential applications in various technological areas such as aerospace and structural and chemical industry. The present work deals with the finite element modeling and free vibration analysis of CNT based functionally graded beam using three-dimensional Timoshenko beam theory. It has been assumed that the material properties of CNT based FG beam vary only along the thickness and these properties are evaluated by rule of mixture. The extended Hamilton principle has been applied to find out the governing equations of CNT based FG beam. Finite element method is used to solve governing equation with the exact shape functions. Initial analysis deals with CNTs assumed to be oriented along the length direction only. But practically it is not possible. So, further work deals with the free vibration analysis of functionally graded nanocomposite beams reinforced by randomly oriented straight single walled carbon nanotubes (SWCNTs. The Eshelby-Mori-Tanaka approach based on an equivalent fiber is used to investigate the material properties of the beam. Results are presented in tabular and graphical forms to show the effects of carbon nanotube orientations, slenderness ratios, and boundary conditions on the dynamic behavior of the beam.

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

    Science.gov (United States)

    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.

  6. Real-Space x-ray tomographic reconstruction of randomly oriented objects with sparse data frames.

    Science.gov (United States)

    Ayyer, Kartik; Philipp, Hugh T; Tate, Mark W; Elser, Veit; Gruner, Sol M

    2014-02-10

    Schemes for X-ray imaging single protein molecules using new x-ray sources, like x-ray free electron lasers (XFELs), require processing many frames of data that are obtained by taking temporally short snapshots of identical molecules, each with a random and unknown orientation. Due to the small size of the molecules and short exposure times, average signal levels of much less than 1 photon/pixel/frame are expected, much too low to be processed using standard methods. One approach to process the data is to use statistical methods developed in the EMC algorithm (Loh & Elser, Phys. Rev. E, 2009) which processes the data set as a whole. In this paper we apply this method to a real-space tomographic reconstruction using sparse frames of data (below 10(-2) photons/pixel/frame) obtained by performing x-ray transmission measurements of a low-contrast, randomly-oriented object. This extends the work by Philipp et al. (Optics Express, 2012) to three dimensions and is one step closer to the single molecule reconstruction problem.

  7. Effect of NICU Department Orientation Program on Mother’s Anxiety: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Leila Valizadeh

    2016-09-01

    Full Text Available 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.

  8. Do Sexually Oriented Massage Parlors Cluster in Specific Neighborhoods? A Spatial Analysis of Indoor Sex Work in Los Angeles and Orange Counties, California

    Science.gov (United States)

    Kim, Anna J.; Takahashi, Lois; Wiebe, Douglas J.

    2015-01-01

    Objective Social determinants of health may be substantially affected by spatial factors, which together may explain the persistence of health inequities. Clustering of possible sources of negative health and social outcomes points to a spatial focus for future interventions. We analyzed the spatial clustering of sex work businesses in Southern California to examine where and why they cluster. We explored economic and legal factors as possible explanations of clustering. Methods We manually coded data from a website used by paying members to post reviews of female massage parlor workers. We identified clusters of sexually oriented massage parlor businesses using spatial autocorrelation tests. We conducted spatial regression using census tract data to identify predictors of clustering. Results A total of 889 venues were identified. Clusters of tracts having higher-than-expected numbers of sexually oriented massage parlors (“hot spots”) were located outside downtowns. These hot spots were characterized by a higher proportion of adult males, a higher proportion of households below the federal poverty level, and a smaller average household size. Conclusion Sexually oriented massage parlors in Los Angeles and Orange counties cluster in particular neighborhoods. More research is needed to ascertain the causal factors of such clusters and how interventions can be designed to leverage these spatial factors. PMID:26327731

  9. Cluster-randomized trial of a German leisure-based alcohol peer education measure

    OpenAIRE

    B?hler, Anneke; Thrul, Johannes; Str?ber, Evelin; Orth, Boris

    2015-01-01

    Because of scarce research, the effectiveness of substance abuse prevention in leisure settings remains unclear. In this study, we evaluated the effectiveness of a peer-led educational prevention measure with adolescent groups in unstructured leisure settings, which is a component of the complex German nationwide ?Na Toll!? campaign. Using a cluster-randomized two-group post-test-only design, we tested whether the measure influenced component-specific goals, namely risk and protective factors...

  10. Demo Abstract: Service Oriented Wireless Sensor Networks - A Cluster-based Approach

    NARCIS (Netherlands)

    Marin Perianu, Raluca; Scholten, Johan; Havinga, Paul J.M.

    In this paper we demonstrate a service-oriented solution for heterogeneous WSNs. The main operations are service discovery and service usage. Our solution is integrated with mobile platforms (smartphones and PDAs), that act as gateways to the GSM network and the Internet.

  11. Guiding the orientation of smooth muscle cells on random and aligned polyurethane/collagen nanofibers.

    Science.gov (United States)

    Jia, Lin; Prabhakaran, Molamma P; Qin, Xiaohong; Ramakrishna, Seeram

    2014-09-01

    Fabricating scaffolds that can simulate the architecture and functionality of native extracellular matrix is a huge challenge in vascular tissue engineering. Various kinds of materials are engineered via nano-technological approaches to meet the current challenges in vascular tissue regeneration. During this study, nanofibers from pure polyurethane and hybrid polyurethane/collagen in two different morphologies (random and aligned) and in three different ratios of polyurethane:collagen (75:25; 50:50; 25:75) are fabricated by electrospinning. The fiber diameters of the nanofibrous scaffolds are in the range of 174-453 nm and 145-419 for random and aligned fibers, respectively, where they closely mimic the nanoscale dimensions of native extracellular matrix. The aligned polyurethane/collagen nanofibers expressed anisotropic wettability with mechanical properties which is suitable for regeneration of the artery. After 12 days of human aortic smooth muscle cells culture on different scaffolds, the proliferation of smooth muscle cells on hybrid polyurethane/collagen (3:1) nanofibers was 173% and 212% higher than on pure polyurethane scaffolds for random and aligned scaffolds, respectively. The results of cell morphology and protein staining showed that the aligned polyurethane/collagen (3:1) scaffold promote smooth muscle cells alignment through contact guidance, while the random polyurethane/collagen (3:1) also guided cell orientation most probably due to the inherent biochemical composition. Our studies demonstrate the potential of aligned and random polyurethane/collagen (3:1) as promising substrates for vascular tissue regeneration. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  12. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.

    Science.gov (United States)

    Arnup, Sarah J; Forbes, Andrew B; Kahan, Brennan C; Morgan, Katy E; McKenzie, Joanne E

    2016-06-01

    To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials. We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus; and citation searches of CRXO methodological articles were conducted to December 2014. We extracted data on design characteristics and statistical methods for sample size, data analysis, and handling of missing data. Ninety-one trials including 139 end point analyses met the inclusion criteria. Trials had a median of nine clusters [interquartile range (IQR), 4-21] and median cluster-period size of 30 individuals (IQR, 14-77); 58 (69%) trials had two periods, and 27 trials (30%) included the same individuals in all periods. A rationale for the design was reported in only 25 trials (27%). A sample size justification was provided in 53 (58%) trials. Only nine (10%) trials accounted appropriately for the design in their sample size calculation. Ten of the 12 cluster-level analyses used a method that accounted for the clustering and multiple-period aspects of the design. In contrast, only 4 of the 127 individual-level analyses used a potentially appropriate method. There is a need for improved application of appropriate analysis and sample size methods, and reporting, in CRXO trials. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Selection bias and subject refusal in a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rochelle Yang

    2017-07-01

    Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

  14. Geometry controlled anomalous diffusion in random fractal geometries: looking beyond the infinite cluster.

    Science.gov (United States)

    Mardoukhi, Yousof; Jeon, Jae-Hyung; Metzler, Ralf

    2015-11-28

    We investigate the ergodic properties of a random walker performing (anomalous) diffusion on a random fractal geometry. Extensive Monte Carlo simulations of the motion of tracer particles on an ensemble of realisations of percolation clusters are performed for a wide range of percolation densities. Single trajectories of the tracer motion are analysed to quantify the time averaged mean squared displacement (MSD) and to compare this with the ensemble averaged MSD of the particle motion. Other complementary physical observables associated with ergodicity are studied, as well. It turns out that the time averaged MSD of individual realisations exhibits non-vanishing fluctuations even in the limit of very long observation times as the percolation density approaches the critical value. This apparent non-ergodic behaviour concurs with the ergodic behaviour on the ensemble averaged level. We demonstrate how the non-vanishing fluctuations in single particle trajectories are analytically expressed in terms of the fractal dimension and the cluster size distribution of the random geometry, thus being of purely geometrical origin. Moreover, we reveal that the convergence scaling law to ergodicity, which is known to be inversely proportional to the observation time T for ergodic diffusion processes, follows a power-law ∼T(-h) with h fractal structure of the accessible space. These results provide useful measures for differentiating the subdiffusion on random fractals from an otherwise closely related process, namely, fractional Brownian motion. Implications of our results on the analysis of single particle tracking experiments are provided.

  15. Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol.

    Science.gov (United States)

    Chavane, Leonardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo-Harris, Jennifer; Bergel, Eduardo; Aleman, Alicia; Colomar, Mercedes; Cafferata, Maria Luisa; Carbonell, Alicia; Crahay, Beatrice; Delvaux, Therese; Geelhoed, Diederike; Gülmezoglu, Metin; Malapende, Celsa Regina; Melo, Armando; Nguyen, My Huong; Osman, Nafissa Bique; Widmer, Mariana; Temmerman, Marleen; Althabe, Fernando

    2014-05-21

    Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in

  16. Deducing fast electron density changes in randomly orientated uncrystallized biomolecules in a pump-probe experiment.

    Science.gov (United States)

    Pande, K; Schwander, P; Schmidt, M; Saldin, D K

    2014-07-17

    We propose a method for deducing time-resolved structural changes in uncrystallized biomolecules in solution. The method relies on measuring the angular correlations of the intensities, when averaged over a large number of diffraction patterns from randomly oriented biomolecules in solution in a liquid solvent. The experiment is somewhat like a pump-probe version of an experiment on small angle X-ray scattering, except that the data expected by the algorithm are not just the radial variation of the averaged intensities. The differences of these correlation functions as measured from a photoexcited and dark structure enable the direct calculation of the difference electron density with a knowledge of only the dark structure. We exploit a linear relation we derive between the difference in these correlation functions and the difference electron density, applicable for small structural changes.

  17. Patient-oriented rehabilitation in the management of chronic mechanical neck pain: a randomized controlled trial.

    Science.gov (United States)

    Paoloni, M; Tavernese, E; Cacchio, A; Tattoli, M; Melis, L; Ronconi, R; Santilli, V

    2013-06-01

    Management of chronic mechanical neck pain (CMNP) still represents a challenge. A patient-oriented (Pa-O) therapeutic approach could be considered as the one in which therapies are scheduled at the start of each therapeutic session according to the patient's current physical status, and differs from a prescription-oriented (Pr-O) therapeutic approach, in which therapies are prescribed at the first medical referral and are not adjusted at any time during the treatment period. To determine if a Pa-O approach may be more beneficial for CMNP patients when compared to a Pr-O one. Randomized controlled trial. 220 CMNP outpatients randomized to either Pa-O group (N.=114) or Pr-O group (N.=106). Each group received 10 therapeutic sessions over 3 weeks. Primary outcome measures were pain assessment, evaluated by Visual-Analog-Scale (VAS), and disability level, evaluated by the Neck Pain and Disability Scale (NPDS-I). Secondary outcome measures included patients' response to treatment and treatment failures. Measurements were carried out at baseline (T0) and 1 month after treatment ended (T1). Data were analysed according to the intention-to-treat principle. Patients in both groups displayed at T1 a significant reduction in VAS and NPDS-I scores. The relative changes at T1 were greater in Pa-O group when compared with Pr-O group both for VAS (61.5% versus 48.8%; Pup in suffers from CMNP. However, the occurrence of a performance-bias due to the increased level of attention from physicians to patients in Pa-O group, cannot be ruled-out. A Pa-O approach should be considered for CMNP also in an outpatient facility.

  18. Effect of SiC Nano powder on Multiaxial Woven and Chopped Randomly Oriented Flax/Sisal Fiber Reinforced composites

    Directory of Open Access Journals (Sweden)

    Kalagi Ganesh R.

    2018-01-01

    Full Text Available A study has been carried out to investigate effect of SiC Nano powder on tensile and impact properties of Multiaxial layers of Flax and Sisal fiber reinforced composites and randomly oriented chopped Flax and Sisal fiber reinforced composites. It has been observed that tensile strength and impact strength were improved using 6% of SiC Nanopowder into Multiaxial layer (+45º/-45º, 0º/90º of Flax and Sisal where as randomly oriented chopped Flax and Sisal fiber reinforced composites are improved in its stiffnes for the same composition of fiber, epoxy and SiC Nano powder. SEM Analysis are done to analyse the distribution of SiC in both Multiaxial layers of Flax and Sisal fiber reinforced composites and randomly oriented chopped Flax and Sisal fiber reinforced composites.

  19. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

    Directory of Open Access Journals (Sweden)

    Quan Sherman

    2007-10-01

    Full Text Available Abstract Background Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in preventable adverse drug events have been shown to occur most often at the stages of ordering and administration. This paper describes the protocol for a pragmatic trial of electronic prescribing to reduce prescription error. The trial was designed to overcome the limitations associated with traditional study design. Design This study was designed as a 65-week, cluster randomized, parallel study. Methods The trial was conducted within ambulatory outpatient clinics in an academic tertiary care centre in Ontario, Canada. The electronic prescribing software for the study is a Canadian electronic prescribing software package which provides physician prescription entry with decision support at the point of care. Using a handheld computer (PDA the physician selects medications using an error minimising menu-based pick list from a comprehensive drug database, create specific prescription instructions and then transmit the prescription directly and electronically to a participating pharmacy via facsimile or to the physician's printer using local area wireless technology. The unit of allocation and randomization is by 'week', i.e. the system is "on" or "off" according to the randomization scheme and the unit of analysis is the prescription, with adjustment for clustering of patients within practitioners. Discussion This paper describes the protocol for a pragmatic cluster randomized trial of point-of-care electronic prescribing, which was specifically designed to overcome the limitations associated with traditional study design. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00252395

  20. Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries

    NARCIS (Netherlands)

    Jager, C.; Freund, T.; Steinhauser, J.; Aakhus, E.; Flottorp, S.; Godycki-Cwirko, M.; Lieshout, J. van; Krause, J.; Szecsenyi, J.; Wensing, M.

    2014-01-01

    BACKGROUND: In the 'Tailored Implementation for Chronic Diseases (TICD)' project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol

  1. Hypertension management in primary care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Weltermann, Birgitta; Viehmann, Anja; Kersting, Christine

    2015-03-21

    Studies worldwide show insufficient blood pressure control rates, and effective management of hypertension remains a challenge in general practice. Although structured forms of care improved blood pressure in randomized controlled trials, little is known about their effects under routine primary care. This cluster randomized trial (CRT) evaluates the effects of a modern interactive medical education series for general practitioners on hypertension management, including practice redesign strategies. For this CRT, 24 primary care academic teaching practices of the University of Duisburg-Essen, Germany, are randomized into two study arms. With the objective of improving hypertension control, general practitioners of the intervention group participate in a three-session medical education program on structured hypertension management. The program aims at changing physician awareness and practice design. Various practice tools are provided: for example, checklists on valid blood pressure readings, medication selection, detection of secondary hypertension, and patient education. General practitioners of both study groups include hypertensive patients with and without hypertension-related diseases such as angiographically proven coronary disease, and peripheral or cerebral vascular disease. Blood pressure is measured by 24-hour readings. Analyses will focus on differences in blood pressure control and changes of practice management between intervention and control group. The study will determine the effectiveness of our practice redesign intervention on hypertension control. The intervention addresses general practitioners and practice assistants, while aiming at benefits on the patient level. Therefore, the cluster design is used to evaluate the effects. DRKS00006315 (date of registration: 14 July 2014).

  2. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

    Science.gov (United States)

    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  3. "Coaching boys into men": a cluster-randomized controlled trial of a dating violence prevention program.

    Science.gov (United States)

    Miller, Elizabeth; Tancredi, Daniel J; McCauley, Heather L; Decker, Michele R; Virata, Maria Catrina D; Anderson, Heather A; Stetkevich, Nicholas; Brown, Ernest W; Moideen, Feroz; Silverman, Jay G

    2012-11-01

    Dating violence (DV)--physical, sexual, and psychological aggression in adolescent romantic relationships--is prevalent among youth. Despite broad calls for primary prevention, few programs with demonstrated effectiveness exist. This cluster-randomized trial examined the effectiveness of a DV perpetration prevention program targeting coaches and high school male athletes. The unit of randomization was the high school (16 schools), and the unit of analysis was the athlete (N = 2,006 students). Primary outcomes were intentions to intervene, recognition of abusive behaviors, and gender-equitable attitudes. Secondary outcomes explored bystander behaviors and abuse perpetration. Regression models for clustered, longitudinal data assessed between-arm differences in over-time changes in mean levels of continuous outcomes in 1,798 athletes followed up at 3 months. Intervention athletes' changes in intentions to intervene were positive compared with control subjects, resulting in an estimated intervention effect of .12 (95% CI: .003, .24). Intervention athletes also reported higher levels of positive bystander intervention behavior than control subjects (.25, 95% CI: .13, .38). Changes in gender-equitable attitudes, recognition of abusive behaviors, and DV perpetration were not significant. Secondary analyses estimated intervention impacts according to intensity of program implementation. Compared with control subjects, athletes exposed to full-intensity implementation of the intervention demonstrated improvements in intentions to intervene (.16, 95% CI: .04, .27), recognition of abusive behaviors (.13, 95% CI: .003, .25), and positive bystander intervention (.28, 95% CI: .14, .41). This cluster-randomized controlled trial supports the effectiveness of a school athletics-based prevention program as one promising strategy to reduce DV perpetration. Copyright © 2012 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  4. Finite-sample corrected generalized estimating equation of population average treatment effects in stepped wedge cluster randomized trials.

    Science.gov (United States)

    Scott, JoAnna M; deCamp, Allan; Juraska, Michal; Fay, Michael P; Gilbert, Peter B

    2017-04-01

    Stepped wedge designs are increasingly commonplace and advantageous for cluster randomized trials when it is both unethical to assign placebo, and it is logistically difficult to allocate an intervention simultaneously to many clusters. We study marginal mean models fit with generalized estimating equations for assessing treatment effectiveness in stepped wedge cluster randomized trials. This approach has advantages over the more commonly used mixed models that (1) the population-average parameters have an important interpretation for public health applications and (2) they avoid untestable assumptions on latent variable distributions and avoid parametric assumptions about error distributions, therefore, providing more robust evidence on treatment effects. However, cluster randomized trials typically have a small number of clusters, rendering the standard generalized estimating equation sandwich variance estimator biased and highly variable and hence yielding incorrect inferences. We study the usual asymptotic generalized estimating equation inferences (i.e., using sandwich variance estimators and asymptotic normality) and four small-sample corrections to generalized estimating equation for stepped wedge cluster randomized trials and for parallel cluster randomized trials as a comparison. We show by simulation that the small-sample corrections provide improvement, with one correction appearing to provide at least nominal coverage even with only 10 clusters per group. These results demonstrate the viability of the marginal mean approach for both stepped wedge and parallel cluster randomized trials. We also study the comparative performance of the corrected methods for stepped wedge and parallel designs, and describe how the methods can accommodate interval censoring of individual failure times and incorporate semiparametric efficient estimators.

  5. Random field Ising model in a uniform magnetic field: Ground states, pinned clusters and scaling laws.

    Science.gov (United States)

    Kumar, Manoj; Banerjee, Varsha; Puri, Sanjay

    2017-11-08

    In this paper, we study the random field Ising model (RFIM) in an external magnetic field h . A computationally efficient graph-cut method is used to study ground state (GS) morphologies in this system for three different disorder types: Gaussian, uniform and bimodal. We obtain the critical properties of this system and find that they are independent of the disorder type. We also study GS morphologies via pinned-cluster distributions, which are scale-free at criticality. The spin-spin correlation functions (and structure factors) are characterized by a roughness exponent [Formula: see text]. The corresponding scaling function is universal for all disorder types and independent of h.

  6. Quantum transport in randomly diluted quantum percolation clusters in two dimensions

    Science.gov (United States)

    Cuansing, Eduardo; Nakanishi, Hisao

    2008-02-01

    We study the hopping transport of a quantum particle through finite, randomly diluted percolation clusters in two dimensions. We investigate how the transmission coefficient T behaves as a function of the energy E of the particle, the occupation concentration p of the disordered cluster, the size of the underlying lattice, and the type of connection chosen between the cluster and the input and output leads. We investigate both the point-to-point contacts and the busbar type of connection. For highly diluted clusters we find the behavior of the transmission to be independent of the type of connection. As the amount of dilution is decreased we find sharp variations in transmission. These variations are the remnants of the resonances at the ordered, zero-dilution, limit. For particles with energies within 0.25≤E≤1.75 (relative to the hopping integral) and with underlying square lattices of size 20×20, the configurations begin transmitting near pα=0.60 with T against p curves following a common pattern as the amount of dilution is decreased. Near pβ=0.90 this pattern is broken and the transmission begins to vary with the energy. In the asymptotic limit of very large clusters we find the systems to be totally reflecting in almost all cases. A few clear exceptions we find are when the amount of dilution is very low, when the particle has energy close to a resonance value at the ordered limit, and when the particle has energy at the middle of the band. These three cases, however, may not exhaust all possible exceptions.

  7. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect......Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...

  8. Inertial particles distribute in turbulence as Poissonian points with random intensity inducing clustering and supervoiding

    CERN Document Server

    Schmidt, Lukas; Holzner, Markus

    2016-01-01

    This work considers the distribution of inertial particles in turbulence using the point-particle approximation. We demonstrate that the random point process formed by the positions of particles in space is a Poisson point process with log-normal random intensity ("log Gaussian Cox process" or LGCP). The probability of having a finite number of particles in a small volume is given in terms of the characteristic function of a log-normal distribution. Corrections due to discreteness of the number of particles to the previously derived statistics of particle concentration in the continuum limit are provided. These are relevant for dealing with experimental or numerical data. The probability of having regions without particles, i.e. voids, is larger for inertial particles than for tracer particles where voids are distributed according to Poisson processes. Further, the probability of having large voids decays only log-normally with size. This shows that particles cluster, leaving voids behind. At scales where the...

  9. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...... strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect...

  10. Comparison of population-averaged and cluster-specific models for the analysis of cluster randomized trials with missing binary outcomes: a simulation study

    Directory of Open Access Journals (Sweden)

    Ma Jinhui

    2013-01-01

    Full Text Available Abstracts Background The objective of this simulation study is to compare the accuracy and efficiency of population-averaged (i.e. generalized estimating equations (GEE and cluster-specific (i.e. random-effects logistic regression (RELR models for analyzing data from cluster randomized trials (CRTs with missing binary responses. Methods In this simulation study, clustered responses were generated from a beta-binomial distribution. The number of clusters per trial arm, the number of subjects per cluster, intra-cluster correlation coefficient, and the percentage of missing data were allowed to vary. Under the assumption of covariate dependent missingness, missing outcomes were handled by complete case analysis, standard multiple imputation (MI and within-cluster MI strategies. Data were analyzed using GEE and RELR. Performance of the methods was assessed using standardized bias, empirical standard error, root mean squared error (RMSE, and coverage probability. Results GEE performs well on all four measures — provided the downward bias of the standard error (when the number of clusters per arm is small is adjusted appropriately — under the following scenarios: complete case analysis for CRTs with a small amount of missing data; standard MI for CRTs with variance inflation factor (VIF 50. RELR performs well only when a small amount of data was missing, and complete case analysis was applied. Conclusion GEE performs well as long as appropriate missing data strategies are adopted based on the design of CRTs and the percentage of missing data. In contrast, RELR does not perform well when either standard or within-cluster MI strategy is applied prior to the analysis.

  11. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m = 12.68 years, SD = 0.51) and their parents randomized over four conditions: parent intervention, student intervention,

  12. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors : A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, Jacqueline E E; Koning, Ina M.|info:eu-repo/dai/nl/304822329; Vollebergh, Wilma A M|info:eu-repo/dai/nl/090632893; van den Eijnden, Regina J J M|info:eu-repo/dai/nl/17399394X; Engels, Rutger C M E

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention,

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

    Science.gov (United States)

    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.…

  14. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

    Science.gov (United States)

    Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

    2016-01-01

    Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

  15. A Coupled Hidden Conditional Random Field Model for Simultaneous Face Clustering and Naming in Videos

    KAUST Repository

    Zhang, Yifan

    2016-08-18

    For face naming in TV series or movies, a typical way is using subtitles/script alignment to get the time stamps of the names, and tagging them to the faces. We study the problem of face naming in videos when subtitles are not available. To this end, we divide the problem into two tasks: face clustering which groups the faces depicting a certain person into a cluster, and name assignment which associates a name to each face. Each task is formulated as a structured prediction problem and modeled by a hidden conditional random field (HCRF) model. We argue that the two tasks are correlated problems whose outputs can provide prior knowledge of the target prediction for each other. The two HCRFs are coupled in a unified graphical model called coupled HCRF where the joint dependence of the cluster labels and face name association is naturally embedded in the correlation between the two HCRFs. We provide an effective algorithm to optimize the two HCRFs iteratively and the performance of the two tasks on real-world data set can be both improved.

  16. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  17. Classification of Autism Spectrum Disorder Using Random Support Vector Machine Cluster

    Directory of Open Access Journals (Sweden)

    Xia-an Bi

    2018-02-01

    Full Text Available Autism spectrum disorder (ASD is mainly reflected in the communication and language barriers, difficulties in social communication, and it is a kind of neurological developmental disorder. Most researches have used the machine learning method to classify patients and normal controls, among which support vector machines (SVM are widely employed. But the classification accuracy of SVM is usually low, due to the usage of a single SVM as classifier. Thus, we used multiple SVMs to classify ASD patients and typical controls (TC. Resting-state functional magnetic resonance imaging (fMRI data of 46 TC and 61 ASD patients were obtained from the Autism Brain Imaging Data Exchange (ABIDE database. Only 84 of 107 subjects are utilized in experiments because the translation or rotation of 7 TC and 16 ASD patients has surpassed ±2 mm or ±2°. Then the random SVM cluster was proposed to distinguish TC and ASD. The results show that this method has an excellent classification performance based on all the features. Furthermore, the accuracy based on the optimal feature set could reach to 96.15%. Abnormal brain regions could also be found, such as inferior frontal gyrus (IFG (orbital and opercula part, hippocampus, and precuneus. It is indicated that the method of random SVM cluster may apply to the auxiliary diagnosis of ASD.

  18. Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

    Science.gov (United States)

    Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

    2015-02-01

    Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

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

    Directory of Open Access Journals (Sweden)

    Jochems EC

    2015-12-01

    Full Text Available Eline C Jochems,1,2 Christina M van der Feltz-Cornelis,1–3 Arno van Dam,3,4 Hugo J Duivenvoorden,5 Cornelis L Mulder1,6 1Department of Psychiatry, Epidemiological and Social Psychiatric Research Institute, Erasmus MC University Medical Center, Rotterdam, the Netherlands; 2GGz Breburg, Top Clinical Center for Body, Mind and Health, Tilburg, the Netherlands; 3Tilburg University, Faculty of Social Sciences, Tranzo Department, Tilburg, the Netherlands; 4GGZ Westelijk Noord Brabant, Bergen op Zoom, the Netherlands; 5Erasmus MC University Medical Center, Rotterdam, the Netherlands; 6BavoEuropoort, Parnassia Psychiatric Institute, Rotterdam, the Netherlands 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

  20. Generalized Pareto for Pattern-Oriented Random Walk Modelling of Organisms' Movements.

    Science.gov (United States)

    Bertrand, Sophie; Joo, Rocío; Fablet, Ronan

    2015-01-01

    How organisms move and disperse is crucial to understand how population dynamics relates to the spatial heterogeneity of the environment. Random walk (RW) models are typical tools to describe movement patterns. Whether Lévy or alternative RW better describes forager movements is keenly debated. We get around this issue using the Generalized Pareto Distribution (GPD). GPD includes as specific cases Normal, exponential and power law distributions, which underlie Brownian, Poisson-like and Lévy walks respectively. Whereas previous studies typically confronted a limited set of candidate models, GPD lets the most likely RW model emerge from the data. We illustrate the wide applicability of the method using GPS-tracked seabird foraging movements and fishing vessel movements tracked by Vessel Monitoring System (VMS), both collected in the Peruvian pelagic ecosystem. The two parameters from the fitted GPD, a scale and a shape parameter, provide a synoptic characterization of the observed movement in terms of characteristic scale and diffusive property. They reveal and quantify the variability, among species and individuals, of the spatial strategies selected by predators foraging on a common prey field. The GPD parameters constitute relevant metrics for (1) providing a synthetic and pattern-oriented description of movement, (2) using top predators as ecosystem indicators and (3) studying the variability of spatial behaviour among species or among individuals with different personalities.

  1. Generalized Pareto for Pattern-Oriented Random Walk Modelling of Organisms’ Movements

    Science.gov (United States)

    Bertrand, Sophie; Joo, Rocío; Fablet, Ronan

    2015-01-01

    How organisms move and disperse is crucial to understand how population dynamics relates to the spatial heterogeneity of the environment. Random walk (RW) models are typical tools to describe movement patterns. Whether Lévy or alternative RW better describes forager movements is keenly debated. We get around this issue using the Generalized Pareto Distribution (GPD). GPD includes as specific cases Normal, exponential and power law distributions, which underlie Brownian, Poisson-like and Lévy walks respectively. Whereas previous studies typically confronted a limited set of candidate models, GPD lets the most likely RW model emerge from the data. We illustrate the wide applicability of the method using GPS-tracked seabird foraging movements and fishing vessel movements tracked by Vessel Monitoring System (VMS), both collected in the Peruvian pelagic ecosystem. The two parameters from the fitted GPD, a scale and a shape parameter, provide a synoptic characterization of the observed movement in terms of characteristic scale and diffusive property. They reveal and quantify the variability, among species and individuals, of the spatial strategies selected by predators foraging on a common prey field. The GPD parameters constitute relevant metrics for (1) providing a synthetic and pattern–oriented description of movement, (2) using top predators as ecosystem indicators and (3) studying the variability of spatial behaviour among species or among individuals with different personalities. PMID:26172045

  2. Generalized Pareto for Pattern-Oriented Random Walk Modelling of Organisms' Movements.

    Directory of Open Access Journals (Sweden)

    Sophie Bertrand

    Full Text Available How organisms move and disperse is crucial to understand how population dynamics relates to the spatial heterogeneity of the environment. Random walk (RW models are typical tools to describe movement patterns. Whether Lévy or alternative RW better describes forager movements is keenly debated. We get around this issue using the Generalized Pareto Distribution (GPD. GPD includes as specific cases Normal, exponential and power law distributions, which underlie Brownian, Poisson-like and Lévy walks respectively. Whereas previous studies typically confronted a limited set of candidate models, GPD lets the most likely RW model emerge from the data. We illustrate the wide applicability of the method using GPS-tracked seabird foraging movements and fishing vessel movements tracked by Vessel Monitoring System (VMS, both collected in the Peruvian pelagic ecosystem. The two parameters from the fitted GPD, a scale and a shape parameter, provide a synoptic characterization of the observed movement in terms of characteristic scale and diffusive property. They reveal and quantify the variability, among species and individuals, of the spatial strategies selected by predators foraging on a common prey field. The GPD parameters constitute relevant metrics for (1 providing a synthetic and pattern-oriented description of movement, (2 using top predators as ecosystem indicators and (3 studying the variability of spatial behaviour among species or among individuals with different personalities.

  3. Promoting physical activity with goal-oriented mental imagery: a randomized controlled trial.

    Science.gov (United States)

    Chan, Carina K Y; Cameron, Linda D

    2012-06-01

    Self-regulation theory and research suggests that different types of mental imagery can promote goal-directed behaviors. The present study was designed to compare the efficacy of approach imagery (attainment of desired goal states) and process imagery (steps for enacting behavior) in promoting physical activity among inactive individuals. A randomized controlled trial was conducted with 182 inactive adults who received one of four interventions for generating mental images related to physical activity over a 4-week period, with Approach Imagery (approach versus neutral) and Process Imagery (process versus no process) as the intervention strategies. Participants received imagery training and practiced daily. Repeated measures ANOVAs revealed that Approach Imagery: (1) increased approach motivations for physical activity at Week 4; (2) induced greater intentions post-session, which subsequently induced more action planning at Week 4; (3) enhanced action planning when combined with process images at post-session and Week 1; and (4) facilitated more physical activity at Week 4 via action planning. These findings suggest that inducing approach orientation via mental imagery may be a convenient and low-cost technique to promote physical activity among inactive individuals.

  4. Influence of crystal shapes on radiative fluxes in visible wavelength: ice crystals randomly oriented in space

    Directory of Open Access Journals (Sweden)

    P. Chervet

    1996-08-01

    Full Text Available Radiative properties of cirrus clouds are one of the major unsolved problems in climate studies and global radiation budget. These clouds are generally composed of various ice-crystal shapes, so we tried to evaluate effects of the ice-crystal shape on radiative fluxes. We calculated radiative fluxes of cirrus clouds with a constant geometrical depth, composed of ice crystals with different shapes (hexagonal columns, bullets, bullet-rosettes, sizes and various concentrations. We considered ice particles randomly oriented in space (3D case and their scattering phase functions were calculated by a ray-tracing method. We calculated radiative fluxes for cirrus layers for different microphysical characteristics by using a discrete-ordinate radiative code. Results showed that the foremost effect of the ice-crystal shape on radiative properties of cirrus clouds was that on the optical thickness, while the variation of the scattering phase function with the ice shape remained less than 3% for our computations. The ice-water content may be a better choice to parameterize the optical properties of cirrus, but the shape effect must be included.

  5. Processing of X-ray snapshots from crystals in random orientations.

    Science.gov (United States)

    Kabsch, Wolfgang

    2014-08-01

    A functional expression is introduced that relates scattered X-ray intensities from a still or a rotation snapshot to the corresponding structure-factor amplitudes. The new approach was implemented in the program nXDS for processing monochromatic diffraction images recorded by a multi-segment detector where each exposure could come from a different crystal. For images containing indexable spots, the intensities of the expected reflections and their variances are obtained by profile fitting after mapping the contributing pixel contents to the Ewald sphere. The varying intensity decline owing to the angular distance of the reflection from the surface of the Ewald sphere is estimated using a Gaussian rocking curve. This decline is dubbed `Ewald offset correction', which is well defined even for still images. Together with an image-scaling factor and other corrections, an explicit expression is defined that predicts each recorded intensity from its corresponding structure-factor amplitude. All diffraction parameters, scaling and correction factors are improved by post-refinement. The ambiguous case of a lower point group than the lattice symmetry is resolved by a method reminiscent of the technique of `selective breeding'. It selects the indexing alternative for each image that yields, on average, the highest correlation with intensities from all other images. Processing a test set of rotation images by XDS and treating the same images by nXDS as snapshots of crystals in random orientations yields data of comparable quality, clearly indicating an anomalous signal from Se atoms.

  6. Structuring communication relationships for interprofessional teamwork (SCRIPT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kenaszchuk Chris

    2007-09-01

    Full Text Available Abstract Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs in general internal medicine (GIM divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS; adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a

  7. Family member-based supervision of patients with hypertension: a cluster randomized trial in rural China.

    Science.gov (United States)

    Shen, Y; Peng, X; Wang, M; Zheng, X; Xu, G; Lü, L; Xu, K; Burstrom, B; Burstrom, K; Wang, J

    2017-01-01

    Empirical evidence has suggested that social support from family can help patients take their medicines correctly. This study aims to evaluate the role of a family member-based supervision package in the management of hypertension using a cluster randomized trial in rural China. We recruited patients with hypertension from four villages in Yangzhong and randomly allocated them to the control group (n=288) and the intervention group (n=266). A family member-based supervision package was applied to the intervention group, while the usual service was applied to the controls. Patients were followed for 12 months and completed face-to-face interviews at the end of 6 and 12 months. The primary outcomes were patients' medication adherence and frequency of blood pressure measurement. Secondary outcomes included changes in blood pressure, altered risk behaviours and occurrence of hypertension-related complications. To control for the effects of cluster randomization, multilevel mixed-effects regression models were used to compare group changes. We observed that the intervention improved patients' blood pressure measurement frequency (OR: 9.00, 95% CI: 4.52-17.91) and adherence to antihypertensive treatment (OR: 1.74, 95% CI: 0.91-3.32). Its effect on the blood pressure control rate was significant at the mid-term investigation (OR: 0.67, 95% CI: 0.40-0.93), but the long-term effect was not significant (OR: 0.89, 95% CI: 0.64-1.26). After 6 months of intervention, either systolic or diastolic blood pressure was significantly decreased in the intervention group. However, this difference was not significant at the final investigation. Findings from this study revealed that the family member-based supervised therapy may have positive effects on patients' adherence to blood monitoring and hypertensive medications.

  8. Bilateral robotic priming before task-oriented approach in subacute stroke rehabilitation: a pilot randomized controlled trial.

    Science.gov (United States)

    Hsieh, Yu-Wei; Wu, Ching-Yi; Wang, Wei-En; Lin, Keh-Chung; Chang, Ku-Chou; Chen, Chih-Chi; Liu, Chien-Ting

    2017-02-01

    To investigate the treatment effects of bilateral robotic priming combined with the task-oriented approach on motor impairment, disability, daily function, and quality of life in patients with subacute stroke. A randomized controlled trial. Occupational therapy clinics in medical centers. Thirty-one subacute stroke patients were recruited. Participants were randomly assigned to receive bilateral priming combined with the task-oriented approach (i.e., primed group) or to the task-oriented approach alone (i.e., unprimed group) for 90 minutes/day, 5 days/week for 4 weeks. The primed group began with the bilateral priming technique by using a bimanual robot-aided device. Motor impairments were assessed by the Fugal-Meyer Assessment, grip strength, and the Box and Block Test. Disability and daily function were measured by the modified Rankin Scale, the Functional Independence Measure, and actigraphy. Quality of life was examined by the Stroke Impact Scale. The primed and unprimed groups improved significantly on most outcomes over time. The primed group demonstrated significantly better improvement on the Stroke Impact Scale strength subscale ( p = 0.012) and a trend for greater improvement on the modified Rankin Scale ( p = 0.065) than the unprimed group. Bilateral priming combined with the task-oriented approach elicited more improvements in self-reported strength and disability degrees than the task-oriented approach by itself. Further large-scale research with at least 31 participants in each intervention group is suggested to confirm the study findings.

  9. Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).

    Science.gov (United States)

    Tancredi, Daniel J; Silverman, Jay G; Decker, Michele R; McCauley, Heather L; Anderson, Heather A; Jones, Kelley A; Ciaravino, Samantha; Hicks, Angela; Raible, Claire; Zelazny, Sarah; James, Lisa; Miller, Elizabeth

    2015-08-06

    Women ages 16-29 utilizing family planning clinics for medical services experience higher rates of intimate partner violence (IPV) and reproductive coercion (RC) than their same-age peers, increasing risk for unintended pregnancy and related poor reproductive health outcomes. Brief interventions integrated into routine family planning care have shown promise in reducing risk for RC, but longer-term intervention effects on partner violence victimization, RC, and unintended pregnancy have not been examined. The 'Addressing Reproductive Coercion in Health Settings (ARCHES)' Intervention Study is a cluster randomized controlled trial evaluating the effectiveness of a brief, clinician-delivered universal education and counseling intervention to reduce IPV, RC and unintended pregnancy compared to standard-of-care in family planning clinic settings. The ARCHES intervention was refined based on formative research. Twenty five family planning clinics were randomized (in 17 clusters) to either a three hour training for all family planning clinic staff on how to deliver the ARCHES intervention or to a standard-of-care control condition. All women ages 16-29 seeking care in these family planning clinics were eligible to participate. Consenting clients use laptop computers to answer survey questions immediately prior to their clinic visit, a brief exit survey immediately after the clinic visit, a first follow up survey 12-20 weeks after the baseline visit (T2), and a final survey 12 months after the baseline (T3). Medical record chart review provides additional data about IPV and RC assessment and disclosure, sexual and reproductive health diagnoses, and health care utilization. Of 4009 women approached and determined to be eligible based on age (16-29 years old), 3687 (92 % participation) completed the baseline survey and were included in the sample. The ARCHES Intervention Study is a community-partnered study designed to provide arigorous assessment of the short (3-4 months

  10. Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

    2016-01-01

    Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline

  11. cluster

    Indian Academy of Sciences (India)

    electron transfer chains involved in a number of biologi- cal systems including respiration and photosynthesis.1. The most common iron–sulphur clusters found as active centres in iron–sulphur proteins are [Fe2S2], [Fe3S4] and [Fe4S4], in which Fe(III) ions are coordinated to cysteines from the peptide and are linked to each ...

  12. Sanitation subsidies. Encouraging sanitation investment in the developing world: a cluster-randomized trial.

    Science.gov (United States)

    Guiteras, Raymond; Levinsohn, James; Mobarak, Ahmed Mushfiq

    2015-05-22

    Poor sanitation contributes to morbidity and mortality in the developing world, but there is disagreement on what policies can increase sanitation coverage. To measure the effects of alternative policies on investment in hygienic latrines, we assigned 380 communities in rural Bangladesh to different marketing treatments-community motivation and information; subsidies; a supply-side market access intervention; and a control-in a cluster-randomized trial. Community motivation alone did not increase hygienic latrine ownership (+1.6 percentage points, P = 0.43), nor did the supply-side intervention (+0.3 percentage points, P = 0.90). Subsidies to the majority of the landless poor increased ownership among subsidized households (+22.0 percentage points, P Subsidies also reduced open defecation by 14 percentage points (P < 0.001). Copyright © 2015, American Association for the Advancement of Science.

  13. Polarimetric SAR Image Classification Using Multifeatures Combination and Extremely Randomized Clustering Forests

    Directory of Open Access Journals (Sweden)

    Zou Tongyuan

    2010-01-01

    Full Text Available Abstract Terrain classification using polarimetric SAR imagery has been a very active research field over recent years. Although lots of features have been proposed and many classifiers have been employed, there are few works on comparing these features and their combination with different classifiers. In this paper, we firstly evaluate and compare different features for classifying polarimetric SAR imagery. Then, we propose two strategies for feature combination: manual selection according to heuristic rules and automatic combination based on a simple but efficient criterion. Finally, we introduce extremely randomized clustering forests (ERCFs to polarimetric SAR image classification and compare it with other competitive classifiers. Experiments on ALOS PALSAR image validate the effectiveness of the feature combination strategies and also show that ERCFs achieves competitive performance with other widely used classifiers while costing much less training and testing time.

  14. Design and protocol of the weight loss lottery- a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

    2016-07-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

    Science.gov (United States)

    Meng, Karin; Musekamp, Gunda; Seekatz, Bettina; Glatz, Johannes; Karger, Gabriele; Kiwus, Ulrich; Knoglinger, Ernst; Schubmann, Rainer; Westphal, Ronja; Faller, Hermann

    2013-08-23

    Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. This study evaluates the effectiveness of a

  16. Safety of Spectacles for Children's Vision: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Ma, Xiaochen; Congdon, Nathan; Yi, Hongmei; Zhou, Zhongqiang; Pang, Xiaopeng; Meltzer, Mirjam E; Shi, Yaojiang; He, Mingguang; Liu, Yizhi; Rozelle, Scott

    2015-11-01

    To study safety of children's glasses in rural China, where fear that glasses harm vision is an important barrier for families and policy makers. Exploratory analysis from a cluster-randomized, investigator-masked, controlled trial. Among primary schools (n = 252) in western China, children were randomized by school to 1 of 3 interventions: free glasses provided in class, vouchers for free glasses at a local facility, or glasses prescriptions only (Control group). The main outcome of this analysis is uncorrected visual acuity after 8 months, adjusted for baseline acuity. Among 19 934 children randomly selected for screening, 5852 myopic (spherical equivalent refractive error ≤-0.5 diopters) eyes of 3001 children (14.7%, mean age 10.5 years) had VA ≤6/12 without glasses correctable to >6/12 with glasses, and were eligible. Among these, 1903 (32.5%), 1798 (30.7%), and 2151 (36.8%) were randomized to Control, Voucher, and Free Glasses, respectively. Intention-to-treat analyses were performed on all 1831 (96.2%), 1699 (94.5%), and 2007 (93.3%) eyes of children with follow-up in Control, Voucher, and Free Glasses groups. Final visual acuity for eyes of children in the treatment groups (Free Glasses and Voucher) was significantly better than for Control children, adjusting only for baseline visual acuity (difference of 0.023 logMAR units [0.23 vision chart lines, 95% CI: 0.03, 0.43]) or for other baseline factors as well (0.025 logMAR units [0.25 lines, 95% CI 0.04, 0.45]). We found no evidence that spectacles promote decline in uncorrected vision with aging among children. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Cluster-randomized xylitol toothpaste trial for early childhood caries prevention

    Science.gov (United States)

    Chi, Donald L.; Tut, Ohnmar K.; Milgrom, Peter

    2013-01-01

    Purpose We assessed the efficacy of supervised toothbrushing with xylitol toothpaste to prevent early childhood caries (ECC) and to reduce mutans streptococci (MS). Methods In this cluster-randomized efficacy trial, 4 Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400ppm/31% fluoride-xylitol (Epic Dental, Provo, UT) or 1,450ppm fluoride-sorbitol toothpaste (Colgate-Palmolive, New York, NY) (N=196 children, ages 4–5 yrs). We hypothesized no difference in efficacy between the two types of toothpaste. The primary outcome was primary molar d2-3mfs increment after 6 mos. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children) and 2 classrooms to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. Results There was no difference between the two groups in baseline or end-of-trial mean d2-3mfs. The mean d2-3mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d2-3mfs, respectively), but the difference was not significant (95% CI:−0.17, 2.37;P=0.07). No adverse effects were reported. Conclusion After 6 mos, brushing with a low strength xylitol/fluoride toothpaste is no more efficacious in reducing ECC than a fluoride only toothpaste in a high caries risk child population. PMID:24709430

  18. Spiritual history taking in palliative home care: A cluster randomized controlled trial.

    Science.gov (United States)

    Vermandere, Mieke; Warmenhoven, Franca; Van Severen, Evie; De Lepeleire, Jan; Aertgeerts, Bert

    2016-04-01

    Many health-care providers experience barriers to addressing spiritual needs, such as not having the right vocabulary. The ars moriendi model might be a feasible tool for spiritual history taking in palliative care. To investigate the effect of a structured spiritual history taking on the spiritual well-being of palliative patients in home care. Cluster randomized controlled trial, conducted between February and October 2013. Registered nurses and general practitioners approached eligible patients with an incurable, life-threatening disease for study participation. Health-care providers allocated to the intervention arm of the study took a spiritual history on the basis of the ars moriendi model. Health-care providers in the control arm provided care as usual. Patient-reported outcomes on spiritual well-being, quality of life, pain, and patient-provider trust were assessed at two points in time. A total of 245 health-care providers participated in the study (204 nurses and 41 physicians). In all, 49 patient-provider dyads completed the entire study protocol. The median age of the patients was 75 years (range: 41-95 years), and 55% of the patients were female. There were no significant differences at any point in time in the scores on spiritual well-being, quality of life, pain, or patient-provider trust between the intervention and the control group. This cluster randomized controlled trial showed no demonstrable effect of spiritual history taking on patient scores for spiritual well-being, quality of life, health-care relationship trust, or pain. Further research is needed to develop instruments that accurately assess the effectiveness of spiritual interventions in palliative care populations. © The Author(s) 2015.

  19. Contraceptive uptake after training community health workers in couples counseling: A cluster randomized trial.

    Directory of Open Access Journals (Sweden)

    Clara Lemani

    Full Text Available Young women in Malawi face many challenges in accessing family planning (FP, including distance to the health facility and partner disapproval. Our primary objective was to assess if training HSAs in couples counseling would increase modern FP uptake among young women.In this cluster randomized controlled trial, 30 HSAs from Lilongwe, Malawi received training in FP. The HSAs were then randomized 1:1 to receive or not receive additional training in couples counseling. All HSAs were asked to provide FP counseling to women in their communities and record their contraceptive uptake over 6 months. Sexually-active women <30 years of age who had never used a modern FP method were included in this analysis. Generalized estimating equations with an exchangeable correlation matrix to account for clustering by HSA were used to estimate risk differences (RDs and 95% confidence intervals (CIs.430 (53% young women were counseled by the 15 HSAs who received couples counseling training, and 378 (47% were counseled by the 15 HSAs who did not. 115 (26% from the couples counseling group had male partners present during their first visit, compared to only 6 (2% from the other group (RD: 0.21, 95% CI: 0.09 to 0.33, p<0.01. Nearly all (99.5% initiated a modern FP method, with no difference between groups (p = 0.09. Women in the couples counseling group were 8% more likely to receive male condoms (RD: 0.08, 95% CI: -7% to 23%, p = 0.28 and 8% more likely to receive dual methods (RD: 0.08, 95% CI: -0.065, 0.232, p = 0.274.Training HSAs in FP led to high modern FP uptake among young women who had never used FP. Couples counseling training increased male involvement with a trend towards higher male condom uptake.

  20. Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

    Science.gov (United States)

    Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

    2017-07-01

    Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  1. A Clustering-Oriented Closeness Measure Based on Neighborhood Chain and Its Application in the Clustering Ensemble Framework Based on the Fusion of Different Closeness Measures

    Directory of Open Access Journals (Sweden)

    Shaoyi Liang

    2017-09-01

    Full Text Available Closeness measures are crucial to clustering methods. In most traditional clustering methods, the closeness between data points or clusters is measured by the geometric distance alone. These metrics quantify the closeness only based on the concerned data points’ positions in the feature space, and they might cause problems when dealing with clustering tasks having arbitrary clusters shapes and different clusters densities. In this paper, we first propose a novel Closeness Measure between data points based on the Neighborhood Chain (CMNC. Instead of using geometric distances alone, CMNC measures the closeness between data points by quantifying the difficulty for one data point to reach another through a chain of neighbors. Furthermore, based on CMNC, we also propose a clustering ensemble framework that combines CMNC and geometric-distance-based closeness measures together in order to utilize both of their advantages. In this framework, the “bad data points” that are hard to cluster correctly are identified; then different closeness measures are applied to different types of data points to get the unified clustering results. With the fusion of different closeness measures, the framework can get not only better clustering results in complicated clustering tasks, but also higher efficiency.

  2. Local radial basis function meshless scheme for vector radiative transfer in participating media with randomly oriented axisymmetric particles.

    Science.gov (United States)

    Sun, Jie; Yi, Hong-Liang; Tan, He-Ping

    2016-02-20

    A local radial basis function meshless scheme (LRBFM) is developed to solve polarized radiative transfer in participating media containing randomly oriented axisymmetric particles in which radial basis functions augmented with polynomial basis are employed to construct the trial functions, and the vector radiative-transfer equation based on the discrete-ordinates approach is discretized directly by collocation method. The LRBFM belongs to a class of truly meshless methods that do not need any mesh or any numerical integration scheme. Performances of the LRBFM are verified with analytical solutions and other numerical results reported earlier in the literature via five various test cases. The predicted angular distribution of brightness temperature and Stokes vector by the LRBFM agree very well with the benchmark. It is demonstrated that the LRBFM is accurate to solve vector radiative transfer in participating media with randomly oriented axisymmetric particles.

  3. A pattern-mixture model approach for handling missing continuous outcome data in longitudinal cluster randomized trials.

    Science.gov (United States)

    Fiero, Mallorie H; Hsu, Chiu-Hsieh; Bell, Melanie L

    2017-11-20

    We extend the pattern-mixture approach to handle missing continuous outcome data in longitudinal cluster randomized trials, which randomize groups of individuals to treatment arms, rather than the individuals themselves. Individuals who drop out at the same time point are grouped into the same dropout pattern. We approach extrapolation of the pattern-mixture model by applying multilevel multiple imputation, which imputes missing values while appropriately accounting for the hierarchical data structure found in cluster randomized trials. To assess parameters of interest under various missing data assumptions, imputed values are multiplied by a sensitivity parameter, k, which increases or decreases imputed values. Using simulated data, we show that estimates of parameters of interest can vary widely under differing missing data assumptions. We conduct a sensitivity analysis using real data from a cluster randomized trial by increasing k until the treatment effect inference changes. By performing a sensitivity analysis for missing data, researchers can assess whether certain missing data assumptions are reasonable for their cluster randomized trial. Copyright © 2017 John Wiley & Sons, Ltd.

  4. Apathy in nursing home residents with dementia: results from a cluster-randomized controlled trial.

    Science.gov (United States)

    Treusch, Y; Majic, T; Page, J; Gutzmann, H; Heinz, A; Rapp, M A

    2015-02-01

    Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n=117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. We found significant group differences with respect to apathy during the 10 month intervention period (F2,82=7.79, Papathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P=0.55). Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  5. Exercise program for prevention of groin pain in football players: a cluster-randomized trial.

    Science.gov (United States)

    Hölmich, P; Larsen, K; Krogsgaard, K; Gluud, C

    2010-12-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect of the intervention (HR=0.69, 95% CI 0.40-1.19). The risk of a groin injury was reduced by 31%, but this reduction was not significant. A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk of developing a groin injury. © 2009 John Wiley & Sons A/S.

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

    Science.gov (United States)

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

    2011-01-01

    PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines. METHODS A 1-year cluster randomized controlled trial was performed using 30 primary care practices (4,105 patients) in southeastern New England. The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein (LDL) and non–high-density lipoprotein (HDL) cholesterol goals. RESULTS After 1 year of intervention, both randomized practice groups improved screening (89% screened), and 74% of patients in both groups were at their LDL and non-HDL cholesterol goals (P management in primary care practices. Post hoc analysis showed a potential benefit in practices that used the e-health tools more frequently in screening and management of dyslipidemia. Further research on how to incorporate and increase adoption of user-friendly, patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted. PMID:22084264

  7. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2011-01-01

    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  8. Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F

    2010-08-01

    To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

  9. Physically Active Math and Language Lessons Improve Academic Achievement: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Mullender-Wijnsma, Marijke J; Hartman, Esther; de Greeff, Johannes W; Doolaard, Simone; Bosker, Roel J; Visscher, Chris

    2016-03-01

    Using physical activity in the teaching of academic lessons is a new way of learning. The aim of this study was to investigate the effects of an innovative physically active academic intervention ("Fit & Vaardig op School" [F&V]) on academic achievement of children. Using physical activity to teach math and spelling lessons was studied in a cluster-randomized controlled trial. Participants were 499 children (mean age 8.1 years) from second- and third-grade classes of 12 elementary schools. At each school, a second- and third-grade class were randomly assigned to the intervention or control group. The intervention group participated in F&V lessons for 2 years, 22 weeks per year, 3 times a week. The control group participated in regular classroom lessons. Children's academic achievement was measured before the intervention started and after the first and second intervention years. Academic achievement was measured by 2 mathematics tests (speed and general math skills) and 2 language tests (reading and spelling). After 2 years, multilevel analysis showed that children in the intervention group had significantly greater gains in mathematics speed test (P elementary school children and are therefore a promising new way of teaching. Copyright © 2016 by the American Academy of Pediatrics.

  10. School snacks decrease morbidity in Kenyan schoolchildren: a cluster randomized, controlled feeding intervention trial.

    Science.gov (United States)

    Neumann, Charlotte G; Bwibo, Nimrod O; Jiang, Luohua; Weiss, Robert E

    2013-09-01

    To examine the effects of three different school snacks on morbidity outcomes. Twelve schools were randomized to either one of three feeding groups or a Control group. There were three schools per group in this cluster randomized trial. Children in feeding group schools received school snacks of a local plant-based dish, githeri, with meat, milk or extra oil added. The oil used was later found to be fortified with retinol. Physical status, food intake and morbidity outcomes were assessed longitudinally over two years. Rural Embu District, Kenya, an area with high prevalence of vitamin A deficiency. Standard 1 schoolchildren (n 902; analytic sample) enrolled in two cohorts from the same schools one year apart. The Meat and Plain Githeri (i.e. githeri+oil) groups showed the greatest declines in the probability of a morbidity outcome (PMO) for total and severe illnesses, malaria, poor appetite, reduced activity, fever and chills. The Meat group showed significantly greater declines in PMO for gastroenteritis (mainly diarrhoea) and typhoid compared with the Control group, for jaundice compared with the Plain Githeri group, and for skin infection compared with the Milk group. The Milk group showed the greatest decline in PMO for upper respiratory infection. For nearly all morbidity outcomes the Control group had the highest PMO and the least decline over time. The intervention study showed beneficial effects of both animal source foods and of vitamin A-fortified oil on morbidity status.

  11. The Chronic CARe for diAbeTes study (CARAT: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Birnbaum Beatrice

    2010-06-01

    Full Text Available Abstract Background Diabetes is a major challenge for the health care system and especially for the primary care provider. The Chronic Care Model represents an evidence-based framework for the care for chronically ill. An increasing number of studies showed that implementing elements of the Chronic Care Model improves patient relevant outcomes and process parameters. However, most of these findings have been performed in settings different from the Swiss health care system which is dominated by single handed practices. Methods/Design CARAT is a cluster randomized controlled trial with general practitioners as the unit of randomization (trial registration: ISRCTN05947538. The study challenges the hypothesis that implementing several elements of the Chronic Care Model via a specially trained practice nurse improves the HbA1c level of diabetes type II patients significantly after one year (primary outcome. Furthermore, we assume that the intervention increases the proportion of patients who achieve the recommended targets regarding blood pressure ( Discussion This study challenges the hypothesis that the Chronic Care Model can be easily implemented by a practice nurse focused approach. If our results will confirm this hypothesis the suggestion arises whether this approach should be implemented in other chronic diseases and multimorbid patients and how to redesign care in Switzerland.

  12. Enhancing oral health via sense of coherence: a cluster-randomized trial.

    Science.gov (United States)

    Nammontri, O; Robinson, P G; Baker, S R

    2013-01-01

    Sense of coherence (SOC) has been related to oral health behaviors and oral-health-related quality of life (OHRQoL) in observational studies. This cluster-randomized trial aimed to test the effect of an intervention to enhance SOC on OHRQoL in children. Twelve primary schools were randomly allocated to intervention and control groups. The intervention was comprised of 7 sessions over 2 mos, focusing on child participation and empowerment. The first 4 sessions were classroom activities, and the last 3 involved working on healthy school projects. Trained teachers who received a one-day course delivered the intervention. Socio-demographic and clinical data, together with self-reported measures of OHRQoL, SOC, and oral health beliefs, were obtained from 261 total 10- to 12-year-olds (133 in the intervention and 128 in the control groups). Data were collected at baseline, 2 wks after the intervention, and at three-month follow-up. Mixed-effects models indicated that the intervention increased SOC and improved OHRQoL, together with oral health beliefs and gingival health. The findings offer experimental evidence that OHRQoL can be influenced by SOC. SOC may also provide an avenue for oral health promotion (Australian New Zealand Clinical Trials Registry ACTRN12612000547842).

  13. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial

    Directory of Open Access Journals (Sweden)

    McCarren M

    2014-10-01

    Full Text Available Madeline McCarren,1 Elaine L Twedt,1 Faizmohamed M Mansuri,2 Philip R Nelson,3 Brian T Peek3 1Pharmacy Benefits Management Services, Department of Veterans Affairs, Hines, IL, 2Wilkes-Barre VA Medical Center, Wilkes-Barre, PA, 3Charles George VA Medical Center, Asheville, NC, USA Purpose: Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers to “favor” a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design.Subjects and methods: Agreeable providers were randomized to “favor” either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate.Results: All four institutional review boards waived documentation of patient consent. Providers (n=18 followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients. In the “favor hydrochlorothiazide” group, there was 99% adherence to that strategy. In the “favor chlorthalidone” group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25–50 mg/day and 100% for chlorthalidone (12.5–25.0 mg/day. Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information

  14. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention.

    Science.gov (United States)

    Korshøj, Mette; Krustrup, Peter; Jørgensen, Marie Birk; Prescott, Eva; Hansen, Åse Marie; Kristiansen, Jesper; Skotte, Jørgen Henrik; Mortensen, Ole Steen; Søgaard, Karen; Holtermann, Andreas

    2012-08-13

    Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I) a reference group, receiving lectures concerning healthy living, or II) an intervention group, performing worksite aerobic exercise "60 min per week". Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Information is lacking about whether an improved cardiorespiratory fitness will affect the cardiovascular health, and additionally decrease the objectively

  15. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    Science.gov (United States)

    2012-01-01

    Background Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. Methods/design A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I) a reference group, receiving lectures concerning healthy living, or II) an intervention group, performing worksite aerobic exercise “60 min per week”. Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Discussion Information is lacking about whether an improved cardiorespiratory fitness will affect the cardiovascular health

  16. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    Directory of Open Access Journals (Sweden)

    Korshøj Mette

    2012-08-01

    Full Text Available Abstract Background Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. Methods/design A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I a reference group, receiving lectures concerning healthy living, or II an intervention group, performing worksite aerobic exercise “60 min per week”. Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Discussion Information is lacking about whether an improved cardiorespiratory fitness will affect

  17. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Pai Menaka

    2013-01-01

    Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

  18. Inertial particles distribute in turbulence as Poissonian points with random intensity inducing clustering and supervoiding

    Science.gov (United States)

    Schmidt, Lukas; Fouxon, Itzhak; Holzner, Markus

    2017-07-01

    inertia, described by the Poisson distribution, the typical void size is of the order of the mean interparticle distance. However, at small but finite inertia, the void size is larger than the mean interparticle distance by a factor that diverges in the continuum limit of infinite number of particles, manifesting strong deviations from the Poisson distribution. Thus, voids are very sensitive to inertia and limits of zero inertia and continuum may not commute. Further, the tail of the probability distribution of the void size is log normal, in contrast with faster than exponential decay of the Poisson distribution. Remarkably, at scales where there is no clustering (so pair-correlation function of concentration splits in the product of averages), there can still be an increase of the void probability so that turbulent voiding is stronger than clustering. These results can find applications in the long-time survival probability of reacting particles where the particle survives in the void of predators. The demonstrated double stochasticity (Poisson with random intensity) of the distribution originates in the two-step formation of fluctuations of the number of particles inside the volume under observation. First, turbulence randomly brings uncorrelated particles below the viscous scale with Poisson-type probability. Then, turbulence compresses the particles inside the observation volume. We confirm the predictions by numerical observations of inertial particle motion in a chaotic Arnold-Beltrami-Childress flow. Our work implies that the particle distribution in arbitrary weakly compressible flow with finite time correlations is a LGCP.

  19. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  20. Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) pilot study: a cluster randomized trial.

    Science.gov (United States)

    Kwong, Jeffrey C; Pereira, Jennifer A; Quach, Susan; Pellizzari, Rosana; Dusome, Edwina; Russell, Margaret L; Hamid, Jemila S; Feinberg, Yael; Winter, Anne-Luise; Gubbay, Jonathan B; Sirtonski, Brittany; Moher, Deanna; Sider, Doug; Finkelstein, Michael; Loeb, Mark

    2015-01-15

    School-based influenza immunization can effectively address accessibility barriers, but injected inactivated influenza vaccines (IIV) may not be acceptable to some children and parents in school settings. To better understand the feasibility of offering intranasal live attenuated influenza vaccines (LAIV) through schools, we assessed uptake, stakeholder acceptability, and cost of school-based delivery of LAIV compared to IIV. We piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario during the 2013-2014 influenza vaccination campaign. Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department. We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school. Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals. We compared the costs per dose of vaccine administered, including staff time and costs of vaccines and supplies. Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV (19.3% vs. 12.2%, p=0.02). Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines, and that LAIV was associated with increased efficiency and calmer children. All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake. The cost per vaccine dose administered was $38.67 for IIV and $43.50 for LAIV. Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety, but also slightly higher vaccine administration costs, compared to IIV. However, uptake was low for both groups. More effective strategies to promote

  1. Testing a workplace physical activity intervention: a cluster randomized controlled trial.

    Science.gov (United States)

    McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

    2011-04-11

    Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.

  2. Lay health educators increase colorectal cancer screening among Hmong Americans: A cluster randomized controlled trial.

    Science.gov (United States)

    Tong, Elisa K; Nguyen, Tung T; Lo, Penny; Stewart, Susan L; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Kagawa-Singer, Marjorie L; Sy, Angela U; Cuaresma, Charlene; Lam, Hy T; Wong, Ching; Tran, Mi T; Chen, Moon S

    2017-01-01

    Asian Americans have lower colorectal cancer (CRC) screening rates than non-Hispanic white individuals. Hmong Americans have limited socioeconomic resources and literacy. The current randomized controlled trial was conducted to determine whether bilingual/bicultural lay health educator (LHE) education could increase CRC screening among Hmong Americans. A cluster randomized controlled trial was conducted among Hmong Americans in Sacramento, California. LHEs and recruited participants were randomized to intervention or control groups. The intervention group received CRC education over 3 months delivered by an LHE. The control group received education regarding nutrition and physical activity delivered by a health educator. The outcomes were changes in self-reported ever-screening and up-to-date CRC screening after 6 months. All 329 participants were foreign-born with mostly no formal education, limited English proficiency, and no employment. The majority of the participants were insured and had a regular source of health care. The intervention group experienced greater changes after the intervention than the control group for ever-screening (P = .068) and being up-to-date with screening (Pscreening (adjusted odds ratio, 1.73; 95% confidence interval, 1.07-2.79) and being up-to-date with screening (adjusted odds ratio, 1.71; 95% confidence interval, 1.26-2.32). Individuals who had health insurance were found to have >4 times the odds of receiving screening, both ever-screening and up-to-date screening. A higher CRC knowledge score mediated the intervention effect for both screening outcomes. A culturally and linguistically appropriate educational intervention delivered by trained LHEs was found to increase CRC screening in an immigrant population with low levels of education, employment, English proficiency, and literacy. Cancer 2017;98-106. © 2016 American Cancer Society. © 2016 American Cancer Society.

  3. Study protocol: optimization of complex palliative care at home via telemedicine. A cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hasselaar Jeroen

    2011-08-01

    Full Text Available Abstract Background Due to the growing number of elderly with advanced chronic conditions, healthcare services will come under increasing pressure. Teleconsultation is an innovative approach to deliver quality of care for palliative patients at home. Quantitative studies assessing the effect of teleconsultation on clinical outcomes are scarce. The aim of this present study is to investigate the effectiveness of teleconsultation in complex palliative homecare. Methods/Design During a 2-year recruitment period, GPs are invited to participate in this cluster randomized controlled trial. When a GP refers an eligible patient for the study, the GP is randomized to the intervention group or the control group. Patients in the intervention group have a weekly teleconsultation with a nurse practitioner and/or a physician of the palliative consultation team. The nurse practitioner, in cooperation with the palliative care specialist of the palliative consultation team, advises the GP on treatment policy of the patient. The primary outcome of patient symptom burden is assessed at baseline and weekly using the Edmonton Symptom Assessment Scale (ESAS and at baseline and every four weeks using the Hospital Anxiety and Depression Scale (HADS. Secondary outcomes are self-perceived burden from informal care (EDIZ, patient experienced continuity of medical care (NCQ, patient and caregiver satisfaction with the teleconsultation (PSQ, the experienced problems and needs in palliative care (PNPC-sv and the number of hospital admissions. Discussion This is one of the first randomized controlled trials in palliative telecare. Our data will verify whether telemedicine positively affects palliative homecare. Trial registration The Netherlands National Trial Register NTR2817

  4. Testing a workplace physical activity intervention: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jackson Cath

    2011-04-01

    Full Text Available Abstract Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg and resting heart rate (B = -2.08 beats and significantly increased body mass index (B = .18 units compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396

  5. Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial.

    Science.gov (United States)

    Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Szturm, Tony

    2016-09-13

    To examine the feasibility of a clinical trial on a novel, home-based task-oriented training with conventional hand exercises in people with rheumatoid arthritis or hand osteoarthritis. To explore the experiences of participants who completed their respective home exercise programmes. Thirty volunteer participants aged between 30 and 60 years and diagnosed with rheumatoid arthritis or hand osteoarthritis were proposed for a single-center, assessor-blinded, randomized controlled trial ( ClinicalTrials.gov : NCT01635582). Participants received task-oriented training with interactive computer games and objects of daily life or finger mobility and strengthening exercises. Both programmes were home based and were done four sessions per week with 20 minutes each session for 6 weeks. Major feasibility outcomes were number of volunteers screened, randomized, and retained; completion of blinded assessments, exercise training, and home exercise sessions; equipment and data management; and clinical outcomes of hand function. Reaching the recruitment target in 18 months and achieving exercise compliance >80% were set as success criteria. Concurrent with the trial, focus group interviews explored experiences of those participants who completed their respective programmes. After trial initiation, revisions in inclusion criteria were required to promote recruitment. A total of 17 participants were randomized and 15 were retained. Completion of assessments, exercise training, and home exercise sessions; equipment and data collection and management demonstrated excellent feasibility. Both groups improved in hand function outcomes and exercise compliance was above 85%. Participants perceived both programmes as appropriate and acceptable. Participants who completed task-oriented training also agreed that playing different computer games was enjoyable, engaging, and motivating. Findings demonstrate initial evidence on recruitment, feasibility of trial procedures, and acceptability of

  6. Preventing heavy alcohol use in adolescents (PAS): cluster randomized trial of a parent and student intervention offered separately and simultaneously

    NARCIS (Netherlands)

    Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.

    2009-01-01

    Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19

  7. Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J.; ten Dam, Hester; Zuithoff, Nicolaas P. A.; Numans, Mattijs E.; de Wit, Niek J.

    Objectives To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Design Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Setting Primary care setting, 39 general practices in the Netherlands.

  8. Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Irene Drubbel; Niek J. de Wit; Prof. Dr. Marieke J. Schuurmans; Mattijs E. Numans; Hester ten Dam; Nienke Bleijenberg; Nicolaas P.F. Zuidhoff

    2016-01-01

    OBJECTIVES: To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. DESIGN: Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. SETTING: Primary care setting, 39 general practices in the

  9. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.J.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting General population of 11-15-year-old adolescents

  10. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use : A randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, Monique; Kleinjan, Marloes; Overbeek, Geertjan; Vermulst, Ad; Monshouwer, Karin; Lammers, Jeroen; Vollebergh, Wilma A M; Engels, Rutger C M E

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  11. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  12. A Cluster-Randomized Trial of Two Strategies to Improve Antibiotic Use for Patients with a Complicated Urinary Tract Infection

    NARCIS (Netherlands)

    Spoorenberg, Veroniek; Hulscher, Marlies E. J. L.; Geskus, Ronald B.; de Reijke, Theo M.; Opmeer, Brent C.; Prins, Jan M.; Geerlings, Suzanne E.

    2015-01-01

    Up to 50% of hospital antibiotic use is inappropriate and therefore improvement strategies are urgently needed. We compared the effectiveness of two strategies to improve the quality of antibiotic use in patients with a complicated urinary tract infection (UTI). In a multicentre, cluster-randomized

  13. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    Science.gov (United States)

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous…

  14. Predicting the random drift of MEMS gyroscope based on K-means clustering and OLS RBF Neural Network

    Science.gov (United States)

    Wang, Zhen-yu; Zhang, Li-jie

    2017-10-01

    Measure error of the sensor can be effectively compensated with prediction. Aiming at large random drift error of MEMS(Micro Electro Mechanical System))gyroscope, an improved learning algorithm of Radial Basis Function(RBF) Neural Network(NN) based on K-means clustering and Orthogonal Least-Squares (OLS) is proposed in this paper. The algorithm selects the typical samples as the initial cluster centers of RBF NN firstly, candidates centers with K-means algorithm secondly, and optimizes the candidate centers with OLS algorithm thirdly, which makes the network structure simpler and makes the prediction performance better. Experimental results show that the proposed K-means clustering OLS learning algorithm can predict the random drift of MEMS gyroscope effectively, the prediction error of which is 9.8019e-007°/s and the prediction time of which is 2.4169e-006s

  15. Community mobilization in Mumbai slums to improve perinatal care and outcomes: a cluster randomized controlled trial.

    Science.gov (United States)

    More, Neena Shah; Bapat, Ujwala; Das, Sushmita; Alcock, Glyn; Patil, Sarita; Porel, Maya; Vaidya, Leena; Fernandez, Armida; Joshi, Wasundhara; Osrin, David

    2012-01-01

    Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health. A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60-1.22), and the neonatal mortality rate higher (1.48, 1.06-2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90-1.57). We have no evidence that these differences could be explained by the intervention. Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors. Current Controlled Trials ISRCTN96256793

  16. Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Wouters, Hans; Scheper, Jessica; Koning, Hedi; Brouwer, Chris; Twisk, Jos W; van der Meer, Helene; Boersma, Froukje; Zuidema, Sytse U; Taxis, Katja

    2017-11-07

    Inappropriate prescribing is a well-known clinical problem in nursing home residents, but few interventions have focused on reducing inappropriate medication use. To examine successful discontinuation of inappropriate medication use and to improve prescribing in nursing home residents. Pragmatic cluster randomized controlled trial, with clustering by elder care physicians and their wards. (ClinicalTrials.gov: NCT01876095). 59 Dutch nursing home wards for long-term care. Residents with a life expectancy greater than 4 weeks who consented to treatment with medication. Multidisciplinary Multistep Medication Review (3MR) consisting of an assessment of the patient perspective, medical history, critical appraisal of medications, a meeting between the treating elder care physician and the pharmacist, and implementation of medication changes. Successful discontinuation of use of at least 1 inappropriate drug (that is, without relapse or severe withdrawal symptoms) and clinical outcomes (neuropsychiatric symptoms, cognitive function, and quality of life) after 4 months of follow-up. Nineteen elder care physicians (33 wards) performed the 3MR, and 16 elder care physicians (26 wards) followed standard procedures. A total of 426 nursing home residents (233 in the intervention group and 193 in the control group) were followed for an average of 144 days (SD, 21). In an analysis of all participants, use of at least 1 inappropriate medication was successfully discontinued for 91 (39.1%) residents in the intervention group versus 57 (29.5%) in the control group (adjusted relative risk, 1.37 [95% CI, 1.02 to 1.75]). Clinical outcomes did not deteriorate between baseline and follow-up. The 3MR was done only once. Some withdrawal symptoms or relapses may have been missed. The 3MR is effective in discontinuing inappropriate medication use in frail nursing home residents without a decline in their well-being. Netherlands Organisation for Health Research and Development.

  17. Improving the Multidisciplinary Treatment of Chronic Pain by Stimulating Body Awareness: A Cluster-randomized Trial.

    Science.gov (United States)

    Van der Maas, Lia C C; Köke, Albère; Pont, Menno; Bosscher, Ruud J; Twisk, Jos W R; Janssen, Thomas W J; Peters, Madelon L

    2015-07-01

    Because of methodological flaws and a lack of theoretical foundation of body awareness (BA) in previous effect studies of interventions directed to stimulate BA, it is impossible to attribute treatment effects to this specific component of a multidisciplinary treatment. Therefore, this study evaluated short-term and long-term effects of a multidisciplinary pain rehabilitation program with and without psychomotor therapy (PMT), which focused on BA (measured by the scale of body connection) as a primary target of intervention. Ninety-four patients clustered in 20 treatment groups were cluster randomized, using a biased-coin design, to multidisciplinary treatment as usual with or without PMT. Outcome variables were health-related quality of life, disability, and depression. BA, catastrophizing, and self-efficacy were measured as potential process variables. Assessments were performed at baseline, directly after treatment, and at 3, 6, and 12 month follow-ups. The data were analyzed by linear mixed-model analysis according to the intention-to-treat principle. Data of all 94 patients were used for analyses. After treatment, significant differences favoring PMT were found between conditions on depression (regression coefficient [RC]=-5.01; 95% confidence interval [CI], -8.81 to -1.21), BA (RC=0.23; 95% CI, 0.04 to 0.42) and catastrophizing (RC=-4.76; 95% CI, -8.03 to -1.48). These differences were no longer significant for depression at the 3-month follow-up and for catastrophizing at the 6-month follow-up. No clinical meaningful differences were found between treatment conditions in the primary outcome measures health-related quality of life and disability. However, this is the first long-term RCT that has shown that PMT improves BA in patients with chronic pain and shows good effect size and a significant decrease for catastrophizing.

  18. Effectiveness of Vi capsular polysaccharide typhoid vaccine among children: a cluster randomized trial in Karachi, Pakistan.

    Science.gov (United States)

    Khan, M Imran; Soofi, Sajid Bashir; Ochiai, R Leon; Habib, Mohammad Atif; Sahito, Shah Muhammad; Nizami, S Qamaruddin; Acosta, Camilo J; Clemens, John D; Bhutta, Zulfiqar A

    2012-08-03

    Typhoid fever is endemic in Karachi, with an incidence among children ranging from 170 to 450 per 100,000 child-years. Vaccination strategies are important for prevention, and the Vi capsular polysaccharide (ViCPS) vaccine has been shown to be effective in reducing the burden of typhoid fever. A cluster randomized trial was conducted in three low socioeconomic urban squatter settlements in Karachi, Pakistan between 2002 and 2007. Subsamples were followed up for assessment of immune response and adverse events after vaccination. The study participants were similar in a wide variety of socio-demographic and economic characteristics at baseline. A total of 27,231 individuals of the total target population of 51,965 in 120 clusters either received a ViCPS vaccine (13,238 [52% coverage]) or the control Hepatitis A vaccine (13,993 [53%]). Typhoid fever was diagnosed in 30 ViCPS vaccine recipients and 49 Hepatitis A vaccine recipients with an adjusted total protective effectiveness of 31% (95%CI: -28%, 63%). The adjusted total vaccine protective effectiveness was -38% (95%CI: -192%, 35%) for children aged 2-5 years and 57% (95%CI: 6%, 81%) for children 5-16 years old. The ViCPS vaccine did not confer statistically significant protection to children in the study areas, and there was a decline in antibody response 2 years post-vaccination. However, the ViCPS vaccine showed significant total protection in children 5-16 years of age, which is consistent with other studies of ViCPS vaccine conducted in India, Nepal, China and South Africa. These findings suggest that ViCPS vaccination of school-aged children will protect the children of urban, typhoid endemic areas against typhoid fever. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial.

    Science.gov (United States)

    Safford, Monika M; Andreae, Susan; Cherrington, Andrea L; Martin, Michelle Y; Halanych, Jewell; Lewis, Marquita; Patel, Ashruta; Johnson, Ethel; Clark, Debra; Gamboa, Christopher; Richman, Joshua S

    2015-08-01

    It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under-resourced areas such as the rural South. We examined the effect of an innovative peer-coaching intervention plus brief education vs brief education alone on diabetes outcomes. This was a community-engaged, cluster-randomized, controlled trial with primary care practices and their surrounding communities serving as clusters. The trial enrolled 424 participants, with 360 completing baseline and follow-up data collection (84.9% retention). The primary outcomes were change in glycated hemoglobin (HbA1c), systolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), body mass index (BMI), and quality of life, with diabetes distress and patient activation as secondary outcomes. Peer coaches were trained for 2 days in community settings; the training emphasized motivational interviewing skills, diabetes basics, and goal setting. All participants received a 1-hour diabetes education class and a personalized diabetes report card at baseline. Intervention arm participants were also paired with peer coaches; the protocol called for telephone interactions weekly for the first 8 weeks, then monthly for a total of 10 months. Due to real-world constraints, follow-up was protracted, and intervention effects varied over time. The analysis that included the 68% of participants followed up by 15 months showed only a significant increase in patient activation in the intervention group. The analysis that included all participants who eventually completed follow-up revealed that intervention arm participants had significant differences in changes in systolic BP (P = .047), BMI (P = .02), quality of life (P = .003), diabetes distress (P = .004), and patient activation (P = .03), but not in HbA1c (P = .14) or LDL-C (P = .97). Telephone-delivered peer coaching holds promise to improve health for individuals with diabetes living in under-resourced areas. © 2015

  20. HIV incidence among people who inject drugs (PWID) in Ukraine: results from a clustered randomized trial

    Science.gov (United States)

    Davis, Jonathan M.; Dvoryak, Sergey; Brewster, John T.; Lisovska, Oksana; Strathdee, Steffanie A.; Latkin, Carl A.

    2016-01-01

    Summary Background In this study, we sought to assess whether a social network intervention was superior to HIV testing and counseling in impacting HIV incidence among PWID. Although this was not a primary study aim, it is associated with reducing drug and sex risk behaviors, which were primary aims. Methods PWID were recruited from street settings in Odessa, Donetsk, and Nikolayev, Ukraine for a clustered randomized clinical trial (RCT). “Index” or peer leaders, along with two of their network members, were randomly assigned to testing and counseling block (N=589) or testing and counseling plus a social network intervention block (N=611). Participants in the network intervention received 5-sessions to train their network members in risk reduction. Those assigned testing and counseling received no further intervention following counseling. Employing an intent to treat analyses, the primary outcome was HIV sero-conversion using Cox regression and incorporating a gamma frailty term to account for clustering. No stratification or minimization was utilized. The trail was registered with ClinicalTrial.gov, NCT01159704. Findings Between July 12, 2010 and November 23, 2012, 2,304 PWID were recruited, 1,200 of whom were HIV negative and included in the present study. At baseline, there were no significant differences between groups. Of the 1,200 HIV negative participants, 1,085 (90.4%) were retained at 12 months. Incidence density revealed 18.45 (95% CI 14.87 – 22.03, 102 events in 553.0 py) per 100 person years (py) for those in the intervention group and 31.78 (95% CI 26.83–36.74, 158 events in 497.1 py) per 100 py among control arm participants. This corresponded to a reduced hazard in the intervention group, HR= 0.53 (95% CI 0.38, 0.76, p =0.0003). There were no study-related adverse events. Interpretation These data provide strong support for integrating peer education into comprehensive HIV prevention programs for PWID and suggest the value in developing and

  1. Does clinical equipoise apply to cluster randomized trials in health research?

    Science.gov (United States)

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

  2. Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

    Science.gov (United States)

    Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

    2016-07-01

    There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  3. School-community partnerships: a cluster-randomized trial of an after-school soccer program.

    Science.gov (United States)

    Madsen, Kristine; Thompson, Hannah; Adkins, Amy; Crawford, Yashica

    2013-04-01

    Identifying community-based programs that increase physical activity among diverse youth could yield sustainable tools to reduce obesity and obesity disparities. To evaluate the impact of a community-based after-school soccer and youth development program, America SCORES, on students' physical activity, weight status, and fitness. Cluster-randomized trial. Study measures were collected in the fall (baseline), winter (midpoint), and spring (end point) of the 2009-2010 school year. After-school programs in 6 schools within a large urban school district. All 4th and 5th grade students in after-school programs at the study schools were eligible. Three schools were randomized to receive the SCORES after-school program, delivered via the train-the-trainer model. Change in minutes of after-school moderate-to-vigorous physical activity (MVPA), fitness (maximal oxygen consumption), and body mass index over 1 school year. Participants (n = 156) were diverse (42% Latino, 32% Asian, and 12% African American) and 76 (49%) had a body mass index at or above the 85th percentile. There were no significant group differences in the change in physical activity, fitness, or weight status among all students. However, among students with a body mass index at or above the 85th percentile, SCORES significantly increased MVPA after school (3.4 min/d; 95% CI, 0.3-6.5) and on Saturdays (18.5 minutes; 95% CI, 3.4-33.6). Existing community-based programs such as SCORES can increase physical activity among low-income youth, particularly those most at risk for weight-related comorbidities. While evaluating existing programs presents special challenges, partnerships between communities, schools, and researchers are an important component of translational research to address obesity. clinicaltrials.gov Identifier: NCT01156103.

  4. Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

    2015-12-01

    Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p smoke-free with increasing intensity of the intervention (control children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial.

    Science.gov (United States)

    Loeb, Mark; Russell, Margaret L; Manning, Vanessa; Fonseca, Kevin; Earn, David J D; Horsman, Gregory; Chokani, Khami; Vooght, Mark; Babiuk, Lorne; Schwartz, Lisa; Neupane, Binod; Singh, Pardeep; Walter, Stephen D; Pullenayegum, Eleanor

    2016-11-01

    Whether vaccinating children with intranasal live attenuated influenza vaccine (LAIV) is more effective than inactivated influenza vaccine (IIV) in providing both direct protection in vaccinated persons and herd protection in unvaccinated persons is uncertain. Hutterite colonies, where members live in close-knit, small rural communities in which influenza virus infection regularly occurs, offer an opportunity to address this question. To determine whether vaccinating children and adolescents with LAIV provides better community protection than IIV. A cluster randomized blinded trial conducted between October 2012 and May 2015 over 3 influenza seasons. (ClinicalTrials.gov: NCT01653015). 52 Hutterite colonies in Alberta and Saskatchewan, Canada. 1186 Canadian children and adolescents aged 36 months to 15 years who received the study vaccine and 3425 community members who did not. Children were randomly assigned according to community in a blinded manner to receive standard dosing of either trivalent LAIV or trivalent IIV. The primary outcome was reverse transcriptase polymerase chain reaction-confirmed influenza A or B virus in all participants (vaccinated children and persons who did not receive the study vaccine). Mean vaccine coverage among children in the LAIV group was 76.9% versus 72.3% in the IIV group. Influenza virus infection occurred at a rate of 5.3% (295 of 5560 person-years) in the LAIV group versus 5.2% (304 of 5810 person-years) in the IIV group. The hazard ratio comparing LAIV with IIV for influenza A or B virus was 1.03 (95% CI, 0.85 to 1.24). The study was conducted in Hutterite communities, which may limit generalizability. Immunizing children with LAIV does not provide better community protection against influenza than IIV. The Canadian Institutes for Health Research.

  6. Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

    Science.gov (United States)

    Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

    2015-01-01

    To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, psmoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  7. Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

    Science.gov (United States)

    Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

    2011-09-01

    To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  8. Who is the research subject in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2011-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

  9. A cluster-randomized evaluation of a responsive stimulation and feeding intervention in bangladesh.

    Science.gov (United States)

    Aboud, Frances E; Akhter, Sadika

    2011-05-01

    The goal of this study was to determine if a responsive stimulation and feeding intervention improved developmental and nutritional outcomes compared with a regular information-based parenting program. The hypothesis was that mothers in the intervention would exhibit better parenting skills and children would exhibit better developmental and nutritional outcomes than controls. A cluster-randomized field trial was conducted with 302 children aged 8 to 20 months and their mothers in rural Bangladesh who were randomly assigned according to village to 1 of 3 groups. The control mothers received 12 informational sessions on health and nutrition. The intervention groups received an additional 6 sessions delivered by peer educators who included modeling and coached practice in self-feeding and verbal responsiveness with the child during play. A second intervention group received, along with the sessions, 6 months of a food powder fortified with minerals and vitamins. Developmental outcomes included the Home Observation for Measurement of the Environment (HOME) Inventory, mother-child responsive talk, and language development. Nutritional outcomes included weight, height, self-feeding, and mouthfuls eaten. We used analysis of covariance to compare the 3 groups at the posttest and at follow-up, covarying the pretest levels and confounders. At follow-up, responsive stimulation-feeding groups had better HOME inventory scores, responsive talking, language, mouthfuls eaten, and hand-washing. Micronutrient fortification resulted in more weight gain. A brief behavior-change program that focused on modeling and practice in stimulation and feeding was found to benefit children's nutrition and language development. Micronutrients benefited children's weight but not length.

  10. Micronutrient-Fortified Rice Can Increase Hookworm Infection Risk: A Cluster Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Brechje de Gier

    Full Text Available Fortification of staple foods is considered an effective and safe strategy to combat micronutrient deficiencies, thereby improving health. While improving micronutrient status might be expected to have positive effects on immunity, some studies have reported increases in infections or inflammation after iron supplementation.To study effects of micronutrient-fortified rice on hookworm infection in Cambodian schoolchildren.A double-blinded, cluster-randomized trial was conducted in 16 Cambodian primary schools partaking in the World Food Program school meal program. Three types of multi-micronutrient fortified rice were tested against placebo rice within the school meal program: UltraRice_original, UltraRice_improved and NutriRice. Four schools were randomly assigned to each study group (placebo n = 492, UltraRice_original n = 479, UltraRice_improved n = 500, NutriRice n = 506. Intestinal parasite infection was measured in fecal samples by Kato-Katz method at baseline and after three and seven months. In a subgroup (N = 330, fecal calprotectin was measured by ELISA as a marker for intestinal inflammation.Baseline prevalence of hookworm infection was 18.6%, but differed considerably among schools (range 0%- 48.1%.Micronutrient-fortified rice significantly increased risk of new hookworm infection. This effect was modified by baseline hookworm prevalence at the school; hookworm infection risk was increased by all three types of fortified rice in schools where baseline prevalence was high (>15%, and only by UltraRice_original in schools with low baseline prevalence. Neither hookworm infection nor fortified rice was related to fecal calprotectin.Consumption of rice fortified with micronutrients can increase hookworm prevalence, especially in environments with high infection pressure. When considering fortification of staple foods, a careful risk-benefit analysis is warranted, taking into account severity of micronutrient deficiencies and local

  11. Cluster-randomized trial demonstrating impact on academic achievement of elementary social-emotional learning.

    Science.gov (United States)

    Schonfeld, David J; Adams, Ryan E; Fredstrom, Bridget K; Weissberg, Roger P; Gilman, Richard; Voyce, Charlene; Tomlin, Ricarda; Speese-Linehan, Dee

    2015-09-01

    This study evaluated the results of a social and emotional learning (SEL) program on academic achievement among students attending a large, urban, high-risk school district. Using a cluster-randomized design, 24 elementary schools were assigned to receive either the intervention curriculum (Promoting Alternative Thinking Strategies, or PATHS) or a curriculum that delivered few if any SEL topics (i.e., the control group). In addition to state mastery test scores, demographic data, school attendance, and dosage information were obtained from 705 students who remained in the same group from the 3rd to the 6th grade. Analyses of odds ratios revealed that students enrolled in the intervention schools demonstrated higher levels of basic proficiency in reading, writing, and math at some grade levels. Although these between-groups differences held for race/ethnicity, gender, and socioeconomic status, significant within-group differences also were noted across these variables. Collectively, these findings indicated that social development instruction may be a promising approach to promote acquisition of academic proficiency, especially among youth attending high-risk school settings. Implications of these findings with respect to SEL programs conclude the article. (c) 2015 APA, all rights reserved).

  12. Comparison of media literacy and usual education to prevent tobacco use: a cluster randomized trial

    Science.gov (United States)

    Douglas, Erika L.; Land, Stephanie R.; Miller, Elizabeth; Fine, Michael J.

    2014-01-01

    BACKGROUND Media literacy programs have shown potential for reduction of adolescent tobacco use. We aimed to determine if an anti-smoking media literacy curriculum improves students’ media literacy and affects factors related to adolescent smoking. METHODS We recruited 1170 9th grade students from 64 classrooms in 3 public urban high schools. Students were randomized by classroom to a media literacy curriculum versus a standard educational program. In an intent-to-treat analysis, we used multi-level modeling to determine if changes in study outcomes were associated with the curricular intervention, controlling for baseline student covariates and the clustering of students within classrooms. RESULTS Among participants, mean age was 14.5 years and 51% were male, with no significant differences in baseline characteristics between groups. Smoking media literacy changed more among intervention participants compared with control participants (0.24 vs. 0.08, p media literacy curriculum is more effective than a standard educational program in teaching media literacy and improving perceptions of the true prevalence of smoking among adolescents. PMID:25099425

  13. Cluster-randomized trial of a German leisure-based alcohol peer education measure.

    Science.gov (United States)

    Bühler, Anneke; Thrul, Johannes; Strüber, Evelin; Orth, Boris

    2016-06-01

    Because of scarce research, the effectiveness of substance abuse prevention in leisure settings remains unclear. In this study, we evaluated the effectiveness of a peer-led educational prevention measure with adolescent groups in unstructured leisure settings, which is a component of the complex German nationwide 'Na Toll!' campaign. Using a cluster-randomized two-group post-test-only design, we tested whether the measure influenced component-specific goals, namely risk and protective factors of alcohol use such as risk perception, group communication and resistance self-efficacy. The sample consisted of 738 adolescents aged 12-20 years who were recruited at recreational locations and completed an online questionnaire 1 week after the peer education or recruitment event. Sixty-three percent of the sample participated in the 3-month follow-up assessment. Data analysis revealed post-test effects on risk perception, perceived norm of alcohol communication in the peer group and resistance self-efficacy. Follow-up effects were not observed, with the exception of a significant effect on risk perception. In conclusion, the peer-led education measure in leisure settings might have supported the adolescents in this study to perceive alcohol-related risks, to feel accepted to talk about alcohol problems with their friends and to be more assertive in resisting alcohol use in the short term. © The Author 2015. Published by Oxford University Press.

  14. Cluster randomized trial to compare spectacle delivery systems at outreach eye camps in South India.

    Science.gov (United States)

    Ramasamy, Dhivya; Joseph, Sanil; Valaguru, Vijayakumar; Mitta, Vinod P; Ravilla, Thulasiraj D; Cotch, Mary Frances

    2013-10-01

    To study the optimal method for delivery of spectacles at eye camps to maximize procurement and use. A cluster randomized controlled trial, undertaken in the catchment districts of Aravind Eye Hospital - Theni, in the state of Tamil Nadu, India. Community eye camps (n = 21) were allocated to offer one of three types of service for purchase of spectacles to correct refractive error: (1) Issuance of a prescription only; (2) booking orders for spectacles with subsequent delivery; (3) on-the-spot fitting and dispensing of spectacles. Follow-up questionnaires were administered 6 weeks after interventions to assess patient outcomes. The primary outcome measured was spectacle procurement at follow-up 6 weeks post-screening. Secondary outcomes included use of and satisfaction with spectacles. Reasons for purchase/non-purchase were also assessed. Compared to those who were issued only a prescription and adjusting for distance from base hospital, spectacle procurement was significantly higher for those allowed to book spectacles for subsequent delivery (odds ratio, OR, 8.79, 95% confidence interval, CI, 4.61-16.78) and for those receiving spectacles on the spot (OR 13.97, 95% CI 8.12-24.05). Among those with spectacles at 6 weeks, spectacle use was nearly universal and satisfaction with spectacles varied between 92 and 94% among the three different dispensing modalities. Making spectacles available on the spot is important to ensure procurement in a context where availability and access to dispensing opticians is poor.

  15. Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

    Directory of Open Access Journals (Sweden)

    McRae Andrew D

    2013-01-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1 ethical challenges in CRTs; (2 the ethics review process for CRTs; and (3 the need for comprehensive ethics guidelines for CRTs. Methods Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers. Results Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees. Conclusions Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

  16. Prevention of Anxiety and Depression in Swedish School Children: a Cluster-Randomized Effectiveness Study.

    Science.gov (United States)

    Ahlen, Johan; Hursti, Timo; Tanner, Lindsey; Tokay, Zelal; Ghaderi, Ata

    2017-07-20

    Our study aimed at evaluating FRIENDS for Life, an intervention to prevent anxiety and depression in Swedish school children. A total of 695 children between the ages of 8 and 11 were recruited from 17 schools in Stockholm, Sweden, and cluster-randomized to either the intervention or control group. Teachers in the intervention group received a full day of training and administered FRIENDS for Life in their classrooms. We assessed the children's anxiety and depressive symptoms, general mental health, and academic performance at pre- and post-intervention as well as at the 12-month follow-up. A multi-informant approach was used with data collected from children, parents, and teachers. Assessment was done with the Spence Children's Anxiety Scale, Children's Depression Inventory, and the Strengths and Difficulties Questionnaire. Children's baseline symptoms, gender, and age as well as their teacher's use of supervision were examined as moderators of effect. Our study found no short- or long-term effects of the intervention for any outcome with regard to the entire sample. We found an enhanced effect of the intervention regarding children with elevated depressive symptoms at baseline. We found a decrease in anxiety symptoms among children whose teachers attended a larger number of supervision sessions, compared to children whose teachers attended fewer supervised sessions or the control group. Mediation analyses showed that this effect was driven by change in the last phase of the intervention, suggesting that supervision might play an important role in enhancing teachers' ability to administer the intervention effectively.

  17. Comparison of media literacy and usual education to prevent tobacco use: a cluster-randomized trial.

    Science.gov (United States)

    Primack, Brian A; Douglas, Erika L; Land, Stephanie R; Miller, Elizabeth; Fine, Michael J

    2014-02-01

    Media literacy programs have shown potential for reduction of adolescent tobacco use. We aimed to determine if an anti-smoking media literacy curriculum improves students' media literacy and affects factors related to adolescent smoking. We recruited 1170 9th-grade students from 64 classrooms in 3 public urban high schools. Students were randomized by classroom to a media literacy curriculum versus a standard educational program. In an intent-to-treat analysis, we used multilevel modeling to determine if changes in study outcomes were associated with the curricular intervention, controlling for baseline student covariates and the clustering of students within classrooms. Among participants, mean age was 14.5 years and 51% were male, with no significant differences in baseline characteristics between groups. Smoking media literacy changed more among intervention participants compared with control participants (0.24 vs. 0.08, p media literacy curriculum is more effective than a standard educational program in teaching media literacy and improving perceptions of the true prevalence of smoking among adolescents. © 2014, American School Health Association.

  18. Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

    Science.gov (United States)

    Duclos, A; Peix, J L; Piriou, V; Occelli, P; Denis, A; Bourdy, S; Carty, M J; Gawande, A A; Debouck, F; Vacca, C; Lifante, J C; Colin, C

    2016-12-01

    The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

  19. Group Music Therapy as a Preventive Intervention for Young People at Risk: Cluster-Randomized Trial.

    Science.gov (United States)

    Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes

    2017-07-01

    Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.

  20. Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

    Science.gov (United States)

    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-03-05

    Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

  1. Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

    Science.gov (United States)

    Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. Methods We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Results Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting “leaked” and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations

  2. Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial.

    Science.gov (United States)

    Sherr, Kenneth; Gimbel, Sarah; Rustagi, Alison; Nduati, Ruth; Cuembelo, Fatima; Farquhar, Carey; Wasserheit, Judith; Gloyd, Stephen

    2014-05-08

    Despite significant increases in global health investment and the availability of low-cost, efficacious interventions to prevent mother-to-child HIV transmission (pMTCT) in low- and middle-income countries with high HIV burden, the translation of scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. A five-step, facility-level systems analysis and improvement intervention (SAIA) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies (step one: cascade analysis), guiding identification and prioritization of low-cost workflow modifications (step two: value stream mapping), and iteratively testing and redesigning these modifications (steps three through five). This protocol describes the SAIA intervention and methods to evaluate the intervention's impact on reducing drop-offs along the pMTCT cascade. This study employs a two-arm, longitudinal cluster randomized trial design. The unit of randomization is the health facility. A total of 90 facilities were identified in Côte d'Ivoire, Kenya and Mozambique (30 per country). A subset was randomly selected and assigned to intervention and comparison arms, stratified by country and service volume, resulting in 18 intervention and 18 comparison facilities across all three countries, with six intervention and six comparison facilities per country. The SAIA intervention will be implemented for six months in the 18 intervention facilities. Primary trial outcomes are designed to assess improvements in the pMTCT service cascade, and include the percentage of pregnant women being tested for HIV at the first antenatal care visit, the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy, and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum. The

  3. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    French Michael T

    2011-04-01

    with outcome data will be included in the analysis, following the intent-to-treat principle. Organizational covariates in the analysis include program size, management score, and state. Discussion The study offers seven recommendations for conducting a large-scale cluster-randomized trial: provide valuable services, have aims that are clear and important, seek powerful allies, understand the recruiting challenge, cultivate commitment, address turnover, and encourage rigor and flexibility. Trial Registration ClinicalTrials. govNCT00934141

  4. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

    Science.gov (United States)

    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 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 rarely corrected in this setting.Trial Registration

  5. Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

    Science.gov (United States)

    Relton, Clare; Strong, Mark; Thomas, Kate J; Whelan, Barbara; Walters, Stephen J; Burrows, Julia; Scott, Elaine; Viksveen, Petter; Johnson, Maxine; Baston, Helen; Fox-Rushby, Julia; Anokye, Nana; Umney, Darren; Renfrew, Mary J

    2018-02-05

    Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government

  6. Effects of Coping-Oriented Couples Therapy on Depression: A Randomized Clinical Trial

    Science.gov (United States)

    Bodenmann, Guy; Plancherel, Bernard; Beach, Steven R. H.; Widmer, Kathrin; Gabriel, Barbara; Meuwly, Nathalie; Charvoz, Linda; Hautzinger, Martin; Schramm, Elisabeth

    2008-01-01

    The aim of this study was to evaluate the effectiveness of treating depression with coping-oriented couples therapy (COCT) as compared with cognitive-behavioral therapy (CBT; A. T. Beck, C. Ward, & M. Mendelson, 1961) and interpersonal psychotherapy (IPT; M. M. Weissman, J. C. Markowitz, & G. L. Klerman, 2000). Sixty couples, including 1…

  7. Shape dependency of the extinction and absorption cross sections of dust aerosols modeled as randomly oriented spheroids

    Directory of Open Access Journals (Sweden)

    R. Wagner

    2011-09-01

    Full Text Available We present computational results on the shape dependency of the extinction and absorption cross sections of dustlike aerosol particles that were modeled as randomly oriented spheroids. Shape dependent variations in the extinction cross sections are largest in the size regime that is governed by the interference structure. Elongated spheroids best fitted measured extinction spectra of re-dispersed Saharan dust samples. For dust particles smaller than 1.5 μm in diameter and low absorption potential, shape effects on the absorption cross sections are very small.

  8. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis.

    Science.gov (United States)

    Gonzales, Ralph; Anderer, Tammy; McCulloch, Charles E; Maselli, Judith H; Bloom, Frederick J; Graf, Thomas R; Stahl, Melissa; Yefko, Michelle; Molecavage, Julie; Metlay, Joshua P

    2013-02-25

    National quality indicators show little change in the overuse of antibiotics for uncomplicated acute bronchitis. We compared the effect of 2 decision support strategies on antibiotic treatment of uncomplicated acute bronchitis. We conducted a 3-arm cluster randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed decision support intervention sites (11 practices) received decision support for acute cough illness through a print-based strategy, the computer-assisted decision support intervention sites (11 practices) received decision support through an electronic medical record-based strategy, and the control sites (11 practices) served as a control arm. Both intervention sites also received clinician education and feedback on prescribing practices, as well as patient education brochures at check-in. Antibiotic prescription rates for uncomplicated acute bronchitis in the winter period (October 1, 2009, through March 31, 2010) following introduction of the intervention were compared with the previous 3 winter periods in an intent-to-treat analysis. Compared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed decision support intervention sites (from 80.0% to 68.3%) and at the computer-assisted decision support intervention sites (from 74.0% to 60.7%) but increased slightly at the control sites (from 72.5% to 74.3%). After controlling for patient and clinician characteristics, as well as clustering of observations by clinician and practice site, the differences for the intervention sites were statistically significant from the control sites (P = .003 for control sites vs printed decision support intervention sites and P = .01 for control sites vs computer-assisted decision support intervention sites) but not between themselves (P = .67 for printed decision support intervention sites vs computer

  9. Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    More, Neena Shah; Bapat, Ujwala; Das, Sushmita; Alcock, Glyn; Patil, Sarita; Porel, Maya; Vaidya, Leena; Fernandez, Armida; Joshi, Wasundhara; Osrin, David

    2012-01-01

    Introduction Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health. Methods and Findings A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention. Conclusions Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors. Trial registration

  10. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

    Science.gov (United States)

    Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare I R; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

    2014-07-29

    An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. The main challenges

  11. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koolhaas Wendy

    2010-08-01

    Full Text Available Abstract Background To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. Methods/design The study is a cluster-randomized controlled trial design (randomized at the supervisor level, with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1 changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2 improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3 enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. Discussion The intervention 'Staying healthy at work' has the

  12. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial.

    Science.gov (United States)

    Koolhaas, Wendy; Brouwer, Sandra; Groothoff, Johan W; van der Klink, Jac Jl

    2010-08-06

    To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. The study is a cluster-randomized controlled trial design (randomized at the supervisor level), with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1) changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2) improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3) enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. The intervention 'Staying healthy at work' has the potential to provide evidence-based knowledge of an innovative

  13. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    Directory of Open Access Journals (Sweden)

    López-García-Franco Alberto

    2012-05-01

    Full Text Available Abstract 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

  14. Strengthening primary health care teams with palliative care leaders: protocol for a cluster randomized clinical trial.

    Science.gov (United States)

    Llobera, Joan; Sansó, Noemí; Ruiz, Amador; Llagostera, Merce; Serratusell, Estefania; Serrano, Carlos; Roselló, María Luisa Martín; Benito, Enric; Castaño, Eusebio J; Leiva, Alfonso

    2017-07-10

    The objective of the Balearic Islands Palliative Care (PC) Program is to improve the quality of PC through a shared model consisting of primary health care professionals, home-based PC teams, and PC units in hospitals. According to the World Health Organization (WHO), patients with advanced cancer and other terminal diseases benefit from early identification and proactive PC. We will evaluate the effectiveness of an intervention in which a PC leader is established in the primary health care center, and assess the effect of this intervention on the early identification of patients in need of PC, the efficient use of health care services, and direct health care costs. Design: A two-arm cluster randomized clinical trial of 30 Primary Health Care Centers (PHCC) in Mallorca (Spain), in which each center was randomized to an intervention arm or a usual care arm. We expect that the number of patients identified as suitable for PC (including non-oncological PC) is at least 5% greater in the intervention arm. A total of 4640 deceased patients. Outcomes will be assessed by a blinded external review of the electronic records. General practitioners (GPs) and nurse leaders in PC for each PHCC will be appointed. These leaders will help promote PC training of colleagues, improve symptom management and psychological support of patients, and evaluate the complexity of individual cases so that these cases receive assistance from PC home-based teams. Early identification (>90 days before death), evaluation of case complexity, level of case complexity (with referral to a home-based PC team), use and cost of hospital and primary care services, and quality of life during the last month of life (≥2 emergency room visits, ≥2 hospital admissions, ≥14 days of hospitalization). PC leaders in primary care teams will improve the early identification of patients eligible for PC. This initiative could improve the quality of end-of-life care and utilization of hospital resources. ISRCTN

  15. Improving the quality of hospital care for children by supportive supervision: a cluster randomized trial, Kyrgyzstan

    Science.gov (United States)

    Shukurova, Venera; Davletbaeva, Marina; Monolbaev, Kubanychbek; Kulichenko, Tatiana; Akoev, Yuri; Bakradze, Maya; Margieva, Tea; Mityushino, Ilya; Namazova-Baranova, Leyla; Boronbayeva, Elnura; Kuttumuratova, Aigul; Weber, Martin Willy; Tamburlini, Giorgio

    2017-01-01

    Abstract Objective To determine whether periodic supportive supervision after a training course improved the quality of paediatric hospital care in Kyrgyzstan, where inappropriate care was common but in-hospital postnatal mortality was low. Methods In a cluster, randomized, parallel-group trial, 10 public hospitals were allocated to a 4-day World Health Organization (WHO) course on hospital care for children followed by periodic supportive supervision by paediatricians for 1 year, while 10 hospitals had no intervention. We assessed prospectively 10 key indicators of inappropriate paediatric case management, as indicated by WHO guidelines. The primary indicator was the combination of the three indicators: unnecessary hospitalization, increased iatrogenic risk and unnecessary painful procedures. An independent team evaluated the overall quality of care. Findings We prospectively reviewed the medical records of 4626 hospitalized children aged 2 to 60 months. In the intervention hospitals, the mean proportion of the primary indicator decreased from 46.9% (95% confidence interval, CI: 24.2 to 68.9) at baseline to 6.8% (95% CI: 1.1 to 12.1) at 1 year, but was unchanged in the control group (45.5%, 95% CI: 25.2 to 67.9, to 64.7%, 95% CI: 43.3 to 86.1). At 1 year, the risk ratio for the primary indicator in the intervention versus the control group was 0.09 (95% CI: 0.06 to 0.13). The proportions of the other nine indicators also decreased in the intervention group (P < 0.0001 for all). Overall quality of care improved significantly in intervention hospitals. Conclusion Periodic supportive supervision for 1 year after a training course improved both adherence to WHO guidelines on hospital care for children and the overall quality of paediatric care. PMID:28603306

  16. Cluster Randomized Trial to Compare Spectacle Delivery Systems at Outreach Eye Camps in South India

    Science.gov (United States)

    Ramasamy, Dhivya; Joseph, Sanil; Valaguru, Vijayakumar; Mitta, Vinod P.; Ravilla, Thulasiraj D; Cotch, Mary Frances

    2014-01-01

    Purpose To study the optimal method for delivery of spectacles at eye camps to maximize procurement and use. Methods A cluster randomized controlled trial, undertaken in the catchment districts of Aravind Eye Hospital – Theni, in the state of Tamil Nadu, India. Community eye camps (n = 21) were allocated to offer one of three types of service for purchase of spectacles to correct refractive error: (1) Issuance of a prescription only; (2) booking orders for spectacles with subsequent delivery; (3) on-the-spot fitting and dispensing of spectacles. Follow-up questionnaires were administered 6 weeks after interventions to assess patient outcomes. The primary outcome measured was spectacle procurement at follow-up 6 weeks post-screening. Secondary outcomes included use of and satisfaction with spectacles. Reasons for purchase/non-purchase were also assessed. Results Compared to those who were issued only a prescription and adjusting for distance from base hospital, spectacle procurement was significantly higher for those allowed to book spectacles for subsequent delivery (odds ratio, OR, 8.79, 95% confidence interval, CI, 4.61–16.78) and for those receiving spectacles on the spot (OR 13.97, 95% CI 8.12–24.05). Among those with spectacles at 6 weeks, spectacle use was nearly universal and satisfaction with spectacles varied between 92 and 94% among the three different dispensing modalities. Conclusion Making spectacles available on the spot is important to ensure procurement in a context where availability and access to dispensing opticians is poor. PMID:24070102

  17. Burns in Baghdad from 2003–2014: results of a randomized household cluster survey

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Shatari, Sahar A Esa Al; Cherewick, Megan; Burnham, Gilbert; Hagopian, Amy; Galway, Lindsay P; Kushner, Adam L

    2015-01-01

    Purpose Civilians living amid conflict are at high-risk of burns. However, the epidemiology of burns among this vulnerable group is poorly understood, yet vital for health policy and relief planning. To address this gap, we aimed to determine the death and disability, healthcare needs and household financial consequences of burns in post-invasion Baghdad. Methods A two-stage, cluster randomized, community-based household survey was performed in May of 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about cause of household member death, households were interviewed regarding burn specifics, healthcare required, disability, relationship to conflict and resultant financial hardship. Results Nine-hundred households, totaling 5,148 individuals, were interviewed. There were 55 burns, which were 10% of all injuries reported. There were an estimated 2,340 serious burn injures (39 per 100,000 persons) in Baghdad in 2003. The frequency of serious burn injuries generally increased post-invasion to 8,780 burns in 2013 (117 per 100,000 persons). Eight burns (15%) were the direct result of conflict. Individuals aged over 45 years had more than twice the odds of burn injury than children aged less than 13 years (aOR 2.42; 95%CI 1.08 – 5.44). Nineteen burns (35%) involved ≥20% body surface area. Death (16% of burn injuries), disability (40%), household financial hardship (48%) and food insecurity (50%) were common after burn injury. Conclusion Civilian burn injury in Baghdad is epidemic, increasing in frequency and associated with household financial hardship. Challenges of healthcare provision during prolonged conflict were evidenced by a high mortality rate and likelihood of disability after burn injury. Ongoing conflict will directly and indirectly generate more burns, which mandates planning for burn prevention and care within local capacity development initiatives, as well as humanitarian assistance. PMID:26526376

  18. Burns in Baghdad from 2003 to 2014: Results of a randomized household cluster survey.

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Esa Al Shatari, Sahar A; Cherewick, Megan; Burnham, Gilbert; Hagopian, Amy; Galway, Lindsay P; Kushner, Adam L

    2016-02-01

    Civilians living amid conflict are at high-risk of burns. However, the epidemiology of burns among this vulnerable group is poorly understood, yet vital for health policy and relief planning. To address this gap, we aimed to determine the death and disability, healthcare needs and household financial consequences of burns in post-invasion Baghdad. A two-stage, cluster randomized, community-based household survey was performed in May 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about cause of household member death, households were interviewed regarding burn specifics, healthcare required, disability, relationship to conflict and resultant financial hardship. Nine-hundred households, totaling 5148 individuals, were interviewed. There were 55 burns, which were 10% of all injuries reported. There were an estimated 2340 serious burns (39 per 100,000 persons) in Baghdad in 2003. The frequency of serious burns generally increased post-invasion to 8780 burns in 2013 (117 per 100,000 persons). Eight burns (15%) were the direct result of conflict. Individuals aged over 45 years had more than twice the odds of burn than children aged less than 13 years (aOR 2.42; 95%CI 1.08-5.44). Nineteen burns (35%) involved ≥ 20% body surface area. Death (16% of burns), disability (40%), household financial hardship (48%) and food insecurity (50%) were common after burn. Civilian burn in Baghdad is epidemic, increasing in frequency and associated with household financial hardship. Challenges of healthcare provision during prolonged conflict were evidenced by a high mortality rate and likelihood of disability after burn. Ongoing conflict will directly and indirectly generates more burns, which mandates planning for burn prevention and care within local capacity development initiatives, as well as humanitarian assistance. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  19. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

    Science.gov (United States)

    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

    2014-07-01

    The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

  20. Mental health first aid training for high school teachers: a cluster randomized trial.

    Science.gov (United States)

    Jorm, Anthony F; Kitchener, Betty A; Sawyer, Michael G; Scales, Helen; Cvetkovski, Stefan

    2010-06-24

    Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. ACTRN12608000561381.

  1. Reducing the use of sugar in public schools: a randomized cluster trial.

    Science.gov (United States)

    Souza, Rita Adriana Gomes de; Mediano, Mauro Felippe Felix; Souza, Amanda de Moura; Sichieri, Rosely

    2013-08-01

    To test the efficacy of nutritional guidelines for school lunch cooks aiming to reduce added sugar in school meals and their own sugar intake. A controlled randomized cluster trial was carried out in twenty public schools in the municipality of Niteroi in Rio de Janeiro, Southeastern Brazil, from March to December 2007. A nutrition educational program was implemented in the schools in question through messages, activities and printed educational materials encouraging reduced levels of added sugar in school meals and in the school lunch cooks' own intake. The reduced availability of added sugar in schools was evaluated using spreadsheets including data on the monthly use of food item supplies. The cooks' individual food intake was evaluated by a Food Frequency Questionnaire. Anthropometric measurements were taken according to standardized techniques and variation in weight was measured throughout the duration of the study. There was a more marked reduction in the intervention schools compared to the control schools (-6.0 kg versus 0.34 kg), but no statistically significant difference (p = 0.21), although the study power was low. Both groups of school lunch cooks showed a reduction in the consumption of sweets and sweetened beverages, but the difference in sugar intake was not statistically significant. Weight loss and a reduction in total energy consumption occurred in both groups, but the difference between them was not statistically significant, and there was no alteration in the percentages of adequacy of macronutrients in relation to energy consumption. The strategy of reducing the use and consumption of sugar by school lunch cooks from public schools could not be proved to be effective.

  2. Effectiveness of the Spirometry 360 Quality Improvement Program for Improving Asthma Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Mangione-Smith, Rita; Zhou, Chuan; Corwin, Michael J; Taylor, James A; Rice, Fiona; Stout, James W

    To determine the effectiveness of the Spirometry 360 distance learning quality improvement (QI) program for enhancing the processes and outcomes of care for children with asthma. Cluster randomized controlled trial involving 25 matched pairs of pediatric primary care practices. Practices were recruited from 2 practice-based research networks: the Slone Center Office-based Research Network at Boston University, Boston, Mass, and the Puget Sound Pediatric Research Network, Seattle, Wash. Study participants included providers from one of the 50 enrolled pediatric practices and 626 of their patients with asthma. Process measures assessed included spirometry test quality and appropriate prescription of asthma controller medications. Outcome measures included asthma-specific health-related quality of life, and outpatient, emergency department, and inpatient utilization for asthma. At baseline, 25.4% of spirometry tests performed in control practices and 50.4% of tests performed in intervention practices were of high quality. During the 6-month postintervention period, 28.7% of spirometry tests performed in control practices and 49.9% of tests performed in intervention practices were of high quality. The adjusted difference-of-differences analysis revealed no intervention effect on spirometry test quality. Adjusted differences-of-differences analysis also revealed no intervention effect on appropriate use of controller medications or any of the parent- or patient-reported outcomes examined. In this study, the Spirometry 360 distance learning QI program was ineffective in improving spirometry test quality or parent- or patient-reported outcomes. QI programs like the one assessed here may need to focus on practices with lower baseline performance levels or may need to be tailored for those with higher baseline performance. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  3. Effects of Positive Action on the emotional health of urban youth: a cluster-randomized trial.

    Science.gov (United States)

    Lewis, Kendra M; DuBois, David L; Bavarian, Niloofar; Acock, Alan; Silverthorn, Naida; Day, Joseph; Ji, Peter; Vuchinich, Samuel; Flay, Brian R

    2013-12-01

    We examined the effects of Positive Action (PA), a school-based social-emotional learning and health promotion program, on the emotional health of predominately low-income and ethnic minority urban youth. The study was a matched-pair, cluster-randomized controlled trial involving 14 Chicago public schools. Outcomes were assessed over a 6-year period of program implementation for a cohort of youth in each school, followed from grades 3 to 8. Youth reported on their emotional health (positive affect, life satisfaction, depression, anxiety) and social-emotional and character development. Growth-curve and structural-equation modeling analyses assessed overall program effects on the emotional health outcomes as well as mediation of these effects via the program's impact on youths' social-emotional and character development. Students in PA schools, compared with those in control schools, had more favorable change over the course of the study in positive affect (standardized mean difference effect size [ES] = .17) and life satisfaction (ES = .13) as well as significantly lower depression (ES = -.14) and anxiety (ES = -.26) at study end point. Program effects for positive affect, depression, and anxiety were mediated by more favorable change over time in social-emotional and character development for students in PA schools. Results suggest that universal, school-based programs can benefit the emotional health of youth in low-income, urban settings. The modest magnitude of effects over an extended period of program implementation, however, reflects the challenges of both mounting interventions and offsetting formidable risks for mental health problems in such environments. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  4. Mental health first aid training for high school teachers: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Jorm Anthony F

    2010-06-01

    Full Text Available Abstract Background Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. Methods The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. Results The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Conclusions Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. Trial registration ACTRN12608000561381

  5. School-based strategies for oral health education of adolescents- a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Haleem Abdul

    2012-12-01

    Full Text Available Abstract Background Oral health education (OHE in schools has largely been imparted by dental professionals. Considering the substantial cost of this expert-led approach, the strategies relying on teachers, peer-leaders and learners themselves have also been utilized. However the evidence for comparative effectiveness of these strategies is lacking in the dental literature. The present study was conducted to compare the effectiveness of dentist-led, teacher-led, peer-led and self-learning strategies of oral health education. Methods A two-year cluster randomized controlled trial following a parallel design was conducted. It involved five groups of adolescents aged 10-11 years at the start of the study. The trial involved process as well as four outcome evaluations. The present paper discusses the findings of the study pertaining to the baseline and final outcome evaluation, both comprising of a self-administered questionnaire, a structured interview and clinical oral examination. The data were analyzed using Generalized Estimating Equations. Results All the three educator-led strategies of OHE had statistically higher mean oral health knowledge (OHK, oral health behavior (OHB, oral hygiene status (OHS and combined knowledge, behavior and oral hygiene status (KBS scores than the self-learning and control groups (p Conclusions The dentist-led, teacher-led and peer-led strategies of oral health education are equally effective in improving the oral health knowledge and oral hygiene status of adolescents. The peer-led strategy, however, is almost as effective as the dentist-led strategy and comparatively more effective than the teacher-led and self-learning strategies in improving their oral health behavior. Trail registration SRCTN39391017

  6. A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Elizabeth; Tancredi, Daniel J; Decker, Michele R; McCauley, Heather L; Jones, Kelley A; Anderson, Heather; James, Lisa; Silverman, Jay G

    2016-07-01

    We assessed the effectiveness of a provider-delivered intervention targeting reproductive coercion, an important factor in unintended pregnancy. We randomized 25 family planning clinics (17 clusters) to deliver an education/counseling intervention or usual care. Reproductive coercion and partner violence victimization at 1 year follow-up were primary outcomes. Unintended pregnancy, recognition of sexual and reproductive coercion, self-efficacy to use and use of harm reduction behaviors to reduce victimization and contraception nonuse, and knowledge and use of partner violence resources were secondary outcomes. Analyses included all available data using an intention-to-treat approach. Among 4009 females ages 16 to 29 years seeking care, 3687 completed a baseline survey prior to clinic visit from October 2011 to November 2012; 3017 provided data at 12-20weeks post-baseline (T2) and 2926 at 12months post-baseline (T3) (79% retention). Intervention effects were not significant for reproductive coercion [adjusted risk ratio (ARR) 1.50 (95% confidence interval 0.95-2.35)] or partner violence [ARR 1.07 (0.84-1.38)]. Intervention participants reported improved knowledge of partner violence resources [ARR 4.25 (3.29-5.50)] and self-efficacy to enact harm reduction behaviors [adjusted mean difference 0.06 (0.02-0.10)]. In time point-specific models which included moderating effects of exposure to reproductive coercion at baseline, a higher reproductive coercion score at baseline was associated with a decrease in reproductive coercion 1 year later (T3). Use and sharing of the domestic violence hotline number also increased. This brief clinic intervention did not reduce partner violence victimization. The intervention enhanced two outcomes that may increase safety for women, specifically awareness of partner violence resources and self-efficacy to enact harm reduction behaviors. It also appeared to reduce reproductive coercion among women experiencing multiple forms of such

  7. School-based strategies for oral health education of adolescents- a cluster randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Oral health education (OHE) in schools has largely been imparted by dental professionals. Considering the substantial cost of this expert-led approach, the strategies relying on teachers, peer-leaders and learners themselves have also been utilized. However the evidence for comparative effectiveness of these strategies is lacking in the dental literature. The present study was conducted to compare the effectiveness of dentist-led, teacher-led, peer-led and self-learning strategies of oral health education. Methods A two-year cluster randomized controlled trial following a parallel design was conducted. It involved five groups of adolescents aged 10-11 years at the start of the study. The trial involved process as well as four outcome evaluations. The present paper discusses the findings of the study pertaining to the baseline and final outcome evaluation, both comprising of a self-administered questionnaire, a structured interview and clinical oral examination. The data were analyzed using Generalized Estimating Equations. Results All the three educator-led strategies of OHE had statistically higher mean oral health knowledge (OHK), oral health behavior (OHB), oral hygiene status (OHS) and combined knowledge, behavior and oral hygiene status (KBS) scores than the self-learning and control groups (poral health education are equally effective in improving the oral health knowledge and oral hygiene status of adolescents. The peer-led strategy, however, is almost as effective as the dentist-led strategy and comparatively more effective than the teacher-led and self-learning strategies in improving their oral health behavior. Trail registration SRCTN39391017 PMID:23249443

  8. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study.

    Science.gov (United States)

    Atkinson, Melissa J; Wade, Tracey D

    2015-11-01

    Successful prevention of eating disorders represents an important goal due to damaging long-term impacts on health and well-being, modest treatment outcomes, and low treatment seeking among individuals at risk. Mindfulness-based approaches have received early support in the treatment of eating disorders, but have not been evaluated as a prevention strategy. This study aimed to assess the feasibility, acceptability, and efficacy of a novel mindfulness-based intervention for reducing the risk of eating disorders among adolescent females, under both optimal (trained facilitator) and task-shifted (non-expert facilitator) conditions. A school-based cluster randomized controlled trial was conducted in which 19 classes of adolescent girls (N = 347) were allocated to a three-session mindfulness-based intervention, dissonance-based intervention, or classes as usual control. A subset of classes (N = 156) receiving expert facilitation were analyzed separately as a proxy for delivery under optimal conditions. Task-shifted facilitation showed no significant intervention effects across outcomes. Under optimal facilitation, students receiving mindfulness demonstrated significant reductions in weight and shape concern, dietary restraint, thin-ideal internalization, eating disorder symptoms, and psychosocial impairment relative to control by 6-month follow-up. Students receiving dissonance showed significant reductions in socio-cultural pressures. There were no statistically significant differences between the two interventions. Moderate intervention acceptability was reported by both students and teaching staff. Findings show promise for the application of mindfulness in the prevention of eating disorders; however, further work is required to increase both impact and acceptability, and to enable successful outcomes when delivered by less expert providers. © 2015 Wiley Periodicals, Inc.

  9. Cluster randomized, controlled trial on patient safety improvement in general practice: a study protocol

    Science.gov (United States)

    2013-01-01

    Background An open, constructive safety culture is key in healthcare since it is seen as a main condition for patient safety. Studies have examined culture improvement strategies in hospitals. In primary care, however, not much is known about effective strategies to improve the safety culture yet. The purpose of this study is to examine the effect of two patient safety culture interventions: a patient safety culture questionnaire solely, the SCOPE, or the SCOPE questionnaire combined with a patient safety workshop. The purpose of this paper is to describe the rationale and design of this trial. Methods/design The SCOPE Intervention Study is a cluster randomized, three-armed controlled trial, that will be conducted in 30 general practices in the Netherlands. Ten practices in the first intervention arm will complete the SCOPE questionnaire and are expected to draw and implement their own improvement initiatives based on a computerised feedback report. In the second intervention arm, staff of the ten practices also will be asked to complete the SCOPE questionnaire and in addition will be given a complementary workshop. This workshop is theoretical and interactive, educating staff and facilitating discussion, leading to a practice specific action plan for patient safety improvement. The results of the SCOPE questionnaire are incorporated in the workshop. The ten practices in the control arm continue care as usual. Baseline and follow-up measurements will be conducted with an implementation period of one year. The primary outcome will include the number of incidents reported and secondary several quality and safety indicators and the patient safety culture. Moreover, interviews will be conducted at follow-up to evaluate the implementation process of the intervention. Discussion Results of this study will give insight in the effect of administering a culture questionnaire or the questionnaire with a complementary workshop. This knowledge will aid implementation of

  10. Cost-consequence analysis of "washing without water" for nursing home residents: a cluster randomized trial.

    Science.gov (United States)

    Schoonhoven, Lisette; van Gaal, Betsie G I; Teerenstra, Steven; Adang, Eddy; van der Vleuten, Carine; van Achterberg, Theo

    2015-01-01

    No-rinse disposable wash gloves are increasingly implemented in health care to replace traditional soap and water bed baths without proper evaluation of (cost) effectiveness. To compare bed baths for effects on skin integrity and resistance against bathing and costs. Cluster randomized trial. Fifty six nursing home wards in the Netherlands. Participants: Five hundred adult care-dependent residents and 275 nurses from nursing home wards. The experimental condition 'washing without water' consists of a bed bath with disposable wash gloves made of non-woven waffled fibers, saturated with a no-rinse, quickly vaporizing skin cleaning and caring lotion. The control condition is a traditional bed bath using soap, water, washcloths and towels. Both conditions were continued for 6 weeks. Outcome measures were prevalence of skin damage distinguished in two levels of severity: any skin abnormality/lesion and significant skin lesions. Additional outcomes: resistance during bed baths, costs. Any skin abnormalities/lesions over time decreased slightly in the experimental group, and increased slightly in the control group, resulting in 72.7% vs 77.6% of residents having any skin abnormalities/lesions after 6 weeks, respectively (p=0.04). There were no differences in significant skin lesions or resistance after 6 weeks. Mean costs for bed baths during 6 weeks per resident were estimated at €218.30 (95%CI 150.52-286.08) in the experimental group and €232.20 (95%CI: 203.80-260.60) in the control group (difference €13.90 (95%CI: -25.61-53.42). Washing without water mildly protects from skin abnormalities/lesions, costs for preparing and performing bed baths do not differ from costs for traditional bed bathing. Thus, washing without water can be considered the more efficient alternative. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Effects of the X:IT smoking intervention: a school-based cluster randomized trial.

    Science.gov (United States)

    Andersen, Anette; Krølner, Rikker; Bast, Lotus Sofie; Thygesen, Lau Caspar; Due, Pernille

    2015-12-01

    Uptake of smoking in adolescence is still of major public health concern. Evaluations of school-based programmes for smoking prevention show mixed results. The aim of this study was to examine the effect of X:IT, a multi-component school-based programme to prevent adolescent smoking. Data from a Danish cluster randomized trial included 4041 year-7 students (mean age: 12.5) from 51 intervention and 43 control schools. Outcome measure 'current smoking' was dichotomized into smoking daily, weekly, monthly or more seldom vs do not smoke. Analyses were adjusted for baseline covariates: sex, family socioeconomic position (SEP), best friend's smoking and parental smoking. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. At baseline, 4.7% and 6.8% of the students at the intervention and the control schools smoked, respectively. After 1 year of the intervention, the prevalence was 7.9% and 10.7%, respectively. At follow-up, 553 students (13.7%) did not answer the question on smoking. Available case analyses: crude odds ratios (OR) for smoking at intervention schools compared with control schools: 0.65 (0.48-0.88) and adjusted: 0.70 (0.47-1.04). ITT analyses: crude OR for smoking at intervention schools compared with control schools: 0.67 (0.50-0.89) and adjusted: 0.61 (0.45-0.82). Students at intervention schools had a lower risk of smoking after a year of intervention in year 7. This multi-component intervention involving educational, parental and context-related intervention components seems to be efficient in lowering or postponing smoking uptake in Danish adolescents. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  12. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial.

    Science.gov (United States)

    Dalager, Tina; Bredahl, Thomas G V; Pedersen, Mogens T; Boyle, Eleanor; Andersen, Lars L; Sjøgaard, Gisela

    2015-10-01

    The aim was to determine the effect of one weekly hour of specific strength training within working hours, performed with the same total training volume but with different training frequencies and durations, or with different levels of supervision, on compliance, muscle health and performance, behavior and work performance. In total, 573 office workers were cluster-randomized to: 1 WS: one 60-min supervised session/week, 3 WS: three 20-min supervised sessions/week, 9 WS: nine 7-min supervised sessions/week, 3 MS: three 20-min sessions/week with minimal supervision, or REF: a reference group without training. Outcomes were diary-based compliance, total training volume, muscle performance and questionnaire-based health, behavior and work performance. Comparisons were made among the WS training groups and between 3 WS and 3 MS. If no difference, training groups were collapsed (TG) and compared with REF. Results demonstrated similar degrees of compliance, mean(range) of 39(33-44)%, and total training volume, 13.266(11.977-15.096)kg. Musculoskeletal pain in neck and shoulders were reduced with approx. 50% in TG, which was significant compared with REF. Only the training groups improved significantly their muscle strength 8(4-13)% and endurance 27(12-37)%, both being significant compared with REF. No change in workability, productivity or self-rated health was demonstrated. Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance. Regardless of training schedule and supervision, similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance. These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace. ClinicalTrials.gov, number NCT01027390. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Physical exercise at the workplace reduces perceived physical exertion during healthcare work: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus Due; Sundstrup, Emil; Brandt, Mikkel; Jay, Kenneth; Aagaard, Per; Andersen, Lars L

    2015-11-01

    High physical exertion during work is a risk factor for musculoskeletal pain and long-term sickness absence. Physical exertion (RPE) reflects the balance between physical work demands and physical capacity of the individual. Thus, increasing the physical capacity through physical exercise may decrease physical exertion during work. This study investigates the effect of workplace-based versus home-based physical exercise on physical exertion during work (WRPE) among healthcare workers. 200 female healthcare workers (age: 42.0, body mass index: 24.1, average pain intensity: 3.1 on a scale of 0 to 10, average WRPE: 3.6 on a scale of 0 to 10) from 18 departments at three participating hospitals. Participants were randomly allocated at the cluster level to 10 weeks of: (1) workplace physical exercise (WORK) performed in groups during working hours for 5×10 minutes per week and up to five group-based coaching sessions on motivation for regular physical exercise, or (2) home-based physical exercise (HOME) performed during leisure time for 5×10 minutes per week. Physical exertion was assessed at baseline and at 10-week follow-up. 2.2 (SD: 1.1) and 1.0 (SD: 1.2) training sessions were performed per week in WORK and HOME, respectively. Physical exertion was reduced more in WORK than HOME (pgroup differences in physical exertion at follow-up (WORK vs. HOME) was -0.5 points (95% CI -0.8 to -0.2). Within-group effect size (Cohen's d) in WORK and HOME was 0.43 and 0.13, respectively. Physical exercise performed at the workplace appears more effective than home-based exercise in reducing physical exertion during daily work tasks in healthcare workers. © 2015 the Nordic Societies of Public Health.

  14. Do post discharge phone calls improve care transitions? A cluster-randomized trial.

    Science.gov (United States)

    Soong, Christine; Kurabi, Bochra; Wells, David; Caines, Lesley; Morgan, Matthew W; Ramsden, Rebecca; Bell, Chaim M

    2014-01-01

    The transition from hospital to home can expose patients to adverse events during the post discharge period. Post discharge care including phone calls may provide support for patients returning home but the impact on care transitions is unknown. To examine the effect of a 72-hour post discharge phone call on the patient's transition of care experience. Cluster-randomized control trial. Urban, academic medical center. General medical patients age 18 and older discharged home after hospitalization. Primary outcome measure was the Care Transition Measure (CTM-3) score, a validated measure of the quality of care transitions. Secondary measures included self-reported adherence to medication and follow up plans, and 30-day composite of emergency department (ED) visits and hospital readmission. 328 patients were included in the study over an 6-month period. 114 (69%) received a post discharge phone call, and 214 of all patients in the study completed the follow outcome survey (65% response rate). A small difference in CTM-3 scores was observed between the intervention and control groups (1.87 points, 95% CI 0.47-3.27, p = 0.01). Self-reported adherence to treatment plans, ED visits, and emergency readmission rates were similar between the two groups (odds ratio 0.57, 95% CI 0.13-2.45, 1.20, 95% CI 0.61-2.37, and 1.18, 95% CI 0.53-2.61, respectively). A single post discharge phone call had a small impact on the quality of care transitions and no effect on hospital utilization. Higher intensity post discharge support may be required to improve the patient experience upon returning home. ClinicalTrials.gov NCT01580774.

  15. Do post discharge phone calls improve care transitions? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Christine Soong

    Full Text Available The transition from hospital to home can expose patients to adverse events during the post discharge period. Post discharge care including phone calls may provide support for patients returning home but the impact on care transitions is unknown.To examine the effect of a 72-hour post discharge phone call on the patient's transition of care experience.Cluster-randomized control trial.Urban, academic medical center.General medical patients age 18 and older discharged home after hospitalization.Primary outcome measure was the Care Transition Measure (CTM-3 score, a validated measure of the quality of care transitions. Secondary measures included self-reported adherence to medication and follow up plans, and 30-day composite of emergency department (ED visits and hospital readmission.328 patients were included in the study over an 6-month period. 114 (69% received a post discharge phone call, and 214 of all patients in the study completed the follow outcome survey (65% response rate. A small difference in CTM-3 scores was observed between the intervention and control groups (1.87 points, 95% CI 0.47-3.27, p = 0.01. Self-reported adherence to treatment plans, ED visits, and emergency readmission rates were similar between the two groups (odds ratio 0.57, 95% CI 0.13-2.45, 1.20, 95% CI 0.61-2.37, and 1.18, 95% CI 0.53-2.61, respectively.A single post discharge phone call had a small impact on the quality of care transitions and no effect on hospital utilization. Higher intensity post discharge support may be required to improve the patient experience upon returning home.ClinicalTrials.gov NCT01580774.

  16. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings.

    Science.gov (United States)

    Paszat, Lawrence; Sutradhar, Rinku; O'Brien, Mary Ann; Lofters, Aisha; Pinto, Andrew; Selby, Peter; Baxter, Nancy; Donnelly, Peter D; Elliott, Regina; Glazier, Richard H; Kyle, Robert; Manca, Donna; Pietrusiak, Mary-Anne; Rabeneck, Linda; Sopcak, Nicolette; Tinmouth, Jill; Wall, Becky; Grunfeld, Eva

    2017-09-29

    The Building on Existing Tools to Improve Chronic Disease Prevention and Screening (BETTER) cluster randomized trial in primary care settings demonstrated a 30% improvement in adherence to evidence-based Chronic Disease Prevention and Screening (CDPS) activities. CDPS activities included healthy activities, lifestyle modifications, and screening tests. We present a protocol for the adaptation of BETTER to a public health setting, and testing the adaptation in a cluster randomized trial (BETTER HEALTH: Durham) among low income neighbourhoods in Durham Region, Ontario (Canada). The BETTER intervention consists of a personalized prevention visit between a participant and a prevention practitioner, which is focused on the participant's eligible CDPS activities, and uses Brief Action Planning, to empower the participant to set achievable short-term goals. Durham aims to establish that the BETTER intervention can be adapted and proven effective among 40-64 year old residents of low income areas when provided in the community by public health nurses trained as prevention practitioners. Focus groups and key informant interviews among stakeholders and eligible residents of low income areas will inform the adaptation, along with feedback from the trial's Community Advisory Committee. We have created a sampling frame of 16 clusters composed of census dissemination areas in the lowest urban quintile of median household income, and will sample 10 clusters to be randomly allocated to immediate intervention or six month wait list control. Accounting for the clustered design effect, the trial will have 80% power to detect an absolute 30% difference in the primary outcome, a composite score of completed eligible CDPS actions six months after enrollment. The prevention practitioner will attempt to link participants without a primary care provider (PCP) to a local PCP. The implementation of BETTER HEALTH: Durham will be evaluated by focus groups and key informant interviews. The

  17. Design of a Phase III cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine.

    Science.gov (United States)

    Delrieu, Isabelle; Leboulleux, Didier; Ivinson, Karen; Gessner, Bradford D

    2015-03-24

    Vaccines interrupting Plasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens (SSM-VIMT) are currently under development to reduce malaria transmission. An international group of malaria experts was established to evaluate the feasibility and optimal design of a Phase III cluster randomized trial (CRT) that could support regulatory review and approval of an SSM-VIMT. The consensus design is a CRT with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. Trials should be conducted first in areas of moderate transmission, where SSM-VIMT impact should be greatest. Sample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Effectiveness of a smartphone app on improving immunization of children in rural Sichuan Province, China: a cluster randomized controlled trial

    OpenAIRE

    Li Chen; Xiaozhen Du; Lin Zhang; Michelle Helena van Velthoven; Qiong Wu; Ruikan Yang; Ying Cao; Wei Wang; Lihui Xie; Xiuqin Rao; Yanfeng Zhang; Jeanne Catherine Koepsell

    2016-01-01

    Abstract Background The aim of this study was to assess the effectiveness of an EPI smartphone application (EPI app) on improving vaccination coverage in rural Sichuan Province, China. Methods This matched-pair cluster randomized controlled study included 32 village doctors, matched in 16 pairs, and took place from 2013 to 2015. Village doctors in the intervention group used the EPI app and reminder text messages while village doctors in the control group used their usual procedures and text ...

  19. Effectiveness of a smartphone app on improving immunization of children in rural Sichuan Province, China: a cluster randomized controlled trial

    OpenAIRE

    Chen, L.; Du, X; Zhang, L; Van Velthoven, MH; Wu, Q.; Yang, R; Cao, Y; Wang, W; Xie, L; Rao, X.; Zhang, Y; Koepsell, JC

    2016-01-01

    Background The aim of this study was to assess the effectiveness of an EPI smartphone application (EPI app) on improving vaccination coverage in rural Sichuan Province, China. Methods This matched-pair cluster randomized controlled study included 32 village doctors, matched in 16 pairs, and took place from 2013 to 2015. Village doctors in the intervention group used the EPI app and reminder text messages while village doctors in the control group used their usual procedures and text messages....

  20. Staff distress improves by treating pain in nursing home patients with dementia: results from a cluster-randomized controlled trial

    OpenAIRE

    Aasmul, Irene; Husebo, Bettina Sandgathe; Flo, Elisabeth

    2016-01-01

    Context. Most people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden. Objectives. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Methods. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n ¼ 175) or control group (27 NH units; n &fr...

  1. Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial.

    OpenAIRE

    Nayiga, S; Diliberto, D; Taaka, L; Nabirye, C; Haaland, A.; Staedke, SG; Chandler, CI

    2014-01-01

    This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including ?patient-centred services.? A process evaluation was designed within this trial to articulate and eval...

  2. Search Result Clustering via Randomized Partitioning of Query-Induced Subgraphs

    Directory of Open Access Journals (Sweden)

    A. Bradic

    2009-06-01

    Full Text Available In this paper, we present an approach to search result clustering, using partitioning of underlying link graph. We define the notion of "query-induced subgraph" and formulate the problem of search result clustering as a problem of efficient partitioning of a given subgraph into topic-related clusters. Also, we propose a novel algorithm for approximative partitioning of such a graph, which results in a cluster quality comparable to the one obtained by deterministic algorithms, while operating in a more efficient computation time, suitable for practical implementations. Finally, we present a practical clustering search engine developed as a part of this research and use it to get results about real-world performance of proposed concepts.

  3. Economic evaluation of schema therapy and clarification-oriented psychotherapy for personality disorders: a multicenter, randomized controlled trial.

    Science.gov (United States)

    Bamelis, Lotte L M; Arntz, Arnoud; Wetzelaer, Pim; Verdoorn, Ryanne; Evers, Silvia M A A

    2015-11-01

    To compare from a societal perspective the cost-effectiveness and cost-utility of schema therapy, clarification-oriented psychotherapy, and treatment as usual for patients with avoidant, dependent, obsessive-compulsive, paranoid, histrionic, and/or narcissistic personality disorder. A multicenter, randomized controlled trial, single-blind parallel design, was conducted between May 2006 and December 2011 in 12 Dutch mental health institutes. Data from 320 patients (diagnosed according to DSM-IV criteria) randomly assigned to schema therapy (n = 145), treatment as usual (n = 134), or clarification-oriented psychotherapy (n = 41) were analyzed. Costs were repeatedly measured during 36 months by interview and patient registries. Primary outcome measures were proportion of recovered patients as measured with the Structured Clinical Interview for DSM-IV Axis II Personality Disorders for the cost-effectiveness analysis, and quality-adjusted life-years (QALYs) for the cost-utility analysis. Bootstrap replications in the cost-effectiveness and the cost-utility planes were used to estimate the probability that one treatment was more cost-effective than the other. Mixed gamma regression on net monetary benefit for different levels of willingness to pay for extra effects was used as sensitivity analysis. Additional sensitivity analyses were done to assess robustness of the results. Due to higher clinical effects and lower costs, schema therapy was dominant over the other treatments in the cost-effectiveness analyses. Schema therapy has the probability of being the most cost-effective treatment (78% at €0 to 96% at €37,500 [$27,375] willingness to pay per extra recovery). Treatment as usual was more cost-effective than clarification-oriented psychotherapy due to lower costs. In the cost-utility analysis, schema therapy had a stable 75% probability of being cost-effective. Sensitivity analyses confirmed these findings. The results support the cost-effectiveness of schema

  4. Fall injuries in Baghdad from 2003 to 2014: results of a randomized household cluster survey

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Shatari, Sahar A Esa Al; Cherewick, Megan; Flaxman, Abraham; Hagopian, Amy; Burnham, Gilbert; Kushner, Adam L

    2015-01-01

    Introduction Falls incur nearly 35 million disability-adjusted life-years annually; 75% of which occur in low- and middle-income countries. The epidemiology of civilian injuries during conflict is relatively unknown, yet important for planning prevention initiatives, health policy and humanitarian assistance. This study aimed to determine the death and disability and household consequences of fall injuries in post-invasion Baghdad. Methods A two-stage, cluster randomized, community-based household survey was performed in May of 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about household member death, households were interviewed regarding injury specifics, healthcare required, disability, relatedness to conflict and resultant financial hardship. Results Nine hundred households totaling 5,148 individuals were interviewed. There were 138 fall injuries (25% of all injuries reported); fall was the most common mechanism of civilian injury in Baghdad. The rate of serious fall injuries increased from 78 to 466 per 100,000 persons in 2003 and 2013, respectively. Fall was the most common mechanism among the injured elderly (i.e. ≥65 years; 15/24 elderly unintentional injuries; 63%). However, 46 fall injuries were children aged injuries) and 77 were respondents aged 15 - 64 years (36%). Respondents who spent significant time within the home (i.e. unemployed, retired, homemaker) had three times greater odds of having suffered a fall injury than student referents (aOR 3.34; 95%CI 1.30 – 8.60). Almost 80% of fall injured were left with life-limiting disability. Affected households often borrowed substantial sums of money (34 households; 30% of affected households) and/or suffered food insecurity after a family member's fall (52; 46%). Conclusion Falls were the most common cause of civilian injury in Baghdad. In part due to the effect of prolonged insecurity on a fragile health system, many injuries resulted in life

  5. Implementing school nursing strategies to reduce LGBTQ adolescent suicide: a randomized cluster trial study protocol.

    Science.gov (United States)

    Willging, Cathleen E; Green, Amy E; Ramos, Mary M

    2016-10-22

    Reducing youth suicide in the United States (U.S.) is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) youth are at elevated risk. The Centers for Disease Control and Prevention (CDC) endorses six evidence-based (EB) strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, "RLAS" (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide), builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS) conceptual framework and the Dynamic Adaptation Process (DAP) to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs) to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20) report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20). Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. The DAP represents a data-informed, collaborative, multiple stakeholder approach to progress from exploration to sustainment and obtain

  6. Implementing school nursing strategies to reduce LGBTQ adolescent suicide: a randomized cluster trial study protocol

    Directory of Open Access Journals (Sweden)

    Cathleen E. Willging

    2016-10-01

    Full Text Available Abstract Background Reducing youth suicide in the United States (U.S. is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ youth are at elevated risk. The Centers for Disease Control and Prevention (CDC endorses six evidence-based (EB strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, “RLAS” (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide, builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS conceptual framework and the Dynamic Adaptation Process (DAP to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Methods/Design Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20 report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20. Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. Discussion The DAP represents a data-informed, collaborative, multiple stakeholder

  7. Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    2017-03-21

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically

  8. Cluster randomized evaluation of Adolescent Girls Empowerment Programme (AGEP: study protocol

    Directory of Open Access Journals (Sweden)

    Paul C. Hewett

    2017-05-01

    Full Text Available Abstract Background Adolescents in less developed countries such as Zambia often face multi-faceted challenges for achieving successful transitions through adolescence to early adulthood. The literature has noted the need to introduce interventions during this period, particularly for adolescent girls, with the perspective that such investments have significant economic, social and health returns to society. The Adolescent Girls Empowerment Programme (AGEP was an intervention designed as a catalyst for change for adolescent girls through themselves, to their family and community. Methods/design AGEP was a multi-sectoral intervention targeting over 10,000 vulnerable adolescent girls ages 10–19 in rural and urban areas, in four of the ten provinces of Zambia. At the core of AGEP were mentor-led, weekly girls’ group meetings of 20 to 30 adolescent girls participating over two years. Three curricula ― sexual and reproductive health and lifeskills, financial literacy, and nutrition ― guided the meetings. An engaging and participatory pedagogical approach was used. Two additional program components, a health voucher and a bank account, were offered to some girls to provide direct mechanisms to improve access to health and financial services. Embedded within AGEP was a rigorous multi-arm randomised cluster trial with randomization to different combinations of programme arms. The study was powered to assess the impact across a set of key longer-term outcomes, including early marriage and first birth, contraceptive use, educational attainment and acquisition of HIV and HSV-2. Baseline behavioural surveys and biological specimen collection were initiated in 2013. Impact was evaluated immediately after the program ended in 2015 and will be evaluated again after two additional years of follow-up in 2017. The primary analysis is intent-to-treat. Qualitative data are being collected in 2013, 2015 and 2017 to inform the programme implementation and the

  9. Cluster randomized evaluation of Adolescent Girls Empowerment Programme (AGEP): study protocol.

    Science.gov (United States)

    Hewett, Paul C; Austrian, Karen; Soler-Hampejsek, Erica; Behrman, Jere R; Bozzani, Fiammetta; Jackson-Hachonda, Natalie A

    2017-05-05

    Adolescents in less developed countries such as Zambia often face multi-faceted challenges for achieving successful transitions through adolescence to early adulthood. The literature has noted the need to introduce interventions during this period, particularly for adolescent girls, with the perspective that such investments have significant economic, social and health returns to society. The Adolescent Girls Empowerment Programme (AGEP) was an intervention designed as a catalyst for change for adolescent girls through themselves, to their family and community. AGEP was a multi-sectoral intervention targeting over 10,000 vulnerable adolescent girls ages 10-19 in rural and urban areas, in four of the ten provinces of Zambia. At the core of AGEP were mentor-led, weekly girls' group meetings of 20 to 30 adolescent girls participating over two years. Three curricula - sexual and reproductive health and lifeskills, financial literacy, and nutrition - guided the meetings. An engaging and participatory pedagogical approach was used. Two additional program components, a health voucher and a bank account, were offered to some girls to provide direct mechanisms to improve access to health and financial services. Embedded within AGEP was a rigorous multi-arm randomised cluster trial with randomization to different combinations of programme arms. The study was powered to assess the impact across a set of key longer-term outcomes, including early marriage and first birth, contraceptive use, educational attainment and acquisition of HIV and HSV-2. Baseline behavioural surveys and biological specimen collection were initiated in 2013. Impact was evaluated immediately after the program ended in 2015 and will be evaluated again after two additional years of follow-up in 2017. The primary analysis is intent-to-treat. Qualitative data are being collected in 2013, 2015 and 2017 to inform the programme implementation and the quantitative findings. An economic evaluation will evaluate

  10. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial.

    Science.gov (United States)

    Beck, Anne Marie; Christensen, Annette Gøgsig; Hansen, Birthe Stenbæk; Damsbo-Svendsen, Signe; Møller, Tina Kreinfeldt Skovgaard

    2016-02-01

    To assess the effect of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care identified with the validated Eating Validation Scheme (EVS). An 11 wk cluster randomized trial with a home-care (3 clusters) or nursing home (3 clusters) setting as the unit of randomization. Before starting the study, a train-the-trainer course was performed to educate the nutrition coordinators. In addition to the nutrition coordinator, the participants assigned to the intervention group strategy received multidisciplinary nutrition support. Focus was on treatment of the potentially modifiable nutritional risk factors identified with the EVS, by involving the physiotherapist, registered dietitian, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system. Outcome parameters were quality of life (by means of EuroQol-5D-3L), physical performance (30-seconds chair stand), nutritional status (weight and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (participants from home-care), and mortality. Respectively, 55 (46 from 2 home-care clusters) and 40 (18 from 1 home-care cluster) were identified with the EVS and comprised the intervention and control group. A difference after 11 wk in quality of life (0.758 [0.222] versus 0.534 [0.355], P = 0.001), 30-seconds chair stand (47% versus 17% improved, P = 0.005) and oral care (1.1 [0.3] versus 1.3 [0.5], P = 0.021) was observed. There was a almost significant difference in mortality (2% versus 13%, P = 0.079). Multidisciplinary nutritional support in older adults in nursing home and home-care could have a positive effect on quality of life, muscle strength, and oral care. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. The Statistical Power of the Cluster Randomized Block Design with Matched Pairs--A Simulation Study

    Science.gov (United States)

    Dong, Nianbo; Lipsey, Mark

    2010-01-01

    This study uses simulation techniques to examine the statistical power of the group- randomized design and the matched-pair (MP) randomized block design under various parameter combinations. Both nearest neighbor matching and random matching are used for the MP design. The power of each design for any parameter combination was calculated from…

  12. Nano-sized cobalt cluster films : Structure and functionality

    NARCIS (Netherlands)

    Palasantzas, G.; Koch, S.A.; Vystavel, T.; de Hosson, J.T.M.

    An exchange interaction between magnetic clusters at ambient temperature leads to a correlated super-spin glass state as a result of frustration between inter-particle exchange interaction and randomly oriented intra-particle anisotropy. In addition, after cluster oxidation a core-shell system

  13. Highly efficient hybrid energy generator: coupled organic photovoltaic device and randomly oriented electrospun poly(vinylidene fluoride) nanofiber.

    Science.gov (United States)

    Park, Boongik; Lee, Kihwan; Park, Jongjin; Kim, Jongmin; Kim, Ohyun

    2013-03-01

    A hybrid architecture consisting of an inverted organic photovoltaic device and a randomly-oriented electrospun PVDF piezoelectric device was fabricated as a highly-efficient energy generator. It uses the inverted photovoltaic device with coupled electrospun PVDF nanofibers as tandem structure to convert solar and mechanical vibrations energy to electricity simultaneously or individually. The power conversion efficiency of the photovoltaic device was also significantly improved up to 4.72% by optimized processes such as intrinsic ZnO, MoO3 and active layer. A simple electrospinning method with the two electrode technique was adopted to achieve a high voltage of - 300 mV in PVDF piezoelectric fibers. Highly-efficient HEG using voltage adder circuit provides the conceptual possibility of realizing multi-functional energy generator whenever and wherever various energy sources are available.

  14. Patients' general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines : Results from a cluster randomized trial

    NARCIS (Netherlands)

    Kooy, Marcel Jan; Van Geffen, Erica C G; Heerdink, Eibert R.; Van Dijk, Liset; Bouvy, Marcel L.

    2015-01-01

    Assess effects of pharmacists' counseling by telephone on patients' satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. Methods: A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included when

  15. Patients’ general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines: results from a cluster randomized trial.

    NARCIS (Netherlands)

    Kooy, M.J.; Geffen, E.C.G. van; Heerdink, E.R.; Dijk, L. van; Bouvy, M.L.

    2015-01-01

    Objective: Assess effects of pharmacists’ counseling by telephone on patients’ satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. Methods: A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included

  16. A New Mother-Child Play Activity Program to Decrease Parenting Stress and Improve Child Cognitive Abilities: A Cluster Randomized Controlled Trial: e38238

    National Research Council Canada - National Science Library

    Yoshiyuki Tachibana; Ai Fukushima; Hitomi Saito; Satoshi Yoneyama; Kazuo Ushida; Susumu Yoneyama; Ryuta Kawashima

    2012-01-01

    .... To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial...

  17. A new mother-child play activity program to decrease parenting stress and improve child cognitive abilities: a cluster randomized controlled trial

    National Research Council Canada - National Science Library

    Tachibana, Yoshiyuki; Fukushima, Ai; Saito, Hitomi; Yoneyama, Satoshi; Ushida, Kazuo; Yoneyama, Susumu; Kawashima, Ryuta

    2012-01-01

    .... To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial...

  18. MicroRNAs in the oriental fruit fly, Bactrocera dorsalis: extending Drosophilid miRNA clusters to the Tephritidae

    Science.gov (United States)

    The oriental fruit fly, Bactrocera dorsalis, is an important pest species in the family Tephritidae. It is a phytophagous species with broad host range, and while not established in the mainland United States, is a species of great concern for introduction. Despite of the vast amount of informatio...

  19. Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial.

    Science.gov (United States)

    Kötter, Thomas; Niebuhr, Frank

    2016-01-01

    The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students. We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item), anxiety and depression (measured by the hospital anxiety and depression scale), as well as medical school stress (measured by the perceived medical school stress instrument). In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis. We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on the development of perceived medical school stress. However, we could not differentiate between the effects of group coaching only and group coaching in combination with two sessions of individual

  20. Object-oriented Markov random model for classification of high resolution satellite imagery based on wavelet transform

    Science.gov (United States)

    Hong, Liang; Liu, Cun; Yang, Kun; Deng, Ming

    2013-07-01

    The high resolution satellite imagery (HRSI) have higher spatial resolution and less spectrum number, so there are some "object with different spectra, different objects with same spectrum" phenomena. The objective of this paper is to utilize the extracted features of high resolution satellite imagery (HRSI) obtained by the wavelet transform(WT) for segmentation. WT provides the spatial and spectral characteristics of a pixel along with its neighbors. The object-oriented Markov random Model in the wavelet domain is proposed in order to segment high resolution satellite imagery (HRSI). The proposed method is made up of three blocks: (1) WT-based feature extrcation.the aim of extraction of feature using WT for original spectral bands is to exploit the spatial and frequency information of the pixels; (2) over-segmentation object generation. Mean-Shift algorithm is employed to obtain over-segmentation objects; (3) classification based on Object-oriented Markov Random Model. Firstly the object adjacent graph (OAG) can be constructed on the over-segmentation objects. Secondly MRF model is easily defined on the OAG, in which WT-based feature of pixels are modeled in the feature field model and the neighbor system, potential cliques and energy functions of OAG are exploited in the labeling model. Experiments are conducted on one HRSI dataset-QuickBird images. We evaluate and compare the proposed approach with the well-known commercial software eCognition(object-based analysis approach) and Maximum Likelihood(ML) based pixels. Experimental results show that the proposed the method in this paper obviously outperforms the other methods.

  1. Magnetic localization and orientation of the capsule endoscope based on a random complex algorithm

    Directory of Open Access Journals (Sweden)

    He XQ

    2015-04-01

    Full Text Available Xiaoqi He,1 Zizhao Zheng,1,2 Chao Hu1 1Ningbo Institute of Technology, Zhejiang University, Ningbo, People's Republic of China; 2Taiyuan University of Science and Technology, Taiyuan, People's Republic of China Abstract: The development of the capsule endoscope has made possible the examination of the whole gastrointestinal tract without much pain. However, there are still some important problems to be solved, among which, one important problem is the localization of the capsule. Currently, magnetic positioning technology is a suitable method for capsule localization, and this depends on a reliable system and algorithm. In this paper, based on the magnetic dipole model as well as magnetic sensor array, we propose nonlinear optimization algorithms using a random complex algorithm, applied to the optimization calculation for the nonlinear function of the dipole, to determine the three-dimensional position parameters and two-dimensional direction parameters. The stability and the antinoise ability of the algorithm is compared with the Levenberg–Marquart algorithm. The simulation and experiment results show that in terms of the error level of the initial guess of magnet location, the random complex algorithm is more accurate, more stable, and has a higher “denoise” capacity, with a larger range for initial guess values. Keywords: wireless capsule endoscope, magnet, optimization 

  2. Robustness of parameter and standard error estimates against ignoring a contextual effect of a subject level covariate in cluster randomized trials

    NARCIS (Netherlands)

    Korendijk, E.J.H.; Hox, J.; Moerbeek, M.

    2011-01-01

    In experimental research, it is not uncommon to assign clusters to conditions.When analysing the data of such cluster-randomized trials, a multilevel analysis should be applied in order to take into account the dependency of firstlevel units (i.e., subjects) within a second-level unit (i.e., a

  3. Emergency Department Management of Sepsis Patients: A Randomized, Goal-Oriented, Noninvasive Sepsis Trial.

    Science.gov (United States)

    Kuan, Win Sen; Ibrahim, Irwani; Leong, Benjamin S H; Jain, Swati; Lu, Qingshu; Cheung, Yin Bun; Mahadevan, Malcolm

    2016-03-01

    The noninvasive cardiac output monitor and passive leg-raising maneuver has been shown to be reasonably accurate in predicting fluid responsiveness in critically ill patients. We examine whether using a noninvasive protocol would result in more rapid lactate clearance after 3 hours in patients with severe sepsis and septic shock in the emergency department. In this open-label randomized controlled trial, 122 adult patients with sepsis and serum lactate concentration of greater than or equal to 3.0 mmol/L were randomized to receive usual care or intravenous fluid bolus administration guided by measurements of change of stroke volume index, using the noninvasive cardiac output monitor after passive leg-raising maneuver. The primary outcome was lactate clearance of more than 20% at 3 hours. Secondary outcomes included mortality, length of hospital and ICU stay, and total hospital cost. Analysis was intention to treat. Similar proportions of patients in the randomized intervention group (70.5%; N=61) versus control group (73.8%; N=61) achieved the primary outcome, with a relative risk of 0.96 (95% confidence interval [CI] 0.77 to 1.19). Secondary outcomes were similar in both groups (P>.05 for all comparisons). Hospital mortality occurred in 6 patients (9.8%) each in the intervention and control groups on or before 28 days (relative risk=1.00; 95% CI 0.34 to 2.93). Among a subgroup of patients with underlying fluid overload states, those in the intervention group tended to receive clinically significantly more intravenous fluids at 3 hours (difference=975 mL; 95% CI -450 to 1,725 mL) and attained better lactate clearance (difference=19.7%; 95% CI -34.6% to 60.2%) compared with the control group, with shorter hospital lengths of stay (difference=-4.5 days; 95% CI -9.5 to 2.5 days). Protocol-based fluid resuscitation of patients with severe sepsis and septic shock with the noninvasive cardiac output monitor and passive leg-raising maneuver did not result in better

  4. The advocacy in action study a cluster randomized controlled trial to reduce pedestrian injuries in deprived communities.

    Science.gov (United States)

    Lyons, R A; Towner, E; Christie, N; Kendrick, D; Jones, S J; Hayes, M; Kimberlee, R; Sarvotham, T; Macey, S; Brussoni, M; Sleney, J; Coupland, C; Phillips, C

    2008-04-01

    Road traffic-related injury is a major global public health problem. In most countries, pedestrian injuries occur predominantly to the poorest in society. A number of evaluated interventions are effective in reducing these injuries. Very little research has been carried out into the distribution and determinants of the uptake of these interventions. Previous research has shown an association between local political influence and the distribution of traffic calming after adjustment for historical crash patterns. This led to the hypothesis that advocacy could be used to increase local politicians knowledge of pedestrian injury risk and effective interventions, ultimately resulting in improved pedestrian safety. To design an intervention to improve the uptake of pedestrian safety measures in deprived communities. Electoral wards in deprived areas of England and Wales with a poor record of pedestrian safety for children and older adults. Design mixedmethods study, incorporating a cluster randomized controlled trial. Data mixture of Geographical Information Systems data collision locations, road safety interventions, telephone interviews, and questionnaires. Randomization 239 electoral wards clustered within 57 local authorities. Participants 615 politicians representing intervention and control wards. Intervention a package of tailored information including maps of pedestrian injuries was designed for intervention politicians, and a general information pack for controls. Primary outcome number of road safety interventions 25 months after randomization. Secondary outcomes politicians interest and involvement in injury prevention cost of interventions. Process evaluation use of advocacy pack, facilitators and barriers to involvement, and success.

  5. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  6. Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

    Science.gov (United States)

    Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

    2013-01-01

    Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

  7. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  8. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.

    Science.gov (United States)

    Yamagata, Kunihiro; Makino, Hirofumi; Iseki, Kunitoshi; Ito, Sadayoshi; Kimura, Kenjiro; Kusano, Eiji; Shibata, Takanori; Tomita, Kimio; Narita, Ichiei; Nishino, Tomoya; Fujigaki, Yoshihide; Mitarai, Tetsuya; Watanabe, Tsuyoshi; Wada, Takashi; Nakamura, Teiji; Matsuo, Seiichi

    2016-01-01

    Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD), the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs) and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD. Stratified open cluster-randomized trial. A total of 489 GPs belonging to 49 local medical associations (clusters) in Japan. A total of 2,379 patients (1,195 in group A (standard intervention) and 1,184 in group B (advanced intervention)) aged between 40 and 74 years, who had CKD and were under consultation with GPs. All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice. The primary outcome measures were 1) the non-adherence rate of accepting continuous medical follow-up of the patients, 2) the collaboration rate between GPs and nephrologists, and 3) the progression of CKD. The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01). Significantly higher referral and co-treatment rates were observed in group B (pbehavior modification of CKD patients, namely, significantly lower discontinuous clinical visits, and behavior modification of both GPs and nephrologists, namely significantly higher referral and co-treatment rates, resulting in the retardation of CKD progression, especially in patients with proteinuric Stage 3 CKD. The University Hospital Medical Information

  9. Efficient treatment allocation in 2 × 2 cluster randomized trials, when costs and variances are heterogeneous.

    Science.gov (United States)

    Lemme, Francesca; van Breukelen, Gerard J P; Berger, Martijn P F

    2016-10-30

    Typically, clusters and individuals in cluster randomized trials are allocated across treatment conditions in a balanced fashion. This is optimal under homogeneous costs and outcome variances. However, both the costs and the variances may be heterogeneous. Then, an unbalanced allocation is more efficient but impractical as the outcome variance is unknown in the design stage of a study. A practical alternative to the balanced design could be a design optimal for known and possibly heterogeneous costs and homogeneous variances. However, when costs and variances are heterogeneous, both designs suffer from loss of efficiency, compared with the optimal design. Focusing on cluster randomized trials with a 2 × 2 design, the relative efficiency of the balanced design and of the design optimal for heterogeneous costs and homogeneous variances is evaluated, relative to the optimal design. We consider two heterogeneous scenarios (two treatment arms with small, and two with large, costs or variances, or one small, two intermediate, and one large costs or variances) at each design level (cluster, individual, and both). Within these scenarios, we compute the relative efficiency of the two designs as a function of the extents of heterogeneity of the costs and variances, and the congruence (the cheapest treatment has the smallest variance) and incongruence (the cheapest treatment has the largest variance) between costs and variances. We find that the design optimal for heterogeneous costs and homogeneous variances is generally more efficient than the balanced design and we illustrate this theory on a trial that examines methods to reduce radiological referrals from general practices. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  10. The non-random clustering of non-synonymous substitutions and its relationship to evolutionary rate

    Directory of Open Access Journals (Sweden)

    Stone Eric A

    2011-08-01

    Full Text Available Abstract Background Protein sequences are subject to a mosaic of constraint. Changes to functional domains and buried residues, for example, are more apt to disrupt protein structure and function than are changes to residues participating in loops or exposed to solvent. Regions of constraint on the tertiary structure of a protein often result in loose segmentation of its primary structure into stretches of slowly- and rapidly-evolving amino acids. This clustering can be exploited, and existing methods have done so by relying on local sequence conservation as a signature of selection to help identify functionally important regions within proteins. We invert this paradigm by leveraging the regional nature of protein structure and function to both illuminate and make use of genome-wide patterns of local sequence conservation. Results Our hypothesis is that the regional nature of structural and functional constraints will assert a positive autocorrelation on the evolutionary rates of neighboring sites, which, in a pairwise comparison of orthologous proteins, will manifest itself as the clustering of non-synonymous changes across the amino acid sequence. We introduce a dispersion ratio statistic to test this and related hypotheses. Using genome-wide interspecific comparisons of orthologous protein pairs, we reveal a strong log-linear relationship between the degree of clustering and the intensity of constraint. We further demonstrate how this relationship varies with the evolutionary distance between the species being compared. We provide some evidence that proteins with a history of positive selection deviate from genome-wide trends. Conclusions We find a significant association between the evolutionary rate of a protein and the degree to which non-synonymous changes cluster along its primary sequence. We show that clustering is a non-redundant predictor of evolutionary rate, and we speculate that conflicting signals of clustering and constraint may

  11. Irritable bowel syndrome and upper dyspepsia among the elderly: a study of symptom clusters in a random 70 year old population

    DEFF Research Database (Denmark)

    Kay, L; Jørgensen, Torben; Schultz-Larsen, K

    1996-01-01

    With the aim to assess the clustering of abdominal symptoms in a random population, data from a cohort study of a 70 year old Danish population were analysed. The cohort comprised 1,119 subjects of which 72% participated in a primary study and 91% of the survivors in a similar study five years la...... symptoms occur in clusters comparable to clusters in younger populations. The clusters, however, does not totally confirm the traditional concept of Upper Dyspepsia and Irritable Bowel Syndrome....... later. The following clusters of symptoms were constantly associated. One group constituted abdominal distension, borborygmi, altering stool consistency and number of bowel movements. Pain relieved by bowel movement was associated with this cluster. Nausea and vomiting comprised another cluster...

  12. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings

    Directory of Open Access Journals (Sweden)

    Lawrence Paszat

    2017-09-01

    Full Text Available Abstract Background The Building on Existing Tools to Improve Chronic Disease Prevention and Screening (BETTER cluster randomized trial in primary care settings demonstrated a 30% improvement in adherence to evidence-based Chronic Disease Prevention and Screening (CDPS activities. CDPS activities included healthy activities, lifestyle modifications, and screening tests. We present a protocol for the adaptation of BETTER to a public health setting, and testing the adaptation in a cluster randomized trial (BETTER HEALTH: Durham among low income neighbourhoods in Durham Region, Ontario (Canada. Methods The BETTER intervention consists of a personalized prevention visit between a participant and a prevention practitioner, which is focused on the participant’s eligible CDPS activities, and uses Brief Action Planning, to empower the participant to set achievable short-term goals. BETTER HEALTH: Durham aims to establish that the BETTER intervention can be adapted and proven effective among 40–64 year old residents of low income areas when provided in the community by public health nurses trained as prevention practitioners. Focus groups and key informant interviews among stakeholders and eligible residents of low income areas will inform the adaptation, along with feedback from the trial’s Community Advisory Committee. We have created a sampling frame of 16 clusters composed of census dissemination areas in the lowest urban quintile of median household income, and will sample 10 clusters to be randomly allocated to immediate intervention or six month wait list control. Accounting for the clustered design effect, the trial will have 80% power to detect an absolute 30% difference in the primary outcome, a composite score of completed eligible CDPS actions six months after enrollment. The prevention practitioner will attempt to link participants without a primary care provider (PCP to a local PCP. The implementation of BETTER HEALTH: Durham will be

  13. Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

    Science.gov (United States)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-06-11

    There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis. We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration. Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for

  14. PRENACEL - a mHealth messaging system to complement antenatal care: a cluster randomized trial.

    Science.gov (United States)

    Oliveira-Ciabati, Lívia; Vieira, Carolina Sales; Franzon, Ana Carolina Arruda; Alves, Domingos; Zaratini, Fabiani Spessoto; Braga, Giordana Campos; Sanchez, Jazmin Andrea Cifuentes; Bonifácio, Lívia Pimenta; Andrade, Magna Santos; Fernandes, Mariana; Quintana, Silvana Maria; Fabio, Suzi Volpato; Pileggi, Vicky Nogueira; Vieira, Elisabeth Meloni; Souza, João Paulo

    2017-11-07

    The aim of this study was to determine whether PRENACEL (a bi-directional, mobile-phone based, short text message service (SMS)) increases the coverage of recommended antenatal care (ANC) practices. A parallel, cluster-randomized trial in which 20 public primary Health Care Units (PHCUs) were randomly allocated to the intervention (10 PHCUs) or control (10 PHCUs) group. The study population included pregnant women aged 18 or above with a gestational age of 20 weeks or less. Pregnant women receiving ANC in intervention PHCUs were invited through leaflets and posters to register in PRENACEL. Women who registered in PRENACEL received a weekly set of short text messages with health education and health promotion content related to pregnancy and childbirth and were also able to clarify ANC queries through SMS. All women received routine ANC. The primary outcome was the proportion of women with high ANC Score, a composite measure of coverage of recommended ANC practices. Chi-square or Fisher's exact tests and multivariate log-binomial regression were used to analyze the outcomes. A total of 1210 eligible women received ANC in the participating PHCUs and took part of this study (770 in the intervention group and 440 in the control group). 20.4% (157/770) of intervention-group women registered in PRENACEL, but only 116 read all messages (73.9% of women who registered in PRENACEL, 116/157). The adjusted intention-to-treat analysis suggested no difference between intervention and control groups in the primary outcome (Adjusted Relative Risk (AdjRR): 1.05 (95% Confidence Interval (CI): 1.00-1.09). Both crude and adjusted per-protocol analysis suggested a positive effect of PRENACEL (Crude RR (95% CI): 1.14 (1.06-1.22), AdjRR (95% CI): 1.12 (1.05-1.21). The multivariate analysis also suggests that the PRENACEL group (women who read all SMS) had higher mean ANC score [48.5 (±4.2) vs 45.2 (±8.7), p syphilis testing (40.5% vs. 24.8%, p = 0.03) and HIV testing (46.6% vs. 25

  15. Random forests prediction of blood metabolic clusters by milk metabolites and enzymes in dairy cows

    DEFF Research Database (Denmark)

    Foldager, Leslie; Sørensen, Martin Tang; Ingvartsen, Klaus Lønne

    2017-01-01

    by clustering of plasma hormone Insulin-like Growth Factor-1 (IGF-1) and three plasma metabolites: Glucose, beta-hydroxybutyrate (BHB), and non-esterified fatty acids (NEFA). Data between calving and 50 days in milk (DIM) were obtained from 209 Holstein Friesian cows in six research herds: AU (Denmark), UCD...

  16. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study.

    Science.gov (United States)

    Silverman, Michael J

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions? Method: Participants (N = 169) were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusion: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  17. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    Directory of Open Access Journals (Sweden)

    Michael J. Silverman

    2016-10-01

    Full Text Available Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: Will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions?Method: Participants (N = 169 were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusions: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  18. Evidence based community mobilization for dengue prevention in Nicaragua and Mexico (Camino Verde, the Green Way): cluster randomized controlled trial.

    Science.gov (United States)

    Andersson, Neil; Nava-Aguilera, Elizabeth; Arosteguí, Jorge; Morales-Perez, Arcadio; Suazo-Laguna, Harold; Legorreta-Soberanis, José; Hernandez-Alvarez, Carlos; Fernandez-Salas, Ildefonso; Paredes-Solís, Sergio; Balmaseda, Angel; Cortés-Guzmán, Antonio Juan; Serrano de Los Santos, René; Coloma, Josefina; Ledogar, Robert J; Harris, Eva

    2015-07-08

    To test whether community mobilization adds effectiveness to conventional dengue control. Pragmatic open label parallel group cluster randomized controlled trial. Those assessing the outcomes and analyzing the data were blinded to group assignment. Centralized computerized randomization after the baseline study allocated half the sites to intervention, stratified by country, evidence of recent dengue virus infection in children aged 3-9, and vector indices. Random sample of communities in Managua, capital of Nicaragua, and three coastal regions in Guerrero State in the south of Mexico. Residents in a random sample of census enumeration areas across both countries: 75 intervention and 75 control clusters (about 140 households each) were randomized and analyzed (60 clusters in Nicaragua and 90 in Mexico), including 85,182 residents in 18,838 households. A community mobilization protocol began with community discussion of baseline results. Each intervention cluster adapted the basic intervention-chemical-free prevention of mosquito reproduction-to its own circumstances. All clusters continued the government run dengue control program. Primary outcomes per protocol were self reported cases of dengue, serological evidence of recent dengue virus infection, and conventional entomological indices (house index: households with larvae or pupae/households examined; container index: containers with larvae or pupae/containers examined; Breteau index: containers with larvae or pupae/households examined; and pupae per person: pupae found/number of residents). Per protocol secondary analysis examined the effect of Camino Verde in the context of temephos use. With cluster as the unit of analysis, serological evidence from intervention sites showed a lower risk of infection with dengue virus in children (relative risk reduction 29.5%, 95% confidence interval 3.8% to 55.3%), fewer reports of dengue illness (24.7%, 1.8% to 51.2%), fewer houses with larvae or pupae among houses visited

  19. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

    Science.gov (United States)

    Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

    2016-01-01

    Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

  20. Efficacy of Art Therapy in Individuals With Personality Disorders Cluster B/C: A Randomized Controlled Trial.

    Science.gov (United States)

    Haeyen, Suzanne; van Hooren, Susan; van der Veld, William; Hutschemaekers, Giel

    2017-09-19

    Multidisciplinary treatment programs for patients with personality disorders (PDs) often include art therapy, but the efficacy of this intervention has hardly been evaluated. The objective of this study is to evaluate the effects of an art therapy intervention on psychological functioning of patients with a PD. In this randomized controlled trial, 57 adult participants diagnosed with a PD cluster B/C (SCID-II) were randomly assigned to either weekly group art therapy (1.5 hours, 10 weeks) or a waiting list group. Outcome measures OQ45, AAQ-II, and SMI were assessed at baseline, at post-test (10 weeks after baseline), and at follow-up (5 weeks after post-test). The results show that art therapy is an effective treatment for PD patients because it not only reduces PD pathology and maladaptive modes but it also helps patients to develop adaptive, positive modes that indicate better mental health and self-regulation.

  1. Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.

    Science.gov (United States)

    Gravenstein, Stefan; Davidson, H Edward; Han, Lisa F; Ogarek, Jessica A; Dahal, Roshani; Gozalo, Pedro L; Taljaard, Monica; Mor, Vincent

    2017-11-01

    Influenza severity increases and vaccine effectiveness decreases with age. High-Dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare-care certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care random assignment with HD (Fluzone® High-Dose) or SD (Fluzone®) influenza vaccine for their facility for the 2012-2013 influenza season. We used Minimum Data Set (MDS) 3.0 and Vital Status records for pre-specified clinical outcomes: 1) all-cause hospitalization, 2) NH mortality, and 3) functional decline. Intent-to-treat analyses were performed at the resident-level using Cox proportional hazards, multivariable Poisson, and logistic regression models accounting for clustering by facility. We randomized 39 NHs (19 SD and 20 HD), coordinated vaccine delivery, implemented web-based data collection, and accessed MDS data, demonstrating feasibility. There were 2,957 eligible residents (SD 1496; HD 1461); characteristics were similar between groups. A total of 301 (20.1%) of SD and 197 (13.5%) of HD allocated residents were ever hospitalized, (adjusted relative risk 0.680; 95% CI: 0.537, 0.862; p = 0.001). NH mortality was 274 (18.3%) SD vs 249 (17.1%) HD, adjusted relative risk 0.834; 95% CI: 0.678, 1.027; p = 0.087). There were no differences in decline in functional status (13.4 vs 13.8%, adjusted relative risk 0.994; 95% CI: 0.774,1.278; p = 0.965). We demonstrate that a pragmatic large-scale trial is feasible in a NH setting.

  2. Effectiveness of a school-based physical activity-related injury prevention program on risk behavior and neuromotor fitness a cluster randomized controlled trial

    NARCIS (Netherlands)

    Collard, D.C.M.; Chinapaw, M.J.M.; Verhagen, E.A.L.M.; Bakker, I.; Mechelen, W. van

    2010-01-01

    Background: To investigate the effects of a school-based physical activity-related injury prevention program, called 'iPlay', on risk behavior and neuromotor fitness.Methods: In this cluster randomized controlled trial 40 primary schools throughout the Netherlands were randomly assigned in an

  3. Start improving the quality of care for people with type 2 diabetes through a general practice support program: a cluster randomized trial.

    NARCIS (Netherlands)

    Goderis, G.; Borgermans, L.D.A.; Grol, R.P.T.M.; Broeke, C. Van Den; Boland, B.; Verbeke, G.; Carbonez, A.; Mathieu, C.; Heyrman, J.

    2010-01-01

    AIMS: To evaluate the effectiveness of a two-arm quality improvement program (QIP) to support general practice with limited tradition in chronic care on type 2 diabetes patient outcomes. METHODS: During 18 months, we performed a cluster randomized trial with randomization of General Practices. The

  4. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  5. Effectiveness of a selective intervention program targeting personality risk factors for alcohol misuse among young adolescents: results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Lammers, J.; Goossens, F.; Conrod, P.; Engels, R.; Wiers, R.W.; Kleinjan, M.

    2015-01-01

    Aim: The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. Design: A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control

  6. Carbon nanotubes randomly decorated with gold clusters: from nano{sup 2}hybrid atomic structures to gas sensing prototypes

    Energy Technology Data Exchange (ETDEWEB)

    Charlier, J-C; Zanolli, Z [Unite de Physico-Chimie et de Physique des Materiaux (PCPM), European Theoretical Spectroscopy Facility (ETSF), Universite Catholique de Louvain, Place Croix du Sud 1, B-1348 Louvain-la-Neuve (Belgium); Arnaud, L; Avilov, I V; Felten, A; Pireaux, J-J [Centre de Recherche en Physique de la Matiere et du Rayonnement (PMR-LISE), Facultes Universitaires Notre-Dame de la Paix, 61 Rue de Bruxelles, B-5000 Namur (Belgium); Delgado, M [Sensotran, s.l., Avenida Remolar 31, E-08820 El Prat de Llobregat, Barcelona (Spain); Demoisson, F; Reniers, F [Service de Chimie Analytique et Chimie des Interfaces (CHANI), Universite Libre de Bruxelles, Faculte des Sciences, CP255, Boulevard du Triomphe 2, B-1050 Bruxelles (Belgium); Espinosa, E H; Ionescu, R; Leghrib, R; Llobet, E [Department of Electronic Engineering, Universitat Rovira i Virgili, Avenida Paisos Catalans 26, E-43007 Tarragona (Spain); Ewels, C P; Suarez-Martinez, I [Institut des Materiaux Jean Rouxel (IMN), Universite de Nantes, 2 rue de la Houssiniere-BP 32229, F-44322 Nantes Cedex 3 (France); Guillot, J; Mansour, A; Migeon, H-N [Departement Science et Analyse des Materiaux, Centre de Recherche Public-Gabriel Lippmann, rue du Brill 41, L-4422 Belvaux (Luxembourg); Watson, G E, E-mail: jean-jacques.pireaux@fundp.ac.b [Vega Science Trust, Unit 118, Science Park SQ, Brighton, BN1 9SB (United Kingdom)

    2009-09-16

    Carbon nanotube surfaces, activated and randomly decorated with metal nanoclusters, have been studied in uniquely combined theoretical and experimental approaches as prototypes for molecular recognition. The key concept is to shape metallic clusters that donate or accept a fractional charge upon adsorption of a target molecule, and modify the electron transport in the nanotube. The present work focuses on a simple system, carbon nanotubes with gold clusters. The nature of the gold-nanotube interaction is studied using first-principles techniques. The numerical simulations predict the binding and diffusion energies of gold atoms at the tube surface, including realistic atomic models for defects potentially present at the nanotube surface. The atomic structure of the gold nanoclusters and their effect on the intrinsic electronic quantum transport properties of the nanotube are also predicted. Experimentally, multi-wall CNTs are decorated with gold clusters using (1) vacuum evaporation, after activation with an RF oxygen plasma and (2) colloid solution injected into an RF atmospheric plasma; the hybrid systems are accurately characterized using XPS and TEM techniques. The response of gas sensors based on these nano{sup 2}hybrids is quantified for the detection of toxic species like NO{sub 2}, CO, C{sub 2}H{sub 5}OH and C{sub 2}H{sub 4}.

  7. Carbon nanotubes randomly decorated with gold clusters: from nano2hybrid atomic structures to gas sensing prototypes.

    Science.gov (United States)

    Charlier, J-C; Arnaud, L; Avilov, I V; Delgado, M; Demoisson, F; Espinosa, E H; Ewels, C P; Felten, A; Guillot, J; Ionescu, R; Leghrib, R; Llobet, E; Mansour, A; Migeon, H-N; Pireaux, J-J; Reniers, F; Suarez-Martinez, I; Watson, G E; Zanolli, Z

    2009-09-16

    Carbon nanotube surfaces, activated and randomly decorated with metal nanoclusters, have been studied in uniquely combined theoretical and experimental approaches as prototypes for molecular recognition. The key concept is to shape metallic clusters that donate or accept a fractional charge upon adsorption of a target molecule, and modify the electron transport in the nanotube. The present work focuses on a simple system, carbon nanotubes with gold clusters. The nature of the gold-nanotube interaction is studied using first-principles techniques. The numerical simulations predict the binding and diffusion energies of gold atoms at the tube surface, including realistic atomic models for defects potentially present at the nanotube surface. The atomic structure of the gold nanoclusters and their effect on the intrinsic electronic quantum transport properties of the nanotube are also predicted. Experimentally, multi-wall CNTs are decorated with gold clusters using (1) vacuum evaporation, after activation with an RF oxygen plasma and (2) colloid solution injected into an RF atmospheric plasma; the hybrid systems are accurately characterized using XPS and TEM techniques. The response of gas sensors based on these nano(2)hybrids is quantified for the detection of toxic species like NO(2), CO, C(2)H(5)OH and C(2)H(4).

  8. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia.

    Science.gov (United States)

    O'Brien, Karel; Bracht, Marianne; Robson, Kate; Ye, Xiang Y; Mirea, Lucia; Cruz, Melinda; Ng, Eugene; Monterrosa, Luis; Soraisham, Amuchou; Alvaro, Ruben; Narvey, Michael; Da Silva, Orlando; Lui, Kei; Tarnow-Mordi, William; Lee, Shoo K

    2015-12-15

    Admission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant's care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge. In the Family Integrated Care (FICare) model, parents provide all except the most advanced medical care for their infants with support from the medical team. Our hypothesis is that infants whose families complete the FICare program will have greater weight gain and better clinical and parental outcomes compared with infants provided with standard NICU care. FICare is being evaluated in a cluster randomized controlled trial among infants born at ≤ 33 weeks' gestation admitted to 19 Canadian, 6 Australian, and 1 New Zealand tertiary-level NICU. Trial enrollment began in April, 2013, with a target sample size of 675 infants in each arm, to be completed by August, 2015. Participating sites were stratified by country, and by NICU size within Canada, for randomization to either the FICare intervention or control arm. In intervention sites, parents are taught how to provide most of their infant's care and supported by nursing staff, veteran parents, a program coordinator, and education sessions. In control sites standard NICU care is provided. The primary outcome is infants' weight gain at 21 days after enrollment, which will be compared between the FICare and control groups using Student's t-test adjusted for site-level clustering, and multi-level hierarchical models accounting for both clustering and potential confounders. Similar analyses will examine secondary outcomes including breastfeeding, clinical outcomes, safety, parental stress and anxiety, and resource use. The trial was

  9. Resource-oriented coaching for reduction of examination-related stress in medical students: an exploratory randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kötter T

    2016-08-01

    Full Text Available Thomas Kötter,1 Frank Niebuhr2 1Institute of Social Medicine and Epidemiology, 2Institute of Family Medicine, University of Lübeck, Lübeck, Germany Introduction: The years spent in acquiring medical education is considered a stressful period in the life of many students. Students whose mental health deteriorates during this long period of study are less likely to become empathic and productive physicians. In addition to other specific stressors, academic examinations seem to further induce medical school-related stress and anxiety. Combined group and individual resource-oriented coaching early in medical education might reduce examination-related stress and anxiety and, consequently, enhance academic performance. Good quality evidence, however, remains scarce. In this study, therefore, we explored the question of whether coaching affects examination-related stress and health in medical students.Methods: We conducted a randomized controlled trial. Students who registered for the first medical academic examination in August 2014 at the University of Lübeck were recruited and randomized into three groups. The intervention groups 1 and 2 received a 1-hour psychoeducative seminar. Group 1 additionally received two 1-hour sessions of individual coaching during examination preparation. Group 3 served as a control group. We compared changes in self-rated general health (measured by a single item, anxiety and depression (measured by the hospital anxiety and depression scale, as well as medical school stress (measured by the perceived medical school stress instrument. In order to further investigate the influence of group allocation on perceived medical school stress, we conducted a linear regression analysis.Results: We saw a significant deterioration of general health and an increase in anxiety and depression scores in medical students while preparing for an examination. We found a small, but statistically significant, effect of group allocation on

  10. The effect of integrated emotion-oriented care versus usual care on elderly persons with dementia in the nursing home and on nursing assistants: a randomized clinical trial

    NARCIS (Netherlands)

    Finnema, E.J.; Dr�es, R.M.; Ettema, T.P.; Ooms, M.E.; Adèr, H.J.; Ribbe, M.W.; van Tilburg, W.

    2005-01-01

    Objectives: To examine the effect of integrated emotion-oriented care on nursing home residents with dementia and nursing assistants. Design: A multi-site randomized clinical trial with matched groups, and measurements at baseline and after seven months. Setting: Sixteen psychogeriatric wards in

  11. The effect of integrated emotion-oriented care versus usual care on elderly persons with dementia in the nursing home and on nursing assistants: a randomized clinical trial

    NARCIS (Netherlands)

    Finnema, E.J.; Dr�es, R.M.; Ettema, T.P.; Ooms, M.E.; Adèr, H.J.; Ribbe, M.W.; Tilburg, van W.

    2005-01-01

    OBJECTIVES: To examine the effect of integrated emotion-oriented care on nursing home residents with dementia and nursing assistants. DESIGN: A multi-site randomized clinical trial with matched groups, and measurements at baseline and after seven months. SETTING: Sixteen psychogeriatric wards in

  12. Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

    Science.gov (United States)

    Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

    2016-10-01

    To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  13. Effectiveness of a community-based responsive feeding programme in rural Bangladesh: a cluster randomized field trial.

    Science.gov (United States)

    Aboud, Frances E; Moore, Anna C; Akhter, Sadika

    2008-10-01

    Responsive complementary feeding, whereby the mother feeds her child in response to child cues of hunger state and psychomotor abilities, is a problem in some countries, and likely contributes to malnutrition. Interventions are needed to evaluate whether promoting responsive feeding would add any benefit. Using a cluster randomized field trial, we evaluated a six-session educational programme that emphasized practice of two key behaviours, namely child self-feeding and maternal responsiveness. One hundred mothers and their 12- to 24-month-olds attended the sessions as part of village clusters randomly assigned to the intervention group. A similar number of controls received sessions on foods to feed and nutritional disorders. Outcomes assessed at pre-test, 2-week post-intervention and again 5-months post-intervention included weight, mouthfuls of food taken, self-feeding and maternal responsiveness. Research assistants, blind to group assignment, observed and coded mother and child behaviours during the midday meal. Secondary measures included foods fed and feeding messages recalled. Analysis was based on intention to treat and accounted for clustering. Only 10% of each group was lost to follow-up. Weight (d = 0.28), weight gain (d = 0.48) and child self-feeding (d = 0.30) were significantly higher in the responsive feeding group. Mouthfuls of food eaten and maternal responsiveness were not significantly increased by the intervention. Mothers in the intervention gave their children more vegetables, and spontaneously recalled more feeding messages at the 5-month follow-up. These results provide evidence that self-feeding and weight gain can improve by targeting specific behaviours, while maternal responsiveness may require more intensive strategies.

  14. Does mass azithromycin distribution impact child growth and nutrition in Niger? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    2014-09-01

    Full Text Available Antibiotic use on animals demonstrates improved growth regardless of whether or not there is clinical evidence of infectious disease. Antibiotics used for trachoma control may play an unintended benefit of improving child growth.In this sub-study of a larger randomized controlled trial, we assess anthropometry of pre-school children in a community-randomized trial of mass oral azithromycin distributions for trachoma in Niger. We measured height, weight, and mid-upper arm circumference (MUAC in 12 communities randomized to receive annual mass azithromycin treatment of everyone versus 12 communities randomized to receive biannual mass azithromycin treatments for children, 3 years after the initial mass treatment. We collected measurements in 1,034 children aged 6-60 months of age.We found no difference in the prevalence of wasting among children in the 12 annually treated communities that received three mass azithromycin distributions compared to the 12 biannually treated communities that received six mass azithromycin distributions (odds ratio = 0.88, 95% confidence interval = 0.53 to 1.49.We were unable to demonstrate a statistically significant difference in stunting, underweight, and low MUAC of pre-school children in communities randomized to annual mass azithromycin treatment or biannual mass azithromycin treatment. The role of antibiotics on child growth and nutrition remains unclear, but larger studies and longitudinal trials may help determine any association.

  15. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

    Science.gov (United States)

    Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

    2014-01-01

    Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), pemail notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

  16. Effects of improved sanitation on diarrheal reduction for children under five in Idiofa, DR Congo: a cluster randomized trial.

    Science.gov (United States)

    Cha, Seungman; Lee, JaeEun; Seo, DongSik; Park, Byoung Mann; Mansiangi, Paul; Bernard, Kabore; Mulakub-Yazho, Guy Jerome Nkay; Famasulu, Honore Minka

    2017-09-19

    The lack of safe water and sanitation contributes to the rampancy of diarrhea in many developing countries. This study describes the design of a cluster-randomized trial in Idiofa, the Democratic Republic of the Congo, seeking evidence of the impact of improved sanitation on diarrhea for children under four. Of the 276 quartiers, 18 quartiers were randomly allocated to the intervention or control arm. Seven hundred and-twenty households were sampled and the youngest under-four child in each household was registered for this study. The primary endpoint of the study is diarrheal incidence, prevalence and duration in children under five. Material subsidies will be provided only to the households who complete pit digging plus superstructure and roof construction, regardless of their income level. This study employs a Sanitation Calendar so that the mother of each household can record the diarrheal episodes of her under-four child on a daily basis. The diary enables examination of the effect of the sanitation intervention on diarrhea duration and also resolves the limitation of the small number of clusters in the trial. In addition, the project will be monitored through the 'Sanitation Map', on which all households in the study area, including both the control and intervention arms, are registered. To avoid information bias or courtesy bias, photos will be taken of the latrine during the household visit, and a supervisor will determine well-equipped latrine uptake based on the photos. This reduces the possibility of recall bias and under- or over-estimation of diarrhea, which was the main limitation of previous studies. The study was approved by the Institutional Review Board of the School of Public Health, Kinshasa University (ESP/CE/040/15; April 13, 2015) and registered as an International Standard Randomized Controlled Trial (ISRCTN: 10,419,317) on March 13, 2015.

  17. Double Star, Cluster, and ground-based observations of magnetic reconnection during an interval of duskward oriented IMF: preliminary results

    Directory of Open Access Journals (Sweden)

    J. A. Wild

    2005-11-01

    Full Text Available We present a space- and ground-based study exploiting data from the coordinated Cluster and Double Star missions in order to investigate dayside magnetic reconnection under BY+ dominated IMF conditions. In-situ observations of magnetosheath flux transfer events combined with measurements of pulsed poleward and dawnward directed flows in the pre-noon sector high-latitude northern hemisphere ionosphere are interpreted as indications of pulsed magnetic reconnection during an interval in which the IMF remained relatively steady. Observations of newly-reconnected magnetic flux tubes anchored in the northern hemisphere both at mid-latitudes and in the vicinity of the subsolar point suggests that during BY+ dominated IMF, reconnection is not, as proposed previously, limited to the high-latitude magnetopause.

  18. Double Star, Cluster, and ground-based observations of magnetic reconnection during an interval of duskward oriented IMF: preliminary results

    Directory of Open Access Journals (Sweden)

    J. A. Wild

    2005-11-01

    Full Text Available We present a space- and ground-based study exploiting data from the coordinated Cluster and Double Star missions in order to investigate dayside magnetic reconnection under BY+ dominated IMF conditions. In-situ observations of magnetosheath flux transfer events combined with measurements of pulsed poleward and dawnward directed flows in the pre-noon sector high-latitude northern hemisphere ionosphere are interpreted as indications of pulsed magnetic reconnection during an interval in which the IMF remained relatively steady. Observations of newly-reconnected magnetic flux tubes anchored in the northern hemisphere both at mid-latitudes and in the vicinity of the subsolar point suggests that during BY+ dominated IMF, reconnection is not, as proposed previously, limited to the high-latitude magnetopause.

  19. Design of a Golf Swing Injury Detection and Evaluation open service platform with Ontology-oriented clustering case-based reasoning mechanism.

    Science.gov (United States)

    Ku, Hao-Hsiang

    2015-01-01

    Nowadays, people can easily use a smartphone to get wanted information and requested services. Hence, this study designs and proposes a Golf Swing Injury Detection and Evaluation open service platform with Ontology-oritened clustering case-based reasoning mechanism, which is called GoSIDE, based on Arduino and Open Service Gateway initative (OSGi). GoSIDE is a three-tier architecture, which is composed of Mobile Users, Application Servers and a Cloud-based Digital Convergence Server. A mobile user is with a smartphone and Kinect sensors to detect the user's Golf swing actions and to interact with iDTV. An application server is with Intelligent Golf Swing Posture Analysis Model (iGoSPAM) to check a user's Golf swing actions and to alter this user when he is with error actions. Cloud-based Digital Convergence Server is with Ontology-oriented Clustering Case-based Reasoning (CBR) for Quality of Experiences (OCC4QoE), which is designed to provide QoE services by QoE-based Ontology strategies, rules and events for this user. Furthermore, GoSIDE will automatically trigger OCC4QoE and deliver popular rules for a new user. Experiment results illustrate that GoSIDE can provide appropriate detections for Golfers. Finally, GoSIDE can be a reference model for researchers and engineers.

  20. Standard practice for X-Ray determination of retained austenite in steel with near random crystallographic orientation

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2003-01-01

    1.1 This practice covers the determination of retained austenite phase in steel using integrated intensities (area under peak above background) of X-ray diffraction peaks using chromium Kα or molybdenum Kα X-radiation. 1.2 The method applies to carbon and alloy steels with near random crystallographic orientations of both ferrite and austenite phases. 1.3 This practice is valid for retained austenite contents from 1 % by volume and above. 1.4 If possible, X-ray diffraction peak interference from other crystalline phases such as carbides should be eliminated from the ferrite and austenite peak intensities. 1.5 Substantial alloy contents in steel cause some change in peak intensities which have not been considered in this method. Application of this method to steels with total alloy contents exceeding 15 weight % should be done with care. If necessary, the users can calculate the theoretical correction factors to account for changes in volume of the unit cells for austenite and ferrite resulting from vari...

  1. Effectiveness of "Primary Bereavement Care" for Widows: A Cluster Randomized Controlled Trial Involving Family Physicians

    Science.gov (United States)

    García, Jesus A.; Landa, Victor; Grandes, Gonzalo; Pombo, Haizea; Mauriz, Amaia

    2013-01-01

    Thirty-one family physicians, from 19 primary care teams in Biscay (Spain), were randomly assigned to intervention or control group. The 15 intervention family physicians, after training in primary bereavement care, saw 43 widows for 7 sessions, from the 4th to 13th month after their loss. The 16 control family physicians, without primary…

  2. A cluster randomized controlled trial of a structured training programme for caregivers of inpatients after stroke (TRACS).

    Science.gov (United States)

    Forster, Anne; Young, John; Nixon, Jane; Kalra, Lalit; Smithard, David; Patel, Anita; Knapp, Martin; Monaghan, Josie; Breen, Rachel; Anwar, Shamaila; Farrin, Amanda

    2012-01-01

    The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living, including bathing, dressing, and toileting. Many caregivers feel unprepared for this role, and this may have a detrimental effect on both the patient and caregiver. To evaluate whether a structured, competency-based training programme for caregivers improves physical and psychological outcomes for patients and their caregivers after disabling stroke, and to determine if such a training programme is cost-effective. A cluster randomized controlled trial. The trial aims to recruit 25 patient and caregiver dyads from each of the 36 participating stroke rehabilitation units. Stroke units have been randomized to either the intervention or control group with randomization stratified by geographical region and quality of care. The intervention is the London Stroke Carer Training Course developed and evaluated in a previous single-centre study. The London Stroke Carer Training Course comprises a number of caregiver training sessions and competency assessment delivered while the patient is in the hospital and one follow-up session after discharge. The multidisciplinary teams in the units randomized to the intervention group have been trained to incorporate delivery of the London Stroke Carer Training Course into ward practice, while those randomized to the control group have continued to provide usual care according to national guidelines. The primary outcomes are extended activities of daily living for the patient and caregiver burden measured at six-months after recruitment. Secondary outcomes include mood and cost-effectiveness, with final follow-up at 12 months. © 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.

  3. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power.

    Directory of Open Access Journals (Sweden)

    Joop eHox

    2014-02-01

    Full Text Available Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen’s theory of planned behaviour is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioural intention. Structural equation modelling (SEM is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g. much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5 to 10 clusters are available per treatment condition even with Bayesian estimation problems occur.

  4. [PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

    Science.gov (United States)

    Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

    2017-10-12

    Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

  5. A particle swarm optimization algorithm with random learning mechanism and Levy flight for optimization of atomic clusters

    Science.gov (United States)

    Yan, Bailu; Zhao, Zheng; Zhou, Yingcheng; Yuan, Wenyan; Li, Jian; Wu, Jun; Cheng, Daojian

    2017-10-01

    Swarm intelligence optimization algorithms are mainstream algorithms for solving complex optimization problems. Among these algorithms, the particle swarm optimization (PSO) algorithm has the advantages of fast computation speed and few parameters. However, PSO is prone to premature convergence. To solve this problem, we develop a new PSO algorithm (RPSOLF) by combining the characteristics of random learning mechanism and Levy flight. The RPSOLF algorithm increases the diversity of the population by learning from random particles and random walks in Levy flight. On the one hand, we carry out a large number of numerical experiments on benchmark test functions, and compare these results with the PSO algorithm with Levy flight (PSOLF) algorithm and other PSO variants in previous reports. The results show that the optimal solution can be found faster and more efficiently by the RPSOLF algorithm. On the other hand, the RPSOLF algorithm can also be applied to optimize the Lennard-Jones clusters, and the results indicate that the algorithm obtains the optimal structure (2-60 atoms) with an extraordinary high efficiency. In summary, RPSOLF algorithm proposed in our paper is proved to be an extremely effective tool for global optimization.

  6. When Things Are Not as They Appear: Assessing the Adequacy of Cluster Randomization When Outcome Events Are Rare at Baseline

    Directory of Open Access Journals (Sweden)

    Veronica Dinaj-Koci

    2012-01-01

    Full Text Available The present study randomly assigned 15 Bahamian elementary schools to one of three intervention conditions. To assess the adequacy of cluster randomization, we examined two concerns identified by the local research team: inequality of gender distribution and environmental risk among groups. Baseline significant differences in risk and protective behaviors were minimal. There were significantly more males in the intervention group. Males had higher rates of risk behavior at all assessments. Poor school performance was also higher among the intervention condition and was significantly associated with increased rates of many but not all risk behaviors. Prior to adjusting for gender and school performance, several risk behaviors appeared to be higher after intervention among intervention youth. Adjusting for gender and school performance eradicated the group differences in risk behavior rates. Results demonstrate the importance of adequate randomization where outcomes of interest are rare events at baseline or differ by gender and there is an unequal gender distribution and the importance of the local research team’s knowledge of potential inequalities in environmental risk (i.e., school performance. Not considering such individual differences could impact the integrity of trial outcomes.

  7. Activity Begins in Childhood (ABC) - inspiring healthy active behaviour in preschoolers: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Adamo, Kristi B; Barrowman, Nick; Naylor, Patti Jean; Yaya, Sanni; Harvey, Alysha; Grattan, Kimberly P; Goldfield, Gary S

    2014-07-29

    Today's children are more overweight than previous generations and physical inactivity is a contributing factor. Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits. The social and physical environments where children spend their time have a powerful influence on behaviour. Since the majority of preschool children spend time in care outside of the home, this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour. This study aims to evaluate the efficacy of the Activity Begins in Childhood (ABC) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers' overall physical activity levels and, specifically, the time spent in moderate to vigorous physical activity. This study is a single site, three-arm, cluster-randomized controlled trial design with a daycare centre as the unit of measurement (clusters). All daycare centres in the National Capital region that serve children between the ages of 3 and 5, expressing an interest in receiving the ABC intervention will be invited to participate. Those who agree will be randomly assigned to one of three groups: i) ABC program delivered at a daycare centre only, ii) ABC program delivered at daycare with a home/parental education component, or iii) regular daycare curriculum. This study will recruit 18 daycare centres, 6 in each of the three groups. The intervention will last approximately 6 months, with baseline assessment prior to ABC implementation and follow-up assessments at 3 and 6 months. Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health. Opportunities for physical activity and motor development in early childhood may, over the lifespan, influence the

  8. Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial.

    Science.gov (United States)

    Molfenter, Todd; Kim, Jee-Seon; Quanbeck, Andrew; Patel-Porter, Terry; Starr, Sandy; McCarty, Dennis

    2013-05-10

    More effective methods are needed to implement evidence-based findings into practice. The Advancing Recovery Framework offers a multi-level approach to evidence-based practice implementation by aligning purchasing and regulatory policies at the payer level with organizational change strategies at the organizational level. The Advancing Recovery Buprenorphine Implementation Study is a cluster-randomized controlled trial designed to increase use of the evidence-based practice buprenorphine medication to treat opiate addiction. Ohio Alcohol, Drug Addiction, and Mental Health Services Boards (ADAMHS), who are payers, and their addiction treatment organizations were recruited for a trial to assess the effects of payer and treatment organization changes (using the Advancing Recovery Framework) versus treatment organization changes alone on the use of buprenorphine. A matched-pair randomization, based on county characteristics, was applied, resulting in seven county ADAMHS boards and twenty-five treatment organizations in each arm. Opioid dependent patients are nested within cluster (treatment organization), and treatment organization clusters are nested within ADAMHS county board. The primary outcome is the percentage of individuals with an opioid dependence diagnosis who use buprenorphine during the 24-month intervention period and the 12-month sustainability period. The trial is currently in the baseline data collection stage. Although addiction treatment providers are under increasing pressure to implement evidence-based practices that have been proven to improve patient outcomes, adoption of these practices lags, compared to other areas of healthcare. Reasons frequently cited for the slow adoption of EBPs in addiction treatment include, regulatory issues, staff, or client resistance and lack of resources. Yet the way addiction treatment is funded, the payer's role-has not received a lot of attention in research on EBP adoption.This research is unique because it

  9. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    Directory of Open Access Journals (Sweden)

    Waldén Markus

    2009-06-01

    Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to

  10. Implementing a Pain Self-Management Protocol in Home Care: A Cluster-Randomized Pragmatic Trial.

    Science.gov (United States)

    Reid, M Carrington; Henderson, Charles R; Trachtenberg, Melissa A; Beissner, Katherine L; Bach, Eileen; Barrón, Yolanda; Sridharan, Sridevi; Murtaugh, Christopher M

    2017-08-01

    To determine the effectiveness of a cognitive-behavioral pain self-management (CBPSM) protocol delivered by physical therapists (PTs) for use by older adults with activity-limiting pain receiving home care. A randomized pragmatic trial comparing delivery of the intervention plus usual care with usual care alone. Community. Individuals aged 55 and older admitted with orders for physical therapy who endorsed activity-limiting pain and reported pain scores of 3 or greater on a scale from 0 to 10 (N = 588). A CBPSM protocol delivered by PTs. Primary outcomes were assessed at 60 days using validated measures of pain-related disability, pain intensity, gait speed, and number of activity of daily living (ADL) deficits. Of 588 participants, 285 received care from a PT randomized to the intervention and 303 from a PT randomized to the usual care group. Both groups had significant reductions in pain-related disability, pain intensity, and ADL limitations and improved gait speed. No significant treatment differences were identified. There were no consistent treatment differences when interactions and subgroups were examined. This real-world pragmatic trial found no effect of implementation of a pain self-management intervention in a home care setting. Despite the lack of positive findings, future studies are indicated to determine how similar protocols that have been found to be effective in efficacy studies can be successfully implemented in routine clinical care. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  11. Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

    Science.gov (United States)

    González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

    2017-10-30

    Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

  12. The Effects of Affect Exposure in Short-term Dynamic Psychoterapy and Cognitive Therapy for Patients with Cluster C Personality Disorder: A randomized controlled process study

    OpenAIRE

    Nyjordet, Randi Fagerli

    2014-01-01

    Objective: This study examined if the amount of exposure to anger/assertiveness, grief, positive feelings for self or closeness in the early stages of treatment could predict treatment outcome in the different Cluster C personality disorders (PDs) independently of treatment modality. Method: The sample consisted of patients who met the criteria for one or more Cluster C PDs (N=50), and was taken from a randomized controlled trial comparing 40 sessions of either short-term dynamic psychotherap...

  13. [MR brain image segmentation based on modified fuzzy C-means clustering using fuzzy GIbbs random field].

    Science.gov (United States)

    Liao, Liang; Lin, Tusheng; Li, Bi; Zhang, Weidong

    2008-12-01

    A modified algorithm using fuzzy Gibbs random field model and fuzzy c-means (FCM) clustering is proposed for segmentation of Magnetic resonance(MR) brain images. Spatial constraints using the definitions of homogeneity of cliques and fuzzy Gibbs clique potential are introduced in this algorithm. A new modified objective function , which is established by introducing the spatial constraints into the traditional intensity based FCM algorithm, leads to the establishment of new iterative formulas for membership matrix and centroids. This algorithm can improve the performance of corresponding traditional one by modifying the original intensity based segmentation model. Experiments on synthetic images and MR phantoms show the validation of the proposed algorithm, which is usually a better alternative for segmenting medical MR images corrupted by noise.

  14. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Directory of Open Access Journals (Sweden)

    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  15. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Science.gov (United States)

    Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J

    2013-01-01

    Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  16. Impact of Free Glasses and a Teacher Incentive on Children's Use of Eyeglasses: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Yi, Hongmei; Zhang, Haiqing; Ma, Xiaochen; Zhang, Linxiu; Wang, Xiuqin; Jin, Ling; Naidoo, Kovin; Minto, Hasan; Zou, Haidong; Lu, Lina; Rozelle, Scott; Congdon, Nathan

    2015-11-01

    To study the effect of free glasses combined with teacher incentives on in-school glasses wear among Chinese urban migrant children. Cluster-randomized controlled trial. Children with visual acuity (VA) ≤6/12 in either eye owing to refractive error in 94 randomly chosen primary schools underwent randomization by school to receive free glasses, education on their use, and a teacher incentive (Intervention), or glasses prescriptions only (Control). Intervention group teachers received a tablet computer if ≥80% of children given glasses wore them during unannounced visits 6 weeks and 6 months (main outcome) after intervention. Among 4376 children, 728 (16.7%, mean age 10.9 years, 51.0% boys) met enrollment criteria and were randomly allocated, 358 (49.2%, 47 schools) to Intervention and 370 (50.8%, 47 schools) to Control. Among these, 693 children (95.2%) completed the study and underwent analysis. Spectacle wear was significantly higher at 6 months among Intervention children (Observed [main outcome]: 68.3% vs 23.9%, adjusted odds ratio [OR] = 11.5, 95% confidence interval [CI] 5.91-22.5, P spectacle wear (P spectacle wear (P = .02). The 6-month observed wear rate was only 41% among similar-aged children provided free glasses in our previous trial without teacher incentives. Free spectacles and teacher incentives maintain classroom wear in the large majority of children needing glasses over a school year. Low wear among Control children demonstrates the need for interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Costello Anthony

    2011-06-01

    Full Text Available Abstract Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs are supported in convening monthly women's groups. Nine groups per cluster (270 in total work through two action research cycles in which they (i identify local issues around maternity, newborn health and nutrition, (ii prioritise key problems, (iii develop strategies to address them, (iv implement the strategies, and (v evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i identify local births, (ii identify low birth weight infants, (iii identify possible newborn infection, (iv manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal

  18. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs) are supported in convening monthly women's groups. Nine groups per cluster (270 in total) work through two action research cycles in which they (i) identify local issues around maternity, newborn health and nutrition, (ii) prioritise key problems, (iii) develop strategies to address them, (iv) implement the strategies, and (v) evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i) identify local births, (ii) identify low birth weight infants, (iii) identify possible newborn infection, (iv) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v) follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal diet

  19. Effectiveness and usage of a decision support system to improve stroke prevention in general practice: A cluster randomized controlled trial.

    Science.gov (United States)

    Arts, Derk L; Abu-Hanna, Ameen; Medlock, Stephanie K; van Weert, Henk C P M

    2017-01-01

    Adherence to guidelines pertaining to stroke prevention in patients with atrial fibrillation is poor. Decision support systems have shown promise in increasing guideline adherence. To improve guideline adherence with a non-obtrusive clinical decision support system integrated in the workflow. Secondly, we seek to capture reasons for guideline non-adherence. A cluster randomized controlled trial in Dutch general practices. A decision support system was developed that implemented properties positively associated with effectiveness: real-time, non-interruptive and based on data from electronic health records. Recommendations were based on the Dutch general practitioners guideline for atrial fibrillation that uses the CHA2DS2-VAsc for stroke risk stratification. Usage data and responses to the recommendations were logged. Effectiveness was measured as adherence to the guideline. We used a chi square to test for group differences and a mixed effects model to correct for clustering and baseline adherence. Our analyses included 781 patients. Usage of the system was low (5%) and declined over time. In total, 76 notifications received a response: 58% dismissal and 42% acceptance. At the end of the study, both groups had improved, by 8% and 5% respectively. There was no statistically significant difference between groups (Control: 50%, Intervention: 55% P = 0.23). Clustered analysis revealed similar results. Only one usable reasons for non-adherence was captured. Our study could not demonstrate the effectiveness of a decision support system in general practice, which was likely due to lack of use. Our findings should be used to develop next generation decision support systems that are effective in the challenging setting of general practice.

  20. Randomized, controlled trial of the effectiveness of short-term dynamic psychotherapy and cognitive therapy for cluster C personality disorders.

    Science.gov (United States)

    Svartberg, Martin; Stiles, Tore C; Seltzer, Michael H

    2004-05-01

    This study compared the effectiveness of short-term dynamic psychotherapy and cognitive therapy for outpatients with cluster C personality disorders. Patients (N=50) who met the criteria for one or more cluster C personality disorders and not for any other personality disorders were randomly assigned to receive 40 weekly sessions of short-term dynamic psychotherapy or cognitive therapy. The most common axis I disorders in the patient group were anxiety and depression diagnoses. Therapists were experienced, full-time clinicians and were receiving manual-guided supervision. Outcome variables included symptom distress, interpersonal problems, and core personality pathology. Measures were administered repeatedly during and after treatment, and change was assessed longitudinally by means of growth modeling procedures. The overall patient group showed, on average, statistically significant improvements on all measures during treatment and also during a 2-year follow-up period. Significant changes in symptom distress after treatment were found for the group of patients who received short-term dynamic psychotherapy but not for the cognitive therapy patients. Despite these differences in intragroup changes, no statistically significant differences between the short-term dynamic psychotherapy group and cognitive therapy group were found on any measure for any time period. Two years after treatment, 54% of the short-term dynamic psychotherapy patients and 42% of the cognitive therapy patients had recovered symptomatically, whereas approximately 40% of the patients in both groups had recovered in terms of interpersonal problems and personality functioning. Both short-term dynamic psychotherapy and cognitive therapy have a place in the treatment of patients with cluster C personality disorders. However, factors other than treatment modality may discriminate better between successful and poor outcomes. Such factors should be explored in future studies.

  1. SSRI versus bupropion effects on symptom clusters in suicidal depression: post-hoc analysis of a randomized clinical trial

    Science.gov (United States)

    Grunebaum, Michael F.; Keilp, John G.; Ellis, Steven P.; Sudol, Katherin; Bauer, Neal; Burke, Ainsley K.; Oquendo, Maria A.; Mann, J. John

    2015-01-01

    Objective Identifying the depression symptoms most closely associated with suicidal thoughts and which medications provide the fastest relief may help suicide prevention. Method Post hoc analysis of data from a randomized, double-blind, eight-week clinical trial of the serotonin reuptake inhibitor paroxetine (N=36) versus the norepinephrine-dopamine reuptake inhibitor bupropion (N=38) in patients with DSM-IV major depressive disorder and past suicide attempt or current suicidal thoughts. Treatment effects on Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory symptom clusters were compared. We hypothesized a superior effect of paroxetine on non-suicide, affective/cognitive depression symptom clusters that our prior work found to be associated with suicidal thoughts and attempts. Data were collected from February 2005 to January 2010. Results There was a treatment main effect on HDRS Psychic Depression (depressed mood, guilt, retardation, helpless, hopeless, worthless) (estimate = −2.2, 95% CI = −3.2 to −1.1, t = −4.01, df = 67.16, p Psychic Depression scores after one week of paroxetine, compared to bupropion, and was statistically significant until Week 4. Results for other depression scale factors were non-significant (p > 0.05). Conclusion The results require replication, but suggest a pathway by which SSRI treatment may exert a stronger effect compared with NDRI treatment on reduction of suicidal thoughts during initial weeks of pharmacotherapy in these higher risk patients. PMID:24107760

  2. Impact of a multicomponent hand hygiene-related intervention on the infectious risk in nursing homes: A cluster randomized trial.

    Science.gov (United States)

    Temime, Laura; Cohen, Nadia; Ait-Bouziad, Karim; Denormandie, Philippe; Dab, William; Hocine, Mounia N

    2017-10-05

    The aim of this study was to assess the impact of a multifaceted hand hygiene (HH) program on the infectious risk in nursing homes (NHs). This was a 2-arm cluster randomized trial; French NHs were allocated randomly to the intervention (13 NHs) or control (13 NHs) groups. The intervention consisted of implementing a bundle of HH-related measures over 1 year, including increased availability of alcohol-based handrub, HH promotion, staff education, and local work groups. The primary end point was the incidence rate of acute respiratory infections and gastroenteritis reported in the context of clustered cases episodes. Secondary end points were mortality, hospitalization, and antibiotic prescription rates. Baseline characteristics did not differ between groups. The overall handrub consumption was higher in the intervention group over the 1-year intervention period. Because of underreporting, data on the primary end points were of insufficient quality for analysis. Hospitalizations did not differ between the 2 groups. However, the intervention group showed significantly lower mortality (2.10 vs 2.65 per 100 residents per month, respectively; P = .003) and antibiotic prescriptions (5.0 vs 5.8 defined daily doses per 100 resident days, respectively; P < .001). These results were confirmed by the longitudinal multivariate analysis adjusted for NH and resident characteristics and for seasonality (mortality rate ratio, 0.76). A multifaceted HH intervention may have a short-term impact on mortality in NHs. Nevertheless, other strategies may remain necessary to reduce morbidity. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  3. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).

    Science.gov (United States)

    Denti, Licia; Caminiti, Caterina; Scoditti, Umberto; Zini, Andrea; Malferrari, Giovanni; Zedde, Maria Luisa; Guidetti, Donata; Baratti, Mario; Vaghi, Luca; Montanari, Enrico; Marcomini, Barbara; Riva, Silvia; Iezzi, Elisa; Castellini, Paola; Olivato, Silvia; Barbi, Filippo; Perticaroli, Eva; Monaco, Daniela; Iafelice, Ilaria; Bigliardi, Guido; Vandelli, Laura; Guareschi, Angelica; Artoni, Andrea; Zanferrari, Carla; Schulz, Peter J

    2017-12-01

    Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends. We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; P=0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance (P=0.07). Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152. © 2017 American Heart Association, Inc.

  4. Data Randomization and Cluster-Based Partitioning for Botnet Intrusion Detection.

    Science.gov (United States)

    Al-Jarrah, Omar Y; Alhussein, Omar; Yoo, Paul D; Muhaidat, Sami; Taha, Kamal; Kim, Kwangjo

    2016-08-01

    Botnets, which consist of remotely controlled compromised machines called bots, provide a distributed platform for several threats against cyber world entities and enterprises. Intrusion detection system (IDS) provides an efficient countermeasure against botnets. It continually monitors and analyzes network traffic for potential vulnerabilities and possible existence of active attacks. A payload-inspection-based IDS (PI-IDS) identifies active intrusion attempts by inspecting transmission control protocol and user datagram protocol packet's payload and comparing it with previously seen attacks signatures. However, the PI-IDS abilities to detect intrusions might be incapacitated by packet encryption. Traffic-based IDS (T-IDS) alleviates the shortcomings of PI-IDS, as it does not inspect packet payload; however, it analyzes packet header to identify intrusions. As the network's traffic grows rapidly, not only the detection-rate is critical, but also the efficiency and the scalability of IDS become more significant. In this paper, we propose a state-of-the-art T-IDS built on a novel randomized data partitioned learning model (RDPLM), relying on a compact network feature set and feature selection techniques, simplified subspacing and a multiple randomized meta-learning technique. The proposed model has achieved 99.984% accuracy and 21.38 s training time on a well-known benchmark botnet dataset. Experiment results demonstrate that the proposed methodology outperforms other well-known machine-learning models used in the same detection task, namely, sequential minimal optimization, deep neural network, C4.5, reduced error pruning tree, and randomTree.

  5. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Park, Jeong-Su; Park, Sunju; Cheon, Chun-Hoo; Jang, Bo-Hyoung; Lee, Song-Hee; Lee, Seung-Hyun; Chung, Sun-Yong; Kim, Jong-Woo; Jeon, Chan-Yong; Park, Jong-Hyeong; Shin, Yong-Cheol; Ko, Seong-Gyu

    2012-09-11

    Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as 'anger syndrome'. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients actively move their bodies and play the

  6. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients

  7. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Jeong-Su

    2012-09-01

    Full Text Available Abstract Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT group and a control music therapy (CMT group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2, all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each. Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI, and the secondary outcomes are the Hwa-byung scale (H-scale, the Center for Epidemiologic Studies Depression Scale (CES-D, the Hwa-byung visual analogue scale (H-VAS for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF, and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2, after the last treatment session (visit 9, and at 4 weeks after the end of all trial sessions (visit 10. From the baseline (visit 2 through the follow-up (visit 10, the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in

  8. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial.

    Science.gov (United States)

    Labhardt, Niklaus Daniel; Motlomelo, Masetsibi; Cerutti, Bernard; Pfeiffer, Karolin; Kamele, Mashaete; Hobbins, Michael A; Ehmer, Jochen

    2014-12-01

    The success of HIV programs relies on widely accessible HIV testing and counseling (HTC) services at health facilities as well as in the community. Home-based HTC (HB-HTC) is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC). The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster) that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect. Out of 3,197 participants from the 12 clusters, 2,563 (80.2%) were eligible (HB-HTC: 1,171; MC-HTC: 1,392). The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18-3.60; p = 0. 011). Among adolescents and adults ≥ 12 y, HTC uptake did not differ significantly between the two groups; however, in children HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; pHTC, 114 (4.9%) tested HIV-positive, 39 (3.6%) in the HB-HTC arm and 75 (6.2%) in the MC-HTC arm (aOR: 0.64; 95% CI: 0.48-0.86; p = 0.002). Ten (25.6%) and 19 (25

  9. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

    Science.gov (United States)

    Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

    2014-06-01

    The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80

  10. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Science.gov (United States)

    Howard, Andrew W; Macarthur, Colin; Rothman, Linda; Willan, Andrew; Macpherson, Alison K

    2009-12-01

    The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing. The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar), and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent) of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed Fibar and seven

  11. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  12. The Influence of Coping-oriented Hypnotic Suggestions on Chronic Pain in Patients with Spinal Cord Injury (SCI): A Randomized Controlled Study

    DEFF Research Database (Denmark)

    Knudsen, Lone; Kjøgx, Heidi; Kasch, Helge

    Background and aims: Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing have been shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the effect on pain post-hypnosis...... is unknown. The aim is to investigate the effect of coping-oriented hypnotic suggestions on chronic pain post-hypnosis. Methods: Seventy-five SCI-patients with chronic pain (>3, NRS 0-10) are randomized into one of three conditions; 1) coping-oriented hypnosis plus current treatment, 2) neutral hypnosis plus...... Strategies Questionnaire), pain catastrophizing (Pain Catastrophizing Scale), anxiety and depression (Hospital Anxiety and Depression Scale). Patients’ global impression of change and side effects of the hypnosis are also assessed for 14 days post-intervention. Results: Preliminary results will be presented...

  13. Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

    Science.gov (United States)

    McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

    2012-11-01

    This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

  14. Effects of the Resident Assessment Instrument in home care settings: results of a cluster randomized controlled trial.

    Science.gov (United States)

    Stolle, C; Wolter, A; Roth, G; Rothgang, H

    2012-06-01

    Deficits in quality, a lack of professional process management and, most importantly, neglect of outcome quality are criticized in long-term care. A cluster randomized, controlled trial was conducted to assess whether the Resident Assessment Instrument (RAI) can help to improve or stabilize functional abilities (ADL, IADL) and cognitive skills (MMST), improve quality of life (EQ-5D), and reduce institutionalization, thereby, increasing outcome quality. A total of 69 home care services throughout Germany were included and randomized. The treatment group (n = 36) received training in RAI and was supported by the research team during the study (13 months). Comparison of mean differences between the treatment and control groups (n = 33) showed no significant effect. Although the multilevel regression results show that clients in the treatment group fared better in terms of ADLs and IADLs (smaller decline) and were less likely to move to nursing homes and be hospitalized, none of these effects is significant. The lack of significance might result from the small number of clients included in the study. Moreover, RAI was not fully implemented and even partial implementation required more time than expected.

  15. Impact of a Text-Messaging Program on Adolescent Reproductive Health: A Cluster-Randomized Trial in Ghana.

    Science.gov (United States)

    Rokicki, Slawa; Cohen, Jessica; Salomon, Joshua A; Fink, Günther

    2017-02-01

    To evaluate whether text-messaging programs can improve reproductive health among adolescent girls in low- and middle-income countries. We conducted a cluster-randomized controlled trial among 756 female students aged 14 to 24 years in Accra, Ghana, in 2014. We randomized 38 schools to unidirectional intervention (n = 12), interactive intervention (n = 12), and control (n = 14). The unidirectional intervention sent participants text messages with reproductive health information. The interactive intervention engaged adolescents in text-messaging reproductive health quizzes. The primary study outcome was reproductive health knowledge at 3 and 15 months. Additional outcomes included self-reported pregnancy and sexual behavior. Analysis was by intent-to-treat. From baseline to 3 months, the unidirectional intervention increased knowledge by 11 percentage points (95% confidence interval [CI] = 7, 15) and the interactive intervention by 24 percentage points (95% CI = 19, 28), from a control baseline of 26%. Although we found no changes in reproductive health outcomes overall, both unidirectional (odds ratio [OR] = 0.14; 95% CI = 0.03, 0.71) and interactive interventions (OR = 0.15; 95% CI = 0.03, 0.86) lowered odds of self-reported pregnancy for sexually active participants. Text-messaging programs can lead to large improvements in reproductive health knowledge and have the potential to lower pregnancy risk for sexually active adolescent girls.

  16. Effectiveness of a school-based multi-component smoking prevention intervention: the LdP cluster randomized controlled trial.

    Science.gov (United States)

    Gorini, Giuseppe; Carreras, Giulia; Bosi, Sandra; Tamelli, Marco; Monti, Claudia; Storani, Simone; Martini, Andrea; Allara, Elias; Angelini, Paola; Faggiano, Fabrizio

    2014-04-01

    We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme. We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia, Italy. The intervention consisted of the "Smoking Prevention Tour" (SPT) out-of-school workshop, one in-depth lesson on one Smoking Prevention Tour topic, a life-skills peer-led intervention, and enforcement surveillance of school antismoking policy. Self-reported past 30-day smoking of ≥ 20 or 1-19 days of cigarette smoking (daily or frequent smoking, respectively) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme. Analysis was by intention to treat. The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses. Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31% and 46% lower, respectively, for intervention students compared to control students. Taking into account non-smokers at baseline only, daily smoking at eighteen months follow-up was 59% lower in intervention students than in controls. Past 30-day smoking in school areas was 62% lower in intervention students compared to controls. The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Preventing weight-related problems among adolescent girls: A cluster randomized trial comparing the Brazilian 'New Moves' program versus observation.

    Science.gov (United States)

    Dunker, Karin Louise Lenz; Claudino, Angélica Medeiros

    2017-08-07

    To conduct a cluster randomized controlled trial comparing the Brazilian version of the New Moves program (NMP) versus observation among Brazilian adolescent girls. Ten schools were randomly allocated to the Brazilian NMP or the observation arm. Study participants included 12-14-year-old girls. Recruitment occurred between February 2014 and March 2015. The NMP included sports, nutritional support, motivational interviews, collective lunch, and parental information materials. Our main outcome was the Body Shape Questionnaire (BSQ). Secondary outcomes included the Rosenberg Self-Esteem Scale and the Unhealthy Weight-Control Behaviors Index, as well as body mass index. Study results were evaluated through generalized estimating equations. A total of 270 adolescents participated in the study. At baseline, mean age was 13.4 years, and average BMI was 21.4. The intervention did not result in any statistically significant differences between the NMP and the observation arm, including BSQ (predicted means of 64.33 - IC 95% 59.2-69.47 vs. 62.02 - IC 95% 56.63-67.4), respectively) and our secondary outcomes. Adherence was low during the intervention (32.9%) and maintenance (19.1%) phases of the program. The New Moves program did not lead to significant changes in our measured outcomes. Future studies should investigate whether changes might occur when comprehensive behavioral programs are sustained over longer periods while also being customized to local population characteristics. Copyright © 2017 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  18. Impact of parent-directed education on parental use of pain treatments during routine infant vaccinations: a cluster randomized trial.

    Science.gov (United States)

    Taddio, Anna; Parikh, Chaitya; Yoon, Eugene W; Sgro, Michael; Singh, Harvinder; Habtom, Erita; Ilersich, Andrew F; Pillai Riddell, Rebecca; Shah, Vibhuti

    2015-01-01

    Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P vaccinations.

  19. Cluster randomized controlled trial of a consumer behavior intervention to improve healthy food purchases from online canteens.

    Science.gov (United States)

    Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Lecathelinais, Christophe; Wolfenden, Luke

    2017-11-01

    Background: School canteens represent an opportune setting in which to deliver public health nutrition strategies because of their wide reach and frequent use by children. Online school-canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer-behavior strategies that have an impact on purchasing decisions. Objective: We assessed the efficacy of a consumer-behavior intervention implemented in an online school-canteen ordering system in reducing the energy, saturated fat, sugar, and sodium contents of primary student lunch orders. Design: A cluster-randomized controlled trial was conducted that involved 2714 students (aged 5-12 y) from 10 primary schools in New South Wales, Australia, who were currently using an online canteen ordering system. Schools were randomized in a 1:1 ratio to receive either the intervention (enhanced system) or the control (standard online ordering only). The intervention included consumer-behavior strategies that were integrated into the online ordering system (targeting menu labeling, healthy food availability, placement, and prompting). Results: Mean energy (difference: -567.25 kJ; 95% CI: -697.95, -436.55 kJ; P canteen infrastructure to improve purchasing behavior from primary school canteens. Such an intervention may represent an appealing policy option as part of a broader government strategy to improve child public health nutrition. This trial was registered at www.anzctr.org.au as ACTRN12616000499482. © 2017 American Society for Nutrition.

  20. Effect on mental health of a participatory intervention to improve psychosocial work environment: a cluster randomized controlled trial among nurses.

    Science.gov (United States)

    Uchiyama, Ayako; Odagiri, Yuko; Ohya, Yumiko; Takamiya, Tomoko; Inoue, Shigeru; Shimomitsu, Teruichi

    2013-01-01

    Improvement of psychosocial work environment has proved to be valuable for workers' mental health. However, limited evidence is available for the effectiveness of participatory interventions. The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment. A cluster randomized controlled trial was conducted in hospital settings. A total of 434 nurses in 24 units were randomly allocated to 11 intervention units (n=183) and 13 control units (n=218). A participatory program was provided to the intervention units for 6 months. Depressive symptoms as mental health status and psychosocial work environment, assessed by the Job Content Questionnaire, the Effort-Reward Imbalance Questionnaire, and the Quality Work Competence questionnaire, were measured before and immediately after the 6-month intervention by a self-administered questionnaire. No significant intervention effect was observed for mental health status. However, significant intervention effects were observed in psychosocial work environment aspects, such as Coworker Support (pwork environment, but not mental health, among Japanese nurses.

  1. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: a cluster randomized trial.

    Science.gov (United States)

    Verdurmen, Jacqueline E E; Koning, Ina M; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

    2014-03-01

    To examine risk moderation of an alcohol intervention targeting parents and adolescents. A cluster randomized trial including 2937 Dutch early adolescents (m=12.68years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combined parent-student intervention, and control group. 152 classes of 19 high schools in The Netherlands (2006). Moderators at baseline (adolescent: gender, educational level and externalizing behavior; parent: educational level and heavy alcohol use) were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 22-month follow-up. The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents, and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents (i.e. those attending lower levels of education and reporting higher levels of externalizing behavior). Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents, with an added effect on postponing heavy weekly drinking in high risk subgroups. Therefore, implementation of this intervention in the general population of schools in The Netherlands is advised. NTR649. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. The Effects of a Community-Based Sodium Reduction Program in Rural China – A Cluster-Randomized Trial

    Science.gov (United States)

    Yan, Lijing L.; Niu, Wenyi; Yao, Chen; Feng, Xiangxian; Zhang, Jianxin; Shi, Jingpu; Zhang, Yuhong; Zhang, Ruijuan; Hao, Zhixin; Chu, Hongling; Zhang, Jing; Li, Xian; Pan, Jianhong; Li, Zhifang; Sun, Jixin; Zhou, Bo; Zhao, Yi; Yu, Yan; Engelgau, Michael; Labarthe, Darwin; Ma, Jixiang; MacMahon, Stephen; Elliott, Paul; Wu, Yangfeng; Neal, Bruce

    2016-01-01

    Background Average sodium intake and stroke mortality in northern China are both among the highest in the world. An effective, low-cost strategy to reduce sodium intake in this population is urgently needed. Objective We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China. Design This study was a cluster-randomized trial done over 18 months in 120 townships (one village from each township) from five provinces. Sixty control villages were compared to 60 intervention villages that were given access to a reduced-sodium, added-potassium salt substitute in conjunction with a community-based health education program focusing on sodium reduction. The primary outcome was the difference in 24-hour urinary sodium excretion between randomized groups. Results Among 1,903 people with valid 24-hour urine collections, mean urinary sodium excretion in intervention compared with control villages was reduced by 5.5% (-14mmol/day, 95% confidence interval -26 to -1; p = 0.03), potassium excretion was increased by 16% (+7mmol/day, +4 to +10; psalt substitute. The absence of effects on blood pressure reflects the moderate changes in sodium and potassium intake achieved. Trial Registration Clinicaltrials.gov identifier: NCT01259700. PMID:27935977

  3. Effects of an Interactive School-Based Program for Preventing Adolescent Sexual Harassment: A Cluster-Randomized Controlled Evaluation Study.

    Science.gov (United States)

    de Lijster, Gaby P A; Felten, Hanneke; Kok, Gerjo; Kocken, Paul L

    2016-05-01

    Many adolescents experience sexual harassment and victims of sexual harassment have higher risks regarding well-being and health behaviors such as higher risks of suicidal thoughts, suicidal ideation and feeling unsafe at school. A peer-performed play and school lessons on preventing sexual harassment behavior were presented to secondary school students. We evaluated its effectiveness, using a cluster-randomized controlled design to assign schools to an experimental condition [n = 14 schools; 431 students (51 % female)] and a control condition [n = 11 schools; 384 students (51 % female)]. To measure the effects of the intervention at first post-test and 6-month follow-up, our multilevel analyses used a two-level random intercept model. Outcome measures were sexual harassment behaviors, behavioral determinants and distal factors influencing these behaviors. At post-test, students in the experimental group reported a reduced intention to commit sexual harassment behavior and higher self-efficacy in rejecting it. At post-test and follow-up there was a significant positive effect on social norms for rejecting sexual harassment behavior. At follow-up, sexual self-esteem was higher in students in the experimental group than in the control group. Effects on these determinants will benefit adolescents' future sexual behaviors. In combination, the play and lessons, possibly together with continued sexual health education and skills programs on social-emotional learning in subsequent school years, have potential for preventing sexual harassment behavior.

  4. A national evaluation of school breakfast clubs: evidence from a cluster randomized controlled trial and an observational analysis.

    Science.gov (United States)

    Shemilt, I; Harvey, I; Shepstone, L; Swift, L; Reading, R; Mugford, M; Belderson, P; Norris, N; Thoburn, J; Robinson, J

    2004-09-01

    To measure the health, educational and social impacts of breakfast club provision in schools serving deprived areas across England. A cluster randomized controlled trial and an observational analysis. England, the UK. funding to establish a school-based breakfast club vs. control (no funding). Intention to treat analysis showed improved concentration (Trail Making Test Part A) amongst the intervention group at 3 months. Fewer pupils within the intervention group reported having skipped classes within the last month and fewer pupils within the intervention group reported having skipped 1 or more days of school within the last month at 1 year. Observational analysis at 1 year showed a higher proportion of primary-aged breakfast club attendees reported eating fruit for breakfast in comparison to non-attendees. A higher proportion of breakfast club attendees had borderline or abnormal conduct and total difficulties scores (primary-aged pupils) and prosocial score (secondary-aged pupils). Analyses revealed a mixed picture of benefit and apparent disbenefit. This study illustrated the challenges of evaluating a complex intervention in which the evaluators had less control than is usual in randomized trials over recruitment, eligibility checking and implementation. If the impact of new policy initiatives is to be assessed using the most robust forms of evaluation, social policy needs to be organized so that evaluations can be constructed as experiments. This is likely to prove most difficult where the perceived value of implementing an intervention rapidly is high.

  5. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study.

    Science.gov (United States)

    Schoenen, Jean; Jensen, Rigmor Højland; Lantéri-Minet, Michel; Láinez, Miguel J A; Gaul, Charly; Goodman, Amy M; Caparso, Anthony; May, Arne

    2013-07-01

    The pain and autonomic symptoms of cluster headache (CH) result from activation of the trigeminal parasympathetic reflex, mediated through the sphenopalatine ganglion (SPG). We investigated the safety and efficacy of on-demand SPG stimulation for chronic CH (CCH). A multicenter, multiple CH attack study of an implantable on-demand SPG neurostimulator was conducted in patients suffering from refractory CCH. Each CH attack was randomly treated with full, sub-perception, or sham stimulation. Pain relief at 15 minutes following SPG stimulation and device- or procedure-related serious adverse events (SAEs) were evaluated. Thirty-two patients were enrolled and 28 completed the randomized experimental period. Pain relief was achieved in 67.1% of full stimulation-treated attacks compared to 7.4% of sham-treated and 7.3% of sub-perception-treated attacks ( P  < 0.0001). Nineteen of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. Five SAEs occurred and most patients (81%) experienced transient, mild/moderate loss of sensation within distinct maxillary nerve regions; 65% of events resolved within three months. On-demand SPG stimulation using the ATI Neurostimulation System is an effective novel therapy for CCH sufferers, with dual beneficial effects, acute pain relief and observed attack prevention, and has an acceptable safety profile compared to similar surgical procedures.

  6. Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial.

    Science.gov (United States)

    Young, Sean D; Cumberland, William G; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

    2013-09-03

    Social networking technologies are an emerging tool for HIV prevention. To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Randomized, controlled trial with concealed allocation. (ClinicalTrials.gov: NCT01701206). Online. 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement were monitored. Participants could request a free, home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more than 93%. Only 2 Facebook communities were included for each group. Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. National Institute of Mental Health.

  7. Promoting physical activity in high-poverty neighborhood parks: A cluster randomized controlled trial.

    Science.gov (United States)

    Cohen, Deborah A; Han, Bing; Derose, Kathryn P; Williamson, Stephanie; Marsh, Terry; Raaen, Laura; McKenzie, Thomas L

    2017-08-01

    Although physical activity can help mitigate or prevent multiple chronic diseases, most people in the U.S., especially high-poverty minority groups, engage in insufficient levels of physical activity. To test ways to promote more physical activity in high-poverty area public parks we conducted a randomized controlled intervention trial. After completing baseline measures of park-based physical activity using systematic direct observation three times/day each month for six months and assessing preferences for park programming among 1445 residents living within 1 mile of study parks, we randomized 48 parks in high poverty neighborhoods in the City of Los Angeles, California during 2013-2014 to four study arms: 1) free physical activity classes over a 6-month period, 2) a frequent user program where participants could win prizes based upon the number of visits they made to the park, 3) both the programs, and 4) neither one (control condition). We re-measured park use in 2014-2015 using the same methods during the six months the intervention programs were in operation. A total of 2047 free park classes were offered attracting 16,718 participants. The frequent user programs enrolled 1452 individuals and prizes were awarded to 830. Residents in the two study arms with free classes were more likely to report being aware of and participating in park-based physical activity programs; however, overall observed park-based physical activity increased similarly across all study arms. The process evaluation uncovered several barriers to program implementation, including inconsistent scheduling of classes, partly due to safety concerns among instructors. Multiple social factors interfere with leisure time physical activity among low-income populations, suggesting modest interventions may be insufficient to overcome these issues. Although new park programs can attract users, new programs alone may be insufficient to increase overall park use in low-income neighborhoods at times

  8. Promoting Afterschool Quality and Positive Youth Development: Cluster Randomized Trial of the Pax Good Behavior Game.

    Science.gov (United States)

    Smith, Emilie Phillips; Osgood, D Wayne; Oh, Yoonkyung; Caldwell, Linda C

    2018-02-01

    This randomized trial tested a strategy originally developed for school settings, the Pax Good Behavior Game (PAX GBG), in the new context of afterschool programs. We examined this approach in afterschool since 70% of all juvenile crime occurs between the hours of 3-6 pm, making afterschool an important setting for prevention and promotion. Dual-career and working families need monitoring and supervision for their children in quality settings that are safe and appropriately structured. While substantial work has identified important features of afterschool programs, increasing attention is being given to how to foster quality. PAX GBG, with its focus on shared norms, cooperative teams, contingent activity rewards, and liberal praise, could potentially enhance not only appropriate structure and supportive relationships, but also youth self-regulation, co-regulation, and socio-emotional development. This study examined the PAX GBG among 76 afterschool programs, serving 811 youth ages 5-12, who were diverse in race-ethnicity, socio-economic status, and geographic locale. Demographically matched pairs of afterschool programs were randomized to PAX GBG or treatment-as-usual. Independent observers conducted ratings of implementation fidelity and program quality across time; along with surveys of children's problem and prosocial behavior. Interaction effects were found using hierarchical linear models such that experimental programs evidencing higher implementation fidelity demonstrated better program quality than controls, (i.e., less harshness, increased appropriate structure, support, and engagement), as well as reduced child-reported hyperactivity and intent-to-treat effects on prosocial behavior. This study demonstrates that best practices fostered by PAX GBG and implemented with fidelity in afterschool result in higher quality contexts for positive youth development.

  9. Core stability exercise is as effective as task-oriented motor training in improving motor proficiency in children with developmental coordination disorder: a randomized controlled pilot study.

    Science.gov (United States)

    Au, Mei K; Chan, Wai M; Lee, Lin; Chen, Tracy Mk; Chau, Rosanna Mw; Pang, Marco Yc

    2014-10-01

    To compare the effectiveness of a core stability program with a task-oriented motor training program in improving motor proficiency in children with developmental coordination disorder (DCD). Randomized controlled pilot trial. Outpatient unit in a hospital. Twenty-two children diagnosed with DCD aged 6-9 years were randomly allocated to the core stability program or the task-oriented motor program. Both groups underwent their respective face-to-face training session once per week for eight consecutive weeks. They were also instructed to carry out home exercises on a daily basis during the intervention period. Short Form of the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) and Sensory Organization Test at pre- and post-intervention. Intention-to-treat analysis revealed no significant between-group difference in the change of motor proficiency standard score (P=0.717), and composite equilibrium score derived from the Sensory Organization Test (P=0.100). Further analysis showed significant improvement in motor proficiency in both the core stability (mean change (SD)=6.3(5.4); p=0.008) and task-oriented training groups (mean change(SD)=5.1(4.0); P=0.007). The composite equilibrium score was significantly increased in the task-oriented training group (mean change (SD)=6.0(5.5); P=0.009), but not in the core stability group (mean change(SD) =0.0(9.6); P=0.812). In the task-oriented training group, compliance with the home program was positively correlated with change in motor proficiency (ρ=0.680, P=0.030) and composite equilibrium score (ρ=0.638, P=0.047). The core stability exercise program is as effective as task-oriented training in improving motor proficiency among children with DCD. © The Author(s) 2014.

  10. Health promotion intervention in mental health care: design and baseline findings of a cluster preference randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Verhaeghe Nick

    2012-06-01

    Full Text Available Abstract Background Growing attention is given to the effects of health promotion programs targeting physical activity and healthy eating in individuals with mental disorders. The design of evaluation studies of public health interventions poses several problems and the current literature appears to provide only limited evidence on the effectiveness of such programs. The aim of the study is to examine the effectiveness and cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders living in sheltered housing. In this paper, the design of the study and baseline findings are described. Methods/design The design consists of a cluster preference randomized controlled trial. All sheltered housing organisations in the Flanders region (Belgium were asked if they were interested to participate in the study and if they were having a preference to serve as intervention or control group. Those without a preference were randomly assigned to the intervention or control group. Individuals in the intervention group receive a 10-week health promotion intervention above their treatment as usual. Outcome assessments occur at baseline, at 10 and at 36 weeks. The primary outcomes include body weight, Body Mass Index, waist circumference, and fat mass. Secondary outcomes consist of physical activity levels, eating habits, health-related quality of life and psychiatric symptom severity. Cost-effectiveness of the intervention will be examined by calculating the Cost-Effectiveness ratio and through economic modeling.Twenty-five sheltered housing organisations agreed to participate. On the individual level 324 patients were willing to participate, including 225 individuals in the intervention group and 99 individuals in the control group. At baseline, no statistical significant differences between the two groups were found for the primary outcome variables. Discussion This is the first trial

  11. Preventing Peer Violence Against Children: Methods and Baseline Data of a Cluster Randomized Controlled Trial in Pakistan.

    Science.gov (United States)

    McFarlane, Judith; Karmaliani, Rozina; Maqbool Ahmed Khuwaja, Hussain; Gulzar, Saleema; Somani, Rozina; Saeed Ali, Tazeen; Somani, Yasmeen H; Shehzad Bhamani, Shireen; Krone, Ryan D; Paulson, Rene M; Muhammad, Atta; Jewkes, Rachel

    2017-03-24

    Violence against and among children is a global public health problem that annually affects 50% of youth worldwide with major impacts on child development, education, and health including increased probability of major causes of morbidity and mortality in adulthood. It is also associated with the experience of and perpetration of later violence against women. The aim of this article is to describe the intervention, study design, methods, and baseline findings of a cluster randomized controlled trial underway in Pakistan to evaluate a school-based play intervention aiming to reduce peer violence and enhance mental health. A cluster randomized controlled design is being conducted with boys and girls in grade 6 in 40 schools in Hyderabad, Pakistan, over a period of 2 years. The Multidimensional Peer-Victimization and Peer Perpetration Scales and the Children's Depression Inventory 2 (CDI 2) are being used to measure the primary outcomes while investigator-derived scales are being used to assess domestic violence within the family. Specifics of the intervention, field logistics, ethical, and fidelity management issues employed to test the program's impact on school age youth in a volatile and politically unstable country form this report. A total of 1,752 school-age youth were enrolled and interviewed at baseline. Over the preceding 4 weeks, 94% of the boys and 85% of the girls reported 1 or more occurrences of victimization, and 85% of the boys and 66% of the girls reported 1 or more acts of perpetration. Boys reported more depression compared with girls, as well as higher negative mood and self-esteem scores and more interpersonal and emotional problems. Globally, prevalence of youth violence perpetration and victimization is high and associated with poor physical and emotional health. Applying a randomized controlled design to evaluate a peer violence prevention program built on a firm infrastructure and that is ready for scale-up and sustainability will make an

  12. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    Directory of Open Access Journals (Sweden)

    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  13. Omitted data in randomized controlled trials for anxiety and depression: A systematic review of the inclusion of sexual orientation and gender identity.

    Science.gov (United States)

    Heck, Nicholas C; Mirabito, Lucas A; LeMaire, Kelly; Livingston, Nicholas A; Flentje, Annesa

    2017-01-01

    The current study examined the frequency with which randomized controlled trials (RCTs) of behavioral and psychological interventions for anxiety and depression include data pertaining to participant sexual orientation and nonbinary gender identities. Using systematic review methodology, the databases PubMed and PsycINFO were searched to identify RCTs published in 2004, 2009, and 2014. Random selections of 400 articles per database per year (2,400 articles in total) were considered for inclusion in the review. Articles meeting inclusion criteria were read and coded by the research team to identify whether the trial reported data pertaining to participant sexual orientation and nonbinary gender identities. Additional trial characteristics were also identified and indexed in our database (e.g., sample size, funding source). Of the 232 articles meeting inclusion criteria, only 1 reported participants' sexual orientation, and zero articles included nonbinary gender identities. A total of 52,769 participants were represented in the trials, 93 of which were conducted in the United States, and 43 acknowledged the National Institutes of Health as a source of funding. Despite known mental health disparities on the basis of sexual orientation and nonbinary gender identification, researchers evaluating interventions for anxiety and depression are not reporting on these important demographic characteristics. Reporting practices must change to ensure that our interventions generalize to lesbian, gay, bisexual, and transgender persons. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  14. Effects of task-oriented robot training on arm function, activity, and quality of life in chronic stroke patients: a randomized controlled trial.

    Science.gov (United States)

    Timmermans, Annick A A; Lemmens, Ryanne J M; Monfrance, Maurice; Geers, Richard P J; Bakx, Wilbert; Smeets, Rob J E M; Seelen, Henk A M

    2014-03-31

    Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Task-oriented training may improve arm hand performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients. In a single-blind randomized controlled trial, 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training (experimental group) or task-oriented non-robotic arm-hand training (control group). For training, the T-TOAT (Technology-supported Task-Oriented Arm Training) method was applied. Training was provided during 8 weeks, 4 times/week, 2 × 30 min/day. A significant improvement after training on the Action Research Arm Test (ARAT) was demonstrated in the experimental group (p = 0.008). Results were maintained until 6 months after cessation of the training. On the perceived performance measure (Motor Activity Log (MAL)), both, the experimental and control group improved significantly after training (control group p = 0.008; experimental group p = 0.013). The improvements on MAL in both groups were maintained until 6 months after cessation of the training. With regard to quality of life, only in the control group a significant improvement after training was found (EuroQol-5D p = 0.015, SF-36 physical p = 0.01). However, the improvement on SF-36 in the control group was not maintained (p = 0.012). No between-group differences could be demonstrated on any of the outcome measures. Arm hand performance improved in chronic stroke

  15. Effectiveness of a school-based physical activity-related injury prevention program on risk behavior and neuromotor fitness a cluster randomized controlled trial

    OpenAIRE

    Bakker Ingrid; Verhagen Evert ALM; Jm, Chinapaw Mai; Collard Dorine CM; van Mechelen Willem

    2010-01-01

    Abstract Background To investigate the effects of a school-based physical activity-related injury prevention program, called 'iPlay', on risk behavior and neuromotor fitness. Methods In this cluster randomized controlled trial 40 primary schools throughout the Netherlands were randomly assigned in an intervention (n = 20) or control group (n = 20). The study includes 2,210 children aged 10-12 years. The iPlay-intervention takes one school year and consists of a teacher manual, informative new...

  16. A Longitudinal Cluster-Randomized Controlled Study on the Accumulating Effects of Individualized Literacy Instruction on Students’ Reading from First Through Third Grade

    OpenAIRE

    Connor, Carol McDonald; Morrison, Frederick J.; Fishman, Barry; Crowe, Elizabeth C; Otaiba, Stephanie Al; Schatschneider, Christopher

    2013-01-01

    Using a longitudinal cluster-randomized controlled design, we examined whether students’ reading outcomes differed when they received 1, 2, or 3 years of individualized reading instruction from first through third grade, compared with a treated control group. More than 45% of students came from families living in poverty. Following students, we randomly assigned their teachers each year to deliver individualized reading instruction or a treated control condition intervention focused on mathem...

  17. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

    Science.gov (United States)

    Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

    2017-01-01

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

  18. Improving management of resistant hypertension: Rationale and protocol for a cluster randomized trial addressing physician managers in primary care.

    Science.gov (United States)

    Weltermann, Birgitta; Viehmann, Anja; Kersting, Christine

    2016-03-01

    Resistant hypertension (RH) is defined as uncontrolled blood pressure (BP) despite ≥3 antihypertensive agents. It is estimated to account for 12-28% of all hypertensive patients. Despite a higher risk of cardiovascular events, hypertension therapy in these patients is often insufficient. In a previous study we successfully tested an evidence-based, physician manager-centered hypertension management. For this cluster randomized trial (CRT), a random sample of 102 German primary care practices will be randomized into two study arms (1:1). Physician managers and practice assistants of the intervention arm will participate in three-session medical education on hypertension management to implement 1) standardized diagnostic and therapeutic procedures for RH patients, 2) structured recall of patients with uncontrolled BP, and 3) teaching and supervision of RH patients on BP self-measurements. Practice tools are provided to facilitate implementation, e.g., how to distinguish true from pseudo RH and guideline-based medication selection. Physicians will specify guideline-algorithms for their practice to manage RH. A secured web-based peer-group exchange with hypertension specialists is offered to both professional groups. Physicians of both study arms will consecutively recruit patients with RH. BP will be measured by ambulatory BP monitoring at baseline and after 12 months. The primary endpoint is defined as treatment success with either normalized BP (24h<130/80 mmHg) and/or a reduction by ≥20 mmHg systolic and/or ≥10 mmHg diastolic. Secondary analyses will focus on changes in physicians' knowledge and practice routines. This CRT will determine the effectiveness of a physician manager-centered intervention on treatment success in high-risk patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. The Fit Study: Design and rationale for a cluster randomized trial of school-based BMI screening and reporting.

    Science.gov (United States)

    Madsen, Kristine A; Linchey, Jennifer; Ritchie, Lorrene; Thompson, Hannah R

    2017-07-01

    In the U.S., 25 states conduct body mass index (BMI) screening in schools, just under half of which report results to parents. While some experts recommend the practice, evidence demonstrating its efficacy to reduce obesity is lacking, and concerns about weight-related stigma have been raised. The Fit Study is a 3-arm cluster-randomized trial assessing the effectiveness of school-based BMI screening and reporting in reducing pediatric obesity and identifying unintended consequences. Seventy-nine elementary and middle schools across California were randomized to 1 of 3 Arms: 1) BMI screening and reporting; 2) BMI screening only; or 3) no BMI screening or reporting. In Arm 1 schools, students were further randomized to receive reports with BMI results alone or both BMI and fitness test results. Over 3 consecutive years, staff in schools in Arms 1 and 2 will measure students' BMI (grades 3-8) and additional aspects of fitness (grades 5-8), and students in grades 4-8 in all Arms will complete surveys to assess weight-based stigmatization. Change in BMI z-score will be compared between Arm 1 and Arm 2 to determine the impact of BMI reporting on weight status, with sub-analyses stratified by report type (BMI results alone versus BMI plus fitness results) and by race/ethnicity. The potential for BMI reports to lead to weight-based stigma will be assessed by comparing student survey results among the 3 study Arms. This study will provide evidence on both the benefit and potential unintended harms of school-based BMI screening and reporting. Copyright © 2017. Published by Elsevier Inc.

  20. Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

    Science.gov (United States)

    Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

    2017-07-11

    The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical

  1. Effect of cooking classes for housewives on salt reduction in family members: a cluster randomized controlled trial.

    Science.gov (United States)

    Takada, T; Imamoto, M; Fukuma, S; Yamamoto, Y; Sasaki, S; Uchida, M; Miura, Y; Shimizu, S; Nihata, K; Fukuhara, S

    2016-11-01

    Sodium reduction is very important in preventing cardiovascular diseases, especially in regions with high salt intake such as Japan. One strategy for salt reduction is to raise consumer awareness of the need to reduce daily salt intake. We investigated whether cooking classes given to housewives focussing on salt reduction would influence not only their own consumption behaviour but also that of their family members. Single-blinded, cluster randomized trial. We randomly assigned housewives to participate in cooking classes focussing on salt reduction (intervention group) or lectures about a healthy lifestyle (control group). The main outcome measure was the difference in estimated daily salt intake by spot urine sampling of housewives and their family members 2 months after intervention between the groups. A total of 35 housewives and 33 family members were randomized. The mean daily salt intake was 10.00 (standard deviation [SD] 1.75) g/day in the control group (17 housewives and 15 family members) and 9.57 (SD 2.45) g/day in the intervention group (18 housewives and 18 family members) at baseline. Two months after the intervention, the mean salt intake was 10.30 (SD 1.78) g/day in the control group and 8.95 (SD 2.45) g/day in the intervention group. The mean difference was -1.19 g/day (95% confidence interval -2.29, -0.09; P = 0.034). A similar tendency was observed in the subgroups of housewives and family members. Our trial suggested that the effects of cooking classes focussing on salt reduction for housewives could be transferred to family members (UMIN-CTR: 000018870). Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  2. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

    2013-05-22

    The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process

  3. A cluster randomized controlled trial of the Promoting Alternative Thinking Strategies (PATHS) curriculum.

    Science.gov (United States)

    Humphrey, Neil; Barlow, Alexandra; Wigelsworth, Michael; Lendrum, Ann; Pert, Kirsty; Joyce, Craig; Stephens, Emma; Wo, Lawrence; Squires, Garry; Woods, Kevin; Calam, Rachel; Turner, Alex

    2016-10-01

    This randomized controlled trial (RCT) evaluated the efficacy of the Promoting Alternative Thinking Strategies curriculum (PATHS; Kusche & Greenberg, 1994) as a means to improve children's social-emotional competence (assessed via the Social Skills Improvement System (SSIS); Gresham & Elliot, 2008) and mental health outcomes (assessed via the Strengths and Difficulties Questionnaire (SDQ); Goodman, 1997). Forty-five schools in Greater Manchester, England, were randomly assigned to treatment and control groups. Allocation was balanced by proportions of children eligible for free school meals and speaking English as an additional language via minimization. Children (N=4516) aged 7-9years at baseline in the participating schools were the target cohort. During the two-year trial period, teachers of this cohort in schools allocated to the intervention group delivered the PATHS curriculum, while their counterparts in the control group continued their usual provision. Teachers in PATHS schools received initial training and on-going support and assistance from trained coaches. Hierarchical linear modeling of outcome data was undertaken to identify both primary (e.g., for all children) and secondary (e.g., for children classified as "at-risk") intervention effects. A primary effect of the PATHS curriculum was found, demonstrating increases in teacher ratings of changes in children's social-emotional competence. Additionally, secondary effects of PATHS were identified, showing reductions in teacher ratings of emotional symptoms and increases in pro-social behavior and child ratings of engagement among children identified as at-risk at baseline. However, our analyses also identified primary effects favoring the usual provision group, showing reductions in teacher ratings of peer problems and emotional symptoms, and secondary effects demonstrating reductions in teacher ratings of conduct problems and child ratings of co-operation among at-risk children. Effect sizes were small

  4. Social media-delivered sexual health intervention: a cluster randomized controlled trial.

    Science.gov (United States)

    Bull, Sheana S; Levine, Deborah K; Black, Sandra R; Schmiege, Sarah J; Santelli, John

    2012-11-01

    Youth are using social media regularly and represent a group facing substantial risk for sexually transmitted infection (STI). Although there is evidence that the Internet can be used effectively in supporting healthy sexual behavior, this has not yet extended to social networking sites. To determine whether STI prevention messages delivered via Facebook are efficacious in preventing increases in sexual risk behavior at 2 and 6 months. Cluster RCT, October 2010-May 2011. Individuals (seeds) recruited in multiple settings (online, via newspaper ads and face-to-face) were asked to recruit three friends, who in turn recruited additional friends, extending three waves from the seed. Seeds and waves of friends were considered networks and exposed to either the intervention or control condition. Exposure to Just/Us, a Facebook page developed with youth input, or to control content on 18-24 News, a Facebook page with current events for 2 months. Condom use at last sex and proportion of sex acts protected by condoms. Repeated measures of nested data were used to model main effects of exposure to Just/Us and time by treatment interaction. A total of 1578 participants enrolled, with 14% Latino and 35% African-American; 75% of participants completed at least one study follow-up. Time by treatment effects were observed at 2 months for condom use (intervention 68% vs control 56%, p=0.04) and proportion of sex acts protected by condoms (intervention 63% vs control 57%, p=0.03) where intervention participation reduced the tendency for condom use to decrease over time. No effects were seen at 6 months. Social networking sites may be venues for efficacious health education interventions. More work is needed to understand what elements of social media are compelling, how network membership influences effects, and whether linking social media to clinical and social services can be beneficial. This study is registered at www.clinicaltrials.govNCT00725959. Copyright © 2012 American

  5. A Cluster Randomized Trial to Promote Healthy Menu Items for Children: The Kids' Choice Restaurant Program.

    Science.gov (United States)

    Ayala, Guadalupe X; Castro, Iana A; Pickrel, Julie L; Lin, Shih-Fan; Williams, Christine B; Madanat, Hala; Jun, Hee-Jin; Zive, Michelle

    2017-12-01

    Evidence indicates that restaurant-based interventions have the potential to promote healthier purchasing and improve the nutrients consumed. This study adds to this body of research by reporting the results of a trial focused on promoting the sale of healthy child menu items in independently owned restaurants. Eight pair-matched restaurants that met the eligibility criteria were randomized to a menu-only versus a menu-plus intervention condition. Both of the conditions implemented new healthy child menu items and received support for implementation for eight weeks. The menu-plus condition also conducted a marketing campaign involving employee trainings and promotional materials. Process evaluation data captured intervention implementation. Sales of new and existing child menu items were tracked for 16 weeks. Results indicated that the interventions were implemented with moderate to high fidelity depending on the component. Sales of new healthy child menu items occurred immediately, but decreased during the post-intervention period in both conditions. Sales of existing child menu items demonstrated a time by condition effect with restaurants in the menu-plus condition observing significant decreases and menu-only restaurants observing significant increases in sales of existing child menu items. Additional efforts are needed to inform sustainable methods for improving access to healthy foods and beverages in restaurants.

  6. A Cluster Randomized Trial to Promote Healthy Menu Items for Children: The Kids’ Choice Restaurant Program

    Science.gov (United States)

    Ayala, Guadalupe X.; Castro, Iana A.; Pickrel, Julie L.; Lin, Shih-Fan; Williams, Christine B.; Madanat, Hala; Jun, Hee-Jin; Zive, Michelle

    2017-01-01

    Evidence indicates that restaurant-based interventions have the potential to promote healthier purchasing and improve the nutrients consumed. This study adds to this body of research by reporting the results of a trial focused on promoting the sale of healthy child menu items in independently owned restaurants. Eight pair-matched restaurants that met the eligibility criteria were randomized to a menu-only versus a menu-plus intervention condition. Both of the conditions implemented new healthy child menu items and received support for implementation for eight weeks. The menu-plus condition also conducted a marketing campaign involving employee trainings and promotional materials. Process evaluation data captured intervention implementation. Sales of new and existing child menu items were tracked for 16 weeks. Results indicated that the interventions were implemented with moderate to high fidelity depending on the component. Sales of new healthy child menu items occurred immediately, but decreased during the post-intervention period in both conditions. Sales of existing child menu items demonstrated a time by condition effect with restaurants in the menu-plus condition observing significant decreases and menu-only restaurants observing significant increases in sales of existing child menu items. Additional efforts are needed to inform sustainable methods for improving access to healthy foods and beverages in restaurants. PMID:29194392

  7. A Cluster Randomized Trial to Promote Healthy Menu Items for Children: The Kids’ Choice Restaurant Program

    Directory of Open Access Journals (Sweden)

    Guadalupe X. Ayala

    2017-12-01

    Full Text Available Evidence indicates that restaurant-based interventions have the potential to promote healthier purchasing and improve the nutrients consumed. This study adds to this body of research by reporting the results of a trial focused on promoting the sale of healthy child menu items in independently owned restaurants. Eight pair-matched restaurants that met the eligibility criteria were randomized to a menu-only versus a menu-plus intervention condition. Both of the conditions implemented new healthy child menu items and received support for implementation for eight weeks. The menu-plus condition also conducted a marketing campaign involving employee trainings and promotional materials. Process evaluation data captured intervention implementation. Sales of new and existing child menu items were tracked for 16 weeks. Results indicated that the interventions were implemented with moderate to high fidelity depending on the component. Sales of new healthy child menu items occurred immediately, but decreased during the post-intervention period in both conditions. Sales of existing child menu items demonstrated a time by condition effect with restaurants in the menu-plus condition observing significant decreases and menu-only restaurants observing significant increases in sales of existing child menu items. Additional efforts are needed to inform sustainable methods for improving access to healthy foods and beverages in restaurants.

  8. Credit with Health Education in Benin: A Cluster Randomized Trial Examining Impacts on Knowledge and Behavior.

    Science.gov (United States)

    Karlan, Dean; Thuysbaert, Bram; Gray, Bobbi

    2017-02-08

    We evaluate whether health education integrated into microcredit lending groups reduces health risks by improving health knowledge and self-reported behaviors among urban and rural borrowers in eastern Benin. In 2007, we randomly assigned 138 villages in the Plateau region of Benin to one of four variations of a group liability credit product, varying lending groups' gender composition and/or inclusion of health education using a 2 × 2 design. Women in villages receiving health education, regardless of gender composition of the groups, showed improved knowledge of malaria and of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), but not of childhood illness danger signs. No significant changes in health behavior were observed except an increase in HIV/AIDS prevention behavior, a result predominantly driven by an increase in respondents' self-reported ability to procure a condom, likely an indicator of increased perceived access rather than improved preventative behavior. Women in villages assigned to mixed-gender groups had significantly lower levels of social capital, compared with villages assigned to female-only groups. This suggests there may be an important trade-off to consider for interventions seeking improved health outcomes and social capital through provision of services to mixed-gender groups. Although bundling health education with microcredit can expand health education coverage and lower service-delivery costs, the approach may not be sufficient to improve health behaviors. © The American Society of Tropical Medicine and Hygiene.

  9. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial

    Science.gov (United States)

    Kerby, Tessa J; Asche, Stephen E; Maciosek, Michael V; O’Connor, Patrick J; Sperl-Hillen, JoAnn M; Margolis, Karen L

    2012-01-01

    Background Hypertension is a leading cause of cardiovascular disease and death worldwide. Advances in technology have added telemedicine as a tool for managing hypertension. The effectiveness of telemedicine depends upon patients’ ability to adhere to schedules of home monitoring and case management. Methods Participants with uncontrolled hypertension in the intervention arm of a randomized trial who had completed 6 months of follow-up were included in this analysis. They were asked to measure their BP a minimum of 6 times per week using a telemonitor that transmitted the readings to their pharmacist case manager. Results Hypertensive patients in this study had high adherence to telemonitoring (73% took at least 6 BP readings per week) and phone visits (88% of expected visits were attended). In a multivariate analysis, older age, male gender, and some college education predicted better telemonitoring adherence. White non-hispanic race/ethnicity predicted better adherence to phone visits with pharmacist case managers. Telemonitoring adherence and phone adherence were highly correlated; participants who did not send readings on schedule were more likely to skip at least one phone visit with their pharmacist case manager. Conclusion The findings from this analysis indicate that hypertensive patients in this study were able to achieve and maintain high adherence to both the telemonitoring and the phone case management visits. PMID:23031143

  10. Oral language supports early literacy: a pilot cluster randomized trial in disadvantaged schools.

    Science.gov (United States)

    Snow, Pamela C; Eadie, Patricia A; Connell, Judy; Dalheim, Brenda; McCusker, Hugh J; Munro, John K

    2014-10-01

    This study examined the impact of teacher professional development aimed at improving the capacity of primary teachers in disadvantaged schools to strengthen children's expressive and receptive oral language skills and early literacy success in the first 2 years of school. Fourteen low-SES schools in Victoria, Australia were randomly allocated to a research (n = 8) or control arm (n = 6), resulting in an initial sample of 1254 students, (n = 602 in research arm and n = 652 in control arm). The intervention comprised 6 days of teacher and principal professional development (delivered by language and literacy experts), school-based continuing contact with the research team and completion by one staff member of each research school of a postgraduate unit on early language and literacy. Schools in the control arm received standard teaching according to state auspiced curriculum guidelines. Full data were available on 979 students at follow-up (time 2). Students in the research arm performed significantly better on Test of Language Development: Primary (Fourth Edition) sub-tests (p ≤ .002) and the Reading Progress Test (F = 10.4(1); p = .001) than students in the control arm at time 2. Narrative scores were not significantly different at time 2, although students in research schools showed greater gains. Findings provide "proof of concept" for this approach, and are discussed with respect to implications for teacher professional development and pre-service education concerning the psycholinguistic competencies that underpin the transition to literacy.

  11. Text Messaging, Teen Outreach Program, and Sexual Health Behavior: A Cluster Randomized Trial.

    Science.gov (United States)

    Bull, Sheana; Devine, Sharon; Schmiege, Sara J; Pickard, Leslie; Campbell, Jon; Shlay, Judith C

    2016-09-01

    To consider whether Youth All Engaged! (a text message intervention) intensified the effects of the adolescent pregnancy prevention Teen Outreach Program (control) for youths. In this trial performed in Denver, Colorado, from 2011 to 2014, we randomized 8 Boys & Girls Clubs each of 4 years into 32 clubs per year combinations to ensure each club would serve as a treatment site for 2 years and a control site for 2 years. Control intervention consisted of the Teen Outreach Program only. We enrolled 852 youths (aged 14-18 years), and 632 were retained at follow-up, with analytic samples ranging from 50 to 624 across outcomes. We examined program costs, and whether the intervention increased condom and contraceptive use, access to care, and pregnancy prevention. Control program costs were $1184 per participant, and intervention costs were an additional $126 per participant (+10.6%). There were no statistically significant differences in primary outcomes for the full sample. Hispanic participants in the intervention condition had fewer pregnancies at follow-up (1.79%) than did those in the control group (6.72%; P = .02). Youth All Engaged is feasible, low cost, and could have potential benefits for Hispanic youths.

  12. Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia : results from a cluster randomized cross-over trial

    NARCIS (Netherlands)

    van Werkhoven, Cornelis H; Postma, Douwe F; Mangen, Marie-Josee J; Oosterheert, Jan Jelrik; Bonten, Marc J M

    2017-01-01

    BACKGROUND: To determine the cost-effectiveness of strategies of preferred antibiotic treatment with beta-lactam/macrolide combination or fluoroquinolone monotherapy compared to beta-lactam monotherapy. METHODS: Costs and effects were estimated using data from a cluster-randomized cross-over trial

  13. Effects of a Physical Education-Based Programme on Health-Related Physical Fitness and Its Maintenance in High School Students: A Cluster-Randomized Controlled Trial

    Science.gov (United States)

    Mayorga-Vega, Daniel; Montoro-Escaño, Jorge; Merino-Marban, Rafael; Viciana, Jesús

    2016-01-01

    The purpose of this study was to examine the effects of a physical education-based development and maintenance programme on objective and perceived health-related physical fitness in high school students. A sample of 111 students aged 12-14 years old from six classes were cluster-randomly assigned to an experimental group (n = 54) or a control…

  14. Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: A cluster randomized controlled trial

    NARCIS (Netherlands)

    S.J.W. Robroek (Suzan); S. Polinder (Suzanne); F.J. Bredt (Folef); A. Burdorf (Alex)

    2012-01-01

    textabstractThis study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the

  15. Cluster-Randomized Controlled Trial Evaluating the Effectiveness of Computer-Assisted Intervention Delivered by Educators for Children with Speech Sound Disorders

    Science.gov (United States)

    McLeod, Sharynne; Baker, Elise; McCormack, Jane; Wren, Yvonne; Roulstone, Sue; Crowe, Kathryn; Masso, Sarah; White, Paul; Howland, Charlotte

    2017-01-01

    Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and…

  16. Short-Term Effects of a Home-Based Smoking Prevention Program on Antismoking Socialization and Smoking-Related Cognitions: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Hiemstra, J.M.; Ringlever, L.; Otten, R.; Schayck, O.C.P. van; Engels, R.C.M.E.

    2013-01-01

    Objective: This study aims to evaluate the short-term effects of a home-based smoking prevention program called 'Smoke-free Kids' on antismoking socialization and smoking-related cognitions and the moderating role of parental smoking. Participants and Methods: A cluster randomized controlled trial

  17. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

    2016-01-01

    Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

  18. Effectiveness of shared goal setting and decision making to achieve treatment targets in type 2 diabetes patients : A cluster-randomized trial (OPTIMAL)

    NARCIS (Netherlands)

    Den Ouden, Henk; Vos, Rimke C.; Rutten, Guy E.H.M.|info:eu-repo/dai/nl/074622781

    2017-01-01

    Objective: About 20% of patients with type 2 diabetes achieve all their treatment targets. Shared decision making (SDM) using a support aid based on the 5-years results of the ADDITION study on multifactorial treatment, could increase this proportion. Research design and methods: Cluster-randomized

  19. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial

    NARCIS (Netherlands)

    Dijk, I. van; Lucassen, P.L.B.J.; Akkermans, R.P.; Engelen, B.G.M. van; Weel, C. van; Speckens, A.E.M.

    2017-01-01

    PURPOSE: To examine the effect of mindfulness-based stress reduction training (MBSR) on the mental health of medical students during clinical clerkships. METHOD: Between February 2011 and May 2014, the authors conducted a cluster-randomized controlled trial of clerkships as usual (CAU) and

  20. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  1. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  2. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  3. A cluster-randomized trial of a middle school gender violence prevention program: Design, rationale, and sample characteristics.

    Science.gov (United States)

    Abebe, Kaleab Z; Jones, Kelley A; Ciaravino, Samantha; Ripper, Lisa; Paglisotti, Taylor; Morrow, Sarah Elizabeth; Grafals, Melanie; Van Dusen, Courtney; Miller, Elizabeth

    2017-11-01

    High rates of adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youth. This is a cluster randomized controlled trial to test an athletic coach-delivered ARA/SV prevention program in 41 middle schools (38 clusters). Trained coaches talk to their male athletes about 1) what constitutes harmful vs. respectful relationship behaviors, 2) dispelling myths that glorify male sexual aggression and promoting more gender-equitable attitudes, and 3) positive bystander intervention when aggressive male behaviors toward females are witnessed. A total of 973 male athletes (ages 11-14, grades 6-8) are participating. Athletes complete surveys at the beginning and end of sports season (Time 2), and one year later (Time 3). The primary outcome is an increase in positive bystander behaviors (i.e., intervening in peers' disrespectful or harmful behaviors); secondary outcomes are changes in recognition of what constitutes abusive behavior, intentions to intervene, and gender equitable attitudes (Time 2 and 3) as well as reduction in abuse perpetration (Time 3). Participating schools have a greater proportion of non-White students and students on free/reduced lunch compared to schools that declined participation. Participants' self-reported ethnicities are 54.5% White, 29.0% Black, 1.4% Hispanic and the remainder, multi-racial, other, or not reported. This study will evaluate the effectiveness of a coach-delivered ARA/SV prevention program for middle school male athletes. Findings will add to the evidence base regarding developmentally appropriate violence prevention programs as well as the role of coaches in adolescent health promotion. Clinical Trials #: NCT02331238. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  4. The 'Expanded HIV care in opioid substitution treatment' (EHOST) cluster-randomized, stepped-wedge trial: A study protocol.

    Science.gov (United States)

    Nosyk, B; Krebs, E; Min, J E; Ahamad, K; Buxton, J; Goldsmith, C; Hull, M; Joe, R; Krajden, M; Lima, V D; Olding, M; Wood, E; Montaner, J S G

    2015-11-01

    The public health response to HIV/AIDS has turned its focus onto optimizing health care system delivery to maximize case identification, access and sustained engagement in antiretroviral treatment (ART). Opioid Agonist Treatment (OAT) provides a critical opportunity for HIV testing and linkage to ART. The EHOST study is a cluster-randomized, stepped-wedge trial to evaluate a prescriber-focused intervention to increase HIV testing rates, and optimize ART engagement and retention outcomes among individuals engaged in OAT. The study will encompass all drug treatment clinics currently admitting patients for the treatment of opioid use disorder across the province of British Columbia, encompassing an estimated 90% of the OAT caseload. The trial will be executed over a 24-month period, with groups of clinics receiving the intervention in 6-month intervals. Evaluation of the proposed intervention's effectiveness will focus on three primary outcomes: (i) the HIV testing rate among those not known to be HIV positive; (ii) the rate of ART initiation among those not on ART; and (iii) the rate of ART continuation among those on ART. A difference-in-differences analytical framework will be applied to estimate the intervention's effect. This approach will assess site-specific changes in primary outcomes across clusters while adjusting for potential residual heterogeneity in patient case mix, volume, and quality of care across clinics. Statistical analysis of outcomes will be conducted entirely with linked population-level administrative health datasets. Facilitated by established collaborations between key stakeholders across the province, the EHOST intervention promises to optimize HIV testing and care within a marginalized and hard-to-reach population. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. A comparison of confidence interval methods for the intraclass correlation coefficient in community-based cluster randomization trials with a binary outcome.

    Science.gov (United States)

    Braschel, Melissa C; Svec, Ivana; Darlington, Gerarda A; Donner, Allan

    2016-04-01

    Many investigators rely on previously published point estimates of the intraclass correlation coefficient rather than on their associated confidence intervals to determine the required size of a newly planned cluster randomized trial. Although confidence interval methods for the intraclass correlation coefficient that can be applied to community-based trials have been developed for a continuous outcome variable, fewer methods exist for a binary outcome variable. The aim of this study is to evaluate confidence interval methods for the intraclass correlation coefficient applied to binary outcomes in community intervention trials enrolling a small number of large clusters. Existing methods for confidence interval construction are examined and compared to a new ad hoc approach based on dividing clusters into a large number of smaller sub-clusters and subsequently applying existing methods to the resulting data. Monte Carlo simulation is used to assess the width and coverage of confidence intervals for the intraclass correlation coefficient based on Smith's large sample approximation of the standard error of the one-way analysis of variance estimator, an inverted modified Wald test for the Fleiss-Cuzick estimator, and intervals constructed using a bootstrap-t applied to a variance-stabilizing transformation of the intraclass correlation coefficient estimate. In addition, a new approach is applied in which clusters are randomly divided into a large number of smaller sub-clusters with the same methods applied to these data (with the exception of the bootstrap-t interval, which assumes large cluster sizes). These methods are also applied to a cluster randomized trial on adolescent tobacco use for illustration. When applied to a binary outcome variable in a small number of large clusters, existing confidence interval methods for the intraclass correlation coefficient provide poor coverage. However, confidence intervals constructed using the new approach combined with Smith

  6. Reasoning Exercises in Assisted Living: a cluster randomized trial to improve reasoning and everyday problem solving

    Directory of Open Access Journals (Sweden)

    Williams K

    2014-06-01

    Full Text Available Kristine Williams,1 Ruth Herman,2 Daniel Bontempo3 1College of Nursing, University of Iowa, Iowa City, IA, USA; 2School of Nursing, University of Kansas Medical Center, Kansas City, KS, USA; 3The Schiefelbusch Institute for Life Span Studies, University of Kansas, Dole Human Development Center, Lawrence, KS, USA Purpose of the study: Assisted living (AL residents are at risk for cognitive and functional declines that eventually reduce their ability to care for themselves, thereby triggering nursing home placement. In developing a method to slow this decline, the efficacy of Reasoning Exercises in Assisted Living (REAL, a cognitive training intervention that teaches everyday reasoning and problem-solving skills to AL residents, was tested. Design and methods: At thirteen randomized Midwestern facilities, AL residents whose Mini Mental State Examination scores ranged from 19–29 either were trained in REAL or a vitamin education attention control program or received no treatment at all. For 3 weeks, treated groups received personal training in their respective programs. Results: Scores on the Every Day Problems Test for Cognitively Challenged Elders (EPCCE and on the Direct Assessment of Functional Status (DAFS showed significant increases only for the REAL group. For EPCCE, change from baseline immediately postintervention was +3.10 (P<0.01, and there was significant retention at the 3-month follow-up (d=2.71; P<0.01. For DAFS, change from baseline immediately postintervention was +3.52 (P<0.001, although retention was not as strong. Neither the attention nor the no-treatment control groups had significant gains immediately postintervention or at follow-up assessments. Post hoc across-group comparison of baseline change also highlights the benefits of REAL training. For EPCCE, the magnitude of gain was significantly larger in the REAL group versus the no-treatment control group immediately postintervention (d=3.82; P<0.01 and at the 3-month

  7. Tailored educational intervention for primary care to improve the management of dementia: the EVIDEM-ED cluster randomized controlled trial.

    Science.gov (United States)

    Wilcock, Jane; Iliffe, Steve; Griffin, Mark; Jain, Priya; Thuné-Boyle, Ingela; Lefford, Frances; Rapp, David

    2013-11-20

    Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead. However, dementia remains underdetected and suboptimally managed in general practice. Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia. The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design, with two arms: usual/normal care control versus educational intervention. The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year. Case identification was a secondary outcome measure. 23 practices in South-East England participated. A total of 1,072 patients with dementia (intervention: 512, control: 560) had information in their medical records showing the number of reviews within 12 months (or a proportion of) before intervention or randomization and within 12 months (or a proportion of) after. The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 (SD 1.09; minimum 0; median 1; maximum 8) compared with 0.89 (SD 0.92; minimum 0; median 1; maximum 4) before intervention. In the control group prior to randomization the mean total number of dementia management reviews was 1.66 (SD 1.87; minimum 0; median 1; maximum 12) and in the period after randomization it was 1.56 (SD 1.79; minimum 0; median 1; maximum 11). Case detection rates were unaffected. The estimated incidence rate ratio for intervention versus control group was 1.03 (P = 0.927, 95% CI 0.57 to 1.86). The trial was timely, coinciding with financial incentives for dementia management in general practice (through the Quality Outcomes Framework); legal imperatives (in the form of the Mental Capacity Act

  8. One-year follow-up of a coach-delivered dating violence prevention program: a cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Elizabeth; Tancredi, Daniel J; McCauley, Heather L; Decker, Michele R; Virata, Maria Catrina D; Anderson, Heather A; O'Connor, Brian; Silverman, Jay G

    2013-07-01

    Perpetration of physical, sexual, and psychological abuse is prevalent in adolescent relationships. One strategy for reducing such violence is to increase the likelihood that youth will intervene when they see peers engaging in disrespectful and abusive behaviors. This 12-month follow-up of a cluster RCT examined the longer-term effectiveness of Coaching Boys Into Men, a dating violence prevention program targeting high school male athletes. This cluster RCT was conducted from 2009 to 2011. The unit of randomization was the school, and the unit of analysis was the athlete. Data were analyzed in 2012. Participants were male athletes in Grades 9-11 (N=1513) participating in athletics in 16 high schools. The intervention consisted of training athletic coaches to integrate violence prevention messages into coaching activities through brief, weekly, scripted discussions with athletes. Primary outcomes were intentions to intervene, recognition of abusive behaviors, and gender-equitable attitudes. Secondary outcomes included bystander behaviors and abuse perpetration. Intervention effects were expressed as adjusted mean between-arm differences in changes in outcomes over time, estimated via regression models for clustered, longitudinal data. Perpetration of dating violence in the past 3 months was less prevalent among intervention athletes relative to control athletes, resulting in an estimated intervention effect of -0.15 (95% CI=-0.27, -0.03). Intervention athletes also reported lower levels of negative bystander behaviors (i.e., laughing and going along with peers' abusive behaviors) compared to controls (-0.41, 95% CI=-0.72, -0.10). No differences were observed in intentions to intervene (0.04, 95% CI=-0.07, 0.16); gender-equitable attitudes (-0.04, 95% CI=-0.11, 0.04); recognition of abusive behaviors (-0.03, 95% CI=-0.15, 0.09); or positive bystander behaviors (0.04, 95% CI=-0.11, 0.19). This school athletics-based dating violence prevention program is a promising

  9. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

    Science.gov (United States)

    Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

    2015-02-01

    The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

  10. Detection of domestic violence by community mental health teams: a multi-center, cluster randomized controlled trial.

    Science.gov (United States)

    Ruijne, Roos E; Howard, Louise M; Trevillion, Kylee; Jongejan, Femke E; Garofalo, Carlo; Bogaerts, Stefan; Mulder, Cornelis L; Kamperman, Astrid M

    2017-08-07

    Domestic Violence and Abuse (DVA) is associated with a range of psychosocial and mental health problems. Having a psychiatric illness increases likelihood of being a victim of DVA. Despite the evidence of a high risk for DVA and the serious effects of violent victimization in psychiatric patients, detection rates are low and responses are inadequate. The aim of the BRAVE (Better Reduction trough Assessment of Violence and Evaluation) study is to improve detection of and response to DVA in psychiatric patients. In this article, we present the protocol of the BRAVE study which follows the SPIRIT guidelines. The BRAVE study is a cluster randomized controlled trial. We will include 24 community mental health teams from Rotterdam and The Hague. Twelve teams will provide care as usual and 12 teams will receive the intervention. The intervention consists of 1) a knowledge and skills training for mental health professionals about DVA, 2) a knowledge and skills training of DVA professionals about mental illness, 3) provision and implementation of a referral pathway between community mental health and DVA services. The follow up period is 12 months. Our primary outcome is the rate of detected cases of recent or any history of DVA in patients per team in 12 months. Detection rates are obtained through a systematic search in electronic patient files. Our secondary aims are to obtain information about the gain and sustainability of knowledge on DVA in mental health professionals, and to obtain insight into the feasibility, sustainability and acceptability of the intervention. Data on our secondary aims will be obtained through structured in depth interviews and a questionnaire on knowledge and attitudes on DVA. This study is the first cluster randomized controlled trial to target both male and female psychiatric patients that experience DVA, using an intervention that involves training of professionals. We expect the rate of detected cases of DVA to increase in the

  11. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hélio Gustavo Santos

    2016-12-01

    Full Text Available Abstract Background Fatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control. Methods/Design This is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18–65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE intervention group or the Compensatory Workplace Exercise (CWE comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM. The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis. Discussion This intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on

  12. Effects of a Stretching Development and Maintenance Program on Hamstring Extensibility in Schoolchildren: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Mayorga-Vega, Daniel; Merino-Marban, Rafael; Manzano-Lagunas, Jorge; Blanco, Humberto; Viciana, Jesús

    2016-03-01

    The main purpose of the present study was to examine the effects of a physical education-based stretching development and maintenance program on hamstring extensibility in schoolchildren. A sample of 150 schoolchildren aged 7-10 years old from a primary school participated in the present study (140 participants were finally included). The six classes balanced by grade were cluster randomly assigned to the experimental group 1 (n = 51), experimental group 2 (n = 51) or control group (n = 49) (i.e., a cluster randomized controlled trial design was used). During the physical education classes, the students from the experimental groups 1 and 2 performed a four-minute stretching program twice a week for nine weeks (first semester). Then, after a five-week period of detraining coinciding with the Christmas holidays, the students from the experimental groups 1 and 2 completed another stretching program twice a week for eleven weeks (second semester). The students from the experimental group 1 continued performing the stretching program for four minutes while those from the experimental group 2 completed a flexibility maintenance program for only one minute. The results of the two-way analysis of variance showed that the physical education-based stretching development program significantly improved the students' hamstring extensibility (p stretching maintenance program (p 0.05). After a short-term stretching development program, a physical education-based stretching maintenance program of only one-minute sessions twice a week is effective in maintaining hamstring extensibility among schoolchildren. This knowledge could help and guide teachers to design programs that allow a feasible and effective development and maintenance of students' flexibility in the physical education setting. Key pointsA physical education-based stretching maintenance program of only one-minute sessions twice a week is effective in maintaining hamstring extensibility among schoolchildren.A four

  13. Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial.

    Science.gov (United States)

    Laws, Rachel A; Fanaian, Mahnaz; Jayasinghe, Upali W; McKenzie, Suzanne; Passey, Megan; Davies, Gawaine Powell; Lyle, David; Harris, Mark F

    2013-05-31

    Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care. This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program. A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and

  14. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

    2015-12-02

    Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results

  15. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Hoffmann Kristina

    2010-01-01

    Full Text Available Abstract Background With rates of childhood obesity increasing, physical activity (PA promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers. Methods/Design Thirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates

  16. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial.

    Science.gov (United States)

    De Bock, Freia; Fischer, Joachim E; Hoffmann, Kristina; Renz-Polster, Herbert

    2010-01-31

    With rates of childhood obesity increasing, physical activity (PA) promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers. Thirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates at the preschool and individual levels. Teacher

  17. Long term effectiveness on prescribing of two multifaceted educational interventions: results of two large scale randomized cluster trials.

    Directory of Open Access Journals (Sweden)

    Nicola Magrini

    Full Text Available INTRODUCTION: Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours. OBJECTIVES: Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists. METHODS: Two cluster open randomised controlled trials (RCTs were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months were also evaluated. RESULTS: In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03. Another primary outcome (prescription of risedronate showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03, but not at six months (-5.1%, p = 0.36. In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04, which persisted or increased over time. INTERPRETATION: These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially

  18. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    Bamelis, L.L.M.; Evers, S.M.A.A.; Spinhoven, P.; Arntz, A.

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  19. How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Erler Antje

    2012-09-01

    Full Text Available Abstract Background Patients with chronic kidney disease (CKD are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care. Methods A cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (≥70 years suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by more than 30%. Results Data from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%. Conclusions A multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices. Trial registration Current Controlled Trials ISRCTN02900734

  20. eLearning course may shorten the duration of mechanical restraint among psychiatric inpatients: a cluster-randomized trial.

    Science.gov (United States)

    Kontio, Raija; Pitkänen, Anneli; Joffe, Grigori; Katajisto, Jouko; Välimäki, Maritta

    2014-10-01

    The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic. Well structured, IT-based educational programmes (eLearning) often ensure quality and may make training more affordable and accessible. The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients. In a cluster-randomized intervention trial, the nursing personnel on 10 wards were randomly assigned to eLearning (intervention) or training-as-usual (control) groups. The eLearning course comprised six modules with specific topics (legal and ethical issues, behaviour-related factors, therapeutic relationship and self-awareness, teamwork and integrating knowledge with practice) and specific learning methods. The rates (incidents per 1000 occupied bed days) and durations of the coercion incidents were examined before and after the course. A total of 1283 coercion incidents (1143 seclusions [89%] and 140 incidents involving the use of mechanical restraints [11%]) were recorded on the study wards during the data collection period. On the intervention wards, there were no statistically significant changes in the rates of seclusion and mechanical restraint. However, the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h (median) (P eLearning course, the duration of incidents involving the use of mechanical restraints decreased. However, more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements. The eLearning course deserves further development and further studies. The duration of coercion incidents merits attention in future research.

  1. Community health workers can improve child growth of antenatally-depressed, South African mothers: a cluster randomized controlled trial.

    Science.gov (United States)

    Tomlinson, Mark; Rotheram-Borus, Mary Jane; Harwood, Jessica; le Roux, Ingrid M; O'Connor, Mary; Worthman, Carol

    2015-09-23

    Maternal antenatal depression has long-term consequences for children's health. We examined if home visits by community health workers (CHW) can improve growth outcomes for children of mothers who are antenatally depressed. A cluster randomized controlled trial of all pregnant, neighbourhood women in Cape Town, South Africa. Almost all pregnant women (98 %, N = 1238) were recruited and assessed during pregnancy, two weeks post-birth (92 %) and 6 months post-birth (88 %). Pregnant women were randomized to either: 1) Standard Care (SC), which provided routine antenatal care; or 2) an intervention, The Philani Intervention Program (PIP), which included SC and home visits by CHW trained as generalists (M = 11 visits). Child standardized weight, length, and weight by length over 6 months based on maternal antenatal depression and intervention condition. Depressed mood was similar across the PIP and SC conditions both antenatally (16.5 % rate) and at 6 months (16.7 %). The infants of depressed pregnant women in the PIP group were similar in height (height-for-age Z scores) to the children of non-depressed mothers in both the PIP and the SC conditions, but significantly taller at 6 months of age than the infants of pregnant depressed mothers in the SC condition. The intervention did not moderate children's growth. Depressed SC mothers tended to have infants less than two standard deviations in height on the World Health Organization's norms at two weeks post-birth compared to infants of depressed PIP mothers and non-depressed mothers in both conditions. A generalist, CHW-delivered home visiting program improved infant growth, even when mothers' depression was not reduced. Focusing on maternal caretaking of infants, even when mothers are depressed, is critical in future interventions. ClinicalTrials.gov registration # NCT00996528 . October 15, 2009.

  2. Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

    2015-07-01

    Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

  3. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial.

    Science.gov (United States)

    Leblanc, Judith; Hejblum, Gilles; Costagliola, Dominique; Durand-Zaleski, Isabelle; Lert, France; de Truchis, Pierre; Verbeke, Geert; Rousseau, Alexandra; Piquet, Hélène; Simon, François; Pateron, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2017-10-30

    This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments. In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis. During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis. The combined strategy of targeted screening and diagnostic testing was effective. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  4. Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Tello-Bernabé Eugenia

    2011-12-01

    Full Text Available Abstract Background Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. Method/design This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain. The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm, all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV. They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D, and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. 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 There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care

  5. Impact of prenatal education on maternal utilization of analgesic interventions at future infant vaccinations: a cluster randomized trial.

    Science.gov (United States)

    Taddio, Anna; Smart, Sarah; Sheedy, Matthuschka; Yoon, Eugene W; Vyas, Charmy; Parikh, Chaitya; Pillai Riddell, Rebecca; Shah, Vibhuti

    2014-07-01

    Analgesic interventions are not routinely used during vaccine injections in infants. Parents report a desire to mitigate injection pain, but lack the knowledge about how to do so. The objective of this cluster-randomized trial was to evaluate the effect of a parent-directed prenatal education teaching module about vaccination pain management on analgesic utilization at future infant vaccinations. Expectant mothers enrolled in prenatal classes at Mount Sinai Hospital in Toronto were randomized to a 20-30minute interactive presentation about vaccination pain management (experimental group) or general vaccination information (control group). Both presentations included a PowerPoint (Microsoft Corporation, Redmond, WA, USA) and video presentation, take-home pamphlet, and "Question and Answer" period. The primary outcome was self-reported utilization of breastfeeding, sugar water, or topical anaesthetics at routine 2-month infant vaccinations. Between October 2012 and July 2013, 197 expectant mothers from 28 prenatal classes participated; follow-up was obtained in 174 (88%). Maternal characteristics did not differ (P>0.05) between groups. Utilization of one or more prespecified pain interventions occurred in 34% of participants in the experimental group, compared to 17% in the control group (P=0.01). Inclusion of a pain management module in prenatal classes led to increased utilization of evidence-based pain management interventions by parents at the 2-month infant vaccination appointment. Educating parents offers a novel and effective way of improving the quality of pain care delivered to infants during vaccination. Additional research is needed to determine if utilization can be bolstered further using techniques such as postnatal hospital reinforcement, reminder cards, and clinician education. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  6. Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial.

    Science.gov (United States)

    Lutge, Elizabeth; Lewin, Simon; Volmink, Jimmy

    2014-06-19

    Poverty undermines the adherence of patients to tuberculosis treatment. A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients' adherence to treatment, and their treatment outcomes. Although the trial showed a modest improvement in the treatment success rates of the intervention group, this was not statistically significant, due in part to the low fidelity to the trial intervention. A qualitative process evaluation, conducted in the final few months of the trial, explained some of the factors that contributed to this low fidelity. In-depth interviews were conducted with patients who received vouchers, nurses in intervention clinics, personnel in shops who administered the vouchers, and managers of the TB Control Programme. These interviews were analyzed thematically. The low fidelity to the trial intervention can be explained by two main factors. The first was nurses' tendency to 'ration' the vouchers, only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable. The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates, necessitating further visits to the clinics which they were not always able to make. This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial. It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as 'street level bureaucrats' who may profoundly affect the way an intervention is administered. Current Controlled Trials ISRCTN50689131, registered 21 April 2009. The trial protocol is available at the following web address: http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa.

  7. Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial.

    Science.gov (United States)

    Cherniak, William; Anguyo, Geoffrey; Meaney, Christopher; Yuan Kong, Ling; Malhame, Isabelle; Pace, Romina; Sodhi, Sumeet; Silverman, Michael

    2017-01-01

    In rural Uganda pregnant women often lack access to health services, do not attend antenatal care, and tend to utilize traditional healers/birth attendants. We hypothesized that receiving a message advertising that "you will be able to see your baby by ultrasound" would motivate rural Ugandan women who otherwise might use a traditional birth attendant to attend antenatal care, and that those women would subsequently be more satisfied with care. A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. Sub-counties were randomized to a control arm, with advertisement of antenatal care with no mention of portable obstetric ultrasound (four communities, n = 59), or an intervention arm, with advertisement of portable obstetric ultrasound. Advertisement of portable obstetric ultrasound was further divided into intervention A) word of mouth advertisement of portable obstetric ultrasound and antenatal care (one communitity, n = 16), B) radio advertisement of only antenatal care and word of mouth advertisement of antenatal care and portable obstetric ultrasound (one community, n = 7), or C) word of mouth + radio advertisement of both antenatal care and portable obstetric ultrasound (two communities, n = 75). The primary outcome was attendance to antenatal care. 159 women presented to antenatal care across eight sub-counties. The rate of attendance was 65.1 (per 1000 pregnant women, 95% CI 38.3-110.4) where portable obstetric ultrasound was advertised by radio and word of mouth, as compared to a rate of 11.1 (95% CI 6.1-20.1) in control communities (rate ratio 5.9, 95% CI 2.6-13.0, pultrasound by radio attendance was significantly improved. This study suggests that women can be motivated to attend antenatal care when offered the concrete incentive of seeing their baby.

  8. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

    Science.gov (United States)

    Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther

    2017-06-20

    Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

  9. Problem-solving in caregiver-counselling (PLiP Study): study protocol of a cluster randomized pragmatic trial.

    Science.gov (United States)

    Pfeiffer, Klaus; Hautzinger, Martin; Patak, Margarete; Grünwald, Julia; Becker, Clemens; Albrecht, Diana

    2017-03-06

    Despite the positive evaluation of various caregiver interventions over the past 3 decades, only very few intervention protocols have been translated to delivery in service contexts. The purpose of this study is to train care counsellors of statutory long term care insurances in problem-solving and to evaluate this approach as an additional component in the statutory care counselling in Germany. A pragmatic cluster randomized controlled trial in which 38 sites with 58 care counsellors are randomly assigned to provide either routine counselling plus additional problem-solving for caregivers or routine counselling alone. The counsellor training comprises an initial 2-day training, a follow-up day after 4 months, and biweekly supervision contacts with a psychotherapist for 6 months over the phone. The agreed minimum counselling intensity is one initial face-to-face contact including a caregiver assessment and at least one telephone follow-up contact. Caregivers who are positively screened for significant strain in their role are followed up at 3 and 6 months after baseline assessment. Main outcome are caregivers' depressive symptoms. While it is unclear if the expected very low amount of additional counselling time is sufficient to yield any additional effects on caregiver depression, it is also unclear if the additional problem-solving component yields to synergies with routine counselling that is based on information and case management. There are different potential individual and organisational barriers to a consistent intervention delivery like gratification for participation, time for extra work or internal motivation to participate. ( ISRCTN23635523 ).

  10. Cost-effectiveness of multidisciplinary wound care in nursing homes: a pseudo-randomized pragmatic cluster trial.

    Science.gov (United States)

    Vu, Trang; Harris, Anthony; Duncan, Gregg; Sussman, Geoff

    2007-09-01

    To evaluate the cost-effectiveness of a multidisciplinary wound care team in the nursing home setting from a health system perspective. Pseudo-randomized pragmatic cluster trial with 20-week follow-up involving 342 uncomplicated leg and pressure ulcers in 176 residents located in 44 high-care nursing homes in Melbourne, Australia in 1999-2000. Twenty-one nursing homes (180 wounds in 94 residents) were assigned to the intervention arm and 23 to the control arm (162 wounds in 82 residents). Residents in the intervention arm received standardized treatment from a wound care team comprising of trained community pharmacists and nurses. Residents in the control arm received usual care. More wounds healed during the trial in the intervention arm than in the control arm (61.7% versus 52.5%, P = 0.07). A Cox regression with shared frailty predicted that the chances of healing increased 73% for intervention wounds [95% confidence interval (CI) 20-150%, P = 0.003]. The mean treatment cost was $A616.4 for intervention and $A977.9 for control patients (P = 0.006). Most cost reduction was obtained from decreases in nursing time and waste disposal. The mean cost saving per wound, adjusted for baseline wound severity and random censoring, was $A277.9 (95% CI $A21.6-$A534.1). Standardized treatment provided by a multidisciplinary wound care team saved costs and improved chronic wound healing in nursing homes. The main source of saving was in the cost of nursing time in applying traditional dressings and in the cost of their disposal.

  11. Reducing smoking in adolescents: cost-effectiveness results from the cluster randomized ASSIST (A Stop Smoking In Schools Trial).

    Science.gov (United States)

    Hollingworth, William; Cohen, David; Hawkins, James; Hughes, Rachael A; Moore, Laurence A R; Holliday, Jo C; Audrey, Suzanne; Starkey, Fenella; Campbell, Rona

    2012-02-01

    School-based smoking prevention programmes can be effective, but evidence on cost-effectiveness is lacking. We conducted a cost-effectiveness analysis of a school-based "peer-led" intervention. We evaluated the ASSIST (A Stop Smoking In Schools Trial) programme in a cluster randomized controlled trial. The ASSIST programme trained students to act as peer supporters during informal interactions to encourage their peers not to smoke. Fifty-nine secondary schools in England and Wales were randomized to receive the ASSIST programme or usual smoking education. Ten thousand seven hundred and thirty students aged 12-13 years attended participating schools. Previous work has demonstrated that the ASSIST programme achieved a 2.1% (95% CI = 0%-4.2%) reduction in smoking prevalence. We evaluated the public sector cost, prevalence of weekly smoking, and cost per additional student not smoking at 24 months. The ASSIST programme cost of £32 (95% CI = £29.70-£33.80) per student. The incremental cost per student not smoking at 2 years was £1,500 (95% CI = £669-£9,947). Students in intervention schools were less likely to believe that they would be a smoker at age 16 years (odds ratio [OR] = 0.80; 95% CI = 0.66-0.96). A peer-led intervention reduced smoking among adolescents at a modest cost. The intervention is cost-effective under realistic assumptions regarding the extent to which reductions in adolescent smoking lead to lower smoking prevalence and/or earlier smoking cessation in adulthood. The annual cost of extending the intervention to Year 8 students in all U.K. schools would be in the region of £38 million and could result in 20,400 fewer adolescent smokers.

  12. Health promotion in older Chinese: a 12-month cluster randomized controlled trial of pedometry and "peer support".

    Science.gov (United States)

    Thomas, G Neil; Macfarlane, Duncan J; Guo, Boliang; Cheung, Bernard M Y; McGhee, Sarah M; Chou, Kee-Lee; Deeks, Jonathan J; Lam, Tai Hing; Tomlinson, Brian

    2012-06-01

    Aging, in conjunction with decreasing physical activity, is associated with a range of health problems. Simple, low-maintenance, population-based means of promoting activity to counteract the age-associated decline are required. We therefore assessed the effect of pedometry and buddy support to increase physical activity. We undertook a clustered randomized trial (HKCTR-346) of 24 community centers involving 399 older Chinese participants (≥ 60 yr). Centers were randomly allocated to 1) pedometry and buddy, 2) pedometry and no buddy, 3) no pedometry and buddy, and 4) no pedometry and no buddy with a 2 × 2 factorial design. The trial simultaneously tested the individual and combined effects of the interventions. The intervention groups also received monthly organized group activities to provide encouragement and support. Outcome measures were assessed at 6 and 12 months, including physical fitness and activity and cardiovascular disease risk factors (anthropometry and blood pressure). From the 24 centers, 356 volunteers (89.2%) completed the study. Those receiving the interventions had higher mean physical activity levels at 12 months of 1820 (95% confidence interval (CI) = 1360-2290) and 1260 (95% CI = 780-1740) MET·min·wk(-1), respectively relative to the decrease in the control groups. The buddy peer support intervention significantly improved mean aerobic fitness (12% [95% CI = 4%-21%]) and reduced both body fat (-0.6% [95% CI = -1.1% to 0.0%]) and time to complete the 2.5-m get-up-and-go test (-0.27 [95% CI = -0.53 to -0.01] s). No other improvements in the cardiovascular disease risk factors were observed. The combination of motivational tools was no better than the individual interventions. Both motivational interventions increased physical activity levels, and the buddy style improved fitness. These tools could be useful adjuncts in the prevention of obesity and age-related complications.

  13. A cluster randomized trial on improving nurses' detection and management of elder abuse and neglect (I-NEED): study protocol.

    Science.gov (United States)

    Loh, Debbie Ann; Choo, Wan Yuen; Hairi, Noran Naqiah; Othman, Sajaratulnisah; Mohd Hairi, Farizah; Mohd Mydin, Fadzilah Hanum; Jaafar, Siti Nur Illiani; Tan, Maw Pin; Mohd Ali, Zainudin; Abdul Aziz, Suriyati; Ramli, Rohaya; Mohamad, Rosmala; Lal Mohammad, Zaiton; Hassan, Norlela; Brownell, Patricia; Bulgiba, Awang

    2015-11-01

    The aim of this study was to describe a trial protocol of an educational intervention for nurses to improve their awareness and practice in detecting and managing elder abuse and neglect. Knowledgeable and skilful nurses are crucial amidst the growing numbers of maltreated older patients. This trial is a multi-site, three-armed, community-based cluster randomized controlled trial with 6-months follow-up. This study will involve 390 community and registered nurses from government health clinics in Negeri Sembilan, Malaysia (protocol approved in October 2013). This three-phased study, premised on the Precede-Proceed Model, comprises baseline focus group discussion and survey (Phase 1), development of training module (Phase 2) and implementation and evaluation of the training (Phase 3). Eligible participants will be randomized to the control group (continuous nursing education), intervention group A (face-to-face intensive training programme) or group B (face-to-face intensive training programme and an educational video). Outcome measures include improvement in knowledge and awareness on elder abuse and neglect and the number of cases identified and managed during follow-up. Data will be collected at baseline, immediate postintervention, 3- and 6-month follow-up. Findings from this study will provide empirical support for the development of a training module for nurses on the detection and management of elder abuse and neglect, towards improving healthcare delivery and the well-being of vulnerable older adults. This study is funded by the University of Malaya Research Grant (RP001C-13HTM), (FL002-13SBS) and University of Malaya Grand Challenge (PEACE) Grant (GC001C-14HTM) awarded in May 2013, July 2013 and September 2014. © 2015 John Wiley & Sons Ltd.

  14. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

  15. Evaluation of a Worksite Cervical Screening Initiative to Increase Pap Smear Uptake in Malaysia: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    O'Rorke, Michael; Murray, Liam; Su, Tin Tin

    2013-01-01

    Background. Despite the significant burden of cervical cancer, Malaysia like many middle-income countries relies on opportunistic cervical screening as opposed to a more organized population-based program. The aim of this study was to ascertain the effectiveness of a worksite screening initiative upon Papanicolaou smear test (Pap test) uptake among educated working women in Malaysia. Methods. 403 female teachers who never or infrequently attended for a Pap test from 40 public secondary schools in Kuala Lumpur were recruited into a cluster randomized trial conducted between January and November 2010. The intervention group participated in a worksite cervical screening initiative whilst the control group received usual care from the existing cervical screening program. Multivariate logistic regression was performed to determine the impact of the intervention program on Pap smear uptake after 24 weeks of followup. Results. The proportion of women attending for a Pap test was significantly higher in the intervention than in the control group (18.1% versus 10.1%, P value < 0.05) with the worksite screening initiative doubling the Pap smear uptake, adjusted odds ratio 2.44 (95% CI: 1.29–4.62). Conclusion. Worksite health promotion interventions can effectively increase cervical smear uptake rates among eligible workers in middle-income countries. Policy makers and health care providers in these countries should include such interventions in strategies for reducing cervical cancer burden. This trial is registered with IRCT201103186088N1. PMID:24073411

  16. Efficacy of an improved absorbent pad on incontinence-associated dermatitis in older women: cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sugama Junko

    2012-05-01

    Full Text Available Abstract Background Most older adults with urinary incontinence use absorbent pads. Because of exposure to moisture and chemical irritating substances in urine, the perineal skin region is always at risk for development of incontinence-associated dermatitis (IAD. The aim of this study was to examine the efficacy of an improved absorbent pad against IAD. Methods A cluster randomized controlled design was used to compare the efficacy of two absorbent pads. Female inpatients aged ≥65 years who had IAD and used an absorbent pad or diaper all day were enrolled. Healing rate of IAD and variables of skin barrier function such as skin pH and skin moisture were compared between the usual absorbent pad group (n = 30 and the test absorbent pad group (n = 30. Results Thirteen patients (43.3% from the test absorbent pad group and 4 patients (13.3% from the usual absorbent pad group recovered completely from IAD. Moreover, the test absorbent pad group healed significantly faster than the usual absorbent pad group (p = 0.009. On the other hand, there were no significant differences between the two groups in skin barrier function. Conclusion The test absorbent pad for older adults with urinary incontinence might be more efficacious against IAD than usual absorbent pad. Trial registration UMIN-CTR: UMIN000006188

  17. Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial.

    Science.gov (United States)

    Reusch, A; Weiland, R; Gerlich, C; Dreger, K; Derra, C; Mainos, D; Tuschhoff, T; Berding, A; Witte, C; Kaltz, B; Faller, H

    2016-12-01

    Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  18. Implementation of a discontinuation letter to reduce long-term benzodiazepine use--a cluster randomized trial.

    Science.gov (United States)

    van de Steeg-van Gompel, Caroline H P A; Wensing, Michel; De Smet, Peter A G M

    2009-01-01

    Although it is recommended to restrict long-term use of benzodiazepines, and considerable attention has been paid to this, long-term use continues to be a problem. An informative discontinuation letter for patients has been shown to reduce long-term benzodiazepine use in general practice. However, little is known about its wide scale implementation in primary care. To determine the effectiveness of an intensive support programme for community pharmacies to send discontinuation letters to patients in cooperation with GPs. In a cluster randomized trial, 43 control pharmacies received a written manual and 47 experimental pharmacies received an intensive support programme. Primary outcome measures were the percentage of GPs who reviewed and returned lists of eligible patients and the percentage of long-term users who were sent a discontinuation letter within 4 months. The outcomes did not differ for the experimental versus control groups: 38% and 31% of the GPs, respectively, returned the patient lists; 14% and 10% of all long-term users in the two groups, respectively, received the discontinuation letter within 4 months. Substantially more pharmacies in the experimental group than in the control group finally managed to send discontinuation letters (70% vs. 40%). About one third of the pharmacies in the control group and two thirds of the pharmacies in the intervention group finally implemented the discontinuation letter. However, this difference was not apparent in the primary outcome measures. It seems crucial to involve GPs more effectively in implementation of the discontinuation letter.

  19. Improving the social and emotional climate of classrooms: a clustered randomized controlled trial testing the RULER Approach.

    Science.gov (United States)

    Rivers, Susan E; Brackett, Marc A; Reyes, Maria R; Elbertson, Nicole A; Salovey, Peter

    2013-02-01

    The RULER Approach ("RULER") is a setting-level, social and emotional learning program that is grounded in theory and evidence. RULER is designed to modify the quality of classroom social interactions so that the climate becomes more supportive, empowering, and engaging. This is accomplished by integrating skill-building lessons and tools so that teachers and students develop their emotional literacy. In a clustered randomized control trial, we tested the hypothesis that RULER improves the social and emotional climate of classrooms. Depending upon condition assignment, 62 schools either integrated RULER into fifth- and sixth-grade English language arts (ELA) classrooms or served as comparison schools, using their standard ELA curriculum only. Multi-level modeling analyses showed that compared to classrooms in comparison schools, classrooms in RULER schools were rated as having higher degrees of warmth and connectedness between teachers and students, more autonomy and leadership among students, and teachers who focused more on students' interests and motivations. These findings suggest that RULER enhances classrooms in ways that can promote positive youth development.

  20. A Clustered Randomized Trial of an Educational Intervention During Transplant Evaluation to Increase Knowledge of Living Donor Kidney Transplant.

    Science.gov (United States)

    Weng, Francis L; Peipert, John D; Holland, Bart K; Brown, Diane R; Waterman, Amy D

    2017-12-01

    Maximizing education about living donor kidney transplant (LDKT) during the in-person evaluation at the transplant center may increase the numbers of kidney patients pursuing LDKT. Research Questions and Design: To test the effectiveness of a 1-time LDKT educational intervention, we performed a cluster-randomized trial among 499 patients who presented for evaluation of kidney transplant. We compared usual care education (n = 250) versus intensive LDKT education (n = 249), which was implemented only on the evaluation day and consisted of viewing a 25-minute video of information and stories about LDKT and discussion of LDKT possibilities with an educator. Our primary outcome was knowledge of LDKT, 1 week after the transplant evaluation. One week after evaluation, patients who received intensive education had higher knowledge than patients who received usual care (12.7 vs. 11.7; P = .0008), but there were no differences in postevaluation readiness for LDKT. Among patients who had not previously identified a potential living donor, receiving intensive education was associated with increased willingness to take steps toward LDKT. In conclusion, expansion of LDKT education within the evaluation day may be helpful, but interventions that are implemented at multiple times and for greater duration may be necessary to ensure larger and long-term behavioral changes in pursuit of LDKT.

  1. Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial.

    Science.gov (United States)

    Nayiga, Susan; DiLiberto, Deborah; Taaka, Lilian; Nabirye, Christine; Haaland, Ane; Staedke, Sarah G; Chandler, Clare I R

    2014-10-01

    This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including 'patient-centred services.' A process evaluation was designed within this trial to articulate and evaluate the implementation and programme theories of the intervention. This article evaluates one hypothesized mechanism of change within the programme theory: the impact of the Patient Centred Services component on health-worker communication. The theory-driven approach extended to evaluation of the outcome measures. The study found that the proximal outcome of patient-centred communication was rated 10 percent higher ( p < 0.008) by care seekers consulting with the health workers who were at the intervention health centres compared with those at control health centres. This finding will strengthen interpretation of more distal trial outcomes.

  2. Does Integrating Family Planning into HIV Services Improve Gender Equitable Attitudes? Results from a Cluster Randomized Trial in Nyanza, Kenya.

    Science.gov (United States)

    Newmann, Sara J; Rocca, Corinne H; Zakaras, Jennifer M; Onono, Maricianah; Bukusi, Elizabeth A; Grossman, Daniel; Cohen, Craig R

    2016-09-01

    This study investigated whether integrating family planning (FP) services into HIV care was associated with gender equitable attitudes among HIV-positive adults in western Kenya. Surveys were conducted with 480 women and 480 men obtaining HIV services from 18 clinics 1 year after the sites were randomized to integrated FP/HIV services (N = 12) or standard referral for FP (N = 6). We used multivariable regression, with generalized estimating equations to account for clustering, to assess whether gender attitudes (range 0-12) were associated with integrated care and with contraceptive use. Men at intervention sites had stronger gender equitable attitudes than those at control sites (adjusted mean difference in scores = 0.89, 95 % CI 0.03-1.74). Among women, attitudes did not differ by study arm. Gender equitable attitudes were not associated with contraceptive use among men (AOR = 1.06, 95 % CI 0.93-1.21) or women (AOR = 1.03, 95 % CI 0.94-1.13). Further work is needed to understand how integrating FP into HIV care affects gender relations, and how improved gender equity among men might be leveraged to improve contraceptive use and other reproductive health outcomes.

  3. A School Support Intervention and Educational Outcomes Among Orphaned Adolescents: Results of a Cluster Randomized Controlled Trial in Kenya.

    Science.gov (United States)

    Cho, Hyunsan; Catherine Ryberg, Renee; Hwang, Karam; Pearce, Lisa D; Iritani, Bonita J

    2017-11-01

    Globally, significant progress has been made in primary school enrollment. However, there are millions of adolescents-including orphans in sub-Saharan Africa-who still experience barriers to remaining in school. We conducted a 4-year cluster randomized controlled trial (cRCT) (N = 835) in a high HIV prevalence area in western Kenya to test whether providing orphaned adolescents with a school support intervention improves their educational outcomes. The school support intervention consisted of directly paying tuition, exam fees, and uniform costs to primary and secondary schools for those students who remained enrolled. In addition, research staff monitored intervention participants' school attendance and helped to address barriers to staying in school. This school support intervention had significant positive impacts on educational outcomes for orphaned adolescents. Over the course of the study, school absence remained stable for intervention group participants but increased in frequency for control group participants. Intervention group participants were less likely to drop out of school compared to the control group. Furthermore, the intervention participants were more likely to make age-appropriate progression in grade, matriculate into secondary school, and achieve higher levels of education by the end of the study. The intervention also increased students' expectations of graduating from college in the future. However, we found no significant intervention impact on primary and secondary school test scores. Results from this cRCT suggest that directly covering school-related expenses for male and female orphaned adolescents in western Kenya can improve their educational outcomes.

  4. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    Directory of Open Access Journals (Sweden)

    Changzheng Yuan

    Full Text Available BACKGROUND: Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. METHODS: STUDY DESIGN: Cross-sectional in-dormitory survey. STUDY POPULATION: Current students from Peking University Health Science Center from April to June, 2009. MEASUREMENT: Self-reported questionnaire on health behaviors: physical activity (including bicycling, dietary intake and tobacco use. RESULTS: Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. CONCLUSION: Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  5. Improving service delivery of water, sanitation, and hygiene in primary schools: a cluster-randomized trial in western Kenya.

    Science.gov (United States)

    Alexander, Kelly T; Dreibelbis, Robert; Freeman, Matthew C; Ojeny, Betty; Rheingans, Richard

    2013-09-01

    Water, sanitation, and hygiene (WASH) programs in schools have been shown to improve health and reduce absence. In resource-poor settings, barriers such as inadequate budgets, lack of oversight, and competing priorities limit effective and sustained WASH service delivery in schools. We employed a cluster-randomized trial to examine if schools could improve WASH conditions within existing administrative structures. Seventy schools were divided into a control group and three intervention groups. All intervention schools received a budget for purchasing WASH-related items. One group received no further intervention. A second group received additional funding for hiring a WASH attendant and making repairs to WASH infrastructure, and a third group was given guides for student and community monitoring of conditions. Intervention schools made significant improvements in provision of soap and handwashing water, treated drinking water, and clean latrines compared with controls. Teachers reported benefits of monitoring, repairs, and a WASH attendant, but quantitative data of WASH conditions did not determine whether expanded interventions out-performed our budget-only intervention. Providing schools with budgets for WASH operational costs improved access to necessary supplies, but did not ensure consistent service delivery to students. Further work is needed to clarify how schools can provide WASH services daily.

  6. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru.

    Science.gov (United States)

    Bernabe-Ortiz, Antonio; Diez-Canseco, Francisco; Gilman, Robert H; Cárdenas, María K; Sacksteder, Katherine A; Miranda, J Jaime

    2014-03-25

    Controlling hypertension rates and maintaining normal blood pressure, particularly in resource-constrained settings, represent ongoing challenges of effective and affordable implementation in health care. One of the strategies being largely advocated to improve high blood pressure calls for salt reduction strategies. This study aims to estimate the impact of a population-level intervention based on sodium reduction and potassium increase - in practice, introducing a low-sodium, high-potassium salt substitute - on adult blood pressure levels. The proposed implementation research study includes two components: Phase 1, an exploratory component, and Phase 2, an intervention component. The exploratory component involves a triangle taste test and a formative research study designed to gain an understanding of the best implementation methods. Phase 2 involves a pragmatic stepped wedge trial design where the intervention will be progressively implemented in several clusters starting the intervention randomly at different times. In addition, we will evaluate the implementation strategy using a cost-effectiveness analysis. This is the first project in a Latin-American setting to implement a salt substitution intervention at the population level to tackle high blood pressure. Data generated and lessons learnt from this study will provide a strong platform to address potential interventions applicable to other similar low- and middle-income settings. This study is registered in ClinicalTrials.gov NCT01960972.

  7. Maternal and Child Health Handbook use for maternal and child care: a cluster randomized controlled study in rural Java, Indonesia.

    Science.gov (United States)

    Osaki, Keiko; Hattori, Tomoko; Toda, Akemi; Mulati, Erna; Hermawan, Lukas; Pritasari, Kirana; Bardosono, Saptawati; Kosen, Soewarta

    2018-01-09

    Effectiveness of the Maternal and Child Health Handbook (MCHHB), a home-based booklet for pregnancy, delivery and postnatal/child health, was evaluated on care acquisition and home care in rural Java, a low service-coverage area. We conducted a health centre-based randomized trial, with a 2-year follow-up. Intervention inc