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Sample records for stratified randomized cluster

  1. Random matrix improved subspace clustering

    KAUST Repository

    Couillet, Romain; Kammoun, Abla

    2017-01-01

    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

  2. Random forcing of geostrophic motion in rotating stratified turbulence

    Science.gov (United States)

    Waite, Michael L.

    2017-12-01

    Random forcing of geostrophic motion is a common approach in idealized simulations of rotating stratified turbulence. Such forcing represents the injection of energy into large-scale balanced motion, and the resulting breakdown of quasi-geostrophic turbulence into inertia-gravity waves and stratified turbulence can shed light on the turbulent cascade processes of the atmospheric mesoscale. White noise forcing is commonly employed, which excites all frequencies equally, including frequencies much higher than the natural frequencies of large-scale vortices. In this paper, the effects of these high frequencies in the forcing are investigated. Geostrophic motion is randomly forced with red noise over a range of decorrelation time scales τ, from a few time steps to twice the large-scale vortex time scale. It is found that short τ (i.e., nearly white noise) results in about 46% more gravity wave energy than longer τ, despite the fact that waves are not directly forced. We argue that this effect is due to wave-vortex interactions, through which the high frequencies in the forcing are able to excite waves at their natural frequencies. It is concluded that white noise forcing should be avoided, even if it is only applied to the geostrophic motion, when a careful investigation of spontaneous wave generation is needed.

  3. 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.

  4. 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.

  5. Stereo imaging and random array stratified imaging for cargo radiation inspecting

    International Nuclear Information System (INIS)

    Wang Jingjin; Zeng Yu

    2003-01-01

    This paper presents a Stereo Imaging and Random Array Stratified Imaging for cargo container radiation Inspecting. By using dual-line vertical detector array scan, a stereo image of inspected cargo can be obtained and watched with virtual reality view. The random detector array has only one-row of detectors but distributed in a certain horizontal dimension randomly. To scan a cargo container with this random array detector, a 'defocused' image is obtained. By using 'anti-random focusing', one layer of the image can be focused on the background of all defocused images from other layers. A stratified X-ray image of overlapped bike wheels is presented

  6. 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

  7. Text Clustering Algorithm Based on Random Cluster Core

    Directory of Open Access Journals (Sweden)

    Huang Long-Jun

    2016-01-01

    Full Text Available Nowadays clustering has become a popular text mining algorithm, but the huge data can put forward higher requirements for the accuracy and performance of text mining. In view of the performance bottleneck of traditional text clustering algorithm, this paper proposes a text clustering algorithm with random features. This is a kind of clustering algorithm based on text density, at the same time using the neighboring heuristic rules, the concept of random cluster is introduced, which effectively reduces the complexity of the distance calculation.

  8. Percolation and epidemics in random clustered networks

    Science.gov (United States)

    Miller, Joel C.

    2009-08-01

    The social networks that infectious diseases spread along are typically clustered. Because of the close relation between percolation and epidemic spread, the behavior of percolation in such networks gives insight into infectious disease dynamics. A number of authors have studied percolation or epidemics in clustered networks, but the networks often contain preferential contacts in high degree nodes. We introduce a class of random clustered networks and a class of random unclustered networks with the same preferential mixing. Percolation in the clustered networks reduces the component sizes and increases the epidemic threshold compared to the unclustered networks.

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

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

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

  10. MUP, CEC-DES, STRADE. Codes for uncertainty propagation, experimental design and stratified random sampling techniques

    International Nuclear Information System (INIS)

    Amendola, A.; Astolfi, M.; Lisanti, B.

    1983-01-01

    The report describes the how-to-use of the codes: MUP (Monte Carlo Uncertainty Propagation) for uncertainty analysis by Monte Carlo simulation, including correlation analysis, extreme value identification and study of selected ranges of the variable space; CEC-DES (Central Composite Design) for building experimental matrices according to the requirements of Central Composite and Factorial Experimental Designs; and, STRADE (Stratified Random Design) for experimental designs based on the Latin Hypercube Sampling Techniques. Application fields, of the codes are probabilistic risk assessment, experimental design, sensitivity analysis and system identification problems

  11. National Coral Reef Monitoring Program: Benthic Images Collected from Stratified Random Sites (StRS) across American Samoa in 2015

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across...

  12. Monitoring oil persistence on beaches : SCAT versus stratified random sampling designs

    International Nuclear Information System (INIS)

    Short, J.W.; Lindeberg, M.R.; Harris, P.M.; Maselko, J.M.; Pella, J.J.; Rice, S.D.

    2003-01-01

    In the event of a coastal oil spill, shoreline clean-up assessment teams (SCAT) commonly rely on visual inspection of the entire affected area to monitor the persistence of the oil on beaches. Occasionally, pits are excavated to evaluate the persistence of subsurface oil. This approach is practical for directing clean-up efforts directly following a spill. However, sampling of the 1989 Exxon Valdez oil spill in Prince William Sound 12 years later has shown that visual inspection combined with pit excavation does not offer estimates of contaminated beach area of stranded oil volumes. This information is needed to statistically evaluate the significance of change with time. Assumptions regarding the correlation of visually-evident surface oil and cryptic subsurface oil are usually not evaluated as part of the SCAT mandate. Stratified random sampling can avoid such problems and could produce precise estimates of oiled area and volume that allow for statistical assessment of major temporal trends and the extent of the impact. The 2001 sampling of the shoreline of Prince William Sound showed that 15 per cent of surface oil occurrences were associated with subsurface oil. This study demonstrates the usefulness of the stratified random sampling method and shows how sampling design parameters impact statistical outcome. Power analysis based on the study results, indicate that optimum power is derived when unnecessary stratification is avoided. It was emphasized that sampling effort should be balanced between choosing sufficient beaches for sampling and the intensity of sampling

  13. Random clustering ferns for multimodal object recognition

    OpenAIRE

    Villamizar Vergel, Michael Alejandro; Garrell Zulueta, Anais; Sanfeliu Cortés, Alberto; Moreno-Noguer, Francesc

    2017-01-01

    The final publication is available at link.springer.com We propose an efficient and robust method for the recognition of objects exhibiting multiple intra-class modes, where each one is associated with a particular object appearance. The proposed method, called random clustering ferns, combines synergically a single and real-time classifier, based on the boosted assembling of extremely randomized trees (ferns), with an unsupervised and probabilistic approach in order to recognize efficient...

  14. Fixed-location hydroacoustic monitoring designs for estimating fish passage using stratified random and systematic sampling

    International Nuclear Information System (INIS)

    Skalski, J.R.; Hoffman, A.; Ransom, B.H.; Steig, T.W.

    1993-01-01

    Five alternate sampling designs are compared using 15 d of 24-h continuous hydroacoustic data to identify the most favorable approach to fixed-location hydroacoustic monitoring of salmonid outmigrants. Four alternative aproaches to systematic sampling are compared among themselves and with stratified random sampling (STRS). Stratifying systematic sampling (STSYS) on a daily basis is found to reduce sampling error in multiday monitoring studies. Although sampling precision was predictable with varying levels of effort in STRS, neither magnitude nor direction of change in precision was predictable when effort was varied in systematic sampling (SYS). Furthermore, modifying systematic sampling to include replicated (e.g., nested) sampling (RSYS) is further shown to provide unbiased point and variance estimates as does STRS. Numerous short sampling intervals (e.g., 12 samples of 1-min duration per hour) must be monitored hourly using RSYS to provide efficient, unbiased point and interval estimates. For equal levels of effort, STRS outperformed all variations of SYS examined. Parametric approaches to confidence interval estimates are found to be superior to nonparametric interval estimates (i.e., bootstrap and jackknife) in estimating total fish passage. 10 refs., 1 fig., 8 tabs

  15. Health service accreditation as a predictor of clinical and organisational performance: a blinded, random, stratified study.

    Science.gov (United States)

    Braithwaite, Jeffrey; Greenfield, David; Westbrook, Johanna; Pawsey, Marjorie; Westbrook, Mary; Gibberd, Robert; Naylor, Justine; Nathan, Sally; Robinson, Maureen; Runciman, Bill; Jackson, Margaret; Travaglia, Joanne; Johnston, Brian; Yen, Desmond; McDonald, Heather; Low, Lena; Redman, Sally; Johnson, Betty; Corbett, Angus; Hennessy, Darlene; Clark, John; Lancaster, Judie

    2010-02-01

    Despite the widespread use of accreditation in many countries, and prevailing beliefs that accreditation is associated with variables contributing to clinical care and organisational outcomes, little systematic research has been conducted to examine its validity as a predictor of healthcare performance. To determine whether accreditation performance is associated with self-reported clinical performance and independent ratings of four aspects of organisational performance. Independent blinded assessment of these variables in a random, stratified sample of health service organisations. Acute care: large, medium and small health-service organisations in Australia. Study participants Nineteen health service organisations employing 16 448 staff treating 321 289 inpatients and 1 971 087 non-inpatient services annually, representing approximately 5% of the Australian acute care health system. Correlations of accreditation performance with organisational culture, organisational climate, consumer involvement, leadership and clinical performance. Results Accreditation performance was significantly positively correlated with organisational culture (rho=0.618, p=0.005) and leadership (rho=0.616, p=0.005). There was a trend between accreditation and clinical performance (rho=0.450, p=0.080). Accreditation was unrelated to organisational climate (rho=0.378, p=0.110) and consumer involvement (rho=0.215, p=0.377). Accreditation results predict leadership behaviours and cultural characteristics of healthcare organisations but not organisational climate or consumer participation, and a positive trend between accreditation and clinical performance is noted.

  16. Properties of the endogenous post-stratified estimator using a random forests model

    Science.gov (United States)

    John Tipton; Jean Opsomer; Gretchen G. Moisen

    2012-01-01

    Post-stratification is used in survey statistics as a method to improve variance estimates. In traditional post-stratification methods, the variable on which the data is being stratified must be known at the population level. In many cases this is not possible, but it is possible to use a model to predict values using covariates, and then stratify on these predicted...

  17. Rationale and Design of Khuzestan Vitamin D Deficiency Screening Program in Pregnancy: A Stratified Randomized Vitamin D Supplementation Controlled Trial.

    Science.gov (United States)

    Rostami, Maryam; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Hosseinpanah, Farhad; Alavi Majd, Hamid

    2017-04-07

    Although there have been marked improvements in our understanding of vitamin D functions in different diseases, gaps on its role during pregnancy remain. Due to the lack of consensus on the most accurate marker of vitamin D deficiency during pregnancy and the optimal level of 25-hydroxyvitamin D, 25(OH)D, for its definition, vitamin D deficiency assessment during pregnancy is a complicated process. Besides, the optimal protocol for treatment of hypovitaminosis D and its effect on maternal and neonatal outcomes are still unclear. The aim of our study was to estimate the prevalence of vitamin D deficiency in the first trimester of pregnancy and to compare vitamin D screening strategy with no screening. Also, we intended to compare the effectiveness of various treatment regimens on maternal and neonatal outcomes in Masjed-Soleyman and Shushtar cities of Khuzestan province, Iran. This was a two-phase study. First, a population-based cross-sectional study was conducted; recruiting 1600 and 900 first trimester pregnant women from health centers of Masjed-Soleyman and Shushtar, respectively, using stratified multistage cluster sampling with probability proportional to size (PPS) method. Second, to assess the effect of screening strategy on maternal and neonatal outcomes, Masjed-Soleyman participants were assigned to a screening program versus Shushtar participants who became the nonscreening arm. Within the framework of the screening regimen, an 8-arm blind randomized clinical trial was undertaken to compare the effects of various treatment protocols. A total of 800 pregnant women with vitamin D deficiency were selected using simple random sampling from the 1600 individuals of Masjed-Soleyman as interventional groups. Serum concentrations of 25(OH)D were classified as: (1) severe deficient (20ng/ml). Those with severe and moderate deficiency were randomly divided into 4 subgroups and received vitamin D3 based on protocol and were followed until delivery. Data was analyzed

  18. Development and enrolee satisfaction with basic medical insurance in China: A systematic review and stratified cluster sampling survey.

    Science.gov (United States)

    Jing, Limei; Chen, Ru; Jing, Lisa; Qiao, Yun; Lou, Jiquan; Xu, Jing; Wang, Junwei; Chen, Wen; Sun, Xiaoming

    2017-07-01

    Basic Medical Insurance (BMI) has changed remarkably over time in China because of health reforms that aim to achieve universal coverage and better health care with adequate efforts by increasing subsidies, reimbursement, and benefits. In this paper, we present the development of BMI, including financing and operation, with a systematic review. Meanwhile, Pudong New Area in Shanghai was chosen as a typical BMI sample for its coverage and management; a stratified cluster sampling survey together with an ordinary logistic regression model was used for the analysis. Enrolee satisfaction and the factors associated with enrolee satisfaction with BMI were analysed. We found that the reenrolling rate superficially improved the BMI coverage and nearly achieved universal coverage. However, BMI funds still faced dual contradictions of fund deficit and insured under compensation, and a long-term strategy is needed to realize the integration of BMI schemes with more homogeneous coverage and benefits. Moreover, Urban Resident Basic Medical Insurance participants reported a higher rate of dissatisfaction than other participants. The key predictors of the enrolees' satisfaction were awareness of the premium and compensation, affordability of out-of-pocket costs, and the proportion of reimbursement. These results highlight the importance that the Chinese government takes measures, such as strengthening BMI fund management, exploring mixed payment methods, and regulating sequential medical orders, to develop an integrated medical insurance system of universal coverage and vertical equity while simultaneously improving enrolee satisfaction. Copyright © 2017 John Wiley & Sons, Ltd.

  19. National Coral Reef Monitoring Program: Benthic Cover Derived from Analysis of Benthic Images Collected during Stratified Random Surveys (StRS) across American Samoa in 2015

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across American Samoa in 2015 as a part of...

  20. National Coral Reef Monitoring Program: Benthic Images Collected from Stratified Random Sites (StRS) across American Samoa in 2015 (NCEI Accession 0159168)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across...

  1. Effects of a random spatial variation of the plasma density on the mode conversion in cold, unmagnetized, and stratified plasmas

    Energy Technology Data Exchange (ETDEWEB)

    Jung Yu, Dae [School of Space Research, Kyung Hee University, Yongin 446-701 (Korea, Republic of); Kim, Kihong [Department of Energy Systems Research, Ajou University, Suwon 443-749 (Korea, Republic of)

    2013-12-15

    We study the effects of a random spatial variation of the plasma density on the mode conversion of electromagnetic waves into electrostatic oscillations in cold, unmagnetized, and stratified plasmas. Using the invariant imbedding method, we calculate precisely the electromagnetic field distribution and the mode conversion coefficient, which is defined to be the fraction of the incident wave power converted into electrostatic oscillations, for the configuration where a numerically generated random density variation is added to the background linear density profile. We repeat similar calculations for a large number of random configurations and take an average of the results. We obtain a peculiar nonmonotonic dependence of the mode conversion coefficient on the strength of randomness. As the disorder increases from zero, the maximum value of the mode conversion coefficient decreases initially, then increases to a maximum, and finally decreases towards zero. The range of the incident angle in which mode conversion occurs increases monotonically as the disorder increases. We present numerical results suggesting that the decrease of mode conversion mainly results from the increased reflection due to the Anderson localization effect originating from disorder, whereas the increase of mode conversion of the intermediate disorder regime comes from the appearance of many resonance points and the enhanced tunneling between the resonance points and the cutoff point. We also find a very large local enhancement of the magnetic field intensity for particular random configurations. In order to obtain high mode conversion efficiency, it is desirable to restrict the randomness close to the resonance region.

  2. Effects of a random spatial variation of the plasma density on the mode conversion in cold, unmagnetized, and stratified plasmas

    International Nuclear Information System (INIS)

    Jung Yu, Dae; Kim, Kihong

    2013-01-01

    We study the effects of a random spatial variation of the plasma density on the mode conversion of electromagnetic waves into electrostatic oscillations in cold, unmagnetized, and stratified plasmas. Using the invariant imbedding method, we calculate precisely the electromagnetic field distribution and the mode conversion coefficient, which is defined to be the fraction of the incident wave power converted into electrostatic oscillations, for the configuration where a numerically generated random density variation is added to the background linear density profile. We repeat similar calculations for a large number of random configurations and take an average of the results. We obtain a peculiar nonmonotonic dependence of the mode conversion coefficient on the strength of randomness. As the disorder increases from zero, the maximum value of the mode conversion coefficient decreases initially, then increases to a maximum, and finally decreases towards zero. The range of the incident angle in which mode conversion occurs increases monotonically as the disorder increases. We present numerical results suggesting that the decrease of mode conversion mainly results from the increased reflection due to the Anderson localization effect originating from disorder, whereas the increase of mode conversion of the intermediate disorder regime comes from the appearance of many resonance points and the enhanced tunneling between the resonance points and the cutoff point. We also find a very large local enhancement of the magnetic field intensity for particular random configurations. In order to obtain high mode conversion efficiency, it is desirable to restrict the randomness close to the resonance region

  3. Prevalence and Risk Factors of Dengue Infection in Khanh Hoa Province, Viet Nam: A Stratified Cluster Sampling Survey.

    Science.gov (United States)

    Mai, Vien Quang; Mai, Trịnh Thị Xuan; Tam, Ngo Le Minh; Nghia, Le Trung; Komada, Kenichi; Murakami, Hitoshi

    2018-05-19

    Dengue is a clinically important arthropod-borne viral disease with increasing global incidence. Here we aimed to estimate the prevalence of dengue infections in Khanh Hoa Province, central Viet Nam, and to identify risk factors for infection. We performed a stratified cluster sampling survey including residents of 3-60 years of age in Nha Trang City, Ninh Hoa District and Dien Khanh District, Khanh Hoa Province, in October 2011. Immunoglobulin G (IgG) and immunoglobulin M (IgM) against dengue were analyzed using a rapid test kit. Participants completed a questionnaire exploring clinical dengue incidence, socio-economic status, and individual behavior. A household checklist was used to examine environment, mosquito larvae presence, and exposure to public health interventions. IgG positivity was 20.5% (urban, 16.3%; rural, 23.0%), IgM positivity was 6.7% (urban, 6.4%; rural, 6.9%), and incidence of clinically compatible dengue during the prior 3 months was 2.8 per 1,000 persons (urban, 1.7; rural, 3.4). For IgG positivity, the adjusted odds ratio (AOR) was 2.68 (95% confidence interval [CI], 1.24-5.81) for mosquito larvae presence in water pooled in old tires and was 3.09 (95% CI, 1.75-5.46) for proximity to a densely inhabited area. For IgM positivity, the AOR was 3.06 (95% CI, 1.50-6.23) for proximity to a densely inhabited area. Our results indicated rural penetration of dengue infections. Control measures should target densely inhabited areas, and may include clean-up of discarded tires and water-collecting waste.

  4. Measurement Error Correction Formula for Cluster-Level Group Differences in Cluster Randomized and Observational Studies

    Science.gov (United States)

    Cho, Sun-Joo; Preacher, Kristopher J.

    2016-01-01

    Multilevel modeling (MLM) is frequently used to detect cluster-level group differences in cluster randomized trial and observational studies. Group differences on the outcomes (posttest scores) are detected by controlling for the covariate (pretest scores) as a proxy variable for unobserved factors that predict future attributes. The pretest and…

  5. Application of a stratified random sampling technique to the estimation and minimization of respirable quartz exposure to underground miners

    International Nuclear Information System (INIS)

    Makepeace, C.E.; Horvath, F.J.; Stocker, H.

    1981-11-01

    The aim of a stratified random sampling plan is to provide the best estimate (in the absence of full-shift personal gravimetric sampling) of personal exposure to respirable quartz among underground miners. One also gains information of the exposure distribution of all the miners at the same time. Three variables (or strata) are considered in the present scheme: locations, occupations and times of sampling. Random sampling within each stratum ensures that each location, occupation and time of sampling has equal opportunity of being selected without bias. Following implementation of the plan and analysis of collected data, one can determine the individual exposures and the mean. This information can then be used to identify those groups whose exposure contributes significantly to the collective exposure. In turn, this identification, along with other considerations, allows the mine operator to carry out a cost-benefit optimization and eventual implementation of engineering controls for these groups. This optimization and engineering control procedure, together with the random sampling plan, can then be used in an iterative manner to minimize the mean value of the distribution and collective exposures

  6. 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.

  7. Relative efficiency and sample size for cluster randomized trials with variable cluster sizes.

    Science.gov (United States)

    You, Zhiying; Williams, O Dale; Aban, Inmaculada; Kabagambe, Edmond Kato; Tiwari, Hemant K; Cutter, Gary

    2011-02-01

    The statistical power of cluster randomized trials depends on two sample size components, the number of clusters per group and the numbers of individuals within clusters (cluster size). Variable cluster sizes are common and this variation alone may have significant impact on study power. Previous approaches have taken this into account by either adjusting total sample size using a designated design effect or adjusting the number of clusters according to an assessment of the relative efficiency of unequal versus equal cluster sizes. This article defines a relative efficiency of unequal versus equal cluster sizes using noncentrality parameters, investigates properties of this measure, and proposes an approach for adjusting the required sample size accordingly. We focus on comparing two groups with normally distributed outcomes using t-test, and use the noncentrality parameter to define the relative efficiency of unequal versus equal cluster sizes and show that statistical power depends only on this parameter for a given number of clusters. We calculate the sample size required for an unequal cluster sizes trial to have the same power as one with equal cluster sizes. Relative efficiency based on the noncentrality parameter is straightforward to calculate and easy to interpret. It connects the required mean cluster size directly to the required sample size with equal cluster sizes. Consequently, our approach first determines the sample size requirements with equal cluster sizes for a pre-specified study power and then calculates the required mean cluster size while keeping the number of clusters unchanged. Our approach allows adjustment in mean cluster size alone or simultaneous adjustment in mean cluster size and number of clusters, and is a flexible alternative to and a useful complement to existing methods. Comparison indicated that we have defined a relative efficiency that is greater than the relative efficiency in the literature under some conditions. Our measure

  8. 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

  9. Cluster Tails for Critical Power-Law Inhomogeneous Random Graphs

    Science.gov (United States)

    van der Hofstad, Remco; Kliem, Sandra; van Leeuwaarden, Johan S. H.

    2018-04-01

    Recently, the scaling limit of cluster sizes for critical inhomogeneous random graphs of rank-1 type having finite variance but infinite third moment degrees was obtained in Bhamidi et al. (Ann Probab 40:2299-2361, 2012). It was proved that when the degrees obey a power law with exponent τ \\in (3,4), the sequence of clusters ordered in decreasing size and multiplied through by n^{-(τ -2)/(τ -1)} converges as n→ ∞ to a sequence of decreasing non-degenerate random variables. Here, we study the tails of the limit of the rescaled largest cluster, i.e., the probability that the scaling limit of the largest cluster takes a large value u, as a function of u. This extends a related result of Pittel (J Combin Theory Ser B 82(2):237-269, 2001) for the Erdős-Rényi random graph to the setting of rank-1 inhomogeneous random graphs with infinite third moment degrees. We make use of delicate large deviations and weak convergence arguments.

  10. Cluster tails for critical power-law inhomogeneous random graphs

    NARCIS (Netherlands)

    van der Hofstad, R.; Kliem, S.; van Leeuwaarden, J.S.H.

    2018-01-01

    Recently, the scaling limit of cluster sizes for critical inhomogeneous random graphs of rank-1 type having finite variance but infinite third moment degrees was obtained in Bhamidi et al. (Ann Probab 40:2299–2361, 2012). It was proved that when the degrees obey a power law with exponent τ∈ (3 , 4)

  11. The dilute random field Ising model by finite cluster approximation

    International Nuclear Information System (INIS)

    Benyoussef, A.; Saber, M.

    1987-09-01

    Using the finite cluster approximation, phase diagrams of bond and site diluted three-dimensional simple cubic Ising models with a random field have been determined. The resulting phase diagrams have the same general features for both bond and site dilution. (author). 7 refs, 4 figs

  12. A cluster expansion approach to exponential random graph models

    International Nuclear Information System (INIS)

    Yin, Mei

    2012-01-01

    The exponential family of random graphs are among the most widely studied network models. We show that any exponential random graph model may alternatively be viewed as a lattice gas model with a finite Banach space norm. The system may then be treated using cluster expansion methods from statistical mechanics. In particular, we derive a convergent power series expansion for the limiting free energy in the case of small parameters. Since the free energy is the generating function for the expectations of other random variables, this characterizes the structure and behavior of the limiting network in this parameter region

  13. Development and assessment of an e-learning course on breast imaging for radiographers: a stratified randomized controlled trial.

    Science.gov (United States)

    Moreira, Inês C; Ventura, Sandra Rua; Ramos, Isabel; Rodrigues, Pedro Pereira

    2015-01-05

    Mammography is considered the best imaging technique for breast cancer screening, and the radiographer plays an important role in its performance. Therefore, continuing education is critical to improving the performance of these professionals and thus providing better health care services. Our goal was to develop an e-learning course on breast imaging for radiographers, assessing its efficacy, effectiveness, and user satisfaction. A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training, using pre- and post-knowledge tests, and satisfaction questionnaires. The primary outcome was the improvement in test results (percentage of correct answers), using intention-to-treat and per-protocol analysis. A total of 54 participants were assigned to the intervention (20 students plus 34 radiographers) with 53 controls (19+34). The intervention was completed by 40 participants (11+29), with 4 (2+2) discontinued interventions, and 10 (7+3) lost to follow-up. Differences in the primary outcome were found between intervention and control: 21 versus 4 percentage points (pp), Peffect in radiographers (23 pp vs 4 pp; P=.004) but was unclear in students (18 pp vs 5 pp; P=.098). Nonetheless, differences in students' posttest results were found (88% vs 63%; P=.003), which were absent in pretest (63% vs 63%; P=.106). The per-protocol analysis showed a higher effect (26 pp vs 2 pp; Pe-learning course is effective, especially for radiographers, which highlights the need for continuing education.

  14. Universal shift of the Brewster angle and disorder-enhanced delocalization of p waves in stratified random media.

    Science.gov (United States)

    Lee, Kwang Jin; Kim, Kihong

    2011-10-10

    We study theoretically the propagation and the Anderson localization of p-polarized electromagnetic waves incident obliquely on randomly stratified dielectric media with weak uncorrelated Gaussian disorder. Using the invariant imbedding method, we calculate the localization length and the disorder-averaged transmittance in a numerically precise manner. We find that the localization length takes an extremely large maximum value at some critical incident angle, which we call the generalized Brewster angle. The disorder-averaged transmittance also takes a maximum very close to one at the same incident angle. Even in the presence of an arbitrarily weak disorder, the generalized Brewster angle is found to be substantially different from the ordinary Brewster angle in uniform media. It is a rapidly increasing function of the average dielectric permittivity and approaches 90° when the average relative dielectric permittivity is slightly larger than two. We make a remarkable observation that the dependence of the generalized Brewster angle on the average dielectric permittivity is universal in the sense that it is independent of the strength of disorder. We also find, surprisingly, that when the average relative dielectric permittivity is less than one and the incident angle is larger than the generalized Brewster angle, both the localization length and the disorder-averaged transmittance increase substantially as the strength of disorder increases in a wide range of the disorder parameter. In other words, the Anderson localization of incident p waves can be weakened by disorder in a certain parameter regime.

  15. Development and Assessment of an E-Learning Course on Breast Imaging for Radiographers: A Stratified Randomized Controlled Trial

    Science.gov (United States)

    Ventura, Sandra Rua; Ramos, Isabel; Rodrigues, Pedro Pereira

    2015-01-01

    Background Mammography is considered the best imaging technique for breast cancer screening, and the radiographer plays an important role in its performance. Therefore, continuing education is critical to improving the performance of these professionals and thus providing better health care services. Objective Our goal was to develop an e-learning course on breast imaging for radiographers, assessing its efficacy, effectiveness, and user satisfaction. Methods A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training, using pre- and post-knowledge tests, and satisfaction questionnaires. The primary outcome was the improvement in test results (percentage of correct answers), using intention-to-treat and per-protocol analysis. Results A total of 54 participants were assigned to the intervention (20 students plus 34 radiographers) with 53 controls (19+34). The intervention was completed by 40 participants (11+29), with 4 (2+2) discontinued interventions, and 10 (7+3) lost to follow-up. Differences in the primary outcome were found between intervention and control: 21 versus 4 percentage points (pp), Pe-learning course is effective, especially for radiographers, which highlights the need for continuing education. PMID:25560547

  16. Evaluating effectiveness of down-sampling for stratified designs and unbalanced prevalence in Random Forest models of tree species distributions in Nevada

    Science.gov (United States)

    Elizabeth A. Freeman; Gretchen G. Moisen; Tracy S. Frescino

    2012-01-01

    Random Forests is frequently used to model species distributions over large geographic areas. Complications arise when data used to train the models have been collected in stratified designs that involve different sampling intensity per stratum. The modeling process is further complicated if some of the target species are relatively rare on the landscape leading to an...

  17. The Design of Cluster Randomized Trials with Random Cross-Classifications

    Science.gov (United States)

    Moerbeek, Mirjam; Safarkhani, Maryam

    2018-01-01

    Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

  18. Representing Degree Distributions, Clustering, and Homophily in Social Networks With Latent Cluster Random Effects Models.

    Science.gov (United States)

    Krivitsky, Pavel N; Handcock, Mark S; Raftery, Adrian E; Hoff, Peter D

    2009-07-01

    Social network data often involve transitivity, homophily on observed attributes, clustering, and heterogeneity of actor degrees. We propose a latent cluster random effects model to represent all of these features, and we describe a Bayesian estimation method for it. The model is applicable to both binary and non-binary network data. We illustrate the model using two real datasets. We also apply it to two simulated network datasets with the same, highly skewed, degree distribution, but very different network behavior: one unstructured and the other with transitivity and clustering. Models based on degree distributions, such as scale-free, preferential attachment and power-law models, cannot distinguish between these very different situations, but our model does.

  19. Stratified random sampling plans designed to assist in the determination of radon and radon daughter concentrations in underground uranium mine atmosphere

    International Nuclear Information System (INIS)

    Makepeace, C.E.

    1981-01-01

    Sampling strategies for the monitoring of deleterious agents present in uranium mine air in underground and surface mining areas are described. These methods are designed to prevent overexposure of the lining of the respiratory system of uranium miners to ionizing radiation from radon and radon daughters, and whole body overexposure to external gamma radiation. A detailed description is provided of stratified random sampling monitoring methodology for obtaining baseline data to be used as a reference for subsequent compliance assessment

  20. The clustering of local maxima in random noise

    International Nuclear Information System (INIS)

    Coles, P.

    1989-01-01

    A mixture of analytic and numerical techniques is used to study the clustering properties of local maxima of random noise. Technical complexities restrict us to the case of 1D noise, but the results obtained should give a reasonably accurate picture of the behaviour of cosmological density peaks in noise defined on a 3D domain. We give estimates of the two-point correlation function of local maxima, for both Gaussian and non-Gaussian noise and show that previous approximations are not accurate. (author)

  1. The random cluster model and a new integration identity

    International Nuclear Information System (INIS)

    Chen, L C; Wu, F Y

    2005-01-01

    We evaluate the free energy of the random cluster model at its critical point for 0 -1 (√q/2) is a rational number. As a by-product, our consideration leads to a closed-form evaluation of the integral 1/(4π 2 ) ∫ 0 2π dΘ ∫ 0 2π dΦ ln[A+B+C - AcosΘ - BcosΦ - Ccos(Θ+Φ)] = -ln(2S) + (2/π)[Ti 2 (AS) + Ti 2 (BS) + Ti 2 (CS)], which arises in lattice statistics, where A, B, C ≥ 0 and S=1/√(AB + BC + CA)

  2. 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.

  3. 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

  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. 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.

  6. Spectra of random networks in the weak clustering regime

    Science.gov (United States)

    Peron, Thomas K. DM.; Ji, Peng; Kurths, Jürgen; Rodrigues, Francisco A.

    2018-03-01

    The asymptotic behavior of dynamical processes in networks can be expressed as a function of spectral properties of the corresponding adjacency and Laplacian matrices. Although many theoretical results are known for the spectra of traditional configuration models, networks generated through these models fail to describe many topological features of real-world networks, in particular non-null values of the clustering coefficient. Here we study effects of cycles of order three (triangles) in network spectra. By using recent advances in random matrix theory, we determine the spectral distribution of the network adjacency matrix as a function of the average number of triangles attached to each node for networks without modular structure and degree-degree correlations. Implications to network dynamics are discussed. Our findings can shed light in the study of how particular kinds of subgraphs influence network dynamics.

  7. Making birthing safe for Pakistan women: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Khan Muhammad

    2012-07-01

    Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national

  8. Re-estimating sample size in cluster randomized trials with active recruitment within clusters

    NARCIS (Netherlands)

    van Schie, Sander; Moerbeek, Mirjam

    2014-01-01

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster

  9. National Coral Reef Monitoring Program: Benthic Cover Derived from Analysis of Benthic Images Collected during Stratified Random Surveys (StRS) across the Mariana Archipelago from 2014-03-25 to 2014-05-07 (NCEI Accession 0159148)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the Mariana archipelago in 2014 as a...

  10. National Coral Reef Monitoring Program: Benthic Cover Derived from Analysis of Benthic Images Collected during Stratified Random Surveys (StRS) across American Samoa in 2015 (NCEI Accession 0157752)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across American Samoa in 2015 as a part of...

  11. National Coral Reef Monitoring Program: benthic images collected from stratified random sites (StRS) across the Hawaiian Archipelago from 2016-07-13 to 2016-09-27 (NCEI Accession 0164293)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the...

  12. National Coral Reef Monitoring Program: Benthic Images Collected from Stratified Random Sites (StRS) across Wake Island from 2014-03-16 to 2014-03-20 (NCEI Accession 0159157)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across Wake...

  13. National Coral Reef Monitoring Program: Benthic Images Collected from Stratified Random Sites (StRS) across the Hawaiian Archipelago from 2013-05-01 to 2013-10-31 (NCEI Accession 0159144)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the...

  14. National Coral Reef Monitoring Program: benthic cover derived from analysis of benthic images collected during stratified random surveys (StRS) across the Hawaiian Archipelago from 2016-07-13 to 2016-09-27 (NCEI Accession 0164295)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the Hawaiian archipelago in 2016 as a...

  15. National Coral Reef Monitoring Program: Benthic Cover Derived from Analysis of Benthic Images Collected during Stratified Random Surveys (StRS) across the Hawaiian Archipelago in 2013 (NCEI Accession 0159140)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the Hawaiian archipelago in 2013 as a...

  16. National Coral Reef Monitoring Program: Benthic Cover Derived from Analysis of Benthic Images Collected during Stratified Random Surveys (StRS) across the Pacific Remote Island Areas from 2015-01-26 to 2015-04-28 (NCEI Accession 0159165)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the Pacific Remote Island Areas since...

  17. National Coral Reef Monitoring Program: Benthic Images Collected from Stratified Random Sites (StRS) across the Mariana Archipelago from 2014-03-25 to 2014-05-07 (NCEI Accession 0159142)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The data described here are benthic habitat imagery that result from benthic photo-quadrat surveys conducted along transects at stratified random sites across the...

  18. Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

    Science.gov (United States)

    Madsen, Kristine; Linchey, Jennifer; Gerstein, Dana; Ross, Michelle; Myers, Esther; Brown, Katie; Crawford, Patricia

    2015-08-01

    Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; pchildren's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

  19. On the limiting characteristics of quantum random number generators at various clusterings of photocounts

    Science.gov (United States)

    Molotkov, S. N.

    2017-03-01

    Various methods for the clustering of photocounts constituting a sequence of random numbers are considered. It is shown that the clustering of photocounts resulting in the Fermi-Dirac distribution makes it possible to achieve the theoretical limit of the random number generation rate.

  20. Timeliness and completeness of measles vaccination among children in rural areas of Guangxi, China: A stratified three-stage cluster survey.

    Science.gov (United States)

    Tang, Xianyan; Geater, Alan; McNeil, Edward; Zhou, Hongxia; Deng, Qiuyun; Dong, Aihu

    2017-07-01

    Large-scale outbreaks of measles occurred in 2013 and 2014 in rural Guangxi, a region in Southwest China with high coverage for measles-containing vaccine (MCV). This study aimed to estimate the timely vaccination coverage, the timely-and-complete vaccination coverage, and the median delay period for MCV among children aged 18-54 months in rural Guangxi. Based on quartiles of measles incidence during 2011-2013, a stratified three-stage cluster survey was conducted from June through August 2015. Using weighted estimation and finite population correction, vaccination coverage and 95% confidence intervals (CIs) were calculated. Weighted Kaplan-Meier analyses were used to estimate the median delay periods for the first (MCV1) and second (MCV2) doses of the vaccine. A total of 1216 children were surveyed. The timely vaccination coverage rate was 58.4% (95% CI, 54.9%-62.0%) for MCV1, and 76.9% (95% CI, 73.6%-80.0%) for MCV2. The timely-and-complete vaccination coverage rate was 47.4% (95% CI, 44.0%-51.0%). The median delay period was 32 (95% CI, 27-38) days for MCV1, and 159 (95% CI, 118-195) days for MCV2. The timeliness and completeness of measles vaccination was low, and the median delay period was long among children in rural Guangxi. Incorporating the timeliness and completeness into official routine vaccination coverage statistics may help appraise the coverage of vaccination in China. Copyright © 2017 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

  1. Timeliness and completeness of measles vaccination among children in rural areas of Guangxi, China: A stratified three-stage cluster survey

    Directory of Open Access Journals (Sweden)

    Xianyan Tang

    2017-07-01

    Full Text Available Background: Large-scale outbreaks of measles occurred in 2013 and 2014 in rural Guangxi, a region in Southwest China with high coverage for measles-containing vaccine (MCV. This study aimed to estimate the timely vaccination coverage, the timely-and-complete vaccination coverage, and the median delay period for MCV among children aged 18–54 months in rural Guangxi. Methods: Based on quartiles of measles incidence during 2011–2013, a stratified three-stage cluster survey was conducted from June through August 2015. Using weighted estimation and finite population correction, vaccination coverage and 95% confidence intervals (CIs were calculated. Weighted Kaplan–Meier analyses were used to estimate the median delay periods for the first (MCV1 and second (MCV2 doses of the vaccine. Results: A total of 1216 children were surveyed. The timely vaccination coverage rate was 58.4% (95% CI, 54.9%–62.0% for MCV1, and 76.9% (95% CI, 73.6%–80.0% for MCV2. The timely-and-complete vaccination coverage rate was 47.4% (95% CI, 44.0%–51.0%. The median delay period was 32 (95% CI, 27–38 days for MCV1, and 159 (95% CI, 118–195 days for MCV2. Conclusions: The timeliness and completeness of measles vaccination was low, and the median delay period was long among children in rural Guangxi. Incorporating the timeliness and completeness into official routine vaccination coverage statistics may help appraise the coverage of vaccination in China.

  2. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR – implications for therapeutic failure and drug resistance

    Directory of Open Access Journals (Sweden)

    Vongsack Latsamy

    2009-07-01

    Full Text Available Abstract Background Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines in the Lao PDR (Laos. Methods In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC, mass spectrometry (MS, X-ray diffractometry and pollen analysis. Results Of 180 outlets sampled, 25 (13.9% sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68–97% sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8% fakes contained detectable amounts of artemisinin (0.26–115.7 mg/tablet. Conclusion This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention.

  3. A systematic review of the usage of flow diagram in cluster randomized trials

    Directory of Open Access Journals (Sweden)

    Kostić M.

    2014-01-01

    Full Text Available Flow diagram represent an integral part of consolidated standards of reporting trials (CONSORT. Its use in reporting cluster randomization trials is highly recommended. The aim of this article is to present frequency of the use of flow diagram in cluster randomized trials in accordance with standards of reporting. The team has researched Medline database and singled-out 474 studies with cluster randomization for analysis. The studies were reviewed to identify the use of graphic representation, compliance with standards of reporting and the date when study was published. Depending from its duration, studies were divided on completed, and those still ongoing. Usage of CONSORT is recorded in 145 (31% literature units. Frequency of flow diagram was statistically much higher in studies which were in compliance with standards (86,2%, in comparison to those which did not use CONSORT guidelines (71,4%, as well as in completed studies (81,2% in comparison to pilot project studies (54,3%. Number of cluster randomized trials gathered through MEDLINE's search of key words 'cluster randomized trial [ti]' and 'cluster randomised trial [ti]', as well as the use of CONSORT in the reports of cluster randomized trials, are showing linear growth over time (p<0,001. Frequency of flow diagram is higher in the reports of cluster randomized trials that were done in accordance with the standards of reporting.

  4. Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy: a stratified single-blind randomized controlled trial.

    Science.gov (United States)

    Herrero, Pablo; Gómez-Trullén, Eva M; Asensio, Angel; García, Elena; Casas, Roberto; Monserrat, Esther; Pandyan, Anand

    2012-12-01

    To investigate whether hippotherapy (when applied by a simulator) improves postural control and balance in children with cerebral palsy. Stratified single-blind randomized controlled trial with an independent assessor. Stratification was made by gross motor function classification system levels, and allocation was concealed. Children between 4 and 18 years old with cerebral palsy. Participants were randomized to an intervention (simulator ON) or control (simulator OFF) group after getting informed consent. Treatment was provided once a week (15 minutes) for 10 weeks. Gross Motor Function Measure (dimension B for balance and the Total Score) and Sitting Assessment Scale were carried out at baseline (prior to randomization), end of intervention and 12 weeks after completing the intervention. Thirty-eight children participated. The groups were balanced at baseline. Sitting balance (measured by dimension B of the Gross Motor Function Measure) improved significantly in the treatment group (effect size = 0.36; 95% CI 0.01-0.71) and the effect size was greater in the severely disabled group (effect size = 0.80; 95% CI 0.13-1.47). The improvements in sitting balance were not maintained over the follow-up period. Changes in the total score of the Gross Motor Function Measure and the Sitting Assessment Scale were not significant. Hippotherapy with a simulator can improve sitting balance in cerebral palsy children who have higher levels of disability. However, this did not lead to a change in the overall function of these children (Gross Motor Function Classification System level V).

  5. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  6. 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.

  7. Motivational Interviewing for Workers with Disabling Musculoskeletal Disorders: Results of a Cluster Randomized Control Trial.

    Science.gov (United States)

    Park, Joanne; Esmail, Shaniff; Rayani, Fahreen; Norris, Colleen M; Gross, Douglas P

    2018-06-01

    Purpose Although functional restoration programs appear effective in assisting injured workers to return-to-work (RTW) after a work related musculoskeletal (MSK) disorder, the addition of Motivational Interviewing (MI) to these programs may result in higher RTW. Methods We conducted a cluster randomized controlled trial with claimants attending an occupational rehabilitation facility from November 17, 2014 to June 30, 2015. Six clinicians provided MI in addition to the standard functional restoration program and formed an intervention group. Six clinicians continued to provide the standard functional restoration program based on graded activity, therapeutic exercise, and workplace accommodations. Independent t tests and chi square analysis were used to compare groups. Multivariable logistic regression was used to obtain the odds ratio of claimants' confirmed RTW status at time of program discharge. Results 728 workers' compensation claimants with MSK disorders were entered into 1 of 12 therapist clusters (MI group = 367, control group = 361). Claimants were predominantly employed (72.7%), males (63.2%), with moderate levels of pain and disability (mean pain VAS = 5.0/10 and mean Pain Disability Index = 48/70). Claimants were stratified based on job attachment status. The proportion of successful RTW at program discharge was 12.1% higher for unemployed workers in the intervention group (intervention group 21.6 vs. 9.5% in control, p = 0.03) and 3.0% higher for job attached workers compared to the control group (intervention group 97.1 vs. 94.1% in control, p = 0.10). Adherence to MI was mixed, but RTW was significantly higher among MI-adherent clinicians. The odds ratio for unemployed claimants was 2.64 (0.69-10.14) and 2.50 (0.68-9.14) for employed claimants after adjusting for age, sex, pain intensity, perceived disability, and therapist cluster. Conclusion MI in addition to routine functional restoration is more effective than routine

  8. Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial.

    Science.gov (United States)

    Lee, Myung Kyung; Park, Bu Kyung

    2018-01-01

    This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums.

  9. 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

  10. 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

  11. Evaluation of stability of k-means cluster ensembles with respect to random initialization.

    Science.gov (United States)

    Kuncheva, Ludmila I; Vetrov, Dmitry P

    2006-11-01

    Many clustering algorithms, including cluster ensembles, rely on a random component. Stability of the results across different runs is considered to be an asset of the algorithm. The cluster ensembles considered here are based on k-means clusterers. Each clusterer is assigned a random target number of clusters, k and is started from a random initialization. Here, we use 10 artificial and 10 real data sets to study ensemble stability with respect to random k, and random initialization. The data sets were chosen to have a small number of clusters (two to seven) and a moderate number of data points (up to a few hundred). Pairwise stability is defined as the adjusted Rand index between pairs of clusterers in the ensemble, averaged across all pairs. Nonpairwise stability is defined as the entropy of the consensus matrix of the ensemble. An experimental comparison with the stability of the standard k-means algorithm was carried out for k from 2 to 20. The results revealed that ensembles are generally more stable, markedly so for larger k. To establish whether stability can serve as a cluster validity index, we first looked at the relationship between stability and accuracy with respect to the number of clusters, k. We found that such a relationship strongly depends on the data set, varying from almost perfect positive correlation (0.97, for the glass data) to almost perfect negative correlation (-0.93, for the crabs data). We propose a new combined stability index to be the sum of the pairwise individual and ensemble stabilities. This index was found to correlate better with the ensemble accuracy. Following the hypothesis that a point of stability of a clustering algorithm corresponds to a structure found in the data, we used the stability measures to pick the number of clusters. The combined stability index gave best results.

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

    Science.gov (United States)

    Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

    2017-01-01

    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.

  13. Effectiveness of a two-step population-based osteoporosis screening program using FRAX: the randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study.

    Science.gov (United States)

    Rubin, K H; Rothmann, M J; Holmberg, T; Høiberg, M; Möller, S; Barkmann, R; Glüer, C C; Hermann, A P; Bech, M; Gram, J; Brixen, K

    2018-03-01

    The Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study investigated the effectiveness of a two-step screening program for osteoporosis in women. We found no overall reduction in fractures from systematic screening compared to the current case-finding strategy. The group of moderate- to high-risk women, who accepted the invitation to DXA, seemed to benefit from the program. The purpose of the ROSE study was to investigate the effectiveness of a two-step population-based osteoporosis screening program using the Fracture Risk Assessment Tool (FRAX) derived from a self-administered questionnaire to select women for DXA scan. After the scanning, standard osteoporosis management according to Danish national guidelines was followed. Participants were randomized to either screening or control group, and randomization was stratified according to age and area of residence. Inclusion took place from February 2010 to November 2011. Participants received a self-administered questionnaire, and women in the screening group with a FRAX score ≥ 15% (major osteoporotic fractures) were invited to a DXA scan. Primary outcome was incident clinical fractures. Intention-to-treat analysis and two per-protocol analyses were performed. A total of 3416 fractures were observed during a median follow-up of 5 years. No significant differences were found in the intention-to-treat analyses with 34,229 women included aged 65-80 years. The per-protocol analyses showed a risk reduction in the group that underwent DXA scanning compared to women in the control group with a FRAX ≥ 15%, in regard to major osteoporotic fractures, hip fractures, and all fractures. The risk reduction was most pronounced for hip fractures (adjusted SHR 0.741, p = 0.007). Compared to an office-based case-finding strategy, the two-step systematic screening strategy had no overall effect on fracture incidence. The two-step strategy seemed, however, to be beneficial in the group of women who were

  14. 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.

  15. 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.

  16. 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

    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...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

  17. Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

    Science.gov (United States)

    Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

    2017-01-01

    Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

  18. Universal Prevention for Anxiety and Depressive Symptoms in Children: A Meta-analysis of Randomized and Cluster-Randomized Trials.

    Science.gov (United States)

    Ahlen, Johan; Lenhard, Fabian; Ghaderi, Ata

    2015-12-01

    Although under-diagnosed, anxiety and depression are among the most prevalent psychiatric disorders in children and adolescents, leading to severe impairment, increased risk of future psychiatric problems, and a high economic burden to society. Universal prevention may be a potent way to address these widespread problems. There are several benefits to universal relative to targeted interventions because there is limited knowledge as to how to screen for anxiety and depression in the general population. Earlier meta-analyses of the prevention of depression and anxiety symptoms among children suffer from methodological inadequacies such as combining universal, selective, and indicated interventions in the same analyses, and comparing cluster-randomized trials with randomized trials without any correction for clustering effects. The present meta-analysis attempted to determine the effectiveness of universal interventions to prevent anxiety and depressive symptoms after correcting for clustering effects. A systematic search of randomized studies in PsychINFO, Cochrane Library, and Google Scholar resulted in 30 eligible studies meeting inclusion criteria, namely peer-reviewed, randomized or cluster-randomized trials of universal interventions for anxiety and depressive symptoms in school-aged children. Sixty-three percent of the studies reported outcome data regarding anxiety and 87 % reported outcome data regarding depression. Seventy percent of the studies used randomization at the cluster level. There were small but significant effects regarding anxiety (.13) and depressive (.11) symptoms as measured at immediate posttest. At follow-up, which ranged from 3 to 48 months, effects were significantly larger than zero regarding depressive (.07) but not anxiety (.11) symptoms. There was no significant moderation effect of the following pre-selected variables: the primary aim of the intervention (anxiety or depression), deliverer of the intervention, gender distribution

  19. Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models.

    Science.gov (United States)

    Liu, Jingxia; Colditz, Graham A

    2018-05-01

    There is growing interest in conducting cluster randomized trials (CRTs). For simplicity in sample size calculation, the cluster sizes are assumed to be identical across all clusters. However, equal cluster sizes are not guaranteed in practice. Therefore, the relative efficiency (RE) of unequal versus equal cluster sizes has been investigated when testing the treatment effect. One of the most important approaches to analyze a set of correlated data is the generalized estimating equation (GEE) proposed by Liang and Zeger, in which the "working correlation structure" is introduced and the association pattern depends on a vector of association parameters denoted by ρ. In this paper, we utilize GEE models to test the treatment effect in a two-group comparison for continuous, binary, or count data in CRTs. The variances of the estimator of the treatment effect are derived for the different types of outcome. RE is defined as the ratio of variance of the estimator of the treatment effect for equal to unequal cluster sizes. We discuss a commonly used structure in CRTs-exchangeable, and derive the simpler formula of RE with continuous, binary, and count outcomes. Finally, REs are investigated for several scenarios of cluster size distributions through simulation studies. We propose an adjusted sample size due to efficiency loss. Additionally, we also propose an optimal sample size estimation based on the GEE models under a fixed budget for known and unknown association parameter (ρ) in the working correlation structure within the cluster. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. 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.

  1. 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.

    1994-07-01

    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 (>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.

  2. Computer-Based Driving in Dementia Decision Tool With Mail Support: Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Rapoport, Mark J; Zucchero Sarracini, Carla; Kiss, Alex; Lee, Linda; Byszewski, Anna; Seitz, Dallas P; Vrkljan, Brenda; Molnar, Frank; Herrmann, Nathan; Tang-Wai, David F; Frank, Christopher; Henry, Blair; Pimlott, Nicholas; Masellis, Mario; Naglie, Gary

    2018-05-25

    Physicians often find significant challenges in assessing automobile driving in persons with mild cognitive impairment and mild dementia and deciding when to report to transportation administrators. Care must be taken to balance the safety of patients and other road users with potential negative effects of issuing such reports. The aim of this study was to assess whether a computer-based Driving in Dementia Decision Tool (DD-DT) increased appropriate reporting of patients with mild dementia or mild cognitive impairment to transportation administrators. The study used a parallel-group cluster nonblinded randomized controlled trial design to test a multifaceted knowledge translation intervention. The intervention included a computer-based decision support system activated by the physician-user, which provides a recommendation about whether to report patients with mild dementia or mild cognitive impairment to transportation administrators, based on an algorithm derived from earlier work. The intervention also included a mailed educational package and Web-based specialized reporting forms. Specialists and family physicians with expertise in dementia or care of the elderly were stratified by sex and randomized to either use the DD-DT or a control version of the tool that required identical data input as the intervention group, but instead generated a generic reminder about the reporting legislation in Ontario, Canada. The trial ran from September 9, 2014 to January 29, 2016, and the primary outcome was the number of reports made to the transportation administrators concordant with the algorithm. A total of 69 participating physicians were randomized, and 36 of these used the DD-DT; 20 of the 35 randomized to the intervention group used DD-DT with 114 patients, and 16 of the 34 randomized to the control group used it with 103 patients. The proportion of all assessed patients reported to the transportation administrators concordant with recommendation did not differ

  3. 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

  4. Assessment of Random Assignment in Training and Test Sets using Generalized Cluster Analysis Technique

    Directory of Open Access Journals (Sweden)

    Sorana D. BOLBOACĂ

    2011-06-01

    Full Text Available Aim: The properness of random assignment of compounds in training and validation sets was assessed using the generalized cluster technique. Material and Method: A quantitative Structure-Activity Relationship model using Molecular Descriptors Family on Vertices was evaluated in terms of assignment of carboquinone derivatives in training and test sets during the leave-many-out analysis. Assignment of compounds was investigated using five variables: observed anticancer activity and four structure descriptors. Generalized cluster analysis with K-means algorithm was applied in order to investigate if the assignment of compounds was or not proper. The Euclidian distance and maximization of the initial distance using a cross-validation with a v-fold of 10 was applied. Results: All five variables included in analysis proved to have statistically significant contribution in identification of clusters. Three clusters were identified, each of them containing both carboquinone derivatives belonging to training as well as to test sets. The observed activity of carboquinone derivatives proved to be normal distributed on every. The presence of training and test sets in all clusters identified using generalized cluster analysis with K-means algorithm and the distribution of observed activity within clusters sustain a proper assignment of compounds in training and test set. Conclusion: Generalized cluster analysis using the K-means algorithm proved to be a valid method in assessment of random assignment of carboquinone derivatives in training and test sets.

  5. 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.

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

    Science.gov (United States)

    Berger, Noam; Mukherjee, Chiranjib; Okamura, Kazuki

    2018-03-01

    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.

  7. Person mobility in the design and analysis of cluster-randomized cohort prevention trials.

    Science.gov (United States)

    Vuchinich, Sam; Flay, Brian R; Aber, Lawrence; Bickman, Leonard

    2012-06-01

    Person mobility is an inescapable fact of life for most cluster-randomized (e.g., schools, hospitals, clinic, cities, state) cohort prevention trials. Mobility rates are an important substantive consideration in estimating the effects of an intervention. In cluster-randomized trials, mobility rates are often correlated with ethnicity, poverty and other variables associated with disparity. This raises the possibility that estimated intervention effects may generalize to only the least mobile segments of a population and, thus, create a threat to external validity. Such mobility can also create threats to the internal validity of conclusions from randomized trials. Researchers must decide how to deal with persons who leave study clusters during a trial (dropouts), persons and clusters that do not comply with an assigned intervention, and persons who enter clusters during a trial (late entrants), in addition to the persons who remain for the duration of a trial (stayers). Statistical techniques alone cannot solve the key issues of internal and external validity raised by the phenomenon of person mobility. This commentary presents a systematic, Campbellian-type analysis of person mobility in cluster-randomized cohort prevention trials. It describes four approaches for dealing with dropouts, late entrants and stayers with respect to data collection, analysis and generalizability. The questions at issue are: 1) From whom should data be collected at each wave of data collection? 2) Which cases should be included in the analyses of an intervention effect? and 3) To what populations can trial results be generalized? The conclusions lead to recommendations for the design and analysis of future cluster-randomized cohort prevention trials.

  8. A semi-supervised method to detect seismic random noise with fuzzy GK clustering

    International Nuclear Information System (INIS)

    Hashemi, Hosein; Javaherian, Abdolrahim; Babuska, Robert

    2008-01-01

    We present a new method to detect random noise in seismic data using fuzzy Gustafson–Kessel (GK) clustering. First, using an adaptive distance norm, a matrix is constructed from the observed seismic amplitudes. The next step is to find centres of ellipsoidal clusters and construct a partition matrix which determines the soft decision boundaries between seismic events and random noise. The GK algorithm updates the cluster centres in order to iteratively minimize the cluster variance. Multiplication of the fuzzy membership function with values of each sample yields new sections; we name them 'clustered sections'. The seismic amplitude values of the clustered sections are given in a way to decrease the level of noise in the original noisy seismic input. In pre-stack data, it is essential to study the clustered sections in a f–k domain; finding the quantitative index for weighting the post-stack data needs a similar approach. Using the knowledge of a human specialist together with the fuzzy unsupervised clustering, the method is a semi-supervised random noise detection. The efficiency of this method is investigated on synthetic and real seismic data for both pre- and post-stack data. The results show a significant improvement of the input noisy sections without harming the important amplitude and phase information of the original data. The procedure for finding the final weights of each clustered section should be carefully done in order to keep almost all the evident seismic amplitudes in the output section. The method interactively uses the knowledge of the seismic specialist in detecting the noise

  9. Handling missing data in cluster randomized trials: A demonstration of multiple imputation with PAN through SAS

    Directory of Open Access Journals (Sweden)

    Jiangxiu Zhou

    2014-09-01

    Full Text Available The purpose of this study is to demonstrate a way of dealing with missing data in clustered randomized trials by doing multiple imputation (MI with the PAN package in R through SAS. The procedure for doing MI with PAN through SAS is demonstrated in detail in order for researchers to be able to use this procedure with their own data. An illustration of the technique with empirical data was also included. In this illustration thePAN results were compared with pairwise deletion and three types of MI: (1 Normal Model (NM-MI ignoring the cluster structure; (2 NM-MI with dummy-coded cluster variables (fixed cluster structure; and (3 a hybrid NM-MI which imputes half the time ignoring the cluster structure, and the other half including the dummy-coded cluster variables. The empirical analysis showed that using PAN and the other strategies produced comparable parameter estimates. However, the dummy-coded MI overestimated the intraclass correlation, whereas MI ignoring the cluster structure and the hybrid MI underestimated the intraclass correlation. When compared with PAN, the p-value and standard error for the treatment effect were higher with dummy-coded MI, and lower with MI ignoring the clusterstructure, the hybrid MI approach, and pairwise deletion. Previous studies have shown that NM-MI is not appropriate for handling missing data in clustered randomized trials. This approach, in addition to the pairwise deletion approach, leads to a biased intraclass correlation and faultystatistical conclusions. Imputation in clustered randomized trials should be performed with PAN. We have demonstrated an easy way for using PAN through SAS.

  10. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Obinna Onwujekwe

    Full Text Available The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT. Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs with basic instruction (control; RDTs with provider training (provider arm; and RDTs with provider training plus a school-based community intervention (provider-school arm. The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93% of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36: stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26 in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19 in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47. Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.ClinicalTrials.gov NCT01350752.

  11. 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.

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

    Directory of Open Access Journals (Sweden)

    Kunihiro Yamagata

    Full Text Available 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 (p<0.01. The average eGFR deterioration rate tended to be lower in group B (group A: 2.6±5.8 ml/min/1.73 m2/year, group B: 2.4±5.1 ml/min/1.73 m2/year, p = 0.07. A significant difference in eGFR deterioration rate was observed in subjects with Stage 3 CKD (group A: 2.4±5.9 ml/min/1.73 m2/year, group B: 1.9±4.4 ml/min/1.73 m2/year, p = 0.03.Our care

  13. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    OpenAIRE

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-01-01

    Abstract Objective To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs...

  14. Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.

    Science.gov (United States)

    Johnsen, Tone Langjordet; Eriksen, Hege Randi; Baste, Valborg; Indahl, Aage; Odeen, Magnus; Tveito, Torill Helene

    2018-05-21

    Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.

  15. RRW: repeated random walks on genome-scale protein networks for local cluster discovery

    Directory of Open Access Journals (Sweden)

    Can Tolga

    2009-09-01

    Full Text Available Abstract Background We propose an efficient and biologically sensitive algorithm based on repeated random walks (RRW for discovering functional modules, e.g., complexes and pathways, within large-scale protein networks. Compared to existing cluster identification techniques, RRW implicitly makes use of network topology, edge weights, and long range interactions between proteins. Results We apply the proposed technique on a functional network of yeast genes and accurately identify statistically significant clusters of proteins. We validate the biological significance of the results using known complexes in the MIPS complex catalogue database and well-characterized biological processes. We find that 90% of the created clusters have the majority of their catalogued proteins belonging to the same MIPS complex, and about 80% have the majority of their proteins involved in the same biological process. We compare our method to various other clustering techniques, such as the Markov Clustering Algorithm (MCL, and find a significant improvement in the RRW clusters' precision and accuracy values. Conclusion RRW, which is a technique that exploits the topology of the network, is more precise and robust in finding local clusters. In addition, it has the added flexibility of being able to find multi-functional proteins by allowing overlapping clusters.

  16. Potts Model with Invisible Colors : Random-Cluster Representation and Pirogov–Sinai Analysis

    NARCIS (Netherlands)

    Enter, Aernout C.D. van; Iacobelli, Giulio; Taati, Siamak

    We study a recently introduced variant of the ferromagnetic Potts model consisting of a ferromagnetic interaction among q “visible” colors along with the presence of r non-interacting “invisible” colors. We introduce a random-cluster representation for the model, for which we prove the existence of

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

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

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

  18. A pilot cluster randomized controlled trial of structured goal-setting following stroke.

    Science.gov (United States)

    Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

    2012-04-01

    To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

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

    Science.gov (United States)

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

    2015-01-01

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

  20. 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 ...

  1. 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

  2. A simple sample size formula for analysis of covariance in cluster randomized trials.

    NARCIS (Netherlands)

    Teerenstra, S.; Eldridge, S.; Graff, M.J.; Hoop, E. de; Borm, G.F.

    2012-01-01

    For cluster randomized trials with a continuous outcome, the sample size is often calculated as if an analysis of the outcomes at the end of the treatment period (follow-up scores) would be performed. However, often a baseline measurement of the outcome is available or feasible to obtain. An

  3. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Science.gov (United States)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  4. Dynamic Load Balanced Clustering using Elitism based Random Immigrant Genetic Approach for Wireless Sensor Networks

    Directory of Open Access Journals (Sweden)

    K. Mohaideen Pitchai

    2017-07-01

    Full Text Available Wireless Sensor Network (WSN consists of a large number of small sensors with restricted energy. Prolonged network lifespan, scalability, node mobility and load balancing are important needs for several WSN applications. Clustering the sensor nodes is an efficient technique to reach these goals. WSN have the characteristics of topology dynamics because of factors like energy conservation and node movement that leads to Dynamic Load Balanced Clustering Problem (DLBCP. In this paper, Elitism based Random Immigrant Genetic Approach (ERIGA is proposed to solve DLBCP which adapts to topology dynamics. ERIGA uses the dynamic Genetic Algorithm (GA components for solving the DLBCP. The performance of load balanced clustering process is enhanced with the help of this dynamic GA. As a result, the ERIGA achieves to elect suitable cluster heads which balances the network load and increases the lifespan of the network.

  5. 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

    2016-11-30

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

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

    NARCIS (Netherlands)

    Vlemmix, Floortje; Rosman, Ageeth N.; Rijnders, Marlies E.; Beuckens, Antje; Opmeer, Brent C.; Mol, Ben W. J.; Kok, Marjolein; Fleuren, Margot A. H.

    2015-01-01

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

  7. 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

  8. How large are the consequences of covariate imbalance in cluster randomized trials: a simulation study with a continuous outcome and a binary covariate at the cluster level.

    Science.gov (United States)

    Moerbeek, Mirjam; van Schie, Sander

    2016-07-11

    The number of clusters in a cluster randomized trial is often low. It is therefore likely random assignment of clusters to treatment conditions results in covariate imbalance. There are no studies that quantify the consequences of covariate imbalance in cluster randomized trials on parameter and standard error bias and on power to detect treatment effects. The consequences of covariance imbalance in unadjusted and adjusted linear mixed models are investigated by means of a simulation study. The factors in this study are the degree of imbalance, the covariate effect size, the cluster size and the intraclass correlation coefficient. The covariate is binary and measured at the cluster level; the outcome is continuous and measured at the individual level. The results show covariate imbalance results in negligible parameter bias and small standard error bias in adjusted linear mixed models. Ignoring the possibility of covariate imbalance while calculating the sample size at the cluster level may result in a loss in power of at most 25 % in the adjusted linear mixed model. The results are more severe for the unadjusted linear mixed model: parameter biases up to 100 % and standard error biases up to 200 % may be observed. Power levels based on the unadjusted linear mixed model are often too low. The consequences are most severe for large clusters and/or small intraclass correlation coefficients since then the required number of clusters to achieve a desired power level is smallest. The possibility of covariate imbalance should be taken into account while calculating the sample size of a cluster randomized trial. Otherwise more sophisticated methods to randomize clusters to treatments should be used, such as stratification or balance algorithms. All relevant covariates should be carefully identified, be actually measured and included in the statistical model to avoid severe levels of parameter and standard error bias and insufficient power levels.

  9. Using the 4 Pillars™ Immunization Toolkit to Increase Pneumococcal Immunizations for Older Adults: A Cluster Randomized Trial

    Science.gov (United States)

    Zimmerman, Richard K.; Brown, Anthony E.; Pavlik, Valory N.; Moehling, Krissy K.; Raviotta, Jonathan M.; Lin, Chyongchiou J.; Zhang, Song; Hawk, Mary; Kyle, Shakala; Patel, Suchita; Ahmed, Faruque; Nowalk, Mary Patricia

    2016-01-01

    BACKGROUND Quality improvement in primary care has focused on improving adult immunization. OBJECTIVES Test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars™ Immunization Toolkit, to increase adult pneumococcal vaccination. DESIGN Randomized controlled cluster trial (RCCT) in Year 1 (6/1/2013–5/31/2014) and a pre-post study in Year 2 (6/1/2014–1/31/2015) with data analyzed in 2016. Baseline year was 6/1/2012–5/31/2013. Demographic and vaccination data were derived from de-identified EMR extractions. SETTING 25 primary care practices stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n=13) or Year 2 (n=12). PARTICIPANTS A cohort of 18,107 patients ≥65 years at baseline with a mean age of 74.2 years; 60.7% were women, 16.5% were non-white and 15.7% were Hispanic. INTERVENTION The Toolkit, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) rates and percentage point (PP) changes. RESULTS In the RCCT, all intervention and control groups had significantly higher PPSV vaccination rates with average increases ranging from 6.5–8.7 PP (P<0.01). The intervention was not related to higher likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh, but not in Houston. CONCLUSION In a randomized controlled cluster trial, both intervention and control groups increased PPSV among adults ≥65 years. In a pre-post study, private primary care practices using the 4 Pillars™ Immunization Toolkit significantly improved PPSV and PCV uptake compared with practices that were in the maintenance phase of the study. PMID:27755655

  10. Bond percolation on a class of correlated and clustered random graphs

    International Nuclear Information System (INIS)

    Allard, A; Hébert-Dufresne, L; Noël, P-A; Marceau, V; Dubé, L J

    2012-01-01

    We introduce a formalism for computing bond percolation properties of a class of correlated and clustered random graphs. This class of graphs is a generalization of the configuration model where nodes of different types are connected via different types of hyperedges, edges that can link more than two nodes. We argue that the multitype approach coupled with the use of clustered hyperedges can reproduce a wide spectrum of complex patterns, and thus enhances our capability to model real complex networks. As an illustration of this claim, we use our formalism to highlight unusual behaviours of the size and composition of the components (small and giant) in a synthetic, albeit realistic, social network. (paper)

  11. 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

  12. Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial.

    Science.gov (United States)

    Zimmerman, Richard K; Brown, Anthony E; Pavlik, Valory N; Moehling, Krissy K; Raviotta, Jonathan M; Lin, Chyongchiou J; Zhang, Song; Hawk, Mary; Kyle, Shakala; Patel, Suchita; Ahmed, Faruque; Nowalk, Mary Patricia

    2017-01-01

    To test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars Practice Transformation Program, to increase adult pneumococcal vaccination. Randomized controlled cluster trial (RCCT) in Year 1 (June 1, 2013 to May 31, 2014) and pre-post study in Year 2 (June 1, 2014 to January 31, 2015) with data analyzed in 2016. Baseline year was June 1, 2012, to May 31, 2013. Demographic and vaccination data were derived from deidentified electronic medical record extractions. Primary care practices (n = 25) stratified according to metropolitan area (Houston, Pittsburgh), location (rural, urban, suburban), and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n = 13) or Year 2 (n = 12). Individuals aged 65 and older at baseline (N = 18,107; mean age 74.2; 60.7% female, 16.5% non-white, 15.7% Hispanic). The 4 Pillars Program, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) vaccination rates and percentage point (PP) changes in vaccination rates. In the Year 1 RCCT, PPSV vaccination rates increased significantly in all intervention and control groups, with average increases ranging from 6.5 to 8.7 PP (P < .001). The intervention was not related to greater likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh but not in Houston. In a RCCT, PPSV vaccination rates increased in the intervention and control groups in Year 1. In a pre-post study, private primary care practices actively participating in the 4 Pillars Practice Transformation Program improved PPSV and PCV uptake significantly more than practices that were in the maintenance phase of the study. © 2016, Copyright the Authors Journal compilation © 2016, The American

  13. Ab initio random structure search for 13-atom clusters of fcc elements

    International Nuclear Information System (INIS)

    Chou, J P; Hsing, C R; Wei, C M; Cheng, C; Chang, C M

    2013-01-01

    The 13-atom metal clusters of fcc elements (Al, Rh, Ir, Ni, Pd, Pt, Cu, Ag, Au) were studied by density functional theory calculations. The global minima were searched for by the ab initio random structure searching method. In addition to some new lowest-energy structures for Pd 13 and Au 13 , we found that the effective coordination numbers of the lowest-energy clusters would increase with the ratio of the dimer-to-bulk bond length. This correlation, together with the electronic structures of the lowest-energy clusters, divides the 13-atom clusters of these fcc elements into two groups (except for Au 13 , which prefers a two-dimensional structure due to the relativistic effect). Compact-like clusters that are composed exclusively of triangular motifs are preferred for elements without d-electrons (Al) or with (nearly) filled d-band electrons (Ni, Pd, Cu, Ag). Non-compact clusters composed mainly of square motifs connected by some triangular motifs (Rh, Ir, Pt) are favored for elements with unfilled d-band electrons. (paper)

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

    DEFF Research Database (Denmark)

    Sokolowski, Ineta; Ørnbøl, Eva; Rosendal, Marianne

    studies have used non-valid analysis of skewed data. We propose two different methods to compare mean cost in two groups. Firstly, we use a non-parametric bootstrap method where the re-sampling takes place on two levels in order to take into account the cluster effect. Secondly, we proceed with a log......-transformation of the cost data and apply the normal theory on these data. Again we try to account for the cluster effect. The performance of these two methods is investigated in a simulation study. The advantages and disadvantages of the different approaches are discussed.......  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...

  15. Non-random intrachromosomal distribution of radiation-induced chromatid aberrations in Vicia faba. [Aberration clustering

    Energy Technology Data Exchange (ETDEWEB)

    Schubert, I; Rieger, R [Akademie der Wissenschaften der DDR, Gatersleben. Zentralinst. fuer Genetik und Kulturpflanzenforschung

    1976-04-01

    A reconstructed karyotype of Vicia faba, with all chromosomes individually distinguishable, was treated with X-rays, fast neutrons, (/sup 3/H) uridine (/sup 3/HU). The distribution within metaphase chromosomes of induced chromatid aberrations was non-random for all agents used. Aberration clustering, in part agent specific, occurred in chromosome segments containing heterochromatin as defined by the presence of G bands. The pattern of aberration clustering found after treatment with /sup 3/HU did not allow the recognition of chromosome regions active in transcription during treatment. Furthermore, it was impossible to obtain unambiguous indications of the presence of AT- and GC-base clusters from the patterns of /sup 3/HT- and /sup 3/HC-induced chromatid aberrations, respectively. Possible reasons underlying these observations are discussed.

  16. The covariance matrix of the Potts model: A random cluster analysis

    International Nuclear Information System (INIS)

    Borgs, C.; Chayes, J.T.

    1996-01-01

    We consider the covariance matrix, G mn = q 2 x ,m); δ(σ y ,n)>, of the d-dimensional q-states Potts model, rewriting it in the random cluster representation of Fortuin and Kasteleyn. In many of the q ordered phases, we identify the eigenvalues of this matrix both in terms of representations of the unbroken symmetry group of the model and in terms of random cluster connectivities and covariances, thereby attributing algebraic significance to these stochastic geometric quantities. We also show that the correlation length and the correlation length corresponding to the decay rate of one on the eigenvalues in the same as the inverse decay rate of the diameter of finite clusters. For dimension of d=2, we show that this correlation length and the correlation length of two-point function with free boundary conditions at the corresponding dual temperature are equal up to a factor of two. For systems with first-order transitions, this relation helps to resolve certain inconsistencies between recent exact and numerical work on correlation lengths at the self-dual point β o . For systems with second order transitions, this relation implies the equality of the correlation length exponents from above below threshold, as well as an amplitude ratio of two. In the course of proving the above results, we establish several properties of independent interest, including left continuity of the inverse correlation length with free boundary conditions and upper semicontinuity of the decay rate for finite clusters in all dimensions, and left continuity of the two-dimensional free boundary condition percolation probability at β o . We also introduce DLR equations for the random cluster model and use them to establish ergodicity of the free measure. In order to prove these results, we introduce a new class of events which we call decoupling events and two inequalities for these events

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

    OpenAIRE

    Jones, Ray B; 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....

  18. A Denoising Scheme for Randomly Clustered Noise Removal in ICCD Sensing Image

    Directory of Open Access Journals (Sweden)

    Fei Wang

    2017-01-01

    Full Text Available An Intensified Charge-Coupled Device (ICCD image is captured by the ICCD image sensor in extremely low-light conditions. Its noise has two distinctive characteristics. (a Different from the independent identically distributed (i.i.d. noise in natural image, the noise in the ICCD sensing image is spatially clustered, which induces unexpected structure information; (b The pattern of the clustered noise is formed randomly. In this paper, we propose a denoising scheme to remove the randomly clustered noise in the ICCD sensing image. First, we decompose the image into non-overlapped patches and classify them into flat patches and structure patches according to if real structure information is included. Then, two denoising algorithms are designed for them, respectively. For each flat patch, we simulate multiple similar patches for it in pseudo-time domain and remove its noise by averaging all the simulated patches, considering that the structure information induced by the noise varies randomly over time. For each structure patch, we design a structure-preserved sparse coding algorithm to reconstruct the real structure information. It reconstructs each patch by describing it as a weighted summation of its neighboring patches and incorporating the weights into the sparse representation of the current patch. Based on all the reconstructed patches, we generate a reconstructed image. After that, we repeat the whole process by changing relevant parameters, considering that blocking artifacts exist in a single reconstructed image. Finally, we obtain the reconstructed image by merging all the generated images into one. Experiments are conducted on an ICCD sensing image dataset, which verifies its subjective performance in removing the randomly clustered noise and preserving the real structure information in the ICCD sensing image.

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

    OpenAIRE

    Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

    2007-01-01

    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 commun...

  20. 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

  1. Dynamic connectivity algorithms for Monte Carlo simulations of the random-cluster model

    International Nuclear Information System (INIS)

    Elçi, Eren Metin; Weigel, Martin

    2014-01-01

    We review Sweeny's algorithm for Monte Carlo simulations of the random cluster model. Straightforward implementations suffer from the problem of computational critical slowing down, where the computational effort per edge operation scales with a power of the system size. By using a tailored dynamic connectivity algorithm we are able to perform all operations with a poly-logarithmic computational effort. This approach is shown to be efficient in keeping online connectivity information and is of use for a number of applications also beyond cluster-update simulations, for instance in monitoring droplet shape transitions. As the handling of the relevant data structures is non-trivial, we provide a Python module with a full implementation for future reference.

  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. Effectiveness of a multi-level implementation strategy for ASD interventions: study protocol for two linked cluster randomized trials.

    Science.gov (United States)

    Brookman-Frazee, Lauren; Stahmer, Aubyn C

    2018-05-09

    The Centers for Disease Control (2018) estimates that 1 in 59 children has autism spectrum disorder, and the annual cost of ASD in the U.S. is estimated to be $236 billion. Evidence-based interventions have been developed and demonstrate effectiveness in improving child outcomes. However, research on generalizable methods to scale up these practices in the multiple service systems caring for these children has been limited and is critical to meet this growing public health need. This project includes two, coordinated studies testing the effectiveness of the Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy (TEAMS) model. TEAMS focuses on improving implementation leadership, organizational climate, and provider attitudes and motivation in order to improve two key implementation outcomes-provider training completion and intervention fidelity and subsequent child outcomes. The TEAMS Leadership Institute applies implementation leadership strategies and TEAMS Individualized Provider Strategies for training applies motivational interviewing strategies to facilitate provider and organizational behavior change. A cluster randomized implementation/effectiveness Hybrid, type 3, trial with a dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. Study #1 will test the TEAMS model with AIM HI (An Individualized Mental Health Intervention for ASD) in publicly funded mental health services. Study #2 will test TEAMS with CPRT (Classroom Pivotal Response Teaching) in education settings. Thirty-seven mental health programs and 37 school districts will be randomized, stratified by county and study, to one of four groups (Standard Provider Training Only, Standard Provider Training + Leader Training, Enhanced Provider Training, Enhanced Provider Training + Leader Training) to test the effectiveness of combining standard, EBI-specific training with the two TEAMS

  4. 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.

  5. 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.…

  6. Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

    DEFF Research Database (Denmark)

    Frederiksen, Pernille; Indahl, Aage; Andersen, Lars L

    2017-01-01

    -randomized controlled trial. METHODS: Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non...

  7. A cluster randomized controlled trial testing the effectiveness of Houvast: A strengths-based intervention for homeless young adults

    NARCIS (Netherlands)

    Krabbenborg, M.A.M.; Boersma, S.N.; Veld, W.M. van der; Hulst, B. van; Vollebergh, W.A.M.; Wolf, J.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

  8. 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)…

  9. Effects of Nurse-Led Multifactorial Care to Prevent Disability in Community-Living Older People : Cluster Randomized Trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; van Rijn, Marjon; Buurman, Bianca M.; ter Riet, Gerben; van Charante, Eric P. Moll; de Rooij, Sophia E.

    2016-01-01

    Background To evaluate the effects of nurse-led multifactorial care to prevent disability in community-living older people. Methods In a cluster randomized trail, 11 practices (n = 1,209 participants) were randomized to the intervention group, and 13 practices (n = 1,074 participants) were

  10. 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.

  11. Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2013-09-01

    Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

  12. Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2016-01-01

    Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

  13. 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.

  14. 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.

  15. 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

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

    Science.gov (United States)

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

    2015-01-01

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

  17. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

    Science.gov (United States)

    Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

    2016-08-24

    Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

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

    Science.gov (United States)

    McCarren, Madeline; Twedt, Elaine L; Mansuri, Faizmohamed M; Nelson, Philip R; Peek, Brian T

    2014-01-01

    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. 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. 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 letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change

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

    Science.gov (United States)

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

    2015-06-01

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

  20. Clustering, randomness, and regularity in cloud fields: 2. Cumulus cloud fields

    Science.gov (United States)

    Zhu, T.; Lee, J.; Weger, R. C.; Welch, R. M.

    1992-12-01

    During the last decade a major controversy has been brewing concerning the proper characterization of cumulus convection. The prevailing view has been that cumulus clouds form in clusters, in which cloud spacing is closer than that found for the overall cloud field and which maintains its identity over many cloud lifetimes. This "mutual protection hypothesis" of Randall and Huffman (1980) has been challenged by the "inhibition hypothesis" of Ramirez et al. (1990) which strongly suggests that the spatial distribution of cumuli must tend toward a regular distribution. A dilemma has resulted because observations have been reported to support both hypotheses. The present work reports a detailed analysis of cumulus cloud field spatial distributions based upon Landsat, Advanced Very High Resolution Radiometer, and Skylab data. Both nearest-neighbor and point-to-cloud cumulative distribution function statistics are investigated. The results show unequivocally that when both large and small clouds are included in the cloud field distribution, the cloud field always has a strong clustering signal. The strength of clustering is largest at cloud diameters of about 200-300 m, diminishing with increasing cloud diameter. In many cases, clusters of small clouds are found which are not closely associated with large clouds. As the small clouds are eliminated from consideration, the cloud field typically tends towards regularity. Thus it would appear that the "inhibition hypothesis" of Ramirez and Bras (1990) has been verified for the large clouds. However, these results are based upon the analysis of point processes. A more exact analysis also is made which takes into account the cloud size distributions. Since distinct clouds are by definition nonoverlapping, cloud size effects place a restriction upon the possible locations of clouds in the cloud field. The net effect of this analysis is that the large clouds appear to be randomly distributed, with only weak tendencies towards

  1. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

    Science.gov (United States)

    Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

    2014-03-26

    Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. Clinical

  2. 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 m 2 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

  3. Control of Phlebotomus argentipes (Diptera: Psychodidae sand fly in Bangladesh: A cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rajib Chowdhury

    2017-09-01

    Full Text Available A number of studies on visceral leishmaniasis (VL vector control have been conducted during the past decade, sometimes came to very different conclusion. The present study on a large sample investigated different options which are partially unexplored including: (1 indoor residual spraying (IRS with alpha cypermethrin 5WP; (2 long lasting insecticide impregnated bed-net (LLIN; (3 impregnation of local bed-nets with slow release insecticide K-O TAB 1-2-3 (KOTAB; (4 insecticide spraying in potential breeding sites outside of house using chlorpyrifos 20EC (OUT and different combinations of the above.The study was a cluster randomized controlled trial where 3089 houses from 11 villages were divided into 10 sections, each section with 6 clusters and each cluster having approximately 50 houses. Based on vector density (males plus females during baseline survey, the 60 clusters were categorized into 3 groups: (1 high, (2 medium and (3 low. Each group had 20 clusters. From these three groups, 6 clusters (about 300 households were randomly selected for each type of intervention and control arms. Vector density was measured before and 2, 4, 5, 7, 11, 14, 15, 18 and 22 months after intervention using CDC light traps. The impact of interventions was measured by using the difference-in-differences regression model.A total of 17,434 sand flies were collected at baseline and during the surveys conducted over 9 months following the baseline measurements. At baseline, the average P. argentipes density per household was 10.6 (SD = 11.5 in the control arm and 7.3 (SD = 8.46 to 11.5 (SD = 20.2 in intervention arms. The intervention results presented as the range of percent reductions of sand flies (males plus females and rate ratios in 9 measurements over 22 months. Among single type interventions, the effect of IRS with 2 rounds of spraying (applied by the research team ranged from 13% to 75% reduction of P. argentipes density compared to the control arm (rate

  4. 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.

  5. Nonlinear random resistor diode networks and fractal dimensions of directed percolation clusters.

    Science.gov (United States)

    Stenull, O; Janssen, H K

    2001-07-01

    We study nonlinear random resistor diode networks at the transition from the nonpercolating to the directed percolating phase. The resistor-like bonds and the diode-like bonds under forward bias voltage obey a generalized Ohm's law V approximately I(r). Based on general grounds such as symmetries and relevance we develop a field theoretic model. We focus on the average two-port resistance, which is governed at the transition by the resistance exponent straight phi(r). By employing renormalization group methods we calculate straight phi(r) for arbitrary r to one-loop order. Then we address the fractal dimensions characterizing directed percolation clusters. Via considering distinct values of the nonlinearity r, we determine the dimension of the red bonds, the chemical path, and the backbone to two-loop order.

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

    DEFF Research Database (Denmark)

    Korshøj, Mette; Krustrup, Peter; Jørgensen, Marie Birk

    2012-01-01

    . 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. Data collection......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...

  7. Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

    Science.gov (United States)

    Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

    2018-01-01

    Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

  8. Sample size adjustments for varying cluster sizes in cluster randomized trials with binary outcomes analyzed with second-order PQL mixed logistic regression.

    Science.gov (United States)

    Candel, Math J J M; Van Breukelen, Gerard J P

    2010-06-30

    Adjustments of sample size formulas are given for varying cluster sizes in cluster randomized trials with a binary outcome when testing the treatment effect with mixed effects logistic regression using second-order penalized quasi-likelihood estimation (PQL). Starting from first-order marginal quasi-likelihood (MQL) estimation of the treatment effect, the asymptotic relative efficiency of unequal versus equal cluster sizes is derived. A Monte Carlo simulation study shows this asymptotic relative efficiency to be rather accurate for realistic sample sizes, when employing second-order PQL. An approximate, simpler formula is presented to estimate the efficiency loss due to varying cluster sizes when planning a trial. In many cases sampling 14 per cent more clusters is sufficient to repair the efficiency loss due to varying cluster sizes. Since current closed-form formulas for sample size calculation are based on first-order MQL, planning a trial also requires a conversion factor to obtain the variance of the second-order PQL estimator. In a second Monte Carlo study, this conversion factor turned out to be 1.25 at most. (c) 2010 John Wiley & Sons, Ltd.

  9. Infrared Extinction Performance of Randomly Oriented Microbial-Clustered Agglomerate Materials.

    Science.gov (United States)

    Li, Le; Hu, Yihua; Gu, Youlin; Zhao, Xinying; Xu, Shilong; Yu, Lei; Zheng, Zhi Ming; Wang, Peng

    2017-11-01

    In this study, the spatial structure of randomly distributed clusters of fungi An0429 spores was simulated using a cluster aggregation (CCA) model, and the single scattering parameters of fungi An0429 spores were calculated using the discrete dipole approximation (DDA) method. The transmittance of 10.6 µm infrared (IR) light in the aggregated fungi An0429 spores swarm is simulated by using the Monte Carlo method. Several parameters that affect the transmittance of 10.6 µm IR light, such as the number and radius of original fungi An0429 spores, porosity of aggregated fungi An0429 spores, and density of aggregated fungi An0429 spores of the formation aerosol area were discussed. Finally, the transmittances of microbial materials with different qualities were measured in the dynamic test platform. The simulation results showed that the parameters analyzed were closely connected with the extinction performance of fungi An0429 spores. By controlling the value of the influencing factors, the transmittance could be lower than a certain threshold to meet the requirement of attenuation in application. In addition, the experimental results showed that the Monte Carlo method could well reflect the attenuation law of IR light in fungi An0429 spore agglomerates swarms.

  10. 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

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

    Science.gov (United States)

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

    2014-01-01

    The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries (ECC) and reduce mutans streptococci. In this cluster-randomized efficacy trial, 196 four- to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste. We hypothesized that there would be no difference in efficacy between the two types of toothpaste. The primary outcome was the surface-level primary molar caries increment (d(2-3)mfs) after six months. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children), and two classrooms were assigned to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. There was no difference between the two groups in baseline or end-of-trial mean d(2-3)mfs. The mean d(2-3)mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d(2-3)mfs, respectively), but the difference was not significant (95% confidence interval: -0.17, 2.37; P=.07). No adverse effects were reported. After six months, brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population.

  12. Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

    Science.gov (United States)

    Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

    2017-05-01

    This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

  13. clusters

    Indian Academy of Sciences (India)

    2017-09-27

    Sep 27, 2017 ... Author for correspondence (zh4403701@126.com). MS received 15 ... lic clusters using density functional theory (DFT)-GGA of the DMOL3 package. ... In the process of geometric optimization, con- vergence thresholds ..... and Postgraduate Research & Practice Innovation Program of. Jiangsu Province ...

  14. clusters

    Indian Academy of Sciences (India)

    environmental as well as technical problems during fuel gas utilization. ... adsorption on some alloys of Pd, namely PdAu, PdAg ... ried out on small neutral and charged Au24,26,27, Cu,28 ... study of Zanti et al.29 on Pdn (n = 1–9) clusters.

  15. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial

    Directory of Open Access Journals (Sweden)

    George Mtove

    2016-07-01

    Full Text Available Abstract Background Despite considerable reductions in malaria achieved by scaling-up long-lasting insecticidal nets (LLINs and indoor residual spraying (IRS, maintaining sustained community protection remains operationally challenging. Increasing insecticide resistance also threatens to jeopardize the future of both strategies. Non-pyrethroid insecticide­treated wall lining (ITWL may represent an alternate or complementary control method and a potential tool to manage insecticide resistance. To date no study has demonstrated whether ITWL can reduce malaria transmission nor provide additional protection beyond the current best practice of universal coverage (UC of LLINs and prompt case management. Methods/design A two-arm cluster randomized controlled trial will be conducted in rural Tanzania to assess whether non-pyrethroid ITWL and UC of LLINs provide added protection against malaria infection in children, compared to UC of LLINs alone. Stratified randomization based on malaria prevalence will be used to select 22 village clusters per arm. All 44 clusters will receive LLINs and half will also have ITWL installed on interior house walls. Study children, aged 6 months to 11 years old, will be enrolled from each cluster and followed monthly to estimate cumulative incidence of malaria parasitaemia (primary endpoint, time to first malaria episode and prevalence of anaemia before and after intervention. Entomological inoculation rate will be estimated using indoor CDC light traps and outdoor tent traps followed by detection of Anopheles gambiae species, sporozoite infection, insecticide resistance and blood meal source. ITWL bioefficacy and durability will be monitored using WHO cone bioassays and household surveys, respectively. Social and cultural factors influencing community and household ITWL acceptability will be explored through focus-group discussions and in-depth interviews. Cost-effectiveness, compared between study arms, will be

  16. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Cynthia K Stanton

    2013-10-01

    Full Text Available BACKGROUND: Oxytocin (10 IU is the drug of choice for prevention of postpartum hemorrhage (PPH. Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km to intervention (one injection of oxytocin [10 IU] one minute after birth and control (no provision of prophylactic oxytocin arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1 blood loss ≥500 mL; (PPH-2 PPH-1 plus women who received early treatment for PPH; and (PPH-3 PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88; PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63, and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6 less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some

  17. 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.

  18. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program.

    Science.gov (United States)

    LaChausse, Robert G

    2016-09-01

    To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use.

  19. 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

  20. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Ai May Tan

    2016-08-01

    Full Text Available Abstract Background Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. Methods A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each. Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day and physical activity level (duration: minutes/week, measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Results Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005 and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005. Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005 and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005

  1. 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

  2. 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.

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

    Science.gov (United States)

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

    2014-02-01

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

  4. [Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

    Science.gov (United States)

    Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

    2014-10-21

    To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  5. 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

  6. 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

  7. 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

  8. Citywide cluster randomized trial to restore blighted vacant land and its effects on violence, crime, and fear

    Science.gov (United States)

    Charles C. Branas; Eugenia South; Michelle C. Kondo; Bernadette C. Hohl; Philippe Bourgois; Douglas J. Wiebe; John M. MacDonald

    2018-01-01

    Vacant and blighted urban land is a widespread and potentially risky environmental condition encountered by millions of people on a daily basis. About 15% of the land in US cities is deemed vacant or abandoned, an area roughly the size of Switzerland. In a citywide cluster randomized controlled trial, we investigated the effects of standardized, reproducible...

  9. Nonpharmacologic Pain Management Interventions in German Nursing Homes: A Cluster Randomized Trial.

    Science.gov (United States)

    Kalinowski, Sonja; Budnick, Andrea; Kuhnert, Ronny; Könner, Franziska; Kissel-Kröll, Angela; Kreutz, Reinhold; Dräger, Dagmar

    2015-08-01

    The reported prevalence of pain among nursing home residents (NHRs) is high. Insufficient use of analgesics, the conventional pain management strategy, is often reported. Whether and to what extent nonpharmacologic therapies (NPTs) are used to manage the pain of NHRs in Germany is largely unknown. The aim of this cluster-randomized trial was to assess the NPTs provided and to enhance the application and prescription of NPTs in NHRs on an individual level. There were six nursing homes in the intervention group and six in the control group. There were 239 NHRs, aged ≥65 years, with an average Mini-Mental State Examination score of at least 18 at baseline. Pain management interventions (cluster level) included an online course for physicians and 1-day seminar for nurses. Data on NPT applied by nurses and therapeutic NPT prescribed by physicians were obtained from residents' nursing documentation. Face-to-face interviews with NHRs assessed the NPT received. At baseline, 82.6% of NHR (mean age 83 years) were affected by pain, but less than 1 in 10 received NPT. The intervention did not result in a significant increase in the NPT applied by nurses, but did significantly increase the therapeutic NPT prescribed by physicians. Residents were active in using NPT to self-manage their pain. Given the prevalence of pain in NHRs, there is a clear need to improve pain management in this population. Extended use of NPT offers a promising approach. We recommend that nurses provide residents with education on pain-management techniques to support them in taking a proactive role in managing their pain. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  10. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial.

    Science.gov (United States)

    Muckelbauer, Rebecca; Libuda, Lars; Clausen, Kerstin; Toschke, André Michael; Reinehr, Thomas; Kersting, Mathilde

    2009-04-01

    The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school. The participants in this randomized, controlled cluster trial were second- and third-graders from 32 elementary schools in socially deprived areas of 2 German cities. Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools (N = 17) to promote water consumption. Control group schools (N = 15) did not receive any intervention. The prevalence of overweight (defined according to the International Obesity Task Force criteria), BMI SD scores, and beverage consumption (in glasses per day; 1 glass was defined as 200 mL) self-reported in 24-hour recall questionnaires, were determined before (baseline) and after the intervention. In addition, the water flow of the fountains was measured during the intervention period of 1 school year (August 2006 to June 2007). Data on 2950 children (intervention group: N = 1641; control group: N = 1309; age, mean +/- SD: 8.3 +/- 0.7 years) were analyzed. After the intervention, the risk of overweight was reduced by 31% in the intervention group, compared with the control group, with adjustment for baseline prevalence of overweight and clustering according to school. Changes in BMI SD scores did not differ between the intervention group and the control group. Water consumption after the intervention was 1.1 glasses per day greater in the intervention group. No intervention effect on juice and soft drink consumption was found. Daily water flow of the fountains indicated lasting use during the entire intervention period, but to varying extent. Our environmental and educational, school-based intervention proved to be effective in the prevention of overweight among children in elementary school, even in a population from socially deprived areas.

  11. 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

  12. The effects of an educational program on depression literacy and stigma among students of secondary schools in Jazan city, 2016: A cluster-randomized controlled trial study protocol.

    Science.gov (United States)

    Darraj, Hussain; Mahfouz, Mohamed Salih; Al Sanosi, Rashad; Badedi, Mohammed; Sabai, Abdullah

    2018-05-01

    Depression is a serious mental health disorder and characterized by sadness, loss of interest in activities, and decreased energy. The aim of this study is to assess the effectiveness of the school intervention program on depression literacy and stigma among students of secondary schools. A cluster randomized trial will be conducted on sample of 360 students to assess the depression literacy and stigma towards depression before and after a designed intervention educational program. The intervention consists of a package of 2 lectures, 1 video contact, and group discussion of 5 myths about depression, posters, and brochure. The target population consists of all secondary school students in Jazan, where there are 13 secondary schools will be stratified according to sex (6 schools for boys and 7 schools for girls). The results of the study will provide evidence of the efficacy of educational intervention programs on increasing depression literacy among students of secondary schools in Jazan City. The expected outcome of this study is to increase the depression literacy rate among high school students in the intervention group.

  13. Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach.

    Science.gov (United States)

    Mamhidir, Anna-Greta; Sjölund, Britt-Marie; Fläckman, Birgitta; Wimo, Anders; Sköldunger, Anders; Engström, Maria

    2017-02-28

    Chronic pain affects nursing home residents' daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs' experiences of the intervention. A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (n = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (n = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of

  14. 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

  15. Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

    Science.gov (United States)

    Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

    2018-01-01

    The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at

  16. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  17. Production of complex particles in low energy spallation and in fragmentation reactions by in-medium random clusterization

    International Nuclear Information System (INIS)

    Lacroix, D.; Durand, D.

    2005-09-01

    Rules for in-medium complex particle production in nuclear reactions are proposed. These rules have been implemented in two models to simulate nucleon-nucleus and nucleus-nucleus reactions around the Fermi energy. Our work emphasizes the effect of randomness in cluster formation, the importance of the nucleonic Fermi motion as well as the role of conservation laws. The concepts of total available phase-space and explored phase-space under constraint imposed by the reaction are clarified. The compatibility of experimental observations with a random clusterization is illustrated in a schematic scenario of a proton-nucleus collision. The role of randomness under constraint is also illustrated in the nucleus-nucleus case. (authors)

  18. Dissemination of Evidence-Based Antipsychotic Prescribing Guidelines to Nursing Homes: A Cluster Randomized Trial.

    Science.gov (United States)

    Tjia, Jennifer; Field, Terry; Mazor, Kathleen; Lemay, Celeste A; Kanaan, Abir O; Donovan, Jennifer L; Briesacher, Becky A; Peterson, Daniel; Pandolfi, Michelle; Spenard, Ann; Gurwitz, Jerry H

    2015-07-01

    To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes (NHs). Three-arm, cluster randomized trial. NHs. NHs in the state of Connecticut. Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders, and 42 NHs were recruited and randomized to one of three toolkit dissemination strategies: mailed toolkit delivery (minimal intensity); mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing (moderate intensity); and in-person toolkit delivery with academic detailing, on-site behavioral management training, and quarterly audit and feedback reports (high intensity). Outcomes were evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Toolkit awareness of 30% (7/23) of leadership of low-intensity NHs, 54% (19/35) of moderate-intensity NHs, and 82% (18/22) of high-intensity NHs reflected adoption and implementation of the intervention. Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs. Antipsychotic prescribing levels declined during the study period, but there were no statistically significant differences between study arms or from secular trends. RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach, adoption, and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends. Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  19. 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.

  20. Involving patients in setting priorities for healthcare improvement: a cluster randomized trial.

    Science.gov (United States)

    Boivin, Antoine; Lehoux, Pascale; Lacombe, Réal; Burgers, Jako; Grol, Richard

    2014-02-20

    Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Professionals established priorities among themselves, without patient involvement. A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. The primary outcome was the level of agreement between patients' and professionals' priorities. Secondary outcomes included professionals' intention to use the selected quality indicators, and the costs of patient involvement. Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p priorities. Patient involvement can change priorities driving healthcare

  1. 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.

  2. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh.

    Science.gov (United States)

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-06-19

    To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source. Switching was more common in the outside-tester (63%) versus community-tester villages (44%). However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio = 0.86[95% confidence interval 0.42-1.77). At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost approach to reduce As exposure in many As-affected areas of

  3. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    Directory of Open Access Journals (Sweden)

    George Christine

    2012-06-01

    Full Text Available Abstract Objective To reduce arsenic (As exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Results Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source . Switching was more common in the outside-tester (63% versus community-tester villages (44%. However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio =0.86[95% confidence interval 0.42-1.77. At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. Conclusion The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost

  4. Web-based consultation between general practitioners and nephrologists: a cluster randomized controlled trial.

    Science.gov (United States)

    van Gelder, Vincent A; Scherpbier-de Haan, Nynke D; van Berkel, Saskia; Akkermans, Reinier P; de Grauw, Inge S; Adang, Eddy M; Assendelft, Pim J; de Grauw, Wim J C; Biermans, Marion C J; Wetzels, Jack F M

    2017-08-01

    Consultation of a nephrologist is important in aligning care for patients with chronic kidney disease (CKD) at the primary-secondary care interface. However, current consultation methods come with practical difficulties that can lead to postponed consultation or patient referral instead. This study aimed to investigate whether a web-based consultation platform, telenephrology, led to a lower referral rate of indicated patients. Furthermore, we assessed consultation rate, quality of care, costs and general practitioner (GPs') experiences with telenephrology. Cluster randomized controlled trial with 47 general practices in the Netherlands was randomized to access to telenephrology or to enhanced usual care. A total of 3004 CKD patients aged 18 years or older who were under primary care were included (intervention group n = 1277, control group n = 1727) and 2693 completed the trial. All practices participated in a CKD management course and were given an overview of their CKD patients. The referral rates amounted to 2.3% (n = 29) in the intervention group and 3.0% (n = 52) in the control group, which was a non-significant difference, OR 0.61; 95% CI 0.31 to 1.23. The intervention group's consultation rate was 6.3% (n = 81) against 5.0% (n = 87) (OR 2.00; 95% CI 0.75-5.33). We found no difference in quality of care or costs. The majority of GPs had a positive opinion about telenephrology. The data in our study do not allow for conclusions on the effect of telenephrology on the rate of patient referrals and provider-to-provider consultations, compared to conventional methods. It was positively evaluated by GPs and was non-inferior in terms of quality of care and costs. © The Author 2017. Published by Oxford University Press. 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. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

    Science.gov (United States)

    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  7. Geographic analysis of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam.

    Science.gov (United States)

    Ali, Mohammad; Thiem, Vu Dinh; Park, Jin-Kyung; Ochiai, Rion Leon; Canh, Do Gia; Danovaro-Holliday, M Carolina; Kaljee, Linda M; Clemens, John D; Acosta, Camilo J

    2007-09-01

    This paper identifies spatial patterns and predictors of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam. Data for this study result from the integration of demographic surveillance, vaccine record, and geographic data of the study area. A multi-level cross-classified (non-hierarchical) model was used for analyzing the non-nested nature of individual's ecological data. Vaccine uptake was unevenly distributed in space and there was spatial variability among predictors of vaccine uptake. Vaccine uptake was higher among students with younger, male, or not literate family heads. Students from households with higher per-capita income were less likely to participate in the trial. Residency south of the river or further from a hospital/polyclinic was associated with higher vaccine uptake. Younger students were more likely to be vaccinated than older students in high- or low-risk areas, but not in the entire study area. The findings are important for the management of vaccine campaigns during a trial and for interpretation of disease patterns during vaccine-efficacy evaluation.

  8. Ant Colony Clustering Algorithm and Improved Markov Random Fusion Algorithm in Image Segmentation of Brain Images

    Directory of Open Access Journals (Sweden)

    Guohua Zou

    2016-12-01

    Full Text Available New medical imaging technology, such as Computed Tomography and Magnetic Resonance Imaging (MRI, has been widely used in all aspects of medical diagnosis. The purpose of these imaging techniques is to obtain various qualitative and quantitative data of the patient comprehensively and accurately, and provide correct digital information for diagnosis, treatment planning and evaluation after surgery. MR has a good imaging diagnostic advantage for brain diseases. However, as the requirements of the brain image definition and quantitative analysis are always increasing, it is necessary to have better segmentation of MR brain images. The FCM (Fuzzy C-means algorithm is widely applied in image segmentation, but it has some shortcomings, such as long computation time and poor anti-noise capability. In this paper, firstly, the Ant Colony algorithm is used to determine the cluster centers and the number of FCM algorithm so as to improve its running speed. Then an improved Markov random field model is used to improve the algorithm, so that its antinoise ability can be improved. Experimental results show that the algorithm put forward in this paper has obvious advantages in image segmentation speed and segmentation effect.

  9. A cluster randomized theory-guided oral hygiene trial in adolescents-A latent growth model.

    Science.gov (United States)

    Aleksejūnienė, J; Brukienė, V

    2018-05-01

    (i) To test whether theory-guided interventions are more effective than conventional dental instruction (CDI) for changing oral hygiene in adolescents and (ii) to examine whether such interventions equally benefit both genders and different socio-economic (SES) groups. A total of 244 adolescents were recruited from three schools, and cluster randomization allocated adolescents to one of the three types of interventions: two were theory-based interventions (Precaution Adoption Process Model or Authoritative Parenting Model) and CDI served as an active control. Oral hygiene levels % (OH) were assessed at baseline, after 3 months and after 12 months. A complete data set was available for 166 adolescents (the total follow-up rate: 69%). There were no significant differences in baseline OH between those who participated throughout the study and those who dropped out. Bivariate and multivariate analyses showed that theory-guided interventions produced significant improvements in oral hygiene and that there were no significant gender or socio-economic differences. Theory-guided interventions produced more positive changes in OH than CDI, and these changes did not differ between gender and SES groups. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Supportive supervision for volunteers to deliver reproductive health education: a cluster randomized trial.

    Science.gov (United States)

    Singh, Debra; Negin, Joel; Orach, Christopher Garimoi; Cumming, Robert

    2016-10-03

    Community Health Volunteers (CHVs) can be effective in improving pregnancy and newborn outcomes through community education. Inadequate supervision of CHVs, whether due to poor planning, irregular visits, or ineffective supervisory methods, is, however, recognized as a weakness in many programs. There has been little research on best practice supervisory or accompaniment models. From March 2014 to February 2015 a proof of concept study was conducted to compare training alone versus training and supportive supervision by paid CHWs (n = 4) on the effectiveness of CHVs (n = 82) to deliver education about pregnancy, newborn care, family planning and hygiene. The pair-matched cluster randomized trial was conducted in eight villages (four intervention and four control) in Budondo sub-county in Jinja, Uganda. Increases in desired behaviors were seen in both the intervention and control arms over the study period. Both arms showed high retention rates of CHVs (95 %). At 1 year follow-up there was a significantly higher prevalence of installed and functioning tippy taps for hand washing (p services. Supportive supervision involves creating a non-threatening, empowering environment in which both the CHV and the supervising CHW learn together and overcome obstacles that might otherwise demotivate the CHV. While the results seem promising for added value with supportive supervision for CHVs undertaking reproductive health activities, further research on a larger scale will be needed to substantiate the effect.

  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. Neuromuscular training reduces lower limb injuries in elite female basketball players. A cluster randomized controlled trial.

    Science.gov (United States)

    Bonato, M; Benis, R; La Torre, A

    2018-04-01

    The study was a two-armed, parallel group, cluster randomized controlled trial in which 15 teams (160 players) were assigned to either an experimental group (EG, 8 teams n = 86), which warmed-up with bodyweight neuromuscular exercises, or a control group (CG, 7 teams, n = 74) that performed standard tactical-technical exercises before training. All injuries during the 2015-2016 regular season were counted. Epidemiologic incidence proportion and incidence rate were also calculated. Countermovement jump (CMJ) and composite Y-Excursion Balance test (YBT) were used to assess lower limb strength and postural control. A total of 111 injuries were recorded. Chi-square test detected statistically significant differences between EG and CG (32 vs 79, P = .006). Significant differences in the injuries sustained in the EG (21 vs 11, P = .024) and CG (52 vs 27, P = .0001) during training and matches, respectively, were observed. Significant differences in post-intervention injuries were observed between in EG and CG during training (21 vs 52, P training into warm-up routines reduced the incidence of serious lower limb injuries in elite female basketball players. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. The stratified Boycott effect

    Science.gov (United States)

    Peacock, Tom; Blanchette, Francois; Bush, John W. M.

    2005-04-01

    We present the results of an experimental investigation of the flows generated by monodisperse particles settling at low Reynolds number in a stably stratified ambient with an inclined sidewall. In this configuration, upwelling beneath the inclined wall associated with the Boycott effect is opposed by the ambient density stratification. The evolution of the system is determined by the relative magnitudes of the container depth, h, and the neutral buoyancy height, hn = c0(ρp-ρf)/|dρ/dz|, where c0 is the particle concentration, ρp the particle density, ρf the mean fluid density and dρ/dz Boycott layer transports dense fluid from the bottom to the top of the system; subsequently, the upper clear layer of dense saline fluid is mixed by convection. For sufficiently strong stratification, h > hn, layering occurs. The lowermost layer is created by clear fluid transported from the base to its neutral buoyancy height, and has a vertical extent hn; subsequently, smaller overlying layers develop. Within each layer, convection erodes the initially linear density gradient, generating a step-like density profile throughout the system that persists after all the particles have settled. Particles are transported across the discrete density jumps between layers by plumes of particle-laden fluid.

  19. Relationship between clustering and algorithmic phase transitions in the random k-XORSAT model and its NP-complete extensions

    International Nuclear Information System (INIS)

    Altarelli, F; Monasson, R; Zamponi, F

    2008-01-01

    We study the performances of stochastic heuristic search algorithms on Uniquely Extendible Constraint Satisfaction Problems with random inputs. We show that, for any heuristic preserving the Poissonian nature of the underlying instance, the (heuristic-dependent) largest ratio α a of constraints per variables for which a search algorithm is likely to find solutions is smaller than the critical ratio α d above which solutions are clustered and highly correlated. In addition we show that the clustering ratio can be reached when the number k of variables per constraints goes to infinity by the so-called Generalized Unit Clause heuristic

  20. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

    Science.gov (United States)

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

    2016-12-01

    The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

  1. Intervention effects on physical activity: the HEIA study - a cluster randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Although school-based interventions to promote physical activity in adolescents have been suggested in several recent reviews, questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective. The aim of the present study was to investigate effects of a school-based intervention program: the HEalth in Adolescents (HEIA) study, on change in physical activity, and furthermore, to explore whether potential effects varied by gender, weight status, initial physical activity level and parental education level. Methods This was a cluster randomized controlled 20 month intervention study which included 700 11-year-olds. Main outcome-variable was mean count per minute (cpm) derived from ActiGraph accelerometers (Model 7164/GT1M). Weight and height were measured objectively. Adolescents reported their pubertal status in a questionnaire and parents reported their education level on the consent form. Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school. Results The present study showed an intervention effect on overall physical activity at the level of p = 0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group (95% CI −0.4, 100). Subgroup analyses showed that the effect appeared to be more profound among girls (Est 65 cpm, CI 5, 124, p = 0.03) and among participants in the low-activity group (Est 92 cpm, CI 41, 142, p activity group, respectively. Furthermore, the intervention affected physical activity among the normal weight group more positively than among the overweight, and participants with parents having 13–16 years of education more positively than participants with parents having either a lower or higher number of years of education. The intervention seemed to succeed in reducing time spent sedentary among girls but not among boys. Conclusions A

  2. E-learning or educational leaflet: does it make a difference in oral health promotion? A clustered randomized trial.

    Science.gov (United States)

    Al Bardaweel, Susan; Dashash, Mayssoon

    2018-05-10

    The early recognition of technology together with great ability to use computers and smart systems have promoted researchers to investigate the possibilities of utilizing technology for improving health care in children. The aim of this study was to compare between the traditional educational leaflets and E-applications in improving oral health knowledge, oral hygiene and gingival health in schoolchildren of Damascus city, Syria. A clustered randomized controlled trial at two public primary schools was performed. About 220 schoolchildren aged 10-11 years were included in this study and grouped into two clusters. Children in Leaflet cluster received oral health education through leaflets, while children in E-learning cluster received oral health education through an E-learning program. A questionnaire was designed to register information related to oral health knowledge and to record Plaque and Gingival indices. Questionnaire administration and clinical assessment were undertaken at baseline, 6 and at 12 weeks of oral health education. Data was analysed using one way repeated measures ANOVA, post hoc Bonferroni test and independent samples t-test. Leaflet cluster (107 participants) had statistically significant better oral health knowledge than E-learning cluster (104 participants) at 6 weeks (P E-learning cluster:100 participants). The mean knowledge gain compared to baseline was higher in Leaflet cluster than in E-learning cluster. A significant reduction in the PI means at 6 weeks and 12 weeks was observed in both clusters (P E-learning cluster at 6 weeks (P E-learning cluster at 6 weeks (P < 0.05) and 12 weeks (P < 0.05). Traditional educational leaflets are an effective tool in the improvement of both oral health knowledge as well as clinical indices of oral hygiene and care among Syrian children. Leaflets can be used in school-based oral health education for a positive outcome. Australian New Zealand Clinical Trials Registry ( ACTRN

  3. Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

    Science.gov (United States)

    Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C

    2018-06-01

    US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60

  4. Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke.

    Science.gov (United States)

    Anderson, Craig S; Arima, Hisatomi; Lavados, Pablo; Billot, Laurent; Hackett, Maree L; Olavarría, Verónica V; Muñoz Venturelli, Paula; Brunser, Alejandro; Peng, Bin; Cui, Liying; Song, Lily; Rogers, Kris; Middleton, Sandy; Lim, Joyce Y; Forshaw, Denise; Lightbody, C Elizabeth; Woodward, Mark; Pontes-Neto, Octavio; De Silva, H Asita; Lin, Ruey-Tay; Lee, Tsong-Hai; Pandian, Jeyaraj D; Mead, Gillian E; Robinson, Thompson; Watkins, Caroline

    2017-06-22

    The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were

  5. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.

    Science.gov (United States)

    Bilimoria, Karl Y; Chung, Jeanette W; Hedges, Larry V; Dahlke, Allison R; Love, Remi; Cohen, Mark E; Hoyt, David B; Yang, Anthony D; Tarpley, John L; Mellinger, John D; Mahvi, David M; Kelz, Rachel R; Ko, Clifford Y; Odell, David D; Stulberg, Jonah J; Lewis, Frank R

    2016-02-25

    Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being. We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care. In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on

  6. Healthy lifestyle promotion in primary schools through the board game Kaledo: a pilot cluster randomized trial.

    Science.gov (United States)

    Viggiano, Emanuela; Viggiano, Alessandro; Di Costanzo, Anna; Viggiano, Adela; Viggiano, Andrea; Andreozzi, Eleonora; Romano, Vincenzo; Vicidomini, Claudia; Di Tuoro, Daniela; Gargano, Giuliana; Incarnato, Lucia; Fevola, Celeste; Volta, Pietro; Tolomeo, Caterina; Scianni, Giuseppina; Santangelo, Caterina; Apicella, Maria; Battista, Roberta; Raia, Maddalena; Valentino, Ilaria; Palumbo, Marianna; Messina, Giovanni; Messina, Antonietta; Monda, Marcellino; De Luca, Bruno; Amaro, Salvatore

    2018-01-20

    The board game Kaledo was proven to be effective in improving nutrition knowledge and in modifying dietary behavior in students attending middle and high school. The present pilot study aims to reproduce these results in younger students (7-11 years old) attending primary school. A total of 1313 children from ten schools were recruited to participate in the present study. Participants were randomized into two groups: (1) the treatment group which consisted of playing Kaledo over 20 sessions and (2) the no intervention group. Anthropometric measures were carried out for both groups at baseline (prior to any treatment) and at two follow-up post-assessments (8 and 18 months). All the participants completed a questionnaire concerning physical activity and a 1-week food diary at each assessment. The primary outcomes were (i) BMI z-score, (ii) scores on physical activity, and (iii) scores on a dietary questionnaire. BMI z-score was significantly lower in the treated group compared to the control group at 8 months. Frequency and duration of self-reported physical activity were also significantly augmented in the treated group compared to the control group at both post-assessments. Moreover, a significant increase in the consumption of healthy food and a significant decrease in junk food intake were observed in the treated group. The present results confirm the efficacy of Kaledo in younger students in primary schools, and it can be used as a useful nutritional tool for obesity prevention programs in children. What is Known: • Kaledo is a new educational board game to improve nutrition knowledge and to promote a healthy lifestyle. • In two cluster randomized trials conducted in Campania region (Italy), we showed that Kaledo could improve nutrition knowledge and dietary behavior and have a positive effect on the BMI z-score in children with age ranging from 9 to 14 years old attending school. • Kaledo may be used as an effective tool for obesity prevention

  7. A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol.

    Science.gov (United States)

    Ogedegbe, Gbenga; Plange-Rhule, Jacob; Gyamfi, Joyce; Chaplin, William; Ntim, Michael; Apusiga, Kingsley; Khurshid, Kiran; Cooper, Richard

    2014-06-12

    Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction. Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140-179/90-99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as

  8. 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

  9. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

    Science.gov (United States)

    LeFevre, Amnesty E; Shillcutt, Samuel D; Waters, Hugh R; Haider, Sabbir; El Arifeen, Shams; Mannan, Ishtiaq; Seraji, Habibur R; Shah, Rasheduzzaman; Darmstadt, Gary L; Wall, Steve N; Williams, Emma K; Black, Robert E; Santosham, Mathuram; Baqui, Abdullah H

    2013-10-01

    To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

  10. 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.

  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. How effective is the comprehensive approach to rehabilitation (CARe) methodology? A cluster randomized controlled trial.

    Science.gov (United States)

    Bitter, Neis; Roeg, Diana; van Assen, Marcel; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

    2017-12-11

    The CARe methodology aims to improve the quality of life of people with severe mental illness by supporting them in realizing their goals, handling their vulnerability and improving the quality of their social environment. This study aims to investigate the effectiveness of the CARe methodology for people with severe mental illness on their quality of life, personal recovery, participation, hope, empowerment, self-efficacy beliefs and unmet needs. A cluster Randomized Controlled Trial (RCT) was conducted in 14 teams of three organizations for sheltered and supported housing in the Netherlands. Teams in the intervention group received training in the CARe methodology. Teams in the control group continued working according to care as usual. Questionnaires were filled out at baseline, after 10 months and after 20 months. A total of 263 clients participated in the study. Quality of life increased in both groups, however, no differences between the intervention and control group were found. Recovery and social functioning did not change over time. Regarding the secondary outcomes, the number of unmet needs decreased in both groups. All intervention teams received the complete training program. The model fidelity at T1 was 53.4% for the intervention group and 33.4% for the control group. At T2 this was 50.6% for the intervention group and 37.2% for the control group. All clients improved in quality of life. However we did not find significant differences between the clients of the both conditions on any outcome measure. Possible explanations of these results are: the difficulty to implement rehabilitation-supporting practice, the content of the methodology and the difficulty to improve the lives of a group of people with longstanding and severe impairments in a relatively short period. More research is needed on how to improve effects of rehabilitation trainings in practice and on outcome level. ISRCTN77355880 , retrospectively registered (05/07/2013).

  13. Implementing Resistance Training in Secondary Schools: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Kennedy, Sarah G; Smith, Jordan J; Morgan, Philip J; Peralta, Louisa R; Hilland, Toni A; Eather, Narelle; Lonsdale, Chris; Okely, Anthony D; Plotnikoff, Ronald C; Salmon, J O; Dewar, Deborah L; Estabrooks, Paul A; Pollock, Emma; Finn, Tara L; Lubans, David R

    2018-01-01

    Guidelines recommend that young people engage in muscle-strengthening activities on at least 3 d·wk. The purpose of this study was to examine the effect of a school-based intervention focused on resistance training (RT) for adolescents. The "Resistance Training for Teens" intervention was evaluated using a cluster-randomized, controlled trial with 607 adolescents (50.1% girls; 14.1 ± 0.5 yr) from 16 secondary schools. Teachers were trained to deliver the intervention, which included the following: (i) an interactive student seminar; (ii) a structured physical activity program, focused on RT; (iii) lunchtime fitness sessions; and (iv) Web-based smartphone apps. The primary outcome was muscular fitness (MF) and secondary outcomes included body mass index, RT skill competency, flexibility, physical activity, self-efficacy, and motivation. Assessments were conducted at baseline, 6 months (postprogram; primary end point), and 12 months (follow-up). Outcomes were assessed using linear mixed models, with three potential moderators tested using interaction terms (and subgroup analyses where appropriate). For the primary outcome (MF), a group-time effect was observed at 6 months for the upper body (2.0 repetitions; 95% confidence interval (CI), 0.8-3.2), but not the lower body (-1.4 cm; 95% CI, -4.7-1.9). At 6 months, there were intervention effects for RT skill competency and self-efficacy, but no other secondary outcomes. Effects for upper body MF and RT skill competency were sustained at 12 months. Despite overall no effect for body mass index, there was a group-time effect at 12 months among students who were overweight/obese at baseline (-0.55 kg·m; 95% CI, -1.01 to -0.08). The school-based RT intervention resulted in immediate and sustained improvements in upper body MF and RT skill competency, demonstrating an effective and scalable approach to delivering RT within secondary schools.

  14. Updated teaching techniques improve CPR performance measures: a cluster randomized, controlled trial.

    Science.gov (United States)

    Ettl, Florian; Testori, Christoph; Weiser, Christoph; Fleischhackl, Sabine; Mayer-Stickler, Monika; Herkner, Harald; Schreiber, Wolfgang; Fleischhackl, Roman

    2011-06-01

    The first-aid training necessary for obtaining a drivers license in Austria has a regulated and predefined curriculum but has been targeted for the implementation of a new course structure with less theoretical input, repetitive training in cardiopulmonary resuscitation (CPR) and structured presentations using innovative media. The standard and a new course design were compared with a prospective, participant- and observer-blinded, cluster-randomized controlled study. Six months after the initial training, we evaluated the confidence of the 66 participants in their skills, CPR effectiveness parameters and correctness of their actions. The median self-confidence was significantly higher in the interventional group [IG, visual analogue scale (VAS:"0" not-confident at all,"100" highly confident):57] than in the control group (CG, VAS:41). The mean chest compression rate in the IG (98/min) was closer to the recommended 100 bpm than in the CG (110/min). The time to the first chest compression (IG:25s, CG:36s) and time to first defibrillator shock (IG:86s, CG:92s) were significantly shorter in the IG. Furthermore, the IG participants were safer in their handling of the defibrillator and started with countermeasures against developing shock more often. The management of an unconscious person and of heavy bleeding did not show a difference between the two groups even after shortening the lecture time. Motivation and self-confidence as well as skill retention after six months were shown to be dependent on the teaching methods and the time for practical training. Courses may be reorganized and content rescheduled, even within predefined curricula, to improve course outcomes. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  15. 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. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  16. 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.

  17. Short stick exercises for fall prevention among older adults: a cluster randomized trial.

    Science.gov (United States)

    Yokoi, Katsushi; Yoshimasu, Kouichi; Takemura, Shigeki; Fukumoto, Jin; Kurasawa, Shigeki; Miyashita, Kazuhisa

    2015-01-01

    To investigate the effects of short stick exercise (SSEs) on fall prevention and improvement of physical function in older adults. A cluster randomized trial was conducted in five residential care facilities. The intervention group (n = 51) practiced SSEs for six months, followed by routine care for six more months. The control group (n = 54) received ordinary care for 12 months. The primary outcome measure was the number of fallers, taking into account the time to first fall using the Kaplan-Meier method. The secondary outcome measures were physical and mental functions. The number of fallers was significantly lower in the intervention group (n = 6) than in the control group (n = 16) during the 12 months. The adjusted hazard ratio for a first fall in the intervention group compared with the control group was 0.15 (CI, 0.03 to 0.74, p = 0.02). The fall-free period was significantly longer in the intervention group than in controls (mean ± SD, 10.1 ± 3.0 versus 9.0 ± 4.1 months, p = 0.027). The functional reach and sit and reach tests were significantly improved at three and six months. The SSEs appeared effective for fall prevention and improvement of physical function in older adults. Implications for Rehabilitation The newly developed short stick exercises appear an effective means of reducing falls among older adults in residential care facilities. The short stick exercises seem to have an immediate effect on improving physical functions. Effects gained by performing the short stick exercises, such as static balance, flexibility and agility may last for six months. The short stick exercises were found to be easy for older adults to practice continuously in residential care facilities.

  18. 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.

  19. 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

  20. Improving Early Adolescent Girls' Motor Skill: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Lander, Natalie; Morgan, Philip J; Salmon, J O; Barnett, Lisa M

    2017-12-01

    Physical activity (PA) levels decline substantially during adolescence and are consistently lower in girls. Competency in a range of fundamental movement skills (FMSs) may serve as a protective factor for the decline in PA typically observed in adolescent girls; yet, girls' mastery in FMS is low. Although interventions can improve FMS, there is a lack of interventions targeting girls, and very few are conducted in high schools. In addition, interventions are usually conducted by researchers, not teachers, and thus have little chance of being embedded into curricula. This study aimed to evaluate the effectiveness of a school-based intervention, delivered by teachers, in improving adolescent girls' FMS. Four all-girls Australian secondary schools were recruited and randomized into intervention or control groups. In total, 190 year 7 girls (103 control/87 intervention; mean age, 12.4 ± 0.3 yr) completed baseline and posttest measures at 12 wk. Six FMS (i.e., catch, throw, kick, jump, leap, and dodge) were measured using the Victorian FMS Assessment instrument. Mixed models with posttest skill (i.e., locomotor, object control, and total skill) as the outcome, adjusting for baseline skill, intervention and control status, and relevant covariates, as well as accounting for clustering at school and class level, were used to assess the intervention impact. There were significant intervention effects, and large effect sizes (Cohen d) noted in locomotor (P = 0.04, t = 5.15, d = 1.6), object control (P < 0.001, t = 11.06, d = 0.83), and total skill (P = 0.02, t = 7.22, d = 1.36). Teachers adequately trained in authentic assessment and student-centered instruction can significantly improve the FMS competency of early adolescent girls. Therefore, comprehensive teacher training should be viewed as an integral component of future school-based interventions.

  1. 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.

  2. 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

  3. 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.

  4. 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 trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team 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.

  5. 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.

  6. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

    Science.gov (United States)

    Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

    2015-04-01

    To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

  7. Cluster-level statistical inference in fMRI datasets: The unexpected behavior of random fields in high dimensions.

    Science.gov (United States)

    Bansal, Ravi; Peterson, Bradley S

    2018-06-01

    Identifying regional effects of interest in MRI datasets usually entails testing a priori hypotheses across many thousands of brain voxels, requiring control for false positive findings in these multiple hypotheses testing. Recent studies have suggested that parametric statistical methods may have incorrectly modeled functional MRI data, thereby leading to higher false positive rates than their nominal rates. Nonparametric methods for statistical inference when conducting multiple statistical tests, in contrast, are thought to produce false positives at the nominal rate, which has thus led to the suggestion that previously reported studies should reanalyze their fMRI data using nonparametric tools. To understand better why parametric methods may yield excessive false positives, we assessed their performance when applied both to simulated datasets of 1D, 2D, and 3D Gaussian Random Fields (GRFs) and to 710 real-world, resting-state fMRI datasets. We showed that both the simulated 2D and 3D GRFs and the real-world data contain a small percentage (<6%) of very large clusters (on average 60 times larger than the average cluster size), which were not present in 1D GRFs. These unexpectedly large clusters were deemed statistically significant using parametric methods, leading to empirical familywise error rates (FWERs) as high as 65%: the high empirical FWERs were not a consequence of parametric methods failing to model spatial smoothness accurately, but rather of these very large clusters that are inherently present in smooth, high-dimensional random fields. In fact, when discounting these very large clusters, the empirical FWER for parametric methods was 3.24%. Furthermore, even an empirical FWER of 65% would yield on average less than one of those very large clusters in each brain-wide analysis. Nonparametric methods, in contrast, estimated distributions from those large clusters, and therefore, by construct rejected the large clusters as false positives at the nominal

  8. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jafar, Tazeen H; Jehan, Imtiaz; de Silva, H Asita; Naheed, Aliya; Gandhi, Mihir; Assam, Pryseley; Finkelstein, Eric A; Quigley, Helena Legido; Bilger, Marcel; Khan, Aamir Hameed; Clemens, John David; Ebrahim, Shah; Turner, Elizabeth L; Kasturiratne, Anuradhani

    2017-06-12

    High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will

  9. Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

    Science.gov (United States)

    Emond, Yvette E J J M; Calsbeek, Hiske; Teerenstra, Steven; Bloo, Gerrit J A; Westert, Gert P; Damen, Johan; Wolff, André P; Wollersheim, Hub C

    2015-01-08

    This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is

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

    KAUST Repository

    Zhang, Yifan; Tang, Zhiqiang; Wu, Baoyuan; Ji, Qiang; Lu, Hanqing

    2016-01-01

    , 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

  11. 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

  12. 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

  13. Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems. Antenatal care has the potential to reduce maternal morbidity and improve newborns’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting. We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy. Methods This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. 24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text-message and voucher component. Primary outcome measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral. Results The mobile phone intervention was associated with an increase in antenatal care attendance. In the intervention group 44% of the women received four or more antenatal care visits versus 31% in the control group (OR, 2.39; 95% CI, 1.03-5.55). There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant. Conclusions The wired mothers’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care

  14. The Cluster-Randomized BRIGHT Trial: Proactive Case Finding for Community-Dwelling Older Adults

    Science.gov (United States)

    Kerse, Ngaire; McLean, Chris; Moyes, Simon A.; Peri, Kathy; Ng, Terence; Wilkinson-Meyers, Laura; Brown, Paul; Latham, Nancy; Connolly, Martin

    2014-01-01

    PURPOSE People are now living longer, but disability may affect the quality of those additional years of life. We undertook a trial to assess whether case finding reduces disability among older primary care patients. METHODS We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool (BRIGHT) among 60 primary care practices in New Zealand, assigning them to an intervention or control group. Intervention practices sent a BRIGHT screening tool to older adults every birthday; those with a score of 3 or higher were referred to regional geriatric services for assessment and, if needed, service provision. Control practices provided usual care. Main outcomes, assessed in blinded fashion, were residential care placement and hospitalization, and secondary outcomes were disability, assessed with Nottingham Extended Activities of Daily Living Scale (NEADL), and quality of life, assessed with the World Health Organization Quality of Life scale, abbreviated version (WHOQOL-BREF). RESULTS All 8,308 community-dwelling patients aged 75 years and older were approached; 3,893 (47%) participated, of whom 3,010 (77%) completed the trial. Their mean age was 80.3 (SD 4.5) years, and 55% were women. Overall, 88% of the intervention group returned a BRIGHT tool; 549 patients were referred. After 36 months, patients in the intervention group were more likely than those in the control group to have been placed in residential care: 8.4% vs 6.2% (hazard ratio = 1.32; 95% CI, 1.04–1.68; P = .02). Intervention patients had smaller declines in mean scores for physical health-related quality of life (1.6 vs 2.9 points, P = .007) and psychological health-related quality of life (1.1 vs 2.4 points, P = .005). Hospitalization, disability, and use of services did not differ between groups, however. CONCLUSIONS Our case-finding strategy was effective in increasing identification of older adults with disability, but there was little evidence of improved outcomes

  15. 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

  16. 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

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

    Science.gov (United States)

    Vlemmix, Floortje; Rosman, Ageeth N; Rijnders, Marlies E; Beuckens, Antje; Opmeer, Brent C; Mol, Ben W J; Kok, Marjolein; Fleuren, Margot A H

    2015-05-01

    To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech presentation from 32 weeks of gestation onwards. We randomized clusters to a client strategy (written information leaflets and decision aid), a care-provider strategy (1-day counseling course focused on knowledge and counseling skills), a combined client and care-provider strategy and care-as-usual strategy. We performed an intention-to-treat analysis. Rate of external cephalic version in various strategies. Secondary outcomes were the percentage of women counseled and opting for a version attempt. The overall implementation rate of external cephalic version was 72% (1169 of 1613 eligible clients) with a range between clusters of 8-95%. Neither the client strategy (OR 0.8, 95% CI 0.4-1.5) nor the care-provider strategy (OR 1.2, 95% CI 0.6-2.3) showed significant improvements. Results were comparable when we limited the analysis to those women who were actually offered intervention (OR 0.6, 95% CI 0.3-1.4 and OR 2.0, 95% CI 0.7-4.5). Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation, neither with regard to the number of version attempts offered nor the number of women accepting the procedure. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  18. 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

  19. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Michael M Chanda

    2017-11-01

    Full Text Available HIV self-testing (HIVST may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs in Zambia.Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1 delivery (direct distribution of an oral HIVST from the peer educator, (2 coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy, or (3 standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320; 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005. Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40. At 1 month, the majority of HIV tests were self-tests (88.4%. HIV self

  20. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Science.gov (United States)

    Chanda, Michael M; Ortblad, Katrina F; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G; Harling, Guy; Bärnighausen, Till; Oldenburg, Catherine E

    2017-11-01

    HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use

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

    KAUST Repository

    Wu, Baoyuan; Hu, Bao-Gang; Ji, Qiang

    2016-01-01

    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

  2. Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children's early self-regulation development: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Howard, Steven J; Vasseleu, Elena; Neilsen-Hewett, Cathrine; Cliff, Ken

    2018-01-24

    For children with low self-regulation in the preschool years, the likelihood of poorer intellectual, health, wealth and anti-social outcomes in adulthood is overwhelming. Yet this knowledge has not yielded a framework for understanding self-regulatory change, nor generated particularly successful methods for enacting this change. Reconciling insights from cross-disciplinary theory, research and practice, this study seeks to implement a newly developed program of low-cost and routine practices and activities for supporting early self-regulatory development within preschool contexts and to evaluate its effect on children's self-regulation, executive function and school readiness; and educator perceived knowledge, attitudes and self-efficacy related to self-regulation. The Early Start to Self-Regulation study is a cluster randomized, controlled trial for evaluating benefits of the Preschool Situational Self-Regulation Toolkit (PRSIST) program, when implemented by early childhood educators, compared with routine practice. The PRSIST program combines professional learning, adult practices, child activities and connections to the home to support children's self-regulation development. Fifty preschool centers in New South Wales, Australia, will be selected to ensure a range of characteristics, namely: National Quality Standards (NQS) ratings, geographic location and socioeconomic status. After collection of baseline child and educator data, participating centers will then be randomly allocated to one of two groups, stratified by NQS rating: (1) an intervention group (25 centers) that will implement the PRSIST program; or (2) a control group (25 centers) that will continue to engage in practice as usual. Primary outcomes at the child level will be two measures of self-regulation: Head-Toes-Knees-Shoulders task and the PRSIST observational assessment. Secondary outcomes at the child level will be adult-reported measures of child self-regulation, executive function and

  3. On the Coupling Time of the Heat-Bath Process for the Fortuin-Kasteleyn Random-Cluster Model

    Science.gov (United States)

    Collevecchio, Andrea; Elçi, Eren Metin; Garoni, Timothy M.; Weigel, Martin

    2018-01-01

    We consider the coupling from the past implementation of the random-cluster heat-bath process, and study its random running time, or coupling time. We focus on hypercubic lattices embedded on tori, in dimensions one to three, with cluster fugacity at least one. We make a number of conjectures regarding the asymptotic behaviour of the coupling time, motivated by rigorous results in one dimension and Monte Carlo simulations in dimensions two and three. Amongst our findings, we observe that, for generic parameter values, the distribution of the appropriately standardized coupling time converges to a Gumbel distribution, and that the standard deviation of the coupling time is asymptotic to an explicit universal constant multiple of the relaxation time. Perhaps surprisingly, we observe these results to hold both off criticality, where the coupling time closely mimics the coupon collector's problem, and also at the critical point, provided the cluster fugacity is below the value at which the transition becomes discontinuous. Finally, we consider analogous questions for the single-spin Ising heat-bath process.

  4. 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

  5. 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

  6. Effectiveness of a multifaceted implementation strategy on physicians? referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

    OpenAIRE

    D?pp, Carola ME; Graff, Maud JL; Teerenstra, Steven; Nijhuis-van der Sanden, Maria WG; Olde Rikkert, Marcel GM; Vernooij-Dassen, Myrra JFJ

    2013-01-01

    BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was conducted. Cluster included a minimum of one physician, one manager, and two occupational therapists. In the control group physicians and managers received no interventions and occupational therap...

  7. Plasmon response in K, Na and Li clusters: systematics using the separable random-phase approximation with pseudo-Hamiltonians

    International Nuclear Information System (INIS)

    Kleinig, W.; Nesterenko, V.O.; Reinhard, P.-G.; Serra, Ll.

    1998-01-01

    The systematics of the plasmon response in spherical K, Na and Li clusters in a wide size region (8≤N≤440) is studied. We have considered two simplifying approximations whose validity has been established previously. First, a separable approach to the random-phase approximation is used. This involves an expansion of the residual interaction into a sum of separable terms until convergence is reached. Second, the electron-ion interaction is modelled by using the pseudo-Hamiltonian jellium model (MHJM) which includes nonlocal effects by means of realistic atomic pseudo-Hamiltonians. In cases where nonlocal effects are negligible the Structure Averaged Jellium Model (SAJM) has been used. Good agreement with available experimental data is achieved for K, Na (using the SAJM) and small Li clusters (invoking the PHJM). The trends for peak position and width are generally well reproduced, even up to details of the Landau fragmentation in several clusters. Less good agreement, however, is found for large Li clusters. This remains an open question

  8. Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Dopp, C.M.E.; Graff, M.J.L.; Teerenstra, S.; Nijhuis-Van der Sanden, M.W.; Olde Rikkert, M.G.M.; Vernooij-Dassen, M.J.F.J.

    2013-01-01

    BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was

  9. 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.

  10. 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.

  11. 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

  12. Effects on musculoskeletal pain from "Take a Stand!" - a cluster-randomized controlled trial reducing sitting time among office workers

    DEFF Research Database (Denmark)

    Danquah, Ida Høgstedt; Kloster, Stine; Holtermann, Andreas

    2017-01-01

    Objectives Prolonged sitting at work has been found to increase risk for musculoskeletal pain. The office-based intervention "Take a Stand!" was effective in reducing sitting time at work. We aimed to study the effect of the intervention on a secondary outcome: musculoskeletal pain. Methods Take...... a Stand! included 19 offices (317 workers) at four workplaces cluster randomized to intervention or control. The multicomponent intervention lasted three months and included management support, environmental changes, and local adaptation. Control participants behaved as usual. Musculoskeletal pain...

  13. 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 celular, aumenta a cobertura das práticas recomendadas de cuidados pr

  14. Stratified B-trees and versioning dictionaries

    OpenAIRE

    Twigg, Andy; Byde, Andrew; Milos, Grzegorz; Moreton, Tim; Wilkes, John; Wilkie, Tom

    2011-01-01

    A classic versioned data structure in storage and computer science is the copy-on-write (CoW) B-tree -- it underlies many of today's file systems and databases, including WAFL, ZFS, Btrfs and more. Unfortunately, it doesn't inherit the B-tree's optimality properties; it has poor space utilization, cannot offer fast updates, and relies on random IO to scale. Yet, nothing better has been developed since. We describe the `stratified B-tree', which beats all known semi-external memory versioned B...

  15. 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.

  16. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

    Science.gov (United States)

    Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

    2012-12-24

    Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

  17. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

    Directory of Open Access Journals (Sweden)

    Mash Bob

    2012-12-01

    Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

  18. QUARITE (quality of care, risk management and technology in obstetrics: a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali

    Directory of Open Access Journals (Sweden)

    Gaye Alioune

    2009-09-01

    Full Text Available Abstract Background Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. Methods/Design This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1 Educational outreach visits; and 2 the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all

  19. QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali.

    Science.gov (United States)

    Dumont, Alexandre; Fournier, Pierre; Fraser, William; Haddad, Slim; Traore, Mamadou; Diop, Idrissa; Gueye, Mouhamadou; Gaye, Alioune; Couturier, François; Pasquier, Jean-Charles; Beaudoin, François; Lalonde, André; Hatem, Marie; Abrahamowicz, Michal

    2009-09-18

    Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been evaluated, in this context, using rigorous methods for analyzing effectiveness in terms of health outcomes. The objective of this trial is to evaluate the effectiveness of the ALARM International Program (AIP) in reducing maternal mortality in referral hospitals in Senegal and Mali. Secondary goals include evaluation of the relationships between effectiveness and resource availability, service organization, medical practices, and satisfaction among health personnel. This is an international, multi-centre, controlled cluster-randomized trial of a complex intervention. The intervention is based on the concept of evidence-based practice and on a combination of two approaches aimed at improving the performance of health personnel: 1) Educational outreach visits; and 2) the implementation of facility-based maternal death reviews. The unit of intervention is the public health facility equipped with a functional operating room. On the basis of consent provided by hospital authorities, 46 centres out of 49 eligible were selected in Mali and Senegal. Using randomization stratified by country and by level of care, 23 centres will be allocated to the intervention group and 23 to the control group. The intervention will last two years. It will be preceded by a pre-intervention one-year period for baseline data collection. A continuous clinical data collection system has been set up in all participating centres. This, along with the inventory of

  20. Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial

    Directory of Open Access Journals (Sweden)

    Chyongchiou J. Lin

    2016-11-01

    Full Text Available Abstract Background An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine. Methods Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh, location (rural, urban, suburban and type (family medicine, internal medicine, and randomized to the intervention (n = 13 or control (n = 12 in Year 1 (2013-14. A follow-up intervention occurred in Year 2 (2014-15. Demographic and vaccination data were derived from de-identified electronic medical record extractions. Results A cohort of 70,549 adults seen in their respective practices (n = 24 with 1 drop out at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (P < 0.001 increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (P < 0.001 and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates but not Pittsburgh (higher baseline rates. In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (P < 0.005. Conclusions Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults. Trial

  1. Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial.

    Science.gov (United States)

    Lin, Chyongchiou J; Nowalk, Mary Patricia; Pavlik, Valory N; Brown, Anthony E; Zhang, Song; Raviotta, Jonathan M; Moehling, Krissy K; Hawk, Mary; Ricci, Edmund M; Middleton, Donald B; Patel, Suchita; South-Paul, Jeannette E; Zimmerman, Richard K

    2016-11-03

    An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine. Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), and randomized to the intervention (n = 13) or control (n = 12) in Year 1 (2013-14). A follow-up intervention occurred in Year 2 (2014-15). Demographic and vaccination data were derived from de-identified electronic medical record extractions. A cohort of 70,549 adults seen in their respective practices (n = 24 with 1 drop out) at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (P < 0.001) increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (P < 0.001) and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates) but not Pittsburgh (higher baseline rates). In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (P < 0.005). Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults. This study was registered as a clinical trial on 03/20/2013 at

  2. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

    Science.gov (United States)

    Islam, Nadia; Gepts, Thomas; Lief, Isaac; Gore, Radhika; Levy, Natalie; Tanner, Michael; Fang, Yixin; Sherman, Scott E; Schwartz, Mark D

    2018-04-19

    Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language

  3. 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.C.M.E.; Wiers, R.W.H.J.; 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

  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 cognitive behavioural workbook for changing beliefs about antipsychotic polypharmacy: analysis from a cluster randomized controlled trial.

    Science.gov (United States)

    Thompson, Andrew; Sullivan, Sarah; Barley, Maddi; Moore, Laurence; Rogers, Paul; Sipos, Attila; Harrison, Glynn

    2010-06-01

    Educational workbooks have been used in psychiatry to influence patient but not clinician behaviour. Targeted education interventions to change prescribing practice in other areas of medicine have only looked at changes in prescribing and not attitudes or beliefs related to the prescribing. We aimed to examine whether clinicians' beliefs about a common prescribing issue in psychiatry (antipsychotic polypharmacy prescription) changed alongside behaviour as a result of a complex intervention. Medical and nursing staff were recruited from 19 general adult psychiatry units in the south-west of the UK as part of a cluster randomized controlled trial. A questionnaire was used to assess beliefs on the prescribing of antipsychotic polypharmacy as a secondary outcome before and after completion of a cognitive behavioural 'self-help' style workbook (one part of a complex intervention). A factor analysis suggested three dimensions of the questionnaire that corresponded to predetermined themes. The data were analysed using a random-effects regression model (adjusting for clustering) controlling for possible confounders. There was a significant change in beliefs on both of the factors: antipsychotic polypharmacy (coefficient = -0.89, P change in antipsychotic polypharmacy prescribing (odds ratio 0.43, 95% confidence intervals 0.21-0.90). The workbook appeared to change staff beliefs about antipsychotic polypharmacy, but achieving substantial changes in clinician behaviour may require further exploration of other factors important in complex prescribing issues.

  6. Electromagnetic waves in stratified media

    CERN Document Server

    Wait, James R; Fock, V A; Wait, J R

    2013-01-01

    International Series of Monographs in Electromagnetic Waves, Volume 3: Electromagnetic Waves in Stratified Media provides information pertinent to the electromagnetic waves in media whose properties differ in one particular direction. This book discusses the important feature of the waves that enables communications at global distances. Organized into 13 chapters, this volume begins with an overview of the general analysis for the electromagnetic response of a plane stratified medium comprising of any number of parallel homogeneous layers. This text then explains the reflection of electromagne

  7. A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

    Science.gov (United States)

    Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

    2014-03-01

    India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

  8. 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.

  9. Comparing the performance of cluster random sampling and integrated threshold mapping for targeting trachoma control, using computer simulation.

    Directory of Open Access Journals (Sweden)

    Jennifer L Smith

    Full Text Available Implementation of trachoma control strategies requires reliable district-level estimates of trachomatous inflammation-follicular (TF, generally collected using the recommended gold-standard cluster randomized surveys (CRS. Integrated Threshold Mapping (ITM has been proposed as an integrated and cost-effective means of rapidly surveying trachoma in order to classify districts according to treatment thresholds. ITM differs from CRS in a number of important ways, including the use of a school-based sampling platform for children aged 1-9 and a different age distribution of participants. This study uses computerised sampling simulations to compare the performance of these survey designs and evaluate the impact of varying key parameters.Realistic pseudo gold standard data for 100 districts were generated that maintained the relative risk of disease between important sub-groups and incorporated empirical estimates of disease clustering at the household, village and district level. To simulate the different sampling approaches, 20 clusters were selected from each district, with individuals sampled according to the protocol for ITM and CRS. Results showed that ITM generally under-estimated the true prevalence of TF over a range of epidemiological settings and introduced more district misclassification according to treatment thresholds than did CRS. However, the extent of underestimation and resulting misclassification was found to be dependent on three main factors: (i the district prevalence of TF; (ii the relative risk of TF between enrolled and non-enrolled children within clusters; and (iii the enrollment rate in schools.Although in some contexts the two methodologies may be equivalent, ITM can introduce a bias-dependent shift as prevalence of TF increases, resulting in a greater risk of misclassification around treatment thresholds. In addition to strengthening the evidence base around choice of trachoma survey methodologies, this study illustrates

  10. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    2014-01-01

    Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

  11. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  12. 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.

  13. 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).

  14. Stratified medicine and reimbursement issues

    NARCIS (Netherlands)

    Fugel, Hans-Joerg; Nuijten, Mark; Postma, Maarten

    2012-01-01

    Stratified Medicine (SM) has the potential to target patient populations who will most benefit from a therapy while reducing unnecessary health interventions associated with side effects. The link between clinical biomarkers/diagnostics and therapies provides new opportunities for value creation to

  15. 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.

  16. Stratified sampling design based on data mining.

    Science.gov (United States)

    Kim, Yeonkook J; Oh, Yoonhwan; Park, Sunghoon; Cho, Sungzoon; Park, Hayoung

    2013-09-01

    To explore classification rules based on data mining methodologies which are to be used in defining strata in stratified sampling of healthcare providers with improved sampling efficiency. We performed k-means clustering to group providers with similar characteristics, then, constructed decision trees on cluster labels to generate stratification rules. We assessed the variance explained by the stratification proposed in this study and by conventional stratification to evaluate the performance of the sampling design. We constructed a study database from health insurance claims data and providers' profile data made available to this study by the Health Insurance Review and Assessment Service of South Korea, and population data from Statistics Korea. From our database, we used the data for single specialty clinics or hospitals in two specialties, general surgery and ophthalmology, for the year 2011 in this study. Data mining resulted in five strata in general surgery with two stratification variables, the number of inpatients per specialist and population density of provider location, and five strata in ophthalmology with two stratification variables, the number of inpatients per specialist and number of beds. The percentages of variance in annual changes in the productivity of specialists explained by the stratification in general surgery and ophthalmology were 22% and 8%, respectively, whereas conventional stratification by the type of provider location and number of beds explained 2% and 0.2% of variance, respectively. This study demonstrated that data mining methods can be used in designing efficient stratified sampling with variables readily available to the insurer and government; it offers an alternative to the existing stratification method that is widely used in healthcare provider surveys in South Korea.

  17. 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.

  18. Development of youth friendly family medicine services in Bosnia and Herzegovina: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Haller, Dagmar M; Narring, Françoise; Chondros, Patty; Pejic, Daliborka; Sredic, Ana; Huseinagic, Senad; Perone, Nicolas; Sanci, Lena A; Meynard, Anne

    2014-01-01

    Young people face many barriers in accessing health services that are responsive to their needs. The World Health Organization has led a call to develop services that address these barriers, i.e. youth-friendly health services. Addressing the needs of young people is one of the priorities of Foundation fami, an organisation working in collaboration with the Swiss Federal Department of Development and Cooperation and Geneva University Hospitals to develop quality family medicine services in Bosnia and Herzegovina. This paper describes the design of a trial to assess the effectiveness of a multifaceted intervention involving family medicine teams (primary care doctors and nurses) to improve the youth-friendliness of family medicine services in Bosnia and Herzegovina. This is a stratified cluster randomised trial with a repeated cross-sectional design involving 59 health services in 10 municipalities of the canton of Zenica in Bosnia and Herzegovina. Municipalities were the unit of randomisation: five municipalities were randomised to the intervention arm and five to a wait-list control arm. Family medicine teams in the intervention arm were invited to participate in an interactive training program about youth-friendly service principles and change processes within their service. The primary outcome was the youth-friendliness of the primary care service measured using the YFHS-WHO + questionnaire, a validated tool which young people aged 15 to 24 years complete following a family medicine consultation. A total of 600 young people aged 15 to 24 years were invited to participate and complete the YFHS-WHO + questionnaire: 300 (30 per municipality) at baseline, and 300 at follow-up, three to five months after the training program. The results of this trial should provide much awaited evidence about the development of youth-friendly primary care services and inform their further development both in Bosnia and Herzegovina and worldwide. Australian New Zealand

  19. 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

  20. Enhancing Executive Functions Among Dutch Elementary School Children Using the Train Your Mind Program: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Bervoets, Joachim; Jonkman, Lisa M; Mulkens, Sandra; de Vries, Hein; Kok, Gerjo

    2018-06-07

    Executive functions are higher cognitive control functions, which are essential to physical and psychological well-being, academic performance, and healthy social relationships. Executive functions can be trained, albeit without broad transfer, to this date. Broad transfer entails the translation of improved cognitive functions to daily life (behaviors). The intervention Train your Mind was designed to train executive functions among elementary school children aged 9 to 11 years, and obtain broad transfer in terms of enhanced physical activity, healthy eating, and socioemotional regulation. This paper aims to describe the cluster randomized trial to test the effectiveness of the Train your Mind intervention. Train your Mind was integrated into the existing school curriculum for 8 months (25 weeks excluding holidays). The effectiveness of the intervention was tested in a cluster randomized trial comprising 13 schools, 34 groups (school classes), and 800 children, using a battery of 6 computer tasks at pre- and postmeasurement. Each of the 3 core executive functions was measured by 2 tasks (Flanker and Go/No-Go; N-Back and Running Span; Attention Switching Task and Dots/Triangles). Moreover, we administered questionnaires that measure emotion-regulation, cognitive errors, physical activity, dietary habits, and the psycho-social determinants of diet and physical activity. Body mass index was also measured. Multilevel analyses will account for clustering at the school and group levels, and randomization took place at the school level. Results are currently being analyzed. The main purpose of this study is to test Train your Mind's effectiveness in enhancing executive functions. Second, we investigate whether increased executive functions lead to improved physical activity and healthy eating. If found effective, executive function training could easily be integrated into school curricula everywhere, and as such, boost health, academic performance, and emotion

  1. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595].

    Science.gov (United States)

    Hägglund, Martin; Waldén, Markus; Atroshi, Isam

    2009-06-23

    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. 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. Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to be effective in reducing the incidence of knee

  2. Short-term effects of the "Together at School" intervention program on children's socio-emotional skills: a cluster randomized controlled trial.

    Science.gov (United States)

    Kiviruusu, Olli; Björklund, Katja; Koskinen, Hanna-Leena; Liski, Antti; Lindblom, Jallu; Kuoppamäki, Heini; Alasuvanto, Paula; Ojala, Tiina; Samposalo, Hanna; Harmes, Nina; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Santalahti, Päivi

    2016-05-26

    Together at School is a universal intervention program designed to promote socio-emotional skills among primary-school children. It is based on a whole school approach, and implemented in school classes by teachers. The aim of the present study is to examine the short-term effects of the intervention program in improving socio-emotional skills and reducing psychological problems among boys and girls. We also examine whether these effects depend on grade level (Grades 1 to 3) and intervention dosage. This cluster randomized controlled trial design included 79 Finnish primary schools (40 intervention and 39 control) with 3 704 children. The outcome measures were the Strengths and Difficulties Questionnaire (SDQ) and the Multisource Assessment of Social Competence Scale (MASCS) with teachers as raters. The intervention dosage was indicated by the frequencies six central tools were used by the teachers. The data was collected at baseline and 6 months later. Intervention effects were analyzed using multilevel modeling. When analyzed across all grades no intervention effect was observed in improving children's socio-emotional skills or in reducing their psychological problems at 6-month follow-up. Among third (compared to first) graders the intervention decreased psychological problems. Stratified analyses by gender showed that this effect was significant only among boys and that among them the intervention also improved third graders' cooperation skills. Among girls the intervention effects were not moderated by grade. Implementing the intervention with intended intensity (i.e. a high enough dosage) had a significant positive effect on cooperation skills. When analyzed separately among genders, this effect was significant only in girls. These first, short-term results of the Together at School intervention program did not show any main effects on children's socio-emotional skills or psychological problems. This lack of effects may be due to the relatively short follow

  3. Cost-benefit and extended cost-effectiveness analysis of a comprehensive adolescent pregnancy prevention program in Zambia: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Mori, Amani Thomas; Kampata, Linda; Musonda, Patrick; Johansson, Kjell Arne; Robberstad, Bjarne; Sandøy, Ingvild

    2017-12-19

    Early marriages, pregnancies and births are the major cause of school drop-out among adolescent girls in sub-Saharan Africa. Birth complications are also one of the leading causes of death among adolescent girls. This paper outlines a protocol for a cost-benefit analysis (CBA) and an extended cost-effectiveness analysis (ECEA) of a comprehensive adolescent pregnancy prevention program in Zambia. It aims to estimate the expected costs, monetary and non-monetary benefits associated with health-related and non-health outcomes, as well as their distribution across populations with different standards of living. The study will be conducted alongside a cluster-randomized controlled trial, which is testing the hypothesis that economic support with or without community dialogue is an effective strategy for reducing adolescent childbearing rates. The CBA will estimate net benefits by comparing total costs with monetary benefits of health-related and non-health outcomes for each intervention package. The ECEA will estimate the costs of the intervention packages per unit health and non-health gain stratified by the standards of living. Cost data include program implementation costs, healthcare costs (i.e. costs associated with adolescent pregnancy and birth complications such as low birth weight, pre-term birth, eclampsia, medical abortion procedures and post-abortion complications) and costs of education and participation in community and youth club meetings. Monetary benefits are returns to education and averted healthcare costs. For the ECEA, health gains include reduced rate of adolescent childbirths and non-health gains include averted out-of-pocket expenditure and financial risk protection. The economic evaluations will be conducted from program and societal perspectives. While the planned intervention is both comprehensive and expensive, it has the potential to produce substantial short-term and long-term health and non-health benefits. These benefits should be

  4. Cluster-cluster clustering

    International Nuclear Information System (INIS)

    Barnes, J.; Dekel, A.; Efstathiou, G.; Frenk, C.S.; Yale Univ., New Haven, CT; California Univ., Santa Barbara; Cambridge Univ., England; Sussex Univ., Brighton, England)

    1985-01-01

    The cluster correlation function xi sub c(r) is compared with the particle correlation function, xi(r) in cosmological N-body simulations with a wide range of initial conditions. The experiments include scale-free initial conditions, pancake models with a coherence length in the initial density field, and hybrid models. Three N-body techniques and two cluster-finding algorithms are used. In scale-free models with white noise initial conditions, xi sub c and xi are essentially identical. In scale-free models with more power on large scales, it is found that the amplitude of xi sub c increases with cluster richness; in this case the clusters give a biased estimate of the particle correlations. In the pancake and hybrid models (with n = 0 or 1), xi sub c is steeper than xi, but the cluster correlation length exceeds that of the points by less than a factor of 2, independent of cluster richness. Thus the high amplitude of xi sub c found in studies of rich clusters of galaxies is inconsistent with white noise and pancake models and may indicate a primordial fluctuation spectrum with substantial power on large scales. 30 references

  5. 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.

  6. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

    Science.gov (United States)

    Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

    2014-02-24

    The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing

  7. The Stratified Legitimacy of Abortions.

    Science.gov (United States)

    Kimport, Katrina; Weitz, Tracy A; Freedman, Lori

    2016-12-01

    Roe v. Wade was heralded as an end to unequal access to abortion care in the United States. However, today, despite being common and safe, abortion is performed only selectively in hospitals and private practices. Drawing on 61 interviews with obstetrician-gynecologists in these settings, we examine how they determine which abortions to perform. We find that they distinguish between more and less legitimate abortions, producing a narrative of stratified legitimacy that privileges abortions for intended pregnancies, when the fetus is unhealthy, and when women perform normative gendered sexuality, including distress about the abortion, guilt about failure to contracept, and desire for motherhood. This stratified legitimacy can perpetuate socially-inflected inequality of access and normative gendered sexuality. Additionally, we argue that the practice by physicians of distinguishing among abortions can legitimate legislative practices that regulate and restrict some kinds of abortion, further constraining abortion access. © American Sociological Association 2016.

  8. 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

  9. A cross-sectional, randomized cluster sample survey of household vulnerability to extreme heat among slum dwellers in ahmedabad, india.

    Science.gov (United States)

    Tran, Kathy V; Azhar, Gulrez S; Nair, Rajesh; Knowlton, Kim; Jaiswal, Anjali; Sheffield, Perry; Mavalankar, Dileep; Hess, Jeremy

    2013-06-18

    Extreme heat is a significant public health concern in India; extreme heat hazards are projected to increase in frequency and severity with climate change. Few of the factors driving population heat vulnerability are documented, though poverty is a presumed risk factor. To facilitate public health preparedness, an assessment of factors affecting vulnerability among slum dwellers was conducted in summer 2011 in Ahmedabad, Gujarat, India. Indicators of heat exposure, susceptibility to heat illness, and adaptive capacity, all of which feed into heat vulnerability, was assessed through a cross-sectional household survey using randomized multistage cluster sampling. Associations between heat-related morbidity and vulnerability factors were identified using multivariate logistic regression with generalized estimating equations to account for clustering effects. Age, preexisting medical conditions, work location, and access to health information and resources were associated with self-reported heat illness. Several of these variables were unique to this study. As sociodemographics, occupational heat exposure, and access to resources were shown to increase vulnerability, future interventions (e.g., health education) might target specific populations among Ahmedabad urban slum dwellers to reduce vulnerability to extreme heat. Surveillance and evaluations of future interventions may also be worthwhile.

  10. Correlation of electron transport and photocatalysis of nanocrystalline clusters studied by Monte-Carlo continuity random walking.

    Science.gov (United States)

    Liu, Baoshun; Li, Ziqiang; Zhao, Xiujian

    2015-02-21

    In this research, Monte-Carlo Continuity Random Walking (MC-RW) model was used to study the relation between electron transport and photocatalysis of nano-crystalline (nc) clusters. The effects of defect energy disorder, spatial disorder of material structure, electron density, and interfacial transfer/recombination on the electron transport and the photocatalysis were studied. Photocatalytic activity is defined as 1/τ from a statistical viewpoint with τ being the electron average lifetime. Based on the MC-RW simulation, a clear physical and chemical "picture" was given for the photocatalytic kinetic analysis of nc-clusters. It is shown that the increase of defect energy disorder and material spatial structural disorder, such as the decrease of defect trap number, the increase of crystallinity, the increase of particle size, and the increase of inter-particle connection, can enhance photocatalytic activity through increasing electron transport ability. The increase of electron density increases the electron Fermi level, which decreases the activation energy for electron de-trapping from traps to extending states, and correspondingly increases electron transport ability and photocatalytic activity. Reducing recombination of electrons and holes can increase electron transport through the increase of electron density and then increases the photocatalytic activity. In addition to the electron transport, the increase of probability for electrons to undergo photocatalysis can increase photocatalytic activity through the increase of the electron interfacial transfer speed.

  11. 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.

  12. RADIAL STABILITY IN STRATIFIED STARS

    International Nuclear Information System (INIS)

    Pereira, Jonas P.; Rueda, Jorge A.

    2015-01-01

    We formulate within a generalized distributional approach the treatment of the stability against radial perturbations for both neutral and charged stratified stars in Newtonian and Einstein's gravity. We obtain from this approach the boundary conditions connecting any two phases within a star and underline its relevance for realistic models of compact stars with phase transitions, owing to the modification of the star's set of eigenmodes with respect to the continuous case

  13. 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

    . Heartburn/acid regurgitation did not show a consistent association to any other symptoms and may be considered as a cluster of it own. Pain characteristics traditionally related to upper dyspepsia did not specifically relate to any cluster. It is concluded that, in this 70-year-old population abdominal......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...

  14. 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 versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; pindividuals in the HB-HTC and in the MC-HTC arms, respectively, linked to HIV care within 1 mo after testing positive. Findings for secondary outcomes were as follows: HB-HTC reached more first-time testers

  15. 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

  16. 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.

  17. 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.

  18. [Work-Related Medical Rehabilitation in Cancer Rehabilitation - Short-Term Results from a Cluster-Randomized Multicenter-Trial].

    Science.gov (United States)

    Wienert, Julian; Bethge, Matthias

    2018-05-25

    Rehabilitation programs that support return to work become increasingly relevant for cancer survivors. In Germany, such programs were established as work-related medical rehabilitation (WMR). The study investigated whether WMR leads to better results compared to medical rehabilitation (MR). We report effects on secondary outcomes when the rehabilitation program was completed. Clusters of participants were randomly assigned to WMR or MR. Patients of working age and an elevated risk of not returning to work were included. The grade of implementation was assessed by dose delivered and dose received. Study outcomes were assessed using scales measuring functioning and symptoms, coping with illness as well as self-reported work ability. Treatment effects were estimated using mixed linear models. From 232 planned randomized intervention groups, 165 (71%) were realized. In total, 476 patients were included. Mean age of participants was 50.7 years (SD=7.3). Most frequent primary diagnoses were malignant neoplasms of the breast. Participants in the WMR program reported significantly better outcomes regarding quality of life (SMD=0.17-0.25), fatigue (SMD=0.18-0.27), coping with illness (SMD=0.17-0.22), and self-reported work-ability (SMD=0.16) compared to participants in MR program (all p<0.05). The results indicate a positive effect in favor of WMR for cancer patients with an elevated risk of not returning to work at the end of their treatment. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic.

    Science.gov (United States)

    Leyrat, Clémence; Caille, Agnès; Foucher, Yohann; Giraudeau, Bruno

    2016-01-22

    Despite randomization, baseline imbalance and confounding bias may occur in cluster randomized trials (CRTs). Covariate imbalance may jeopardize the validity of statistical inferences if they occur on prognostic factors. Thus, the diagnosis of a such imbalance is essential to adjust statistical analysis if required. We developed a tool based on the c-statistic of the propensity score (PS) model to detect global baseline covariate imbalance in CRTs and assess the risk of confounding bias. We performed a simulation study to assess the performance of the proposed tool and applied this method to analyze the data from 2 published CRTs. The proposed method had good performance for large sample sizes (n =500 per arm) and when the number of unbalanced covariates was not too small as compared with the total number of baseline covariates (≥40% of unbalanced covariates). We also provide a strategy for pre selection of the covariates needed to be included in the PS model to enhance imbalance detection. The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs.

  20. Does routine psychosocial screening improve referral to psychosocial care providers and patient-radiotherapist communication? A cluster randomized controlled trial.

    Science.gov (United States)

    Braeken, Anna P B M; Lechner, Lilian; Eekers, Daniëlle B P; Houben, Ruud M A; van Gils, Francis C J M; Ambergen, Ton; Kempen, Gertrudis I J M

    2013-11-01

    This study tests whether using a screening instrument improves referral to psychosocial care providers (e.g. psychologist) and facilitates patient-radiotherapist communication. A cluster randomized controlled trial was used. Fourteen radiotherapists were randomly allocated to the experimental or control group and 568 of their patients received care in accordance with the group to which their radiotherapist was allocated. Patients in the experimental group were asked to complete a screening instrument before and at the end of the radiation treatment period. All patients were requested to complete questionnaires concerning patient-physician communication after the first consultation and concerning psychosocial care 3 and 12 months post-intervention. Patients who completed the screening instrument were referred to social workers at an earlier stage than patients who did not (Pcommunication. Our results suggest that a simple screening procedure can be valuable for the timely treatment of psychosocial problems in patients. Future efforts should be directed at appropriate timing of screening and enhancing physicians' awareness regarding the importance of identifying, discussing and treating psychosocial problems in cancer patients. Psychosocial screening can be enhanced by effective radiotherapist-patient communication. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  1. 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.

  2. 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.

  3. Evaluating the impact of continuous quality improvement methods at hospitals in Tanzania: a cluster-randomized trial.

    Science.gov (United States)

    Kamiya, Yusuke; Ishijma, Hisahiro; Hagiwara, Akiko; Takahashi, Shizu; Ngonyani, Henook A M; Samky, Eleuter

    2017-02-01

    To evaluate the impact of implementing continuous quality improvement (CQI) methods on patient's experiences and satisfaction in Tanzania. Cluster-randomized trial, which randomly allocated district-level hospitals into treatment group and control group, was conducted. Sixteen district-level hospitals in Kilimanjaro and Manyara regions of Tanzania. Outpatient exit surveys targeting totally 3292 individuals, 1688 in the treatment and 1604 in the control group, from 3 time-points between September 2011 and September 2012. Implementation of the 5S (Sort, Set, Shine, Standardize, Sustain) approach as a CQI method at outpatient departments over 12 months. Cleanliness, waiting time, patient's experience, patient's satisfaction. The 5S increased cleanliness in the outpatient department, patients' subjective waiting time and overall satisfaction. However, negligible effects were confirmed for patient's experiences on hospital staff behaviours. The 5S as a CQI method is effective in enhancing hospital environment and service delivery; that are subjectively assessed by outpatients even during the short intervention period. Nevertheless, continuous efforts will be needed to connect CQI practices with the further improvement in the delivery of quality health care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  4. A cluster randomized trial of alcohol prevention in small businesses: a cascade model of help seeking and risk reduction.

    Science.gov (United States)

    Reynolds, G Shawn; Bennett, Joel B

    2015-01-01

    The current study adapted two workplace substance abuse prevention programs and tested a conceptual model of workplace training effects on help seeking and alcohol consumption. Questionnaires were collected 1 month before, 1 month after, and 6 months within a cluster randomized field experiment. Texas small businesses in construction, transportation, and service industries. A total of 1510 employees from 45 businesses were randomly assigned to receive no training or one of the interventions. The interventions were 4-hour on-the-job classroom trainings that encouraged healthy lifestyles and seeking professional help (e.g., from the Employee Assistance Program [EAP]). The Team Awareness Program focused on peer referral and team building. The Choices in Health Promotion Program delivered various health topics based on a needs assessment. Questionnaires measured help-seeking attitudes and behavior, frequency of drinking alcohol, and job-related incidents. Mixed-model repeated-measures analyses of covariance were computed. Relative to the control group, training was associated with significantly greater reductions in drinking frequency, willingness to seek help, and seeking help from the EAP. After including help-seeking attitudes as a covariate, the correlation between training and help seeking becomes nonsignificant. Help-seeking behavior was not correlated with drinking frequency. Training improved help-seeking attitudes and behaviors and decreased alcohol risks. The reductions in drinking alcohol were directly correlated with training and independent from help seeking.

  5. Results of a lay health education intervention to increase colorectal cancer screening among Filipino Americans: A cluster randomized controlled trial.

    Science.gov (United States)

    Cuaresma, Charlene F; Sy, Angela U; Nguyen, Tung T; Ho, Reginald C S; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Tong, Elisa K; Kagawa-Singer, Marjorie; Stewart, Susan L

    2018-04-01

    Filipino colorectal cancer (CRC) screening rates fall below Healthy People 2020 goals. In this study, the authors explore whether a lay health educator (LHE) approach can increase CRC screening among Filipino Americans ages 50 to 75 years in Hawai'i. A cluster randomized controlled trial from 2012 through 2015 compared an intervention, which consisted of LHEs delivering 2 education sessions and 2 telephone follow-up calls on CRC screening plus a CRC brochure versus an attention control, in which 2 lectures and 2 follow-up calls on nutrition and physical activity plus a CRC brochure were provided. The primary outcome was change in self-reported ever receipt of CRC screening at 6 months. Among 304 participants (77% women, 86% had > 10 years of residence in the United States), the proportion of participants who reported ever having received CRC screening increased significantly in the intervention group (from 80% to 89%; P = .0003), but not in the control group (from 73% to 74%; P = .60). After covariate adjustment, there was a significant intervention effect (odds ratio, 1.9; 95% confidence interval, 1.0-3.5). There was no intervention effect on up-to-date screening. This first randomized controlled trial for CRC screening among Hawai'i's Filipinos used an LHE intervention with mixed, but promising, results. Cancer 2018;124:1535-42. © 2018 American Cancer Society. © 2018 American Cancer Society.

  6. Cluster randomized controlled trial of a peer support program for people with diabetes

    DEFF Research Database (Denmark)

    Riddell, Michaela A; Renwick, Carla; Wolfe, Rory

    2012-01-01

    ABSTRACT: BACKGROUND: Well managed diabetes requires active self-management in order to ensure optimal glycaemic control and appropriate use of available clinical services and other supports. Peer supporters can assist people with their daily diabetes self-management activities, provide emotional...... and social support, assist and encourage clinical care and be available when needed. METHODS: A national database of Australians diagnosed with type 2 diabetes is being used to invite people in pre-determined locations to participate in community-based peer support groups. Peer supporters are self......-identified from these communities. All consenting participants receive diabetes self-management education and education manual prior to randomization by community to a peer support intervention or usual care. This multi-faceted intervention comprises four interconnected components for delivering support...

  7. PROMOTING GROSS MOTOR SKILLS IN TODDLERS: THE ACTIVE BEGINNINGS PILOT CLUSTER RANDOMIZED TRIAL.

    Science.gov (United States)

    Veldman, Sanne L C; Okely, Anthony D; Jones, Rachel A

    2015-12-01

    This study examined the feasibility, acceptability, and potential efficacy of a gross motor skill program for toddlers. An 8-wk. skills program in which children practiced three skills was implemented for 10 min. daily in two randomly designated childcare centers. Two other centers served as the control group. Recruitment and retention rates were collected for feasibility. Data on professional development, children's participation, program duration, and appropriateness of the lessons were collected for acceptability, and the Test of Gross Motor Development-2 and Get Skilled, Get Active (total of 28 points) were used to look at the potential efficacy. The participants were 60 toddlers (M age=2.5 yr., SD=0.4; n=29 boys), and the retention rate was 95%. Overall participation was 76%, and educators rated 98% of the lessons as appropriate. Compared with the control group, the intervention group showed significantly greater improvements in motor skills (pmotor skills among toddlers.

  8. Gaussian free field in the background of correlated random clusters, formed by metallic nanoparticles

    Science.gov (United States)

    Cheraghalizadeh, Jafar; Najafi, Morteza N.; Mohammadzadeh, Hossein

    2018-05-01

    The effect of metallic nano-particles (MNPs) on the electrostatic potential of a disordered 2D dielectric media is considered. The disorder in the media is assumed to be white-noise Coulomb impurities with normal distribution. To realize the correlations between the MNPs we have used the Ising model with an artificial temperature T that controls the number of MNPs as well as their correlations. In the T → 0 limit, one retrieves the Gaussian free field (GFF), and in the finite temperature the problem is equivalent to a GFF in iso-potential islands. The problem is argued to be equivalent to a scale-invariant random surface with some critical exponents which vary with T and correspondingly are correlation-dependent. Two type of observables have been considered: local and global quantities. We have observed that the MNPs soften the random potential and reduce its statistical fluctuations. This softening is observed in the local as well as the geometrical quantities. The correlation function of the electrostatic and its total variance are observed to be logarithmic just like the GFF, i.e. the roughness exponent remains zero for all temperatures, whereas the proportionality constants scale with T - T c . The fractal dimension of iso-potential lines ( D f ), the exponent of the distribution function of the gyration radius ( τ r ), and the loop lengths ( τ l ), and also the exponent of the loop Green function x l change in terms of T - T c in a power-law fashion, with some critical exponents reported in the text. Importantly we have observed that D f ( T) - D f ( T c ) 1/√ ξ( T), in which ξ( T) is the spin correlation length in the Ising model.

  9. Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique.

    Science.gov (United States)

    Pfeiffer, James T; Napúa, Manuel; Wagenaar, Bradley H; Chale, Falume; Hoek, Roxanne; Micek, Mark; Manuel, João; Michel, Cathy; Cowan, Jessica Greenberg; Cowan, James F; Gimbel, Sarah; Sherr, Kenneth; Gloyd, Stephen; Chapman, Rachel R

    2017-11-01

    This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics. The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique. Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25-35 days of previous refills. During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure-women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively. The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.

  10. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population

    Directory of Open Access Journals (Sweden)

    Gardini Andrea

    2007-11-01

    Full Text Available Abstract Background The hospital treatment of heart failure frequently does not follow published guidelines, potentially contributing to the high morbidity, mortality and economic cost of this disorder. Consequently the development of clinical pathways has the potential to reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of clinical pathways in hospital treatment of acute heart failure. The primary objective of the trial was to evaluate the effectiveness of the implementation of clinical pathways for hospital treatment of heart failure in Italian hospitals. Methods/design Two-arm, cluster-randomized trial. 14 community hospitals were randomized either to arm 1 (clinical pathway: appropriate use of practice guidelines and supplies of drugs and ancillary services, new organization and procedures, patient education, etc. or to arm 2 (no intervention, usual care. 424 patients sample (212 in each group, 80% of power at the 5% significance level (two-sided. The primary outcome measure is in-hospital mortality. We will also analyze the impact of the clinical pathways comparing the length and the appropriateness of the stay, the rate of unscheduled readmissions, the customers' satisfaction and the costs treating the patients with the pathways and with the current practice along all the observation period. The quality of the care will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and by measuring key quality indicators at discharge. Discussion This paper examines the design of the evaluation of a complex

  11. 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

  12. Effectiveness of individualized fall prevention program in geriatric rehabilitation hospital setting: a cluster randomized trial.

    Science.gov (United States)

    Aizen, Efraim; Lutsyk, Galina; Wainer, Lea; Carmeli, Sarit

    2015-10-01

    There is no conclusive evidence that hospital fall prevention programs can reduce the number of falls. We aimed to investigate the effect of a targeted individualized falls prevention program in a geriatric rehabilitation hospital. This was a two-stage cluster-controlled trial carried out in five geriatric rehabilitation wards. Participants were 752 patients with mean age 83.2 years. The intervention was a two-phase targeted intervention falls prevention program. The intervention included an assessment of patient's risk by a risk assessment tool and an individual management that includes medical, behavioral, cognitive and environmental modifications. Patients with moderate risk received additionally orientation guidance, and mobility restriction. Patients determined as high risk were additionally placed under permanent personal supervision. Outcome measures were falls during hospital stay. In both stages of the trial, intervention and control wards were almost similar at baseline for individual patient characteristics. Overall, 37 falls occurred during the study. No significant difference was found in fall rates during follow-up between intervention and control wards: 1.306 falls per 1000 bed days in the intervention groups and 1.763-1.826 falls per 1000 bed days in the control groups. The adjusted hazard ratio for falls in the intervention groups was 1.36 (95 % confidence interval 0.89-1.77) (P = 0.08) in the first stage and 1.27 (95 % confidence interval 0.92-1.67) (P = 0.12) in the second stage. These results suggest that in a geriatric rehabilitation hospital a targeted individualized intervention falls prevention program is not effective in reducing falls.

  13. Pain management in cancer center inpatients: a cluster randomized trial to evaluate a systematic integrated approach—The Edinburgh Pain Assessment and Management Tool

    OpenAIRE

    Fallon, M; Walker, J; Colvin, L; Rodriguez, A; Murray, G; Sharpe, M

    2018-01-01

    Purpose Pain is suboptimally managed in patients with cancer. We aimed to compare the effect of a policy of adding a clinician-delivered bedside pain assessment and management tool (Edinburgh Pain Assessment and management Tool [EPAT]) to usual care (UC) versus UC alone on pain outcomes. Patients and Methods In a two-arm, parallel group, cluster randomized (1:1) trial, we observed pain outcomes in 19 cancer centers in the United Kingdom and then randomly assigned the centers to eithe...

  14. 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

  15. 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

  16. Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

    Science.gov (United States)

    Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-08-01

    We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

  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. The role of repetition and reinforcement in school-based oral health education-a cluster randomized controlled trial.

    Science.gov (United States)

    Haleem, Abdul; Khan, Muhammad Khalil; Sufia, Shamta; Chaudhry, Saima; Siddiqui, Muhammad Irfanullah; Khan, Ayyaz Ali

    2016-01-04

    Repetition and reinforcement have been shown to play a crucial role in the sustainability of the effect of Oral Health Education (OHE) programs. However, its relevance to school-based OHE imparted by different personnel is not depicted by the existing dental literature. The present study was undertaken to determine the effectiveness of the repeated and reinforced OHE (RR-OHE) compared to one-time OHE intervention and to assess its role in school-based OHE imparted by dentist, teachers and peers. The study was a cluster randomized controlled trial that involved 935 adolescents aged 10-11 years. Twenty four boys' and girls' schools selected at random in two towns of Karachi, Pakistan were randomly assigned to three groups to receive OHE by dentist (DL), teachers (TL) and peer-leaders (PL). The groups received a single OHE session and were evaluated post-intervention and 6 months after. The three groups were then exposed to OHE for 6 months followed by 1 year of no OHE activity. Two further evaluations at 6-month and 12-month intervals were conducted. The data were collected by a self-administered questionnaire preceded by a structured interview and followed by oral examination of participants. The adolescents' oral health knowledge (OHK) in the DL and PL groups increased significantly by a single OHE session compared to their baseline knowledge (p strategy. Although the OHK scores of the DL and PL groups decreased significantly at 12-month evaluation of RR-OHE (p play a key role in school-based OHE irrespective of educators. The trained teachers and peers can play a complementary role in RR-OHE.

  19. Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

    Science.gov (United States)

    Jairath, Vipul; Kahan, Brennan C.; Gray, Alasdair; Doré, Caroline J.; Mora, Ana; Dyer, Claire; Stokes, Elizabeth A.; Llewelyn, Charlotte; Bailey, Adam A.; Dallal, Helen; Everett, Simon M.; James, Martin W.; Stanley, Adrian J.; Church, Nicholas; Darwent, Melanie; Greenaway, John; Le Jeune, Ivan; Reckless, Ian; Campbell, Helen E.; Meredith, Sarah; Palmer, Kelvin R.; Logan, Richard F.A.; Travis, Simon P.L.; Walsh, Timothy S.; Murphy, Michael F.

    2013-01-01

    Acute upper gastrointestinal bleeding (AUGIB) is the commonest reason for hospitalization with hemorrhage in the UK and the leading indication for transfusion of red blood cells (RBCs). Observational studies suggest an association between more liberal RBC transfusion and adverse patient outcomes, and a recent randomised trial reported increased further bleeding and mortality with a liberal transfusion policy. TRIGGER (Transfusion in Gastrointestinal Bleeding) is a pragmatic, cluster randomized trial which aims to evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB. The trial will take place in 6 UK hospitals, and each centre will be randomly allocated to a transfusion policy. Clinicians throughout each hospital will manage all eligible patients according to the transfusion policy for the 6-month trial recruitment period. In the restrictive centers, patients become eligible for RBC transfusion when their hemoglobin is bleeding, mortality, thromboembolic events, and infections. Quality of life will be measured using the EuroQol EQ-5D at day 28, and the costs associated with hospitalization for AUGIB in the UK will be estimated. Consent will be sought from participants or their representatives according to patient capacity for use of routine hospital data and day 28 follow up. The study has ethical approval for conduct in England and Scotland. Results will be analysed according to a pre-defined statistical analysis plan and disseminated in peer reviewed publications to relevant stakeholders. The results of this study will inform the feasibility and design of a phase III randomized trial. PMID:23706959

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. Promoting physical activity using a wearable activity tracker in college students: A cluster randomized controlled trial.

    Science.gov (United States)

    Kim, Youngdeok; Lumpkin, Angela; Lochbaum, Marc; Stegemeier, Steven; Kitten, Karla

    2018-08-01

    This study examined the effects of utilizing a wearable activity tracker in a credit-based physical activity instructional program (PAIP) for promoting physical activity (PA) in college students. Fourteen PAIP courses in a large public university were randomly assigned into intervention (k = 7; n = 101) and control (k = 7; n = 86) groups. All courses focused on a core curriculum that covers basic exercise and behavioral science contents through lectures and activity sessions. A Misfit Flash activity tracker was provided to students in the intervention group. Objective PA assessments occurred at baseline, mid-, and end-of-semester during a 15-week academic semester. The control group showed a significant reduction in moderate- and vigorous-intensity PA (MVPA) minutes from baseline to the end-of-semester (P <.05), whereas the intervention group showed no changes in MVPA minutes over time. However, the intervention group also showed increased sedentary time and decreased time spent in light-intensity PA during the intervention period. Taken together, the present study found null effects of utilizing the wearable activity tracker in promoting PA in college students suggesting that intervention of primary using the wearable activity tracker as a behavior change strategy may not be effective to increase in PA in this setting.

  5. Replicating Reducing the Risk: 12-Month Impacts of a Cluster Randomized Controlled Trial

    Science.gov (United States)

    Blocklin, Michelle; Layzer, Jean; Price, Cristofer; Juras, Randall; Freiman, Lesley

    2016-01-01

    Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or “business as usual.” Youths completed Web-based surveys at baseline (preintervention, August 2012–January 2014) and 12 months later (August 2013–January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. PMID:27689492

  6. Improving attitudes towards children with disabilities in a school context: a cluster randomized intervention study.

    Science.gov (United States)

    Godeau, Emmanuelle; Vignes, Céline; Sentenac, Mariane; Ehlinger, Virginie; Navarro, Félix; Grandjean, Hélène; Arnaud, Catherine

    2010-10-01

    although inclusive education of disabled children is now an accepted practice, it is often challenged by negative peer attitudes. We undertook an interventional study aimed at improving students' attitudes towards their disabled peers. the participants were students from the 7th grade of twelve paired schools (1509 students from 62 classes; age 12-13y), randomly allocated to an intervention group (205 males, 285 females) or a control group (132 males, 165 females). The intervention consisted of a mandatory comprehensive educational project on disability. The Chedoke-McMaster Attitudes Towards Children with Handicaps Scale (CATCH) was used to assess children's attitudes before (T0) and after (T1) intervention. The hierarchical structure of the data was taken into account by adjusting standard deviations and using linear multilevel models. seven hundred and eighty-four students had at least one score on the three domains (cognitive, affective, behavioural) of the CATCH at T0 and T1. The final scores were higher than baseline scores (total scores, intervention group: baseline score 25.6 (SD=5.4), final score 26.8 (5.9), pattitudes was found in students from schools with special units for their peers with cognitive impairment for total (p=0.013), affective (pattitudes in the intervention and control groups that could be a result of the nature of the scales and questionnaires the students had to complete before the intervention.

  7. 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.

  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. Text Messaging, Teen Outreach Program, and Sexual Health Behavior: A Cluster Randomized Trial.

    Science.gov (United States)

    Bull, Sheana; Devine, Sharon; Schmiege, Sarah 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.

  10. Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial.

    Science.gov (United States)

    Picado, Albert; Das, Murari L; Kumar, Vijay; Kesari, Shreekant; Dinesh, Diwakar S; Roy, Lalita; Rijal, Suman; Das, Pradeep; Rowland, Mark; Sundar, Shyam; Coosemans, Marc; Boelaert, Marleen; Davies, Clive R

    2010-01-26

    Visceral leishmaniasis (VL) control in the Indian subcontinent is currently based on case detection and treatment, and on vector control using indoor residual spraying (IRS). The use of long-lasting insecticidal nets (LN) has been postulated as an alternative or complement to IRS. Here we tested the impact of comprehensive distribution of LN on the density of Phlebotomus argentipes in VL-endemic villages. A cluster-randomized controlled trial with household P. argentipes density as outcome was designed. Twelve clusters from an ongoing LN clinical trial--three intervention and three control clusters in both India and Nepal--were selected on the basis of accessibility and VL incidence. Ten houses per cluster selected on the basis of high pre-intervention P. argentipes density were monitored monthly for 12 months after distribution of LN using CDC light traps (LT) and mouth aspiration methods. Ten cattle sheds per cluster were also monitored by aspiration. A random effect linear regression model showed that the cluster-wide distribution of LNs significantly reduced the P. argentipes density/house by 24.9% (95% CI 1.80%-42.5%) as measured by means of LTs. The ongoing clinical trial, designed to measure the impact of LNs on VL incidence, will confirm whether LNs should be adopted as a control strategy in the regional VL elimination programs. The entomological evidence described here provides some evidence that LNs could be usefully deployed as part of the VL control program. ClinicalTrials.gov CT-2005-015374.

  11. Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation

    NARCIS (Netherlands)

    Gude, Wouter T.; van Engen-Verheul, Mariëtte M.; van der Veer, Sabine N.; Kemps, Hareld M. C.; Jaspers, Monique W. M.; de Keizer, Nicolette F.; Peek, Niels

    2016-01-01

    The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in

  12. The effectiveness of a construction worksite prevention program on work ability, health, and sick leave: Results from a cluster randomized controlled trial

    NARCIS (Netherlands)

    Oude Hengel, K.M.; Blatter, B.M.; Molen, H.F. van der; Bongers, P.M.; Beek, A.J. van der

    2013-01-01

    Objective This study aimed to investigate the effectiveness of a prevention program on work ability, health, and sick leave targeted at construction worksites. Methods A total of 15 departments (N=297 workers) from 6 construction companies participated in this cluster randomized controlled trial and

  13. 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

  14. 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.…

  15. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, K.M.; Bosmans, J.E.; Jansen, A.P.D.; Hoogendijk, E.O.; Muntinga, M.E.; van Hout, H.P.J.; Nijpels, G.; van der Horst, H.E.; van Tulder, M.W.

    2015-01-01

    Objectives To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Design Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Setting

  16. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care : Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

    2015-01-01

    OBJECTIVES: To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. DESIGN: Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. SETTING:

  17. 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

  18. Reducing Tobacco Use among Low Socio-Economic Status Youth in Delhi, India: Outcomes from Project ACTIVITY, a Cluster Randomized Trial

    Science.gov (United States)

    Harrell, Melissa B.; Arora, Monika; Bassi, Shalini; Gupta, Vinay K.; Perry, Cheryl L.; Reddy, K. Srinath

    2016-01-01

    To test the efficacy of an intervention to reduce tobacco use among youth (10-19 years old) in slum communities in Delhi, India. This community-based cluster-randomized trial included 14 slums composed of purposely built resettlement colonies and adjacent inhabitant-built Jhuggi Jhopris. Youth in the intervention received a 2 year…

  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. 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…

  1. A Cluster-Randomized Controlled Intervention Study to Assess the Effect of a Contact Intervention in Reducing Leprosy-Related Stigma in Indonesia

    NARCIS (Netherlands)

    Peters, R.M.H.; Zweekhorst, M.B.M.; Bunders-Aelen, J.G.F.; van Brakel, W.H.

    2015-01-01

    Background: Can deliberate interaction between the public and persons affected by leprosy reduce stigmatization? The study described in this paper hypothesises that it can and assesses the effectiveness of a ‘contact intervention’. Methods/Principal Findings: This cluster-randomized controlled

  2. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; van Charente, Eric P. Moll; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  3. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people: Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; Moll van Charante, Eric P.; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  4. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J; MacNeil-Vroomen, Janet L; van Rijn, Marjon; Buurman, Bianca M; de Rooij, Sophia E; Moll van Charante, Eric P; Bosmans, Judith E

    2017-01-01

    OBJECTIVE: To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. METHODS: We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  5. 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…

  6. 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.P.; 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

  7. Using Brothel Leadership to Improve Condom Use among Brothel-based Female Sex Workers in Abuja, Nigeria : Results of a Cluster Randomized Pilot Study

    NARCIS (Netherlands)

    Okafor, Uchenna O.; Crutzen, Rik; Sylvia, Adebajo; Ifeanyi, Okekearu; Van Den Borne, Bart

    2017-01-01

    Support by brothel leaders and the promotion of a conducive environment for HIV prevention programs within brothel establishments are important to promote a safe working environment for Brothel-Based Female Sex Workers (BB FSWs). This study assesses the effects of a cluster randomized pilot trial

  8. The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Wiria, Aprilianto E.; Hamid, Firdaus; Wammes, Linda J.; Kaisar, Maria M. M.; May, Linda; Prasetyani, Margaretta A.; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T.; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J. M.; van Ree, Ronald; Verweij, Jaco J.; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J.; Luty, Adrian J. F.; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

    2013-01-01

    Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. A household-based cluster-randomized,

  9. A Communication Intervention to Reduce Resistiveness in Dementia Care: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Williams, Kristine N; Perkhounkova, Yelena; Herman, Ruth; Bossen, Ann

    2017-08-01

    Nursing home (NH) residents with dementia exhibit challenging behaviors or resistiveness to care (RTC) that increase staff time, stress, and NH costs. RTC is linked to elderspeak communication. Communication training (Changing Talk [CHAT]) was provided to staff to reduce their use of elderspeak. We hypothesized that CHAT would improve staff communication and subsequently reduce RTC. Thirteen NHs were randomized to intervention and control groups. Dyads (n = 42) including 29 staff and 27 persons with dementia were videorecorded during care before and/or after the intervention and at a 3-month follow-up. Videos were behaviorally coded for (a) staff communication (normal, elderspeak, or silence) and (b) resident behaviors (cooperative or RTC). Linear mixed modeling was used to evaluate training effects. On average, elderspeak declined from 34.6% (SD = 18.7) at baseline by 13.6% points (SD = 20.00) post intervention and 12.2% points (SD = 22.0) at 3-month follow-up. RTC declined from 35.7% (SD = 23.2) by 15.3% points (SD = 32.4) post intervention and 13.4% points (SD = 33.7) at 3 months. Linear mixed modeling determined that change in elderspeak was predicted by the intervention (b = -12.20, p = .028) and baseline elderspeak (b = -0.65, p communication and reduce RTC, providing an effective nonpharmacological intervention to manage behavior and improve the quality of dementia care. No adverse events occurred. © The Author 2016. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Impact of educational intervention on implementation of tobacco counselling among oral health professionals: a cluster-randomized community trial.

    Science.gov (United States)

    Amemori, Masamitsu; Virtanen, Jorma; Korhonen, Tellervo; Kinnunen, Taru H; Murtomaa, Heikki

    2013-04-01

    Tobacco use adversely affects oral health. Clinical guidelines recommend that oral health professionals promote tobacco abstinence and provide patients who use tobacco with brief tobacco use cessation counselling. Research shows that these guidelines are seldom implemented successfully. This study aimed to evaluate two interventions to enhance tobacco use prevention and cessation (TUPAC) counselling among oral health professionals in Finland. We used a cluster-randomized community trial to test educational and fee-for-service interventions in enhancing TUPAC counselling among a sample of dentists (n=73) and dental hygienists (n=22) in Finland. Educational intervention consisted of 1 day of training, including lectures, interactive sessions, multimedia demonstrations and a role play session with standard patient cases. Fee-for-service intervention consisted of monetary compensation for providing tobacco use prevention or cessation counselling. TUPAC counselling procedures provided were reported and measured using an electronic dental records system. In data analysis, intent-to-treat principles were followed at both individual and cluster levels. Descriptive analysis included chi-square and t-tests. A general linear model for repeated measures was used to compare the outcome measures by intervention group. Of 95 providers, 73 participated (76.8%). In preventive counselling, there was no statistically significant time effect or group-by-time interaction. In cessation counselling, statistically significant group-by-time interaction was found after a 6-month follow-up (F=2.31; P=0.007), indicating that counselling activity increased significantly in intervention groups. On average, dental hygienists showed greater activity in tobacco prevention (F=12.13; P=0.001) and cessation counselling (F=30.19; PTUPAC counselling performance. Other approaches than monetary incentives may be needed to enhance the effectiveness of educational intervention. Further studies with focus

  11. Free Falling in Stratified Fluids

    Science.gov (United States)

    Lam, Try; Vincent, Lionel; Kanso, Eva

    2017-11-01

    Leaves falling in air and discs falling in water are examples of unsteady descents due to complex interaction between gravitational and aerodynamic forces. Understanding these descent modes is relevant to many branches of engineering and science such as estimating the behavior of re-entry space vehicles to studying biomechanics of seed dispersion. For regularly shaped objects falling in homogenous fluids, the motion is relatively well understood. However, less is known about how density stratification of the fluid medium affects the falling behavior. Here, we experimentally investigate the descent of discs in both pure water and in stable linearly stratified fluids for Froude numbers Fr 1 and Reynolds numbers Re between 1000 -2000. We found that stable stratification (1) enhances the radial dispersion of the disc at landing, (2) increases the descent time, (3) decreases the inclination (or nutation) angle, and (4) decreases the fluttering amplitude while falling. We conclude by commenting on how the corresponding information can be used as a predictive model for objects free falling in stratified fluids.

  12. Stratified Medicine and Reimbursement Issues

    Directory of Open Access Journals (Sweden)

    Hans-Joerg eFugel

    2012-10-01

    Full Text Available Stratified Medicine (SM has the potential to target patient populations who will most benefit from a therapy while reducing unnecessary health interventions associated with side effects. The link between clinical biomarkers/diagnostics and therapies provides new opportunities for value creation to strengthen the value proposition to pricing and reimbursement (P&R authorities. However, the introduction of SM challenges current reimbursement schemes in many EU countries and the US as different P&R policies have been adopted for drugs and diagnostics. Also, there is a lack of a consistent process for value assessment of more complex diagnostics in these markets. New, innovative approaches and more flexible P&R systems are needed to reflect the added value of diagnostic tests and to stimulate investments in new technologies. Yet, the framework for access of diagnostic–based therapies still requires further development while setting the right incentives and appropriate align stakeholders interests when realizing long- term patient benefits. This article addresses the reimbursement challenges of SM approaches in several EU countries and the US outlining some options to overcome existing reimbursement barriers for stratified medicine.

  13. 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

  14. 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

  15. 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

  16. Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Mohammad Ali

    2016-09-01

    Full Text Available Vaccinating a buffer of individuals around a case (ring vaccination has the potential to target those who are at highest risk of infection, reducing the number of doses needed to control a disease. We explored the potential vaccine effectiveness (VE of oral cholera vaccines (OCVs for such a strategy.This analysis uses existing data from a cluster-randomized clinical trial in which OCV or placebo was given to 71,900 participants in Kolkata, India, from 27 July to 10 September 2006. Cholera surveillance was then conducted on 144,106 individuals living in the study area, including trial participants, for 5 y following vaccination. First, we explored the risk of cholera among contacts of cholera patients, and, second, we measured VE among individuals living within 25 m of cholera cases between 8 and 28 d after onset of the index case. For the first analysis, individuals living around each index case identified during the 5-y period were assembled using a ring to define cohorts of individuals exposed to cholera index cases. An index control without cholera was randomly selected for each index case from the same population, matched by age group, and individuals living around each index control were assembled using a ring to define cohorts not exposed to cholera cases. Cholera attack rates among the exposed and non-exposed cohorts were compared using different distances from the index case/control to define the rings and different time frames to define the period at risk. For the VE analysis, the exposed cohorts were further stratified according to the level of vaccine coverage into high and low coverage strata. Overall VE was assessed by comparing the attack rates between high and low vaccine coverage strata irrespective of individuals' vaccination status, and indirect VE was assessed by comparing the attack rates among unvaccinated members between high and low vaccine coverage strata. Cholera risk among the cohort exposed to cholera cases was 5

  17. Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Todd Molfenter

    2017-11-01

    Full Text Available Abstract Background Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the USA. Buprenorphine and extended-release naltrexone are key evidence-based pharmacotherapies available to addiction treatment providers to address opioid use disorder (OUD and prevent overdose deaths. Treatment organizations’ efforts to provide these pharmacotherapies have, however, been stymied by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants to prescribe these medications. Historically, the addiction treatment field has not attracted physicians, and many barriers to implementing OUD pharmacotherapy exist, ranging from lack of confidence in treating OUD patients to concerns regarding reimbursement. Throughout the USA, the prevalence of OUD far exceeds the capacity of the OUD pharmacotherapy treatment system. Poor access to OUD pharmacotherapy prescribers has become a workforce development need for the addiction treatment field and a significant health issue. Methods This cluster randomized controlled trial (RCT is designed to increase buprenorphine and extended-release naltrexone treatment capacity for OUD. The implementation intervention to be tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB, which was developed and piloted in a previous statewide buprenorphine implementation study. For this cluster RCT, organizational sites will be recruited and then randomized into one of two arms: (1 control, with treatment as usual and access to a website with PRB resources, or (2 intervention, with organizations implementing the PRB using the Network for the Improvement of Addiction Treatment organizational change model over a 24-month intervention period and a 10-month sustainability period. The primary treatment outcomes for each organizational site are self-reported monthly counts of

  18. EHLS at School: school-age follow-up of the Early Home Learning Study cluster randomized controlled trial.

    Science.gov (United States)

    Westrupp, Elizabeth M; Bennett, Clair; Cullinane, Meabh; Hackworth, Naomi J; Berthelsen, Donna; Reilly, Sheena; Mensah, Fiona K; Gold, Lisa; Bennetts, Shannon K; Levickis, Penny; Nicholson, Jan M

    2018-05-02

    Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the parent

  19. Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial.

    Science.gov (United States)

    Molfenter, Todd; Knudsen, Hannah K; Brown, Randy; Jacobson, Nora; Horst, Julie; Van Etten, Mark; Kim, Jee-Seon; Haram, Eric; Collier, Elizabeth; Starr, Sanford; Toy, Alexander; Madden, Lynn

    2017-11-15

    Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the USA. Buprenorphine and extended-release naltrexone are key evidence-based pharmacotherapies available to addiction treatment providers to address opioid use disorder (OUD) and prevent overdose deaths. Treatment organizations' efforts to provide these pharmacotherapies have, however, been stymied by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe these medications. Historically, the addiction treatment field has not attracted physicians, and many barriers to implementing OUD pharmacotherapy exist, ranging from lack of confidence in treating OUD patients to concerns regarding reimbursement. Throughout the USA, the prevalence of OUD far exceeds the capacity of the OUD pharmacotherapy treatment system. Poor access to OUD pharmacotherapy prescribers has become a workforce development need for the addiction treatment field and a significant health issue. This cluster randomized controlled trial (RCT) is designed to increase buprenorphine and extended-release naltrexone treatment capacity for OUD. The implementation intervention to be tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB), which was developed and piloted in a previous statewide buprenorphine implementation study. For this cluster RCT, organizational sites will be recruited and then randomized into one of two arms: (1) control, with treatment as usual and access to a website with PRB resources, or (2) intervention, with organizations implementing the PRB using the Network for the Improvement of Addiction Treatment organizational change model over a 24-month intervention period and a 10-month sustainability period. The primary treatment outcomes for each organizational site are self-reported monthly counts of buprenorphine slots, extended

  20. 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

  1. 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

  2. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial.

    Science.gov (United States)

    Martínez-Vizcaíno, Vicente; Sánchez-López, Mairena; Notario-Pacheco, Blanca; Salcedo-Aguilar, Fernando; Solera-Martínez, Montserrat; Franquelo-Morales, Pablo; López-Martínez, Sara; García-Prieto, Jorge C; Arias-Palencia, Natalia; Torrijos-Niño, Coral; Mora-Rodríguez, Ricardo; Rodríguez-Artalejo, Fernando

    2014-12-10

    Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results. The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren. Cluster randomized trial study of 712 schoolchildren, 8-10 years, from 20 public schools in the Province of Cuenca, Spain. The intervention (MOVI-2) consisted of play-based and non-competitive activities. MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011. We measured changes in adiposity (overweight/obesity prevalence, body mass index [BMI], triceps skinfold thickness [TST], body fat %, fat-free mass, waist circumference) and other cardiometabolic risk factors (LDL-cholesterol, triglycerides/HDL-cholesterol ratio, insulin, C-reactive protein and blood pressure). The analyses used mixed regression models to adjust for baseline covariates under cluster randomization. Among girls, we found a reduction of adiposity in intervention versus control schools, with a decrease in TST (-1.1 mm; 95% confidence interval [CI] -2.3 to -0.7), body fat % (-0.9%; 95% CI -1.3 to -0.4), waist circumference (-2.7 cm; 95% CI -4.5 to -0.9), and an increase in fat-free mass (0.3 kg; 95% CI 0.01 to 0.6). The intervention also led to lower serum LDL-cholesterol and insulin levels. Among boys, a reduction in waist circumference (-1.4 cm; 95% CI -2.6 to -0.1; P = 0.03), and an increase in fat-free mass (0.5 kg; 95% CI 0.2 to 0.9; P = 0.003) was associated with the intervention versus control schools. The prevalence of overweight/obesity or underweight, BMI, and other cardiometabolic risk factors was not modified by the intervention. No important adverse events were registered. An extracurricular intervention of non-competitive physical activity during an academic year, targeting all

  3. 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

  4. 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

  5. A hand hygiene intervention to decrease infections among children attending day care centers: design of a cluster randomized controlled trial.

    Science.gov (United States)

    Zomer, Tizza P; Erasmus, Vicki; Vlaar, Nico; van Beeck, Ed F; Tjon-A-Tsien, Aimée; Richardus, Jan Hendrik; Voeten, Hélène A C M

    2013-06-03

    Day care center attendance has been recognized as a risk factor for acquiring gastrointestinal and respiratory infections, which can be prevented with adequate hand hygiene (HH). Based on previous studies on environmental and sociocognitive determinants of caregivers' compliance with HH guidelines in day care centers (DCCs), an intervention has been developed aiming to improve caregivers' and children's HH compliance and decrease infections among children attending DCCs. The aim of this paper is to describe the design of a cluster randomized controlled trial to evaluate the effectiveness of this intervention. The intervention will be evaluated in a two-arm cluster randomized controlled trial among 71 DCCs in the Netherlands. In total, 36 DCCs will receive the intervention consisting of four components: 1) HH products (dispensers and refills for paper towels, soap, alcohol-based hand sanitizer, and hand cream); 2) training to educate about the Dutch national HH guidelines; 3) two team training sessions aimed at goal setting and formulating specific HH improvement activities; and 4) reminders and cues to action (posters/stickers). Intervention DCCs will be compared to 35 control DCCs continuing usual practice. The primary outcome measure will be observed HH compliance of caregivers and children, measured at baseline and one, three, and six months after start of the intervention. The secondary outcome measure will be the incidence of gastrointestinal and respiratory infections in 600 children attending DCCs, monitored over six months by parents using a calendar to mark the days their child has diarrhea and/or a cold. Multilevel logistic regression will be performed to assess the effect of the intervention on HH compliance. Multilevel poisson regression will be performed to assess the incidence of gastrointestinal and respiratory infections in children attending DCCs. This is one of the first DCC intervention studies to assess HH compliance of both caregivers and

  6. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial.

    Science.gov (United States)

    Santos, Hélio Gustavo; Chiavegato, Luciana Dias; Valentim, Daniela Pereira; da Silva, Patricia Rodrigues; Padula, Rosimeire Simprini

    2016-12-22

    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. 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. 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 adherence to the program, which may result in significant and

  7. 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

  8. Design of dry sand soil stratified sampler

    Science.gov (United States)

    Li, Erkang; Chen, Wei; Feng, Xiao; Liao, Hongbo; Liang, Xiaodong

    2018-04-01

    This paper presents a design of a stratified sampler for dry sand soil, which can be used for stratified sampling of loose sand under certain conditions. Our group designed the mechanical structure of a portable, single - person, dry sandy soil stratified sampler. We have set up a mathematical model for the sampler. It lays the foundation for further development of design research.

  9. Types of Obesity and Its Association with the Clustering of Cardiovascular Disease Risk Factors in Jilin Province of China

    OpenAIRE

    Zhang, Peng; Wang, Rui; Gao, Chunshi; Song, Yuanyuan; Lv, Xin; Jiang, Lingling; Yu, Yaqin; Wang, Yuhan; Li, Bo

    2016-01-01

    Cardiovascular disease (CVD) has become a serious public health problem in recent years in China. Aggregation of CVD risk factors in one individual increases the risk of CVD and the risk increases substantially with each additional risk factor. This study aims to explore the relationship between the number of clustered CVD risk factors and different types of obesity. A multistage stratified random cluster sampling design was used in this population-based cross-sectional study in 2012. Informa...

  10. Differential effect of exposure-based therapy and cognitive therapy on post-traumatic stress disorder symptom clusters: A randomized controlled trial.

    Science.gov (United States)

    Horesh, Danny; Qian, Meng; Freedman, Sara; Shalev, Arieh

    2017-06-01

    A question remains regarding differential effects of exposure-based versus non-exposure-based therapies on specific post-traumatic stress disorder (PTSD) symptom clusters. Traumatized emergency room patients were randomized to receive prolonged exposure (PE) or cognitive therapy (CT) without exposure. PE/CT had no differential effect on individual symptom clusters, and change in total PTSD score remained significant even after controlling for the reductions in all three symptom clusters. In addition, baseline levels of PTSD avoidance/intrusion/hyperarousal did not moderate the effects of PE and CT on total PTSD symptom scores. Taken together, these findings challenge the notion that PE and CT are specifically, and differentially, useful in treating one particular PTSD symptom cluster. Despite their different theoretical backgrounds and techniques, the notion that PE and CT (without exposure) target different PTSD symptoms was not confirmed in this study. Thus, both interventions may in fact be equally effective for treating intrusion, avoidance and hyperarousal symptoms. Baseline levels of avoidance, intrusion and hyperarousal may not be good a priori indicators for PTSD treatment selection. The effect of PE and CT on PTSD as a whole does not seem to depend on a reduction in any specific symptom cluster. These findings indicate that exposure and non-exposure interventions may lead to similar results in terms of reductions in specific PTSD symptoms. It is quite possible that individual PTSD clusters may respond to therapy in an inter-related fashion, with one cluster affecting the other. © 2016 The British Psychological Society.

  11. Effectiveness of educational outreach in infectious diseases management: a cluster randomized trial in Uganda

    Directory of Open Access Journals (Sweden)

    Martin Kayitale Mbonye

    2016-08-01

    Full Text Available Abstract Background Integrated Infectious Diseases Capacity Building Evaluation (IDCAP teams designed and implemented two health worker in-service training approaches: 1 an off-site classroom-based integrated management of infectious diseases (IMID course with distance learning aspects, and 2 on-site support (OSS, an educational outreach intervention. We tested the effects of OSS on workload and 12 facility performance indicators for emergency triage assessment and treatment, HIV testing, and malaria and pneumonia case management among outpatients by two subgroups: 1 mid-level practitioners (MLP who attended IMID training (IMID-MLP and 2 health workers who did not (No-IMID. Methods Thirty-six health facilities participated in the IDCAP trial, with 18 randomly assigned to Arm A and 18 to Arm B. Two MLP in both arms received IMID. All providers at Arm A facilities received nine monthly OSS visits from April to December 2010 while Arm B did not. From November 2009 to December 2010, 777,667 outpatient visits occurred. We analyzed 669,580 (86.1 % outpatient visits, where provider cadre was reported. Treatment was provided by 64 IMID-MLP and 1,515 No-IMID providers. The effect of OSS was measured by the difference in pre/post changes across arms after controlling for covariates (adjusted ratio of relative risks = a RRR. Results The effect of OSS on patients-per-provider-per-day (workload among IMID-MLP (aRRR = 1.21; p = 0.48 and No-IMID (aRRR = 0.90; p = 0.44 was not statistically significant. Among IMID-MLP, OSS was effective for three indicators: malaria cases receiving an appropriate antimalarial (aRRR = 1.26, 99 % CI = 1.02-1.56, patients with negative malaria test result prescribed an antimalarial (aRRR = 0.49, 99 % CI = 0.26-0.92, and patients with acid-fast bacilli smear negative result receiving empiric treatment for acute respiratory infection (aRRR = 2.04, 99 % CI = 1.06-3.94. Among No-IMID, OSS

  12. 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.

  13. The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Nicole Li

    Full Text Available 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.We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China.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.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; p<0.001, and sodium to potassium ratio declined by 15% (-0.9, -1.2 to -0.5; p<0.001. Mean blood pressure differences were -1.1 mm Hg systolic (-3.3 to +1.1; p = 0.33 and -0.7 mm Hg diastolic (-2.2 to +0.8, p = 0.35 and the difference in the proportion with hypertension was -1.3% (-5.1 to 2.5, p = 0.56.There were clear differences in population sodium and potassium intake between villages that were most likely a consequence of increased use of salt substitute. The absence of effects on blood pressure reflects the moderate changes in sodium and potassium intake achieved.Clinicaltrials.gov identifier: NCT01259700.

  14. 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.

  15. Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

    Science.gov (United States)

    Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

    2013-01-01

    Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

  16. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study].

    Science.gov (United States)

    Walther, C; Mende, M; Gaede, L; Müller, U; Machalica, K; Schuler, G

    2011-11-01

    It was the aim of this study to measure the effects over two years of daily sport activity during the school-day on their physical fitness (primary endpoint), motor coordination and blood pressure (secondary endpoints). A total of 232 children from eleven different 6 (th) grade classes were enrolled after informed parental consent. Their mean age was 11.1  ±  0.6 years. Six classes were randomly assigned for intervention (n=141), five as control (n=91). Those of the intervention cohort undertook, for five days weekly during the school year one hour of regulated sport exercise, including 15 min of endurance training. The pupils of the control group undertook customary sport activity (two hours a week). Anthropometric data were recorded and maximal oxygen uptake measured in each pupil, as well as blood pressure and motor coordination at the beginning and at the end of each of the two years of the study. The data were analyzed using the cluster randomization method. Maximal oxygen uptake (VO (2)max) had improved among the intervention group after two years, compared with the controls (3.12 m/kg/min, 95% confindence interval [CI] 0.06-6.19), while improvement in motor coordination just failed to reach statistical significance (3.06, 95% CI -0.17-6.29). There was no significant difference in systolic and diastolic blood pressure, but a downward trend in the prevalence of overweight and obesity from 12.1% to 7.8% in the intervention group. The results indicate that daily physical exercise during school hours should be given greater importance. But it will require a long-term trial to determine whether promotion of increased physical activity at school influences the prevalence of cardiovascular risk factors when the pupils reach adulthood. © Georg Thieme Verlag KG Stuttgart · New York.

  17. Evaluation of a nurse-led dementia education and knowledge translation programme in primary care: A cluster randomized controlled trial.

    Science.gov (United States)

    Wang, Yao; Xiao, Lily Dongxia; Ullah, Shahid; He, Guo-Ping; De Bellis, Anita

    2017-02-01

    The lack of dementia education programmes for health professionals in primary care is one of the major factors contributing to the unmet demand for dementia care services. To determine the effectiveness of a nurse-led dementia education and knowledge translation programme for health professionals in primary care; participants' satisfaction with the programme; and to understand participants' perceptions of and experiences in the programme. A cluster randomized controlled trial was used as the main methodology to evaluate health professionals' knowledge, attitudes and care approach. Focus groups were used at the end of the project to understand health professionals' perceptions of and experiences in the programme. Fourteen community health service centres in a province in China participated in the study. Seven centres were randomly assigned to the intervention or control group respectively and 85 health professionals in each group completed the programme. A train-the-trainer model was used to implement a dementia education and knowledge translation programme. Outcome variables were measured at baseline, on the completion of the programme and at 3-month follow-up. A mixed effect linear regression model was applied to compare the significant differences of outcome measures over time between the two groups. Focus groups were guided by four semi-structured questions and analysed using content analysis. Findings revealed significant effects of the education and knowledge translation programme on participants' knowledge, attitudes and a person-centred care approach. Focus groups confirmed that the programme had a positive impact on dementia care practice. A dementia education and knowledge translation programme for health professionals in primary care has positive effects on their knowledge, attitudes, care approach and care practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial.

    Science.gov (United States)

    Tello-Bernabé, Eugenia; Sanz-Cuesta, Teresa; del Cura-González, Isabel; de Santiago-Hernando, María L; Jurado-Sueiro, Montserrat; Fernández-Girón, Mercedes; García-de Blas, Francisca; Pensado-Freire, Higinio; Góngora-Maldonado, Francisco; de la Puente-Chamorro, María J; Rodríguez-Pasamontes, Carmen; Martín-Iglesias, Susana

    2011-12-01

    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. 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. 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 patients receive. ISRCTN: ISRCTN83365316.

  19. 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, padvertising antenatal care and portable obstetric ultrasound 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.

  20. 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.

  1. Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial.

    Science.gov (United States)

    Grossman, Daniel; Onono, Maricianah; Newmann, Sara J; Blat, Cinthia; Bukusi, Elizabeth A; Shade, Starley B; Steinfeld, Rachel L; Cohen, Craig R

    2013-10-01

    To determine whether integrating family planning services into HIV care is associated with increased use of more effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral contraceptives). Cluster-randomized trial. Eighteen public HIV clinics in Nyanza Province, Kenya. Women aged 18-45 years receiving care at participating HIV clinics; 5682 clinical encounters from baseline period (December 2009-February 2010) and 12,531 encounters from end-line period (July 2011-September 2011, 1 year after site training). Twelve sites were randomized to integrate family planning services into the HIV clinic, whereas six clinics were controls where clients desiring contraception were referred to family planning clinics at the same facility. Increase in use of more effective contraceptive methods between baseline and end-line periods. Pregnancy rates during the follow-up year (October 2010-September 2011) were also compared. Women seen at integrated sites were significantly more likely to use more effective contraceptive methods at the end of the study [increased from 16.7 to 36.6% at integrated sites, compared to increase from 21.1 to 29.8% at controls; odds ratio (OR) 1.81, 95% confidence interval (CI) 1.24-2.63]. Condom use decreased non-significantly at intervention sites compared to controls (OR 0.64, 95% CI 0.35-1.19). No difference was observed in incident pregnancy in the first year after integration comparing intervention to control sites (incidence rate ratio 0.90; 95% CI 0.68-1.20). Integration of family planning services into HIV care clinics increased use of more effective contraceptive methods with a non-significant reduction in condom use. Although no significant reduction in pregnancy incidence was observed during the study, 1 year may be too short a period of observation for this outcome.

  2. 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 consumer-behavior intervention using an existing online 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.

  3. 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.

  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. 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

  6. Suppression of stratified explosive interactions

    Energy Technology Data Exchange (ETDEWEB)

    Meeks, M.K.; Shamoun, B.I.; Bonazza, R.; Corradini, M.L. [Wisconsin Univ., Madison, WI (United States). Dept. of Nuclear Engineering and Engineering Physics

    1998-01-01

    Stratified Fuel-Coolant Interaction (FCI) experiments with Refrigerant-134a and water were performed in a large-scale system. Air was uniformly injected into the coolant pool to establish a pre-existing void which could suppress the explosion. Two competing effects due to the variation of the air flow rate seem to influence the intensity of the explosion in this geometrical configuration. At low flow rates, although the injected air increases the void fraction, the concurrent agitation and mixing increases the intensity of the interaction. At higher flow rates, the increase in void fraction tends to attenuate the propagated pressure wave generated by the explosion. Experimental results show a complete suppression of the vapor explosion at high rates of air injection, corresponding to an average void fraction of larger than 30%. (author)

  7. 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.

  8. A Physical Activity Intervention for Brazilian Students From Low Human Development Index Areas: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Filho, Valter C Barbosa; da Silva, Kelly Samara; Mota, Jorge; Beck, Carmem; da Silva Lopes, Adair

    2016-11-01

    Promoting physical activity (PA) in low- and middle-income countries is an important public health topic as well as a challenge for practice. This study aimed to assess the effect of a school-based intervention on different PA-related variables among students. This cluster-randomized-controlled trial included 548 students in the intervention group and 537 in the control group (11-18 years-old) from 6 schools in neighborhoods with low Human Development Index (0.170-0.491) in Fortaleza, Brazil. The intervention included strategies focused on training teachers, opportunities for PA in the school environment and health education. Variables measured at baseline and again at the 4-months follow-up included the weekly time in different types of moderate-to-vigorous PA (MVPA), preference for PA during leisure-time, PA behavioral change stage and active commuting to school. Generalized linear models and binary logistic regressions were used. An intervention effect was found by increasing the weekly time in MVPA (effect size = 0.17), popular games (effect size = 0.35), and the amount of PA per week (effect size = 0.27) among students (all P effective in promoting improvements in some PA outcomes, but the changes were not sufficient to increase the proportion of those meeting PA recommendations.

  9. Educational Interventions to Promote Healthy Nutrition and Physical Activity Among Older Chinese Americans: A Cluster-Randomized Trial.

    Science.gov (United States)

    Jih, Jane; Le, Gem; Woo, Kent; Tsoh, Janice Y; Stewart, Susan; Gildengorin, Ginny; Burke, Adam; Wong, Ching; Chan, Elaine; Fung, Lei-Chun; Yu, Filmer; Pasick, Rena; McPhee, Stephen J; Nguyen, Tung T

    2016-06-01

    To evaluate the efficacy of an in-language intervention of 2 lectures plus printed materials versus printed materials alone on knowledge and adherence to nutrition and physical activity guidelines among older Chinese Americans in San Francisco, California. From August 2010 to September 2013, we randomized 756 Chinese Americans aged 50 to 75 years to either lectures plus print (n = 361) or print (n = 357). Clusters were the participants recruited by each lay health worker. Intervention outcomes were changes in knowledge of recommended vegetable intake, fruit intake, and physical activity level and adherence to those recommendations from pre- to 6 months postintervention. The retention rate was 99%. At baseline, knowledge and adherence to recommendations were low. Print yielded increases in knowledge of recommended vegetable intake and physical activity level and adherence to fruit intake and physical activity recommendations. Lectures plus print had significant increases in all 6 outcomes. In multivariable models, lectures plus print was superior to print for knowledge of vegetable (adjusted odds ratio [AOR] = 12.61; 95% confidence interval [CI] = 6.50, 24.45) and fruit (AOR = 16.16; 95% CI = 5.61, 46.51) intake recommendations and adherence to vegetable intake recommendations (AOR = 5.53; 95% CI = 1.96, 15.58). In-language print materials, alone and combined with lectures, increased nutrition and physical activity knowledge and behaviors among older Chinese Americans.

  10. 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 included (i) MCHHB provision at antenatal care visits; (ii) records and guides by health personnel on and with the MCHHB; and (iii) sensitization of care by volunteers using the MCHHB. The follow-up rate was 70.2% (183, intervention area; 271, control area). Respondents in the intervention area received consecutive MCH services including two doses of tetanus toxoid injections and antenatal care four times or more during pregnancy, professional assistance during child delivery and vitamin A supplements administration to their children, after adjustment for confounding variables and cluster effects (OR = 2.03, 95% CI: 1.19-3.47). In the intervention area, home care (continued breastfeeding; introducing complementary feeding; proper feeding order; varied foods feeding; self-feeding training; and care for cough), perceived support by husbands, and lower underweight rates and stunting rates among children were observed. MCHHB use promoted continuous care acquisition and care at home from pregnancy to early child-rearing stages in rural Java. © The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health.

  11. Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes.

    Science.gov (United States)

    Linn, Annemiek J; van Dijk, Liset; van Weert, Julia C M; Gebeyehu, Beniam G; van Bodegraven, Ad A; Smit, Edith G

    2018-03-17

    Improving adherence is a challenge and multiple barriers are likely to explain non-adherence. These barriers differ per patient and over course of the regimen. Hence, personalized interventions tailored to the specific barriers are needed. In a theoretical and evidence-based Tailored Multimedia Intervention, technology (online preparatory assessment, text messaging) was used as an add-on to a tailored counseling session (learned during a communication skills training), with the expectation of synergistic effects. A cluster randomized controlled trial was conducted in six hospitals, eight nurses and 160 chronic patients. Patient satisfaction with communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after six months. Intervention effects were found for patient satisfaction with nurses' affective communication and self-efficacy at the initiation of treatment. The effect on self-efficacy remained after six months. By combining tailored counseling with technology, this intervention resulted in positive changes in important prerequisites of medication adherence. Technology can contribute significantly to health care providers' ability to tailor information to the patients' needs. Copyright © 2018. Published by Elsevier B.V.

  12. Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial.

    Science.gov (United States)

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

    2016-12-01

    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. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n = 175) or control group (27 NH units; n = 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n = 138) used the Neuropsychiatric Inventory-NH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (Mini-Mental State Examination). Using hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P pain treatment reduced staff distress in the intervention group compared to control group especially in regard to agitation-related symptoms and apathy. Furthermore, our results indicated a multifactorial model of staff distress, in which enhanced knowledge and understanding of NPSs and pain in people with advanced dementia may play an important role. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  13. Effect of fortified complementary food supplementation on child growth in rural Bangladesh: a cluster-randomized trial.

    Science.gov (United States)

    Christian, Parul; Shaikh, Saijuddin; Shamim, Abu Ahmed; Mehra, Sucheta; Wu, Lee; Mitra, Maithilee; Ali, Hasmot; Merrill, Rebecca D; Choudhury, Nuzhat; Parveen, Monira; Fuli, Rachel D; Hossain, Md Iqbal; Islam, Md Munirul; Klemm, Rolf; Schulze, Kerry; Labrique, Alain; de Pee, Saskia; Ahmed, Tahmeed; West, Keith P

    2015-12-01

    Growth faltering in the first 2 years of life is high in South Asia where prevalence of stunting is estimated at 40-50%. Although nutrition counselling has shown modest benefits, few intervention trials of food supplementation exist showing improvements in growth and prevention of stunting. A cluster-randomized controlled trial was conducted in rural Bangladesh to test the effect of two local, ready-to-use foods (chickpea and rice-lentil based) and a fortified blended food (wheat-soy-blend++, WSB++) compared with Plumpy'doz, all with nutrition counselling vs nutrition counselling alone (control) on outcomes of linear growth (length and length-for-age z-score, LAZ), stunting (LAZ food groups, provided with one of the allocated supplements daily for a year. Growth deceleration occurred from 6 to 18 months of age but deceleration in LAZ was lower (by 0.02-0.04/month) in the Plumpy'doz (P = 0.02), rice-lentil (food groups relative to the control. In rural Bangladesh, small amounts of daily fortified complementary foods, provided for a year in addition to nutrition counselling, modestly increased linear growth and reduced stunting at 18 months of age. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.

  14. The effects of humor therapy on nursing home residents measured using observational methods: the SMILE cluster randomized trial.

    Science.gov (United States)

    Low, Lee-Fay; Goodenough, Belinda; Fletcher, Jennifer; Xu, Kenny; Casey, Anne-Nicole; Chenoweth, Lynn; Fleming, Richard; Spitzer, Peter; Bell, Jean-Paul; Brodaty, Henry

    2014-08-01

    To evaluate the effects of humor therapy assessed using observational methods on agitation, engagement, positive behaviors, affect, and contentment. Single-blind cluster randomized controlled trial. A total of 35 Sydney nursing homes. All eligible residents within geographically defined areas within each nursing home were invited to participate. Professional "ElderClowns" provided 9 to 12 weekly humor therapy sessions, augmented by resident engagement by trained staff "LaughterBosses." Controls received usual care. The Behavior Engagement Affect Measure (BEAM) touchpad observational tool was used to capture real-time behavioral data. The tool assesses the duration in seconds of agitation, positive behavior toward others, engagement, and affect (angry, anxious, happy, neutral, sad). Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Over 26 weeks, in comparison with controls, the humor therapy group decreased in duration of high agitation (effect size = 0.168 and 0.129 at 13 and 26 weeks, respectively) and increased in duration of happiness (effect size = 0.4 and 0.236 at 13 and 26 weeks, respectively). We confirmed that humor therapy decreases agitation and also showed that it increases happiness. Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes. Computer-assisted observational measures should be considered, particularly for residents with dementia and when the reliability of staff is uncertain. Copyright © 2014 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  15. Behavioral Reactivity Associated With Electronic Monitoring of Environmental Health Interventions--A Cluster Randomized Trial with Water Filters and Cookstoves.

    Science.gov (United States)

    Thomas, Evan A; Tellez-Sanchez, Sarita; Wick, Carson; Kirby, Miles; Zambrano, Laura; Abadie Rosa, Ghislaine; Clasen, Thomas F; Nagel, Corey

    2016-04-05

    Subject reactivity--when research participants change their behavior in response to being observed--has been documented showing the effect of human observers. Electronics sensors are increasingly used to monitor environmental health interventions, but the effect of sensors on behavior has not been assessed. We conducted a cluster randomized controlled trial in Rwanda among 170 households (70 blinded to the presence of the sensor, 100 open) testing whether awareness of an electronic monitor would result in a difference in weekly use of household water filters and improved cookstoves over a four-week surveillance period. A 63% increase in number of uses of the water filter per week between the groups was observed in week 1, an average of 4.4 times in the open group and 2.83 times in the blind group, declining in week 4 to an insignificant 55% difference of 2.82 uses in the open, and 1.93 in the blind. There were no significant differences in the number of stove uses per week between the two groups. For both filters and stoves, use decreased in both groups over four-week installation periods. This study suggests behavioral monitoring should attempt to account for reactivity to awareness of electronic monitors that persists for weeks or more.

  16. Testing the leadership and organizational change for implementation (LOCI) intervention in substance abuse treatment: a cluster randomized trial study protocol.

    Science.gov (United States)

    Aarons, Gregory A; Ehrhart, Mark G; Moullin, Joanna C; Torres, Elisa M; Green, Amy E

    2017-03-03

    Evidence-based practice (EBP) implementation represents a strategic change in organizations that requires effective leadership and alignment of leadership and organizational support across organizational levels. As such, there is a need for combining leadership development with organizational strategies to support organizational climate conducive to EBP implementation. The leadership and organizational change for implementation (LOCI) intervention includes leadership training for workgroup leaders, ongoing implementation leadership coaching, 360° assessment, and strategic planning with top and middle management regarding how they can support workgroup leaders in developing a positive EBP implementation climate. This test of the LOCI intervention will take place in conjunction with the implementation of motivational interviewing (MI) in 60 substance use disorder treatment programs in California, USA. Participants will include agency executives, 60 program leaders, and approximately 360 treatment staff. LOCI will be tested using a multiple cohort, cluster randomized trial that randomizes workgroups (i.e., programs) within agency to either LOCI or a webinar leadership training control condition in three consecutive cohorts. The LOCI intervention is 12 months, and the webinar control intervention takes place in months 1, 5, and 8, for each cohort. Web-based surveys of staff and supervisors will be used to collect data on leadership, implementation climate, provider attitudes, and citizenship. Audio recordings of counseling sessions will be coded for MI fidelity. The unit of analysis will be the workgroup, randomized by site within agency and with care taken that co-located workgroups are assigned to the same condition to avoid contamination. Hierarchical linear modeling (HLM) will be used to analyze the data to account for the nested data structure. LOCI has been developed to be a feasible and effective approach for organizations to create a positive climate and

  17. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  18. The role of commitment strength in enhancing safe water consumption: mediation analysis of a cluster-randomized trial.

    Science.gov (United States)

    Inauen, Jennifer; Tobias, Robert; Mosler, Hans-Joachim

    2014-11-01

    The objectives of this study were to investigate the importance of commitment strength in the theory of planned behaviour (TPB) and to test whether behaviour change techniques (BCTs) aimed at increasing commitment strength indeed promote switching to arsenic-safe wells by changing commitment strength. A cluster-randomized controlled trial with four arms was conducted to compare an information-only intervention to information plus one, two, or three commitment-enhancing BCTs. Randomly selected households (N = 340) of Monoharganj, Bangladesh, in seven geographically separate areas, whose members were drinking arsenic-contaminated water at baseline and had access to arsenic-safe wells, participated in this trial. The areas were randomly allocated to the four intervention arms. Water consumption behaviour, variables of the TPB, commitment strength, and socio-demographic characteristics were assessed at baseline and at 3-month follow-up by structured face-to-face interviews. Mediation analysis was used to investigate the mechanisms of behaviour change. Changes in commitment strength significantly increased the explanatory power of the TPB to predict well-switching. Commitment-enhancing BCTs - public self-commitment, implementation intentions, and reminders - increased the behaviour change effects of information by up to 50%. Mediation analyses confirmed that the BCTs indeed increased well-switching by increasing commitment strength. Unexpectedly, however, mediation via changes in behavioural intentions was the strongest mechanism of the intervention effects. Commitment is an important construct to consider in water- and health-related behaviour change and may be for other health behaviours as well. BCTs that alter behavioural intentions and commitment strength proved highly effective at enhancing the behaviour change effects of information alone. Statement of contribution What is already known on this subject? Millions of people drink contaminated water even if they

  19. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kristensen Peter L

    2011-10-01

    Full Text Available Abstract Background The aim of the School site, Play Spot, Active transport, Club fitness and Environment (SPACE Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday physical activity (PA among 11-15-year-old adolescents. The study is based on a social ecological framework, and is designed to implement organizational and structural changes in the physical environment. Methods/design The SPACE Study used a cluster randomized controlled study design. Twenty-one eligible schools in the Region of Southern Denmark were matched and randomized in seven pairs according to eight matching variables summarized in an audit tool (crow-fly distance from residence to school for 5-6th graders; area household income; area education level; area ethnicity distribution; school district urbanity; condition and characteristics of school outdoor areas; school health policy; and active transport in the local area. Baseline measurements with accelerometers, questionnaires, diaries, and physical fitness tests were obtained in Spring 2010 in 5-6th grade in 7 intervention and 7 control schools, with follow-up measurements to be taken in Spring 2012 in 7-8th grade. The primary outcome measure is objective average daily physical activity and will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary. Other secondary outcome measures will be obtained, such as, overweight, physical fitness, active commuting to/from school and physical activity in recess periods. Discussion A total of 1348 adolescents in 5-6th grade in the Region of Southern Denmark participated at baseline (n = 14 schools. The response rate was high in all type of measurements (72.6-97.4%. There were no significant differences between intervention and control groups at baseline according to selected background variables and outcome measures: gender (p = .54, age (p = .17, BMI (p = .59, waist

  20. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

    Science.gov (United States)

    Adams, Alyce S; Bayliss, Elizabeth A; Schmittdiel, Julie A; Altschuler, Andrea; Dyer, Wendy; Neugebauer, Romain; Jaffe, Marc; Young, Joseph D; Kim, Eileen; Grant, Richard W

    2016-06-01

    Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age

  1. Increasing students’ physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Amy S. Ha

    2017-07-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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

  2. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial.

    Science.gov (United States)

    Persell, Stephen D; Lloyd-Jones, Donald M; Friesema, Elisha M; Cooper, Andrew J; Baker, David W

    2013-04-01

    Many individuals at higher risk for cardiovascular disease (CVD) do not receive recommended treatments. Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness. To perform a 9-month cluster-randomized trial, comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care. Patients of participating physicians with a Framingham Risk Score of at least 5 %, low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment, and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis. Patients of physicians randomized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin (and controlling hypertension or quitting smoking when relevant). The primary outcome was occurrence of a LDL-cholesterol level, repeated in routine practice, that was at least 30 mg/dl lower than prior. A secondary outcome was lipid-lowering drug prescribing. Clinicaltrials.gov identifier: NCT01286311. Fourteen physicians with 218 patients were randomized to intervention, and 15 physicians with 217 patients to control. The mean patient age was 60.7 years and 77% were male. There was no difference in the primary outcome (11.0 % vs. 11.1 %, OR 0.99, 95 % CI 0.56-1.74, P = 0.96), but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication (11.9 %, vs. 6.0 %, OR 2.13, 95 % CI 1.05-4.32, p = 0.038). In post hoc analysis with extended follow-up to 18 months, the primary outcome occurred more often in the intervention group (22.5 % vs. 16.1 %, OR 1.59, 95 % CI 1.05-2.41, P = 0.029). In this effectiveness trial, individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions, but we observed no difference in proportions lowering LDL

  3. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Niklaus Daniel Labhardt

    2014-12-01

    Full Text Available 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 <12 y, HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; p<0.001. Out of those who took up HTC, 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

  4. PHOTOSPHERIC EMISSION FROM STRATIFIED JETS

    International Nuclear Information System (INIS)

    Ito, Hirotaka; Nagataki, Shigehiro; Ono, Masaomi; Lee, Shiu-Hang; Mao, Jirong; Yamada, Shoichi; Pe'er, Asaf; Mizuta, Akira; Harikae, Seiji

    2013-01-01

    We explore photospheric emissions from stratified two-component jets, wherein a highly relativistic spine outflow is surrounded by a wider and less relativistic sheath outflow. Thermal photons are injected in regions of high optical depth and propagated until the photons escape at the photosphere. Because of the presence of shear in velocity (Lorentz factor) at the boundary of the spine and sheath region, a fraction of the injected photons are accelerated using a Fermi-like acceleration mechanism such that a high-energy power-law tail is formed in the resultant spectrum. We show, in particular, that if a velocity shear with a considerable variance in the bulk Lorentz factor is present, the high-energy part of observed gamma-ray bursts (GRBs) photon spectrum can be explained by this photon acceleration mechanism. We also show that the accelerated photons might also account for the origin of the extra-hard power-law component above the bump of the thermal-like peak seen in some peculiar bursts (e.g., GRB 090510, 090902B, 090926A). We demonstrate that time-integrated spectra can also reproduce the low-energy spectrum of GRBs consistently using a multi-temperature effect when time evolution of the outflow is considered. Last, we show that the empirical E p -L p relation can be explained by differences in the outflow properties of individual sources

  5. Community risk factors for ocular Chlamydia infection in Niger: pre-treatment results from a cluster-randomized trachoma trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    Full Text Available Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection.This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies. Univariate and multivariate associations were tested using linear regression and Bayes model averaging.There were a total of 24,536 participants (4,484 children aged 0-5 years in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system was 26.0% (95% CI: 21.9% to 30.0% and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9% in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P = 0.03, presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P = 0.001, and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P = 0.03 were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P = 0.03 and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P = 0.02 were associated risk factors for ocular chlamydial infection.We have found that the presence of facial flies and years of education of the head

  6. Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial.

    Science.gov (United States)

    Wienert, Julian; Schwarz, Betje; Bethge, Matthias

    2016-07-27

    Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors. To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60 years with a Karnofsky Performance Status of ≥70 %, a preliminary positive social-medical prognosis of employability for at least 3 h/day within the next 6 months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients' capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC

  7. Minimal improvement of nurses' motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial.

    Science.gov (United States)

    Jansink, Renate; Braspenning, Jozé; Laurant, Miranda; Keizer, Ellen; Elwyn, Glyn; Weijden, Trudy van der; Grol, Richard

    2013-03-28

    The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients' readiness to change lifestyle, and quality of life. Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients' readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, "inviting the patient to talk about behaviour change" (mean difference=0.39, p=0.009), and "assessing patient's confidence in changing their lifestyle" (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients' readiness to change health behaviour was associated positively with applying MI skills. The maintenance of the MI skills one year after the training program was minimal. The question is whether the success of MI to change unhealthy behaviour must be

  8. Minimal improvement of nurses’ motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial

    Science.gov (United States)

    2013-01-01

    Background The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients’ readiness to change lifestyle, and quality of life. Methods Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients’ readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. Results At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, “inviting the patient to talk about behaviour change” (mean difference=0.39, p=0.009), and “assessing patient’s confidence in changing their lifestyle” (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients’ readiness to change health behaviour was associated positively with applying MI skills. Conclusions The maintenance of the MI skills one year after the training program was minimal. The question is whether

  9. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial.

    Science.gov (United States)

    Mehta, Rajvi; Platt, Alyssa C; Sun, Xizi; Desai, Mukesh; Clements, Dennis; Turner, Elizabeth L

    2017-03-01

    Background: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron. Objective: We assessed the efficacy of the consumption of iron-supplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration Indian women of reproductive age. Design: The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively. Results: Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04). Conclusions: The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat anemia

  10. Mobile-health tool to improve maternal and neonatal health care in Bangladesh: a cluster randomized controlled trial.

    Science.gov (United States)

    Tobe, Ruoyan Gai; Haque, Syed Emdadul; Ikegami, Kiyoko; Mori, Rintaro

    2018-04-16

    In Bangladesh, the targets on reduction of maternal mortality and utilization of related obstetric services provided by skilled health personnel in Millennium Development Goals 5 remains unmet, and the progress in reduction of neonatal mortality lag behind that in the reduction of infant and under-five mortalities, remaining as an essential issue towards the achievement of maternal and neonatal health targets in health related Sustainable Development Goals (SDGs). As access to appropriate perinatal care is crucial to reduce maternal and neonatal deaths, recently several mobile platform-based health programs sponsored by donor countries and Non-Governmental Organizations have targeted to reduce maternal and child mortality. On the other hand, good health-care is necessary for the development. Thus, we designed this implementation research to improve maternal and child health care for targeting SDGs. This cluster randomized trial will be conducted in Lohagora of Narail District and Dhamrai of Dhaka District. Participants are pregnant women in the respective areas. The total sample size is 3000 where 500 pregnant women will get Mother and Child Handbook (MCH) and messages using mobile phone on health care during pregnancy and antenatal care about one year in each area. The other 500 in each area will get health education using only MCH book. The rest 1000 participants will be controlled; it means 500 in each area. We randomly assigned the intervention and controlled area based on smallest administrative area (Unions) in Bangladesh. The data collection and health education will be provided through trained research officers starting from February 2017 to August 2018. Each health education session is conducting in their house. The study proposal was reviewed and approved by NCCD, Japan and Bangladesh Medical Research Council (BMRC), Bangladesh. The data will be analyzed using STATA and SPSS software. For the improvement of maternal and neonatal care, this community

  11. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial.

    Science.gov (United States)

    Vitolo, Márcia Regina; Louzada, Maria Laura da Costa; Rauber, Fernanda

    2014-12-01

    To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. Cluster-randomized field trial conducted in the city of Porto Alegre, (RS), Brazil. Twenty primary health care centers (HCC) were randomized into intervention (n = 9) and control (n = 11) groups. The health professionals (n = 200) at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38), second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53), and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56) was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03). The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80), chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83), petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98) and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85) in their six first months of life was lower in the intervention group. The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  12. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial

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    Márcia Regina Vitolo

    2014-12-01

    Full Text Available OBJECTIVE: To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. METHODS: Cluster-randomized field trial conducted in the city of Porto Alegre, (RS, Brazil. Twenty primary health care centers (HCC were randomized into intervention (n = 9 and control (n = 11 groups. The health professionals (n = 200 at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. RESULTS: 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38, second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53, and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56 was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03. The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80, chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83, petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98 and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85 in their six first months of life was lower in the intervention group. CONCLUSION: The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  13. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China.

    Science.gov (United States)

    Zhang, Yuting; Tang, Wenxi; Zhang, Yan; Liu, Lulu; Zhang, Liang

    2017-03-11

    Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. A clustered randomized controlled trial was conducted in six towns in China's Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization's International Clinical Trials Registry, number ChiCTR-OOR-14005563. We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063-3.8), improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094-0.24). We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73-2.79) and reduced rates of hospitalization and inpatient spending, but it also reduced patients' self-assessed health-related quality of life. Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563) on November 23, 2014

  14. Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial.

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    William Cherniak

    Full Text Available 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, p<0.0001. Attendance was also improved in women who had previously seen a traditional healer (13.0, 95% CI 5.4-31.2 compared to control (1.5, 95% CI 0.5-5.0, rate ratio 8.7, 95% CI 2.0-38.1, p = 0.004. By advertising antenatal care and portable obstetric ultrasound by radio attendance was significantly improved. This study suggests that women can

  15. Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

    Science.gov (United States)

    Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

    2014-01-16

    Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of

  16. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

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    Mansikkamäki Kirsi

    2010-08-01

    Full Text Available Abstract Background Annual prevalence of gestational diabetes mellitus (GDM is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g, age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost

  17. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China

    Directory of Open Access Journals (Sweden)

    Yuting Zhang

    2017-03-01

    Full Text Available Abstract Background Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. Methods A clustered randomized controlled trial was conducted in six towns in China’s Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization’s International Clinical Trials Registry, number ChiCTR-OOR-14005563. Results We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063–3.8, improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094–0.24. We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73–2.79 and reduced rates of hospitalization and inpatient spending, but it also reduced patients’ self-assessed health-related quality of life. Conclusions Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at

  18. Interventions to address deficits of pharmacological pain management in nursing home residents--A cluster-randomized trial.

    Science.gov (United States)

    Könner, F; Budnick, A; Kuhnert, R; Wulff, I; Kalinowski, S; Martus, P; Dräger, D; Kreutz, R

    2015-10-01

    To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD ), respectively. At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, non-significant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved. © 2015 European Pain Federation - EFIC®

  19. Effects of a brief school-based media literacy intervention on digital media use in adolescents: cluster randomized controlled trial.

    Science.gov (United States)

    Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis

    2014-09-01

    The aim of this study was to evaluate the effects of a four-session school-based media literacy curriculum on adolescent computer gaming and Internet use behavior. The study comprised a cluster randomized controlled trial with three assessments (baseline, posttest, and 12-month follow-up). At baseline, a total of 2,303 sixth and seventh grade adolescents from 27 secondary schools were assessed. Of these, 1,843 (80%) could be reached at all three assessments (Mage=12.0 years; SD=0.83). Students of the intervention group received the media literacy program Vernetzte www.Welten ("Connected www.Worlds ") implemented by trained teachers during class time. The control group attended regular class. Main outcome measures were adolescents' computer gaming and Internet use: days per month, hours per day, and addictive use patterns. Parental media monitoring and rules at home were assessed as secondary outcomes. Results of multilevel growth-curve models revealed a significant intervention effect in terms of a lower increase in self-reported gaming frequency (β = -1.10 [95% CI -2.06, -0.13]), gaming time (β = -0.27 [95% CI -0.40, -0.14]), and proportion of excessive gamers (AOR=0.21 [95% CI 0.08, 0.57]) in the intervention group. There were also significant group-time interactions for the addictive gaming scale (β=-0.08 [95% CI -0.12, -0.04]), and the Internet Addiction Scale (β = -0.06 [95% CI -0.10, -0.01]). No effect was found for days and hours of Internet use or parental media behavior. The study shows that the program Vernetzte www.Welten can influence adolescents' media use behavior. Future research should address mediating and moderating variables of program effects.

  20. Practice context affects efforts to improve diabetes care for primary care patients: a pragmatic cluster randomized trial.

    Science.gov (United States)

    Dickinson, L Miriam; Dickinson, W Perry; Nutting, Paul A; Fisher, Lawrence; Harbrecht, Marjie; Crabtree, Benjamin F; Glasgow, Russell E; West, David R

    2015-04-01

    Efforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes. To examine practice contextual features that moderate intervention effectiveness. Secondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care. Forty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment. The primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos). Across the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm. This study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

  1. A school intervention for mental health literacy in adolescents: effects of a non-randomized cluster controlled trial

    Science.gov (United States)

    2013-01-01

    Background “Mental health for everyone” is a school program for mental health literacy and prevention aimed at secondary schools (13–15 yrs). The main aim was to investigate whether mental health literacy, could be improved by a 3-days universal education programme by: a) improving naming of symptom profiles of mental disorder, b) reducing prejudiced beliefs, and c) improving knowledge about where to seek help for mental health problems. A secondary aim was to investigate whether adolescent sex and age influenced the above mentioned variables. A third aim was to investigate whether prejudiced beliefs influenced knowledge about available help. Method This non-randomized cluster controlled trial included 1070 adolescents (53.9% boys, M age14 yrs) from three schools in a Norwegian town. One school (n = 520) received the intervention, and two schools (n = 550) formed the control group. Pre-test and follow-up were three months apart. Linear mixed models and generalized estimating equations models were employed for analysis. Results Mental health literacy improved contingent on the intervention, and there was a shift towards suggesting primary health care as a place to seek help. Those with more prejudiced beleifs did not suggest places to seek help for mental health problems. Generally, girls and older adolescents recognized symptom profiles better and had lower levels of prejudiced beliefs. Conclusions A low cost general school program may improve mental health literacy in adolescents. Gender specific programs and attention to the age and maturity of the students should be considered when mental health literacy programmes are designed and tried out. Prejudice should be addressed before imparting information about mental health issues. PMID:24053381

  2. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

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    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  3. Sex Differences in Civilian Injury in Baghdad From 2003 to 2014: Results of a Randomized Household Cluster Survey.

    Science.gov (United States)

    Shaak, Kyle; Lafta, Riyadh; Stewart, Barclay T; Fowler, Thomas R; Al-Shatari, Sahar A Esa; Burnham, Gilbert; Cherewick, Megan; Wren, Sherry M; Groen, Reinou S; Kushner, Adam L

    2018-06-01

    To examine sex differences in injury mechanisms, injury-related death, injury-related disability, and associated financial consequences in Baghdad since the 2003 invasion of Iraq to inform prevention initiatives, health policy, and relief planning. Reliable estimates of injury burden among civilians during conflict are lacking, particularly among vulnerable subpopulations, such as women. A 2-stage, cluster randomized, community-based household survey was conducted in May 2014 to determine the civilian burden of injury in Baghdad since 2003. Households were surveyed regarding injury mechanisms, healthcare required, disability, deaths, connection to conflict, and resultant financial hardship. We surveyed 900 households (5148 individuals), reporting 553 injuries, 162 (29%) of which were injuries among women. The mean age of injury was higher among women compared with men (34 ± 21.3 vs 27 ± 16.5 years; P < 0.001). More women than men were injured while in the home [104 (64%) vs 82 (21%); P < 0.001]. Fewer women than men died from injuries [11 (6.8%) vs 77 (20%); P < 0.001]; however, women were more likely than men to live with reduced function [101 (63%) vs 192 (49%); P = 0.005]. Of intentional injuries, women had higher rates of injury by shell fragments (41% vs 26%); more men were injured by gunshots [76 (41%) vs 6 (17.6%); P = .011). Women experienced fewer injuries than men in postinvasion Baghdad, but were more likely to suffer disability after injury. Efforts to improve conditions for injured women should focus on mitigating financial and provisional hardships, providing counseling services, and ensuring access to rehabilitation services.

  4. Parent and child care provider partnerships: Protocol for the Healthy Me, Healthy We (HMHW) cluster randomized control trial.

    Science.gov (United States)

    Hennink-Kaminski, Heidi; Vaughn, Amber E; Hales, Derek; Moore, Reneé H; Luecking, Courtney T; Ward, Dianne S

    2018-01-01

    Formation of diet and physical activity habits begins during early childhood. However, many preschool-aged children in the United States do not achieve recommendations for a nutritious diet or active lifestyle. Two important spheres of influence, home and child care, could ensure that children receive consistent health messages. Innovative approaches that engage both parents and child care providers in a substantial way are needed. Social marketing, a promising approach for health promotion targeting children, uses principles that recognize the need to engage multiple stakeholders and to emphasize benefits and overcome barriers associated with behavior change. Yet, application of social marketing principles in interventions for preschool-age children is limited. Healthy Me, Healthy We (HMHW) is 2-arm, cluster randomized controlled trial to evaluate the effect of a 8-month social marketing campaign on the diet and physical activity behaviors of preschool children (3-4years old), their parents, and child care providers. The campaign is delivered by the child care center and includes branded classroom and at-home activities and materials. Primary outcomes are children's diet quality (assessed with Healthy Eating Index scores) and minutes of non-sedentary activity (measured via accelerometers). Secondary outcomes assess children's body mass index, nutrition and physical activity practices at the child care center and at home, and health behaviors of child care providers and parents. HMHW is an innovative approach to promoting healthy eating and physical activity in preschool children. The campaign targets children during a key developmental period and leverages a partnership between providers and parents to affect behavior change. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    Directory of Open Access Journals (Sweden)

    Craig R Cohen

    Full Text Available To determine if integration of family planning (FP and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices and decreased pregnancy rates.Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration sites and oversaw integrated services at the original intervention (early integration sites.Eighteen health facilities in Kenya.Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2."One-stop shop" approach to integrating FP and HIV services.Use of more effective contraceptive methods and incident pregnancy across two years of follow-up.Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR = 1.39 (1.19-1.63. Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%. Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87.Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model.ClinicalTrials.gov NCT01001507.

  6. Effectiveness of advance care planning with family carers in dementia nursing homes: A paired cluster randomized controlled trial.

    Science.gov (United States)

    Brazil, Kevin; Carter, Gillian; Cardwell, Chris; Clarke, Mike; Hudson, Peter; Froggatt, Katherine; McLaughlin, Dorry; Passmore, Peter; Kernohan, W George

    2018-03-01

    In dementia care, a large number of treatment decisions are made by family carers on behalf of their family member who lacks decisional capacity; advance care planning can support such carers in the decision-making of care goals. However, given the relative importance of advance care planning in dementia care, the prevalence of advance care planning in dementia care is poor. To evaluate the effectiveness of advance care planning with family carers in dementia care homes. Paired cluster randomized controlled trial. The intervention comprised a trained facilitator, family education, family meetings, documentation of advance care planning decisions and intervention orientation for general practitioners and nursing home staff. A total of 24 nursing homes with a dementia nursing category located in Northern Ireland, United Kingdom. Family carers of nursing home residents classified as having dementia and judged as not having decisional capacity to participate in advance care planning discussions. The primary outcome was family carer uncertainty in decision-making about the care of the resident (Decisional Conflict Scale). There was evidence of a reduction in total Decisional Conflict Scale score in the intervention group compared with the usual care group (-10.5, 95% confidence interval: -16.4 to -4.7; p planning was effective in reducing family carer uncertainty in decision-making concerning the care of their family member and improving perceptions of quality of care in nursing homes. Given the global significance of dementia, the implications for clinicians and policy makers include them recognizing the importance of family carer education and improving communication between family carers and formal care providers.

  7. Psychosocial behaviour management programme for home-dwelling people with dementia: A cluster-randomized controlled trial.

    Science.gov (United States)

    Nakanishi, Miharu; Endo, Kaori; Hirooka, Kayo; Granvik, Eva; Minthon, Lennart; Nägga, Katarina; Nishida, Atsushi

    2018-03-01

    Little is known about the effectiveness of a psychosocial behaviour management programme on home-dwelling people with dementia. We developed a Behaviour Analytics & Support Enhancement (BASE) programme for care managers and professional caregivers of home care services in Japan. We investigated the effects of BASE on challenging behaviour of home-dwelling people with dementia. A cluster-randomized controlled trial was conducted with home care providers from 3 different districts in Tokyo. Each provider recruited persons with dementia aged 65 years or older to receive home care in the BASE programme in August 2016. An online monitoring and assessment system was introduced to the intervention group for repeated measures of challenging behaviour with a total score of the Neuropsychiatric Inventory. Care professionals in both the intervention and control groups evaluated challenging behaviour of persons with dementia at baseline (September 2016) and follow-up (February 2017). A majority of persons with dementia had Alzheimer disease (59.3%). One-hundred and forty-one persons with dementia were included in the intervention group and 142 in the control group. Multilevel modelling revealed a significant reduction in challenging behaviour in the intervention group after 6 months (mean score, 18.3 to 11.2) compared with that of the control group (11.6 to 10.8; P dwelling people with dementia. Future research should examine the long-term effects of behaviour management programmes on behaviour, nursing home placement, and hospital admission of home-dwelling people with dementia. Copyright © 2017 John Wiley & Sons, Ltd.

  8. Physical exercise at the workplace prevents deterioration of work ability among healthcare workers: cluster randomized controlled trial.

    Science.gov (United States)

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

    2015-11-25

    Imbalance between individual resources and work demands can lead to musculoskeletal disorders and reduced work ability. The purpose of this study was to investigate the effect of workplace- versus home-based physical exercise on work ability among healthcare workers. Two hundred female healthcare workers (Age: 42.0, BMI: 24.1, work ability index [WAI]: 43.1) from 18 departments at three Danish hospitals participated (Copenhagen, Denmark, Aug 2013-Jan 2014). Participants were randomly allocated at the cluster level to 10 weeks of: 1) workplace physical exercise (WORK) performed during working hours for 5x10 min per week and up to 5 group-based coaching sessions on motivation for regular physical exercise, or 2) home-based physical exercise (HOME) performed during leisure time for 5x10 min per week. Both groups received ergonomic counseling on patient handling and use of lifting aides. The main outcome measure was the change from baseline to 10-week follow-up in WAI. Significant group by time interaction was observed for WAI (p WORK compared with HOME corresponding to a small effect size (Cohens'd = 0.24). Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in HOME. Of the seven items of WAI, item 2 (work ability in relation to the demands of the job) and item 5 (sickness absence during the past year) were improved in WORK compared with HOME (P work ability among female healthcare workers. ClinicalTrials.gov NCT01921764 . Registered 10 August 2013.

  9. Promoting STI testing among senior vocational students in Rotterdam, the Netherlands: effects of a cluster randomized study

    Directory of Open Access Journals (Sweden)

    Wolfers Mireille

    2011-12-01

    Full Text Available Abstract Background Adolescents are a risk group for acquiring sexually transmitted infections (STIs. In the Netherlands, senior vocational school students are particular at risk. However, STI test rates among adolescents are low and interventions that promote testing are scarce. To enhance voluntary STI testing, an intervention was designed and evaluated in senior vocational schools. The intervention combined classroom health education with sexual health services at the school site. The purpose of this study was to assess the combined and single effects on STI testing of health education and school-based sexual health services. Methods In a cluster-randomized study the intervention was evaluated in 24 schools, using three experimental conditions: 1 health education, 2 sexual health services; 3 both components; and a control group. STI testing was assessed by self reported behavior and registrations at regional sexual health services. Follow-up measurements were performed at 1, 3, and 6-9 months. Of 1302 students present at baseline, 739 (57% completed at least 1 follow-up measurement, of these students 472 (64% were sexually experienced, and considered to be susceptible for the intervention. Multi-level analyses were conducted. To perform analyses according to the principle of intention-to-treat, missing observations at follow-up on the outcome measure were imputed with multiple imputation techniques. Results were compared with the complete cases analysis. Results Sexually experienced students that received the combined intervention of health education and sexual health services reported more STI testing (29% than students in the control group (4% (OR = 4.3, p Conclusions Despite a low dose of intervention that was received by the students and a high attrition, we were able to show an intervention effect among sexually experienced students on STI testing. This study confirmed our hypothesis that offering health education to vocational students

  10. Protocol for work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (VIMS): a cluster randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Lars L.; Zebis, Mette K.; Pedersen, Mogens Theisen

    2010-01-01

    of training supervision for safe and effective training. METHODS/DESIGN: A cluster randomized controlled trial of 20 weeks duration where employed office workers are randomized to 1 x 60 min, 3 x 20 min, 9 x 7 min per week of specific strength training with training supervision, to 3 x 20 min per week...... of specific strength training with a minimal amount of training supervision, or to a reference group without training. A questionnaire will be sent to 2000 employees in jobs characterized by intensive computer work. Employees with cardiovascular disease, trauma, hypertension, or serious chronic disease...

  11. Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

    Science.gov (United States)

    Pandey, Priyanka; Sehgal, Ashwini R; Riboud, Michelle; Levine, David; Goyal, Madhav

    2007-10-24

    A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. To determine the impact of informing resource-poor rural populations about entitled services. Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. clinicaltrials.gov Identifier: NCT00421291.

  12. A cluster-randomized controlled study to evaluate a team coaching concept for improving teamwork and patient-centeredness in rehabilitation teams

    OpenAIRE

    K?rner, Mirjam; Luzay, Leonie; Plewnia, Anne; Becker, Sonja; Rundel, Manfred; Zimmermann, Linda; M?ller, Christian

    2017-01-01

    Purpose Although the relevance of interprofessional teamwork in the delivery of patient-centered care is well known, there is a lack of interventions for improving team interaction in the context of rehabilitation in Germany. The aim of the present study is to evaluate whether a specially developed team coaching concept (TCC) could improve both teamwork and patient-centeredness. Method A multicenter, cluster-randomized controlled intervention study was conducted with both staff and patient qu...

  13. Effects of Individual Physician-Level and Practice-Level Financial Incentives on Hypertension Care: A Cluster Randomized Trial

    Science.gov (United States)

    Petersen, Laura A.; Simpson, Kate; Pietz, Kenneth; Urech, Tracy H.; Hysong, Sylvia J.; Profit, Jochen; Conrad, Douglas A.; Dudley, R. Adams; Woodard, LeChauncy D.

    2014-01-01

    Importance Pay for performance is intended to align incentives to promote high quality care, but results have been contradictory. Objective To test the effect of explicit financial incentives to reward guideline-recommended hypertension care. Design, Setting, and Participants Cluster randomized controlled trial of 12 Veterans Affairs hospital-based outpatient clin