What affects response rates in primary healthcare-based programmes? An analysis of individual and unit-related factors associated with increased odds of non-response based on HCV screening in the general population in Poland.

PubMed

Parda, Natalia; Stępień, Małgorzata; Zakrzewska, Karolina; Madaliński, Kazimierz; Kołakowska, Agnieszka; Godzik, Paulina; Rosińska, Magdalena

2016-12-07

Response rate in public health programmes may be a limiting factor. It is important to first consider their delivery and acceptability for the target. This study aimed at determining individual and unit-related factors associated with increased odds of non-response based on hepatitis C virus screening in primary healthcare. Primary healthcare units (PHCUs) were extracted from the Register of Health Care Centres. Each of the PHCUs was to enrol adult patients selected on a random basis. Data on the recruitment of PHCUs and patients were analysed. Multilevel modelling was applied to investigate individual and unit-related factors associated with non-response. Multilevel logistic model was developed with fixed effects and only a random intercept for the unit. Preliminary analysis included a random effect for unit and each of the individual or PHCU covariates separately. For each of the PHCU covariates, we applied a two-level model with individual covariates, unit random effect and a single fixed effect of this unit covariate. This study was conducted in primary care units in selected provinces in Poland. A total of 242 PHCUs and 24 480 adults were invited. Of them, 44 PHCUs and 20 939 patients agreed to participate. Both PHCUs and patients were randomly selected. Data on 44 PHCUs and 24 480 patients were analysed. PHCU-level factors and recruitment strategies were important predictors of non-response. Unit random effect was significant in all models. Larger and private units reported higher non-response rates, while for those with a history of running public health programmes the odds of non-response was lower. Proactive recruitment, more working hours devoted to the project and patient resulted in higher acceptance of the project. Higher number of personnel had no such effect. Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Generalized SAMPLE SIZE Determination Formulas for Investigating Contextual Effects by a Three-Level Random Intercept Model.

PubMed

Usami, Satoshi

2017-03-01

Behavioral and psychological researchers have shown strong interests in investigating contextual effects (i.e., the influences of combinations of individual- and group-level predictors on individual-level outcomes). The present research provides generalized formulas for determining the sample size needed in investigating contextual effects according to the desired level of statistical power as well as width of confidence interval. These formulas are derived within a three-level random intercept model that includes one predictor/contextual variable at each level to simultaneously cover various kinds of contextual effects that researchers can show interest. The relative influences of indices included in the formulas on the standard errors of contextual effects estimates are investigated with the aim of further simplifying sample size determination procedures. In addition, simulation studies are performed to investigate finite sample behavior of calculated statistical power, showing that estimated sample sizes based on derived formulas can be both positively and negatively biased due to complex effects of unreliability of contextual variables, multicollinearity, and violation of assumption regarding the known variances. Thus, it is advisable to compare estimated sample sizes under various specifications of indices and to evaluate its potential bias, as illustrated in the example.

Random Forests for Evaluating Pedagogy and Informing Personalized Learning

ERIC Educational Resources Information Center

Spoon, Kelly; Beemer, Joshua; Whitmer, John C.; Fan, Juanjuan; Frazee, James P.; Stronach, Jeanne; Bohonak, Andrew J.; Levine, Richard A.

2016-01-01

Random forests are presented as an analytics foundation for educational data mining tasks. The focus is on course- and program-level analytics including evaluating pedagogical approaches and interventions and identifying and characterizing at-risk students. As part of this development, the concept of individualized treatment effects (ITE) is…

Smooth individual level covariates adjustment in disease mapping.

PubMed

Huque, Md Hamidul; Anderson, Craig; Walton, Richard; Woolford, Samuel; Ryan, Louise

2018-05-01

Spatial models for disease mapping should ideally account for covariates measured both at individual and area levels. The newly available "indiCAR" model fits the popular conditional autoregresssive (CAR) model by accommodating both individual and group level covariates while adjusting for spatial correlation in the disease rates. This algorithm has been shown to be effective but assumes log-linear associations between individual level covariates and outcome. In many studies, the relationship between individual level covariates and the outcome may be non-log-linear, and methods to track such nonlinearity between individual level covariate and outcome in spatial regression modeling are not well developed. In this paper, we propose a new algorithm, smooth-indiCAR, to fit an extension to the popular conditional autoregresssive model that can accommodate both linear and nonlinear individual level covariate effects while adjusting for group level covariates and spatial correlation in the disease rates. In this formulation, the effect of a continuous individual level covariate is accommodated via penalized splines. We describe a two-step estimation procedure to obtain reliable estimates of individual and group level covariate effects where both individual and group level covariate effects are estimated separately. This distributed computing framework enhances its application in the Big Data domain with a large number of individual/group level covariates. We evaluate the performance of smooth-indiCAR through simulation. Our results indicate that the smooth-indiCAR method provides reliable estimates of all regression and random effect parameters. We illustrate our proposed methodology with an analysis of data on neutropenia admissions in New South Wales (NSW), Australia. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Assessing different measures of population-level vaccine protection using a case-control study.

PubMed

Ali, Mohammad; You, Young Ae; Kanungo, Suman; Manna, Byomkesh; Deen, Jacqueline L; Lopez, Anna Lena; Wierzba, Thomas F; Bhattacharya, Sujit K; Sur, Dipika; Clemens, John D

2015-11-27

Case-control studies have not been examined for their utility in assessing population-level vaccine protection in individually randomized trials. We used the data of a randomized, placebo-controlled trial of a cholera vaccine to compare the results of case-control analyses with those of cohort analyses. Cases of cholera were selected from the trial population followed for three years following dosing. For each case, we selected 4 age-matched controls who had not developed cholera. For each case and control, GIS was used to calculate vaccine coverage of individuals in a surrounding "virtual" cluster. Specific selection strategies were used to evaluate the vaccine protective effects. 66,900 out of 108,389 individuals received two doses of the assigned regimen. For direct protection among subjects in low vaccine coverage clusters, we observed 78% (95% CI: 47-91%) protection in a cohort analysis and 84% (95% CI: 60-94%) in case-control analysis after adjusting for confounding factors. Using our GIS-based approach, estimated indirect protection was 52% (95% CI: 10-74%) in cohort and 76% (95% CI: 47-89%) in case control analysis. Estimates of total and overall effectiveness were similar for cohort and case-control analyses. The findings show that case-control analyses of individually randomized vaccine trials may be used to evaluate direct as well as population-level vaccine protection. Copyright © 2015. Published by Elsevier Ltd.

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

PubMed Central

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 clinics with five performance periods and a 12-month washout. We enrolled 83 primary care physicians and 42 non-physician personnel (e.g., nurses, pharmacists) working with physicians to deliver hypertension care. Interventions Clinics randomized to one of four groups: physician-level (individual) incentives; practice-level incentives; individual- plus practice-level incentives (combined); or none. Intervention participants received up to five payments every four months; all participants could access feedback reports. Main outcome measures For each four-month period, the number of hypertensive patients among a random sample who achieved guideline-recommended blood pressure thresholds or received an appropriate response to uncontrolled blood pressure; and/or been prescribed guideline-recommended medications and the number who developed hypotension. Results Mean (standard deviation) total payments over the study were $4,270 ($459), $2,672 ($153), and $1,648 ($248) for the combined, individual, and practice-level interventions, respectively. The adjusted change over the study in patients meeting the combined blood pressure/appropriate response measure was 8.84 percentage points (95% confidence interval [CI], 4.20–11.80) for the individual-level, 3.70 (95% CI, 0.24–7.68) for the practice-level, 5.54 (95% CI, 1.92–9.52) for the combined, and 0.47 (95% CI, −3.12–4.04) for the control groups. For medications, the change was 9.07 (95% CI, 4.52–13.44), 4.98 (95% CI, 0.64–10.08), 7.26 (95% CI, 2.92–12.48), and 4.35 (95% CI, −0.28–9.28) percentage points, respectively. The adjusted estimated difference in the change between the proportion of patients with blood pressure control/appropriate response for individual incentive and control groups was 8.36 percentage points (95% CI, 2.40–13.00; P=.005). Use of guideline-recommended medications did not significantly change compared to controls, nor did the incidence of hypotension. The effect of the incentive was not sustained after a washout. Conclusions and Relevance Individual financial incentives, but not practice-level or combined incentives, resulted in greater blood pressure control or appropriate response to uncontrolled blood pressure; none of the incentives resulted in greater use of guideline-recommended medications or increased incidence of hypotension compared to controls. Further research is needed to understand the factors that contributed to our findings. Trial registration NCT00302718; www.clinicaltrials.gov PMID:24026599

Controlling Chronic Diseases Through Evidence-Based Decision Making: A Group-Randomized Trial.

PubMed

Brownson, Ross C; Allen, Peg; Jacob, Rebekah R; deRuyter, Anna; Lakshman, Meenakshi; Reis, Rodrigo S; Yan, Yan

2017-11-30

Although practitioners in state health departments are ideally positioned to implement evidence-based interventions, few studies have examined how to build their capacity to do so. The objective of this study was to explore how to increase the use of evidence-based decision-making processes at both the individual and organization levels. We conducted a 2-arm, group-randomized trial with baseline data collection and follow-up at 18 to 24 months. Twelve state health departments were paired and randomly assigned to intervention or control condition. In the 6 intervention states, a multiday training on evidence-based decision making was conducted from March 2014 through March 2015 along with a set of supplemental capacity-building activities. Individual-level outcomes were evidence-based decision making skills of public health practitioners; organization-level outcomes were access to research evidence and participatory decision making. Mixed analysis of covariance models was used to evaluate the intervention effect by accounting for the cluster randomized trial design. Analysis was performed from March through May 2017. Participation 18 to 24 months after initial training was 73.5%. In mixed models adjusted for participant and state characteristics, the intervention group improved significantly in the overall skill gap (P = .01) and in 6 skill areas. Among the 4 organizational variables, only access to evidence and skilled staff showed an intervention effect (P = .04). Tailored and active strategies are needed to build capacity at the individual and organization levels for evidence-based decision making. Our study suggests several dissemination interventions for consideration by leaders seeking to improve public health practice.

A multivariate spatial mixture model for areal data: examining regional differences in standardized test scores

PubMed Central

Neelon, Brian; Gelfand, Alan E.; Miranda, Marie Lynn

2013-01-01

Summary Researchers in the health and social sciences often wish to examine joint spatial patterns for two or more related outcomes. Examples include infant birth weight and gestational length, psychosocial and behavioral indices, and educational test scores from different cognitive domains. We propose a multivariate spatial mixture model for the joint analysis of continuous individual-level outcomes that are referenced to areal units. The responses are modeled as a finite mixture of multivariate normals, which accommodates a wide range of marginal response distributions and allows investigators to examine covariate effects within subpopulations of interest. The model has a hierarchical structure built at the individual level (i.e., individuals are nested within areal units), and thus incorporates both individual- and areal-level predictors as well as spatial random effects for each mixture component. Conditional autoregressive (CAR) priors on the random effects provide spatial smoothing and allow the shape of the multivariate distribution to vary flexibly across geographic regions. We adopt a Bayesian modeling approach and develop an efficient Markov chain Monte Carlo model fitting algorithm that relies primarily on closed-form full conditionals. We use the model to explore geographic patterns in end-of-grade math and reading test scores among school-age children in North Carolina. PMID:26401059

Not accounting for interindividual variability can mask habitat selection patterns: a case study on black bears.

PubMed

Lesmerises, Rémi; St-Laurent, Martin-Hugues

2017-11-01

Habitat selection studies conducted at the population scale commonly aim to describe general patterns that could improve our understanding of the limiting factors in species-habitat relationships. Researchers often consider interindividual variation in selection patterns to control for its effects and avoid pseudoreplication by using mixed-effect models that include individuals as random factors. Here, we highlight common pitfalls and possible misinterpretations of this strategy by describing habitat selection of 21 black bears Ursus americanus. We used Bayesian mixed-effect models and compared results obtained when using random intercept (i.e., population level) versus calculating individual coefficients for each independent variable (i.e., individual level). We then related interindividual variability to individual characteristics (i.e., age, sex, reproductive status, body condition) in a multivariate analysis. The assumption of comparable behavior among individuals was verified only in 40% of the cases in our seasonal best models. Indeed, we found strong and opposite responses among sampled bears and individual coefficients were linked to individual characteristics. For some covariates, contrasted responses canceled each other out at the population level. In other cases, interindividual variability was concealed by the composition of our sample, with the majority of the bears (e.g., old individuals and bears in good physical condition) driving the population response (e.g., selection of young forest cuts). Our results stress the need to consider interindividual variability to avoid misinterpretation and uninformative results, especially for a flexible and opportunistic species. This study helps to identify some ecological drivers of interindividual variability in bear habitat selection patterns.

The Effectiveness of Kindergarten Peer-Assisted Learning Strategies for Students with Disabilities

ERIC Educational Resources Information Center

Rafdal, Brooke H.; McMaster, Kristen L.; McConnell, Scott R.; Fuchs, Douglas; Fuchs, Lynn S.

2011-01-01

This study determined the effectiveness of Kindergarten Peer-Assisted Learning Strategies (K-PALS) for students with disabilities. The researchers randomly assigned 89 kindergartners with individualized education programs (IEPs) from 47 classrooms to control (n = 9); K-PALS Level 1 (teachers received 1-day workshop; n = 19); or K-PALS Level 2…

Effect of packing method on the randomness of disc packings

NASA Astrophysics Data System (ADS)

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

1996-06-01

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

ESTIMATING PERSON-CENTERED TREATMENT (PeT) EFFECTS USING INSTRUMENTAL VARIABLES: AN APPLICATION TO EVALUATING PROSTATE CANCER TREATMENTS

PubMed Central

BASU, ANIRBAN

2014-01-01

SUMMARY This paper builds on the methods of local instrumental variables developed by Heckman and Vytlacil (1999, 2001, 2005) to estimate person-centered treatment (PeT) effects that are conditioned on the person’s observed characteristics and averaged over the potential conditional distribution of unobserved characteristics that lead them to their observed treatment choices. PeT effects are more individualized than conditional treatment effects from a randomized setting with the same observed characteristics. PeT effects can be easily aggregated to construct any of the mean treatment effect parameters and, more importantly, are well suited to comprehend individual-level treatment effect heterogeneity. The paper presents the theory behind PeT effects, and applies it to study the variation in individual-level comparative effects of prostate cancer treatments on overall survival and costs. PMID:25620844

Estimating individual influences of behavioral intentions: an application of random-effects modeling to the theory of reasoned action.

PubMed

Hedeker, D; Flay, B R; Petraitis, J

1996-02-01

Methods are proposed and described for estimating the degree to which relations among variables vary at the individual level. As an example of the methods, M. Fishbein and I. Ajzen's (1975; I. Ajzen & M. Fishbein, 1980) theory of reasoned action is examined, which posits first that an individual's behavioral intentions are a function of 2 components: the individual's attitudes toward the behavior and the subjective norms as perceived by the individual. A second component of their theory is that individuals may weight these 2 components differently in assessing their behavioral intentions. This article illustrates the use of empirical Bayes methods based on a random-effects regression model to estimate these individual influences, estimating an individual's weighting of both of these components (attitudes toward the behavior and subjective norms) in relation to their behavioral intentions. This method can be used when an individual's behavioral intentions, subjective norms, and attitudes toward the behavior are all repeatedly measured. In this case, the empirical Bayes estimates are derived as a function of the data from the individual, strengthened by the overall sample data.

Successful ingredients in the SMILE study: resident, staff, and management factors influence the effects of humor therapy in residential aged care.

PubMed

Brodaty, Henry; Low, Lee-Fay; Liu, Zhixin; Fletcher, Jennifer; Roast, Joel; Goodenough, Belinda; Chenoweth, Lynn

2014-12-01

To test the hypothesis that individual and institutional-level factors influence the effects of a humor therapy intervention on aged care residents. Data were from the humor therapy group of the Sydney Multisite Intervention of LaughterBosses and ElderClowns, or SMILE, study, a single-blind cluster randomized controlled trial of humor therapy conducted over 12 weeks; assessments were performed at baseline, week 13, and week 26. One hundred eighty-nine individuals from 17 Sydney residential aged care facilities were randomly allocated to the humor therapy intervention. Professional performers called "ElderClowns" provided 9-12 weekly humor therapy 2-hour sessions, augmented by trained staff, called "LaughterBosses." Outcome measures were as follows: Cornell Scale for Depression in Dementia, Cohen-Mansfield Agitation Inventory, Neuropsychiatric Inventory, the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and proxy-rated quality of life in dementia population scale. Facility-level measures were as follows: support of the management for the intervention, commitment levels of LaughterBosses, Environmental Audit Tool scores, and facility level of care provided (high/low). Resident-level measures were engagement, functional ability, disease severity, and time-in-care. Multilevel path analyses simultaneously modeled resident engagement at the individual level (repeated measures) and the effects of management support and staff commitment to humor therapy at the cluster level. Models indicated flow-on effects, whereby management support had positive effects on LaughterBoss commitment, and LaughterBoss commitment increased resident engagement. Higher resident engagement was associated with reduced depression, agitation, and neuropsychiatric scores. Effectiveness of psychosocial programs in residential aged care can be enhanced by management support, staff commitment, and active resident engagement. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV Infection in Young Women in South Africa-Study Design and Baseline Results.

PubMed

Pettifor, Audrey; MacPhail, Catherine; Selin, Amanda; Gómez-Olivé, F Xavier; Rosenberg, Molly; Wagner, Ryan G; Mabuza, Wonderful; Hughes, James P; Suchindran, Chirayath; Piwowar-Manning, Estelle; Wang, Jing; Twine, Rhian; Daniel, Tamu; Andrew, Philip; Laeyendecker, Oliver; Agyei, Yaw; Tollman, Stephen; Kahn, Kathleen

2016-09-01

Young women in South Africa are at high risk for HIV infection. Cash transfers offer promise to reduce HIV risk. We present the design and baseline results from HPTN 068, a phase III, individually randomized trial to assess the effect of a conditional cash transfer on HIV acquisition among South African young women. A total of 2533 young women were randomized to receive a monthly cash transfer conditional on school attendance or to a control group. A number of individual-, partner-, household- and school-level factors were associated with HIV and HSV-2 infection. After adjusting for age, all levels were associated with an increased odds of HIV infection with partner-level factors conveying the strongest association (aOR 3.05 95 % CI 1.84-5.06). Interventions like cash transfers that address structural factors such as schooling and poverty have the potential to reduce HIV risk in young women in South Africa.

Perception of Muscular Effort During Dynamic Elbow Extension in Multiple Sclerosis.

PubMed

Heller, Mario; Retzl, Irene; Kiselka, Anita; Greisberger, Andrea

2016-02-01

To investigate the perception of muscular effort in individuals with multiple sclerosis (MS) and healthy controls during dynamic contractions. Case-control study. MS day care center. Individuals with MS (n=28) and controls (n=28) (N=56). Not applicable. Perceived muscular effort during dynamic elbow extensions was rated at 9 different weight intensities (10%-90% of 1-repetition maximum) in a single-blind, randomized order using the OMNI-Resistance Exercise Scale. Muscle activity of the triceps brachii muscle (lateral head) was measured via surface electromyography and normalized to maximal voluntary excitation. According to OMNI-level ratings, significant main effects were found for the diagnostic condition (F=27.33, P<.001, η(2)=.11), indicating 0.7 (95% confidence interval [CI], 0.3-1.1) lower mean OMNI-level ratings for MS, and for the intensity level (F=46.81, P<.001, η(2)=.46), showing increased OMNI-level ratings for increased intensity levels for both groups. Furthermore, significant main effects were found for the diagnostic condition (F=16.52, P<.001, η(2)=.07), indicating 7.1% (95% CI, -8.6 to 22.8) higher maximal voluntary excitation values for MS, and for the intensity level (F=33.09, P<.001, η(2)=.36), showing higher relative muscle activities for increasing intensity levels in both groups. Similar to controls, individuals with MS were able to differentiate between different intensities of weight during dynamic elbow extensions when provided in a single-blind, randomized order. Therefore, perceived muscular effort might be considered to control resistance training intensities in individuals with MS. However, training intensity for individuals with MS should be chosen at approximately 1 OMNI level lower than recommended, at least for dynamic elbow extension exercises. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Vasopressin, but not oxytocin, increases empathic concern among individuals who received higher levels of paternal warmth: A randomized controlled trial.

PubMed

Tabak, Benjamin A; Meyer, Meghan L; Castle, Elizabeth; Dutcher, Janine M; Irwin, Michael R; Han, Jung H; Lieberman, Matthew D; Eisenberger, Naomi I

2015-01-01

Empathy improves our ability to communicate in social interactions and motivates prosocial behavior. The neuropeptides arginine vasopressin and oxytocin play key roles in socioemotional processes such as pair bonding and parental care, which suggests that they may be involved in empathic processing. We investigated how vasopressin and oxytocin affect empathic responding in a randomized, double-blind, placebo controlled, between-subjects study design. We also examined the moderating role of parental warmth, as reported in the early family environment, on empathic responding following vasopressin, oxytocin, or placebo administration. Among participants who reported higher levels of paternal warmth (but not maternal warmth), vasopressin (vs. placebo and oxytocin) increased ratings of empathic concern after viewing distressing and uplifting videos. No main or interaction effects were found for individuals who received oxytocin. Vasopressin has a role in enhancing empathy among individuals who received higher levels of paternal warmth. NCT01680718. Copyright © 2014 Elsevier Ltd. All rights reserved.

Aged Garlic Extract Improves Adiponectin Levels in Subjects with Metabolic Syndrome: A Double-Blind, Placebo-Controlled, Randomized, Crossover Study

PubMed Central

Gómez-Arbeláez, Diego; Lahera, Vicente; Oubiña, Pilar; Valero-Muñoz, Maria; de las Heras, Natalia; Rodríguez, Yudy; García, Ronald Gerardo; Camacho, Paul Anthony; López-Jaramillo, Patricio

2013-01-01

Background. Garlic (Allium sativum) has been shown to have important benefits in individuals at high cardiovascular risk. The aim of the present study was to evaluate the effects of the administration of aged garlic extract (AGE) on the risk factors that constitute the cluster of metabolic syndrome (MS). Methods and Design. Double-blind, crossover, randomized, placebo-controlled clinical trial to assess the effect of 1.2 g/day of AGE (Kyolic), for 24 weeks of treatment (12 weeks of AGE and 12 weeks of placebo), on subjects with MS. Results. The administration of AGE increased the plasma levels of adiponectin (P = 0.027). No serious side effects associated with the intervention were reported. Conclusion. The present results have shown for the first time that the administration of AGE for 12 weeks increased plasma adiponectin levels in patients with MS. This suggests that AGE might be a useful, novel, nonpharmacological therapeutic intervention to increase adiponectin and to prevent cardiovascular (CV) complications in individuals with MS. PMID:23533302

Bootstrap-based methods for estimating standard errors in Cox's regression analyses of clustered event times.

PubMed

Xiao, Yongling; Abrahamowicz, Michal

2010-03-30

We propose two bootstrap-based methods to correct the standard errors (SEs) from Cox's model for within-cluster correlation of right-censored event times. The cluster-bootstrap method resamples, with replacement, only the clusters, whereas the two-step bootstrap method resamples (i) the clusters, and (ii) individuals within each selected cluster, with replacement. In simulations, we evaluate both methods and compare them with the existing robust variance estimator and the shared gamma frailty model, which are available in statistical software packages. We simulate clustered event time data, with latent cluster-level random effects, which are ignored in the conventional Cox's model. For cluster-level covariates, both proposed bootstrap methods yield accurate SEs, and type I error rates, and acceptable coverage rates, regardless of the true random effects distribution, and avoid serious variance under-estimation by conventional Cox-based standard errors. However, the two-step bootstrap method over-estimates the variance for individual-level covariates. We also apply the proposed bootstrap methods to obtain confidence bands around flexible estimates of time-dependent effects in a real-life analysis of cluster event times.

Effectiveness of an individual school-based intervention for children with aggressive behaviour: a randomized controlled trial.

PubMed

Stoltz, Sabine; van Londen, Monique; Deković, Maja; de Castro, Bram O; Prinzie, Peter; Lochman, John E

2013-10-01

For elementary school-children with aggressive behaviour problems, there is a strong need for effective preventive interventions to interrupt the developmental trajectory towards more serious behaviour problems. The aim of this RCT-study was to evaluate a school-based individual tailor-made intervention (Stay Cool Kids), designed to reduce aggressive behaviour in selected children by enhancing cognitive behavioural skills. The sample consisted of 48 schools, with 264 fourth-grade children selected by their teachers because of elevated levels of externalizing behaviour (TRF T-score>60), randomly assigned to the intervention or no-intervention control condition. The intervention was found to be effective in reducing reactive and proactive aggressive behaviour as reported by children, mothers, fathers or teachers, with effect sizes ranging from .11 to .32. Clinically relevant changes in teacher-rated externalizing behaviour were found: the intervention reduced behaviour problems to (sub) clinical or normative levels for significantly more children than the control condition. Some aspects of problems in social cognitive functioning were reduced and children showed more positive self-perception. Ethnic background and gender moderated intervention effects on child and teacher reported aggression and child response generation. The results of this study demonstrate the effectiveness on outcome behaviour and child cognitions of an individual tailor-made intervention across informants under real-world conditions.

The effect of individualized nutritional counseling on muscle mass and treatment outcome in patients with metastatic colorectal cancer undergoing chemotherapy: a randomized controlled trial protocol.

PubMed

van der Werf, Anne; Blauwhoff-Buskermolen, Susanne; Langius, Jacqueline A E; Berkhof, Johannes; Verheul, Henk M W; de van der Schueren, Marian A E

2015-03-05

A low muscle mass is prevalent in patients with metastatic colorectal cancer (mCRC) and has been associated with poor treatment outcome. Chemotherapeutic treatment has an additional unfavorable effect on muscle mass. Sufficient protein intake and physical activity are known to induce muscle protein anabolism in healthy individuals, however it is unclear whether optimal nutrition is effective to preserve muscle mass in patients with mCRC during first-line chemotherapy as well. We hypothesize that individual nutritional counseling by a trained dietitian during first-line chemotherapy is effective in preserving muscle mass and may improve clinical outcomes in patients with mCRC. In this multi-center single-blind randomized controlled trial, patients with mCRC scheduled for first-line combination chemotherapy consisting of oxaliplatin and fluoropyrimidine, with or without bevacizumab (n = 110), will be randomized to receive either individualized nutritional counseling by a trained dietitian to achieve a sufficient dietary intake and an adequate physical activity level, or usual care. Outcome measures will be assessed at baseline and after two and four months of treatment. The primary endpoint will be the change in skeletal muscle area (measured by CT-scan) at the first treatment evaluation. Secondary endpoints will be quality of life, physical functioning, treatment toxicity, treatment intensity and survival. Statistical analyses include one-sided t-tests for the primary endpoint and mixed models and the Kaplan-Meier method for secondary endpoints. This randomized controlled trial will provide evidence whether individualized nutritional counseling during chemotherapy is effective in preventing loss of muscle mass in patients with mCRC. ClinicalTrials.gov NCT01998152 ; Netherlands Trial Register NTR4223.

Power Analysis for Cross Level Mediation in CRTs

ERIC Educational Resources Information Center

Kelcey, Ben

2014-01-01

A common design in education research for interventions operating at a group or cluster level is a cluster randomized trial (CRT) (Bloom, 2005). In CRTs, intact clusters (e.g., schools) are assigned to treatment conditions rather than individuals (e.g., students) and are frequently an effective way to study interventions because they permit…

Effect of a low glycemic index diet versus a high-cereal fibre diet on markers of subclinical cardiac injury in healthy individuals with type 2 diabetes mellitus: An exploratory analysis of a randomized dietary trial.

PubMed

Ha, Vanessa; Viguiliouk, Effie; Kendall, Cyril W C; Balachandran, Bashyam; Jenkins, David J A; Kavsak, Peter A; Sievenpiper, John L

2017-12-01

Markers of subclinical cardiac injury are elevated in individuals with type 2 diabetes mellitus (T2DM) compared to healthy individuals. Low glycemic index (LGI) diets may improve both diabetes and cardiovascular risk but their effects on cardiac injury and fibrosis have not been previously studied. To test the effect of a LGI diet on markers of subclinical cardiac injury and fibrosis, we assessed the effect of a LGI compared with a high-cereal fibre diet on high-sensitivity cardiac troponin I (hs-cTnI) and galectin-3 in otherwise healthy individuals with T2DM in an exploratory analysis of a completed randomized trial. A total of 201 participants completed the trial and had measurements of hs-cTnI and galectin-3 at baseline and at trial completion. Participants were randomized to follow a LGI or a high-cereal fibre diet over a 6-month period. Treatment differences were tested using Analysis of Covariance (ANCOVA) with sex, baseline values, and diet x sex interaction included as covariates. In a completer's analysis, no significant differences were observed for change in hs-cTnI (-0.16ng/L vs. -0.22ng/L, p=0.713) and galectin-3 levels (0.64μg/L vs. 0.14μg/L, p=0.166) when a LGI diet was compared to a high-cereal fibre diet. The effect of a LGI diet was similar to a high-cereal fibre diet on hs-cTnI and galectin-3 levels in otherwise healthy individuals with T2DM over a 6-month period. Nevertheless, in the absence of any adverse effects, LGI diets remain an option for diabetes and cardiovascular disease risk management. ClinicalTrials.gov identifier: NCT00438698. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Cooperation and charity in spatial public goods game under different strategy update rules

NASA Astrophysics Data System (ADS)

Li, Yixiao; Jin, Xiaogang; Su, Xianchuang; Kong, Fansheng; Peng, Chengbin

2010-03-01

Human cooperation can be influenced by other human behaviors and recent years have witnessed the flourishing of studying the coevolution of cooperation and punishment, yet the common behavior of charity is seldom considered in game-theoretical models. In this article, we investigate the coevolution of altruistic cooperation and egalitarian charity in spatial public goods game, by considering charity as the behavior of reducing inter-individual payoff differences. Our model is that, in each generation of the evolution, individuals play games first and accumulate payoff benefits, and then each egalitarian makes a charity donation by payoff transfer in its neighborhood. To study the individual-level evolutionary dynamics, we adopt different strategy update rules and investigate their effects on charity and cooperation. These rules can be classified into two global rules: random selection rule in which individuals randomly update strategies, and threshold selection rule where only those with payoffs below a threshold update strategies. Simulation results show that random selection enhances the cooperation level, while threshold selection lowers the threshold of the multiplication factor to maintain cooperation. When charity is considered, it is incapable in promoting cooperation under random selection, whereas it promotes cooperation under threshold selection. Interestingly, the evolution of charity strongly depends on the dispersion of payoff acquisitions of the population, which agrees with previous results. Our work may shed light on understanding human egalitarianism.

Individual, household, programme and community effects on childhood malnutrition in rural India.

PubMed

Rajaram, S; Zottarelli, Lisa K; Sunil, T S

2007-04-01

The children living in rural areas of India disproportionately suffer from malnutrition compared with their urban counterparts. The present article analyses the individual, household, community and programme factors on nutritional status of children in rural India. Additionally, we consider the random variances at village and state levels after introducing various observed individual-, household- and programme-level characteristics in the model. A multilevel model is conducted using data from the National Family and Health Survey 2. The results show that maternal characteristics, such as socio-economic and behavioural factors, are more influential in determining childhood nutritional status than the prevalence of programme factors. Also, it was found that individual factors show evidence of state- and village-level clustering of malnutrition.

A Multilevel AR(1) Model: Allowing for Inter-Individual Differences in Trait-Scores, Inertia, and Innovation Variance.

PubMed

Jongerling, Joran; Laurenceau, Jean-Philippe; Hamaker, Ellen L

2015-01-01

In this article we consider a multilevel first-order autoregressive [AR(1)] model with random intercepts, random autoregression, and random innovation variance (i.e., the level 1 residual variance). Including random innovation variance is an important extension of the multilevel AR(1) model for two reasons. First, between-person differences in innovation variance are important from a substantive point of view, in that they capture differences in sensitivity and/or exposure to unmeasured internal and external factors that influence the process. Second, using simulation methods we show that modeling the innovation variance as fixed across individuals, when it should be modeled as a random effect, leads to biased parameter estimates. Additionally, we use simulation methods to compare maximum likelihood estimation to Bayesian estimation of the multilevel AR(1) model and investigate the trade-off between the number of individuals and the number of time points. We provide an empirical illustration by applying the extended multilevel AR(1) model to daily positive affect ratings from 89 married women over the course of 42 consecutive days.

Efficacy of an internet-based intervention for burnout: a randomized controlled trial in the German working population.

PubMed

Jonas, Benjamin; Leuschner, Fabian; Tossmann, Peter

2017-03-01

Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout. Two-arm, Internet-based, randomized, wait-list controlled trial (RCT). Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21. Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75). The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely.

Dropout from individual psychotherapy for major depression: A meta-analysis of randomized clinical trials.

PubMed

Cooper, Andrew A; Conklin, Laren R

2015-08-01

Dropout from mental health treatment poses a substantial problem, but rates vary substantially across studies and diagnoses. Focused reviews are needed to provide more detailed estimates for specific areas of research. Randomized clinical trials involving individual psychotherapy for unipolar depression are ubiquitous and important, but empirical data on average dropout rates from these studies is lacking. We conducted a random-effects meta-analysis of 54 such studies (N=5852) including 80 psychotherapy conditions, and evaluated a number of predictors of treatment- and study-level dropout rates. Our overall weighted dropout estimates were 19.9% at the study level, and 17.5% for psychotherapy conditions specifically. Therapy orientation did not significantly account for variance in dropout estimates, but estimates were significantly higher in psychotherapy conditions with more patients of minority racial status or with comorbid personality disorders. Treatment duration was also positively associated with dropout rates at trend level. Studies with an inactive control comparison had higher dropout rates than those without such a condition. Limitations include the inability to test certain potential predictors (e.g., socioeconomic status) due to infrequent reporting. Overall, our findings suggest the need to consider how specific patient and study characteristics may influence dropout rates in clinical research on individual therapy for depression. Copyright © 2015 Elsevier Ltd. All rights reserved.

No effect of escitalopram versus placebo on brain-derived neurotrophic factor in healthy individuals: a randomised trial.

PubMed

Knorr, Ulla; Koefoed, Pernille; Soendergaard, Mia H Greisen; Vinberg, Maj; Gether, Ulrik; Gluud, Christian; Wetterslev, Jørn; Winkel, Per; Kessing, Lars V

2016-04-01

Brain-derived neurotrophic factor (BDNF) seems to play an important role in the course of depression including the response to antidepressants in patients with depression. We aimed to study the effect of an antidepressant intervention on peripheral BDNF in healthy individuals with a family history of depression. We measured changes in BDNF messenger RNA (mRNA) expression and whole-blood BDNF levels in 80 healthy first-degree relatives of patients with depression randomly allocated to receive daily tablets of escitalopram 10 mg versus placebo for 4 weeks. We found no statistically significant difference between the escitalopram and the placebo group in the change in BDNF mRNA expression and whole-blood BDNF levels. Post hoc analyses showed a statistically significant negative correlation between plasma escitalopram concentration and change in whole-blood BDNF levels in the escitalopram-treated group. The results of this randomised trial suggest that escitalopram 10 mg has no effect on peripheral BDNF levels in healthy individuals.

[How to fit and interpret multilevel models using SPSS].

PubMed

Pardo, Antonio; Ruiz, Miguel A; San Martín, Rafael

2007-05-01

Hierarchic or multilevel models are used to analyse data when cases belong to known groups and sample units are selected both from the individual level and from the group level. In this work, the multilevel models most commonly discussed in the statistic literature are described, explaining how to fit these models using the SPSS program (any version as of the 11 th ) and how to interpret the outcomes of the analysis. Five particular models are described, fitted, and interpreted: (1) one-way analysis of variance with random effects, (2) regression analysis with means-as-outcomes, (3) one-way analysis of covariance with random effects, (4) regression analysis with random coefficients, and (5) regression analysis with means- and slopes-as-outcomes. All models are explained, trying to make them understandable to researchers in health and behaviour sciences.

Statistical Power for Causally Defined Indirect Effects in Group-Randomized Trials with Individual-Level Mediators

ERIC Educational Resources Information Center

Kelcey, Benjamin; Dong, Nianbo; Spybrook, Jessaca; Cox, Kyle

2017-01-01

Designs that facilitate inferences concerning both the total and indirect effects of a treatment potentially offer a more holistic description of interventions because they can complement "what works" questions with the comprehensive study of the causal connections implied by substantive theories. Mapping the sensitivity of designs to…

Multilevel Models for Intensive Longitudinal Data with Heterogeneous Autoregressive Errors: The Effect of Misspecification and Correction with Cholesky Transformation

PubMed Central

Jahng, Seungmin; Wood, Phillip K.

2017-01-01

Intensive longitudinal studies, such as ecological momentary assessment studies using electronic diaries, are gaining popularity across many areas of psychology. Multilevel models (MLMs) are most widely used analytical tools for intensive longitudinal data (ILD). Although ILD often have individually distinct patterns of serial correlation of measures over time, inferences of the fixed effects, and random components in MLMs are made under the assumption that all variance and autocovariance components are homogenous across individuals. In the present study, we introduced a multilevel model with Cholesky transformation to model ILD with individually heterogeneous covariance structure. In addition, the performance of the transformation method and the effects of misspecification of heterogeneous covariance structure were investigated through a Monte Carlo simulation. We found that, if individually heterogeneous covariances are incorrectly assumed as homogenous independent or homogenous autoregressive, MLMs produce highly biased estimates of the variance of random intercepts and the standard errors of the fixed intercept and the fixed effect of a level 2 covariate when the average autocorrelation is high. For intensive longitudinal data with individual specific residual covariance, the suggested transformation method showed lower bias in those estimates than the misspecified models when the number of repeated observations within individuals is 50 or more. PMID:28286490

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

PubMed

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

2011-05-23

Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain.

Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials.

PubMed

Brown, Andrew W; Li, Peng; Bohan Brown, Michelle M; Kaiser, Kathryn A; Keith, Scott W; Oakes, J Michael; Allison, David B

2015-08-01

Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples. © 2015 American Society for Nutrition.

Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

PubMed Central

Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

2016-01-01

Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

Learning Experiment: Determine Effectiveness of Controlling Environmental Distractions at the Student Level.

ERIC Educational Resources Information Center

Sumter, Paul Edward

The purpose of this study was to see if learning could be improved by controlling the environment at the individual student's level. A pretest, post-test, random choice design was chosen to obtain data from over 900 subjects of technical-vocational schools, area community colleges, and high schools of Iowa, with emphasis on grades 11 and 12 and…

Current evidence demonstrates similar effects of kilohertz-frequency and low-frequency current on quadriceps evoked torque and discomfort in healthy individuals: a systematic review with meta-analysis.

PubMed

da Silva, Vinicius Zacarias Maldaner; Durigan, João Luiz Quaglioti; Arena, Ross; de Noronha, Marcos; Gurney, Burke; Cipriano, Gerson

2015-01-01

Neuromuscular electrical stimulation (NMES) is widely utilized to enhance muscle performance. However, the optimal NMES waveform with respect to treatment effect has not been established. To investigate the effects of kilohertz-frequency alternating current (KFAC) and low-frequency pulsed current (PC) on quadriceps evoked torque and self-reported discomfort. PubMed, The Cochrane Library, EMBASE, MEDLINE, Physiotherapy Evidence Database (PEDro), SinoMed, ISI Web of Knowledge, and CINAHL were searched for randomized controlled trials (RCTs) and quasi-randomized controlled trials (QRCTs). Two reviewers independently selected potential studies according to the inclusion criteria, extracted data, and assessed methodological quality. Studies were eligible if they compared KFAC versus PC interventions. Studies that included outcome measures for percentage of maximal isometric voluntary contraction (%MIVC) torque and self-reported discomfort level were eligible for evaluation. Seven studies involving 127 individuals were included. The methodological quality of eligible trials was moderate, with a mean of 5 on the 10-point PEDro scale. Overall, PC was no better than KFAC in terms of evoked torque and there was no difference in self-reported discomfort level. KFAC and PC have similar effects on quadriceps evoked torque and self-reported discomfort level in healthy individuals. The small number and overall methodological quality of currently available studies included in this meta-analysis indicate that new RCTs are needed to better determine optimal NMES treatment parameters.

Association Between Random Measured Glucose Levels in Middle and Old Age and Risk of Dementia-Related Death.

PubMed

Rosness, Tor Atle; Engedal, Knut; Bjertness, Espen; Strand, Bjørn Heine

2016-01-01

To investigate the association between random measured glucose levels in middle and old age and dementia-related death. Population-based cohort study. Norwegian Counties Study (middle-aged individuals; 35-49) and Cohort of Norway participants (older individuals; 65-80). Individuals without (n=74,630) and with (n=3,095) known diabetes mellitus (N=77,725); 67,865 without and 2,341 with diabetes mellitus were included in the complete case analyses (nonmissing for all included covariates), of whom 1,580 without and 131 with diabetes mellitus died from dementia-related causes. Dementia-related death was ascertained according to the Norwegian Cause of Death Registry. Cox regression was used to assess the relationship between random glucose levels (nonfasting) in individuals without and with diabetes mellitus and dementia-related death. Education, smoking, cardiovascular disease, body mass index, cholesterol, blood pressure, and physical activity were adjusted for. Individuals without diabetes mellitus at midlife with glucose levels between 6.5 and 11.0 mmol/L had a significantly greater risk of dementia-related death than those with levels less than 5.1 mmol/L (hazard ratio=1.32, 95% confidence interval=1.04-1.67) in a fully adjusted model. A dose-response relationship (P=.02) was observed. No significant association between high glucose levels in individuals aged 65 to 80 and dementia-related death was detected. High random glucose levels measured in middle-aged but not older age persons without known diabetes mellitus were associated with greater risk of dementia-related death up to four decades later. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Using frames to influence consumer willingness to pay for the patient health record: a randomized experiment.

PubMed

Vishwanath, Arun

2009-07-01

The American College of Medical Informatics rated the lack of willingness to pay for the patient health record (PHR) as the biggest obstacles to its rapid diffusion. Extending research propositions from the decision sciences and political communication, this study tests the influence of different types of emphasis frames on increasing consumer willingness to pay for the PHR. Using a randomized experiment embedded within a probability survey, the effects of 3 different types of emphasis frames (individual-focused, collective-focused, and joint), along with a no-frames control, are tested on a sample of early and later technology adopters. The results indicate a significant relationship between the type of frame and the type of adopter. Early adopters were more susceptible to individual-focused frames that made causal attributions at the individual level, whereas later adopters were significantly influenced by collective-focused frames that made causal attributions at the societal level. Interestingly, the framing effect continued and significantly influenced both early and later adopters' willingness to pay for the PHR. The findings demonstrate the need to carefully communicate the value of a technology to adopters and suggest the possibility of using frames to spur the diffusion of PHRs.

Mapping disease at an approximated individual level using aggregate data: a case study of mapping New Hampshire birth defects.

PubMed

Shi, Xun; Miller, Stephanie; Mwenda, Kevin; Onda, Akikazu; Reese, Judy; Onega, Tracy; Gui, Jiang; Karagas, Margret; Demidenko, Eugene; Moeschler, John

2013-09-06

Limited by data availability, most disease maps in the literature are for relatively large and subjectively-defined areal units, which are subject to problems associated with polygon maps. High resolution maps based on objective spatial units are needed to more precisely detect associations between disease and environmental factors. We propose to use a Restricted and Controlled Monte Carlo (RCMC) process to disaggregate polygon-level location data to achieve mapping aggregate data at an approximated individual level. RCMC assigns a random point location to a polygon-level location, in which the randomization is restricted by the polygon and controlled by the background (e.g., population at risk). RCMC allows analytical processes designed for individual data to be applied, and generates high-resolution raster maps. We applied RCMC to the town-level birth defect data for New Hampshire and generated raster maps at the resolution of 100 m. Besides the map of significance of birth defect risk represented by p-value, the output also includes a map of spatial uncertainty and a map of hot spots. RCMC is an effective method to disaggregate aggregate data. An RCMC-based disease mapping maximizes the use of available spatial information, and explicitly estimates the spatial uncertainty resulting from aggregation.

Evaluating the Effect of a Diabetes Health Coach in Individuals with Type 2 Diabetes.

PubMed

Sherifali, Diana; Viscardi, Virginia; Bai, Johnny-Wei; Ali, R Muhammad Usman

2016-02-01

Diabetes health coaching has not been adequately assessed in individuals with type 2 diabetes. The objective of this review was to synthesize the evidence of health coaching for individuals with diabetes to determine the effects of coaching on diabetes control, specifically on glycated hemoglobin (A1C) levels. The EMBASE, MEDLINE, CINAHL, PsychINFO and Cochrane Central Register of Controlled Trials databases were searched from inception to January 2015. Reference lists from important publications were also reviewed. At least 2 evaluators independently screened and extracted data from eligible studies. A total of 8 trials met the selection criteria, which included 724 adult participants; 353 participants were randomized to a diabetes health coaching intervention, and 371 were randomized to usual care. The pooled effect of diabetes health coaching overall was a statistically significant reduction of A1C levels by 0.32 (95% CI, -0.50 to -0.15). Longer diabetes health coaching exposure (>6 months) resulted in a 0.57% reduction in A1C levels (95% CI, -0.76 to -0.38), compared to shorter diabetes health coaching exposure (≤6 months) (-0.23%; 95% CI, -0.37 to -0.09). Across all studies, diabetes health coaching consisted of goal setting, knowledge acquisition, individualized care and frequent follow up. Diabetes health coaching has an emerging role in healthcare that facilitates self-care, behaviour change and offers frequent follow up and support. This review finds that health coaching for those with diabetes is an effective intervention for improving glycemic control, which may be of greater benefit when offered in addition to existing diabetes care. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial

PubMed Central

Epel, Elissa S.; Kristeller, Jean; Moran, Patricia J.; Dallman, Mary; Lustig, Robert H.; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A.; Hecht, Frederick M.; Daubenmier, Jennifer

2016-01-01

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78 % women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels. PMID:26563148

Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial.

PubMed

Mason, Ashley E; Epel, Elissa S; Kristeller, Jean; Moran, Patricia J; Dallman, Mary; Lustig, Robert H; Acree, Michael; Bacchetti, Peter; Laraia, Barbara A; Hecht, Frederick M; Daubenmier, Jennifer

2016-04-01

We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels. We randomized 194 obese individuals (M age = 47.0 ± 12.7 years; BMI = 35.5 ± 3.6; 78% women) to a 5.5-month diet-exercise program with or without mindfulness training. The mindfulness group, relative to the active control group, evidenced increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment. Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants, but this association was not statistically significant among active control group participants. Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment. Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels.

Sample size estimation for alternating logistic regressions analysis of multilevel randomized community trials of under-age drinking.

PubMed

Reboussin, Beth A; Preisser, John S; Song, Eun-Young; Wolfson, Mark

2012-07-01

Under-age drinking is an enormous public health issue in the USA. Evidence that community level structures may impact on under-age drinking has led to a proliferation of efforts to change the environment surrounding the use of alcohol. Although the focus of these efforts is to reduce drinking by individual youths, environmental interventions are typically implemented at the community level with entire communities randomized to the same intervention condition. A distinct feature of these trials is the tendency of the behaviours of individuals residing in the same community to be more alike than that of others residing in different communities, which is herein called 'clustering'. Statistical analyses and sample size calculations must account for this clustering to avoid type I errors and to ensure an appropriately powered trial. Clustering itself may also be of scientific interest. We consider the alternating logistic regressions procedure within the population-averaged modelling framework to estimate the effect of a law enforcement intervention on the prevalence of under-age drinking behaviours while modelling the clustering at multiple levels, e.g. within communities and within neighbourhoods nested within communities, by using pairwise odds ratios. We then derive sample size formulae for estimating intervention effects when planning a post-test-only or repeated cross-sectional community-randomized trial using the alternating logistic regressions procedure.

Identifying individual- and population-level characteristics that influence rates of risky alcohol consumption in regional communities.

PubMed

Breen, Courtney; Shakeshaft, Anthony; Sanson-Fisher, Rob; D'Este, Catherine; Mattick, Richard P; Gilmour, Stuart

2014-02-01

To examine the extent to which individual- and community- level characteristics account for differences in risky alcohol consumption. A cross-sectional postal survey of 2,977 randomly selected individuals from 20 regional communities in NSW, Australia. Individuals drinking at harmful levels on the AUDIT and for risk of harm in the short term and long-term were identified. Multi-level modelling of the correlates of risky alcohol consumption at the individual and community level was conducted. There were differences between communities in alcohol consumption patterns. Being male, unmarried and reporting worse health were significant individual-level correlates for drinking at levels for risk of harm in the long term. The number of GPs (+) and police (-) were significant community characteristics. Being younger (≤25), unmarried, Australian born and with a larger income was associated with drinking at levels for risk of harm in the short term and harmful drinking on the AUDIT. The number of hotels and clubs was positively associated with drinking at levels for risk of harm in the short term. Rates of risky drinking vary significantly between communities and both individual and community characteristics are significantly associated with risky alcohol consumption. A combination of individual- and population-level interventions, tailored to the risk profile of individual communities, is most likely to be optimally effective. © 2014 The Authors. ANZJPH © 2014 Public Health Association of Australia.

Experimental effects of exposure to pornography: the moderating effect of personality and mediating effect of sexual arousal.

PubMed

Hald, Gert Martin; Malamuth, Neil N

2015-01-01

Using a randomly selected community sample of 200 Danish young adult men and women in a randomized experimental design, the study investigated the effects of a personality trait (agreeableness), past pornography consumption, and experimental exposure to non-violent pornography on attitudes supporting violence against women (ASV). We found that lower levels of agreeableness and higher levels of past pornography consumption significantly predicted ASV. In addition, experimental exposure to pornography increased ASV but only among men low in agreeableness. This relationship was found to be significantly mediated by sexual arousal with sexual arousal referring to the subjective assessment of feeling sexually excited, ready for sexual activities, and/or bodily sensations associated with being sexually aroused. In underscoring the importance of individual differences, the results supported the hierarchical confluence model of sexual aggression and the media literature on affective engagement and priming effects.

Individual relocation decisions after tornadoes: a multi-level analysis.

PubMed

Cong, Zhen; Nejat, Ali; Liang, Daan; Pei, Yaolin; Javid, Roxana J

2018-04-01

This study examines how multi-level factors affected individuals' relocation decisions after EF4 and EF5 (Enhanced Fujita Tornado Intensity Scale) tornadoes struck the United States in 2013. A telephone survey was conducted with 536 respondents, including oversampled older adults, one year after these two disaster events. Respondents' addresses were used to associate individual information with block group-level variables recorded by the American Community Survey. Logistic regression revealed that residential damage and homeownership are important predictors of relocation. There was also significant interaction between these two variables, indicating less difference between homeowners and renters at higher damage levels. Homeownership diminished the likelihood of relocation among younger respondents. Random effects logistic regression found that the percentage of homeownership and of higher income households in the community buffered the effect of damage on relocation; the percentage of older adults reduced the likelihood of this group relocating. The findings are assessed from the standpoint of age difference, policy implications, and social capital and vulnerability. © 2018 The Author(s). Disasters © Overseas Development Institute, 2018.

Effect of national wealth on BMI: An analysis of 206,266 individuals in 70 low-, middle- and high-income countries

PubMed Central

Reidpath, Daniel D.

2017-01-01

Background This study explores the relationship between BMI and national-wealth and the cross-level interaction effect of national-wealth and individual household-wealth using multilevel analysis. Methods Data from the World Health Survey conducted in 2002–2004, across 70 low-, middle- and high-income countries was used. Participants aged 18 years and over were selected using multistage, stratified cluster sampling. BMI was used as outcome variable. The potential determinants of individual-level BMI were participants’ sex, age, marital-status, education, occupation, household-wealth and location(rural/urban) at the individual-level. The country-level factors used were average national income (GNI-PPP) and income inequality (Gini-index). A two-level random-intercepts and fixed-slopes model structure with individuals nested within countries was fitted, treating BMI as a continuous outcome. Results The weighted mean BMI and standard-error of the 206,266 people from 70-countries was 23.90 (4.84). All the low-income countries were below the 25.0 mean BMI level and most of the high-income countries were above. All wealthier quintiles of household-wealth had higher scores in BMI than lowest quintile. Each USD10000 increase in GNI-PPP was associated with a 0.4 unit increase in BMI. The Gini-index was not associated with BMI. All these variables explained 28.1% of country-level, 4.9% of individual-level and 7.7% of total variance in BMI. The cross-level interaction effect between GNI-PPP and household-wealth was significant. BMI increased as the GNI-PPP increased in first four quintiles of household-wealth. However, the BMI of the wealthiest people decreased as the GNI-PPP increased. Conclusion Both individual-level and country-level factors made an independent contribution to the BMI of the people. Household-wealth and national-income had significant interaction effects. PMID:28662041

Effect of national wealth on BMI: An analysis of 206,266 individuals in 70 low-, middle- and high-income countries.

PubMed

Masood, Mohd; Reidpath, Daniel D

2017-01-01

This study explores the relationship between BMI and national-wealth and the cross-level interaction effect of national-wealth and individual household-wealth using multilevel analysis. Data from the World Health Survey conducted in 2002-2004, across 70 low-, middle- and high-income countries was used. Participants aged 18 years and over were selected using multistage, stratified cluster sampling. BMI was used as outcome variable. The potential determinants of individual-level BMI were participants' sex, age, marital-status, education, occupation, household-wealth and location(rural/urban) at the individual-level. The country-level factors used were average national income (GNI-PPP) and income inequality (Gini-index). A two-level random-intercepts and fixed-slopes model structure with individuals nested within countries was fitted, treating BMI as a continuous outcome. The weighted mean BMI and standard-error of the 206,266 people from 70-countries was 23.90 (4.84). All the low-income countries were below the 25.0 mean BMI level and most of the high-income countries were above. All wealthier quintiles of household-wealth had higher scores in BMI than lowest quintile. Each USD10000 increase in GNI-PPP was associated with a 0.4 unit increase in BMI. The Gini-index was not associated with BMI. All these variables explained 28.1% of country-level, 4.9% of individual-level and 7.7% of total variance in BMI. The cross-level interaction effect between GNI-PPP and household-wealth was significant. BMI increased as the GNI-PPP increased in first four quintiles of household-wealth. However, the BMI of the wealthiest people decreased as the GNI-PPP increased. Both individual-level and country-level factors made an independent contribution to the BMI of the people. Household-wealth and national-income had significant interaction effects.

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

PubMed Central

2011-01-01

Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. Conclusions On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain. PMID:21605357

Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial.

PubMed

Du, Xin; Wang, Dan; Wang, Xuan; Yang, Shiru; Zhang, Xinping

2015-03-21

The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field. However, little research has been conducted on the transparency mechanism, and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement. The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants. This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities (clusters). Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial. The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score. As the unit of randomization, each pair of facilities is assigned at random to a control or an intervention group through coin flipping. Prescribed ranking information is publicly reported in the intervention group. The public materials include the posters of individuals and of facilities, the ranking lists of general practitioners, and brochures of patients, which are updated monthly. The intervention began on 13th November 2013 and lasted for one year. Specifically, participants are surveyed at five points in time (baseline, quarterly following the intervention) through questionnaires, interviews, and observations. These participants include an average of 600 patients, 300 general practitioners, 15 directors, and 6 health bureau administrators. The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe. Subsequently, the modifications in the transparency mechanism constructs are evaluated. The outcomes are measured at the individual participant level, and the professional who analyzes the data is blind to the randomization status. This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription. The research design is significant in the field of public policy. Furthermore, this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription.

A Portuguese value set for the SF-6D.

PubMed

Ferreira, Lara N; Ferreira, Pedro L; Pereira, Luis N; Brazier, John; Rowen, Donna

2010-08-01

The SF-6D is a preference-based measure of health derived from the SF-36 that can be used for cost-effectiveness analysis using cost-per-quality adjusted life-year analysis. This study seeks to estimate a system weight for the SF-6D for Portugal and to compare the results with the UK system weights. A sample of 55 health states defined by the SF-6D has been valued by a representative random sample of the Portuguese population, stratified by sex and age (n = 140), using the Standard Gamble (SG). Several models are estimated at both the individual and aggregate levels for predicting health-state valuations. Models with main effects, with interaction effects and with the constant forced to unity are presented. Random effects (RE) models are estimated using generalized least squares (GLS) regressions. Generalized estimation equations (GEE) are used to estimate RE models with the constant forced to unity. Estimations at the individual level were performed using 630 health-state valuations. Alternative functional forms are considered to account for the skewed distribution of health-state valuations. The models are analyzed in terms of their coefficients, overall fit, and the ability for predicting the SG-values. The RE models estimated using GLS and through GEE produce significant coefficients, which are robust across model specification. However, there are concerns regarding some inconsistent estimates, and so parsimonious consistent models were estimated. There is evidence of under prediction in some states assigned to poor health. The results are consistent with the UK results. The models estimated provide preference-based quality of life weights for the Portuguese population when health status data have been collected using the SF-36. Although the sample was randomly drowned findings should be treated with caution, given the small sample size, even knowing that they have been estimated at the individual level.

Sample size calculation in cost-effectiveness cluster randomized trials: optimal and maximin approaches.

PubMed

Manju, Md Abu; Candel, Math J J M; Berger, Martijn P F

2014-07-10

In this paper, the optimal sample sizes at the cluster and person levels for each of two treatment arms are obtained for cluster randomized trials where the cost-effectiveness of treatments on a continuous scale is studied. The optimal sample sizes maximize the efficiency or power for a given budget or minimize the budget for a given efficiency or power. Optimal sample sizes require information on the intra-cluster correlations (ICCs) for effects and costs, the correlations between costs and effects at individual and cluster levels, the ratio of the variance of effects translated into costs to the variance of the costs (the variance ratio), sampling and measuring costs, and the budget. When planning, a study information on the model parameters usually is not available. To overcome this local optimality problem, the current paper also presents maximin sample sizes. The maximin sample sizes turn out to be rather robust against misspecifying the correlation between costs and effects at the cluster and individual levels but may lose much efficiency when misspecifying the variance ratio. The robustness of the maximin sample sizes against misspecifying the ICCs depends on the variance ratio. The maximin sample sizes are robust under misspecification of the ICC for costs for realistic values of the variance ratio greater than one but not robust under misspecification of the ICC for effects. Finally, we show how to calculate optimal or maximin sample sizes that yield sufficient power for a test on the cost-effectiveness of an intervention.

Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study.

PubMed

Provenzano, Robert; Besarab, Anatole; Wright, Steven; Dua, Sohan; Zeig, Steven; Nguyen, Peter; Poole, Lona; Saikali, Khalil G; Saha, Gopal; Hemmerich, Stefan; Szczech, Lynda; Yu, K H Peony; Neff, Thomas B

2016-06-01

Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Phase 2, randomized (3:1), open-label, active-comparator, safety and efficacy study. Patients with stable end-stage renal disease treated with hemodialysis who previously had hemoglobin (Hb) levels maintained with epoetin alfa. Part 1: 6-week dose-ranging study in 54 individuals of thrice-weekly oral roxadustat doses versus continuation of intravenous epoetin alfa. Part 2: 19-week treatment in 90 individuals in 6 cohorts with various starting doses and adjustment rules (1.0-2.0mg/kg or tiered weight based) in individuals with a range of epoetin alfa responsiveness. Intravenous iron was prohibited. Primary end point was Hb level response, defined as end-of-treatment Hb level change (ΔHb) of -0.5g/dL or greater from baseline (part 1) and as mean Hb level ≥ 11.0g/dL during the last 4 treatment weeks (part 2). Hepcidin, iron parameters, cholesterol, and plasma erythropoietin (the latter in a subset). Baseline epoetin alfa doses were 138.3±51.3 (SD) and 136.3±47.7U/kg/wk in part 1 and 152.8±80.6 and 173.4±83.7U/kg/wk in part 2, in individuals randomly assigned to roxadustat and epoetin alfa, respectively. Hb level responder rates in part 1 were 79% in pooled roxadustat 1.5 to 2.0mg/kg compared to 33% in the epoetin alfa control arm (P=0.03). Hepcidin level reduction was greater at roxadustat 2.0mg/kg versus epoetin alfa (P<0.05). In part 2, the average roxadustat dose requirement for Hb level maintenance was ∼1.7mg/kg. The least-squares-mean ΔHb in roxadustat-treated individuals was comparable to that in epoetin alfa-treated individuals (about -0.5g/dL) and the least-squares-mean difference in ΔHb between both treatment arms was -0.03 (95% CI, -0.39 to 0.33) g/dL (mixed effect model-repeated measure). Roxadustat significantly reduced mean total cholesterol levels, not observed with epoetin alfa. No safety concerns were raised. Short treatment duration and small sample size. In this phase 2 study of anemia therapy in patients with end-stage renal disease on maintenance hemodialysis therapy, roxadustat was well tolerated and effectively maintained Hb levels. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Enhancement of epidemic spread by noise and stochastic resonance in spatial network models with viral dynamics.

PubMed

Tuckwell, H C; Toubiana, L; Vibert, J F

2000-05-01

We extend a previous dynamical viral network model to include stochastic effects. The dynamical equations for the viral and immune effector densities within a host population of size n are bilinear, and the noise is white, additive, and Gaussian. The individuals are connected with an n x n transmission matrix, with terms which decay exponentially with distance. In a single individual, for the range of noise parameters considered, it is found that increasing the amplitude of the noise tends to decrease the maximum mean virion level, and slightly accelerate its attainment. Two different spatial dynamical models are employed to ascertain the effects of environmental stochasticity on viral spread. In the first model transmission is unrestricted and there is no threshold within individuals. This model has the advantage that it can be analyzed using a Fokker-Planck approach. The noise is found both to synchronize and uniformize the trajectories of the viral levels across the population of infected individuals, and thus to promote the epidemic spread of the virus. Quantitative measures of the speed of spread and overall amplitude of the epidemic are obtained as functions of the noise and virulence parameters. The mean amplitude increases steadily without threshold effects for a fixed value of the virulence as the noise amplitude sigma is increased, and there is no evidence of a stochastic resonance. However, the speed of transmission, both with respect to its mean and variance, undergoes rapid increases as sigma changes by relatively small amounts. In the second, more realistic, model, there is a threshold for infection and an upper limit to the transmission rate. There may be no spread of infection at all in the absence of noise. With increasing noise level and a low threshold, the mean maximum virion level grows quickly and shows a broad-based stochastic resonance effect. When the threshold within individuals is increased, the mean population virion level increases only slowly as sigma increases, until a critical value is reached at which the mean infection level suddenly increases. Similar results are obtained when the parameters of the model are also randomized across the population. We conclude with a discussion and a description of a diffusion approximation for a model in which stochasticity arises through random contacts rather than fluctuation in ambient virion levels.

Modeling the impact of post-diagnosis behavior change on HIV prevalence in Southern California men who have sex with men (MSM).

PubMed

Khanna, Aditya S; Goodreau, Steven M; Gorbach, Pamina M; Daar, Eric; Little, Susan J

2014-08-01

Our objective here is to demonstrate the population-level effects of individual-level post-diagnosis behavior change (PDBC) in Southern Californian men who have sex with men (MSM), recently diagnosed with HIV. While PDBC has been empirically documented, the population-level effects of such behavior change are largely unknown. To examine these effects, we develop network models derived from the exponential random graph model family. We parameterize our models using behavioral data from the Southern California Acute Infection and Early Disease Research Program, and biological data from a number of published sources. Our models incorporate vital demographic processes, biology, treatment and behavior. We find that without PDBC, HIV prevalence among MSM would be significantly higher at any reasonable frequency of testing. We also demonstrate that higher levels of HIV risk behavior among HIV-positive men relative to HIV-negative men observed in some cross-sectional studies are consistent with individual-level PDBC.

A randomized controlled trial of the effects of aerobic dance training on blood lipids among individuals with hypertension on a thiazide.

PubMed

Maruf, Fatai A; Akinpelu, Aderonke O; Salako, Babatunde L

2014-12-01

Hypertension is associated with dyslipidemia. Thiazides adversely affect serum lipid levels in hypertensives. There is currently a dearth of information on benefits of aerobic exercise training on serum lipid levels in individuals on thiazides and this study aimed at bridging this gap in knowledge. This randomized-controlled trial involved 120 newly-diagnosed adults with essential hypertension (≥65 years). They were treated with 50 mg of hydrochlorothiazide + 5 mg of hydrochloride amiloride and 5 or 10 mg of amlodipine for 4-6 weeks before they were randomly assigned into exercise group (EG) and control croup (CG). Only EG underwent 12-week aerobic dance training at 50-70 % of heart rate reserve three times per week. Low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, triglyceride and total cholesterol were measured and recorded at baseline and post-study. Eighty-eight (45 in EG and 43 in CG) of 120 participants randomly assigned to groups completed the study. Systolic (p = 0.370) and diastolic (p = 0.771) blood pressures (BP) were similar between the two groups at baseline. Systolic (p < 0.001) and diastolic (p < 0.001) BPs reduced significantly in exercise and control groups. LDL-C (from 120.10 ± 33.41 to 110.50 ± 31.68 mg/dl; p = 0.037) and triglyceride (from 117.49 ± 45.12 to 100.63 ± 35.42 mg/dl; p = 0.002) decreased in EG post-study but no significant between-group differences were observed. Although, LDL-C and triglyceride are reduced after aerobic dance training, they were not any more than without it. Aerobic dance training has favorable effects on LDL-C, triglyceride, and systolic and diastolic BP in individuals with hypertension on a thiazide.

Effects of Contingency Management and Bupropion on Cigarette Smoking in Smokers with Schizophrenia

PubMed Central

Tidey, Jennifer W.; Rohsenow, Damaris J.; Kaplan, Gary B.; Swift, Robert M; Reid, Netesha

2013-01-01

Rationale Individuals with schizophrenia have high smoking-related morbidity and mortality rates and need powerful and innovative smoking cessation interventions. Objectives This proof-of-concept study investigated the feasibility and initial efficacy of combining a contingency management intervention with bupropion to reduce smoking in people with schizophrenia. Methods Using a double-blind, placebo-controlled, between-groups design, 57 non-treatment seeking participants were randomized to receive 300 mg/day bupropion or placebo. One week later, participants were randomized to a contingency management (CM) intervention in which reductions in urinary cotinine levels were reinforced, or a non-contingent reinforcement (NR) condition in which session attendance was reinforced, regardless of cotinine level. Over the 22-day study period, participants visited the laboratory approximately three times per week to provide urine samples for analysis of cotinine levels, to give breath samples for analysis of carbon monoxide (CO) levels, and to report number of cigarettes smoked per day, nicotine withdrawal symptoms, cigarette craving and psychiatric symptoms. Results Cotinine and CO levels significantly decreased during the study period in participants randomized to the CM condition, but not the NR condition. Bupropion did not reduce cotinine levels or increase the efficacy of CM. Cigarette craving and psychiatric symptom levels significantly decreased during the study in all groups. Conclusions The results of this study indicate the efficacy and feasibility of this CM intervention for reducing smoking in individuals with schizophrenia. PMID:21475970

Exploring individual adaptations to an anterior cruciate ligament injury prevention programme.

PubMed

Fox, Aaron S; Bonacci, Jason; McLean, Scott G; Saunders, Natalie

2018-01-01

Individual responses to anterior cruciate ligament injury prevention programmes (ACL IPPs) have received little attention. This study examined the effects of an ACL IPP on neuromuscular control and lower limb biomechanics during landing at the group and individual levels. Sixteen female athletes were randomly allocated to training (n=8) or control (n=8) groups. Electromyography, and three-dimensional kinematic and kinetic data were collected during landing at two testing sessions. Repeated measures ANOVA and effect sizes (Cohen's d) examined the effect of the IPP at the group and individual levels. A sub-group analysis comparing the effect of the IPP on 'high-' (i.e. large peak knee abduction moment at baseline) versus 'low-risk' individuals was also conducted. At the group level; the IPP increased activation of the medial hamstrings prior to landing (p<0.001; d=0.264) and the medial gastrocnemius at landing (p<0.001; d=0.426), and increased hip external rotation early after initial contact (p<0.001; d=0.476). Variable adaptations were seen across individuals within the training group for all variables (p<0.001). The IPP had a large effect in reducing frontal plane knee moments for 'high-risk' individuals (d>0.91), however these results did not reach statistical significance (p>0.05). The IPP induced adaptations during landing, however, individual data revealed dissimilar responses to the programme. Individuals displaying a pre-existing high-risk strategy may incur greater benefits from IPPs, yet only if the programme targets the relevant high-risk strategy. Copyright © 2017 Elsevier B.V. All rights reserved.

Variations in Carboxyhaemoglobin Levels in Smokers

PubMed Central

Castleden, C. M.; Cole, P. V.

1974-01-01

Three experiments on smokers have been performed to determine variations in blood levels of carboxyhaemoglobin (COHb) throughout the day and night and whether a random measurement of COHb gives a true estimation of a smoker's mean COHb level. In the individual smoker the COHb level does not increase gradually during the day but is kept within relatively narrow limits. Moderately heavy smokers rise in the morning with a substantially raised COHb level because the half life of COHb is significantly longer during sleep than during the day. Women excrete their carbon monoxide faster than men. A random COHb estimation gives a good indication of the mean COHb level of an individual. PMID:4441877

Individual Characteristics vs. Experience: An Experimental Study on Cooperation in Prisoner's Dilemma

PubMed Central

Barreda-Tarrazona, Iván; Jaramillo-Gutiérrez, Ainhoa; Pavan, Marina; Sabater-Grande, Gerardo

2017-01-01

Cooperative behavior is often assumed to depend on individuals' characteristics, such as altruism and reasoning ability. Evidence is mixed about what the precise impact of these characteristics is, as the subjects of study are generally randomly paired, generating a heterogeneous mix of the two characteristics. In this study we ex-ante create four different groups of subjects by factoring their higher or lower than the median scores in both altruism and reasoning ability. Then we use these groups in order to analyze the joint effect of the two characteristics on the individual choice of cooperating and on successful paired cooperation. Subjects belonging to each group play first 10 one-shot prisoner's dilemma (PD) games with ten random partners and then three consecutive 10-round repeated PD games with three random partners. In all games, we elicit players' beliefs regarding cooperation using an incentive compatible method. Individuals with high altruism are more optimistic about the cooperative behavior of the other player in the one-shot game. They also show higher individual cooperation and paired cooperation rates in the first repetitions of this game. Contrary to the one-shot PD games where high reasoning ability reduces the probability of playing cooperatively, the sign of the relationship is inverted in the first repeated PD game, showing that high reasoning ability individuals better adjust their behavior to the characteristics of the game they are playing. In this sense, the joint effect of reasoning ability and altruism is not linear, with reasoning ability counteracting the cooperative effect of altruism in the one-shot game and reinforcing it in the first repeated game. However, experience playing the repeated PD games takes over the two individual characteristics in explaining individual and paired cooperation. Thus, in a (PD) setting, altruism and reasoning ability significantly affect behavior in single encounters, while in repeated interactions individual and paired cooperation reach similarly high levels independently of these individual characteristics. PMID:28473787

Support vector machine learning-based fMRI data group analysis.

PubMed

Wang, Ze; Childress, Anna R; Wang, Jiongjiong; Detre, John A

2007-07-15

To explore the multivariate nature of fMRI data and to consider the inter-subject brain response discrepancies, a multivariate and brain response model-free method is fundamentally required. Two such methods are presented in this paper by integrating a machine learning algorithm, the support vector machine (SVM), and the random effect model. Without any brain response modeling, SVM was used to extract a whole brain spatial discriminance map (SDM), representing the brain response difference between the contrasted experimental conditions. Population inference was then obtained through the random effect analysis (RFX) or permutation testing (PMU) on the individual subjects' SDMs. Applied to arterial spin labeling (ASL) perfusion fMRI data, SDM RFX yielded lower false-positive rates in the null hypothesis test and higher detection sensitivity for synthetic activations with varying cluster size and activation strengths, compared to the univariate general linear model (GLM)-based RFX. For a sensory-motor ASL fMRI study, both SDM RFX and SDM PMU yielded similar activation patterns to GLM RFX and GLM PMU, respectively, but with higher t values and cluster extensions at the same significance level. Capitalizing on the absence of temporal noise correlation in ASL data, this study also incorporated PMU in the individual-level GLM and SVM analyses accompanied by group-level analysis through RFX or group-level PMU. Providing inferences on the probability of being activated or deactivated at each voxel, these individual-level PMU-based group analysis methods can be used to threshold the analysis results of GLM RFX, SDM RFX or SDM PMU.

Effects of massage therapy and occlusal splint therapy on mandibular range of motion in individuals with temporomandibular disorder: a randomized clinical trial.

PubMed

Gomes, Cid André Fidelis de Paula; Politti, Fabiano; Andrade, Daniel Ventura; de Sousa, Dowglas Fernando Magalhães; Herpich, Carolina Marciela; Dibai-Filho, Almir Vieira; Gonzalez, Tabajara de Oliveira; Biasotto-Gonzalez, Daniela Aparecida

2014-01-01

The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion (ROM) in individuals with temporomandibular disorder (TMD) and compare the results with ROM obtained in a group of individuals without this disorder. A blinded randomized clinical trial was conducted. Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group. Both treatments were provided for 4 weeks. Fourteen individuals without TMD were consecutively allocated to a comparison group. Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group. Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons (level of significance was set to 5%). Cohen d was used to calculate the effect size. In the intragroup analysis, significant increases in ROM were found for all measures in both the massage and occlusal splint groups (P < .05). A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups (0.2

School differences in adolescent health and wellbeing: findings from the Canadian Health Behaviour in School-aged Children Study.

PubMed

Saab, Hana; Klinger, Don

2010-03-01

The goal of this study was to assess the relationship between student- and school-level factors and student health and wellbeing outcomes, and to estimate the variability present at each of the student and school levels for each of three selected health-related outcomes. The data are from the 2006 Canadian Health Behaviour in School-aged children (HBSC) study in which Grades 6-10 students (N=9670) and administrators (N=187) were surveyed. The three outcome measures are Self-Rated Health (SRH), Emotional Wellbeing (EWB), and Subjective Health Complaints (SHC). Individual and school-level effects on the three outcomes were estimated using multi-level modeling. Both individual and school-level factors were associated with students' health. Gender, family wealth, family structure, academic achievement and neighbourhood were significant student-level predictors. We identified random associations between the student-level variables and reported health outcomes. These random effects indicate that the relationships between these student variables and health are not consistent across schools. Student Problem Behaviours at the school were significant predictors of SRH and SHC, while Student Aggression and the school's average socioeconomic standing were significant school-level predictors of EWB. Findings suggest that the environment and disciplinary climate in schools can predict student health and wellbeing outcomes, and may have important implications for school initiatives aimed at students who are struggling both emotionally and academically. Copyright 2009 Elsevier Ltd. All rights reserved.

A population-based randomized controlled trial of the effect of combining a pedometer with an intervention toolkit on physical activity among individuals with low levels of physical activity or fitness.

PubMed

Petersen, Christina Bjørk; Severin, Maria; Hansen, Andreas Wolff; Curtis, Tine; Grønbæk, Morten; Tolstrup, Janne Schurmann

2012-02-01

To examine if receiving a pedometer along with an intervention toolkit is associated with increased physical activity, aerobic fitness and better self-rated health among individuals with low levels of physical activity or fitness. The intervention was nested in the Danish Health Examination Survey (DANHES) and carried out in 2008. Participants were randomly assigned to either a pedometer group (n=326) or a control group (n=329). Physical activity, aerobic fitness, and self-rated health were measured at baseline and at 3-month follow-up, and differences were tested by Wilcoxons signed rank tests and Chi-squared tests. At follow-up, no significant differences in physical activity, aerobic fitness and self-rated health were found between the groups. However, the oldest participants in the pedometer group reported significantly more walking time compared to the controls (controls=368 min/week, pedometer group=680 min/week, P=0.05). Among participants who completed the intervention, a significant effect on total walking time was observed (median difference=225 min/week, P=0.04). The results suggest that receiving a pedometer and along with an intervention toolkit can increase walking time in older individuals, but not in younger individuals. Thus, this type of intervention offers great potential for promoting physical activity in older individuals. NCT01071811. Copyright © 2011 Elsevier Inc. All rights reserved.

Randomized controlled clinical trial of yoga in the treatment of eating disorders.

PubMed

Carei, T Rain; Fyfe-Johnson, Amber L; Breuner, Cora C; Brown, Margaret A

2010-04-01

This was a pilot project designed to assess the effect of individualized yoga treatment on eating disorder outcomes among adolescents receiving outpatient care for diagnosed eating disorders (anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified). A total of 50 girls and 4 boys aged 11-21 years were randomized to an 8-week trial of standard care vs. individualized yoga plus standard care. Of these, 27 were randomized to standard care and 26 to yoga plus standard care (attrition: n = 4). Standard care (every other week physician and/or dietician appointments) was required to meet ethical guidelines. The No Yoga group was offered yoga after study completion as an incentive to maintain participation. Outcomes evaluated at baseline, end of trial, and 1-month follow-up included Eating Disorder Examination (EDE), Body Mass Index (BMI), Beck Depression Inventory, State-Trait Anxiety Inventory, and Food Preoccupation questionnaire. The Yoga group demonstrated greater decreases in eating disorder symptoms. Specifically, the EDE scores decreased over time in the Yoga group, whereas the No Yoga group showed some initial decline but then returned to baseline EDE levels at week 12. Food preoccupation was measured before and after each yoga session, and decreased significantly after all sessions. Both groups maintained current BMI levels and decreased in anxiety and depression over time. Individualized yoga treatment decreased EDE scores at 12 weeks, and significantly reduced food preoccupation immediately after yoga sessions. Yoga treatment did not have a negative effect on BMI. Results suggest that individualized yoga therapy holds promise as adjunctive therapy to standard care. Copyright 2010 Society for Adolescent Medicine. Published by Elsevier Inc. All rights reserved.

Effect of vitamin E supplementation on serum C-reactive protein level: a meta-analysis of randomized controlled trials.

PubMed

Saboori, S; Shab-Bidar, S; Speakman, J R; Yousefi Rad, E; Djafarian, K

2015-08-01

C-reactive protein (CRP), a marker of chronic inflammation, has a major role in the etiology of chronic disease. Vitamin E may have anti-inflammatory effects. However, there is no consensus on the effects of vitamin E supplementation on CRP levels in clinical trials. The aim of this study was to systematically review randomized controlled trials (RCTs) that report on the effects of vitamin E supplementation (α- and γ-tocopherols) on CRP levels. A systematic search of RCTs was conducted on Medline and EMBASE through PubMed, Scopus, Ovid and Science Direct, and completed by a manual review of the literature up to May 2014. Pooled effects were estimated by using random-effects models and heterogeneity was assessed by Cochran's Q and I(2) tests. Subgroup analyses and meta-regression analyses were also performed according to intervention duration, dose of supplementation and baseline level of CRP. Of 4734 potentially relevant studies, only 12 trials met the inclusion criteria with 246 participants in the intervention arms and 249 participants in control arms. Pooled analysis showed a significant reduction in CRP levels of 0.62 mg/l (95% confidence interval = -0.92, -0.31; P < 0.001) in vitamin E-treated individuals, with the evidence of heterogeneity across studies. This significant effect was maintained in all subgroups, although the univariate meta-regression analysis showed that the vitamin E supplementation dose, baseline level of CRP and duration of intervention were not the sources of the observed heterogeneity. The results of this meta-analysis suggest that supplementation with vitamin E in the form of either α-tocopherol or γ-tocopherol would reduce serum CRP levels.

The Power of the Test for Treatment Effects in Three-Level Block Randomized Designs

ERIC Educational Resources Information Center

Konstantopoulos, Spyros

2008-01-01

Experiments that involve nested structures may assign treatment conditions either to subgroups (such as classrooms) or individuals within subgroups (such as students). The design of such experiments requires knowledge of the intraclass correlation structure to compute the sample sizes necessary to achieve adequate power to detect the treatment…

Episodic and Individual Effects of Elementary Students' Optimal Experience: An HLM Study

ERIC Educational Resources Information Center

Cheng, Chao-Yang; Chen, Sherry Y.; Lin, Sunny S. J.

2017-01-01

The authors defined optimal experience as a functional state of a relatively high level of concentration, time distortion, satisfaction, and enjoyment (Csikszentmihalyi, 1992) and collected data through the Day Reconstruction Method. In three random days, 147 fifth-grade students answered questionnaires for each school event in the previous day…

Effects of 21st birthday brief interventions on college student celebratory drinking: A systematic review and meta-analysis.

PubMed

Steinka-Fry, Katarzyna T; Tanner-Smith, Emily E; Grant, Sean

2015-11-01

College students' 21st birthday celebrations often involve consumption of extreme amounts of alcohol as well as alcohol-related risks. This systematic review aims to determine whether birthday-focused, individually-targeted, no-contact (email or letter-based) brief alcohol interventions (BAIs) reduce college students' 21st birthday celebratory drinking. A systematic search identified 9 randomized evaluations with 10 interventions to reduce 21st birthday drinking. Quantity of alcohol consumed and estimated blood alcohol concentration (BAC) were measured. Random-effects meta-analysis was used to summarize the effects of the interventions. There was no evidence that birthday-focused BAIs reduce quantities of alcohol consumed during birthday celebrations (g = 0.05, 95% CI [-0.03 to 0.13]). The interventions were associated with significant reductions in estimated BAC levels (g = 0.20, 95% CI [0.07 to 0.33]), but this effect was small in absolute terms. The quality of this body of evidence was very low, as evaluated using the GRADE approach. In particular, it was limited by substantial participant attrition post-randomization due to included studies' recruitment and randomization procedures. There is no evidence that birthday-focused, individually-targeted BAIs reduce the quantity of alcohol consumed by students during 21st birthday celebrations, although these interventions may yield small beneficial effects on estimated BAC. Many methodological concerns were identified in included studies. This area of research would benefit from theory-based RCTs that are well-designed and executed. Future research should also investigate strategies other than birthday-focused, individually-targeted, brief interventions to curb 21st birthday celebratory drinking. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effects of 21st Birthday Brief Interventions on College Student Celebratory Drinking: A Systematic Review and Meta-Analysis

PubMed Central

Steinka-Fry, Katarzyna T.; Tanner-Smith, Emily E.; Grant, Sean

2015-01-01

Introduction College students' 21st birthday celebrations often involve consumption of extreme amounts of alcohol as well as alcohol-related risks. This systematic review aims to determine whether birthday-focused, individually-targeted, no-contact (email or letter-based) brief alcohol interventions (BAIs) reduce college students' 21st birthday celebratory drinking. Methods A systematic search identified 9 randomized evaluations with 10 interventions to reduce 21st birthday drinking. Quantity of alcohol consumed and estimated blood alcohol concentration (BAC) were measured. Random-effects meta-analysis was used to summarize the effects of the interventions. Results There was no evidence that birthday-focused BAIs reduce quantities of alcohol consumed during birthday celebrations (ḡ = 0.05, 95% CI [-0.03 to 0.13]). The interventions were associated with significant reductions in estimated BAC levels (ḡ = 0.20, 95% CI [0.07 to 0.33]), but this effect was small in absolute terms. The quality of this body of evidence was very low, as evaluated using the GRADE approach. In particular, it was limited by substantial participant attrition post-randomization due to included studies' recruitment and randomization procedures. Conclusions There is no evidence that birthday-focused, individually-targeted BAIs reduce the quantity of alcohol consumed by students during 21st birthday celebrations, although these interventions may yield small beneficial effects on estimated BAC. Many methodological concerns were identified in included studies. This area of research would benefit from theory-based RCTs that are well-designed and executed. Future research should also investigate strategies other than birthday-focused, individually-targeted, brief interventions to curb 21st birthday celebratory drinking. PMID:26093502

The Effect of Relaxation Interventions on Cortisol Levels in HIV-Sero-Positive Women

PubMed Central

Jones, Deborah; Owens, Mary; Kumar, Mahendra; Cook, Ryan; Weiss, Stephen M.

2016-01-01

Purpose Activation of the hypothalamic–pituitary–adrenal axis, assessed in terms of cortisol levels, may enhance the ability of HIV to infect lymphocytes and downregulate the immune system, accelerating disease progression. This study sought to determine the effects of relaxation techniques on cortisol levels in HIV-sero-positive women. Methods Women (n = 150) were randomized to a group cognitive–behavioral stress management (CBSM) condition or an individual information condition and underwent 3 types of relaxation training (progressive muscle relaxation, imagery, and autogenic training). Cortisol levels were obtained pre- and postrelaxation. Results Guided imagery was effective in reducing cortisol in the group condition (t = 3.90, P < .001), and muscle relaxation reduced cortisol in the individual condition (t = 3.11, P = .012). Among participants in the group condition attending all sessions, the magnitude of pre- to postsession reduction became greater over time. Conclusions Results suggest that specific relaxation techniques may be partially responsible for cortisol decreases associated with relaxation and CBSM. PMID:23715264

Study protocol of hypoalgesic effects of low frequency and burst-modulated alternating currents on healthy individuals.

PubMed

Rampazo da Silva, Érika Patrícia; da Silva, Viviane Ribeiro; Bernardes, Anabelly Sato; Matuzawa, Fabio Massao; Liebano, Richard Eloin

2018-03-01

The aim of the study will be to compare different types of analgesic electrical currents in relation to the pressure pain threshold and sensory comfort in healthy individuals. A total of 100 individuals will be randomly assigned to four groups: transcutaneous electrical nerve stimulation, interferential current, Aussie current or placebo. The electrical stimulation will be administered with a strong level for 30 min and to the placebo group, the electrodes will be positioned while the equipment will remain switched off. The pressure pain threshold and sensory comfort will be measured with an algometer and the visual analogue scale, respectively. The level of significance will be p < 0.05. NCT01950728 (clinical trials).

Long-term effect of September 11 on the political behavior of victims’ families and neighbors

PubMed Central

Hersh, Eitan D.

2013-01-01

This article investigates the long-term effect of September 11, 2001 on the political behaviors of victims’ families and neighbors. Relative to comparable individuals, family members and residential neighbors of victims have become—and have stayed—significantly more active in politics in the last 12 years, and they have become more Republican on account of the terrorist attacks. The method used to demonstrate these findings leverages the random nature of the terrorist attack to estimate a causal effect and exploits new techniques to link multiple, individual-level, governmental databases to measure behavioral change without relying on surveys or aggregate analysis. PMID:24324145

Long-term effect of September 11 on the political behavior of victims' families and neighbors.

PubMed

Hersh, Eitan D

2013-12-24

This article investigates the long-term effect of September 11, 2001 on the political behaviors of victims' families and neighbors. Relative to comparable individuals, family members and residential neighbors of victims have become--and have stayed--significantly more active in politics in the last 12 years, and they have become more Republican on account of the terrorist attacks. The method used to demonstrate these findings leverages the random nature of the terrorist attack to estimate a causal effect and exploits new techniques to link multiple, individual-level, governmental databases to measure behavioral change without relying on surveys or aggregate analysis.

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.

PubMed

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.

Effect of an Internet-based, personalized nutrition randomized trial on dietary changes associated with the Mediterranean diet: the Food4Me Study.

PubMed

Livingstone, Katherine M; Celis-Morales, Carlos; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Macready, Anna L; Fallaize, Rosalind; Forster, Hannah; Woolhead, Clara; O'Donovan, Clare B; Marsaux, Cyril Fm; Kolossa, Silvia; Tsirigoti, Lydia; Lambrinou, Christina P; Moschonis, George; Godlewska, Magdalena; Surwiłło, Agnieszka; Drevon, Christian A; Manios, Yannis; Traczyk, Iwona; Gibney, Eileen R; Brennan, Lorraine; Walsh, Marianne C; Lovegrove, Julie A; Saris, Wim H; Daniel, Hannelore; Gibney, Mike; Martinez, J Alfredo; Mathers, John C

2016-08-01

Little is known about the efficacy of personalized nutrition (PN) interventions for improving consumption of a Mediterranean diet (MedDiet). The objective was to evaluate the effect of a PN intervention on dietary changes associated with the MedDiet. Participants (n = 1607) were recruited into a 6-mo, Internet-based, PN randomized controlled trial (Food4Me) designed to evaluate the effect of PN on dietary change. Participants were randomly assigned to receive conventional dietary advice [control; level 0 (L0)] or PN advice on the basis of current diet [level 1 (L1)], diet and phenotype [level 2 (L2)], or diet, phenotype, and genotype [level 3 (L3)]. Dietary intakes from food-frequency questionnaires at baseline and at 6 mo were converted to a MedDiet score. Linear regression compared participant characteristics between high (>5) and low (≤5) MedDiet scores. Differences in MedDiet scores between treatment arms at month 6 were evaluated by using contrast analyses. At baseline, high MedDiet scorers had a 0.5 lower body mass index (in kg/m(2); P = 0.007) and a 0.03 higher physical activity level (P = 0.003) than did low scorers. MedDiet scores at month 6 were greater in individuals randomly assigned to receive PN (L1, L2, and L3) than in controls (PN compared with controls: 5.20 ± 0.05 and 5.48 ± 0.07, respectively; P = 0.002). There was no significant difference in MedDiet scores at month 6 between PN advice on the basis of L1 compared with L2 and L3. However, differences in MedDiet scores at month 6 were greater in L3 than in L2 (L3 compared with L2: 5.63 ± 0.10 and 5.38 ± 0.10, respectively; P = 0.029). Higher MedDiet scores at baseline were associated with healthier lifestyles and lower adiposity. After the intervention, MedDiet scores were greater in individuals randomly assigned to receive PN than in controls, with the addition of DNA-based dietary advice resulting in the largest differences in MedDiet scores. Although differences were significant, their clinical relevance is modest. This trial was registered at clinicaltrials.gov as NCT01530139. © 2016 American Society for Nutrition.

Linear mixed-effects models to describe individual tree crown width for China-fir in Fujian Province, southeast China.

PubMed

Hao, Xu; Yujun, Sun; Xinjie, Wang; Jin, Wang; Yao, Fu

2015-01-01

A multiple linear model was developed for individual tree crown width of Cunninghamia lanceolata (Lamb.) Hook in Fujian province, southeast China. Data were obtained from 55 sample plots of pure China-fir plantation stands. An Ordinary Linear Least Squares (OLS) regression was used to establish the crown width model. To adjust for correlations between observations from the same sample plots, we developed one level linear mixed-effects (LME) models based on the multiple linear model, which take into account the random effects of plots. The best random effects combinations for the LME models were determined by the Akaike's information criterion, the Bayesian information criterion and the -2logarithm likelihood. Heteroscedasticity was reduced by three residual variance functions: the power function, the exponential function and the constant plus power function. The spatial correlation was modeled by three correlation structures: the first-order autoregressive structure [AR(1)], a combination of first-order autoregressive and moving average structures [ARMA(1,1)], and the compound symmetry structure (CS). Then, the LME model was compared to the multiple linear model using the absolute mean residual (AMR), the root mean square error (RMSE), and the adjusted coefficient of determination (adj-R2). For individual tree crown width models, the one level LME model showed the best performance. An independent dataset was used to test the performance of the models and to demonstrate the advantage of calibrating LME models.

Dietary interventions to prevent and manage diabetes in worksite settings: a meta-analysis.

PubMed

Shrestha, Archana; Karmacharya, Biraj Man; Khudyakov, Polyna; Weber, Mary Beth; Spiegelman, Donna

2018-01-25

The translation of lifestyle intervention to improve glucose tolerance into the workplace has been rare. The objective of this meta-analysis is to summarize the evidence for the effectiveness of dietary interventions in worksite settings on lowering blood sugar levels. We searched for studies in PubMed, Embase, Econlit, Ovid, Cochrane, Web of Science, and Cumulative Index to Nursing and Allied Health Literature. Search terms were as follows: (1) Exposure-based: nutrition/diet/dietary intervention/health promotion/primary prevention/health behavior/health education/food /program evaluation; (2) Outcome-based: diabetes/hyperglycemia/glucose/HbA1c/glycated hemoglobin; and (3) Setting-based: workplace/worksite/occupational/industry/job/employee. We manually searched review articles and reference lists of articles identified from 1969 to December 2016. We tested for between-studies heterogeneity and calculated the pooled effect sizes for changes in HbA1c (%) and fasting glucose (mg/dl) using random effect models for meta-analysis in 2016. A total of 17 articles out of 1663 initially selected articles were included in the meta-analysis. With a random-effects model, worksite dietary interventions led to a pooled -0.18% (95% CI, -0.29 to -0.06; P<0.001) difference in HbA1c. With the random-effects model, the interventions resulted in 2.60 mg/dl lower fasting glucose with borderline significance (95% CI: -5.27 to 0.08, P=0.06). In the multivariate meta-regression model, the interventions with high percent of female participants and that used the intervention directly delivered to individuals, rather the environment changes, were associated with more effective interventions. Workplace dietary interventions can improve HbA1c. The effects were larger for the interventions with greater number of female participants and with individual-level interventions.

Effects of chlorhexidine preprocedural rinse on bacteremia in periodontal patients: a randomized clinical trial

PubMed Central

Balejo, Rodrigo Dalla Pria; Cortelli, José Roberto; Costa, Fernando Oliveira; Cyrino, Renata Magalhães; Aquino, Davi Romeiro; Cogo-Müller, Karina; Miranda, Taís Browne; Moura, Sara Porto; Cortelli, Sheila Cavalca

2017-01-01

Abstract Objective: Single dose of systemic antibiotics and short-term use of mouthwashes reduce bacteremia. However, the effects of a single dose of preprocedural rinse are still controversial. This study evaluated, in periodontally diseased patients, the effects of a pre-procedural mouth rinse on induced bacteremia. Material and Methods: Systemically healthy individuals with gingivitis (n=27) or periodontitis (n = 27) were randomly allocated through a sealed envelope system to: 0.12% chlorhexidine pre-procedural rinse (13 gingivitis and 13 periodontitis patients) or no rinse before dental scaling (14 gingivitis and 15 periodontitis patients). Periodontal probing depth, clinical attachment level, plaque, and gingival indices were measured and subgingival samples were collected. Blood samples were collected before dental scaling, 2 and 6 minutes after scaling. Total bacterial load and levels of P. gingivalis were determined in oral and blood samples by real-time polymerase chain reaction, while aerobic and anaerobic counts were determined by culture in blood samples. The primary outcome was the antimicrobial effect of the pre-procedural rinse. Data was compared by Mann-Whitney and Signal tests (p<0.05). Results: In all sampling times, polymerase chain reaction revealed higher blood bacterial levels than culture (p<0.0001), while gingivitis patients presented lower bacterial levels in blood than periodontitis patients (p<0.0001). Individuals who experienced bacteremia showed worse mean clinical attachment level (3.4 mm vs. 1.1 mm) and more subgingival bacteria (p<0.005). The pre-procedural rinse did not reduce induced bacteremia. Conclusions: Bacteremia was influenced by periodontal parameters. In periodontally diseased patients, pre-procedural rinsing showed a discrete effect on bacteremia control. PMID:29211279

The association between plasminogen activator inhibitor type 1 (PAI-1) levels, PAI-1 4G/5G polymorphism, and myocardial infarction: a Mendelian randomization meta-analysis.

PubMed

Nikolopoulos, Georgios K; Bagos, Pantelis G; Tsangaris, Iraklis; Tsiara, Chrissa G; Kopterides, Petros; Vaiopoulos, Aristides; Kapsimali, Violetta; Bonovas, Stefanos; Tsantes, Argirios E

2014-07-01

The circulating levels of plasminogen activator inhibitor type 1 (PAI-1) are increased in individuals carrying the 4G allele at position -675 of the PAI-1 gene. In turn, overexpression of PAI-1 has been found to affect both atheroma and thrombosis. However, the association between PAI-1 levels and the incidence of myocardial infarction (MI) is complicated by the potentially confounding effects of well-known cardiovascular risk factors. The current study tried to investigate in parallel the association of PAI-1 activity with the PAI-1 4G/5G polymorphism, with MI, and some components of metabolic syndrome (MetS). Using meta-analytical Mendelian randomization approaches, genotype-disease and genotype-phenotype associations were modeled simultaneously. According to an additive model of inheritance and the Mendelian randomization approach, the MI-related odd ratio for individuals carrying the 4G allele was 1.088 with 95% confidence interval (CI) 1.007, 1.175. Moreover, the 4G carriers had, on average, higher PAI-1 activity than 5G carriers by 1.136 units (95% CI 0.738, 1.533). The meta-regression analyses showed that the levels of triglycerides (p=0.005), cholesterol (p=0.037) and PAI-1 (p=0.021) in controls were associated with the MI risk conferred by the 4G carriers. The Mendelian randomization meta-analysis confirmed previous knowledge that the PAI-1 4G allele slightly increases the risk for MI. In addition, it supports the notion that PAI-1 activity and established cardiovascular determinants, such as cholesterol and triglyceride levels, could lie in the etiological pathway from PAI-1 4G allele to the occurrence of MI. Further research is warranted to elucidate these interactions.

Effects of neighbourhood-level educational attainment on HIV prevalence among young women in Zambia.

PubMed

Kayeyi, Nkomba; Sandøy, Ingvild F; Fylkesnes, Knut

2009-08-25

Investigations of the association between socio-economic position indicators and HIV in East, Central and Southern Africa have chiefly focused on factors that pertain to individual-level characteristics. This study investigated the effect of neighbourhood educational attainment on HIV prevalence among young women in selected urban and rural areas in Zambia. This study re-analysed data from a cross-sectional population survey conducted in Zambia in 2003. The analyses were restricted to women aged 15-24 years (n = 1295). Stratified random cluster sampling was used to select 10 urban and 10 rural clusters. A measure for neighbourhood-level educational attainment was constructed by aggregating individual-level years-in-school. Multi-level mixed effects regression models were run to examine the neighbourhood-level educational effect on HIV prevalence after adjusting for individual-level underlying variables (education, currently a student, marital status) and selected proximate determinants (ever given birth, sexual activity, lifetime sexual partners). HIV prevalence among young women aged 15-24 years was 12.5% in the urban and 6.8% in the rural clusters. Neighbourhood educational attainment was found to be a strong determinant of HIV infection in both urban and rural population, i.e. HIV prevalence decreased substantially by increasing level of neighbourhood education. The likelihood of infection in low vs. high educational attainment of neighbourhoods was 3.4 times among rural women and 1.8 times higher among the urban women after adjusting for age and other individual-level underlying variables, including education. However, the association was not significant for urban young women after this adjustment. After adjusting for level of education in the neighbourhood, the effect of the individual-level education differed by residence, i.e. a strong protective effect among urban women whereas tending to be a risk factor among rural women. The findings suggested structural effects on HIV prevalence. Future research should include more detailed mapping of neighbourhood factors of relevance to HIV transmission as part of the effort to better understand the causal mechanisms involved.

Pilates and aerobic training improve levels of depression, anxiety and quality of life in overweight and obese individuals.

PubMed

Vancini, Rodrigo Luiz; Rayes, Angeles Bonal Rosell; Lira, Claudio Andre Barbosa de; Sarro, Karine Jacon; Andrade, Marilia Santos

2017-12-01

To compare the effects of Pilates and walking on quality of life, depression, and anxiety levels. Sixty-three overweight/obese participants were randomly divided into: control (n = 20), walking (n = 21), and Pilates (n = 22) groups. Pilates and walking groups attended eight weeks of 60-minute exercise sessions three times per week. Quality of life, depression, and state- and trait-anxiety levels were evaluated before and after eight weeks of training. Scores of quality of life, depression, and trait-anxiety improved in the Pilates and walking groups. State-anxiety levels improved only in the walking group. Pilates and walking positively impact quality of life, depression and anxiety. The Pilates method could be used as an alternative to improve mood disorders in overweight/obese individuals.

Effectiveness of repeated examination to diagnose enterobiasis in nursery school groups.

PubMed

Remm, Mare; Remm, Kalle

2009-09-01

The aim of this study was to estimate the benefit from repeated examinations in the diagnosis of enterobiasis in nursery school groups, and to test the effectiveness of individual-based risk predictions using different methods. A total of 604 children were examined using double, and 96 using triple, anal swab examinations. The questionnaires for parents, structured observations, and interviews with supervisors were used to identify factors of possible infection risk. In order to model the risk of enterobiasis at individual level, a similarity-based machine learning and prediction software Constud was compared with data mining methods in the Statistica 8 Data Miner software package. Prevalence according to a single examination was 22.5%; the increase as a result of double examinations was 8.2%. Single swabs resulted in an estimated prevalence of 20.1% among children examined 3 times; double swabs increased this by 10.1%, and triple swabs by 7.3%. Random forest classification, boosting classification trees, and Constud correctly predicted about 2/3 of the results of the second examination. Constud estimated a mean prevalence of 31.5% in groups. Constud was able to yield the highest overall fit of individual-based predictions while boosting classification tree and random forest models were more effective in recognizing Enterobius positive persons. As a rule, the actual prevalence of enterobiasis is higher than indicated by a single examination. We suggest using either the values of the mean increase in prevalence after double examinations compared to single examinations or group estimations deduced from individual-level modelled risk predictions.

Effectiveness of Repeated Examination to Diagnose Enterobiasis in Nursery School Groups

PubMed Central

Remm, Kalle

2009-01-01

The aim of this study was to estimate the benefit from repeated examinations in the diagnosis of enterobiasis in nursery school groups, and to test the effectiveness of individual-based risk predictions using different methods. A total of 604 children were examined using double, and 96 using triple, anal swab examinations. The questionnaires for parents, structured observations, and interviews with supervisors were used to identify factors of possible infection risk. In order to model the risk of enterobiasis at individual level, a similarity-based machine learning and prediction software Constud was compared with data mining methods in the Statistica 8 Data Miner software package. Prevalence according to a single examination was 22.5%; the increase as a result of double examinations was 8.2%. Single swabs resulted in an estimated prevalence of 20.1% among children examined 3 times; double swabs increased this by 10.1%, and triple swabs by 7.3%. Random forest classification, boosting classification trees, and Constud correctly predicted about 2/3 of the results of the second examination. Constud estimated a mean prevalence of 31.5% in groups. Constud was able to yield the highest overall fit of individual-based predictions while boosting classification tree and random forest models were more effective in recognizing Enterobius positive persons. As a rule, the actual prevalence of enterobiasis is higher than indicated by a single examination. We suggest using either the values of the mean increase in prevalence after double examinations compared to single examinations or group estimations deduced from individual-level modelled risk predictions. PMID:19724696

Examining the relationship between the physical availability of medical marijuana and marijuana use across fifty California cities.

PubMed

Freisthler, Bridget; Gruenewald, Paul J

2014-10-01

The purpose of the current study is to assess statistical associations between individual demographic and personality characteristics, the city-level physical availability of medical marijuana (as measured through densities per roadway mile of storefront dispensaries and delivery services), and the incidence and prevalence of marijuana use. Individual level data on marijuana use were collected during a telephone survey of 8853 respondents living in 50 mid-size cities in California. Data on medical marijuana dispensaries and delivery services were obtained via six different websites and official city lists. Three outcome variables pertaining to lifetime, past year use, and frequency of past year use were analyzed using random effects logistic models (for lifetime and past year use) and random effects tobit models (for frequency of past 365-day use). The current study finds that the total physical availability of medical marijuana through dispensaries and delivery services per roadway mile at the city-level is positively related to current marijuana use and greater frequency of use, controlling for a variety of demographic and personality characteristics. As expected, current physical availability of medical marijuana was unrelated to lifetime use. Regulations on the number and densities of marijuana outlets may be a sufficient means to restrain overall levels of marijuana use within cities. However, alternative use of delivery services may also provide easy access to marijuana and mitigate these effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

EXAMINING THE RELATIONSHIP BETWEEN THE PHYSICAL AVAILABILITY OF MEDICAL MARIJUANA AND MARIJUANA USE ACROSS FIFTY CALIFORNIA CITIES

PubMed Central

Freisthler, Bridget; Gruenewald, Paul J.

2014-01-01

Background The purpose of the current study is to assess statistical associations between individual demographic and personality characteristics, the city-level physical availability of medical marijuana (as measured through densities per roadway mile of storefront dispensaries and delivery services), and the incidence and prevalence of marijuana use. Method Individual level data on marijuana use were collected during a telephone survey of 8,853 respondents living in 50 mid-size cities in California. Data on medical marijuana dispensaries and delivery services were obtained via six different websites and official city lists. Three outcome variables pertaining to lifetime, past year use, and frequency of past year use were analyzed using random effects logistic models (for lifetime and past year use) and random effects tobit models (for frequency of past 365-day use). Results The current study finds that the total physical availability of medical marijuana through dispensaries and delivery services per roadway mile at the city-level is positively related to current marijuana use and greater frequency of use, controlling for a variety of demographic and personality characteristics. As expected, current physical availability of medical marijuana was unrelated to lifetime use. Conclusions Regulations on the number and densities of marijuana outlets may be a sufficient means to restrain overall levels of marijuana use within cities. However, alternative use of delivery services may also provide easy access to marijuana and mitigate these effects. PMID:25156224

Economic stress or random variation? Revisiting German reunification as a natural experiment to investigate the effect of economic contraction on sex ratios at birth.

PubMed

Schnettler, Sebastian; Klüsener, Sebastian

2014-12-22

The economic stress hypothesis (ESH) predicts decreases in the sex ratio at birth (SRB) following economic decline. However, as many factors influence the SRB, this hypothesis is difficult to test empirically. Thus, researchers make use of quasi-experiments such as German reunification: The economy in East, but not in West Germany, underwent a rapid decline in 1991. A co-occurrence of a decline in the East German SRB in 1991 has been interpreted by some as support for the ESH. However, another explanation might be that the low SRB in 1991 stems from increased random variation in the East German SRB due to a drastically reduced number of births during the crisis. We look into this alternative random variation hypothesis (RVH) by re-examining the German case with more detailed data. Our analysis has two parts. First, using aggregate-level birth register data for all births in the period between 1946 and 2011, we plot the quantum and variance of the SRB and the number of births and unemployment rates, separately for East and West Germany, and conduct a time series analysis on the East German SRB over time. Second, we model the odds for a male birth at the individual level in a multiple logistic regression (1991-2010, ~13.9 million births). Explanatory variables are related to the level of the individual birth, the mother of the child born, and the regional economic context. The aggregate-level analysis reveals a higher degree of variation of the SRB in East Germany. Deviations from the time trend occur in several years, seemingly unrelated to economic development, and the deviation in 1991 is not statistically significant. The individual-level analysis confirms that the 1991-drop in the East German SRB cannot directly be attributed to economic development and that there is no statistically significant effect of economic development on sex determination in East or West Germany. Outcomes support the RVH but not the ESH. Furthermore, our results speak against a statistically significant effect of the reunification event itself on the East German SRB. We discuss the relative importance of behavioral and physiological responses to macro-level stressors, a distinction that may help integrate previously mixed findings.

Individual covariation in life-history traits: seeing the trees despite the forest

USGS Publications Warehouse

Cam, E.; Link, W.A.; Cooch, E.G.; Monnat, J.-Y.; Danchin, E.

2002-01-01

We investigated the influence of age on survival and breeding rates in a long-lived species Rissa tridactyla using models with individual random effects permitting variation and covariation in fitness components among individuals. Differences in survival or breeding probabilities among individuals are substantial, and there was positive covariation between survival and breeding probability; birds that were more likely to survive were also more likely to breed, given that they survived. The pattern of age-related variation in these rates detected at the individual level differed from that observed at the population level. Our results provided confirmation of what has been suggested by other investigators: within-cohort phenotypic selection can mask senescence. Although this phenomenon has been extensively studied in humans and captive animals, conclusive evidence of the discrepancy between population-level and individual-level patterns of age-related variation in life-history traits is extremely rare in wild animal populations. Evolutionary studies of the influence of age on life-history traits should use approaches differentiating population level from the genuine influence of age: only the latter is relevant to theories of life-history evolution. The development of models permitting access to individual variation in fitness is a promising advance for the study of senescence and evolutionary processes.

Clustered multistate models with observation level random effects, mover-stayer effects and dynamic covariates: modelling transition intensities and sojourn times in a study of psoriatic arthritis.

PubMed

Yiu, Sean; Farewell, Vernon T; Tom, Brian D M

2018-02-01

In psoriatic arthritis, it is important to understand the joint activity (represented by swelling and pain) and damage processes because both are related to severe physical disability. The paper aims to provide a comprehensive investigation into both processes occurring over time, in particular their relationship, by specifying a joint multistate model at the individual hand joint level, which also accounts for many of their important features. As there are multiple hand joints, such an analysis will be based on the use of clustered multistate models. Here we consider an observation level random-effects structure with dynamic covariates and allow for the possibility that a subpopulation of patients is at minimal risk of damage. Such an analysis is found to provide further understanding of the activity-damage relationship beyond that provided by previous analyses. Consideration is also given to the modelling of mean sojourn times and jump probabilities. In particular, a novel model parameterization which allows easily interpretable covariate effects to act on these quantities is proposed.

Estimating peer effects in networks with peer encouragement designs.

PubMed

Eckles, Dean; Kizilcec, René F; Bakshy, Eytan

2016-07-05

Peer effects, in which the behavior of an individual is affected by the behavior of their peers, are central to social science. Because peer effects are often confounded with homophily and common external causes, recent work has used randomized experiments to estimate effects of specific peer behaviors. These experiments have often relied on the experimenter being able to randomly modulate mechanisms by which peer behavior is transmitted to a focal individual. We describe experimental designs that instead randomly assign individuals' peers to encouragements to behaviors that directly affect those individuals. We illustrate this method with a large peer encouragement design on Facebook for estimating the effects of receiving feedback from peers on posts shared by focal individuals. We find evidence for substantial effects of receiving marginal feedback on multiple behaviors, including giving feedback to others and continued posting. These findings provide experimental evidence for the role of behaviors directed at specific individuals in the adoption and continued use of communication technologies. In comparison, observational estimates differ substantially, both underestimating and overestimating effects, suggesting that researchers and policy makers should be cautious in relying on them.

Analysis of sensitive questions across cultures: an application of multigroup item randomized response theory to sexual attitudes and behavior.

PubMed

de Jong, Martijn G; Pieters, Rik; Stremersch, Stefan

2012-09-01

Answers to sensitive questions are prone to social desirability bias. If not properly addressed, the validity of the research can be suspect. This article presents multigroup item randomized response theory (MIRRT) to measure self-reported sensitive topics across cultures. The method was specifically developed to reduce social desirability bias by making an a priori change in the design of the survey. The change involves the use of a randomization device (e.g., a die) that preserves participants' privacy at the item level. In cases where multiple items measure a higher level theoretical construct, the researcher could still make inferences at the individual level. The method can correct for under- and overreporting, even if both occur in a sample of individuals or across nations. We present and illustrate MIRRT in a nontechnical manner, provide WinBugs software code so that researchers can directly implement it, and present 2 cross-national studies in which it was applied. The first study compared nonstudent samples from 2 countries (total n = 927) on permissive sexual attitudes and risky sexual behavior and related these to individual-level characteristics such as the Big Five personality traits. The second study compared nonstudent samples from 17 countries (total n = 6,195) on risky sexual behavior and related these to individual-level characteristics, such as gender and age, and to country-level characteristics, such as sex ratio.

Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care.

PubMed

Nordin, Karin; Rissanen, Ritva; Ahlgren, Johan; Burell, Gunilla; Fjällskog, Marie-Louise; Börjesson, Susanne; Arving, Cecilia

2012-05-04

A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients' quality of life and psychological well-being. ClinicalTrials.gov Identifier: NCT01555645.

Group level effects of social versus individual learning.

PubMed

Jost, Jürgen; Li, Wei

2013-06-01

We study the effects of learning by imitating others within the framework of an iterated game in which the members of two complementary populations interact via random pairing at each round. This allows us to compare both the fitness of different strategies within a population and the performance of populations in which members have access to different types of strategies. Previous studies reveal some emergent dynamics at the population level, when players learn individually. We here investigate a different mechanism in which players can choose between two different learning strategies, individual or social. Imitating behavior can spread within a mixed population, with the frequency of imitators varying over generation time. When compared to a pure population with solely individual learners, a mixed population with both individual and social learners can do better, independently of the precise learning scheme employed. We can then search for the best imitating strategy. Imitating the neighbor with the highest payoff turns out to be consistently superior. This is in agreement with findings in experimental and model studies that have been carried out in different settings.

Novelty-seeking trait predicts the effect of methylphenidate on creativity.

PubMed

Gvirts, Hila Z; Mayseless, Naama; Segev, Aviv; Lewis, D Yael; Feffer, Kfir; Barnea, Yael; Bloch, Yuval; Shamay-Tsoory, Simon G

2017-05-01

In recent years the use of psychostimulants for cognitive enhancement in healthy individuals with no psychiatric disorders has been on the rise. However, it is still unclear whether psychostimulants improve certain cognitive functions at the cost of others, and how these psychostimulants interact with individual personality differences. In the current study, we investigated whether the effect of one common stimulant, methylphenidate (MPH), on creativity is associated with novelty seeking. Thirty-six healthy adults, without attention-deficit hyperactivity disorder (ADHD) symptomology, were assigned randomly in a double-blind fashion to receive MPH or placebo. We found that the effect of MPH on creativity was dependent on novelty-seeking (NS) personality characteristics of the participants. MPH increased creativity in individuals with lower NS, while it reduced creativity levels in individuals with high NS. These findings highlight the role of the dopaminergic system in creativity, and indicate that among healthy individuals NS can be seen as a predictor of the effect of MPH on creativity.

Teachers' support and depression among Japanese adolescents: a multilevel analysis.

PubMed

Mizuta, Akiko; Suzuki, Kohta; Yamagata, Zentaro; Ojima, Toshiyuki

2017-02-01

Depression is a major cause of suicide among adolescents. Therefore, childhood and adolescent depression is an important public health concern. This study explored factors as class and individual levels that may influence depression among adolescents in Japan. A questionnaire survey among junior high school students (N = 2968) from two cities in Japan was conducted. Depression was assessed using the Depression Self-Rating Scale for Children; teachers' support was assessed using the Scale of Expectancy for Social Support. The class average score of teachers' support was calculated to indicate what we termed the "homeroom teachers' support." Multilevel analysis was applied to clarify the relation between homeroom teachers' support and depression. Finally, 2466 students completed the questionnaire without missing variables (valid response rate, 83.1%). There was no random effect of the teachers' support at the class level on depression, although there was a significant association between teachers' support and depression for 9th graders (β = -0.12, p = 0.009). Moreover, there were significant associations between economic status, having a best friend, and experiencing unforgettable stress at the individual level and depression in all grades. There was no significant random effect of homeroom teachers' support in class level although there might be marginal negative association between teacher's support and depression. It is suggested that homeroom teachers need to promote population approaches to mental health.

A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease

PubMed Central

Bell, K.L.; Galasko, D.; Galvin, J.E.; Thomas, R.G.; van Dyck, C.H.; Aisen, P.S.

2011-01-01

Background: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. Objective: To determine if the lipid-lowering agent simvastatin slows the progression of symptoms in AD. Methods: This randomized, double-blind, placebo-controlled trial of simvastatin was conducted in individuals with mild to moderate AD and normal lipid levels. Participants were randomly assigned to receive simvastatin, 20 mg/day, for 6 weeks then 40 mg per day for the remainder of 18 months or identical placebo. The primary outcome was the rate of change in the Alzheimer's Disease Assessment Scale–cognitive portion (ADAS-Cog). Secondary outcomes measured clinical global change, cognition, function, and behavior. Results: A total of 406 individuals were randomized: 204 to simvastatin and 202 to placebo. Simvastatin lowered lipid levels but had no effect on change in ADAS-Cog score or the secondary outcome measures. There was no evidence of increased adverse events with simvastatin treatment. Conclusion: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. Classification of evidence: This study provides Class I evidence that simvastatin 40 mg/day does not slow decline on the ADAS-Cog. PMID:21795660

Influence of heat and moisture exchanger respiratory load on transcutaneous oxygenation in laryngectomized individuals: a randomized crossover study.

PubMed

Zuur, J Karel; Muller, Sara H; Sinaasappel, Michiel; Hart, Guus A M; van Zandwijk, Nico; Hilgers, Frans J M

2007-12-01

High-resistance heat and moisture exchangers (HMEs) have been reported to increase transcutaneous oxygenation (tcpO(2)) values in laryngectomized individuals and to negatively influence patient compliance. The goal of the present study was to validate earlier published results on short-term transcutaneous oxygenation changes by high-resistance HMEs. We conducted a randomized crossover study, monitoring the influence of an HME on tcpO(2) over a 2-hour time interval in 20 subjects. No evidence of an immediate HME effect (95% CI: -14.9-13.3 mm Hg, p = .91), or a time-dependent HME effect (95% CI: -.121 - .172 mm Hg/minute, p = .74), on tcpO(2) was found. After fitting the statistical model without time dependency, again no evidence of HME presence was seen (95% CI: -.5 mm Hg - 3.6 mm Hg, p = .15). In contrast to earlier suggestions, there is no evidence of increased tcpO(2) levels by high-resistance HMEs in laryngectomized individuals. Thus, using such HMEs has no added clinical value in this respect.

A three-level model for binary time-series data: the effects of air pollution on school absences in the Southern California Children's Health Study.

PubMed

Rondeau, Virginie; Berhane, Kiros; Thomas, Duncan C

2005-04-15

A three-level model is proposed to simultaneously examine the effects of daily exposure to air pollution and individual risk factors on health outcomes without aggregating over subjects or time. We used a logistic transition model with random effects to take into account heterogeneity and overdispersion of the observations. A distributed lag structure for pollution has been included, assuming that the event on day t for a subject depends on the levels of air pollution for several preceding days. We illustrate this proposed model via detailed analysis of the effect of air pollution on school absenteeism based on data from the Southern California Children's Health Study.

Associations of Neighborhood Crime and Safety and With Changes in Body Mass Index and Waist Circumference: The Multi-Ethnic Study of Atherosclerosis.

PubMed

Powell-Wiley, Tiffany M; Moore, Kari; Allen, Norrina; Block, Richard; Evenson, Kelly R; Mujahid, Mahasin; Diez Roux, Ana V

2017-08-01

Using data from the Multi-Ethnic Study of Atherosclerosis (MESA), we evaluated associations of neighborhood crime and safety with changes in adiposity (body mass index (BMI) and waist circumference). MESA is a longitudinal study of cardiovascular disease among adults aged 45-84 years at baseline in 2000-2002, from 6 US sites, with follow-up for MESA participants until 2012. Data for this study were limited to Chicago, Illinois, participants in the MESA Neighborhood Ancillary Study, for whom police-recorded crime data were available, and who had complete baseline data (n = 673). We estimated associations of individual-level safety, aggregated neighborhood-level safety, and police-recorded crime with baseline levels and trajectories of BMI and waist circumference over time using linear mixed modeling with random effects. We also estimated how changes in these factors related to changes in BMI and waist circumference using econometric fixed-effects models. At baseline, greater individual-level safety was associated with more adiposity. Increasing individual- and neighborhood-level safety over time were associated with decreasing BMI over the 10-year period, with a more pronounced effect observed in women for individual-level safety and men for neighborhood-level safety. Police-recorded crime was not associated with adiposity. Neighborhood-level safety likely influences adiposity change and subsequent cardiovascular risk in multiethnic populations. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Methods for Synthesizing Findings on Moderation Effects Across Multiple Randomized Trials

PubMed Central

Brown, C Hendricks; Sloboda, Zili; Faggiano, Fabrizio; Teasdale, Brent; Keller, Ferdinand; Burkhart, Gregor; Vigna-Taglianti, Federica; Howe, George; Masyn, Katherine; Wang, Wei; Muthén, Bengt; Stephens, Peggy; Grey, Scott; Perrino, Tatiana

2011-01-01

This paper presents new methods for synthesizing results from subgroup and moderation analyses across different randomized trials. We demonstrate that such a synthesis generally results in additional power to detect significant moderation findings above what one would find in a single trial. Three general methods for conducting synthesis analyses are discussed, with two methods, integrative data analysis, and parallel analyses, sharing a large advantage over traditional methods available in meta-analysis. We present a broad class of analytic models to examine moderation effects across trials that can be used to assess their overall effect and explain sources of heterogeneity, and present ways to disentangle differences across trials due to individual differences, contextual level differences, intervention, and trial design. PMID:21360061

Methods for synthesizing findings on moderation effects across multiple randomized trials.

PubMed

Brown, C Hendricks; Sloboda, Zili; Faggiano, Fabrizio; Teasdale, Brent; Keller, Ferdinand; Burkhart, Gregor; Vigna-Taglianti, Federica; Howe, George; Masyn, Katherine; Wang, Wei; Muthén, Bengt; Stephens, Peggy; Grey, Scott; Perrino, Tatiana

2013-04-01

This paper presents new methods for synthesizing results from subgroup and moderation analyses across different randomized trials. We demonstrate that such a synthesis generally results in additional power to detect significant moderation findings above what one would find in a single trial. Three general methods for conducting synthesis analyses are discussed, with two methods, integrative data analysis and parallel analyses, sharing a large advantage over traditional methods available in meta-analysis. We present a broad class of analytic models to examine moderation effects across trials that can be used to assess their overall effect and explain sources of heterogeneity, and present ways to disentangle differences across trials due to individual differences, contextual level differences, intervention, and trial design.

The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

PubMed

Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

2011-01-01

PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also significantly improved self-reported productivity. CONCLUSION. An effective intervention can change employee health risk status and activation both at the population level and at the individual high risk level. However, program engagement at the population level was low, indicating that additional promotional strategies, such as greater use of incentives, need to be examined. Less intensive coaching can be as effective as more intensive, albeit both interventions produced modest behavior change and retention in the consumer activation arm was most difficult. Further research is needed concerning recruitment and retention methods that will enable populations to realize the full potential of activated consumerism.

Does low workplace social capital have detrimental effect on workers' health?

PubMed

Suzuki, Etsuji; Takao, Soshi; Subramanian, S V; Komatsu, Hirokazu; Doi, Hiroyuki; Kawachi, Ichiro

2010-05-01

While the majority of studies of social capital and health have focused on conceptualizing social capital at the geographic level, evidence remains sparse on workplace social capital. We examined the association between workplace social capital and health status among Japanese private sector employees in a cross-sectional study. By employing a two-stage stratified random sampling procedure, 1147 employees were identified from 46 companies in Okayama in 2007. Workplace social capital was measured based on two components; trust and reciprocity. Company-level social capital was based on aggregating employee responses and calculating the proportion of workers reporting mistrust and lack of reciprocity. Multilevel logistic regression analysis was conducted using Markov Chain Monte Carlo methods to explore whether individual- and company-level mistrust and lack of reciprocity were associated with poor self-rated health. Odds ratios (ORs) and 95% credible intervals (CIs) for poor health were obtained for each variable. Workers reporting individual-level mistrust and lack of reciprocity had approximately double the odds of poor health even after controlling for sex, age, occupation, educational attainment, smoking, alcohol use, physical activity, body mass index, and chronic diseases. While we found some suggestion of a contextual association between company-level mistrust and poor health, no association was found between company-level lack of reciprocity and health. Despite the thorough examination of cross-level interaction terms between company-level social capital and individual characteristics, no clear patterns were observed. Individual perceptions of mistrust and lack of reciprocity at work have adverse effects on self-rated health among Japanese workers. Although the present study possibly suggests the contextual effect of workplace mistrust on workers' health, the contextual effect of workplace lack of reciprocity was not supported. Copyright 2010 Elsevier Ltd. All rights reserved.

A pilot randomized controlled trial evaluating motivationally matched pedometer feedback to increase physical activity behavior in older adults.

PubMed

Strath, Scott J; Swartz, Ann M; Parker, Sarah J; Miller, Nora E; Grimm, Elizabeth K; Cashin, Susan E

2011-09-01

Increasing physical activity (PA) levels in older adults represents an important public health challenge. The purpose of this study was to evaluate the feasibility of combining individualized motivational messaging with pedometer walking step targets to increase PA in previously inactive and insufficiently active older adults. In this 12-week intervention study older adults were randomized to 1 of 4 study arms: Group 1--control; Group 2--pedometer 10,000 step goal; Group 3--pedometer step goal plus individualized motivational feedback; or Group 4--everything in Group 3 augmented with biweekly telephone feedback. 81 participants were randomized into the study, 61 participants completed the study with an average age of 63.8 ± 6.0 years. Group 1 did not differ in accumulated steps/day following the 12-week intervention compared with participants in Group 2. Participants in Groups 3 and 4 took on average 2159 (P < .001) and 2488 (P < .001) more steps/day, respectively, than those in Group 1 after the 12-week intervention. In this 12-week pilot randomized control trial, a pedometer feedback intervention partnered with individually matched motivational messaging was an effective intervention strategy to significantly increase PA behavior in previously inactive and insufficiently active older adults.

Individualized predictions of time to menopause using multiple measurements of antimüllerian hormone.

PubMed

Gohari, Mahmood Reza; Ramezani Tehrani, Fahime; Chenouri, Shojaeddin; Solaymani-Dodaran, Masoud; Azizi, Fereidoun

2016-08-01

The ability of antimüllerian hormone (AMH) to predict age at menopause has been reported in several studies, and a decrease in AMH level has been found to increase the probability of menopause. The rate of decline varies among women, and there is also a variability of decline between women's cycles. As a result, individualized evaluation is required to accurately predict time of menopause. To this end, we have used the AMH trajectories of individual women to predict each one's age at menopause. From a cohort study, 266 women (ages 20-50 y) who had regular and predictable menstrual cycles at the initiation of the study were randomly selected from among 1,265 women for multiple AMH measurements. Participants were visited at approximately 3-year intervals and followed for an average of 6.5 years. Individual likelihood of menopause was predicted by fitting the shared random-effects joint model to the baseline covariates and the specific AMH trajectory of each woman. In total, 23.7% of the women reached menopause during the follow-up period. The estimated mean (SD) AMH concentration at the time of menopause was 0.05 ng/mL (0.06 ng/mL), compared with 1.36 ng/mL (1.85 ng/mL) for those with a regular menstrual cycle at their last assessment. The decline rate in the AMH level varied among age groups, and age was a significant prognostic factor for AMH level (P < 0.001). Adjusting for age and body mass index, each woman had her own specific AMH trajectory. Lower AMH and older age had significant effects on the onset of menopause. Individualized prediction of time to menopause was obtained from the fitted model. Longitudinal measurements of AMH will enable physicians to individualize the prediction of menopause, thereby facilitating counseling on the timing of childbearing or medical management of health issues associated with menopause.

Can we get some cooperation around here? The mediating role of group norms on the relationship between team personality and individual helping behaviors.

PubMed

Gonzalez-Mulé, Erik; DeGeest, David S; McCormick, Brian W; Seong, Jee Young; Brown, Kenneth G

2014-09-01

Drawing on the group-norms theory of organizational citizenship behaviors and person-environment fit theory, we introduce and test a multilevel model of the effects of additive and dispersion composition models of team members' personality characteristics on group norms and individual helping behaviors. Our model was tested using regression and random coefficients modeling on 102 research and development teams. Results indicated that high mean levels of extraversion are positively related to individual helping behaviors through the mediating effect of cooperative group norms. Further, low variance on agreeableness (supplementary fit) and high variance on extraversion (complementary fit) promote the enactment of individual helping behaviors, but only the effects of extraversion were mediated by cooperative group norms. Implications of these findings for theories of helping behaviors in teams are discussed. PsycINFO Database Record (c) 2014 APA, all rights reserved.

surrosurv: An R package for the evaluation of failure time surrogate endpoints in individual patient data meta-analyses of randomized clinical trials.

PubMed

Rotolo, Federico; Paoletti, Xavier; Michiels, Stefan

2018-03-01

Surrogate endpoints are attractive for use in clinical trials instead of well-established endpoints because of practical convenience. To validate a surrogate endpoint, two important measures can be estimated in a meta-analytic context when individual patient data are available: the R indiv 2 or the Kendall's τ at the individual level, and the R trial 2 at the trial level. We aimed at providing an R implementation of classical and well-established as well as more recent statistical methods for surrogacy assessment with failure time endpoints. We also intended incorporating utilities for model checking and visualization and data generating methods described in the literature to date. In the case of failure time endpoints, the classical approach is based on two steps. First, a Kendall's τ is estimated as measure of individual level surrogacy using a copula model. Then, the R trial 2 is computed via a linear regression of the estimated treatment effects; at this second step, the estimation uncertainty can be accounted for via measurement-error model or via weights. In addition to the classical approach, we recently developed an approach based on bivariate auxiliary Poisson models with individual random effects to measure the Kendall's τ and treatment-by-trial interactions to measure the R trial 2 . The most common data simulation models described in the literature are based on: copula models, mixed proportional hazard models, and mixture of half-normal and exponential random variables. The R package surrosurv implements the classical two-step method with Clayton, Plackett, and Hougaard copulas. It also allows to optionally adjusting the second-step linear regression for measurement-error. The mixed Poisson approach is implemented with different reduced models in addition to the full model. We present the package functions for estimating the surrogacy models, for checking their convergence, for performing leave-one-trial-out cross-validation, and for plotting the results. We illustrate their use in practice on individual patient data from a meta-analysis of 4069 patients with advanced gastric cancer from 20 trials of chemotherapy. The surrosurv package provides an R implementation of classical and recent statistical methods for surrogacy assessment of failure time endpoints. Flexible simulation functions are available to generate data according to the methods described in the literature. Copyright © 2017 Elsevier B.V. All rights reserved.

Baseline participant characteristics and risk for dropout from ten obesity randomized controlled trials: a pooled analysis of individual level data.

PubMed

Kaiser, Kathryn A; Affuso, Olivia; Desmond, Renee; Allison, David B

Understanding participant demographic characteristics that inform the optimal design of obesity RCTs have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs) in obesity randomized controlled trials (RCT) by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual-level characteristics. We obtained and analyzed nine publicly-available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed. Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR= 1.24, 95% CI = 1.05, 1.46). Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR= 1.62, 95% CI = 1.37, 1.91; HR= 1.22, 95% CI = 1.11, 1.35, respectively). There was a significantly increased risk of dropout associated with advancing age (HR= 1.02, 95% CI = 1.01, 1.02) and increasing BMI (HR= 1.03, 95% CI = 1.03, 1.04). As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected dropout rates, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g. time on treatment.

Effects of a cyclic NSAID regimen on levels of gingival crevicular fluid prostaglandin E2and Interleukin-1β: A 6-month randomized controlled clinical trial.

PubMed

Oduncuoglu, B F; Kayar, N A; Haliloglu, S; Serpek, B; Ataoglu, T; Alptekin, N O

2018-05-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for inflammation control and pain relief. However, while the adjunct use of NSAIDs is avoided for periodontal therapy because of related side effects, cyclic administration of NSAIDs may reduce or eliminate these effects. We evaluated the effect of a cyclic diclofenac potassium (DP) regimen on clinical parameters and levels of prostaglandin E 2 (PGE 2 ) and interleukin-1β (IL-1β) in the gingival crevicular fluid (GCF) of individuals with periodontitis. The study protocol was approved by the Ethics Committee (2000/071). Forty-one individuals with chronic periodontitis (33 men, 8 women) were divided into two groups (test and control) after initial periodontal therapy. During this 6-month, randomized, double-blind, placebo-controlled study, test (n = 28) and control (n = 13) groups were administered a cyclic regimen of DP (50 mg, twice daily) or placebo. Clinical measurements and GCF sample collections were made at baseline, 2, 4, and 6 months. GCF levels of PGE 2 and IL-1β were determined using enzyme immunoassay and enzyme-linked immunoassay kits, respectively. At baseline, no significant differences existed between groups for plaque indices, gingival indices, bleeding on probing, probing depth (PD), or attachment levels (P > 0.05). Compared with the control group, cyclic regimen in the test group suppressed increased levels of PGE 2 found in GCF at the end of the study (P < 0.05). Significant differences for PD and relative attachment gain were also noted in favor of the test group (P < 0.05). These results suggest that a cyclic regimen of DP may be efficacious in the management of chronic periodontitis in adults.

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals.

PubMed

Shimizu, Mikiko; Hashiguchi, Masayuki; Shiga, Tsuyoshi; Tamura, Hiro-omi; Mochizuki, Mayumi

2015-01-01

Recent experimental and clinical studies have suggested that probiotic supplementation has beneficial effects on serum lipid profiles. However, there are conflicting results on the efficacy of probiotic preparations in reducing serum cholesterol. To evaluate the effects of probiotics on human serum lipid levels, we conducted a meta-analysis of interventional studies. Eligible reports were obtained by searches of electronic databases. We included randomized, controlled clinical trials comparing probiotic supplementation with placebo or no treatment (control). Statistical analysis was performed with Review Manager 5.3.3. Subanalyses were also performed. Eleven of 33 randomized clinical trials retrieved were eligible for inclusion in the meta-analysis. No participant had received any cholesterol-lowering agent. Probiotic interventions (including fermented milk products and probiotics) produced changes in total cholesterol (TC) (mean difference -0.17 mmol/L, 95% CI: -0.27 to -0.07 mmol/L) and low-density lipoprotein cholesterol (LDL-C) (mean difference -0.22 mmol/L, 95% CI: -0.30 to -0.13 mmol/L). High-density lipoprotein cholesterol and triglyceride levels did not differ significantly between probiotic and control groups. In subanalysis, long-term (> 4-week) probiotic intervention was statistically more effective in decreasing TC and LDL-C than short-term (≤ 4-week) intervention. The decreases in TC and LDL-C levels with probiotic intervention were greater in mildly hypercholesterolemic than in normocholesterolemic individuals. Both fermented milk product and probiotic preparations decreased TC and LDL-C levels. Gaio and the Lactobacillus acidophilus strain reduced TC and LDL-C levels to a greater extent than other bacterial strains. In conclusion, this meta-analysis showed that probiotic supplementation could be useful in the primary prevention of hypercholesterolemia and may lead to reductions in risk factors for cardiovascular disease.

Neighbourhood social capital and adolescent self-reported wellbeing in New Zealand: a multilevel analysis.

PubMed

Aminzadeh, Kaveh; Denny, Simon; Utter, Jennifer; Milfont, Taciano L; Ameratunga, Shanthi; Teevale, Tasileta; Clark, Terryann

2013-05-01

The association between neighbourhood social capital and individual health and wellbeing has been explored mainly by focussing on adult outcomes. This study explores the relationship between neighbourhood social capital and adolescent subjective wellbeing, and its interaction with adolescents' socioeconomic status. Data was taken from a random sample of 9107 students who participated in a nationally representative health survey of high school students in New Zealand in 2007. Students' wellbeing was measured by questions on general mood, life satisfaction and WHO-5 Wellbeing Index. Neighbourhood social capital was assessed according to five indicators: neighbourhood social cohesion, facilities, physical disintegration, membership in community organisations, and residential stability. All neighbourhood measures were created based on students' responses aggregated to the neighbourhood level. Neighbourhood was defined as a Census Area Unit, with a median population of 2000 people. Analyses included only neighbourhoods with more than 10 students, and were conducted using cross-classified random intercept multilevel models controlling for students' age, sex, ethnicity and socioeconomic status, with both schools and neighbourhoods treated as random effects. A total of 5567 students within 262 neighbourhoods were considered in the analysis. Students living in neighbourhoods characterised by higher levels of social cohesion and membership in community organisations reported higher levels of wellbeing. The association between student self-reported wellbeing and neighbourhood membership in community organisations varied according to the individual socioeconomic status of students. Neighbourhood membership in community organisations showed a stronger protective effect for students who were more socioeconomically deprived. Copyright © 2013 Elsevier Ltd. All rights reserved.

Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

PubMed

Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, Noro Lantoniaina Rosa; Tabala, Martine; Okitolonda, Emile W

2017-04-26

Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation. The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

Peer effects on risk behaviour: the importance of group identity.

PubMed

Gioia, Francesca

2017-01-01

This paper investigates whether and to what extent group identity plays a role in peer effects on risk behaviour. We run a laboratory experiment in which different levels of group identity are induced through different matching protocols (random or based on individual painting preferences) and the possibility to interact with group members via an online chat in a group task. Risk behaviour is measured by using the Bomb Risk Elicitation Task and peer influence is introduced by giving subjects feedback regarding group members' previous decisions. We find that subjects are affected by their peers when taking decisions and that group identity influences the magnitude of peer effects: painting preferences matching significantly reduces the heterogeneity in risk behaviour compared with random matching. On the other hand, introducing a group task has no significant effect on behaviour, possibly because interaction does not always contribute to enhancing group identity. Finally, relative riskiness within the group matters and individuals whose peers are riskier than they are take on average riskier decisions, even when controlling for regression to the mean.

Epidemiology, epigenetics and the 'Gloomy Prospect': embracing randomness in population health research and practice.

PubMed

Smith, George Davey

2011-06-01

Epidemiologists aim to identify modifiable causes of disease, this often being a prerequisite for the application of epidemiological findings in public health programmes, health service planning and clinical medicine. Despite successes in identifying causes, it is often claimed that there are missing additional causes for even reasonably well-understood conditions such as lung cancer and coronary heart disease. Several lines of evidence suggest that largely chance events, from the biographical down to the sub-cellular, contribute an important stochastic element to disease risk that is not epidemiologically tractable at the individual level. Epigenetic influences provide a fashionable contemporary explanation for such seemingly random processes. Chance events-such as a particular lifelong smoker living unharmed to 100 years-are averaged out at the group level. As a consequence population-level differences (for example, secular trends or differences between administrative areas) can be entirely explicable by causal factors that appear to account for only a small proportion of individual-level risk. In public health terms, a modifiable cause of the large majority of cases of a disease may have been identified, with a wild goose chase continuing in an attempt to discipline the random nature of the world with respect to which particular individuals will succumb. The quest for personalized medicine is a contemporary manifestation of this dream. An evolutionary explanation of why randomness exists in the development of organisms has long been articulated, in terms of offering a survival advantage in changing environments. Further, the basic notion that what is near-random at one level may be almost entirely predictable at a higher level is an emergent property of many systems, from particle physics to the social sciences. These considerations suggest that epidemiological approaches will remain fruitful as we enter the decade of the epigenome.

Parent Involvement and Child Development: First-Year Results from a School-Randomized Trial in Latino Communities

ERIC Educational Resources Information Center

Gamoran, Adam; Turley, Ruth Lopez; Turner, Alyn; Fish, Rachel

2010-01-01

The purpose of this study is to test the effects on children's social, behavioral, and academic outcomes of an intervention, Families and Schools Together (FAST), when implemented in two novel ways: (a) in schools with predominantly Latino children and (b) on an entire grade-level cohort instead of with individual families targeted for the…

Community-wide promotion of physical activity in middle-aged and older Japanese: a 3-year evaluation of a cluster randomized trial.

PubMed

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

2015-06-23

Promotion of physical activity (PA) is a key strategy to prevent non-communicable diseases. However, evidence on the effectiveness of community-wide interventions (CWIs) for promoting PA is limited. To evaluate the effectiveness of a 3-year CWI for promoting PA in middle-aged and older adults compared with usual public health services. This study is an extension to an original 1-year investigation study. Cluster randomized controlled trial with community as unit of randomization and individual as unit of analysis. 12 communities in Unnan, Japan were randomly allocated to the intervention (9) or the control (3). Additionally intervention communities were randomly allocated to aerobic activity promotion (Group A), flexibility and muscle-strengthening activities promotion (Group FM), or aerobic, flexibility, and muscle-strengthening activities promotion (Group AFM), each consisting of three communities. Randomly-sampled 4414 residents aged 40 to 79 years responded to the baseline survey (74%), and were analyzed in 2013-2014. A 3-year CWI based on social marketing, to promote PA from 2009 to 2012. The primary outcome was a change in regular aerobic, flexibility, and/or muscle-strengthening activities, defined by (1) engaging in 150 mins/week or more of walking, (2) engaging in daily flexibility activity, or (3) engaging 2 or more days/week in muscle-strengthening activities, evaluated at the individual level. Secondary outcomes were changes in specific types of PA and musculoskeletal pain. Outcomes were measured at baseline and at 1 and 3 years (2009, 2010, and 2012). The CWI did not significantly increase the proportion of adults who reached recommended levels of aerobic, flexibility, and/or muscle-strengthening activities (adjusted change difference = 1.6% [95% CI: -3.5, 6.6]). In the subgroup analysis, compared to the controls, adults doing flexibility activity daily significantly increased in Group FM (6.3% [95% CI: 1.9, 10.7]). In Group A and AFM for PA outcomes and in all groups for pain outcomes, there was no significant change compared to controls. The CWI did not achieve significant increase in the proportion of adults who reached recommended PA levels. However, it might be effective in promoting flexibility activity in middle-aged and older Japanese. UMIN-CTR UMIN000002683 .

Productivity, vitality and utility in a group of healthy professionally active individuals with nocturia.

PubMed

Kobelt, G; Borgström, F; Mattiasson, A

2003-02-01

To assess the effect of nocturia on productivity, vitality and utility in a selected group of professionally active individuals with nocturia, compared with matched controls, and investigate the effect of symptom severity, to test the hypothesis that lack of sleep caused by frequent sleep interruptions could reduce an individuals' daytime energy and activity levels. Subjects (203) were recruited in Sweden through advertisements, and their suitability for the study assessed in a structured interview. Controls (80) matched for age and gender were randomly selected from a market research panel and given the same interview. Both groups completed a productivity questionnaire, a generic quality-of-life questionnaire with a specific domain for vitality and a utility instrument. The study group with nocturia had a significantly lower level of vitality and utility, and greater impairment of work and activity, than the control group. Women were more affected than men. Symptom severity correlated with all three measures. In an otherwise healthy and professionally active group of individuals, waking at night to void significantly diminishes their overall well-being, vitality and productivity, leading to a significant level of indirect and intangible costs.

Effects of Physical Activity on Cancer Survival: A Systematic Review

PubMed Central

Barbaric, Mary; Brooks, Eleanor; Moore, Lisa

2010-01-01

ABSTRACT Purpose: Physical activity (PA) has been suggested to help increase the survival of individuals with cancer. The objective of this review was to systematically evaluate and summarize the available evidence investigating the effect of PA on the survival of individuals with cancer. Methods: Electronic databases (CINAHL, EMBASE, and MEDLINE) were systematically searched for randomized controlled trials and cohort studies. Selected studies were assessed by two independent investigators for methodological quality, using the PEDro scale. Results: Ten prospective cohort studies met the inclusion criteria. Quality-assessment scores averaged 5/10 on the PEDro scale, with two articles obtaining a score of 6/10. The majority of studies found that individuals participating in higher levels of physical activity had a reduced risk of cancer-related mortality. This trend was observed specifically for breast, colon, and colorectal cancers. On average, it appears that engaging in higher levels of metabolic equivalent hours per week may help to improve survival rates among individuals diagnosed with cancer. Conclusion: Patients diagnosed with cancer demonstrated a trend toward increased survival with greater levels of PA. However, because only prospective cohort studies were included in the study, the conclusions drawn should be regarded with caution. PMID:21197176

Effects of carnosine supplementation on glucose metabolism: Pilot clinical trial.

PubMed

de Courten, Barbora; Jakubova, Michaela; de Courten, Maximilian Pj; Kukurova, Ivica Just; Vallova, Silvia; Krumpolec, Patrik; Valkovic, Ladislav; Kurdiova, Timea; Garzon, Davide; Barbaresi, Silvia; Teede, Helena J; Derave, Wim; Krssak, Martin; Aldini, Giancarlo; Ukropec, Jozef; Ukropcova, Barbara

2016-05-01

Carnosine is a naturally present dipeptide in humans and an over-the counter food additive. Evidence from animal studies supports the role for carnosine in the prevention and treatment of diabetes and cardiovascular disease, yet there is limited human data. This study investigated whether carnosine supplementation in individuals with overweight or obesity improves diabetes and cardiovascular risk factors. In a double-blind randomized pilot trial in nondiabetic individuals with overweight and obesity (age 43 ± 8 years; body mass index 31 ± 4 kg/m(2) ), 15 individuals were randomly assigned to 2 g carnosine daily and 15 individuals to placebo for 12 weeks. Insulin sensitivity and secretion, glucose tolerance (oral glucose tolerance test), blood pressure, plasma lipid profile, skeletal muscle ((1) H-MRS), and urinary carnosine levels were measured. Carnosine concentrations increased in urine after supplementation (P < 0.05). An increase in fasting insulin and insulin resistance was hampered in individuals receiving carnosine compared to placebo, and this remained significant after adjustment for age, sex, and change in body weight (P = 0.02, P = 0.04, respectively). Two-hour glucose and insulin were both lower after carnosine supplementation compared to placebo in individuals with impaired glucose tolerance (P < 0.05). These pilot intervention data suggest that carnosine supplementation may be an effective strategy for prevention of type 2 diabetes. © 2016 The Obesity Society.

A systematic review and meta-analysis: Effectiveness of internet empowerment-based self-management interventions on adults with metabolic diseases.

PubMed

Kuo, Chia-Chi; Su, Yu-Jen; Lin, Chiu-Chu

2018-03-25

To synthesize the effects of Internet empowerment-based self-management interventions on adults with metabolic diseases. Metabolic diseases are prevalent and burden healthcare systems; they have become a major health problem worldwide. The effects of IESMIs on lifestyle changes have been shown to improve adults' physiological and psychological conditions. However, we found no systematic review evaluating these effects. Systematic review and meta-analysis of randomized and non-randomized controlled trials, conducted according to the Cochrane handbook. A literature search was conducted using the Airiti Library, Association for Computing Machinery, CINAHL, Cochrane Library, Embase, ProQuest, PubMed/MEDLINE and Index of the Taiwan Periodical Literature System databases (earliest-June 2016). Two reviewers used the Cochrane Collaboration bias assessment tool to assess the methodological quality of included studies. Extracted data were entered and analysed using RevMan 5.3.5 software. Inverse variance was used to estimate effect sizes. Weighted and standardized mean differences with 95% confidence intervals were calculated using a random effects model. Subgroup and sensitivity analyses were performed. Twenty-one randomized controlled trials were reviewed. Meta-analysis showed that the intervention significantly improved adults' exercise habits, glycated haemoglobin (HbA1c) levels, body weight, empowerment levels and quality of life. The intervention significantly improve the health status of adults with metabolic diseases, in particular their exercise habits, HbA1c levels, body weight, empowerment and quality of life. The intervention provides more convenient and faster access to healthcare for busy individuals with time constraints. These results suggest that healthcare professionals could develop accessible and friendly interactive online interfaces for patients to expand the use of these interventions in the clinical setting. © 2018 John Wiley & Sons Ltd.

Couple-Focused Prevention at the Transition to Parenthood, a Randomized Trial: Effects on Coparenting, Parenting, Family Violence, and Parent and Child Adjustment.

PubMed

Feinberg, Mark E; Jones, Damon E; Hostetler, Michelle L; Roettger, Michael E; Paul, Ian M; Ehrenthal, Deborah B

2016-08-01

The transition to parenthood is a stressful period for most parents as individuals and as couples, with variability in parent mental health and couple relationship functioning linked to children's long-term emotional, mental health, and academic outcomes. Few couple-focused prevention programs targeting this period have been shown to be effective. The purpose of this study was to test the short-term efficacy of a brief, universal, transition-to-parenthood intervention (Family Foundations) and report the results of this randomized trial at 10 months postpartum. This was a randomized controlled trial; 399 couples expecting their first child were randomly assigned to intervention or control conditions after pretest. Intervention couples received a manualized nine-session (five prenatal and four postnatal classes) psychoeducational program delivered in small groups. Intent-to-treat analyses indicated that intervention couples demonstrated better posttest levels than control couples on more than two thirds of measures of coparenting, parent mental health, parenting, child adjustment, and family violence. Program effects on family violence were particularly large. Of eight outcome variables that did not demonstrate main effects, seven showed moderated intervention impact; such that, intervention couples at higher levels of risk during pregnancy showed better outcomes than control couples at similar levels of risk. These findings replicate a prior smaller study of Family Foundations, indicating that the Family Foundations approach to supporting couples making the transition to parenthood can have broad impact for parents, family relationships, and children's adjustment. Program effects are consistent and benefit all families, with particularly notable effects for families at elevated prenatal risk.

Weight gain prevention in the school worksite setting: Results of a multi-level cluster randomized trial

PubMed Central

Lemon, Stephenie C.; Wang, Monica L.; Wedick, Nicole M.; Estabrook, Barbara; Druker, Susan; Schneider, Kristin L.; Li, Wenjun; Pbert, Lori

2014-01-01

Objective To describe the effectiveness, reach and implementation of a weight gain prevention intervention among public school employees. Method A multi-level intervention was tested in a cluster randomized trial among 782 employees in 12 central Massachusetts public high schools from 2009 to 2012. The intervention targeted the nutrition and physical activity environment and policies, the social environment and individual knowledge, attitudes and skills. The intervention was compared to a materials only condition. The primary outcome measures were change in weight and body mass index (BMI) at 24-month follow-up. Implementation of physical environment, policy and social environment strategies at the school and interpersonal levels, and intervention participation at the individual level were assessed. Results At 24-month follow-up, there was a net change (difference of the difference) of −3.03 pounds (p=.04) and of −.48 BMI units (p=.05) between intervention and comparison conditions. The majority of intervention strategies were successfully implemented by all intervention schools, although establishing formal policies was challenging. Employee participation in programs targeting the physical and social environment was maintained over time. Conclusion This study supports that a multi-level intervention integrated within the organizational culture can be successfully implemented and prevent weight gain in public high school employees. PMID:24345602

Effectiveness and sustainability of the ViSC Social Competence Program to prevent cyberbullying and cyber-victimization: Class and individual level moderators.

PubMed

Gradinger, Petra; Yanagida, Takuya; Strohmeier, Dagmar; Spiel, Christiane

2016-01-01

We investigated whether the general anti-bullying program ViSC sustainably prevents cyberbullying and cyber-victimization. A longitudinal randomized control group design was used to examine (i) program effectiveness immediately after a 1 year implementation phase and (ii) sustainable program effects 6 months later taking several moderators on the class level (class climate and ethnic diversity) and on the individual level (gender, age, internet usage, traditional bullying/victimization) into account. Effectiveness (e.g., the change between waves 2 and 1) was examined in 2,042 students (47.6% girls), aged 11.7 years (SD = 0.88) enrolled in 18 schools and 103 classes. Sustainability (e.g., the change between waves 3 and 2) was examined in a sub-sample of 6 schools and 35 classes comprising 659 students. The self-assessment multiple-item scales showed longitudinal and multiple group invariance. Factor scores were extracted to compute difference scores for effectiveness (Posttest minus Pretest) and sustainability (Follow-up test minus Posttest) for cyberbullying and cyber-victimization. Multilevel Modeling was applied to examine (i) the effectiveness and (ii) the sustainability of the ViSC intervention controlling for several individual and class level variables. Controlling for covariates, it was demonstrated that the ViSC program is effective in preventing cyberbullying and cyber-victimization and that the effects are sustainable after 6 months. The consequences for cyberbullying prevention are discussed. © 2016 Wiley Periodicals, Inc.

Education and cognitive change over 15 years: the atherosclerosis risk in communities study.

PubMed

Schneider, Andrea L C; Sharrett, A Richey; Patel, Mehul D; Alonso, Alvaro; Coresh, Josef; Mosley, Thomas; Selnes, Ola; Selvin, Elizabeth; Gottesman, Rebecca F

2012-10-01

To evaluate whether education level is associated with change in cognitive performance. Prospective cohort study. The Atherosclerosis Risk in Communities (ARIC) Study, a community-based cohort. Nine thousand two hundred sixty-eight ARIC participants who underwent cognitive evaluation at least twice over a 15-year period. Education was evaluated as a predictor of change in word recall, the Digit Symbol Substitution Test (DSST), and word fluency. A random-effects linear regression model, and a time by educational level interaction was used. Educational level was highly associated with cognitive performance. The effect on performance of a less than high school education (vs more than high school) was equivalent to the effect of as much as 22 years of cognitive aging, but educational level was not associated with change in cognitive performance in whites or blacks, with the exception of the DSST for whites, in whom those with lower levels of education had less decline in scores. Educational level was not associated with change in cognitive performance, although the higher baseline cognitive performance of individuals with more education might explain lower rates of dementia in more-educated individuals, because more decline would have to take place between baseline higher performance and time at which dementia was diagnosed in more-educated individuals. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

Irisin in response to exercise in humans with and without metabolic syndrome.

PubMed

Huh, Joo Young; Siopi, Aikaterina; Mougios, Vassilis; Park, Kyung Hee; Mantzoros, Christos S

2015-03-01

Irisin is a recently identified exercise-induced myokine. However, the circulating levels of irisin in response to different types of exercise in subjects with metabolic syndrome are unknown. This study aimed to study the levels of irisin in healthy males and subjects with metabolic syndrome at baseline and in response to exercise. Each individual completed high-intensity interval exercise (HIIE), continuous moderate-intensity exercise (CME), and resistance exercise (RE) sessions in a random, crossover design. Percentage change in circulating irisin levels was examined. Two different irisin assays were used to compare the results of the RE study. Circulating irisin increased immediately after HIIE, CME, and RE and declined 1 hour later. The increase was greater in response to resistance compared with either high-intensity intermittent exercise or CME. Change in irisin in response to exercise did not differ between individuals with and without metabolic syndrome. Exercise is able to increase circulating irisin levels in individuals with the metabolic syndrome as well as healthy individuals. Whether this increase may contribute to the beneficial effects of exercise on patients with the metabolic syndrome remains to be studied further.

On "feeling right" in cultural contexts: how person-culture match affects self-esteem and subjective well-being.

PubMed

Fulmer, C Ashley; Gelfand, Michele J; Kruglanski, Arie W; Kim-Prieto, Chu; Diener, Ed; Pierro, Antonio; Higgins, E Tory

2010-11-01

Whether one is in one's native culture or abroad, one's personality can differ markedly from the personalities of the majority, thus failing to match the "cultural norm." Our studies examined how the interaction of individual- and cultural-level personality affects people's self-esteem and well-being. We propose a person-culture match hypothesis that predicts that when a person's personality matches the prevalent personalities of other people in a culture, culture functions as an important amplifier of the positive effect of personality on self-esteem and subjective well-being at the individual level. Across two studies, using data from more than 7,000 individuals from 28 societies, multilevel random-coefficient analyses showed that when a relation between a given personality trait and well-being or self-esteem exists at the individual level, the relation is stronger in cultures characterized by high levels of that personality dimension. Results were replicated across extraversion, promotion focus, and locomotive regulatory mode. Our research has practical implications for the well-being of both cultural natives and migrants.

Public authority control strategy for opinion evolution in social networks

NASA Astrophysics Data System (ADS)

Chen, Xi; Xiong, Xi; Zhang, Minghong; Li, Wei

2016-08-01

This paper addresses the need to deal with and control public opinion and rumors. Existing strategies to control public opinion include degree, random, and adaptive bridge control strategies. In this paper, we use the HK model to present a public opinion control strategy based on public authority (PA). This means utilizing the influence of expert or high authority individuals whose opinions we control to obtain the optimum effect in the shortest time possible and thus reach a consensus of public opinion. Public authority (PA) is only influenced by individuals' attributes (age, economic status, and education level) and not their degree distribution; hence, in this paper, we assume that PA complies with two types of public authority distribution (normal and power-law). According to the proposed control strategy, our experiment is based on random, degree, and public authority control strategies in three different social networks (small-world, scale-free, and random) and we compare and analyze the strategies in terms of convergence time (T), final number of controlled agents (C), and comprehensive efficiency (E). We find that different network topologies and the distribution of the PA in the network can influence the final controlling effect. While the effect of PA strategy differs in different network topology structures, all structures achieve comprehensive efficiency with any kind of public authority distribution in any network. Our findings are consistent with several current sociological phenomena and show that in the process of public opinion/rumor control, considerable attention should be paid to high authority individuals.

Public authority control strategy for opinion evolution in social networks.

PubMed

Chen, Xi; Xiong, Xi; Zhang, Minghong; Li, Wei

2016-08-01

This paper addresses the need to deal with and control public opinion and rumors. Existing strategies to control public opinion include degree, random, and adaptive bridge control strategies. In this paper, we use the HK model to present a public opinion control strategy based on public authority (PA). This means utilizing the influence of expert or high authority individuals whose opinions we control to obtain the optimum effect in the shortest time possible and thus reach a consensus of public opinion. Public authority (PA) is only influenced by individuals' attributes (age, economic status, and education level) and not their degree distribution; hence, in this paper, we assume that PA complies with two types of public authority distribution (normal and power-law). According to the proposed control strategy, our experiment is based on random, degree, and public authority control strategies in three different social networks (small-world, scale-free, and random) and we compare and analyze the strategies in terms of convergence time (T), final number of controlled agents (C), and comprehensive efficiency (E). We find that different network topologies and the distribution of the PA in the network can influence the final controlling effect. While the effect of PA strategy differs in different network topology structures, all structures achieve comprehensive efficiency with any kind of public authority distribution in any network. Our findings are consistent with several current sociological phenomena and show that in the process of public opinion/rumor control, considerable attention should be paid to high authority individuals.

Estimating peer effects in networks with peer encouragement designs

PubMed Central

Eckles, Dean; Kizilcec, René F.; Bakshy, Eytan

2016-01-01

Peer effects, in which the behavior of an individual is affected by the behavior of their peers, are central to social science. Because peer effects are often confounded with homophily and common external causes, recent work has used randomized experiments to estimate effects of specific peer behaviors. These experiments have often relied on the experimenter being able to randomly modulate mechanisms by which peer behavior is transmitted to a focal individual. We describe experimental designs that instead randomly assign individuals’ peers to encouragements to behaviors that directly affect those individuals. We illustrate this method with a large peer encouragement design on Facebook for estimating the effects of receiving feedback from peers on posts shared by focal individuals. We find evidence for substantial effects of receiving marginal feedback on multiple behaviors, including giving feedback to others and continued posting. These findings provide experimental evidence for the role of behaviors directed at specific individuals in the adoption and continued use of communication technologies. In comparison, observational estimates differ substantially, both underestimating and overestimating effects, suggesting that researchers and policy makers should be cautious in relying on them. PMID:27382145

Universality properties of school-based preventive intervention targeted at cannabis use.

PubMed

Miovský, Michal; Voňková, Hana; Gabrhelík, Roman; Šťastná, Lenka

2015-02-01

This study aims to examine the effect of school-based preventive intervention on cannabis use in Czech adolescents with different levels of risk factors and provide evidence of its universality. A randomized controlled prevention trial with six waves was conducted over a period of 33 months. We used a two-level logistic random-intercept model for panel data; we first looked at the statistical significance of the effect of the intervention on cannabis use, controlling for the characteristics of the children and time dummies. Then we analyzed the effects of the interactions between the intervention and the characteristics of the children on cannabis use and related it to the definition of universal preventive interventions. The setting for the study was in basic schools in the Czech Republic in the years 2007-2010. A total of 1,874 sixth-graders (mean age 11.82 years) who completed the baseline testing. According to our results, the prevention intervention was effective. We found all the selected characteristics of the children to be relevant in relation to cannabis use, except their relationships with their friends. We showed empirically that the intervention is universal in two dimensions for the selected characteristics of the children. First, all adolescents who undergo the intervention are expected to benefit. Second, with respect to the effect of the intervention on cannabis use, the total level of individual risk of cannabis use is superior to the composition of the risk factors in the individual risk profile. We present indicative evidence that the drug prevention intervention may be considered a true universal preventive intervention.

Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials.

PubMed

Wijeysundera, Duminda N; Austin, Peter C; Hux, Janet E; Beattie, W Scott; Laupacis, Andreas

2009-01-01

Randomized trials generally use "frequentist" statistics based on P-values and 95% confidence intervals. Frequentist methods have limitations that might be overcome, in part, by Bayesian inference. To illustrate these advantages, we re-analyzed randomized trials published in four general medical journals during 2004. We used Medline to identify randomized superiority trials with two parallel arms, individual-level randomization and dichotomous or time-to-event primary outcomes. Studies with P<0.05 in favor of the intervention were deemed "positive"; otherwise, they were "negative." We used several prior distributions and exact conjugate analyses to calculate Bayesian posterior probabilities for clinically relevant effects. Of 88 included studies, 39 were positive using a frequentist analysis. Although the Bayesian posterior probabilities of any benefit (relative risk or hazard ratio<1) were high in positive studies, these probabilities were lower and variable for larger benefits. The positive studies had only moderate probabilities for exceeding the effects that were assumed for calculating the sample size. By comparison, there were moderate probabilities of any benefit in negative studies. Bayesian and frequentist analyses complement each other when interpreting the results of randomized trials. Future reports of randomized trials should include both.

A Bayesian random effects discrete-choice model for resource selection: Population-level selection inference

USGS Publications Warehouse

Thomas, D.L.; Johnson, D.; Griffith, B.

2006-01-01

Modeling the probability of use of land units characterized by discrete and continuous measures, we present a Bayesian random-effects model to assess resource selection. This model provides simultaneous estimation of both individual- and population-level selection. Deviance information criterion (DIC), a Bayesian alternative to AIC that is sample-size specific, is used for model selection. Aerial radiolocation data from 76 adult female caribou (Rangifer tarandus) and calf pairs during 1 year on an Arctic coastal plain calving ground were used to illustrate models and assess population-level selection of landscape attributes, as well as individual heterogeneity of selection. Landscape attributes included elevation, NDVI (a measure of forage greenness), and land cover-type classification. Results from the first of a 2-stage model-selection procedure indicated that there is substantial heterogeneity among cow-calf pairs with respect to selection of the landscape attributes. In the second stage, selection of models with heterogeneity included indicated that at the population-level, NDVI and land cover class were significant attributes for selection of different landscapes by pairs on the calving ground. Population-level selection coefficients indicate that the pairs generally select landscapes with higher levels of NDVI, but the relationship is quadratic. The highest rate of selection occurs at values of NDVI less than the maximum observed. Results for land cover-class selections coefficients indicate that wet sedge, moist sedge, herbaceous tussock tundra, and shrub tussock tundra are selected at approximately the same rate, while alpine and sparsely vegetated landscapes are selected at a lower rate. Furthermore, the variability in selection by individual caribou for moist sedge and sparsely vegetated landscapes is large relative to the variability in selection of other land cover types. The example analysis illustrates that, while sometimes computationally intense, a Bayesian hierarchical discrete-choice model for resource selection can provide managers with 2 components of population-level inference: average population selection and variability of selection. Both components are necessary to make sound management decisions based on animal selection.

Group medical consultations (GMCs) and tablet-based online support group sessions in the follow-up of breast cancer: A multicenter randomized controlled trial.

PubMed

Visser, Annemiek; Prins, Judith B; Jansen, Lisette; Radema, Sandra A; Schlooz, Margrethe S; van Dalen, Thijs; van Laarhoven, Hanneke W M

2018-06-12

Group medical consultations (GMCs) provide individual medical visits in the presence of ≤7 peer-patients. In the follow-up of breast cancer, we evaluated the efficacy of a new type of blended care My-GMC, a GMC combined with a tablet-based online app, consisting of three online support group sessions (SGS) and additional information. This randomized controlled trial compared the effect of My-GMC (n = 59) with one individual medical visit (n = 50) (care as usual). Between-group differences on the outcomes distress and empowerment were analyzed 1 week, 3 and 6 months after the visit. No between-group differences were found for the primary outcomes distress and empowerment. More themes were discussed in GMCs compared to individual visits. Significantly more patients experienced peer-support in GMCs (78%) than via the online app (29%). Satisfaction with the online app was low. My-GMC did not result in improvements in distress or empowerment, which might partly be explained by low baseline distress levels. This paper provides valuable information concerning factors on organizational level as well as individual level influencing the evaluation of a blended care intervention. My-GMC provided an innovative alternative, combining professional and peer-support in face-to-face and online SGS, resulting in additional information provision and peer-support. Further improvement of the apps is needed to improve user satisfaction. NTR3771. Copyright © 2018 Elsevier Ltd. All rights reserved.

Statistical methods for efficient design of community surveys of response to noise: Random coefficients regression models

NASA Technical Reports Server (NTRS)

Tomberlin, T. J.

1985-01-01

Research studies of residents' responses to noise consist of interviews with samples of individuals who are drawn from a number of different compact study areas. The statistical techniques developed provide a basis for those sample design decisions. These techniques are suitable for a wide range of sample survey applications. A sample may consist of a random sample of residents selected from a sample of compact study areas, or in a more complex design, of a sample of residents selected from a sample of larger areas (e.g., cities). The techniques may be applied to estimates of the effects on annoyance of noise level, numbers of noise events, the time-of-day of the events, ambient noise levels, or other factors. Methods are provided for determining, in advance, how accurately these effects can be estimated for different sample sizes and study designs. Using a simple cost function, they also provide for optimum allocation of the sample across the stages of the design for estimating these effects. These techniques are developed via a regression model in which the regression coefficients are assumed to be random, with components of variance associated with the various stages of a multi-stage sample design.

Effect of risk ladder format on risk perception in high- and low-numerate individuals.

PubMed

Keller, Carmen; Siegrist, Michael; Visschers, Vivianne

2009-09-01

Utilizing a random sample from the general population (N= 257), we examined the effect of the radon risk ladder on risk perception, as qualified by respondents' numeracy. The radon risk ladder provides comparative risk information about the radon equivalent of smoking risk. We compared a risk ladder providing smoking risk information with a risk ladder not providing this information. A 2 (numeracy; high, low) x 3 (risk level; high, medium, low) x 2 (smoking risk comparison: with/without) between subjects experimental design was used. A significant (p < 0.045) three-way interaction between format, risk level, and numeracy was identified. Participants with low numeracy skills, as well as participants with high numeracy skills, generally distinguished between low, medium, and high risk levels when the risk ladder with comparative smoking risk information was presented. When the risk ladder without the comparative information about the smoking risk was presented, low-numerate individuals differentiated between risk levels to a much lesser extent than high-numerate individuals did. These results provide empirical evidence that the risk ladder can be a useful tool in enabling people to interpret various risk levels. Additionally, these results allow us to conclude that providing comparative information within a risk ladder is particularly helpful to the understanding of different risk levels by people with low numeracy skills.

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

PubMed

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

2017-11-01

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

A Randomized Controlled Trial of a Long-Term Professional Mentoring Program for Children at Risk: Outcomes Across the First 5 Years.

PubMed

Eddy, J Mark; Martinez, Charles R; Grossman, Jean Baldwin; Cearley, Jennifer J; Herrera, Danita; Wheeler, Alice C; Rempel, Jeff S; Foney, Dana; Gau, Jeff M; Burraston, Bert O; Harachi, Tracy W; Haggerty, Kevin P; Seeley, John R

2017-11-01

Child outcomes due to a paid professional mentoring program, Friends of the Children (FOTC), were investigated across the first 5 years of an ongoing multi-site randomized controlled trial. Participants were 278 children attending kindergarten or first grade who were identified as "at risk" for adjustment problems during adolescence. The program was delivered through established nonprofit community-based organizations. Mentors were hired to work full time and were provided training, supervision, and support to work individually with small numbers of children. Recruitment took place across a 3-year period. Random assignment to the intervention condition or a services as usual control condition was conducted at the level of the individual, blocking on school and child sex. After the initial assessment, follow-up assessments were conducted every 6 months. Differences in growth curves across the elementary school years were examined in intent-to-treat analyses. Significant effects favoring FOTC were found in terms of caregiver ratings of positive school behavior and less trouble in school, with a trend for higher child behavioral and emotional strengths. Effect sizes were in the range typical in recent trials of youth mentoring.

A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis.

PubMed

Kiropoulos, Litza A; Kilpatrick, Trevor; Holmes, Alex; Threader, Jennifer

2016-12-07

To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis. The current study presents a pilot, parallel group randomized controlled trial (RCT) with an allocation ratio of 1:1 conducted in a large research and teaching hospital in Melbourne, Australia. 30 individuals with a mean age of 36.93 years (SD = 9.63) who were newly diagnosed with multiple sclerosis (MS) (X = 24.87 months, SD = 15.61) were randomized to the CBT intervention (n = 15) or treatment as usual (TAU) (n = 15). The primary outcome was level of depressive symptoms using the Beck Depression Inventory-II (BDI-II). Secondary outcomes were level of anxiety, fatigue and pain impact, sleep quality, coping, acceptance of MS illness, MS related quality of life, social support, and resilience. Tertiary outcomes were acceptability and adherence to the intervention. Large between group treatment effects were found for level of depressive symptoms at post and at 20 weeks follow-up (d = 1.66-1.34). There were also small to large group treatment effects for level of anxiety, fatigue and pain impact, sleep quality, MS related quality of life, resilience, and social support at post and at 20 weeks follow-up (d = 0.17-1.63). There were no drop-outs and participants completed all treatment modules. All participants reported the treatment as 'very useful', and most (73.4%) reported that the intervention had addressed their problems 'completely'. These data suggest that the tailored early intervention is appropriate and clinically effective for the treatment of depressive symptoms in those newly diagnosed with MS. A larger RCT comparing the CBT intervention with an active comparative treatment with longer term follow-up and cost effectiveness analyses is warranted. The pilot trial has been retrospectively registered on 28/04/2016 with the ISRCTN registry (trial ID ISRCTN10423371).

A Meta-Analysis of Smoking Cessation Interventions With Individuals in Substance Abuse Treatment or Recovery

ERIC Educational Resources Information Center

Prochaska, Judith J.; Delucchi, Kevin; Hall, Sharon M.

2004-01-01

This meta-analysis examined outcomes of smoking cessation interventions evaluated in 19 randomized controlled trials with individuals in current addictions treatment or recovery. Smoking and substance use outcomes at posttreatment and long-term follow-up (? 6 months) were summarized with random effects models. Intervention effects for smoking…

Prenatal vitamin D supplementation reduces risk of asthma/recurrent wheeze in early childhood: A combined analysis of two randomized controlled trials

PubMed Central

Wolsk, Helene M.; Chawes, Bo L.; Litonjua, Augusto A.; Hollis, Bruce W.; Waage, Johannes; Stokholm, Jakob; Bønnelykke, Klaus; Bisgaard, Hans

2017-01-01

Background We recently published two independent randomized controlled trials of vitamin D supplementation during pregnancy, both indicating a >20% reduced risk of asthma/recurrent wheeze in the offspring by 3 years of age. However, neither reached statistical significance. Objective To perform a combined analysis of the two trials and investigate whether maternal 25-hydroxy-vitamin D (25(OH)D) level at trial entry modified the intervention effect. Methods VDAART (N = 806) and COPSAC2010. (N = 581) randomized pregnant women to daily high-dose vitamin D3 (4,000 IU/d and 2,400 IU/d, respectively) or placebo. All women also received a prenatal vitamin containing 400 IU/d vitamin D3. The primary outcome was asthma/recurrent wheeze from 0-3yrs. Secondary end-points were specific IgE, total IgE, eczema and lower respiratory tract infections (LRTI). We conducted random effects combined analyses of the treatment effect, individual patient data (IPD) meta-analyses, and analyses stratified by 25(OH)D level at study entry. Results The analysis showed a 25% reduced risk of asthma/recurrent wheeze at 0-3yrs: adjusted odds ratio (aOR) = 0.74 (95% CI, 0.57–0.96), p = 0.02. The effect was strongest among women with 25(OH)D level ≥30ng/ml at study entry: aOR = 0.54 (0.33–0.88), p = 0.01, whereas no significant effect was observed among women with 25(OH)D level <30ng/ml at study entry: aOR = 0.84 (0.62–1.15), p = 0.25. The IPD meta-analyses showed similar results. There was no effect on the secondary end-points. Conclusions This combined analysis shows that vitamin D supplementation during pregnancy results in a significant reduced risk of asthma/recurrent wheeze in the offspring, especially among women with 25(OH)D level ≥ 30 ng/ml at randomization, where the risk was almost halved. Future studies should examine the possibility of raising 25(OH)D levels to at least 30 ng/ml early in pregnancy or using higher doses than used in our studies. Trial registration COPSAC2010: ClinicalTrials.gov NCT00856947; VDAART: ClinicalTrials.gov NCT00920621 PMID:29077711

Reputation-based partner choice promotes cooperation in social networks

NASA Astrophysics Data System (ADS)

Fu, Feng; Hauert, Christoph; Nowak, Martin A.; Wang, Long

2008-08-01

We investigate the cooperation dynamics attributed to the interplay between the evolution of individual strategies and evolution of individual partnerships. We focus on the effect of reputation on an individual’s partner-switching process. We assume that individuals can either change their strategies by imitating their partners or adjust their partnerships based on local information about reputations. We manipulate the partner switching in two ways; that is, individuals can switch from the lowest reputation partners, either to their partners’ partners who have the highest reputation (i.e., ordering in partnership) or to others randomly chosen from the entire population (i.e., randomness in partnership). We show that when individuals are able to alter their behavioral strategies and their social interaction partnerships on the basis of reputation, cooperation can prevail. We find that the larger temptation to defect and the denser the partner network, the more frequently individuals need to shift their partnerships in order for cooperation to thrive. Furthermore, an increasing tendency of switching to partners’ partners is more likely to lead to a higher level of cooperation. We show that when reputation is absent in such partner-switching processes, cooperation is much less favored than that of the reputation involved. Moreover, we investigate the effect of discounting an individual’s reputation on the evolution of cooperation. Our results highlight the importance of the consideration of reputation (indirect reciprocity) on the promotion of cooperation when individuals can adjust their partnerships.

Effect of Uric Acid-Lowering Agents on Endothelial Function: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Borgi, Lea; McMullan, Ciaran; Wohlhueter, Ann; Curhan, Gary C; Fisher, Naomi D; Forman, John P

2017-02-01

Higher levels of serum uric acid are independently associated with endothelial dysfunction, a mechanism for incident hypertension. Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts. However, the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly. In this randomized, double-blind, placebo-controlled trial of nonhypertensive, overweight, or obese individuals with higher serum uric acid (body mass index ≥25 kg/m 2 and serum uric acid ≥5.0 mg/dL), we assigned subjects to probenecid (500-1000 mg/d), allopurinol (300-600 mg/d), or matching placebo. The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks. By the end of the trial, 47, 49, and 53 participants had been allocated to receive probenecid, allopurinol, and placebo, respectively. Mean serum uric acid levels significantly decreased in the probenecid (from 6.1 to 3.5 mg/dL) and allopurinol groups (from 6.1 to 2.9 mg/dL) but not in the placebo group (6.1 to 5.6 mg/dL). None of the interventions produced any significant change in endothelium-dependent vasodilation (probenecid, 7.4±5.1% at baseline and 8.3±5.1% at 8 weeks; allopurinol, 7.6±6.0% at baseline and 6.2±4.8% at 8 weeks; and placebo, 6.5±3.8% at baseline and 7.1±4.9% at 8 weeks). In this randomized, double-blind, placebo-controlled trial, uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals. These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction, a potential mechanism for development of hypertension. © 2016 American Heart Association, Inc.

Effect of diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease: A randomized controlled trial

PubMed Central

Piovesan, Fabiana; Tres, Glaucia S.; Moreira, Leila B.; Andrades, Michael E.; Lisboa, Hugo K.

2017-01-01

Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30–80 years, with glycated hemoglobin levels from 53–97 mmol/mol (7.0–11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. Trial registration: Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255 PMID:29049415

Effect of diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease: A randomized controlled trial.

PubMed

Piovesan, Fabiana; Tres, Glaucia S; Moreira, Leila B; Andrades, Michael E; Lisboa, Hugo K; Fuchs, Sandra C

2017-01-01

Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255.

External supports improve knee performance in anterior cruciate ligament reconstructed individuals with higher kinesiophobia levels.

PubMed

Harput, Gulcan; Ulusoy, Burak; Ozer, Hamza; Baltaci, Gul; Richards, Jim

2016-10-01

The objectives of this study were to investigate the effects of knee brace (KB) and kinesiotaping (KT) on functional performance and self-reported function in individuals six months post-ACLR who desired to return to their pre-injury activity levels but felt unable to do so due to kinesiophobia. This was a cross-sectional study involving 30 individuals six months post-ACLR with Tampa Kinesiophobia Scores >37. Individuals were tested under three conditions: no intervention, KB and KT in a randomized order. Isokinetic concentric quadriceps and hamstring strength tests, one leg hop test, star excursion balance test and global rating scale were assessed under the three conditions. The involved side showed that KT and KB significantly increased the hop distance (P=0.01, P=0.04) and improved balance (P=0.01, P=0.04), respectively, but only KB was found to increase the quadriceps and hamstring peak torques compared to no intervention (P<0.05). Individuals reported having better knee function with KB when compared to no intervention (P<0.001) and KT (P=0.03). Both KB and KT have positive effects in individuals post-ACLR which may assist in reducing kinesiophobia when returning to their pre-injury activity levels, with the KB appearing to offer the participants better knee function compared to KT. Copyright © 2016 Elsevier B.V. All rights reserved.

Efficacy of a multilevel intervention on the mental health of people living with HIV and their family members in rural China.

PubMed

Li, Li; Ji, Guoping; Liang, Li-Jung; Lin, Chunqing; Hsieh, Julie; Lan, Chiao-Wen; Xiao, Yongkang

2017-09-01

HIV has a profound impact on infected individuals and their families. This study evaluated the efficacy of an intervention aimed at improving the mental health of people living with HIV (PLH) and their family members. A randomized controlled trial of 475 PLH and 522 family members was conducted in Anhui, China. The intervention comprised activities at individual, family, and community levels. The study outcomes, which included depressive symptoms and coping with illness for the PLH and depressive symptoms and caregiver burden for the family members, were assessed at baseline and at 6-, 12-, 18-, and 24-month follow-up. We used a mixed-effects regression model with village- and participant-level random effects to assess the intervention effect on the improvement of outcome measures. Relative to the control condition, the PLH and family members of the intervention group reported a significant reduction in depressive symptoms. The largest difference in depressive symptoms was observed at 6 months for the PLH and at 12 months for family members. Decreases in perceived caregiver burden over time were observed for family members in both conditions; however, the group difference did not reach statistical significance. Significant intervention effect on the coping with illness was reported by the PLH. The study highlights the importance of empowering families affected by HIV to confront the challenges together rather than individually. It may be optimal for future programs to include both PLH and their family members to maximize intervention effects through strengthening interactions and support within a family. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

High deductible health plans: does cost sharing stimulate increased consumer sophistication?

PubMed

Gupta, Neal; Polsky, Daniel

2015-06-01

To determine whether increased cost sharing in health insurance plans induces higher levels of consumer sophistication in a non-elderly population. This analysis is based on the collection of survey and demographic data collected from enrollees in the RAND health insurance experiment (HIE). During the RAND HIE, enrollees were randomly assigned to different levels of cost sharing (0, 25, 50 and 95%). The study population compromises about 2000 people enrolled in the RAND HIE, between the years 1974 and 1982. Effects on health-care decision making were measured using the results of a standardized questionnaire, administered at the beginning and end of the experiment. Points of enquiry included whether or not enrollees' (i) recognized the need for second opinions (ii) questioned the effectiveness of certain therapies and (iii) researched the background/skill of their medical providers. Consumer sophistication was also measured for regular health-care consumers, as indicated by the presence of a chronic disease. We found no statically significant changes (P < 0.05) in the health-care decision-making strategies between individuals randomized to high cost sharing plans and low cost sharing plans. Furthermore, we did not find a stronger effect for patients with a chronic disease. The evidence from the RAND HIE does not support the hypothesis that a higher level of cost sharing incentivizes the development of consumer sophistication. As a result, cost sharing alone will not promote individuals to become more selective in their health-care decision-making. © 2012 Blackwell Publishing Ltd.

Trends in health complaints from 2002 to 2010 in 34 countries and their association with health behaviours and social context factors at individual and macro-level.

PubMed

Ottová-Jordan, Veronika; Smith, Otto R F; Augustine, Lilly; Gobina, Inese; Rathmann, Katharina; Torsheim, Torbjørn; Mazur, Joanna; Välimaa, Raili; Cavallo, Franco; Jericek Klanscek, Helena; Vollebergh, Wilma; Meilstrup, Charlotte; Richter, Matthias; Moor, Irene; Ravens-Sieberer, Ulrike

2015-04-01

This article describes trends and stability over time in health complaints in adolescents from 2002 to 2010 and investigates associations between health complaints, behavioural and social contextual factors at individual level and economic factors at macro-level. Comprising N = 510 876 11-, 13- and 15-year-old children and adolescents in Europe, North America and Israel, data came from three survey cycles of the international Health Behaviour in School-aged Children (HBSC) study. Age- and gender-adjusted trends in health complaints were examined in each country by means of linear regression. By using the country as the random effects variable, we tested to what extent individual and contextual variables were associated with health complaints. Significant associations are stronger for individual level determinants (e.g. being bullied, smoking) than for determinants at macro-level (e.g. GDP, Gini), as can be seen by the small effect sizes (less than 5% for different trends). Health complaints are fairly stable over time in most countries, and no clear international trend in health complaints can be observed between 2002 and 2010. The most prominent stable determinants were being female, being bullied, school pressure and smoking. Factors associated with health complaints are more related to the proximal environment than to distal macro-level factors. This points towards intensifying targeted interventions, (e.g. for bullying) and also targeting specific risk groups. The comparably small effect size at country-level indicates that country-level factors have an impact on health and should not be ignored. © The Author 2015. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment.

PubMed

Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O; Morin, Stephen F; Neilands, Torsten B; Remien, Robert H; Rotheram-Borus, Mary Jane; Lennie Wong, F

2009-06-01

Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.

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

PubMed

Howie, Amanda J; Malouff, John M

2014-01-01

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

Inter-individual differences in trait negative affect moderate cortisol's effects on memory formation: preliminary findings from two studies.

PubMed

Abercrombie, Heather C; Wirth, Michelle M; Hoks, Roxanne M

2012-05-01

Acute emotional arousal moderates the effects of cortisol on memory. However, it is currently unknown how stable inter-individual differences (i.e., traits) moderate cortisol's effects on memory. In two studies using within-subjects designs - 31 healthy males in Study 1 and 42 healthy subjects (22 female) in Study 2 - we measured trait negative affect (NA) and presented emotional and neutral pictures. In Study 1, we manipulated endogenous cortisol levels using a speech stressor following encoding. In Study 2, using a randomized placebo-controlled design, we pharmacologically manipulated cortisol levels prior to encoding (0.1mg/kg hydrocortisone vs. saline infused over 30min). Free recall for pictures was subsequently assessed. Trait NA repeatedly moderated the relationship between cortisol and memory formation. Findings suggested the speculative conclusion that the direction of effects may vary by sex. In males, cortisol was related to memory facilitation in subjects with lower Trait NA. Conversely, females with higher Trait NA showed greater cortisol-related increases in memory. Trait NA may be a stable inter-individual difference predicting neurocognitive effects of cortisol during stressors. Copyright © 2011 Elsevier Ltd. All rights reserved.

THE EFFECTS OF SONIC ENVIRONMENT OF INDIVIDUALIZED INSTRUCTION IN LEARNING DIFFICULT AND EASY TASKS BY HIGH ACHIEVERS.

ERIC Educational Resources Information Center

MCCARTHY, EDWARD H.

THE SIXTH-GRADE STUDENTS OBTAINING THE 80 HIGHEST MEAN SCORES ON THE METROPOLITAN ACHIEVEMENT TEST FORM D WERE RANDOMLY ASSIGNED TO GROUPS OF EASY OR DIFFICULT TASKS WITHIN EACH OF FIVE DECIBEL LEVEL GROUPS. THE LEARNING TASKS WERE TAKEN FROM THE MEANINGFULNESS OF ALL POSSIBLE CVC TRIGRAMS (ARCHER, 1960). THE APPARATUS INCLUDED A TAPE RECORDING OF…

The Educational Electronic Book as a Tool for Supporting Children's Emergent Literacy in Low versus Middle SES Groups

ERIC Educational Resources Information Center

Korat, O.; Shamir, A.

2008-01-01

The effects of an educational electronic book (e-book) on 149 five- to six-year-old kindergarteners' emergent literacy levels were researched in two SES groups: low (LSES) (79 children) vs. middle (MSES) (70 children). In each SES group, children were randomly assigned to four groups. Three groups were assigned to work individually in one of three…

Do conscientious individuals live longer? A quantitative review.

PubMed

Kern, Margaret L; Friedman, Howard S

2008-09-01

Following up on growing evidence that higher levels of conscientiousness are associated with greater health protection, the authors conducted a meta-analysis of the association between conscientiousness-related traits and longevity. Using a random-effects analysis model, the authors statistically combined 20 independent samples. In addition, the authors used fixed-effects analyses to examine specific facets of conscientiousness and study characteristics as potential moderators of this relationship. Effect sizes were computed for each individual sample as the correlation coefficient r, based on the relationship between conscientiousness and mortality risk (all-cause mortality risk, longevity, or length of survival). Higher levels of conscientiousness were significantly and positively related to longevity (r = .11, 95% confidence interval = .05-.17). Associations were strongest for the achievement (persistent, industrious) and order (organized, disciplined) facets of conscientiousness. Results strongly support the importance of conscientiousness-related traits to health across the life span. Future research and interventions should consider how individual differences in conscientiousness may cause and be shaped by health-relevant biopsychosocial events across many years. PsycINFO Database Record (c) 2008 APA, all rights reserved.

Nature of alpha and beta particles in glycogen using molecular size distributions.

PubMed

Sullivan, Mitchell A; Vilaplana, Francisco; Cave, Richard A; Stapleton, David; Gray-Weale, Angus A; Gilbert, Robert G

2010-04-12

Glycogen is a randomly hyperbranched glucose polymer. Complex branched polymers have two structural levels: individual branches and the way these branches are linked. Liver glycogen has a third level: supramolecular clusters of beta particles which form larger clusters of alpha particles. Size distributions of native glycogen were characterized using size exclusion chromatography (SEC) to find the number and weight distributions and the size dependences of the number- and weight-average masses. These were fitted to two distinct randomly joined reference structures, constructed by random attachment of individual branches and as random aggregates of beta particles. The z-average size of the alpha particles in dimethylsulfoxide does not change significantly with high concentrations of LiBr, a solvent system that would disrupt hydrogen bonding. These data reveal that the beta particles are covalently bonded to form alpha particles through a hitherto unsuspected enzyme process, operative in the liver on particles above a certain size range.

Childhood trauma, psychosis liability and social stress reactivity: a virtual reality study.

PubMed

Veling, W; Counotte, J; Pot-Kolder, R; van Os, J; van der Gaag, M

2016-12-01

Childhood trauma is associated with higher risk for mental disorders, including psychosis. Heightened sensitivity to social stress may be a mechanism. This virtual reality study tested the effect of childhood trauma on level of paranoid ideations and distress in response to social stress, in interaction with psychosis liability and level of social stress exposure. Seventy-five individuals with higher psychosis liability (55 with recent onset psychotic disorder and 20 at ultra-high risk for psychosis) and 95 individuals with lower psychosis liability (42 siblings and 53 controls) were exposed to a virtual café in five experiments with 0-3 social stressors (crowded, other ethnicity and hostility). Paranoid ideation was measured after each experiment. Subjective distress was self-rated before and after experiments. Multilevel random regression analyses were used to test main effects of childhood trauma and interaction effects. Childhood trauma was more prevalent in individuals with higher psychosis liability, and was associated with higher level of (subclinical) psychotic and affective symptoms. Individuals with a history of childhood trauma responded with more subjective distress to virtual social stress exposures. The effects of childhood trauma on paranoia and subjective distress were significantly stronger when the number of virtual environmental stressors increased. Higher psychosis liability increased the effect of childhood trauma on peak subjective distress and stress reactivity during experiments. Childhood trauma is associated with heightened social stress sensitivity and may contribute to psychotic and affective dysregulation later in life, through a sensitized paranoid and stress response to social stressors.

The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial.

PubMed

Fernandes, Walkyria Vilas Boas; Blanco, Cleofás Rodríguez; Politti, Fabiano; de Cordoba Lanza, Fernanda; Lucareli, Paulo Roberto Garcia; Corrêa, João Carlos Ferrari

2018-03-02

The aim of the proposed study is to analyze the effect of a six-week osteopathic visceral manipulation (OVM) program on the flexion-relaxation phenomenon in individuals with non-specific chronic low back pain (LBP) and functional constipation. An assessor-blinded, two-arm, randomized, placebo-controlled trial will be conducted. The sample will comprise 76 individuals with non-specific chronic LBP who have functional intestinal constipation, aged 18-65 years. The participants will be randomly allocated to two groups: (1) OVM and (2) sham OVM (SOVM). Evaluations will involve an interview, the Oswestry Disability Index, Fear-Avoidance Beliefs Questionnaire, functional constipation according to Rome III criteria, Biering-Sorensen test to normalize electromyographic (EMG) data, T12-L1 paraspinal level of the EMG signal during the flexion-relaxation phenomenon, 11-point numeric pain rating scale and fingertip-to-floor test. OVM and SOVM will be performed once per week for six weeks. Group 1 will receive OVM for 15 min and Group 2 will receive a sham visceral technique. Evaluations will be performed before and after the first session, after six weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05). The limitation of the study is that the therapist will not be blinded. This will be the first trial to analyze the clinical response and electromyographic signals during the flexion-relaxation phenomenon after OVM. Brazilian Clinical Trial Registry, RBR-7sx8j3 . Registered on 26 October 2017.

Patient or treatment centre? Where are efforts invested to improve cancer patients' psychosocial outcomes?

PubMed Central

Carey, ML; Clinton-McHarg, T; Sanson-Fisher, RW; Campbell, S; Douglas, HE

2011-01-01

The psychosocial outcomes of cancer patients may be influenced by individual-level, social and treatment centre predictors. This paper aimed to examine the extent to which individual, social and treatment centre variables have been examined as predictors or targets of intervention for psychosocial outcomes of cancer patients. Medline was searched to find studies in which the psychological outcomes of cancer patient were primary variables. Papers published in English between 1999 and 2009 that reported primary data relevant to psychosocial outcomes for cancer patients were included, with 20% randomly selected for further coding. Descriptive studies were coded for inclusion of individual, social or treatment centre variables. Intervention studies were coded to determine if the unit of intervention was the individual patient, social unit or treatment centre. After random sampling, 412 publications meeting the inclusion criteria were identified, 169 were descriptive and 243 interventions. Of the descriptive papers 95.0% included individual predictors, and 5.0% social predictors. None of the descriptive papers examined treatment centre variables as predictors of psychosocial outcomes. Similarly, none of the interventions evaluated the effectiveness of treatment centre interventions for improving psychosocial outcomes. Potential reasons for the overwhelming dominance of individual predictors and individual-focused interventions in psychosocial literature are discussed. PMID:20646035

A cross-sectional study of workplace social capital and blood pressure: a multilevel analysis at Japanese manufacturing companies.

PubMed

Fujino, Yoshihisa; Kubo, Tatsuhiko; Kunimoto, Masamizu; Tabata, Hidetoshi; Tsuchiya, Takuto; Kadowaki, Koji; Nakamura, Takehiro; Oyama, Ichiro

2013-01-01

We examined the contextual effect of workplace social capital on systolic blood pressure (SBP). Cross-sectional. A conglomerate from 58 workplaces in Japan. Of the 5844 workers at a Japanese conglomerate from 58 workplaces, 5368 were recruited. Individuals who received drugs for hypertension (n=531) and who lacked information on any variable (n=167) were excluded from the analyses, leaving 4735 individuals (3281 men and 1454 women) for inclusion. Systolic blood pressure. The contextual effect of workplace social capital on SBP was examined using a multilevel regression analysis with a random intercept. Coworker support had a contextual effect at the workplace level (coefficient=-1.97, p=0.043), while a lack of trust for coworkers (coefficient=0.27, p=0.039) and lack of helpfulness from coworkers were associated with SBP (coefficient=0.28, p=0.002). The present study suggested that social capital at the workplace level has beneficial effects on SBP.

Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

2016-01-01

This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual…

Assessing risk of baleen whale hearing loss from seismic surveys: The effect of uncertainty and individual variation.

PubMed

Gedamke, Jason; Gales, Nick; Frydman, Sascha

2011-01-01

The potential for seismic airgun "shots" to cause acoustic trauma in marine mammals is poorly understood. There are just two empirical measurements of temporary threshold shift (TTS) onset levels from airgun-like sounds in odontocetes. Considering these limited data, a model was developed examining the impact of individual variability and uncertainty on risk assessment of baleen whale TTS from seismic surveys. In each of 100 simulations: 10000 "whales" are assigned TTS onset levels accounting for: inter-individual variation; uncertainty over the population's mean; and uncertainty over weighting of odontocete data to obtain baleen whale onset levels. Randomly distributed whales are exposed to one seismic survey passage with cumulative exposure level calculated. In the base scenario, 29% of whales (5th/95th percentiles of 10%/62%) approached to 1-1.2 km range were exposed to levels sufficient for TTS onset. By comparison, no whales are at risk outside 0.6 km when uncertainty and variability are not considered. Potentially "exposure altering" parameters (movement, avoidance, surfacing, and effective quiet) were also simulated. Until more research refines model inputs, the results suggest a reasonable likelihood that whales at a kilometer or more from seismic surveys could potentially be susceptible to TTS and demonstrate that the large impact uncertainty and variability can have on risk assessment.

Relationships between middle childhood outdoor experiences and an adult individual's knowledge of the environment

NASA Astrophysics Data System (ADS)

Gillette, Brandon A.

During the last several decades, the nature of childhood has changed. There is not much nature in it anymore. Numerous studies in environmental education, environmental psychology, and conservation psychology show that the time children spend outdoors encourages healthy physical development, enriches creativity and imagination, and enhances classroom performance. Additional research shows that people's outdoor experiences as children, and adults can lead to more positive attitudes and behavior towards the environment, along with more environmental knowledge with which to guide public policy decisions. The overall purpose of this study was to examine the effect of middle childhood (age 6-11) outdoor experiences on an individual's current knowledge of the environment. This correlational study evaluated the following potential relationships: 1) The effect of "outdoorsiness" (defined as a fondness or enjoyment of the outdoors and related activities) on an individual's environmental knowledge; 2) The effect of gender on an individual's level of outdoorsiness; 3) The effect of setting (urban, suburban, rural, farm) on an individual's level of outdoorsiness and environmental knowledge; 4) The effect of formal [science] education on an individual's level of outdoorsiness and environmental knowledge; and 5) The effect of informal, free-choice learning on an individual's level of outdoorsiness and environmental knowledge. Outdoorsiness was measured using the Natural Experience Scale (NES), which was developed through a series of pilot surveys and field-tested in this research study. Participants included 382 undergraduate students at the University of Kansas with no preference or bias given to declared or undeclared majors. The information from this survey was used to analyze the question of whether outdoor experiences as children are related in some way to an adult's environmental knowledge after accounting for other factors of knowledge acquisition such as formal education, media, and free-choice learning. Though a statistically significant positive correlation was found between an individual's NES and their level of environmental knowledge as an adult, the relationship was weak (r= .112). One-on-one interviews also were conducted with 15 individuals selected from a random sample of the 382 participants. A post-survey focus group comprised of experts from the fields of environmental science and environmental education was also conducted to discuss results from the quantitative portion of the study and provide face validity to the questionnaire.

Marginal and Random Intercepts Models for Longitudinal Binary Data With Examples From Criminology.

PubMed

Long, Jeffrey D; Loeber, Rolf; Farrington, David P

2009-01-01

Two models for the analysis of longitudinal binary data are discussed: the marginal model and the random intercepts model. In contrast to the linear mixed model (LMM), the two models for binary data are not subsumed under a single hierarchical model. The marginal model provides group-level information whereas the random intercepts model provides individual-level information including information about heterogeneity of growth. It is shown how a type of numerical averaging can be used with the random intercepts model to obtain group-level information, thus approximating individual and marginal aspects of the LMM. The types of inferences associated with each model are illustrated with longitudinal criminal offending data based on N = 506 males followed over a 22-year period. Violent offending indexed by official records and self-report were analyzed, with the marginal model estimated using generalized estimating equations and the random intercepts model estimated using maximum likelihood. The results show that the numerical averaging based on the random intercepts can produce prediction curves almost identical to those obtained directly from the marginal model parameter estimates. The results provide a basis for contrasting the models and the estimation procedures and key features are discussed to aid in selecting a method for empirical analysis.

Effects of resource-building group intervention on career management and mental health in work organizations: randomized controlled field trial.

PubMed

Vuori, Jukka; Toppinen-Tanner, Salla; Mutanen, Pertti

2012-03-01

A resource-building group intervention was developed to enhance career management, mental health, and job retention in work organizations. The in-company training program provided employees with better preparedness to manage their own careers. The program activities were universally implemented using an organization-level, 2-trainer model with trainers from the human resources management and occupational health services. The study was a within-organizations, randomly assigned field experimental study; it investigated the impacts of the intervention on immediate career management preparedness and later mental health and intentions to retire early. A total of 718 eligible individuals returned a questionnaire in 17 organizations and became voluntary participants. The respondents were randomly assigned to either an intervention (N = 369) or a comparison group (N = 349). Those in the intervention group were invited to group intervention workshops, whereas those in the comparison group received printed information about career and health-related issues. The 7-month follow-up results showed that the program significantly decreased depressive symptoms and intentions to retire early and increased mental resources among the group participants compared to the others. The mediation analyses demonstrated that the increase in career management preparedness as a proximal impact of the intervention mediated the longer term mental health effects. Those who benefited most from the intervention as regards their mental health were employees with elevated levels of depression or exhaustion and younger employees, implying additional benefits of a more targeted use of the intervention. The results demonstrated the benefits of the enhancement of individual-level career management and resilience resources as career and health promotion practice in work organizations.

Effectiveness of preventive home visits in reducing the risk of falls in old age: a randomized controlled trial

PubMed Central

Luck, Tobias; Motzek, Tom; Luppa, Melanie; Matschinger, Herbert; Fleischer, Steffen; Sesselmann, Yves; Roling, Gudrun; Beutner, Katrin; König, Hans-Helmut; Behrens, Johann; Riedel-Heller, Steffi G

2013-01-01

Background Falls in older people are a major public health issue, but the underlying causes are complex. We sought to evaluate the effectiveness of preventive home visits as a multifactorial, individualized strategy to reduce falls in community-dwelling older people. Methods Data were derived from a prospective randomized controlled trial with follow-up examination after 18 months. Two hundred and thirty participants (≥80 years of age) with functional impairment were randomized to intervention and control groups. The intervention group received up to three preventive home visits including risk assessment, home counseling intervention, and a booster session. The control group received no preventive home visits. Structured interviews at baseline and follow-up provided information concerning falls in both study groups. Random-effects Poisson regression evaluated the effect of preventive home visits on the number of falls controlling for covariates. Results Random-effects Poisson regression showed a significant increase in the number of falls between baseline and follow-up in the control group (incidence rate ratio 1.96) and a significant decrease in the intervention group (incidence rate ratio 0.63) controlling for age, sex, family status, level of care, and impairment in activities of daily living. Conclusion Our results indicate that a preventive home visiting program can be effective in reducing falls in community-dwelling older people. PMID:23788832

Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial.

PubMed

Mejuto-Vázquez, María J; Salom-Moreno, Jaime; Ortega-Santiago, Ricardo; Truyols-Domínguez, Sebastián; Fernández-de-Las-Peñas, César

2014-04-01

Randomized clinical trial. To determine the effects of trigger point dry needling (TrPDN) on neck pain, widespread pressure pain sensitivity, and cervical range of motion in patients with acute mechanical neck pain and active trigger points in the upper trapezius muscle. TrPDN seems to be effective for decreasing pain in individuals with upper-quadrant pain syndromes. Potential effects of TrPDN for decreasing pain and sensitization in individuals with acute mechanical neck pain are needed. Methods Seventeen patients (53% female) were randomly assigned to 1 of 2 groups: a single session of TrPDN or no intervention (waiting list). Pressure pain thresholds over the C5-6 zygapophyseal joint, second metacarpal, and tibialis anterior muscle; neck pain intensity; and cervical spine range-of-motion data were collected at baseline (pretreatment) and 10 minutes and 1 week after the intervention by an assessor blinded to the treatment allocation of the patient. Mixed-model analyses of variance were used to examine the effects of treatment on each outcome variable. Patients treated with 1 session of TrPDN experienced greater decreases in neck pain, greater increases in pressure pain threshold, and higher increases in cervical range of motion than those who did not receive an intervention at both 10 minutes and 1 week after the intervention (P<.01 for all comparisons). Between-group effect sizes were medium to large immediately after the TrPDN session (standardized mean score differences greater than 0.56) and large at the 1-week follow-up (standardized mean score differences greater than 1.34). The results of the current randomized clinical trial suggest that a single session of TrPDN may decrease neck pain intensity and widespread pressure pain sensitivity, and also increase active cervical range of motion, in patients with acute mechanical neck pain. Changes in pain, pressure pain threshold, and cervical range of motion surpassed their respective minimal detectable change values, supporting clinically relevant treatment effects. Level of Evidence Therapy, level 1b-.

Social inequalities in residential exposure to road traffic noise: an environmental justice analysis based on the RECORD Cohort Study.

PubMed

Havard, Sabrina; Reich, Brian J; Bean, Kathy; Chaix, Basile

2011-05-01

To explore social inequalities in residential exposure to road traffic noise in an urban area. Environmental injustice in road traffic noise exposure was investigated in Paris, France, using the RECORD Cohort Study (n = 2130) and modelled noise data. Associations were assessed by estimating noise exposure within the local area around participants' residence, considering various socioeconomic variables defined at both individual and neighbourhood level, and comparing different regression models attempting or not to control for spatial autocorrelation in noise levels. After individual-level adjustment, participants' noise exposure increased with neighbourhood educational level and dwelling value but also with proportion of non-French citizens, suggesting seemingly contradictory findings. However, when country of citizenship was defined according to its human development level, noise exposure in fact increased and decreased with the proportions of citizens from advantaged and disadvantaged countries, respectively. These findings were consistent with those reported for the other socioeconomic characteristics, suggesting higher road traffic noise exposure in advantaged neighbourhoods. Substantial collinearity between neighbourhood explanatory variables and spatial random effects caused identifiability problems that prevented successful control for spatial autocorrelation. Contrary to previous literature, this study shows that people living in advantaged neighbourhoods were more exposed to road traffic noise in their residential environment than their deprived counterparts. This case study demonstrates the need to systematically perform sensitivity analyses with multiple socioeconomic characteristics to avoid incorrect inferences about an environmental injustice situation and the complexity of effectively controlling for spatial autocorrelation when fixed and random components of the model are correlated.

Dietary interventions to prevent and manage diabetes in worksite settings: a meta-analysis

PubMed Central

Shrestha, Archana; Karmacharya, Biraj Man; Khudyakov, Polyna; Weber, Mary Beth; Spiegelman, Donna

2017-01-01

Objectives: The translation of lifestyle intervention to improve glucose tolerance into the workplace has been rare. The objective of this meta-analysis is to summarize the evidence for the effectiveness of dietary interventions in worksite settings on lowering blood sugar levels. Methods: We searched for studies in PubMed, Embase, Econlit, Ovid, Cochrane, Web of Science, and Cumulative Index to Nursing and Allied Health Literature. Search terms were as follows: (1) Exposure-based: nutrition/diet/dietary intervention/health promotion/primary prevention/health behavior/health education/food /program evaluation; (2) Outcome-based: diabetes/hyperglycemia/glucose/HbA1c/glycated hemoglobin; and (3) Setting-based: workplace/worksite/occupational/industry/job/employee. We manually searched review articles and reference lists of articles identified from 1969 to December 2016. We tested for between-studies heterogeneity and calculated the pooled effect sizes for changes in HbA1c (%) and fasting glucose (mg/dl) using random effect models for meta-analysis in 2016. Results: A total of 17 articles out of 1663 initially selected articles were included in the meta-analysis. With a random-effects model, worksite dietary interventions led to a pooled -0.18% (95% CI, -0.29 to -0.06; P<0.001) difference in HbA1c. With the random-effects model, the interventions resulted in 2.60 mg/dl lower fasting glucose with borderline significance (95% CI: -5.27 to 0.08, P=0.06). In the multivariate meta-regression model, the interventions with high percent of female participants and that used the intervention directly delivered to individuals, rather the environment changes, were associated with more effective interventions. Conclusion: Workplace dietary interventions can improve HbA1c. The effects were larger for the interventions with greater number of female participants and with individual-level interventions. PMID:29187673

Inflammatory Biomarkers and Risk of Schizophrenia: A 2-Sample Mendelian Randomization Study.

PubMed

Hartwig, Fernando Pires; Borges, Maria Carolina; Horta, Bernardo Lessa; Bowden, Jack; Davey Smith, George

2017-12-01

Positive associations between inflammatory biomarkers and risk of psychiatric disorders, including schizophrenia, have been reported in observational studies. However, conventional observational studies are prone to bias, such as reverse causation and residual confounding, thus limiting our understanding of the effect (if any) of inflammatory biomarkers on schizophrenia risk. To evaluate whether inflammatory biomarkers have an effect on the risk of developing schizophrenia. Two-sample mendelian randomization study using genetic variants associated with inflammatory biomarkers as instrumental variables to improve inference. Summary association results from large consortia of candidate gene or genome-wide association studies, including several epidemiologic studies with different designs, were used. Gene-inflammatory biomarker associations were estimated in pooled samples ranging from 1645 to more than 80 000 individuals, while gene-schizophrenia associations were estimated in more than 30 000 cases and more than 45 000 ancestry-matched controls. In most studies included in the consortia, participants were of European ancestry, and the prevalence of men was approximately 50%. All studies were conducted in adults, with a wide age range (18 to 80 years). Genetically elevated circulating levels of C-reactive protein (CRP), interleukin-1 receptor antagonist (IL-1Ra), and soluble interleukin-6 receptor (sIL-6R). Risk of developing schizophrenia. Individuals with schizophrenia or schizoaffective disorders were included as cases. Given that many studies contributed to the analyses, different diagnostic procedures were used. The pooled odds ratio estimate using 18 CRP genetic instruments was 0.90 (random effects 95% CI, 0.84-0.97; P = .005) per 2-fold increment in CRP levels; consistent results were obtained using different mendelian randomization methods and a more conservative set of instruments. The odds ratio for sIL-6R was 1.06 (95% CI, 1.01-1.12; P = .02) per 2-fold increment. Estimates for IL-1Ra were inconsistent among instruments, and pooled estimates were imprecise and centered on the null. Under mendelian randomization assumptions, our findings suggest a protective effect of CRP and a risk-increasing effect of sIL-6R (potentially mediated at least in part by CRP) on schizophrenia risk. It is possible that such effects are a result of increased susceptibility to early life infection.

Efficacy of the I-SOCIAL intervention for loneliness in old age: Lessons from a randomized controlled trial.

PubMed

Cohen-Mansfield, Jiska; Hazan, Haim; Lerman, Yaffa; Shalom, Vera; Birkenfeld, Shlomo; Cohen, Rinat

2018-04-01

Loneliness is common among older persons and is associated with adverse health and wellbeing outcomes. We investigated a theory-based intervention that addresses barriers to social contacts and aims at increasing social self-efficacy. Individuals that met pre-assessment criteria of cognitive function, physical health, and loneliness levels were randomly assigned either to the I-SOCIAL intervention that combined both individual and group sessions to address individuals' unique social challenges, or to the control group. Assessment was administered at baseline, after the completion of the intervention, and after a 3-month follow-up period. The intervention group showed significant decline in loneliness level compared to the control group, both after the intervention and after the follow-up period. This innovative combination of analysis of personal barriers, support provided by the counselors, group activities, and individualized suggestions for social activities in the participant's neighborhood, may account for the success of the intervention in decreasing participants' loneliness levels. Copyright © 2018 Elsevier Ltd. All rights reserved.

Strict or graduated punishment? Effect of punishment strictness on the evolution of cooperation in continuous public goods games.

PubMed

Shimao, Hajime; Nakamaru, Mayuko

2013-01-01

Whether costly punishment encourages cooperation is one of the principal questions in studies on the evolution of cooperation and social sciences. In society, punishment helps deter people from flouting rules in institutions. Specifically, graduated punishment is a design principle for long-enduring common-pool resource institutions. In this study, we investigate whether graduated punishment can promote a higher cooperation level when each individual plays the public goods game and has the opportunity to punish others whose cooperation levels fall below the punisher's threshold. We then examine how spatial structure affects evolutionary dynamics when each individual dies inversely proportional to the game score resulting from the social interaction and another player is randomly chosen from the population to produce offspring to fill the empty site created after a player's death. Our evolutionary simulation outcomes demonstrate that stricter punishment promotes increased cooperation more than graduated punishment in a spatially structured population, whereas graduated punishment increases cooperation more than strict punishment when players interact with randomly chosen opponents from the population. The mathematical analysis also supports the results.

Strict or Graduated Punishment? Effect of Punishment Strictness on the Evolution of Cooperation in Continuous Public Goods Games

PubMed Central

Shimao, Hajime; Nakamaru, Mayuko

2013-01-01

Whether costly punishment encourages cooperation is one of the principal questions in studies on the evolution of cooperation and social sciences. In society, punishment helps deter people from flouting rules in institutions. Specifically, graduated punishment is a design principle for long-enduring common-pool resource institutions. In this study, we investigate whether graduated punishment can promote a higher cooperation level when each individual plays the public goods game and has the opportunity to punish others whose cooperation levels fall below the punisher’s threshold. We then examine how spatial structure affects evolutionary dynamics when each individual dies inversely proportional to the game score resulting from the social interaction and another player is randomly chosen from the population to produce offspring to fill the empty site created after a player’s death. Our evolutionary simulation outcomes demonstrate that stricter punishment promotes increased cooperation more than graduated punishment in a spatially structured population, whereas graduated punishment increases cooperation more than strict punishment when players interact with randomly chosen opponents from the population. The mathematical analysis also supports the results. PMID:23555826

Evaluation of Model Specification, Variable Selection, and Adjustment Methods in Relation to Propensity Scores and Prognostic Scores in Multilevel Data

ERIC Educational Resources Information Center

Yu, Bing; Hong, Guanglei

2012-01-01

This study uses simulation examples representing three types of treatment assignment mechanisms in data generation (the random intercept and slopes setting, the random intercept setting, and a third setting with a cluster-level treatment and an individual-level outcome) in order to determine optimal procedures for reducing bias and improving…

Machine Learning for Treatment Assignment: Improving Individualized Risk Attribution

PubMed Central

Weiss, Jeremy; Kuusisto, Finn; Boyd, Kendrick; Liu, Jie; Page, David

2015-01-01

Clinical studies model the average treatment effect (ATE), but apply this population-level effect to future individuals. Due to recent developments of machine learning algorithms with useful statistical guarantees, we argue instead for modeling the individualized treatment effect (ITE), which has better applicability to new patients. We compare ATE-estimation using randomized and observational analysis methods against ITE-estimation using machine learning, and describe how the ITE theoretically generalizes to new population distributions, whereas the ATE may not. On a synthetic data set of statin use and myocardial infarction (MI), we show that a learned ITE model improves true ITE estimation and outperforms the ATE. We additionally argue that ITE models should be learned with a consistent, nonparametric algorithm from unweighted examples and show experiments in favor of our argument using our synthetic data model and a real data set of D-penicillamine use for primary biliary cirrhosis. PMID:26958271

Machine Learning for Treatment Assignment: Improving Individualized Risk Attribution.

PubMed

Weiss, Jeremy; Kuusisto, Finn; Boyd, Kendrick; Liu, Jie; Page, David

2015-01-01

Clinical studies model the average treatment effect (ATE), but apply this population-level effect to future individuals. Due to recent developments of machine learning algorithms with useful statistical guarantees, we argue instead for modeling the individualized treatment effect (ITE), which has better applicability to new patients. We compare ATE-estimation using randomized and observational analysis methods against ITE-estimation using machine learning, and describe how the ITE theoretically generalizes to new population distributions, whereas the ATE may not. On a synthetic data set of statin use and myocardial infarction (MI), we show that a learned ITE model improves true ITE estimation and outperforms the ATE. We additionally argue that ITE models should be learned with a consistent, nonparametric algorithm from unweighted examples and show experiments in favor of our argument using our synthetic data model and a real data set of D-penicillamine use for primary biliary cirrhosis.

[Studies on occupational stress intervention in workplaces abroad: a systematic review].

PubMed

Hua, Yujie; Dai, Junming

2015-10-01

To evaluate the effects of occupational stress intervention in the workplaces abroad by systematic review and to provide a reference for domestic research. The Medline database was searched to collect the literature on occupational stress intervention published from January 1 in 2000 to September 4 in 2014, Using standardized forms, the methods, contents, subjects, study design, result indicator, effectiveness and evidence of the intervention were extracted and analyzed. Thirty studies met the inclusion criteria, with a total sample size of 5699 participants, including 20 randomized trials and 10 non-randomized or self-controlled studies from 12 countries, such as Germany, Japan, and Britain. The course of intervention ranged from 4 to 16 weeks. Six types of intervention were identified, i.e., cognitive-behavioral treatment (CBT), relaxation technique, physical activity, organization-focused intervention, combined intervention, and multilevel intervention, among which CBT was used most frequently. The outcome variables mainly included social psychological variable and work-related variable. Occupational stress intervention could significantly improve the occupational stress and depressive symptoms, and also had some effects on the work-related outcomes. The effectiveness of the intervention might vary between the subjects with different occupational stress levels before intervention. The effectiveness of the intervention was better at an organizational level than at an individual level, but the effectiveness at a multiple level was not necessarily better than that at a single level. Occupational stress intervention is an effective method to improve the occupational stress at workplace. However, the occupational stress level before intervention, the duration and frequency of intervention, measures and level of intervention, and follow-up period have certain influence on the effectiveness of intervention. Future research should pay attention to methodology, focus on organizational level and network-based intervention, and increase the cost-benefit analysis.

Attendance at cultural events and physical exercise and health: a randomized controlled study.

PubMed

Konlaan, B B; Björby, N; Bygren, L O; Weissglas, G; Karlsson, L G; Widmark, M

2000-09-01

The aim of this study was to assess the specific biomedico-social effects of participating in cultural events and gentle physical exercise effects apart from the general effect of participating in group activities. This was a randomized controlled investigation using a factorial design, where attending cultural events and taking easy physical exercise were tested simultaneously. The 21 participants, aged between 18 and 74 y were from a simple random sample of people registered as residents in Umeå, a town in northern Sweden. Among the 1000 in the sample, 21 individuals (11 men, 10 women) were recruited into the experiment. Two out of the 21 subjects dropped out and were discounted from our analysis. Nine people were encouraged to engage in cultural activity for a two-month period. Diastolic blood pressure in eight of these nine was significantly reduced following the experiment. There were no marked changes observed in either systolic or diastolic blood pressure in those not required to engage in any form of extra-cultural activity. A decrease in the levels of both adrenocorticotropical hormone (ACTH) and s-prolactin was observed in culturally stimulated subjects, whereas the average baseline s-prolactin level of 7 ng/l for the non-culturally stimulated group was unchanged after the experiment. Physical exercise produced an increase in the high density lipoprotein (HDL) cholesterol level and in the ratio of HDL to LDL (low density lipoprotein). It was concluded that cultural stimulation may have specific effects on health related determinants.

The NordICC Study: Rationale and design of a randomized trial on colonoscopy screening for colorectal cancer

PubMed Central

F.Kaminski, Michal; Bretthauer, Michael; Zauber, Ann G.; Kuipers, Ernst J.; Adami, Hans-Olov; van Ballegooijen, Marjolein; Regula, Jaroslaw; van Leerdam, Monique; Stefansson, Tryggvi; Påhlman, Lars; Dekker, Evelien; Hernán, Miguel A.; Garborg, Kjetil; Hoff, Geir

2017-01-01

Background While colonoscopy screening is widely used in several European countries and the United States, no randomised trials exist to quantify its benefits. The Nordic-European Initiative on Colorectal Cancer (NordICC) is a multinational, randomized controlled trial aiming at investigating the effect of colonoscopy screening on CRC incidence and mortality. This paper describes the rationale and design of the NordICC trial. Material and methods Men and women age 55 to 64 years are drawn from the population registries in the participating countries and randomly assigned to either once-only colonoscopy screening with removal of all detected lesions, or no screening (standard of care in the trial regions). All individuals are followed for 15 years after inclusion using dedicated national registries. Results The primary endpoints of the trial are cumulative CRC-specific death and CRC incidence during 15 years of follow up. We hypothesize a 50% CRC mortality-reducing efficacy of the colonoscopy intervention and predict 50% compliance, yielding a 25% mortality reduction among those invited to screening. For 90% power and a two-sided alpha level of 0.05, using a 2:1 randomisation, 45,600 individuals will be randomised to control, and 22,800 individuals to the colonoscopy group. Interim analyses of the effect of colonoscopy on CRC incidence and mortality will be performed at 10 years follow-up. Conclusions The aim of the NordICC trial is to quantify the effectiveness of population-based colonoscopy screening. This will allow development of evidence-based guidelines for CRC screening in the general population. PMID:22723185

A combined planning and self-efficacy intervention to promote physical activity: a multiple mediation analysis.

PubMed

Koring, Milena; Richert, Jana; Parschau, Linda; Ernsting, Anna; Lippke, Sonia; Schwarzer, Ralf

2012-01-01

Many individuals are motivated to improve their physical activity levels, but often fail to act upon their intention. Interventions fostering volitional strategies, such as action planning, coping planning, and self-efficacy beliefs, can help to translate intentions into behavior. This study examines the effectiveness and the mechanisms of a combined planning and self-efficacy intervention to promote physical activity among motivated individuals. Participants (N = 883) were randomly assigned to the intervention or to a waiting-list control condition. Multivariate analysis of variance revealed that the intervention resulted in significantly more physical activity, higher levels of action planning, coping planning, and volitional self-efficacy beliefs (p < 0.01). In addition, multiple mediation analysis showed that action planning, coping planning, and volitional self-efficacy mediate between the intervention and physical activity. The study shows that the intervention successfully fostered physical activity and unfolds the underlying self-regulatory mechanisms of the intervention's effectiveness.

Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study

PubMed Central

Spigoni, Valentina; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo C.; Dei Cas, Alessandra

2017-01-01

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m2) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (−30 ± 20 mg/dL; p = 0.012), LDL cholesterol (−31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (−14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention. PMID:28704936

Effects of a New Nutraceutical Formulation (Berberine, Red Yeast Rice and Chitosan) on Non-HDL Cholesterol Levels in Individuals with Dyslipidemia: Results from a Randomized, Double Blind, Placebo-Controlled Study.

PubMed

Spigoni, Valentina; Aldigeri, Raffaella; Antonini, Monica; Micheli, Maria Maddalena; Fantuzzi, Federica; Fratter, Andrea; Pellizzato, Marzia; Derlindati, Eleonora; Zavaroni, Ivana; Bonadonna, Riccardo C; Dei Cas, Alessandra

2017-07-12

Increased non high-density lipoprotein (HDL)/low-density lipoprotein (LDL) cholesterol levels are independent risk factors for cardiovascular (CV) mortality with no documented threshold. A new combination of nutraceuticals (berberine 200 mg, monacolin K 3 mg, chitosan 10 mg and coenzyme Q 10 mg) with additive lipid-lowering properties has become available. The aim of the study is to test the efficacy of the nutraceutical formulation (one daily) in lowering non-HDL cholesterol vs. placebo at 12 weeks in individuals with non-HDL-cholesterol levels ≥160 mg/dL. 39 subjects (age 52 ± 11 years; 54% females; body mass index 27 ± 4 kg/m²) were randomized (3:1) in a double blind phase II placebo-controlled study. At baseline, 4 and 12 weeks main clinical/biohumoral parameters, pro-inflammatory cytokines, (gut)-hormones, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels and endothelial progenitor cell (EPC) number were assessed. Baseline characteristics were comparable in the two groups. The intervention significantly decreased non-HDL cholesterol (-30 ± 20 mg/dL; p = 0.012), LDL cholesterol (-31 ± 18 mg/dL, p = 0.011) and apolipoprotein (Apo) B (-14 ± 12 mg/dL, p = 0.030) levels compared to the placebo. Pro-inflammatory, hormonal, PCSK9 and EPC levels remained stable throughout the study in both groups. The intervention was well tolerated. Three adverse events occurred: Epstein Barr virus infection, duodenitis and asymptomatic but significant increase in creatine phosphokinase (following intense physical exercise) which required hospitalization. The tested nutraceutical formulation may represent a possible therapeutic strategy in dyslipidemic individuals in primary prevention.

The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions

PubMed Central

Esserman, Denise; Allore, Heather G.; Travison, Thomas G.

2016-01-01

Cluster-randomized clinical trials (CRT) are trials in which the unit of randomization is not a participant but a group (e.g. healthcare systems or community centers). They are suitable when the intervention applies naturally to the cluster (e.g. healthcare policy); when lack of independence among participants may occur (e.g. nursing home hygiene); or when it is most ethical to apply an intervention to all within a group (e.g. school-level immunization). Because participants in the same cluster receive the same intervention, CRT may approximate clinical practice, and may produce generalizable findings. However, when not properly designed or interpreted, CRT may induce biased results. CRT designs have features that add complexity to statistical estimation and inference. Chief among these is the cluster-level correlation in response measurements induced by the randomization. A critical consideration is the experimental unit of inference; often it is desirable to consider intervention effects at the level of the individual rather than the cluster. Finally, given that the number of clusters available may be limited, simple forms of randomization may not achieve balance between intervention and control arms at either the cluster- or participant-level. In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC). CRTs, which are often pragmatic, may eschew such restrictions. Failure to account for imbalance may induce bias and reducing validity. This article focuses on the complexities of randomization in the design of CRTs, such as the inclusion of patients with MCC, and imbalances in covariate factors across clusters. PMID:27478520

Does short-term exposure to mobile phone base station signals increase symptoms in individuals who report sensitivity to electromagnetic fields? A double-blind randomized provocation study.

PubMed

Eltiti, Stacy; Wallace, Denise; Ridgewell, Anna; Zougkou, Konstantina; Russo, Riccardo; Sepulveda, Francisco; Mirshekar-Syahkal, Dariush; Rasor, Paul; Deeble, Roger; Fox, Elaine

2007-11-01

Individuals with idiopathic environmental illness with attribution to electromagnetic fields (IEI-EMF) believe they suffer negative health effects when exposed to electromagnetic fields from everyday objects such as mobile phone base stations. This study used both open provocation and double-blind tests to determine if sensitive and control individuals experience more negative health effects when exposed to base station-like signals compared with sham. Fifty-six self-reported sensitive and 120 control participants were tested in an open provocation test. Of these, 12 sensitive and 6 controls withdrew after the first session. The remainder completed a series of double-blind tests. Subjective measures of well-being and symptoms as well as physiological measures of blood volume pulse, heart rate, and skin conductance were obtained. During the open provocation, sensitive individuals reported lower levels of well-being in both the global system for mobile communication (GSM) and universal mobile telecommunications system (UMTS) compared with sham exposure, whereas controls reported more symptoms during the UMTS exposure. During double-blind tests the GSM signal did not have any effect on either group. Sensitive participants did report elevated levels of arousal during the UMTS condition, whereas the number or severity of symptoms experienced did not increase. Physiological measures did not differ across the three exposure conditions for either group. Short-term exposure to a typical GSM base station-like signal did not affect well-being or physiological functions in sensitive or control individuals. Sensitive individuals reported elevated levels of arousal when exposed to a UMTS signal. Further analysis, however, indicated that this difference was likely to be due to the effect of order of exposure rather than the exposure itself.

Does Short-Term Exposure to Mobile Phone Base Station Signals Increase Symptoms in Individuals Who Report Sensitivity to Electromagnetic Fields? A Double-Blind Randomized Provocation Study

PubMed Central

Eltiti, Stacy; Wallace, Denise; Ridgewell, Anna; Zougkou, Konstantina; Russo, Riccardo; Sepulveda, Francisco; Mirshekar-Syahkal, Dariush; Rasor, Paul; Deeble, Roger; Fox, Elaine

2007-01-01

Background Individuals with idiopathic environmental illness with attribution to electromagnetic fields (IEI-EMF) believe they suffer negative health effects when exposed to electromagnetic fields from everyday objects such as mobile phone base stations. Objectives This study used both open provocation and double-blind tests to determine if sensitive and control individuals experience more negative health effects when exposed to base station-like signals compared with sham. Methods Fifty-six self-reported sensitive and 120 control participants were tested in an open provocation test. Of these, 12 sensitive and 6 controls withdrew after the first session. The remainder completed a series of double-blind tests. Subjective measures of well-being and symptoms as well as physiological measures of blood volume pulse, heart rate, and skin conductance were obtained. Results During the open provocation, sensitive individuals reported lower levels of well-being in both the global system for mobile communication (GSM) and universal mobile telecommunications system (UMTS) compared with sham exposure, whereas controls reported more symptoms during the UMTS exposure. During double-blind tests the GSM signal did not have any effect on either group. Sensitive participants did report elevated levels of arousal during the UMTS condition, whereas the number or severity of symptoms experienced did not increase. Physiological measures did not differ across the three exposure conditions for either group. Conclusions Short-term exposure to a typical GSM base station-like signal did not affect well-being or physiological functions in sensitive or control individuals. Sensitive individuals reported elevated levels of arousal when exposed to a UMTS signal. Further analysis, however, indicated that this difference was likely to be due to the effect of order of exposure rather than the exposure itself. PMID:18007992

Healthy and happy in Europe? On the association between happiness and life expectancy over time.

PubMed

Bjørnskov, Christian

2008-04-01

This paper revisits the standard finding in individual-level studies that happiness leads to longevity. It does so in a cross-country time-series analysis in which the use of a random effects estimator controls for most relevant time-invariant factors. The findings suggest that happiness is negatively associated with longevity at the national level, and suggests a potential indirect transmission channel, as national happiness is negatively associated with public health expenditures. The paper concludes by discussing the implications of the results for public policy and future research.

The effect of neighborhood-based community organizing: results from the Seattle Minority Youth Health Project.

PubMed

Cheadle, A; Wagner, E; Walls, M; Diehr, P; Bell, M; Anderman, C; McBride, C; Catalano, R F; Pettigrew, E; Simmons, R; Neckerman, H

2001-08-01

To evaluate the effect of a community mobilization and youth development strategy to prevent drug abuse, violence, and risky sexual activity. Primary surveys of youth, parents, and key neighborhood leaders were carried out at baseline (1994) and at the end of the intervention period (1997). The study took place in four intervention and six control neighborhoods in Seattle. The study was designed as a randomized controlled trial with neighborhood as the unit of randomization. The intervention consisted of a paid community organizer in each neighborhood who recruited a group of residents to serve as a community action board. Key variables included perceptions of neighborhood mobilization by youth, parents, and key neighborhood leaders. Youth surveys were self-administered during school hours. Parent and neighborhood leader surveys were conducted over the phone by trained interviewers. Survey results showed that mobilization increased to the same degree in both intervention and control neighborhoods with no evidence of an overall intervention effect. There did appear to be a relative increase in mobilization in the neighborhood with the highest level of intervention activity. This randomized study failed to demonstrate a measurable effect for a community mobilization intervention. It is uncertain whether the negative finding was because of a lack of strength of the interventions or problems detecting intervention effects using individual-level closed-end surveys.

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial.

PubMed

Lieberman, Jesse A; McClelland, Jacquelyn W; Goff, David C; Racine, Elizabeth; Dulin, Michael F; Bauman, William A; Niemeier, Janet; Hirsch, Mark A; Norton, H James; Moore, Charity G

2017-12-04

Individuals with chronic spinal cord injuries (SCIs) have an increased prevalence of cardiovascular disease (CVD) and associated risk factors compared with age-matched control subjects. Exercise has been shown to improve selected CVD risk factors in individuals with SCI, but using nutrition education as an intervention has not been evaluated in this population. This paper describes our research plan for evaluating the effect of nutrition education on individuals with SCI. In the present study, called Eat Smart, Live Better, we are using a randomized controlled design to test an intervention adapted from an existing evidence-based program that showed a positive effect on nutrition knowledge and behavior of older adults from the general population. There will be an inpatient group (n = 100) and a community group (n = 100). The aims of our study are to compare the intervention and control groups for (1) changes in nutritional behavior, nutritional knowledge, and dietary quality by participants in the program; (2) levels of adiposity and metabolic CVD risk factors at 12-month follow-up; and (3) differential effects among individuals with SCI in the acute rehabilitation setting and those living in the community. This is a randomized controlled trial of nutrition education. The treatment groups receive six nutrition education sessions. The control groups receive the one "standard of care" nutrition lecture that is required by the Commission on Accreditation of Rehabilitation Facilities. Treatment groups include both an inpatient group, comprising patients who have been admitted to an acute rehabilitation facility because of their recent SCI, and an outpatient group, consisting of community-dwelling adults who are at least 1 year after their SCI. A total of 200 participants will be randomized 1:1 to the intervention or control group, stratified by location (acute rehabilitation facility or community dwelling). To our knowledge, this will be the first reported study of nutrition education in individuals with SCI. The low cost and feasibility of the intervention, if shown to improve nutritional behavior, suggests that it could be implemented in rehabilitation facilities across the country. This has the potential of lowering the burden of CVD and CVD risk factors in this high-risk population. ClinicalTrials.gov, NCT02368405 . Registered on February 10, 2015.

Effectiveness of Musculoskeletal Education Interventions in People With Low Literacy Levels: A Systematic Review

PubMed Central

Lowe, Wendy; Ballinger, Claire; Protheroe, Jo; Lueddeke, Jill; Nutbeam, Don; Armstrong, Ray; Falzon, Louise; Edwards, Chris; Russell, Cynthia; McCaffery, Kirsten; Adams, Jo

2013-01-01

Objective To conduct a systematic review to assess the effectiveness of patient education interventions delivered or directed by health professionals for people with musculoskeletal conditions who also have lower levels of literacy. Methods Electronic databases were searched from 1946 to May 2012. Randomized controlled trials with primary interventions designed specifically for individuals with musculoskeletal conditions and lower levels of literacy were eligible for inclusion. The quality of the study was determined by assessing method of randomization, allocation concealment, creation and maintenance of comparable groups, blinding of patients and providers, control of confounding, and the validity and reliability of outcome measures. Results Of the 2,440 studies located using the search strategy, 6 studies met the inclusion criteria. Three public health community studies and 3 rheumatology clinic-based studies delivered educational programs to people with musculoskeletal conditions who also had lower levels of literacy. Three moderate quality studies suggest that musculoskeletal educational interventions had a small short-term effect on knowledge and 2 moderate quality studies suggest musculoskeletal interventions had a small effect on self-efficacy (although results on self-efficacy were conflicting in 1 of these studies). Only 1 moderate quality study showed a small effect on anxiety and 1 on self-perceived health and well-being in people with lower literacy. Conclusion High quality evidence is lacking on the effectiveness of musculoskeletal education interventions for people with lower literacy levels. Research programs that test the effectiveness of patient education interventions for arthritis must recruit and engage people with lower levels of literacy. PMID:23925869

Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety.

PubMed

Attias, Samuel; Keinan Boker, Lital; Arnon, Zahi; Ben-Arye, Eran; Bar'am, Ayala; Sroka, Gideon; Matter, Ibrahim; Somri, Mostafa; Schiff, Elad

2016-03-01

Preoperative anxiety is commonly reported by people undergoing surgery. A significant number of studies have found a correlation between preoperative anxiety and post-operative morbidity. Various methods of complementary and alternative medicine (CAM) were found to be effective in alleviating preoperative anxiety. This study examined the relative effectiveness of various individual and generic CAM methods combined with standard treatment (ST) in relieving preoperative anxiety, in comparison with ST alone. Randomized controlled trial. Holding room area Three hundred sixty patients. Patients were randomly divided into 6 equal-sized groups. Group 1 received the standard treatment (ST) for anxiety alleviation with anxiolytics. The five other groups received the following, together with ST (anxiolytics): Compact Disk Recording of Guided Imagery (CDRGI); acupuncture; individual guided imagery; reflexology; and individual guided imagery combined with reflexology, based on medical staff availability. Assessment of anxiety was taken upon entering the holding room area (surgery preparation room) ('pre-treatment assessment'), and following the treatment, shortly before transfer to the operating room ('post-treatment assessment'), based on the Visual Analogue Scale (VAS) questionnaire. Data processing included comparison of VAS averages in the 'pre' and 'post' stages among the various groups. Preoperatively, CAM treatments were associated with significant reduction of anxiety level (5.54-2.32, p<0.0001). In contrast, no significant change was noted in the standard treatment group (4.92-5.44, p=0.15). Individualized CAM treatments did not differ significantly in outcomes. However, CDRGI was less effective than individualized CAM (P<0.001), but better than ST (p=0.005). Individual CAM treatments integrated within ST reduce preoperative anxiety significantly, compared to standard treatment alone, and are more effective than generic CDRGI. In light of the scope of preoperative anxiety and its implications for public health, integration of CAM therapies with ST should be considered for reducing preoperative anxiety. Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of N-acetylcysteine supplementation on oxidative stress status and alveolar inflammation in people exposed to asbestos: a double-blind, randomized clinical trial.

PubMed

Alfonso, Helman; Franklin, Peter; Ching, Simon; Croft, Kevin; Burcham, Phil; Olsen, Nola; Reid, Alison; Joyce, David; de Klerk, Nick; Musk, Aw Bill

2015-10-01

Many of the pathological consequences in the lung following inhalation of asbestos fibres arise as a consequence of persistent oxidative stress and inflammation. Inflammatory responses can be observed in asymptomatic asbestos-exposed individuals. There are currently no interventions to reduce inflammatory or oxidative responses to asbestos before disease develops. We investigated the effects of oral N-acetylcysteine (NAC) on indicators of inflammation or oxidative stress in asymptomatic people previously exposed to asbestos. A double-blind, randomized, placebo-controlled study was conducted to assess the effectiveness and safety of 1800 mg of NAC given orally over a period of 4 months. This was a proof of principle study. Effectiveness was assessed using indicators of inflammation or oxidation as primary end-points. Serum levels of total combined thiols (cysteine, cysteinylglycine, glutathione and homocysteine) were used to monitor the NAC supplementation. Thirty-four subjects were randomly allocated to NAC and 32 to placebo. Serum levels of total combined thiols were similar between the groups after intervention. There were no differences in levels of inflammatory or oxidative stress end-points between the groups. No adverse effects were identified. No evidence was found that NAC supplementation replenishes total combined thiols in the blood of healthy subjects with a history of asbestos exposure. There was also no evidence of reduced indicators of inflammation or oxidative stress. Further studies should determine the conditions required to increase levels of total anti-oxidant capacity in the blood and in the lungs of subjects with either asbestos-related diseases or subclinical lung inflammation. © 2015 Asian Pacific Society of Respirology.

Physical activity and adolescents: an exploratory randomized controlled trial investigating the influence of affective and instrumental text messages.

PubMed

Sirriyeh, Reema; Lawton, Rebecca; Ward, Jane

2010-11-01

The present study attempts to develop and pilot the feasibility and efficacy of a novel intervention using affective messages as a strategy to increase physical activity (PA) levels in adolescents. Design An exploratory pilot randomized control trial was used to compare behaviour change over 2 weeks. A modified form of the International Physical Activity Questionnaire was used to assess PA behaviour. A total of 120 adolescents (16-19 years) from 4 sixth forms in West Yorkshire completed the field-based study. Participants were randomly assigned to one of three experimental conditions, or the control condition (N=28). Participants in experimental conditions received 1 short messaging service (SMS) text message per day over the 2 weeks, which included manipulations of either affective beliefs (enjoyable/unenjoyable; N=31), instrumental beliefs (beneficial/harmful; N=30), or a combination of these (N=31). Control participants received one SMS text message per week. Outcomes were measured at baseline and at the end of the 2 week intervention. PA levels increased by the equivalent of 31.5  minutes of moderate (four metabolic equivalent) activity per week during the study. Main effects of condition (p=.049), and current physical activity level (p=.002) were identified, along with a significant interaction between condition and current activity level (p=.006). However, when the sample was split at baseline into active and inactive participants, a main effect of condition remained for inactive participants only (p=.001). Post hoc analysis revealed that inactive participants who received messages targeting affective beliefs increased their activity levels significantly more than the instrumental (p=.012), combined (p=.002), and control groups (p=.018). Strategies based on affective associations may be more effective for increasing PA levels in inactive individuals.

Effects of psychoeducation on helpful support for complicated grief: a preliminary randomized controlled single-blind study.

PubMed

Nam, I S

2016-01-01

Complicated grief is a distinct psychological response of individuals facing the loss of a loved one and can lead to many types of adverse health outcomes. Although social support may be beneficial, few studies have examined the beneficial effects of helpful support on complicated grief following bereavement. A randomized controlled trial was conducted. Bereaved participants and supporters were randomized to psychoeducation on complicated grief and helpful social support or psychoeducation on complicated grief. The primary outcome was the Inventory of Complicated Grief. The results showed that psychoeducation of supporters of bereaved individuals has significant beneficial effects. Particularly, symptoms of complicated grief were decreased in bereaved individuals with supporters that received psychoeducation. The results highlight the potential of psychoeducation to facilitate helpful social support and reduce complicated grief.

Genetically Predicted Body Mass Index and Alzheimer’s Disease Related Phenotypes in Three Large Samples: Mendelian Randomization Analyses

PubMed Central

Mukherjee, Shubhabrata; Walter, Stefan; Kauwe, John S.K.; Saykin, Andrew J.; Bennett, David A.; Larson, Eric B.; Crane, Paul K.; Glymour, M. Maria

2015-01-01

Observational research shows that higher body mass index (BMI) increases Alzheimer’s disease (AD) risk, but it is unclear whether this association is causal. We applied genetic variants that predict BMI in Mendelian Randomization analyses, an approach that is not biased by reverse causation or confounding, to evaluate whether higher BMI increases AD risk. We evaluated individual level data from the AD Genetics Consortium (ADGC: 10,079 AD cases and 9,613 controls), the Health and Retirement Study (HRS: 8,403 participants with algorithm-predicted dementia status) and published associations from the Genetic and Environmental Risk for AD consortium (GERAD1: 3,177 AD cases and 7,277 controls). No evidence from individual SNPs or polygenic scores indicated BMI increased AD risk. Mendelian Randomization effect estimates per BMI point (95% confidence intervals) were: ADGC OR=0.95 (0.90, 1.01); HRS OR=1.00 (0.75, 1.32); GERAD1 OR=0.96 (0.87, 1.07). One subscore (cellular processes not otherwise specified) unexpectedly predicted lower AD risk. PMID:26079416

Social capital and health: Does egalitarianism matter? A literature review

PubMed Central

Islam, M Kamrul; Merlo, Juan; Kawachi, Ichiro; Lindström, Martin; Gerdtham, Ulf-G

2006-01-01

The aim of the paper is to critically review the notion of social capital and review empirical literature on the association between social capital and health across countries. The methodology used for the review includes a systematic search on electronic databases for peer-reviewed published literature. We categorize studies according to level of analysis (single and multilevel) and examine whether studies reveal a significant health impact of individual and area level social capital. We compare the study conclusions according to the country's degrees of economic egalitarianism. Regardless of study design, our findings indicate that a positive association (fixed effect) exists between social capital and better health irrespective of countries degree of egalitarianism. However, we find that the between-area variance (random effect) in health tends to be lower in more egalitarian countries than in less egalitarian countries. Our tentative conclusion is that an association between social capital and health at the individual level is robust with respect to the degree of egalitarianism within a country. Area level or contextual social capital may be less salient in egalitarian countries in explaining health differences across places. PMID:16597324

Food insecurity and family structure in Nigeria.

PubMed

Owoo, Nkechi S

2018-04-01

The article explores a series of questions and hypotheses related to polygynous family structures and both household and individual-level food security outcomes, using the World Bank Living Standards Measurement Survey data from Nigeria, collected in 2011, 2013 and 2015. A Correlated Random Effects (CRE) model is used to examine the relationship between polygyny and household-level food security, and the degree to which it is mediated by household wealth, size, and livelihood. A Household Fixed Effect model is employed to explore whether a mother's status as monogamous versus polygynous relates systematically to her child's health, and also whether child outcomes of senior wives are better than outcomes of junior wives within polygynous households. At the household level, polygynous households are found to have better food security outcomes than monogamous households with differences in household composition and agricultural livelihood as potential explanatory mechanisms. At the individual level, however, children of polygynous mothers have worse nutrition outcomes than children of monogamous mothers in the long run. Within polygynous households, children of junior wives appear to have better nutritional outcomes in the long run, compared to children of more senior wives.

Contextual and individual influences on diabetes and heart disease in Havana primary care catchment areas.

PubMed

Díaz-Perera, Georgia; Bacallao, Jorge; Alemañy, Eduardo

2013-04-01

A population health profile is a cumulative product of socioenvironmental and political factors that create the contexts in which health problems arise, as well as opportunities and barriers to addressing them. Research on context has focused on demonstrating its effects, direct or indirect, on health indicators, but has made few incursions into assessing its role as a mediator of other factors. While individual risk factors for chronic diseases are well known, the same cannot be said for the complex of contextual factors operating at various levels and over the lifespan. Estimate relative influences by contextual versus individual factors as determinants of diabetes type 2 and heart disease. A cross-sectional study was carried out in populations served by 12 family doctor-and-nurse practices in Havana, in 840 families selected by simple random sampling, 70 per practice. Principal components analysis was used, as well as contextual logistic regression models with a nested model strategy, whose fit was meant to estimate the relative contributions of contextual compared to individual risk factors for diabetes and heart disease. Context was described and analyzed at two levels: that of the family or household and that of the catchment area served by a family doctor-and-nurse practice (geographically defined as a neighborhood). For diabetes, the contextual effect of neighborhood was modified when household effect was removed; that is, the effect of neighborhood was indirect and mediated by household. Individual coefficients were practically invariant; the principal effect of household changed noticeably on removal of individual effects, while age maintained its effect without variation. For heart disease, the effect of neighborhood was slightly modified when household effect was controlled for. Individual coefficients showed little change. There was an important direct effect of household on risk of heart disease. Age and high blood pressure coefficients hardly varied. We confirmed interactions between individual and contextual (neighborhood and household) factors, whose effects on individual health are not entirely mediated by individual factors. Research needs to pay more attention to context beyond its direct effect on individual risk factors.

SPIRITUALITY AND RELIGION AMONG HIV-INFECTED INDIVIDUALS

PubMed Central

Szaflarski, Magdalena

2017-01-01

Spirituality and religion are important to many people living with HIV (PLWH). Recent research has focused on special populations (ethnic-minorities, women, and youth), spirituality/religion measurement, mediating/moderating mechanisms, and individual and community-level interventions. Spirituality/religion in PLWH has been refined as a multidimensional phenomenon which improves health/quality of life directly and through mediating factors (healthy behaviors, optimism, social support). Spirituality/religion helps people to cope with stressors, especially stigma/discrimination. Spiritual interventions utilizing the power of prayer and meditation and addressing spiritual struggle are under way. Faith-based community interventions have focused on stigma and could improve individual outcomes through access to spiritual/social support and care/treatment for PLWA. Community engagement is necessary to design/implement effective and sustainable programs. Future efforts should focus on vulnerable populations; utilize state-of the art methods (randomized clinical trials, community-based participatory research); and, address population-specific interventions at individual and community levels. Clinical and policy implications across geographic settings also need attention. PMID:23996649

Spirituality and religion among HIV-infected individuals.

PubMed

Szaflarski, Magdalena

2013-12-01

Spirituality and religion are important to many people living with HIV (PLWH). Recent research has focused on special populations (ethnic-minorities, women, and youth), spirituality/religion measurement, mediating/moderating mechanisms, and individual and community-level interventions. Spirituality/religion in PLWH has been refined as a multidimensional phenomenon, which improves health/quality of life directly and through mediating factors (healthy behaviors, optimism, social support). Spirituality/religion helps people to cope with stressors, especially stigma/discrimination. Spiritual interventions utilizing the power of prayer and meditation and addressing spiritual struggle are under way. Faith-based community interventions have focused on stigma and could improve individual outcomes through access to spiritual/social support and care/treatment for PLWA. Community engagement is necessary to design/implement effective and sustainable programs. Future efforts should focus on vulnerable populations; utilize state-of-the-art methods (randomized clinical trials, community-based participatory research); and, address population-specific interventions at individual and community levels. Clinical and policy implications across geographic settings also need attention.

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

PubMed

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

2018-02-05

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

Using published data in Mendelian randomization: a blueprint for efficient identification of causal risk factors.

PubMed

Burgess, Stephen; Scott, Robert A; Timpson, Nicholas J; Davey Smith, George; Thompson, Simon G

2015-07-01

Finding individual-level data for adequately-powered Mendelian randomization analyses may be problematic. As publicly-available summarized data on genetic associations with disease outcomes from large consortia are becoming more abundant, use of published data is an attractive analysis strategy for obtaining precise estimates of the causal effects of risk factors on outcomes. We detail the necessary steps for conducting Mendelian randomization investigations using published data, and present novel statistical methods for combining data on the associations of multiple (correlated or uncorrelated) genetic variants with the risk factor and outcome into a single causal effect estimate. A two-sample analysis strategy may be employed, in which evidence on the gene-risk factor and gene-outcome associations are taken from different data sources. These approaches allow the efficient identification of risk factors that are suitable targets for clinical intervention from published data, although the ability to assess the assumptions necessary for causal inference is diminished. Methods and guidance are illustrated using the example of the causal effect of serum calcium levels on fasting glucose concentrations. The estimated causal effect of a 1 standard deviation (0.13 mmol/L) increase in calcium levels on fasting glucose (mM) using a single lead variant from the CASR gene region is 0.044 (95 % credible interval -0.002, 0.100). In contrast, using our method to account for the correlation between variants, the corresponding estimate using 17 genetic variants is 0.022 (95 % credible interval 0.009, 0.035), a more clearly positive causal effect.

Treatment of helminth co-infection in HIV-1 infected individuals in resource-limited settings

PubMed Central

Walson, Judd L; John-Stewart, Grace

2012-01-01

Background The HIV-1 pandemic has disproportionately affected individuals in resource-constrained settings. These areas often also have high prevalence of other infectious diseases, such as helminth infections. It is important to determine if helminth infection affects the progression of HIV-1 in these co-infected individuals. There are biologically plausible reasons for possible effects of helminth infection in HIV-1 infected individuals and findings from some observational studies suggest that helminth infection may adversely affect HIV-1 progression. We sought to evaluate the available evidence from published and unpublished studies to determine if treatment of helminth infection in HIV-1 co-infected individuals impacts HIV-1 progression. Objectives Our objective was to determine if treating helminth infection in individuals with HIV-1 can reduce the progression of HIV-1 as determined by changes in CD4 count, viral load, or clinical disease progression (including mortality). Search strategy We searched online for published and unpublished studies in The Cochrane Library (Issue 3, 2006), MEDLINE (November 2006), EMBASE (November 2006), CENTRAL (July 2006), AIDSEARCH (August 2006). We also searched databases listing conference abstracts, scanned reference lists of articles, and contacted authors of included studies. Selection criteria We searched for randomized and quasi-randomized controlled trials that compared HIV-1 progression as measured by changes in CD4 count, viral load, or clinical disease progression in HIV-1 infected individuals receiving anti-helminth therapy. Observational studies with relevant data were also included. Data collection and analysis Data regarding changes in CD4 count, HIV-1 RNA levels, clinical staging and/or mortality after treatment of helminth co-infection were extracted from the reports of the studies. Main results Of 6,384 abstracts identified, 15 met criteria for potential inclusion, of which five were eligible for inclusion. In the single randomized controlled trial (RCT) identified, HIV-1 and schistosomiasis co-infected individuals receiving treatment for schistosomiasis had a significantly lower change in plasma HIV-1 RNA over three months (−0.001 log10 copies/mL) compared to those receiving no treatment (+0.21 log10 copies/mL), (p=0.03). Four observational studies met inclusion criteria and all of these suggested a possible beneficial effect of helminth eradication on plasma HIV-1 RNA levels when compared to plasma HIV-1 RNA changes prior to helminth treatment or to helminth-uninfected or persistently helminth-infected individuals. Follow-up duration in these studies ranged from three to six months. The reported magnitude of effect on HIV-1 RNA was variable, ranging from 0.07–1.05 log10 copies/mL. None of the included studies showed a significant benefit of helminth treatment on CD4 decline, clinical staging, or mortality. Authors' conclusions There are insufficient data available to determine the potential benefit of helminth eradication in HIV-1 and helminth co-infected adults. Data from a single RCT and multiple observational studies suggest possible benefit in reducing plasma viral load. The impact of de-worming on markers of HIV-1 progression should be addressed in larger randomized studies evaluating species-specific effects and with a sufficient duration of follow-up to document potential differences on clinical outcomes and CD4 decline. PMID:18254104

An investigation of emotion dynamics in major depressive disorder patients and healthy persons using sparse longitudinal networks.

PubMed

de Vos, Stijn; Wardenaar, Klaas J; Bos, Elisabeth H; Wit, Ernst C; Bouwmans, Mara E J; de Jonge, Peter

2017-01-01

Differences in within-person emotion dynamics may be an important source of heterogeneity in depression. To investigate these dynamics, researchers have previously combined multilevel regression analyses with network representations. However, sparse network methods, specifically developed for longitudinal network analyses, have not been applied. Therefore, this study used this approach to investigate population-level and individual-level emotion dynamics in healthy and depressed persons and compared this method with the multilevel approach. Time-series data were collected in pair-matched healthy persons and major depressive disorder (MDD) patients (n = 54). Seven positive affect (PA) and seven negative affect (NA) items were administered electronically at 90 times (30 days; thrice per day). The population-level (healthy vs. MDD) and individual-level time series were analyzed using a sparse longitudinal network model based on vector autoregression. The population-level model was also estimated with a multilevel approach. Effects of different preprocessing steps were evaluated as well. The characteristics of the longitudinal networks were investigated to gain insight into the emotion dynamics. In the population-level networks, longitudinal network connectivity was strongest in the healthy group, with nodes showing more and stronger longitudinal associations with each other. Individually estimated networks varied strongly across individuals. Individual variations in network connectivity were unrelated to baseline characteristics (depression status, neuroticism, severity). A multilevel approach applied to the same data showed higher connectivity in the MDD group, which seemed partly related to the preprocessing approach. The sparse network approach can be useful for the estimation of networks with multiple nodes, where overparameterization is an issue, and for individual-level networks. However, its current inability to model random effects makes it less useful as a population-level approach in case of large heterogeneity. Different preprocessing strategies appeared to strongly influence the results, complicating inferences about network density.

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

PubMed

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.

Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

ERIC Educational Resources Information Center

Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

2016-01-01

Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

Group versus individual family planning counseling in Ghana: a randomized, noninferiority trial.

PubMed

Schwandt, Hilary M; Creanga, Andreea A; Danso, Kwabena A; Adanu, Richard M K; Agbenyega, Tsiri; Hindin, Michelle J

2013-08-01

Group, rather than individual, family planning counseling has the potential to increase family planning knowledge and use through more efficient use of limited human resources. A randomized, noninferiority study design was utilized to identify whether group family planning counseling is as effective as individual family planning counseling in Ghana. Female gynecology patients were enrolled from two teaching hospitals in Ghana in June and July 2008. Patients were randomized to receive either group or individual family planning counseling. The primary outcome in this study was change in modern contraceptive method knowledge. Changes in family planning use intention before and after the intervention and intended method type were also explored. Comparisons between the two study arms suggest that randomization was successful. The difference in change in modern contraceptive methods known from baseline to follow-up between the two study arms (group-individual), adjusted for study site, was -0.21, (95% confidence interval: -0.53 to 0.12) suggesting no difference between the two arms. Group family planning counseling was as effective as individual family planning counseling in increasing modern contraceptive knowledge among female gynecology patients in Ghana. Copyright © 2013 Elsevier Inc. All rights reserved.

Meta-Analysis: Effects of Probiotic Supplementation on Lipid Profiles in Normal to Mildly Hypercholesterolemic Individuals

PubMed Central

Shimizu, Mikiko; Hashiguchi, Masayuki; Shiga, Tsuyoshi; Tamura, Hiro-omi; Mochizuki, Mayumi

2015-01-01

Introduction Recent experimental and clinical studies have suggested that probiotic supplementation has beneficial effects on serum lipid profiles. However, there are conflicting results on the efficacy of probiotic preparations in reducing serum cholesterol. Objective To evaluate the effects of probiotics on human serum lipid levels, we conducted a meta-analysis of interventional studies. Methods Eligible reports were obtained by searches of electronic databases. We included randomized, controlled clinical trials comparing probiotic supplementation with placebo or no treatment (control). Statistical analysis was performed with Review Manager 5.3.3. Subanalyses were also performed. Results Eleven of 33 randomized clinical trials retrieved were eligible for inclusion in the meta-analysis. No participant had received any cholesterol-lowering agent. Probiotic interventions (including fermented milk products and probiotics) produced changes in total cholesterol (TC) (mean difference –0.17 mmol/L, 95% CI: –0.27 to –0.07 mmol/L) and low-density lipoprotein cholesterol (LDL-C) (mean difference –0.22 mmol/L, 95% CI: –0.30 to –0.13 mmol/L). High-density lipoprotein cholesterol and triglyceride levels did not differ significantly between probiotic and control groups. In subanalysis, long-term (>4-week) probiotic intervention was statistically more effective in decreasing TC and LDL-C than short-term (≤4-week) intervention. The decreases in TC and LDL-C levels with probiotic intervention were greater in mildly hypercholesterolemic than in normocholesterolemic individuals. Both fermented milk product and probiotic preparations decreased TC and LDL-C levels. Gaio and the Lactobacillus acidophilus strain reduced TC and LDL-C levels to a greater extent than other bacterial strains. Conclusions In conclusion, this meta-analysis showed that probiotic supplementation could be useful in the primary prevention of hypercholesterolemia and may lead to reductions in risk factors for cardiovascular disease. PMID:26473340

The effects of reality television on weight bias: an examination of The Biggest Loser.

PubMed

Domoff, Sarah E; Hinman, Nova G; Koball, Afton M; Storfer-Isser, Amy; Carhart, Victoria L; Baik, Kyoung D; Carels, Robert A

2012-05-01

Weight-loss reality shows, a popular form of television programming, portray obese individuals and their struggles to lose weight. While the media is believed to reinforce obesity stereotypes and contribute to weight stigma, it is not yet known whether weight-loss reality shows have any effect on weight bias. The goal of this investigation was to examine how exposure to 40-min of The Biggest Loser impacted participants' levels of weight bias. Fifty-nine participants (majority of whom were white females) were randomly assigned to either an experimental (one episode of The Biggest Loser) or control (one episode of a nature reality show) condition. Levels of weight bias were measured by the Implicit Associations Test (IAT), the Obese Person Trait Survey (OPTS), and the Anti-fat Attitudes scale (AFA) at baseline and following the episode viewing (1 week later). Participants in The Biggest Loser condition had significantly higher levels of dislike of overweight individuals and more strongly believed that weight is controllable after the exposure. No significant condition effects were found for implicit bias or traits associated with obese persons. Exploratory analyses examining moderation of the condition effect by BMI and intention to lose weight indicated that participants who had lower BMIs and were not trying to lose weight had significantly higher levels of dislike of overweight individuals following exposure to The Biggest Loser compared to similar participants in the control condition. These results indicate that anti-fat attitudes increase after brief exposure to weight-loss reality television.

Phase IIB Randomized Study of Topical Difluoromethylornithine and Topical Diclofenac on Sun-Damaged Skin of the Forearm.

PubMed

Jeter, Joanne M; Curiel-Lewandrowski, Clara; Stratton, Steven P; Myrdal, Paul B; Warneke, James A; Einspahr, Janine G; Bartels, Hubert G; Yozwiak, Michael; Bermudez, Yira; Hu, Chengcheng; Bartels, Peter; Alberts, David S

2016-02-01

Prevention of nonmelanoma skin cancers remains a health priority due to high costs associated with this disease. Diclofenac and difluoromethylornithine (DFMO) have demonstrated chemopreventive efficacy for cutaneous squamous cell carcinomas. We designed a randomized study of the combination of DFMO and diclofenac in the treatment of sun-damaged skin. Individuals with visible cutaneous sun damage were eligible. Subjects were randomized to one of the three groups: topical DFMO applied twice daily, topical diclofenac applied daily, or DFMO plus diclofenac. The treatment was limited to an area on the left forearm, and the duration of use was 90 days. We hypothesized that combination therapy would have increased efficacy compared with single-agent therapy. The primary outcome was change in karyometric average nuclear abnormality (ANA) in the treated skin. Individuals assessing the biomarkers were blinded regarding the treatment for each subject. A total of 156 subjects were randomized; 144 had baseline and end-of-study biopsies, and 136 subjects completed the study. The ANA unexpectedly increased for all groups, with higher values correlating with clinical cutaneous inflammation. Nearly all of the adverse events were local cutaneous effects. One subject had cutaneous toxicity that required treatment discontinuation. Significantly more adverse events were seen in the groups taking diclofenac. Overall, the study indicated that the addition of topical DFMO to topical diclofenac did not enhance its activity. Both agents caused inflammation on a cellular and clinical level, which may have confounded the measurement of chemopreventive effects. More significant effects may be observed in subjects with greater baseline cutaneous damage. ©2015 American Association for Cancer Research.

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

PubMed

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

2012-03-01

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

Effects of live sax music on various physiological parameters, pain level, and mood level in cancer patients: a randomized controlled trial.

PubMed

Burrai, Francesco; Micheluzzi, Valentina; Bugani, Valentina

2014-01-01

Few randomized controlled trial studies have focused on the effect of music in cancer patients, and there are no randomized controlled trials on the effects of live music with saxophone in cancer patients. To determine the effects of live saxophone music on various physiological parameters, pain level, and mood level. A randomized controlled trial study. 52 cancer patients were randomized to a control group (n = 26), an experimental group (n = 26) whose members received 30 minutes of live music therapy with saxophone. Systolic and diastolic blood pressure, pulse rate, glycemia, oxygen saturation, pain level, and mood level were measured before and after the live music performance. There was a statistical difference between the groups for oxygen saturation (0.003) and mood level (0.001). Live music performed with a saxophone could be introduced in oncology care to improve the oxygen saturation and mood in cancer patients.

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

PubMed

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 modules individually and together on multiple implementation outcomes. Implementation outcomes including provider training completion, fidelity (coded by observers blind to group assignment) and child behavior change will be examined for 295 mental health providers, 295 teachers, and 590 children. This implementation intervention has the potential to increase quality of care for ASD in publicly funded settings by improving effectiveness of intervention implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in community services. This study is registered with Clinicaltrials.gov ( NCT03380078 ). Registered 20 December 2017, retrospectively registered.

Effects of a common transcranial direct current stimulation (tDCS) protocol on motor evoked potentials found to be highly variable within individuals over 9 testing sessions.

PubMed

Horvath, Jared Cooney; Vogrin, Simon J; Carter, Olivia; Cook, Mark J; Forte, Jason D

2016-09-01

Transcranial direct current stimulation (tDCS) uses a weak electric current to modulate neuronal activity. A neurophysiologic outcome measure to demonstrate reliable tDCS modulation at the group level is transcranial magnetic stimulation engendered motor evoked potentials (MEPs). Here, we conduct a study testing the reliability of individual MEP response patterns following a common tDCS protocol. Fourteen participants (7m/7f) each underwent nine randomized sessions of 1 mA, 10 min tDCS (3 anode; 3 cathode; 3 sham) delivered using an M1/orbito-frontal electrode montage (sessions separated by an average of ~5.5 days). Fifteen MEPs were obtained prior to, immediately following and in 5 min intervals for 30 min following tDCS. TMS was delivered at 130 % resting motor threshold using neuronavigation to ensure consistent coil localization. A number of non-experimental variables were collected during each session. At the individual level, considerable variability was seen among different testing sessions. No participant demonstrated an excitatory response ≥20 % to all three anodal sessions, and no participant demonstrated an inhibitory response ≥20 % to all three cathodal sessions. Intra-class correlation revealed poor anodal and cathodal test-retest reliability [anode: ICC(2,1) = 0.062; cathode: ICC(2,1) = 0.055] and moderate sham test-retest reliability [ICC(2,1) = 0.433]. Results also revealed no significant effect of tDCS at the group level. Using this common protocol, we found the effects of tDCS on MEP amplitudes to be highly variable at the individual level. In addition, no significant effects of tDCS on MEP amplitude were found at the group level. Future studies should consider utilizing a more strict experimental protocol to potentially account for intra-individual response variations.

Air pollution, neighbourhood and maternal-level factors modify the effect of smoking on birth weight: a multilevel analysis in British Columbia, Canada.

PubMed

Erickson, Anders C; Ostry, Aleck; Chan, Hing Man; Arbour, Laura

2016-07-16

Maternal smoking during pregnancy negatively impacts fetal growth, but the effect is not homogenous across the population. We sought to determine how the relationship between cigarette use and fetal growth is modified by the social and physical environment. Birth records with covariates were obtained from the BC Perinatal Database Registry (N = 232,291). Maternal smoking status was self-reported as the number of cigarettes smoked per day usually at the first prenatal care visit. Census dissemination areas (DAs) were used as neighbourhood-level units and linked to individual births using residential postal codes to assign exposure to particulate air pollution (PM 2.5 ) and neighbourhood-level attributes such as socioeconomic status (SES), proportion of post-secondary education, immigrant density and living in a rural place. Random coefficient models were used with cigarettes/day modeled with a random slope to estimate its between-DA variability and test cross-level interactions with the neighbourhood-level variables on continuous birth weight. A significant negative and non-linear association was found between maternal smoking and birth weight. There was significant between-DA intercept variability in birth weight as well as between-DA slope variability of maternal smoking on birth weight of which 68 and 30 % respectively was explained with the inclusion of DA-level variables and their cross-level interactions. High DA-level SES had a strong positive association with birth weight but the effect was moderated with increased cigarettes/day. Conversely, heavy smokers showed the largest increases in birth weight with rising neighbourhood education levels. Increased levels of PM 2.5 and immigrant density were negatively associated with birth weight, but showed positive interactions with increased levels of smoking. Older maternal age and suspected drug or alcohol use both had negative interactions with increased levels of maternal smoking. Maternal smoking had a negative and non-linear dose-response association with birth weight which was highly variable between neighbourhoods and evidence of effect modification with neighbourhood-level factors. These results suggest that focusing exclusively on individual behaviours may have limited success in improving outcomes without addressing the contextual influences at the neighbourhood-level. Further studies are needed to corroborate our findings and to understand how neighbourhood-level attributes interact with smoking to affect birth outcomes.

The Association of Workplace Social Capital With Work Engagement of Employees in Health Care Settings: A Multilevel Cross-Sectional Analysis.

PubMed

Fujita, Sumiko; Kawakami, Norito; Ando, Emiko; Inoue, Akiomi; Tsuno, Kanami; Kurioka, Sumiko; Kawachi, Ichiro

2016-03-01

The aim of the study was to examine the cross-sectional multilevel association between unit-level workplace social capital and individual-level work engagement among employees in health care settings. The data were collected from employees of a Japanese health care corporation using a questionnaire. The analyses were limited to 440 respondents from 35 units comprising five or more respondents per unit. Unit-level workplace social capital was calculated as an average score of the Workplace Social Capital Scale for each unit. Multilevel regression analysis with a random intercept model was conducted. After adjusting for demographic variables, unit-level workplace social capital was significantly and positively associated with respondents' work engagement (P < 0.001). The association remained significant after additionally adjusting for individual-level perceptions of workplace social capital (P < 0.001). Workplace social capital might exert a positive contextual effect on work engagement of employees in health care settings.

Effect of moderate- and high-intensity acute exercise on appetite in obese individuals.

PubMed

Martins, Catia; Stensvold, Dorthe; Finlayson, Graham; Holst, Jens; Wisloff, Ulrik; Kulseng, Bård; Morgan, Linda; King, Neil A

2015-01-01

The effect of acute exercise, and exercise intensity, on appetite control in obese individuals requires further study. The aim of this study was to compare the effects of acute isocaloric bouts (250 kcal) of high-intensity intermittent cycling (HIIC) and moderate-intensity continuous cycling (MICC) or short-duration HIIC (S-HIIC) (125 kcal) and a resting control condition on the appetite hormone responses, subjective feelings of appetite, energy intake (EI), and food reward in overweight/obese individuals. This study is a randomized crossover study on 12 overweight/obese volunteers. Participants were assigned to the control, MICC, HIIC, and S-HIIC conditions, 1 wk apart, in a counterbalanced order. Exercise was performed 1 h after a standard breakfast. An ad libitum test lunch was served 3 h after breakfast. Fasting/postprandial plasma samples of insulin, acylated ghrelin, polypeptide YY3-36, and glucagon-like peptide 1 and subjective feelings of appetite were measured every 30 min for 3 h. Nutrient and taste preferences were measured at the beginning and end of each condition using the Leeds Food Preference Questionnaire. Insulin levels were significantly reduced, and glucagon-like peptide 1 levels significantly increased during all exercise bouts compared with those during rest. Acylated ghrelin plasma levels were lower in the MICC and HIIC, but not in S-HIIC, compared with those in control. There were no significant differences for polypeptide YY3-36 plasma levels, hunger or fullness ratings, EI, or food reward. Our findings suggest that, in overweight/obese individuals, isocaloric bouts of moderate- or high-intensity exercise lead to a similar appetite response. This strengthens previous findings in normal-weight individuals that acute exercise, even at high intensity, does not induce any known physiological adaptation that would lead to increased EI.

Social capital and administrative contextual determinants of lack of access to a regular doctor: a multilevel analysis in southern Sweden.

PubMed

Lindström, Martin; Axén, Elin; Lindström, Christine; Beckman, Anders; Moghaddassi, Mahnaz; Merlo, Juan

2006-12-01

The aim of this study was to investigate the influence of contextual (social capital and administrative/neo-materialist) and individual factors on lack of access to a regular doctor. The 2000 public health survey in Scania is a cross-sectional study. A total of 13,715 persons answered a postal questionnaire, which is 59% of the random sample. A multilevel logistic regression model, with individuals at the first level and municipalities at the second, was performed. The effect (intra-class correlations, cross-level modification and odds ratios) of individual and municipality (social capital and health care district) factors on lack of access to a regular doctor was analysed using simulation method. The Deviance Information Criterion (DIC) was used as information criterion for the models. The second level municipality variance in lack of access to a regular doctor is substantial even in the final models with all individual and contextual variables included. The model that results in the largest reduction in DIC is the model including age, sex and individual social participation (which is a network aspect of social capital), but the models which include administrative and social capital second level factors also reduced the DIC values. This study suggests that both administrative health care district and social capital may partly explain the individual's self reported lack of access to a regular doctor.

Low level laser therapy and hair regrowth: an evidence-based review.

PubMed

Zarei, Mina; Wikramanayake, Tongyu C; Falto-Aizpurua, Leyre; Schachner, Lawrence A; Jimenez, Joaquin J

2016-02-01

Despite the current treatment options for different types of alopecia, there is a need for more effective management options. Recently, low-level laser therapy (LLLT) was evaluated for stimulating hair growth. Here, we reviewed the current evidence on the LLLT effects with an evidence-based approach, focusing more on randomized controlled studies by critically evaluating them. In order to investigate whether in individuals presenting with hair loss (male pattern hair loss (MPHL), female pattern hair loss (FPHL), alopecia areata (AA), and chemotherapy-induced alopecia (CIA)) LLLT is effective for hair regrowth, several databases including PubMed, Google Scholar, Medline, Embase, and Cochrane Database were searched using the following keywords: Alopecia, Hair loss, Hair growth, Low level laser therapy, Low level light therapy, Low energy laser irradiation, and Photobiomodulation. From the searches, 21 relevant studies were summarized in this review including 2 in vitro, 7 animal, and 12 clinical studies. Among clinical studies, only five were randomized controlled trials (RCTs), which evaluated LLLT effect on male and female pattern hair loss. The RCTs were critically appraised using the created checklist according to the Critical Appraisal for Therapy Articles Worksheet created by the Center of Evidence-Based Medicine, Oxford. The results demonstrated that all the performed RCTs have moderate to high quality of evidence. However, only one out of five studies performed intention-to-treat analysis, and only another study reported the method of randomization and subsequent concealment of allocation clearly; all other studies did not include this very important information in their reports. None of these studies reported the treatment effect of factors such as number needed to treat. Based on this review on all the available evidence about effect of LLLT in alopecia, we found that the FDA-cleared LLLT devices are both safe and effective in patients with MPHL and FPHL who did not respond or were not tolerant to standard treatments. Future randomized controlled trials of LLLT are strongly encouraged to be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement to facilitate analysis and comparison.

Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial

PubMed Central

Go, Vivian F.; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W.; Zelaya, Carla; Vu, Pham The; Celentano, David D.; Quan, Vu Minh

2015-01-01

Introduction Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. Methods 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Results Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Discussion Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. Trial Registration ClinicalTrials.gov NCT01689545 PMID:26011427

Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W; Zelaya, Carla; Vu, Pham The; Celentano, David D; Quan, Vu Minh

2015-01-01

Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. ClinicalTrials.gov NCT01689545.

The Impact of Individual Differences on a Bilingual Vocabulary Approach for Latino Preschoolers.

PubMed

Méndez, Lucía I; Crais, Elizabeth R; Kainz, Kirsten

2018-04-17

The purpose of this study was twofold: First, we replicated in a new sample our previous findings that a culturally and linguistically responsive (CLR) bilingual approach for English vocabulary instruction for preschool Latino dual language learners was effective. Subsequently, we investigated whether the positive effect of CLR instruction varies as a function of individual child characteristics, including baseline vocabulary levels and gender. Using a randomized pretest-posttest follow-up group design, we first replicated our previous study (N = 42) with a new sample by randomly assigning 35 Spanish-speaking Latino preschoolers to a CLR bilingual group or an English-only group. The preschoolers received small-group evidence-informed shared readings targeting 30 English words 3 times a week for 5 weeks in their preschools. Vocabulary outcomes were measured using both standardized and researcher-developed measures. We subsequently conducted further studies with the combined sample size of 77 children to examine the variability in intervention effects related to child gender and baseline vocabulary levels. The direct replication study confirmed findings of our earlier work suggesting that the CLR bilingual approach promoted greater gains in L1 and L2 vocabulary than in an English-only approach. The extension studies revealed that the effect of the CLR bilingual vocabulary approach on English and Spanish vocabulary outcomes was not impacted by gender or vocabulary status at baseline. This study provides additional evidence of the benefits of strategically combining L1 and L2 for vocabulary instruction over an English-only approach. Our findings also suggest that preschool Latino dual language learners can benefit from a bilingual vocabulary instructional approach regardless of gender or baseline vocabulary levels in L1.

Sitagliptin but not alpha glucosidase inhibitor reduced the serum soluble CD163, a marker for activated macrophage, in individuals with type 2 diabetes mellitus.

PubMed

Hattori, Akiko; Takemoto, Minoru; Tokuyama, Hirotake; Koshizaka, Masaya; Yokote, Koutaro

2017-04-01

Dipeptidyl peptidase-4 inhibitor (DPP-4i) is commonly used worldwide for the treatment of type 2 diabetes mellitus. In addition to its hypoglycemic activity, DPP-4i might have anti-inflammatory effects. In this study we examined the effects of DPP-4i on the serum levels of soluble CD163 (sCD163), a marker for activated macrophages, in individuals with type 2 diabetes mellitus. We compared these anti-inflammatory effects with those of α glucosidase inhibitor (αGI). Japanese patients with type 2 diabetes mellitus who were stably maintained on ≤2mg/day glimepiride alone were recruited and randomly assigned to receive additional sitagliptin (n=37) or αGI (n=37). Levels of sCD163 were measured before the addition and after a 24-week treatment period. Addition of sitagliptin significantly reduced the serum sCD163 (632 vs. 575ng/mL, p<0.05), while αGI did not display this effect (624 vs. 607ng/mL). The changes in levels of sCD163 were not related to changes in either HbA1c or body mass index (BMI). Our results suggested that DPP-4i might exert anti-inflammatory effects in individuals with type 2 diabetes mellitus, which are independent of its effects on glycemia and BMI. Copyright © 2017 Elsevier B.V. All rights reserved.

Strengths-based positive psychology interventions: a randomized placebo-controlled online trial on long-term effects for a signature strengths- vs. a lesser strengths-intervention.

PubMed

Proyer, René T; Gander, Fabian; Wellenzohn, Sara; Ruch, Willibald

2015-01-01

Recent years have seen an increasing interest in research in positive psychology interventions. There is broad evidence for their effectiveness in increasing well-being and ameliorating depression. Intentional activities that focus on those character strengths, which are most typical for a person (i.e., signature strengths, SS) and encourage their usage in a new way have been identified as highly effective. The current study aims at comparing an intervention aimed at using SS with one on using individual low scoring (or lesser) strengths in a randomized placebo-controlled trial. A total of 375 adults were randomly assigned to one of the two intervention conditions [i.e., using five signature vs. five lesser strengths (LS) in a new way] or a placebo control condition (i.e., early memories). We measured happiness and depressive symptoms at five time points (i.e., pre- and post-test, 1-, 3-, and 6-months follow-ups) and character strengths at pre-test. The main findings are that (1) there were increases in happiness for up to 3 months and decreases in depressive symptoms in the short term in both intervention conditions; (2) participants found working with strengths equally rewarding (enjoyment and benefit) in both conditions; (3) those participants that reported generally higher levels of strengths benefitted more from working on LS rather than SS and those with comparatively lower levels of strengths tended to benefit more from working on SS; and (4) deviations from an average profile derived from a large sample of German-speakers completing the Values-in-Action Inventory of Strengths were associated with greater benefit from the interventions in the SS-condition. We conclude that working on character strengths is effective for increasing happiness and discuss how these interventions could be tailored to the individual for promoting their effectiveness.

Mirror therapy for patients with severe arm paresis after stroke--a randomized controlled trial.

PubMed

Thieme, Holm; Bayn, Maria; Wurg, Marco; Zange, Christian; Pohl, Marcus; Behrens, Johann

2013-04-01

To evaluate the effects of individual or group mirror therapy on sensorimotor function, activities of daily living, quality of life and visuospatial neglect in patients with a severe arm paresis after stroke. Randomized controlled trial. Inpatient rehabilitation centre. Sixty patients with a severe paresis of the arm within three months after stroke. Three groups: (1) individual mirror therapy, (2) group mirror therapy and (3) control intervention with restricted view on the affected arm. Motor function on impairment (Fugl-Meyer Test) and activity level (Action Research Arm Test), independence in activities of daily living (Barthel Index), quality of life (Stroke Impact Scale) and visuospatial neglect (Star Cancellation Test). After five weeks, no significant group differences for motor function were found (P > 0.05). Pre-post differences for the Action Research Arm Test and Fugl-Meyer Test: individual mirror therapy: 3.4 (7.1) and 3.2 (3.8), group mirror therapy: 1.1 (3.1) and 5.1 (10.0) and control therapy: 2.8 (6.7) and 5.2 (8.7). However, a significant effect on visuospatial neglect for patients in the individual mirror therapy compared to control group could be shown (P < 0.01). Furthermore, it was possible to integrate a mirror therapy group intervention for severely affected patients after stroke. This study showed no effect on sensorimotor function of the arm, activities of daily living and quality of life of mirror therapy compared to a control intervention after stroke. However, a positive effect on visuospatial neglect was indicated.

A Mixed Effects Randomized Item Response Model

ERIC Educational Resources Information Center

Fox, J.-P.; Wyrick, Cheryl

2008-01-01

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

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

PubMed

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

2010-01-01

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

Neoadjuvant rectal score as individual-level surrogate for disease-free survival in rectal cancer in the CAO/ARO/AIO-04 randomized phase 3 trial.

PubMed

Fokas, E; Fietkau, R; Hartmann, A; Hohenberger, W; Grützmann, R; Ghadimi, M; Liersch, T; Ströbel, P; Grabenbauer, G G; Graeven, U; Hofheinz, R-D; Köhne, C-H; Wittekind, C; Sauer, R; Kaufmann, M; Hothorn, T; Rödel, C

2018-04-27

Surrogate endpoints in rectal cancer after preoperative chemoradiation are lacking as their statistical validation poses major challenges, including confirmation based on large phase 3 trials. We examined the prognostic role and individual-level surrogacy of neoadjuvant rectal (NAR) score that incorporates weighted cT, ypT and ypN categories for disease-free survival (DFS) in 1191 patients with rectal carcinoma treated within the CAO/ARO/AIO-04 phase 3 trial. Cox regression models adjusted for treatment arm, resection status, and NAR score were used in multivariable analysis. The four Prentice criteria (PC1-4) were used to assess individual-level surrogacy of NAR for DFS. After a median follow-up of 50 months, the addition of oxaliplatin to fluorouracil-based chemoradiotherapy (CRT) significantly improved 3-year DFS (75.9% [95% CI 72.30-79.50] vs 71.3% [95% CI 67.60-74.90]; P = 0.034; PC 1) and resulted in a shift towards lower NAR groups (P = 0.034, PC 2) compared to fluorouracil-only CRT. The 3-year DFS was 91.7% (95% CI, 88.2 95.2), 81.8% (95% CI, 78.4-85.1) and 58.1 (95% CI 52.4-63.9) for low, intermediate and high NAR score, respectively (P < 0.001; PC 3). NAR score remained an independent prognostic factor for DFS (low vs high NAR: HR 4.670; 95% CI 3.106-7.020; P < 0.001; low vs intermediate NAR: HR 1.971; 95% CI 1.303-2.98; P = 0.001) in multivariable analysis. Notwithstanding the inherent methodological difficulty in interpretation of PC 4 to establish surrogacy, the treatment effect on DFS was captured by NAR, supporting satisfaction of individual-level PC4. Our study validates the prognostic role and individual-level surrogacy of NAR score for DFS within a large randomized phase 3 trial. NAR score could help oncologists to speed up response-adapted therapeutic decision, and further large phase 3 trial datasets should aim to confirm trial-level surrogacy.

Individualizing drug dosage with longitudinal data.

PubMed

Zhu, Xiaolu; Qu, Annie

2016-10-30

We propose a two-step procedure to personalize drug dosage over time under the framework of a log-linear mixed-effect model. We model patients' heterogeneity using subject-specific random effects, which are treated as the realizations of an unspecified stochastic process. We extend the conditional quadratic inference function to estimate both fixed-effect coefficients and individual random effects on a longitudinal training data sample in the first step and propose an adaptive procedure to estimate new patients' random effects and provide dosage recommendations for new patients in the second step. An advantage of our approach is that we do not impose any distribution assumption on estimating random effects. Moreover, the new approach can accommodate more general time-varying covariates corresponding to random effects. We show in theory and numerical studies that the proposed method is more efficient compared with existing approaches, especially when covariates are time varying. In addition, a real data example of a clozapine study confirms that our two-step procedure leads to more accurate drug dosage recommendations. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis.

PubMed

Serpa Neto, Ary; Hemmes, Sabrine N T; Barbas, Carmen S V; Beiderlinden, Martin; Biehl, Michelle; Binnekade, Jan M; Canet, Jaume; Fernandez-Bustamante, Ana; Futier, Emmanuel; Gajic, Ognjen; Hedenstierna, Göran; Hollmann, Markus W; Jaber, Samir; Kozian, Alf; Licker, Marc; Lin, Wen-Qian; Maslow, Andrew D; Memtsoudis, Stavros G; Reis Miranda, Dinis; Moine, Pierre; Ng, Thomas; Paparella, Domenico; Putensen, Christian; Ranieri, Marco; Scavonetto, Federica; Schilling, Thomas; Schmid, Werner; Selmo, Gabriele; Severgnini, Paolo; Sprung, Juraj; Sundar, Sugantha; Talmor, Daniel; Treschan, Tanja; Unzueta, Carmen; Weingarten, Toby N; Wolthuis, Esther K; Wrigge, Hermann; Gama de Abreu, Marcelo; Pelosi, Paolo; Schultz, Marcus J

2015-07-01

Recent studies show that intraoperative mechanical ventilation using low tidal volumes (VT) can prevent postoperative pulmonary complications (PPCs). The aim of this individual patient data meta-analysis is to evaluate the individual associations between VT size and positive end-expiratory pressure (PEEP) level and occurrence of PPC. Randomized controlled trials comparing protective ventilation (low VT with or without high levels of PEEP) and conventional ventilation (high VT with low PEEP) in patients undergoing general surgery. The primary outcome was development of PPC. Predefined prognostic factors were tested using multivariate logistic regression. Fifteen randomized controlled trials were included (2,127 patients). There were 97 cases of PPC in 1,118 patients (8.7%) assigned to protective ventilation and 148 cases in 1,009 patients (14.7%) assigned to conventional ventilation (adjusted relative risk, 0.64; 95% CI, 0.46 to 0.88; P < 0.01). There were 85 cases of PPC in 957 patients (8.9%) assigned to ventilation with low VT and high PEEP levels and 63 cases in 525 patients (12%) assigned to ventilation with low VT and low PEEP levels (adjusted relative risk, 0.93; 95% CI, 0.64 to 1.37; P = 0.72). A dose-response relationship was found between the appearance of PPC and VT size (R2 = 0.39) but not between the appearance of PPC and PEEP level (R2 = 0.08). These data support the beneficial effects of ventilation with use of low VT in patients undergoing surgery. Further trials are necessary to define the role of intraoperative higher PEEP to prevent PPC during nonopen abdominal surgery.

Social capital and neo-materialist contextual determinants of sense of insecurity in the neighbourhood: a multilevel analysis in Southern Sweden.

PubMed

Lindström, Martin; Lindström, Christine; Moghaddassi, Mahnaz; Merlo, Juan

2006-12-01

The aim of this study was to investigate the influence of contextual (social capital and neo-materialist) and individual factors on sense of insecurity in the neighbourhood. The 2000 public health survey in Scania is a cross-sectional study. A total of 13,715 persons answered a postal questionnaire, which is 59% of the random sample. A multilevel logistic regression model, with individuals at the first level and municipalities at the second, was performed. The effect (median odds ratios, intra-class correlation, cross-level modification and odds ratios) of individual and municipality/city quarter (social capital and police district) factors on sense of insecurity was analysed. The crude variance between municipalities/city quarters was not affected by individual factors. The introduction of administrative police district in the model reduced the municipality variance, although some of the significant variance between municipalities remained. The introduction of social capital did not affect the municipality variance. This study suggests that the neo-materialist factor administrative police district may partly explain the individual's sense of insecurity in the neighbourhood.

Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease.

PubMed

Offenbacher, Steven; Beck, James D; Moss, Kevin; Mendoza, Luisito; Paquette, David W; Barrow, David A; Couper, David J; Stewart, Dawn D; Falkner, Karen L; Graham, Susan P; Grossi, Sara; Gunsolley, John C; Madden, Theresa; Maupome, Gerardo; Trevisan, Maurizio; Van Dyke, Thomas E; Genco, Robert J

2009-02-01

In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). After 6 months, there was a significant reduction in mean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serum hs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95% confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.

Results From the Periodontitis and Vascular Events (PAVE) Study: A Pilot Multicentered, Randomized, Controlled Trial to Study Effects of Periodontal Therapy in a Secondary Prevention Model of Cardiovascular Disease

PubMed Central

Offenbacher, Steven; Beck, James D.; Moss, Kevin; Mendoza, Luisito; Paquette, David W.; Barrow, David A.; Couper, David J.; Stewart, Dawn D.; Falkner, Karen L.; Graham, Susan P.; Grossi, Sara; Gunsolley, John C.; Madden, Theresa; Maupome, Gerardo; Trevisan, Maurizio; Van Dyke, Thomas E.; Genco, Robert J.

2009-01-01

Background In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac– dental centers. Methods Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). Results After 6 months, there was a significant reduction in mean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serum hs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95%confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. Conclusion This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk. PMID:19186958

Does Mother Know Best? Treatment Adherence as a Function of Anticipated Treatment Benefit

PubMed Central

Glymour, M. Maria; Nguyen, Quynh; Matsouaka, Roland; Tchetgen Tchetgen, Eric J.; Schmidt, Nicole M.; Osypuk, Theresa L.

2016-01-01

Background We describe bias resulting from individualized treatment selection, which occurs when treatment has heterogeneous effects and individuals selectively choose treatments of greatest benefit to themselves. This pernicious bias may confound estimates from observational studies and lead to important misinterpretation of intent-to-treat analyses of randomized trials. Despite the potentially serious threat to inferences, individualized treatment selection has rarely been formally described or assessed. Methods The Moving to Opportunity (MTO) trial randomly assigned subsidized rental vouchers to low-income families in high-poverty public housing. We assessed the Kessler-6 psychological distress and Behavior Problems Index outcomes for 2,829 adolescents 4–7 years after randomization. Among families randomly assigned to receive vouchers, we estimated probability of moving (treatment), predicted by pre-randomization characteristics (c-statistic=0.63). We categorized families into tertiles of this estimated probability of moving, and compared instrumental variable effect estimates for moving on Behavior Problems Index and Kessler-6 across tertiles. Results Instrumental variable estimated effects of moving on behavioral problems index were most adverse for boys least likely to move (b=0.93; 95% CI: 0.33, 1.53) compared to boys most likely to move (b=0.14; 95% CI: −0.15, 0.44; p=.02 for treatment*tertile interaction). Effects on Kessler-6 were more beneficial for girls least likely to move compared to girls most likely to move (−0.62 vs. 0.02; interaction p=.03). Conclusions Evidence of Individualized treatment selection differed by child gender and outcome and should be evaluated in randomized trial reports, especially when heterogeneous treatment effects are likely and non-adherence is common. PMID:26628424

Comparing Effectiveness of Mindfulness-Based Relapse Prevention with Treatment as Usual on Impulsivity and Relapse for Methadone-Treated Patients: A Randomized Clinical Trial.

PubMed

Yaghubi, Mehdi; Zargar, Fatemeh; Akbari, Hossein

2017-07-01

Impulsivity is one of the causes of relapse that can affect treatment outcomes. Studies have shown that addiction treatments can reduce impulsivity in drug-dependent individuals. Studies also have suggested that mindfulness is associated with impulsivity. However, no study has investigated the effectiveness of the mindfulness-based intervention on impulsivity in opioid-dependent individuals. This study aimed to compare the effectiveness of mindfulness-based relapse prevention (MBRP) with treatment as usual (TAU) in terms of impulsivity and relapse for methadone-treated patients. The present randomized controlled clinical trial was performed in Kashan, Iran, in 2015. The study population was opioid-dependent patients referred to Maintenance Treatment Centers. Seventy patients were selected by random sampling and were assigned in two groups (MBRP and TAU) randomly. The participants of two groups filled out Barratt impulsivity scale (BIS-11) as a pre-test and 8 weeks later as post-test and 2 months later as a follow-up. Both groups received methadone-therapy. The MBRP group received 8 sessions of group therapy, while the control group did not receive any group psychotherapy session. Finally, data from 60 patients were analyzed statistically. The MBRP group had decreased impulsivity significantly (P < 0.001). The mean impulsivity score was 74.76 ± 4.72 before intervention that was significantly decreased to 57.66 ± 3.73 and 58.86 ± 3.57 after the intervention and follow-up (P < 0.001), respectively. In addition, significant differences were observed between MBRP and TAU groups for relapse frequency (P < 0.050). This study showed that MBRP compared to TAU can decrease the mean impulsivity score in opioid-dependent and reduce relapse probability. These findings suggest that MBRP is useful for opioid-dependent individuals with high-level impulsivity, and relapse prevention.

Cost-effectiveness of an experimental caries-control regimen in a 3.4-yr randomized clinical trial among 11-12-yr-old Finnish schoolchildren.

PubMed

Hietasalo, Pauliina; Seppä, Liisa; Lahti, Satu; Niinimaa, Ahti; Kallio, Jouko; Aronen, Pasi; Sintonen, Harri; Hausen, Hannu

2009-12-01

The aim of this study was to assess the cost-effectiveness of an experimental caries-control regimen in a randomized clinical trial (RCT) conducted in Pori, Finland, in 2001-2005. Children (n = 497) who were 11-12 yr of age and had at least one active initial caries lesion at baseline were studied. The children in the experimental group (n = 250) were offered an individually designed patient-centered regimen for caries control. The children in the control group (n = 247) received standard dental care. Furthermore, the whole population was exposed to continuous community-level oral health promotion. Individual costs of treatment procedures and outcomes (DMFS increment score) for the follow-up period of 3.4 yr were calculated for each child in both groups. The incremental cost-effectiveness ratio was euro 34.07 per averted DMF surface. The experimental regimen was more effective, and also more costly. However, the total costs decreased year after year, and for the last 2 yr the experimental regimen was less expensive than the standard dental care. The experimental regimen would probably have been more cost-effective than standard dental care if the follow-up period had been longer, the regimen less comprehensive, and/or if dental nurses had conducted the preventive procedures.

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

PubMed

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

2018-04-29

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

Persistent and transient cost efficiency—an application to the Swiss hydropower sector

DOE PAGES

Filippini, Massimo; Geissmann, Thomas; Greene, William H.

2017-11-27

Electricity prices on the European market have decreased significantly over the past few years, resulting in a deterioration of Swiss hydropower firms’ competitiveness and profitability. One option to improve the sector’s competitiveness is to increase cost efficiency. The goal of this study is to quantify the level of persistent and transient cost efficiency of individual firms by applying the generalized true random effects (GTRE) model introduced by Colombi et al. (Journal of Productivity Analysis 42(2): 123–136, 2014) and Filippini and Greene (Journal of Productivity Analysis 45(2): 187–196, 2016). Applying this newly developed GTRE model to a total cost function, themore » level of cost efficiency of 65 Swiss hydropower firms is analyzed for the period between 2000 and 2013. A true random effects specification is estimated as a benchmark for the transient level of cost efficiency. The results show the presence of both transient as well as persistent cost inefficiencies. The GTREM predicts the aggregate level of cost inefficiency to amount to 21.8% (8.0% transient, 13.8% persistent) on average between 2000 and 2013. These two components differ in interpretation and implication. From an individual firm’s perspective, the two types of cost inefficiencies might require a firm’s management to respond with different improvement strategies. The existing level of persistent inefficiency could prevent the hydropower firms from adjusting their production processes to new market environments. From a regulatory point of view, the results of this study could be used in the scope and determination of the amount of financial support given to struggling firms.« less

Persistent and transient cost efficiency—an application to the Swiss hydropower sector

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

Filippini, Massimo; Geissmann, Thomas; Greene, William H.

Electricity prices on the European market have decreased significantly over the past few years, resulting in a deterioration of Swiss hydropower firms’ competitiveness and profitability. One option to improve the sector’s competitiveness is to increase cost efficiency. The goal of this study is to quantify the level of persistent and transient cost efficiency of individual firms by applying the generalized true random effects (GTRE) model introduced by Colombi et al. (Journal of Productivity Analysis 42(2): 123–136, 2014) and Filippini and Greene (Journal of Productivity Analysis 45(2): 187–196, 2016). Applying this newly developed GTRE model to a total cost function, themore » level of cost efficiency of 65 Swiss hydropower firms is analyzed for the period between 2000 and 2013. A true random effects specification is estimated as a benchmark for the transient level of cost efficiency. The results show the presence of both transient as well as persistent cost inefficiencies. The GTREM predicts the aggregate level of cost inefficiency to amount to 21.8% (8.0% transient, 13.8% persistent) on average between 2000 and 2013. These two components differ in interpretation and implication. From an individual firm’s perspective, the two types of cost inefficiencies might require a firm’s management to respond with different improvement strategies. The existing level of persistent inefficiency could prevent the hydropower firms from adjusting their production processes to new market environments. From a regulatory point of view, the results of this study could be used in the scope and determination of the amount of financial support given to struggling firms.« less

Intercellular Variability in Protein Levels from Stochastic Expression and Noisy Cell Cycle Processes

PubMed Central

Soltani, Mohammad; Vargas-Garcia, Cesar A.; Antunes, Duarte; Singh, Abhyudai

2016-01-01

Inside individual cells, expression of genes is inherently stochastic and manifests as cell-to-cell variability or noise in protein copy numbers. Since proteins half-lives can be comparable to the cell-cycle length, randomness in cell-division times generates additional intercellular variability in protein levels. Moreover, as many mRNA/protein species are expressed at low-copy numbers, errors incurred in partitioning of molecules between two daughter cells are significant. We derive analytical formulas for the total noise in protein levels when the cell-cycle duration follows a general class of probability distributions. Using a novel hybrid approach the total noise is decomposed into components arising from i) stochastic expression; ii) partitioning errors at the time of cell division and iii) random cell-division events. These formulas reveal that random cell-division times not only generate additional extrinsic noise, but also critically affect the mean protein copy numbers and intrinsic noise components. Counter intuitively, in some parameter regimes, noise in protein levels can decrease as cell-division times become more stochastic. Computations are extended to consider genome duplication, where transcription rate is increased at a random point in the cell cycle. We systematically investigate how the timing of genome duplication influences different protein noise components. Intriguingly, results show that noise contribution from stochastic expression is minimized at an optimal genome-duplication time. Our theoretical results motivate new experimental methods for decomposing protein noise levels from synchronized and asynchronized single-cell expression data. Characterizing the contributions of individual noise mechanisms will lead to precise estimates of gene expression parameters and techniques for altering stochasticity to change phenotype of individual cells. PMID:27536771

The Effects of Compensatory Auditory Stimulation and High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Tinnitus Perception - A Randomized Pilot Study.

PubMed

Henin, Simon; Fein, Dovid; Smouha, Eric; Parra, Lucas C

2016-01-01

Tinnitus correlates with elevated hearing thresholds and reduced cochlear compression. We hypothesized that reduced peripheral input leads to elevated neuronal gain resulting in the perception of a phantom sound. The purpose of this pilot study was to test whether compensating for this peripheral deficit could reduce the tinnitus percept acutely using customized auditory stimulation. To further enhance the effects of auditory stimulation, this intervention was paired with high-definition transcranial direct current stimulation (HD-tDCS). A randomized sham-controlled, single blind study was conducted in a clinical setting on adult participants with chronic tinnitus (n = 14). Compensatory auditory stimulation (CAS) and HD-tDCS were administered either individually or in combination in order to access the effects of both interventions on tinnitus perception. CAS consisted of sound exposure typical to daily living (20-minute sound-track of a TV show), which was adapted with compressive gain to compensate for deficits in each subject's individual audiograms. Minimum masking levels and the visual analog scale were used to assess the strength of the tinnitus percept immediately before and after the treatment intervention. CAS reduced minimum masking levels, and visual analog scale trended towards improvement. Effects of HD-tDCS could not be resolved with the current sample size. The results of this pilot study suggest that providing tailored auditory stimulation with frequency-specific gain and compression may alleviate tinnitus in a clinical population. Further experimentation with longer interventions is warranted in order to optimize effect sizes.

A longitudinal cluster-randomized controlled study on the accumulating effects of individualized literacy instruction on students' reading from first through third grade.

PubMed

Connor, Carol McDonald; Morrison, Frederick J; Fishman, Barry; Crowe, Elizabeth C; Al Otaiba, Stephanie; Schatschneider, Christopher

2013-08-01

Using a longitudinal cluster-randomized controlled design, we examined whether students' reading outcomes differed when they received 1, 2, or 3 years of individualized reading instruction from first through third grade, compared with a treated control group. More than 45% of students came from families living in poverty. Following students, we randomly assigned their teachers each year to deliver individualized reading instruction or a treated control condition intervention focused on mathematics. Students who received individualized reading instruction in all three grades showed the strongest reading skills by the end of third grade compared with those who received fewer years of such instruction. There was inconsistent evidence supporting a sustained first-grade treatment effect: Individualized instruction in first grade was necessary but not sufficient for stronger third-grade reading outcomes. These effects were achieved by regular classroom teachers who received professional development, which indicates that policies that support the use of evidence-based reading instruction and teacher training can yield increased student achievement.

Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

PubMed

Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

2013-08-01

This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

The Mediterranean Diet decreases LDL atherogenicity in high cardiovascular risk individuals: a randomized controlled trial.

PubMed

Hernáez, Álvaro; Castañer, Olga; Goday, Alberto; Ros, Emilio; Pintó, Xavier; Estruch, Ramón; Salas-Salvadó, Jordi; Corella, Dolores; Arós, Fernando; Serra-Majem, Lluis; Martínez-González, Miguel Ángel; Fiol, Miquel; Lapetra, José; de la Torre, Rafael; López-Sabater, M Carmen; Fitó, Montserrat

2017-09-01

Traditional Mediterranean diet (TMD) protects against cardiovascular disease through several mechanisms such as decreasing LDL cholesterol levels. However, evidence regarding TMD effects on LDL atherogenic traits (resistance against oxidation, size, composition, cytotoxicity) is scarce. We assessed the effects of a 1-year intervention with a TMD on LDL atherogenic traits in a random sub-sample of individuals from the PREDIMED study (N = 210). We compared two TMDs: one enriched with virgin olive oil (TMD-VOO, N = 71) and another with nuts (TMD-Nuts, N = 68), versus a low-fat control diet (N = 71). After the TMD-VOO intervention, LDL resistance against oxidation increased (+6.46%, p = 0.007), the degree of LDL oxidative modifications decreased (-36.3%, p<0.05), estimated LDL particle size augmented (+3.06%, p = 0.021), and LDL particles became cholesterol-rich (+2.41% p = 0.013) relative to the low-fat control diet. LDL lipoproteins became less cytotoxic for macrophages only relative to baseline (-13.4%, p = 0.019). No significant effects of the TMD-Nuts intervention on LDL traits were observed versus the control diet. Adherence to a TMD, particularly when enriched with virgin olive oil, decreased LDL atherogenicity in high cardiovascular risk individuals. The development of less atherogenic LDLs could contribute to explaining some of the cardioprotective benefits of this dietary pattern. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms.

PubMed

Heo, Moonseong; Litwin, Alain H; Blackstock, Oni; Kim, Namhee; Arnsten, Julia H

2017-02-01

We derived sample size formulae for detecting main effects in group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms. Such designs are necessary when experimental interventions need to be administered to groups of subjects whereas control conditions need to be administered to individual subjects. This type of trial, often referred to as a partially nested or partially clustered design, has been implemented for management of chronic diseases such as diabetes and is beginning to emerge more commonly in wider clinical settings. Depending on the research setting, the level of hierarchy of data structure for the experimental arm can be three or two, whereas that for the control arm is two or one. Such different levels of data hierarchy assume correlation structures of outcomes that are different between arms, regardless of whether research settings require two or three level data structure for the experimental arm. Therefore, the different correlations should be taken into account for statistical modeling and for sample size determinations. To this end, we considered mixed-effects linear models with different correlation structures between experimental and control arms to theoretically derive and empirically validate the sample size formulae with simulation studies.

A preliminary, randomized trial of aerobic exercise for alcohol dependence

PubMed Central

Brown, Richard A.; Abrantes, Ana M.; Minami, Haruka; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John M.; Strong, David R.; Dubreuil, Mary Ella; Gordon, Alan A.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory L.

2015-01-01

Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relative untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n = 25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use. PMID:24666811

A cross-sectional study of workplace social capital and blood pressure: a multilevel analysis at Japanese manufacturing companies

PubMed Central

Fujino, Yoshihisa; Kubo, Tatsuhiko; Kunimoto, Masamizu; Tabata, Hidetoshi; Tsuchiya, Takuto; Kadowaki, Koji; Nakamura, Takehiro; Oyama, Ichiro

2013-01-01

Objectives We examined the contextual effect of workplace social capital on systolic blood pressure (SBP). Design Cross-sectional. Setting A conglomerate from 58 workplaces in Japan. Participants Of the 5844 workers at a Japanese conglomerate from 58 workplaces, 5368 were recruited. Individuals who received drugs for hypertension (n=531) and who lacked information on any variable (n=167) were excluded from the analyses, leaving 4735 individuals (3281 men and 1454 women) for inclusion. Primary and secondary outcome measures Systolic blood pressure. Results The contextual effect of workplace social capital on SBP was examined using a multilevel regression analysis with a random intercept. Coworker support had a contextual effect at the workplace level (coefficient=−1.97, p=0.043), while a lack of trust for coworkers (coefficient=0.27, p=0.039) and lack of helpfulness from coworkers were associated with SBP (coefficient=0.28, p=0.002). Conclusions The present study suggested that social capital at the workplace level has beneficial effects on SBP. PMID:23386581

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency

PubMed Central

Kapadia, Naaz; Masani, Kei; Catharine Craven, B.; Giangregorio, Lora M.; Hitzig, Sander L.; Richards, Kieva; Popovic, Milos R.

2014-01-01

Background Multi-channel surface functional electrical stimulation (FES) for walking has been used to improve voluntary walking and balance in individuals with spinal cord injury (SCI). Objective To investigate short- and long-term benefits of 16 weeks of thrice-weekly FES-assisted walking program, while ambulating on a body weight support treadmill and harness system, versus a non-FES exercise program, on improvements in gait and balance in individuals with chronic incomplete traumatic SCI, in a randomized controlled trial design. Methods Individuals with traumatic and chronic (≥18 months) motor incomplete SCI (level C2 to T12, American Spinal Cord Injury Association Impairment Scale C or D) were recruited from an outpatient SCI rehabilitation hospital, and randomized to FES-assisted walking therapy (intervention group) or aerobic and resistance training program (control group). Outcomes were assessed at baseline, and after 4, 6, and 12 months. Gait, balance, spasticity, and functional measures were collected. Results Spinal cord independence measure (SCIM) mobility sub-score improved over time in the intervention group compared with the control group (baseline/12 months: 17.27/21.33 vs. 19.09/17.36, respectively). On all other outcome measures the intervention and control groups had similar improvements. Irrespective of group allocation walking speed, endurance, and balance during ambulation all improved upon completion of therapy, and majority of participants retained these gains at long-term follow-ups. Conclusions Task-oriented training improves walking ability in individuals with incomplete SCI, even in the chronic stage. Further randomized controlled trials, involving a large number of participants are needed, to verify if FES-assisted treadmill training is superior to aerobic and strength training. PMID:25229735

A randomized, single-blind cross-over design evaluating the effectiveness of an individually defined, targeted physical therapy approach in treatment of children with cerebral palsy.

PubMed

Franki, Inge; Van den Broeck, Christine; De Cat, Josse; Tijhuis, Wieke; Molenaers, Guy; Vanderstraeten, Guy; Desloovere, Kaat

2014-10-01

A pilot study to compare the effectiveness of an individual therapy program with the effects of a general physical therapy program. A randomized, single-blind cross-over design. Ten ambulant children with bilateral spastic cerebral palsy, age four to nine years. Participants were randomly assigned into a ten-week individually defined, targeted or a general program, followed by a cross-over. Evaluation was performed using the Gross Motor Function Measure-88 and three-dimensional gait analysis. General outcome parameters were Gross Motor Function Measure-88 scores, time and distance parameters, gait profile score and movement analysis profiles. Individual goal achievement was evaluated using z-scores for gait parameters and Goal Attainment Scale for gross motor function. No significant changes were observed regarding gross motor function. Only after individualized therapy, step- and stride-length increased significantly (p = 0.022; p = 0.017). Change in step-length was higher after the individualized program (p = 0.045). Within-group effects were found for the pelvis in transversal plane after the individualized program (p = 0.047) and in coronal plane after the general program (p = 0.047). Between-program differences were found for changes in the knee in sagittal plane, in the advantage of the individual program (p = 0.047). A median difference in z-score of 0.279 and 0.419 was measured after the general and individualized program, respectively. Functional goal attainment was higher after the individual therapy program compared with the general program (48 to 43.5). The results indicate slightly favorable effects towards the individualized program. To detect clinically significant changes, future studies require a minimal sample size of 72 to 90 participants. © The Author(s) 2014.

Increased Survival Among HIV-Infected PWID Receiving a Multi-Level HIV Risk and Stigma Reduction Intervention: Results From a Randomized Controlled Trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Ha, Tran Viet; Latkin, Carl A; Sripaipan, Teerada; Zelaya, Carla E; Davis, Wendy W; Celentano, David D; Quan, Vu Minh

2017-02-01

In Vietnam, where 58% of prevalent HIV cases are attributed to people who inject drugs, we evaluated whether a multi-level intervention could improve care outcomes and increase survival. We enrolled 455 HIV-infected males who inject drugs from 32 communes in Thai Nguyen Province. Communes were randomized to a community stigma reduction intervention or standard of care and then within each commune, to an individual enhanced counseling intervention or standard of care, resulting into 4 arms: Arm 1 (standard of care); Arm 2 (community intervention alone); Arm 3 (individual intervention alone); and Arm 4 (community + individual interventions). Follow-up was conducted at 6, 12, 18, and 24 months to assess survival. Overall mortality was 23% (n = 103/455) more than 2 years. There were no losses to follow-up for the mortality endpoint. Survival at 24 months was different across arms: Arm 4 (87%) vs Arm 1 (82%) vs Arm 2 (68%) vs Arm 3 (73%); log-rank test for comparison among arms: P = 0.001. Among those with CD4 cell count <200 cells/mm and not on antiretroviral therapy at baseline (n = 162), survival at 24 months was higher in Arm 4 (84%) compared with other arms (Arm 1: 61%; Arm 2: 50%; Arm 3: 53%; P-value = 0.002). Overall, Arm 4 (community + individual interventions) had increased uptake of antiretroviral therapy compared with Arms 1, 2, and 3. This multi-level behavioral intervention seemed to increase survival of HIV-infected participants more than a 2-year period. Relative to the standard of care, the greatest intervention effect was among those with lower CD4 cell counts.

Exploring individual cognitions, self-regulation skills, and environmental-level factors as mediating variables of two versions of a Web-based computer-tailored nutrition education intervention aimed at adults: A randomized controlled trial.

PubMed

Springvloet, Linda; Lechner, Lilian; Candel, Math J J M; de Vries, Hein; Oenema, Anke

2016-03-01

This study explored whether the determinants that were targeted in two versions of a Web-based computer-tailored nutrition education intervention mediated the effects on fruit, high-energy snack, and saturated fat intake among adults who did not comply with dietary guidelines. A RCT was conducted with a basic (tailored intervention targeting individual cognitions and self-regulation), plus (additionally targeting environmental-level factors), and control group (generic nutrition information). Participants were recruited from the general Dutch adult population and randomly assigned to one of the study groups. Online self-reported questionnaires assessed dietary intake and potential mediating variables (behavior-specific cognitions, action- and coping planning, environmental-level factors) at baseline and one (T1) and four (T2) months post-intervention (i.e. four and seven months after baseline). The joint-significance test was used to establish mediating variables at different time points (T1-mediating variables - T2-intake; T1-mediating variables - T1-intake; T2-mediating variables - T2-intake). Educational differences were examined by testing interaction terms. The effect of the plus version on fruit intake was mediated (T2-T2) by intention and fruit availability at home and for high-educated participants also by attitude. Among low/moderate-educated participants, high-energy snack availability at home mediated (T1-T1) the effect of the basic version on high-energy snack intake. Subjective norm mediated (T1-T1) the effect of the basic version on fat intake among high-educated participants. Only some of the targeted determinants mediated the effects of both intervention versions on fruit, high-energy snack, and saturated fat intake. A possible reason for not finding a more pronounced pattern of mediating variables is that the educational content was tailored to individual characteristics and that participants only received feedback for relevant and not for all assessed mediating variables. Netherlands Trial Registry NTR3396. Copyright © 2015. Published by Elsevier Ltd.

Examining individual, interpersonal, and environmental influences on children's physical activity levels.

PubMed

Wilk, Piotr; Clark, Andrew F; Maltby, Alana; Smith, Christine; Tucker, Patricia; Gilliland, Jason A

2018-04-01

The purpose of this study was to explore individual-level socio-demographic factors and interpersonal-level factors related to social support, as well as the potential role of neighborhood and school environments that may influence the physical activity (PA) levels of children (ages 9-11). Child and parent questionnaires included individual and interpersonal factors, and PA behaviour. Home postal codes were used to determine the neighbourhood the child resides within, as well as their geographic accessibility to recreation opportunities. The models were assessed using a series of cross-classified random-intercept multi-level regression models as children's PA may be affected by both the school they attend and the neighbourhood in which they live. In the unadjusted model, PA varied significantly across school environments (γ = 0.023; CI: 0.003-0.043), but not across neighbourhoods (γ = 0.007; CI: -0.008 to 0.021). Boys were found to be more active compared to girls (b = 0.183; CI: 0.092-0.275), while the level of PA was lower for children whose fathers achieved post-secondary education (b = - 0.197; CI: -0.376 to 0.018) than for those whose parents completed only high school. The addition of the individual-level correlates did not have a substantial effect on level 2 variances and the level 2 variance associated with school environment remained statistically significant. At the interpersonal level, children's perception of parental support (b = 0.117; CI: 0.091-0.143) and peer support (b = 0.111; CI: 0.079-0.142) were positively related to PA. The level 2 variance for the school environment became statistically non-significant when the interpersonal factors were added to the model. At the environmental level, geographic accessibility did not have a significant association with PA and they did not significantly affect level 1 or 2 variance. As many children do not accrue sufficient levels of PA, identifying modifiable determinants is necessary to develop effective strategies to increase PA.

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

PubMed

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.

Role of Statistical Random-Effects Linear Models in Personalized Medicine

PubMed Central

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

2012-01-01

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

Sudden gains in cognitive therapy and interpersonal therapy for social anxiety disorder.

PubMed

Bohn, Christiane; Aderka, Idan M; Schreiber, Franziska; Stangier, Ulrich; Hofmann, Stefan G

2013-02-01

The present study examined the effects of sudden gains on treatment outcome in a randomized controlled trial including individual cognitive therapy (CT) and interpersonal therapy (IPT) for social anxiety disorder (SAD). Participants were 67 individuals with SAD who received 16 treatment sessions. Symptom severity at each session was assessed using the Social Phobia Weekly Summary Scale (Clark et al., 2003). Results indicate that 22.4% of participants experienced a sudden gain during treatment. Individuals with sudden gains had significantly lower social anxiety symptoms at post-treatment and follow-up compared to individuals without sudden gains. Sudden gains in CT and IPT had similar magnitudes, frequencies, and timings. However, sudden gains resulted in lower levels of post-treatment symptoms in CT compared to IPT. Cognitive changes did not precede sudden gains, but sudden gains resulted in cognitive changes. Sudden gains in CT and IPT for SAD are predictive of long-term outcome. In addition, the effect of sudden gains may be greater in CT compared to IPT.

Attention Bias Modification training in individuals with depressive symptoms: A randomized controlled trial.

PubMed

Yang, Wenhui; Ding, Zhirui; Dai, Ting; Peng, Fang; Zhang, John X

2015-12-01

Negative attentional biases are often considered to have a causal role in the onset and maintenance of depressive symptoms. This suggests that reduction of such biases may be a plausible strategy in the treatment of depressive symptoms. The present clinical randomized controlled trial examined long-term effects of a computerized attention bias modification (ABM) procedure on individuals with elevated depressive symptoms. In a double-blind study design, 77 individuals with ongoing mild to severe symptoms of depression were randomly assigned to one of three conditions: 1) ABM training (n = 27); 2) placebo (n = 27); 3) assessment-only (n = 23). In both the ABM and placebo conditions, participants completed 8 sessions of 216-trials (1728 in total) during a 2-week period. Assessments were conducted at pre-training and post-training (0, 2, 4, 8-week, 3, 7-month follow-ups). Change in depressive symptoms and restoration of asymptomatic level were the primary outcome measures. In the ABM, but not the other two conditions, significant reductions in depressive symptoms were found at post-training and maintained during the 3-month follow-up. Importantly, more participants remained asymptomatic in the ABM condition, as compared to the other two conditions, from post-training to 7-month follow-up. ABM also significantly reduced secondary outcome measures including rumination and trait anxiety, and notably, the ABM effect on reducing depressive symptoms was mediated by rumination. Generalization of the findings may be limited because the present sample included only college students. The ABM effect on reducing depressive symptoms was maintained for at least 3-month duration in individuals with elevated depressive symptoms, and these results suggest that ABM may be a useful tool for the prevention of depressive symptoms. CLINICALTRIALS.GOV: NCT01628016. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Unprotected sex of homeless youth: results from a multilevel dyadic analysis of individual, social network, and relationship factors.

PubMed

Kennedy, David P; Tucker, Joan S; Green, Harold D; Golinelli, Daniela; Ewing, Brett

2012-10-01

Homeless youth have elevated risk of HIV through sexual behavior. This project investigates the multiple levels of influence on unprotected sex among homeless youth, including social network, individual, and partner level influences. Findings are based on analyses of an exploratory, semi-structured interview (n = 40) and a structured personal network interview (n = 240) with randomly selected homeless youth in Los Angeles. Previous social network studies of risky sex by homeless youth have collected limited social network data from non-random samples and have not distinguished sex partner influences from other network influences. The present analyses have identified significant associations with unprotected sex at multiple levels, including individual, partner, and, to a lesser extent, the social network. Analyses also distinguished between youth who did or did not want to use condoms when they had unprotected sex. Implications for social network based HIV risk interventions with homeless youth are discussed.

Unprotected Sex of Homeless Youth: Results from a Multilevel Analysis of Individual, Social Network, and Relationship Factors

PubMed Central

Kennedy, David P.; Tucker, Joan S.; Green, Harold D.; Golinelli, Daniela; Ewing, Brett

2012-01-01

Homeless youth have elevated risk of HIV through sexual behavior. This project investigates the multiple levels of influence on unprotected sex among homeless youth, including social network, individual, and partner level influences. Findings are based on analyses of an exploratory, semi-structured interview (n=40) and a structured personal network interview (n=240) with randomly selected homeless youth in Los Angeles. Previous social network studies of risky sex by homeless youth have collected limited social network data from non-random samples and have not distinguished sex partner influences from other network influences. The present analyses have identified significant associations with unprotected sex at multiple levels, including individual, partner, and, to a lesser extent, the social network. Analyses also distinguished between youth who wished they used condoms after having unprotected sex and youth who did not regret having unprotected sex. Implications for social network based HIV risk interventions with homeless youth are discussed. PMID:22610421

Allocating under the influence: Effects of alcohol intoxication and social identification on in-group favoritism.

PubMed

Zhou, Jin; Heim, Derek; Monk, Rebecca; Levy, Andrew; Pollard, Paul

2018-06-01

The "social lubrication" function of alcohol during interpersonal interactions is well documented. However, less is known about the effects of alcohol consumption on group-level behavior. Empirical findings from social psychological literature suggest that individuals tend to favor those who are considered as members of their own social group. Not yet evaluated is how alcohol intoxication interacts with this group-level bias. Therefore, the current study examined experimentally the effects of intoxication on group bias. Ninety-four individuals (M age = 20.18, SD = 2.36, 55 women, 39 men) were randomly assigned to consume an alcoholic (n = 48) or a placebo (n = 46) drink before completing manipulated allocation matrices, a task which measured the distribution of hypothetical monetary awards based on social groups. Results point to an interaction between drink condition and social group identification, whereby identification was significantly associated with in-group favoritism among intoxicated individuals only. Following alcohol consumption, participants with higher identification with their social group were more likely to demonstrate allocation strategies that favored their own group members. However, nonsignificant effects were observed for those in the placebo condition. The findings highlight how alcohol intoxication may facilitate group bias that results from social group identification. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Modeling spatial effects of PM{sub 2.5} on term low birth weight in Los Angeles County

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

Coker, Eric, E-mail: cokerer@onid.orst.edu; Ghosh, Jokay; Jerrett, Michael

Air pollution epidemiological studies suggest that elevated exposure to fine particulate matter (PM{sub 2.5}) is associated with higher prevalence of term low birth weight (TLBW). Previous studies have generally assumed the exposure–response of PM{sub 2.5} on TLBW to be the same throughout a large geographical area. Health effects related to PM{sub 2.5} exposures, however, may not be uniformly distributed spatially, creating a need for studies that explicitly investigate the spatial distribution of the exposure–response relationship between individual-level exposure to PM{sub 2.5} and TLBW. Here, we examine the overall and spatially varying exposure–response relationship between PM{sub 2.5} and TLBW throughout urbanmore » Los Angeles (LA) County, California. We estimated PM{sub 2.5} from a combination of land use regression (LUR), aerosol optical depth from remote sensing, and atmospheric modeling techniques. Exposures were assigned to LA County individual pregnancies identified from electronic birth certificates between the years 1995-2006 (N=1,359,284) provided by the California Department of Public Health. We used a single pollutant multivariate logistic regression model, with multilevel spatially structured and unstructured random effects set in a Bayesian framework to estimate global and spatially varying pollutant effects on TLBW at the census tract level. Overall, increased PM{sub 2.5} level was associated with higher prevalence of TLBW county-wide. The spatial random effects model, however, demonstrated that the exposure–response for PM{sub 2.5} and TLBW was not uniform across urban LA County. Rather, the magnitude and certainty of the exposure–response estimates for PM{sub 2.5} on log odds of TLBW were greatest in the urban core of Central and Southern LA County census tracts. These results suggest that the effects may be spatially patterned, and that simply estimating global pollutant effects obscures disparities suggested by spatial patterns of effects. Studies that incorporate spatial multilevel modeling with random coefficients allow us to identify areas where air pollutant effects on adverse birth outcomes may be most severe and policies to further reduce air pollution might be most effective. - Highlights: • We model the spatial dependency of PM{sub 2.5} effects on term low birth weight (TLBW). • PM{sub 2.5} effects on TLBW are shown to vary spatially across urban LA County. • Modeling spatial dependency of PM{sub 2.5} health effects may identify effect 'hotspots'. • Birth outcomes studies should consider the spatial dependency of PM{sub 2.5} effects.« less

COGNITIVE BEHAVIORAL THERAPY AGE EFFECTS IN CHILD AND ADOLESCENT ANXIETY: AN INDIVIDUAL PATIENT DATA METAANALYSIS

PubMed Central

Bennett, Kathryn; Manassis, Katharina; Walter, Stephen D.; Cheung, Amy; Wilansky-Traynor, Pamela; Diaz-Granados, Natalia; Duda, Stephanie; Rice, Maureen; Baer, Susan; Barrett, Paula; Bodden, Denise; Cobham, Vanessa E.; Dadds, Mark R.; Flannery-Schroeder, Ellen; Ginsburg, Golda; Heyne, David; Hudson, Jennifer L.; Kendall, Philip C.; Liber, Juliette; Warner, Carrie Masia; Mendlowitz, Sandra; Nauta, Maaike H.; Rapee, Ronald M.; Silverman, Wendy; Siqueland, Lynne; Spence, Susan H.; Utens, Elisabeth; Wood, Jeffrey J.

2015-01-01

Background Investigations of age effects on youth anxiety outcomes in randomized trials (RCTs) of cognitive behavior therapy (CBT) have failed to yield a clear result due to inadequate statistical power and methodologic weaknesses. We conducted an individual patient data metaanalysis to address this gap. Question Does age moderate CBT effect size, measured by a clinically and statistically significant interaction between age and CBT exposure? Methods All English language RCTs of CBT for anxiety in 6–19 year olds were identified using systematic review methods. Investigators of eligible trials were invited to submit their individual patient data. The anxiety disorder interview schedule (ADIS) primary diagnosis severity score was the primary outcome. Age effects were investigated using multilevel modeling to account for study level data clustering and random effects. Results Data from 17 of 23 eligible trials were obtained (74%); 16 studies and 1,171 (78%) cases were available for the analysis. No interaction between age and CBT exposure was found in a model containing age, sex, ADIS baseline severity score, and comorbid depression diagnosis (power ≥ 80%). Sensitivity analyses, including modeling age as both a categorical and continuous variable, revealed this result was robust. Conclusions Adolescents who receive CBT in efficacy research studies show benefits comparable to younger children. However, CBT protocol modifications routinely carried out by expert trial therapists may explain these findings. Adolescent CBT protocols are needed to facilitate the transportability of efficacy research effects to usual care settings where therapists may have less opportunity for CBT training and expertise development. PMID:23658135

Using anthropomorphic avatars resembling sedentary older individuals as models to enhance self-efficacy and adherence to physical activity: psychophysiological correlates.

PubMed

Ruiz, Jorge G; Andrade, Allen D; Anam, Ramankumar; Aguiar, Rudxandra; Sun, Huaping; Roos, Bernard A

2012-01-01

The prevalence of obesity and associated health complications are currently at unprecedented levels. Physical activity in this population can improve patient outcomes. Virtual reality (VR) self-modeling may improve self-efficacy and adherence to physical activity. We conducted a comparative study of 30 participants randomized to 3 versions of a 3D avatar-based VR intervention about exercise: virtual representation of the self exercising condition; virtual representation of other person exercising and control condition. Participants in the virtual representation of the self group significantly increased their levels of physical activity. The improvement in physical activity for participants in the visual representation of other person exercising was marginal. The improvement for the control group was not significant. However, the effect sizes for comparing the pre and post intervention physical activity levels were quite large for all three groups. We did not find any group difference in the improvements of physical activity levels and self-efficacy among sedentary, overweight or obese individuals.

Group navigation and the "many-wrongs principle" in models of animal movement.

PubMed

Codling, E A; Pitchford, J W; Simpson, S D

2007-07-01

Traditional studies of animal navigation over both long and short distances have usually considered the orientation ability of the individual only, without reference to the implications of group membership. However, recent work has suggested that being in a group can significantly improve the ability of an individual to align toward and reach a target direction or point, even when all group members have limited navigational ability and there are no leaders. This effect is known as the "many-wrongs principle" since the large number of individual navigational errors across the group are suppressed by interactions and group cohesion. In this paper, we simulate the many-wrongs principle using a simple individual-based model of movement based on a biased random walk that includes group interactions. We study the ability of the group as a whole to reach a target given different levels of individual navigation error, group size, interaction radius, and environmental turbulence. In scenarios with low levels of environmental turbulence, simulation results demonstrate a navigational benefit from group membership, particularly for small group sizes. In contrast, when movement takes place in a highly turbulent environment, simulation results suggest that the best strategy is to navigate as individuals rather than as a group.

Neuronal effects of nicotine during auditory selective attention.

PubMed

Smucny, Jason; Olincy, Ann; Eichman, Lindsay S; Tregellas, Jason R

2015-06-01

Although the attention-enhancing effects of nicotine have been behaviorally and neurophysiologically well-documented, its localized functional effects during selective attention are poorly understood. In this study, we examined the neuronal effects of nicotine during auditory selective attention in healthy human nonsmokers. We hypothesized to observe significant effects of nicotine in attention-associated brain areas, driven by nicotine-induced increases in activity as a function of increasing task demands. A single-blind, prospective, randomized crossover design was used to examine neuronal response associated with a go/no-go task after 7 mg nicotine or placebo patch administration in 20 individuals who underwent functional magnetic resonance imaging at 3T. The task design included two levels of difficulty (ordered vs. random stimuli) and two levels of auditory distraction (silence vs. noise). Significant treatment × difficulty × distraction interaction effects on neuronal response were observed in the hippocampus, ventral parietal cortex, and anterior cingulate. In contrast to our hypothesis, U and inverted U-shaped dependencies were observed between the effects of nicotine on response and task demands, depending on the brain area. These results suggest that nicotine may differentially affect neuronal response depending on task conditions. These results have important theoretical implications for understanding how cholinergic tone may influence the neurobiology of selective attention.

A randomized controlled study of power posing before public speaking exposure for social anxiety disorder: No evidence for augmentative effects.

PubMed

Davis, Michelle L; Papini, Santiago; Rosenfield, David; Roelofs, Karin; Kolb, Sarah; Powers, Mark B; Smits, Jasper A J

2017-12-01

This manuscript details a randomized controlled study designed to test the efficacy of power posing (i.e., briefly holding postures associated with dominance and power) as an augmentative strategy for exposure therapy for social anxiety disorder (SAD). Seventy-three individuals diagnosed with SAD were assigned to one of three conditions: power posing, submissive posing, or rest (no posing) prior to participating in an exposure therapy session. Participants were assessed for between-group differences in pre- and post-manipulation salivary hormone levels, within-session subjective experiences of fear, and pre- and 1-week post-treatment SAD severity outcome measures. Though the intervention resulted in decreased SAD symptom severity one week later, analyses revealed no significant between-group differences on any tested variables. Accordingly, this study provides no evidence to suggest that power posing impacts hormone levels or exposure therapy outcomes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Exercise as Treatment for Anxiety: Systematic Review and Analysis

PubMed Central

Stonerock, Gregory L.; Hoffman, Benson M.; Smith, Patrick J.; Blumenthal, James A.

2015-01-01

Background Exercise has been shown to reduce symptoms of anxiety, but few studies have studied exercise in individuals pre-selected because of their high anxiety. Purpose To review and critically evaluate studies of exercise training in adults with either high levels of anxiety or an anxiety disorder. Methods We conducted a systematic review of randomized clinical trials (RCTs) in which anxious adults were randomized to an exercise or non-exercise control condition. Data were extracted concerning anxiety outcomes and study design. Existing meta-analyses were also reviewed. Results Evidence from 12 RCTs suggested benefits of exercise, for select groups, similar to established treatments and greater than placebo. However, most studies had significant methodological limitations, including small sample sizes, concurrent therapies, and inadequate assessment of adherence and fitness levels. Conclusions Exercise may be a useful treatment for anxiety, but lack of data from rigorous, methodologically sound RCTs precludes any definitive conclusions about its effectiveness. PMID:25697132

Exercise as Treatment for Anxiety: Systematic Review and Analysis.

PubMed

Stonerock, Gregory L; Hoffman, Benson M; Smith, Patrick J; Blumenthal, James A

2015-08-01

Exercise has been shown to reduce symptoms of anxiety, but few studies have studied exercise in individuals preselected because of their high anxiety. The objective of this study is to review and critically evaluate studies of exercise training in adults with either high levels of anxiety or an anxiety disorder. We conducted a systematic review of randomized clinical trials (RCTs) in which anxious adults were randomized to an exercise or nonexercise control condition. Data were extracted concerning anxiety outcomes and study design. Existing meta-analyses were also reviewed. Evidence from 12 RCTs suggested benefits of exercise, for select groups, similar to established treatments and greater than placebo. However, most studies had significant methodological limitations, including small sample sizes, concurrent therapies, and inadequate assessment of adherence and fitness levels. Exercise may be a useful treatment for anxiety, but lack of data from rigorous, methodologically sound RCTs precludes any definitive conclusions about its effectiveness.

Mixed Effects Models for Resampled Network Statistics Improves Statistical Power to Find Differences in Multi-Subject Functional Connectivity

PubMed Central

Narayan, Manjari; Allen, Genevera I.

2016-01-01

Many complex brain disorders, such as autism spectrum disorders, exhibit a wide range of symptoms and disability. To understand how brain communication is impaired in such conditions, functional connectivity studies seek to understand individual differences in brain network structure in terms of covariates that measure symptom severity. In practice, however, functional connectivity is not observed but estimated from complex and noisy neural activity measurements. Imperfect subject network estimates can compromise subsequent efforts to detect covariate effects on network structure. We address this problem in the case of Gaussian graphical models of functional connectivity, by proposing novel two-level models that treat both subject level networks and population level covariate effects as unknown parameters. To account for imperfectly estimated subject level networks when fitting these models, we propose two related approaches—R2 based on resampling and random effects test statistics, and R3 that additionally employs random adaptive penalization. Simulation studies using realistic graph structures reveal that R2 and R3 have superior statistical power to detect covariate effects compared to existing approaches, particularly when the number of within subject observations is comparable to the size of subject networks. Using our novel models and methods to study parts of the ABIDE dataset, we find evidence of hypoconnectivity associated with symptom severity in autism spectrum disorders, in frontoparietal and limbic systems as well as in anterior and posterior cingulate cortices. PMID:27147940

Unexpected Decrease in Milk Production after Fenbendazole Treatment of Dairy Cows during Early Grazing Season

PubMed Central

Ravinet, Nadine; Chartier, Christophe; Bareille, Nathalie; Lehebel, Anne; Ponnau, Adeline; Brisseau, Nadine; Chauvin, Alain

2016-01-01

Gastrointestinal nematodes (GIN) infection can impair milk production (MP) in dairy cows. To investigate whether MP would be optimized by spring targeted-selective anthelmintic treatment in grazing cows, we assessed (1) the effect on MP of an anthelmintic treatment applied 1.5 to 2 months after turn-out, and (2) herd and individual indicators associated with the post-treatment MP response. A randomized controlled clinical trial was conducted in 13 dairy farms (578 cows) in western France in spring 2012. In each herd, lactating cows of the treatment group received fenbendazole orally, control cows remained untreated. Daily cow MP was recorded from 2 weeks before until 15 weeks after treatment. Individual serum pepsinogen and anti-Ostertagia antibody levels (expressed as ODR), faecal egg count and bulk tank milk (BTM) Ostertagia ODR were measured at treatment time. Anthelmintic treatment applied during the previous housing period was recorded for each cow. In each herd, information regarding heifers’ grazing and anthelmintic treatment history was collected to assess the Time of Effective Contact (TEC, in months) with GIN infective larvae before the first calving. The effect of treatment on weekly MP averages and its relationships with herd and individual indicators were studied using linear mixed models with two nested random effects (cow within herd). Unexpectedly, spring treatment had a significant detrimental effect on MP (-0.92 kg/cow/day on average). This negative MP response was particularly marked in high producing cows, in cows not treated during the previous housing period or with high pepsinogen levels, and in cows from herds with a high TEC or a high BTM ODR. This post-treatment decrease in MP may be associated with immuno-inflammatory mechanisms. Until further studies can assess whether this unexpected result can be generalized, non-persistent treatment of immunized adult dairy cows against GIN should not be recommended in early grazing season. PMID:26808824

Unexpected Decrease in Milk Production after Fenbendazole Treatment of Dairy Cows during Early Grazing Season.

PubMed

Ravinet, Nadine; Chartier, Christophe; Bareille, Nathalie; Lehebel, Anne; Ponnau, Adeline; Brisseau, Nadine; Chauvin, Alain

2016-01-01

Gastrointestinal nematodes (GIN) infection can impair milk production (MP) in dairy cows. To investigate whether MP would be optimized by spring targeted-selective anthelmintic treatment in grazing cows, we assessed (1) the effect on MP of an anthelmintic treatment applied 1.5 to 2 months after turn-out, and (2) herd and individual indicators associated with the post-treatment MP response. A randomized controlled clinical trial was conducted in 13 dairy farms (578 cows) in western France in spring 2012. In each herd, lactating cows of the treatment group received fenbendazole orally, control cows remained untreated. Daily cow MP was recorded from 2 weeks before until 15 weeks after treatment. Individual serum pepsinogen and anti-Ostertagia antibody levels (expressed as ODR), faecal egg count and bulk tank milk (BTM) Ostertagia ODR were measured at treatment time. Anthelmintic treatment applied during the previous housing period was recorded for each cow. In each herd, information regarding heifers' grazing and anthelmintic treatment history was collected to assess the Time of Effective Contact (TEC, in months) with GIN infective larvae before the first calving. The effect of treatment on weekly MP averages and its relationships with herd and individual indicators were studied using linear mixed models with two nested random effects (cow within herd). Unexpectedly, spring treatment had a significant detrimental effect on MP (-0.92 kg/cow/day on average). This negative MP response was particularly marked in high producing cows, in cows not treated during the previous housing period or with high pepsinogen levels, and in cows from herds with a high TEC or a high BTM ODR. This post-treatment decrease in MP may be associated with immuno-inflammatory mechanisms. Until further studies can assess whether this unexpected result can be generalized, non-persistent treatment of immunized adult dairy cows against GIN should not be recommended in early grazing season.

Individual mineral supplement intake by ewes swath grazing or confinement fed pea-barley forage

USDA-ARS?s Scientific Manuscript database

Sixty mature ewes (non-pregnant, non-lactating) were used in a completely randomized design to determine if feeding method of pea-barley forage (swath grazing or hay in confinement) had an effect on individual ewe mineral consumption. Thirty ewes were randomly allocated to 3 confinement pens and 30 ...

Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

ERIC Educational Resources Information Center

Braam, W.; Didden, R.; Smits, M.; Curfs, L.

2008-01-01

Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

A Wii Bit of Fun: A Novel Platform to Deliver Effective Balance Training to Older Adults.

PubMed

Whyatt, Caroline; Merriman, Niamh A; Young, William R; Newell, Fiona N; Craig, Cathy

2015-12-01

Falls and fall-related injuries are symptomatic of an aging population. This study aimed to design, develop, and deliver a novel method of balance training, using an interactive game-based system to promote engagement, with the inclusion of older adults at both high and low risk of experiencing a fall. Eighty-two older adults (65 years of age and older) were recruited from sheltered accommodation and local activity groups. Forty volunteers were randomly selected and received 5 weeks of balance game training (5 males, 35 females; mean, 77.18 ± 6.59 years), whereas the remaining control participants recorded levels of physical activity (20 males, 22 females; mean, 76.62 ± 7.28 years). The effect of balance game training was measured on levels of functional balance and balance confidence in individuals with and without quantifiable balance impairments. Balance game training had a significant effect on levels of functional balance and balance confidence (P < 0.05). This was further demonstrated in participants who were deemed at high risk of falls. The overall pattern of results suggests the training program is effective and suitable for individuals at all levels of ability and may therefore play a role in reducing the risk of falls. Commercial hardware can be modified to deliver engaging methods of effective balance assessment and training for the older population.

Neighborhood availability of convenience stores and diet quality: findings from 20 years of follow-up in the coronary artery risk development in young adults study.

PubMed

Rummo, Pasquale E; Meyer, Katie A; Boone-Heinonen, Janne; Jacobs, David R; Kiefe, Catarina I; Lewis, Cora E; Steffen, Lyn M; Gordon-Larsen, Penny

2015-05-01

We examined the association between neighborhood convenience stores and diet outcomes for 20 years of the Coronary Artery Risk Development in Young Adults study. We used dietary data from the Coronary Artery Risk Development in Young Adults study years 1985-1986, 1992-1993, and 2005-2006 (n = 3299; Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA) and geographically and temporally matched neighborhood-level food resource and US Census data. We used random effects repeated measures regression to estimate associations between availability of neighborhood convenience stores with diet outcomes and whether these associations differed by individual-level income. In multivariable-adjusted analyses, greater availability of neighborhood convenience stores was associated with lower diet quality (mean score = 66.3; SD = 13.0) for participants with lower individual-level income (b = -2.40; 95% CI = -3.30, -1.51); associations at higher individual-level income were weaker. We observed similar associations with whole grain consumption across time but no statistically significant associations with consumption of sugar-sweetened beverages, artificially sweetened beverages, snacks, processed meats, fruits, or vegetables. The presence of neighborhood convenience stores may be associated with lower quality diets. Low-income individuals may be most sensitive to convenience store availability.

Effectiveness of Essence of Chicken in Improving Cognitive Function in Young People Under Work-Related Stress: A Randomized Double-Blind Trial.

PubMed

Chan, Lung; Wang, Hsuan-Min; Chen, Kuan-Yu; Lin, Ying-Chin; Wu, Pei-Jung; Hsieh, Wan-Lin; Chen, Ying-Ru; Liu, Cheung-Pin; Tsai, Han-Yin; Chen, Yun-Ru; Chang, Hsiu-Hui; Hsieh, Yi-Chen; Hu, Chaur-Jong

2016-05-01

Work-related stress (WS) can result in considerable and extensive changes in physiological and psychological performance. WS beyond the optimal levels induces anxiety, confusion, exhaustion, and burnout. Chronic WS affects neurocognitive performance, particularly attention and visuospatial memory. Essence of chicken (EC) has been reported to improve neurocognitive function after mental stress.To investigate the beneficial effects of EC in improving neurocognitive performance under WS, we conducted a randomized, double blind trial. Total 102 young workers in New Taipei City with high WS, evaluated using the Individual Subjective Perception Job Stress Scale scores (>36 for job leaders and 33 for nonleaders) were recruited. Fifty-one participants received 70 mL of EC and 51 received a placebo daily for 2 weeks. Blood tests and neurocognitive assessment were performed before treatment, at the end of treatment, and 2 weeks after treatment.EC improved the performance of participants with high depression scores in the form-color associative memory test, used for assessing short-term memory. Although creatinine and glutamic-pyruvic transaminase (GPT) levels increased in week 2, but the levels returned to the baseline in week 4. Blood urea nitrogen (BUN) levels decreased in week 4.EC significantly improved short-term memory in participants with high WS and concomitant depressive mood, although it slightly increased GPT and creatinine levels and reduced BUN levels. The long-term treatment effects of EC warrant further investigation.

Effects of Mangifera indica (Careless) on Microcirculation and Glucose Metabolism in Healthy Volunteers.

PubMed

Buchwald-Werner, Sybille; Schön, Christiane; Frank, Sonja; Reule, Claudia

2017-07-01

A commercial Mangifera indica fruit powder (Careless) showed beneficial acute effects on microcirculation in a randomized, double-blind, crossover pilot study. Here, long-term effects on microcirculation and glucose metabolism were investigated in a double-blind, randomized, placebo-controlled, 3-arm parallel-design study in healthy individuals. A daily dose of 100 mg or 300 mg of the fruit powder was compared to placebo after supplementation for 4 weeks. Microcirculation and endothelial function were assessed by the Oxygen-to-see System and pulse amplitude tonometry, respectively. Glucose metabolism was assessed under fasting and postprandial conditions by capillary glucose and HbA1c values.Microcirculatory reactive hyperemia flow increased, especially in the 100 mg group (p = 0.025). The 300 mg of the M. indica fruit preparation reduced postprandial glucose levels by trend if compared to placebo (p = 0.0535) accompanied by significantly lower HbA1c values compared to baseline. Furthermore, 300 mg intake significantly improved postprandial endothelial function in individuals with decreased endothelial function after high-dose glucose intake (p = 0.0408; n = 11).In conclusion, the study suggests moderate beneficial effects of M. indica fruit preparation on microcirculation, endothelial function, and glucose metabolism. Georg Thieme Verlag KG Stuttgart · New York.

Impact of Flavonols on Cardiometabolic Biomarkers: A Meta-Analysis of Randomized Controlled Human Trials to Explore the Role of Inter-Individual Variability

PubMed Central

Menezes, Regina; Rodriguez-Mateos, Ana; Kaltsatou, Antonia; González-Sarrías, Antonio; Greyling, Arno; Giannaki, Christoforos; Andres-Lacueva, Cristina; Milenkovic, Dragan; Gibney, Eileen R.; Dumont, Julie; Schär, Manuel; Garcia-Aloy, Mar; Palma-Duran, Susana Alejandra; Ruskovska, Tatjana; Maksimova, Viktorija; Combet, Emilie; Pinto, Paula

2017-01-01

Several epidemiological studies have linked flavonols with decreased risk of cardiovascular disease (CVD). However, some heterogeneity in the individual physiological responses to the consumption of these compounds has been identified. This meta-analysis aimed to study the effect of flavonol supplementation on biomarkers of CVD risk such as, blood lipids, blood pressure and plasma glucose, as well as factors affecting their inter-individual variability. Data from 18 human randomized controlled trials were pooled and the effect was estimated using fixed or random effects meta-analysis model and reported as difference in means (DM). Variability in the response of blood lipids to supplementation with flavonols was assessed by stratifying various population subgroups: age, sex, country, and health status. Results showed significant reductions in total cholesterol (DM = −0.10 mmol/L; 95% CI: −0.20, −0.01), LDL cholesterol (DM = −0.14 mmol/L; 95% CI: −0.21, 0.07), and triacylglycerol (DM = −0.10 mmol/L; 95% CI: −0.18, 0.03), and a significant increase in HDL cholesterol (DM = 0.05 mmol/L; 95% CI: 0.02, 0.07). A significant reduction was also observed in fasting plasma glucose (DM = −0.18 mmol/L; 95% CI: −0.29, −0.08), and in blood pressure (SBP: DM = −4.84 mmHg; 95% CI: −5.64, −4.04; DBP: DM = −3.32 mmHg; 95% CI: −4.09, −2.55). Subgroup analysis showed a more pronounced effect of flavonol intake in participants from Asian countries and in participants with diagnosed disease or dyslipidemia, compared to healthy and normal baseline values. In conclusion, flavonol consumption improved biomarkers of CVD risk, however, country of origin and health status may influence the effect of flavonol intake on blood lipid levels. PMID:28208791

Oxytocin Effect on Collective Decision Making: A Randomized Placebo Controlled Study.

PubMed

Hertz, Uri; Kelly, Maria; Rutledge, Robb B; Winston, Joel; Wright, Nicholas; Dolan, Raymond J; Bahrami, Bahador

2016-01-01

Collective decision making often benefits both the individuals and the group in a variety of contexts. However, for the group to be successful, individuals should be able to strike a balance between their level of competence and their influence on the collective decisions. The hormone oxytocin has been shown to promote trust, conformism and attention to social cues. We wondered if this hormone may increase participants' (unwarranted) reliance on their partners' opinion, resulting in a reduction in collective benefit by disturbing the balance between influence and competence. To test this hypothesis we employed a randomized double-blind placebo-controlled design in which male dyads self-administered intranasal oxytocin or placebo and then performed a visual search task together. Compared to placebo, collective benefit did not decrease under oxytocin. Using an exploratory time dependent analysis, we observed increase in collective benefit over time under oxytocin. Moreover, trial-by-trial analysis showed that under oxytocin the more competent member of each dyad was less likely to change his mind during disagreements, while the less competent member showed a greater willingness to change his mind and conform to the opinion of his more reliable partner. This role-dependent effect may be mediated by enhanced monitoring of own and other's performance level under oxytocin. Such enhanced social learning could improve the balance between influence and competence and lead to efficient and beneficial collaboration.

Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial.

PubMed

Bove, Allyn M; Smith, Kenneth J; Bise, Christopher G; Fritz, Julie M; Childs, John; Brennan, Gerard P; Abbott, J Haxby; Fitzgerald, G Kelley

2018-01-01

Limited information exists regarding the cost-effectiveness of rehabilitation strategies for individuals with knee osteoarthritis (OA). The study objective was to compare the cost-effectiveness of 4 different combinations of exercise, manual therapy, and booster sessions for individuals with knee OA. This economic evaluation involved a cost-effectiveness analysis performed alongside a multicenter randomized controlled trial. The study took place in Pittsburgh, Pennsylvania; Salt Lake City, Utah; and San Antonio, Texas. The study participants were 300 individuals taking part in a randomized controlled trial investigating various physical therapy strategies for knee OA. Participants were randomized into 4 treatment groups: exercise only (EX), exercise plus booster sessions (EX+B), exercise plus manual therapy (EX+MT), and exercise plus manual therapy and booster sessions (EX+MT+B). For the 2-year base case scenario, a Markov model was constructed using the United States societal perspective and a 3% discount rate for costs and quality-adjusted life years (QALYs). Incremental cost-effectiveness ratios were calculated to compare differences in cost per QALY gained among the 4 treatment strategies. In the 2-year analysis, booster strategies (EX+MT+B and EX+B) dominated no-booster strategies, with both lower health care costs and greater effectiveness. EX+MT+B had the lowest total health care costs. EX+B cost ${\\$}$1061 more and gained 0.082 more QALYs than EX+MT+B, for an incremental cost-effectiveness ratio of ${\\$}$12,900/QALY gained. The small number of total knee arthroplasty surgeries received by individuals in this study made the assessment of whether any particular strategy was more successful at delaying or preventing surgery in individuals with knee OA difficult. Spacing exercise-based physical therapy sessions over 12 months using periodic booster sessions was less costly and more effective over 2 years than strategies not containing booster sessions for individuals with knee OA. © 2017 American Physical Therapy Association

The extent to which garments affect the assessment of body shapes of males from faceless CCTV images.

PubMed

Lucas, Teghan; Kumaratilake, Jaliya; Henneberg, Maciej

2014-01-01

Closed circuit television (CCTV) systems are being widely used in crime surveillance. The images produced are of poor quality often face details are not visible, however expert witnesses in the field of biological anthropology use morphological descriptions of body shapes in an attempt to identify persons of interest. These methods can be applied to individual images when other cues such as gait, are not present. Criminals commonly disguise their faces, but body shape characteristics can be used to distinguish a person of interest from others. Garments may distort the body shape appearance, thus this study was undertaken to investigate the effects of garments on the description of body shape from CCTV images. Twelve adult males representing a wide body shape range of Sheldonian somatotypes were photographed in identical garments comprising of tight fitting black shirt, horizontally striped shirt, padded leather jacket and in naked torso. These photographs were assessed by 51 males and females aged 18-50 years, with varying levels of education, and different experience in use of CCTV images for identification of people, to identify the 12 participants. The effect of assessors was not significant. They correctly distinguished 88.6% of individuals wearing the same wear, but could not match the same individuals wearing different wear above the random expectations. However, they matched somatotypes above random expectation. Type of clothing produced little bias in somatotype matching; ectomorphic component of individuals wearing black shirts and padded jackets was overestimated and underestimated, respectively. In conclusion, type of the wear had little effect in the description of individuals from CCTV images using the body shapes.

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

ERIC Educational Resources Information Center

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

2011-01-01

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

Acceptance and mindfulness-based stress management for support staff caring for individuals with intellectual disabilities.

PubMed

McConachie, Douglas Alexander James; McKenzie, Karen; Morris, Paul Graham; Walley, Robert M

2014-06-01

Support staff working with individuals with intellectual disability (ID) and challenging behaviour experience high levels of work-related stress. Preliminary theoretical and experimental research has highlighted the potential suitability of acceptance and mindfulness approaches for addressing support staff stress. This study examines the effectiveness of an acceptance and mindfulness-based stress management workshop on the levels of psychological distress and well-being of support staff working with individuals with ID and challenging behaviour. Support staff (n=120) were randomly assigned to a workshop intervention condition (n=66) or to a waiting list control condition (n=54). Measurements were completed at three time points (pre-, post and 6 week follow-up) for: psychological distress, well-being, perceived work stressors, thought suppression, and emotional avoidance/psychological inflexibility. The intervention led to significantly greater reductions in distress in the intervention group than in the control group. This was largely maintained at 6 week follow-up. This effect was more pronounced amongst a subsample that had shown higher levels of psychological distress at baseline. Thought suppression was found to reduce significantly in the intervention group between post intervention and follow-up, although no significant change was found in well-being or experiential avoidance/psychological inflexibility. Overall, results demonstrated support for the effectiveness of an acceptance and mindfulness-based intervention in reducing distress. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effects of exercise on kidney function among non-diabetic patients with hypertension and renal disease: randomized controlled trial.

PubMed

Barcellos, Franklin C; Santos, Iná S; Mielke, Grégore Iven; del Vecchio, Fabrício B; Hallal, Pedro C

2012-08-28

Chronic kidney disease is an important public health threat. Such patients present high morbidity and mortality due to cardiovascular disease, with low quality of life and survival, and also high expenditure resulting from the treatment. Arterial hypertension is both a cause and a complication of kidney disease; also, arterial hypertension is a risk factor for cardiovascular disease among patients with kidney diseases. There is some evidence that exercise interventions may be beneficial to chronic kidney disease patients, but previous studies included only end-stage patients, i.e. those undergoing dialysis. This study aims to evaluate the effect of exercise on kidney function, quality of life and other risk factors for cardiovascular disease among non-diabetic chronic hypertensive kidney disease patients who are not undergoing dialysis. The participants will be located through screening hypertensive patients attended within the public healthcare network in Pelotas, a city in south of Brazil. Eligible individuals will be those with glomerular filtration rate between 15 and 59 ml/min x 1.73 m(2). The randomization will be done in fixed-size blocks of six individuals such that 75 participants will be allocated to each group. At baseline, information on demographic, socioeconomic, behavioral, anthropometric, blood pressure and quality-of-life variables will be collected, and laboratory tests will be performed. The intervention will consist of three weekly physical exercise sessions lasting 60-75 minutes each, with a total duration of 16 weeks. The outcomes will be the kidney function progression rate, quality of life, blood pressure, lipid profile, hemoglobin level, ultrasensitive C-reactive protein level, and ankle-arm index. The patients in both groups (intervention and control) will be reassessed and compared partway through the study (8th week), at the end of the intervention (16th week) and in the 8th week after the end of the intervention. There is still a scarcity of data relating to the effect of physical exercise among the most numerous group of individuals with kidney disease, i.e. patients undergoing conservative treatment. In particular, there is a lack of randomized controlled studies. This study will help fill this gap.

Motivational Interviewing Versus Cognitive Behavioral Group Therapy in the Treatment of Problem and Pathological Gambling: A Randomized Controlled Trial

PubMed Central

Carlbring, Per; Jonsson, Jakob; Josephson, Henrik; Forsberg, Lars

2009-01-01

Pathological gambling is a widespread problem with major implications for society and the individual. There are effective treatments, but little is known about the relative effectiveness of different treatments. The aim of this study was to test the effectiveness of motivational interviewing, cognitive behavioral group therapy, and a no-treatment control (wait-list) in the treatment of pathological gambling. This was done in a randomized controlled trial at an outpatient dependency clinic at Karolinska Institute (Stockholm, Sweden). A total of 150 primarily self-recruited patients with current gambling problems or pathological gambling according to an NORC DSM-IV screen for gambling problems were randomized to four individual sessions of motivational interviewing (MI), eight sessions of cognitive behavioral group therapy (CBGT), or a no-treatment wait-list control. Gambling-related measures derived from timeline follow-back as well as general levels of anxiety and depression were administered at baseline, termination, and 6 and 12 months posttermination. Treatment showed superiority in some areas over the no-treatment control in the short term, including the primary outcome measure. No differences were found between MI and CBGT at any point in time. Instead, both MI and CBGT produced significant within-group decreases on most outcome measures up to the 12-month follow-up. Both forms of intervention are promising treatments, but there is room for improvement in terms of both outcome and compliance. PMID:19967577

Testing moderation in network meta-analysis with individual participant data.

PubMed

Dagne, Getachew A; Brown, C Hendricks; Howe, George; Kellam, Sheppard G; Liu, Lei

2016-07-10

Meta-analytic methods for combining data from multiple intervention trials are commonly used to estimate the effectiveness of an intervention. They can also be extended to study comparative effectiveness, testing which of several alternative interventions is expected to have the strongest effect. This often requires network meta-analysis (NMA), which combines trials involving direct comparison of two interventions within the same trial and indirect comparisons across trials. In this paper, we extend existing network methods for main effects to examining moderator effects, allowing for tests of whether intervention effects vary for different populations or when employed in different contexts. In addition, we study how the use of individual participant data may increase the sensitivity of NMA for detecting moderator effects, as compared with aggregate data NMA that employs study-level effect sizes in a meta-regression framework. A new NMA diagram is proposed. We also develop a generalized multilevel model for NMA that takes into account within-trial and between-trial heterogeneity and can include participant-level covariates. Within this framework, we present definitions of homogeneity and consistency across trials. A simulation study based on this model is used to assess effects on power to detect both main and moderator effects. Results show that power to detect moderation is substantially greater when applied to individual participant data as compared with study-level effects. We illustrate the use of this method by applying it to data from a classroom-based randomized study that involved two sub-trials, each comparing interventions that were contrasted with separate control groups. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A double blind placebo controlled randomized trial of the effect of acute uric acid changes on inflammatory markers in humans: A pilot study

PubMed Central

Milaneschi, Yuri; Zhang, Yongqing; Becker, Kevin G.; Zukley, Linda; Ferrucci, Luigi

2017-01-01

Uric acid has been linked with increased risk of chronic disease such as cardiovascular disease and this association has been attributed to a pro-inflammatory effect. Indeed, observational studies have shown that high uric acid is associated with high level of pro-inflammatory cytokines in the blood. However, whether high uric acid directly affects inflammation or rather represents a parallel defensive antioxidant mechanism in response to pathology that causes inflammation is unknown. To determine whether acute increase or decrease uric acid levels affects inflammation in healthy individuals, a randomized, placebo-controlled, double blind clinical study of uric acid or rasburicase with 20 healthy volunteers in each treatment-placebo group was conducted at the National Institute on Aging (NIA) Clinical Research Unit (CRU) at Harbor Hospital in Baltimore, MD. Change in inflammatory response was assessed by administering an oral lipid tolerance before and after the treatment of uric acid, rasburicase and placebo. Following uric acid administration, there was an accentuated increase in IL-6 during the oral lipid tolerance test (P<0.001). No significant differences were observed after lowering of uric acid with rasburicase. No side effects were reported throughout the trial. In health individuals, acute increase in uric acid results in an increased IL-6 response when challenged with lipid load. Such effect of amplification of inflammatory response may explain the higher risk of chronic diseases observed in subclinical hyperuricemia in observational studies. Trial Registration: ClinicalTrials.gov NCT01323335 PMID:28786993

New Estimates of Design Parameters for Clustered Randomization Studies: Findings from North Carolina and Florida. Working Paper 43

ERIC Educational Resources Information Center

Xu, Zeyu; Nichols, Austin

2010-01-01

The gold standard in making causal inference on program effects is a randomized trial. Most randomization designs in education randomize classrooms or schools rather than individual students. Such "clustered randomization" designs have one principal drawback: They tend to have limited statistical power or precision. This study aims to…

Effect of Behavioral Intervention on Dilated Fundus Examination Rates in Older African American Individuals With Diabetes Mellitus: A Randomized Clinical Trial.

PubMed

Weiss, David M; Casten, Robin J; Leiby, Benjamin E; Hark, Lisa A; Murchison, Ann P; Johnson, Deiana; Stratford, Shayla; Henderer, Jeffrey; Rovner, Barry W; Haller, Julia A

2015-09-01

African American individuals are at high risk of diabetes mellitus and diabetic retinopathy but have suboptimal rates of dilated fundus examinations (DFEs). Early intervention is crucial for the prevention of diabetic retinopathy in this high-risk population. To test the efficacy of behavioral activation for diabetic retinopathy prevention on rates of DFEs in older African American individuals with diabetes mellitus. Masked randomized clinical trial at 2 urban medical centers from October 1, 2010, to May 31, 2014. Participants included 206 African American individuals 65 years and older with diabetes mellitus who had not obtained a DFE in the preceding 12 months. Participants were randomized to either behavioral activation for diabetic retinopathy prevention, a behavioral intervention designed to provide education, facilitate identifying and addressing health care barriers, and promote goal setting to improve rates of DFEs, or supportive therapy, a control condition. The primary outcome was medical documentation of a DFE at 6 months' follow-up. Secondary outcomes included the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus, Diabetes Self-Care Inventory, Patient Health Questionnaire 9, and National Eye Institute Vision Function Questionnaire 25 scores and hemoglobin A1c levels. More participants in the behavioral activation for diabetic retinopathy prevention group (87.9%) obtained a DFE compared with those in the supportive therapy group (34.1%) by the 6-month follow-up assessment (P < .001). Overall, participants in the behavioral activation for diabetic retinopathy prevention group were 2.5 times more likely to obtain a DFE compared with those in the supportive therapy group (risk ratio = 2.58; 95% CI, 1.91-3.48; P < .001). The intervention had no short-term effect on secondary outcomes of hemoglobin A1c levels, depression, or the Risk Perceptions and Risk Knowledge Survey of Diabetes Mellitus or National Eye Institute Vision Function Questionnaire 25 composite scores; however, both groups had improved adherence to diabetes mellitus self-care behaviors from baseline to 6-month follow-up. Behavioral activation for diabetic retinopathy prevention significantly increased rates of DFEs in older African American individuals with diabetes mellitus. Behavioral interventions may have the potential to positively affect screening for diabetic retinopathy in at-risk populations. clinicaltrials.gov Identifier: NCT01179555.

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

PubMed Central

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

2018-01-01

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

Effects of rose hip intake on risk markers of type 2 diabetes and cardiovascular disease: a randomized, double-blind, cross-over investigation in obese persons

PubMed Central

Andersson, U; Berger, K; Högberg, A; Landin-Olsson, M; Holm, C

2012-01-01

BACKGROUND/OBJECTIVES: In studies performed in mice, rose hip powder has been shown to both prevent and reverse high-fat diet-induced obesity and glucose intolerance as well as reduce plasma levels of cholesterol. The aim of this study was to investigate whether daily intake of rose hip powder over 6 weeks exerts beneficial metabolic effects in obese individuals. SUBJECTS/METHODS: A total of 31 obese individuals with normal or impaired glucose tolerance were enrolled in a randomized, double-blind, cross-over study in which metabolic effects of daily intake of a rose hip powder drink over 6 weeks was compared with a control drink. Body weight, glucose tolerance, blood pressure, blood lipids and markers of inflammation were assessed in the subjects. RESULTS: In comparison with the control drink, 6 weeks of daily consumption of the rose hip drink resulted in a significant reduction of systolic blood pressure (−3.4% P=0.021), total plasma cholesterol (−4.9% P=0.0018), low-density lipoprotein (LDL) cholesterol (−6.0% P=0.012) and LDL/HDL ratio (−6.5% P=0.041). The Reynolds risk assessment score for cardiovascular disease was decreased in the rose hip group compared with the control group (−17% P=0.007). Body weight, diastolic blood pressure, glucose tolerance, and plasma levels of high-density lipoprotein (HDL) cholesterol, triglycerides, incretins and markers of inflammation did not differ between the two groups. CONCLUSIONS: Daily consumption of 40 g of rose hip powder for 6 weeks can significantly reduce cardiovascular risk in obese people through lowering of systolic blood pressure and plasma cholesterol levels. PMID:22166897

Do HMO market level factors lead to racial/ethnic disparities in colorectal cancer screening? A comparison between high-risk Asian and Pacific Islander Americans and high-risk whites.

PubMed

Ponce, Ninez A; Huh, Soonim; Bastani, Roshan

2005-11-01

Few studies have explored health care market structure and colorectal cancer (CRC) screening test use, and little is known whether market factors contribute to racial/ethnic screening disparities. We investigated whether HMO market level factors, controlling for individual covariates, differentially impact Asian American and Pacific Islander (AAPI) subjects' access to CRC screening compared with white subjects. We used random intercept hierarchical models to predict CRC test use. Individual-level survey data was linked to market data by metropolitan statistical areas from InterStudy. Insured first-degree relatives, ages 40-80, of a random sample of colorectal cancer cases identified from the California Cancer Registry: 515 white subjects and 396 AAPI subjects residing in 36 metropolitan statistical areas (MSAs). Dependent variables were receipt of (1) annual fecal occult blood test only; (2) sigmoidoscopy in the past 5 years; (3) colonoscopy in the past 10 years; and (4) any of these tests over the recommended time interval. Market characteristics were HMO penetration, HMO competition, and proportion of staff/group/network HMOs. Market characteristics were as important as individual-level characteristics for AAPI but not for white subjects. Among AAPI subjects, a 10% increase in the percent of group/staff/network model HMO was associated with a reduction in colonoscopy use (28.9% to 20.5%) and in receipt of any of the CRC tests (53.2% to 45.4%). The prevailing organizational structure of a health care market confers a penalty on access to CRC test use among high-risk AAPI subjects but not among high-risk white subjects. Identifying the differential effect of market structure on race/ethnicity can potentially reduce the cancer burden among disadvantaged racial groups.

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

PubMed

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 administrators. Although we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials. Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.

Dental movement acceleration: Literature review by an alternative scientific evidence method

PubMed Central

Camacho, Angela Domínguez; Cujar, Sergio Andres Velásquez

2014-01-01

The aim of this study was to analyze the majority of publications using effective methods to speed up orthodontic treatment and determine which publications carry high evidence-based value. The literature published in Pubmed from 1984 to 2013 was reviewed, in addition to well-known reports that were not classified under this database. To facilitate evidence-based decision making, guidelines such as the Consolidation Standards of Reporting Trials, Preferred Reporting items for systematic Reviews and Meta-analyses, and Transparent Reporting of Evaluations with Non-randomized Designs check list were used. The studies were initially divided into three groups: local application of cell mediators, physical stimuli, and techniques that took advantage of the regional acceleration phenomena. The articles were classified according to their level of evidence using an alternative method for orthodontic scientific article classification. 1a: Systematic Reviews (SR) of randomized clinical trials (RCTs), 1b: Individual RCT, 2a: SR of cohort studies, 2b: Individual cohort study, controlled clinical trials and low quality RCT, 3a: SR of case-control studies, 3b: Individual case-control study, low quality cohort study and short time following split mouth designs. 4: Case-series, low quality case-control study and non-systematic review, and 5: Expert opinion. The highest level of evidence for each group was: (1) local application of cell mediators: the highest level of evidence corresponds to a 3B level in Prostaglandins and Vitamin D; (2) physical stimuli: vibratory forces and low level laser irradiation have evidence level 2b, Electrical current is classified as 3b evidence-based level, Pulsed Electromagnetic Field is placed on the 4th level on the evidence scale; and (3) regional acceleration phenomena related techniques: for corticotomy the majority of the reports belong to level 4. Piezocision, dentoalveolar distraction, alveocentesis, monocortical tooth dislocation and ligament distraction technique, only had case series or single report cases (4th level of evidence). Surgery first and periodontal distraction have 1 study at level 2b and corticision one report at level 5. Multiple orthodontic acceleration reports on humans were identified by an alternative evidence level scale, which is a simple and accurate way of determining which techniques are better and have a higher rate of effectiveness. The highest level of evidence for a specific procedure to accelerate orthodontic dental movement up to October 2013 was surgery first followed by low level laser application, corticotomy and periodontal distraction located on level 2, recommendation grade b from this proposed scientific evidence-based scale. PMID:25332914

The Effects of Individual Versus Cooperative Testing in a Flipped Classroom on the Academic Achievement, Motivation Toward Science, and Study Time for 9th Grade Biology Students

NASA Astrophysics Data System (ADS)

McCall, Megan O'Neill

This study examined the effects of cooperative testing versus traditional or individual testing and the impacts on academic achievement, motivation toward science, and study time for 9th grade biology students. Research questions centered on weekly quizzes given in a flipped classroom format for a period of 13 weeks. The study used a mixed methods research design, which combined quantitative and qualitative data collection techniques. The study examined 66 students enrolled in three sections of a 9 th grade biology course at a private K-12 school. Students were randomly assigned to groups of three or four students. Weekly quizzes on regularly assigned curriculum material were provided from the flipped classroom videos. Six quizzes were randomly selected for each class to be in the cooperative testing format and six quizzes were randomly selected to be given individually or traditional-style testing format. Week 7 was reserved for administration of the mid-study questionnaire and no quiz was administered. Quantitative data collected included student grades on the 12 weekly quizzes. Qualitative data were also collected from pre-study, mid-study, and post-study questionnaires as well as semi-structured individual interviews and one focus group. Cooperative testing groups scored higher on the quizzes than when students took quizzes as individuals for five of the nine quizzes analyzed. Students did not score significantly higher than the best scorer in groups taking quizzes individually. For one quiz, the best scorer did better than the cooperative groups. Overall, cooperatively tested groups in some cases scored higher than the average of groups taking the quizzes individually, but the impact was not consistent across all quiz weeks. Difficulty level of the material, contextual factors, and ceiling effects are among potential explanations of the inconsistent outcomes. Across the study, motivation toward science stayed the same or increased depending on the aspect of motivation examined. Student attitudes of cooperative testing, group functioning, and overall satisfaction were positive throughout the study. The student responses indicated they found the experience in cooperative testing beneficial to their own learning process and relevant for future career success. Study time was consistent throughout the study and corresponded to the length of the video lesson each week.

Effects of the communities that care prevention system on youth reports of protective factors.

PubMed

Kim, B K Elizabeth; Gloppen, Kari M; Rhew, Isaac C; Oesterle, Sabrina; Hawkins, J David

2015-07-01

Many interventions seeking to reduce problem behaviors and promote healthy youth development target both risk and protective factors, yet few studies have examined the effect of preventive interventions on overall levels of protection community wide. In a community-randomized controlled trial, this study tested the effect of Communities That Care (CTC) on protective factors in 24 communities across seven states. Data on protective factors were collected from a panel of 4407 youths in CTC and control communities followed from grade 5 through grade 8. Hierarchical linear modeling compared mean levels of 15 protective factors derived from the social development model in CTC and control communities in grade 8, adjusted for individual and community characteristics and baseline levels of protective factors in grade 5. Global test statistics were calculated to examine effects on protection overall and by domain. Analyses across all protective factors found significantly higher levels of overall protection in CTC compared to control communities. Analyses by domain found significantly higher levels of protection in CTC than control communities in the community, school, and peer/individual domains, but not in the family domain. Significantly higher levels of opportunities for prosocial involvement in the community, recognition for prosocial involvement in school, interaction with prosocial peers, and social skills among CTC compared to control youth contributed to the overall and domain-specific results. This is consistent with CTC's theory of change, which posits that strengthening protective factors is a mechanism through which CTC prevents behavior problems.

The effects of vitamin E and omega-3 PUFAs on endothelial function among adolescents with metabolic syndrome.

PubMed

Ahmadi, Alireza; Gharipour, Mojgan; Arabzadeh, Gholamreza; Moin, Payam; Hashemipour, Mahin; Kelishadi, Roya

2014-01-01

The present study aims to explore the effects of vitamin E and omega-3 on endothelial function indicators among adolescents with metabolic syndrome. In a randomized, double blind, and placebo-controlled trial, 90 young individuals, aged 10 to 18 years, with metabolic syndrome were randomly assigned to receive either vitamin E tablets (400 IU/day) or omega-3 tablets (2.4 gr/day) or placebo. For assessing endothelial functional state, the serum level of vascular endothelial growth factor (VEGF) was measured by ELISA test. The use of omega-3 supplementation for eight weeks led to significant increase in serum HDL level compared with the group treated with vitamin E or placebo group. In this regard, no significant correlations were found between the change in VEGF and baseline levels of other markers including anthropometric indices and serum lipids. Omega-3 could significantly reduce VEGF with the presence of other baseline variables (Beta = -12.55; P = 0.012). The administration of omega-3 can effectively improve endothelial function in adolescents with metabolic syndrome by reducing the level of serum VEGF, as a major index for atherosclerosis progression and endothelial destabilization. Omega-3 can be proposed as a VEGF antagonist for improving endothelial function in metabolic syndrome. The clinical implications of our findings should be assessed in future studies.

Impact of an Intervention Designed to Reduce Sexual Health Risk Behaviors of African American Adolescents: Results of a Randomized Controlled Trial

PubMed Central

Jenner, Lynne W.; Walsh, Sarah; Demby, Hilary; Gregory, Alethia; Davis, Erin

2016-01-01

Objectives. To replicate an evidence-based HIV risk reduction program and assess its impact on 2 behavioral outcomes—inconsistency of condom use and frequency of sex—6 months after the program. Methods. The study was an individual-level randomized controlled trial in which we randomly assigned 850 youths (aged 14–18 years) to 1 of 2 conditions. The treatment (Becoming a Responsible Teen) is a group-level sociocognitive and skills training sexual education course; the control is a general health intervention that includes the same initial informational component as the treatment. Participants were recruited over 3 summers (2012–2014) from a summer employment program in New Orleans, Louisiana, that serves primarily African American adolescents. Results. Six months after program exposure, we found no statistically significant difference between treatment and control group members’ self-reported inconsistency of condom use or frequency of sex (P > .05). Conclusions. Although previous evidence has indicated that this particular program can be effective, this study’s findings indicate that it was not effective in this setting with this specific population. Results should provide an incentive to learn why the intervention works in some cases and what conditions are necessary for causal impacts. PMID:27689499

Individual and group-level job resources and their relationships with individual work engagement.

PubMed

Füllemann, Désirée; Brauchli, Rebecca; Jenny, Gregor J; Bauer, Georg F

2016-06-16

This study adds a multilevel perspective to the well-researched individual-level relationship between job resources and work engagement. In addition, we explored whether individual job resources cluster within work groups because of a shared psychosocial environment and investigated whether a resource-rich psychosocial work group environment is beneficial for employee engagement over and above the beneficial effect of individual job resources and independent of their variability within groups. Data of 1,219 employees nested in 103 work groups were obtained from a baseline employee survey of a large stress management intervention project implemented in six medium and large-sized organizations in diverse sectors. A variety of important job resources were assessed and grouped to an overall job resource factor with three subfactors (manager behavior, peer behavior, and task-related resources). Data were analyzed using multilevel random coefficient modeling. The results indicated that job resources cluster within work groups and can be aggregated to a group-level job resources construct. However, a resource-rich environment, indicated by high group-level job resources, did not additionally benefit employee work engagement but on the contrary, was negatively related to it. On the basis of this unexpected result, replication studies are encouraged and suggestions for future studies on possible underlying within-group processes are discussed. The study supports the presumed value of integrating work group as a relevant psychosocial environment into the motivational process and indicates a need to further investigate emergent processes involved in aggregation procedures across levels.

Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study

PubMed Central

Farokhnia, M; Schwandt, M L; Lee, M R; Bollinger, J W; Farinelli, L A; Amodio, J P; Sewell, L; Lionetti, T A; Spero, D E; Leggio, L

2017-01-01

Baclofen has been suggested as a potential pharmacotherapy for alcohol use disorder, but the clinical data are conflicting. Here we investigated the biobehavioral effects of baclofen in a sample of anxious alcohol-dependent individuals. This was a randomized, double-blind, placebo-controlled, human laboratory study in non-treatment seeking alcohol-dependent individuals with high trait anxiety (N=34). Participants received baclofen (30 mg per day) or placebo for at least 8 days, then performed an experimental session consisting of alcohol cue-reactivity followed by alcohol administration procedure (alcohol priming, then alcohol self-administration). Total amount of alcohol self-administered was the primary outcome; alcohol craving, subjective/physiological responses and mood/anxiety symptoms were also evaluated. There was no significant medication effect on the total amount of alcohol consumed during the alcohol self-administration (P=0.76). Baclofen blunted the positive association between maximum breath alcohol concentration during priming and the amount of alcohol consumption (significant interaction, P=0.03). Ratings of feeling intoxicated were significantly higher in the baclofen group after consuming the priming drink (P=0.006). During the self-administration session, baclofen significantly increased ratings of feeling high (P=0.01) and intoxicated (P=0.01). A significant reduction in heart rate (P<0.001) and a trend-level increase in diastolic blood pressure (P=0.06) were also detected in the baclofen group during the alcohol laboratory session. In conclusion, baclofen was shown to affect subjective and physiological responses to alcohol drinking in anxious alcohol-dependent individuals. These results do not support an anti-craving or anti-reinforcing effect of baclofen, but rather suggest that baclofen may act as a substitution medication for alcohol use disorder. PMID:28440812

Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study.

PubMed

Farokhnia, M; Schwandt, M L; Lee, M R; Bollinger, J W; Farinelli, L A; Amodio, J P; Sewell, L; Lionetti, T A; Spero, D E; Leggio, L

2017-04-25

Baclofen has been suggested as a potential pharmacotherapy for alcohol use disorder, but the clinical data are conflicting. Here we investigated the biobehavioral effects of baclofen in a sample of anxious alcohol-dependent individuals. This was a randomized, double-blind, placebo-controlled, human laboratory study in non-treatment seeking alcohol-dependent individuals with high trait anxiety (N=34). Participants received baclofen (30 mg per day) or placebo for at least 8 days, then performed an experimental session consisting of alcohol cue-reactivity followed by alcohol administration procedure (alcohol priming, then alcohol self-administration). Total amount of alcohol self-administered was the primary outcome; alcohol craving, subjective/physiological responses and mood/anxiety symptoms were also evaluated. There was no significant medication effect on the total amount of alcohol consumed during the alcohol self-administration (P=0.76). Baclofen blunted the positive association between maximum breath alcohol concentration during priming and the amount of alcohol consumption (significant interaction, P=0.03). Ratings of feeling intoxicated were significantly higher in the baclofen group after consuming the priming drink (P=0.006). During the self-administration session, baclofen significantly increased ratings of feeling high (P=0.01) and intoxicated (P=0.01). A significant reduction in heart rate (P<0.001) and a trend-level increase in diastolic blood pressure (P=0.06) were also detected in the baclofen group during the alcohol laboratory session. In conclusion, baclofen was shown to affect subjective and physiological responses to alcohol drinking in anxious alcohol-dependent individuals. These results do not support an anti-craving or anti-reinforcing effect of baclofen, but rather suggest that baclofen may act as a substitution medication for alcohol use disorder.

Iterative usage of fixed and random effect models for powerful and efficient genome-wide association studies

USDA-ARS?s Scientific Manuscript database

False positives in a Genome-Wide Association Study (GWAS) can be effectively controlled by a fixed effect and random effect Mixed Linear Model (MLM) that incorporates population structure and kinship among individuals to adjust association tests on markers; however, the adjustment also compromises t...

Estimating degradation in real time and accelerated stability tests with random lot-to-lot variation: a simulation study.

PubMed

Magari, Robert T

2002-03-01

The effect of different lot-to-lot variability levels on the prediction of stability are studied based on two statistical models for estimating degradation in real time and accelerated stability tests. Lot-to-lot variability is considered as random in both models, and is attributed to two sources-variability at time zero, and variability of degradation rate. Real-time stability tests are modeled as a function of time while accelerated stability tests as a function of time and temperatures. Several data sets were simulated, and a maximum likelihood approach was used for estimation. The 95% confidence intervals for the degradation rate depend on the amount of lot-to-lot variability. When lot-to-lot degradation rate variability is relatively large (CV > or = 8%) the estimated confidence intervals do not represent the trend for individual lots. In such cases it is recommended to analyze each lot individually. Copyright 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91: 893-899, 2002

Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study).

PubMed

Lind, Marcus; Polonsky, William; Hirsch, Irl B; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Pehrsson, Nils-Gunnar; Moström, Peter

2016-05-01

The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI). Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase. A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016. It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability. © 2016 Diabetes Technology Society.

The prevalence, metabolic risk and effects of lifestyle intervention for metabolically healthy obesity: a systematic review and meta-analysis: A PRISMA-compliant article.

PubMed

Lin, Hanli; Zhang, Liqun; Zheng, Ruizhi; Zheng, Yishan

2017-11-01

We conducted a systematic review and meta-analysis to firstly obtain a reliable estimation of the prevalence of metabolically healthy obese (MHO) individuals in obesity, then assessed the risk of developing metabolic abnormalities (MA) among MHO individuals. At last, we evaluated the effects of traditional lifestyle interventions on metabolic level for MHO subjects. A systematic review and meta-analysis (PRISMA) guideline were conducted, and original studies were searched up to December 31, 2016. The prevalence of MHO in obesity from each study was pooled using random effects models. The relative risks (RRs) were pooled to determine the risk of developing MA for MHO compared with metabolically healthy normal-weight (MHNW) subjects. For the meta-analysis of intervention studies, the mean difference and standardized mean differences were both estimated for each metabolic parameter within each study, and then pooled using a random-effects model. Overall, 40 population-based studies reported the prevalence of MHO in obesity, 12 cohort studies and 7 intervention studies were included in the meta-analysis. About 35.0% obese individuals were metabolically healthy in the obese subjects. There were dramatic differences in the prevalence among different areas. However, 0.49 (95% confidence intervals [CI]: 0.38 to 0.60) of the MHO individuals would develop one or more MA within 10 years. Compared with MHNW subjects, the MHO subjects presented higher risk of incident MA (pooled RR = 1.80, 95%CI: 1.53-2.11). Following intervention, there was certain and significant improvement of metabolic state for metabolically abnormal obesity (MAO) subjects. Only diastolic blood pressure had reduced for MHO individuals after intervention. Almost one-third of the obese individuals are in metabolic health. However, they are still at higher risk of advancing to unhealthy state. Therefore, it is still needed to advise MHO individuals to maintain or adopt a healthy lifestyle, so as to counterbalance the adverse effects of obesity. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Effectiveness of active-online, an individually tailored physical activity intervention, in a real-life setting: randomized controlled trial.

PubMed

Wanner, Miriam; Martin-Diener, Eva; Braun-Fahrländer, Charlotte; Bauer, Georg; Martin, Brian W

2009-07-28

Effective interventions are needed to reduce the chronic disease epidemic. The Internet has the potential to provide large populations with individual advice at relatively low cost. The focus of the study was the Web-based tailored physical activity intervention Active-online. The main research questions were (1) How effective is Active-online, compared to a nontailored website, in increasing self-reported and objectively measured physical activity levels in the general population when delivered in a real-life setting? (2) Do respondents recruited for the randomized study differ from spontaneous users of Active-online, and how does effectiveness differ between these groups? (3) What is the impact of frequency and duration of use of Active-online on changes in physical activity behavior? Volunteers recruited via different media channels completed a Web-based baseline survey and were randomized to Active-online (intervention group) or a nontailored website (control group). In addition, spontaneous users were recruited directly from the Active-online website. In a subgroup of participants, physical activity was measured objectively using accelerometers. Follow-up assessments took place 6 weeks (FU1), 6 months (FU2), and 13 months (FU3) after baseline. A total of 1531 respondents completed the baseline questionnaire (intervention group n = 681, control group n = 688, spontaneous users n = 162); 133 individuals had valid accelerometer data at baseline. Mean age of the total sample was 43.7 years, and 1146 (74.9%) were women. Mixed linear models (adjusted for sex, age, BMI category, and stage of change) showed a significant increase in self-reported mean minutes spent in moderate- and vigorous-intensity activity from baseline to FU1 (coefficient = 0.14, P = .001) and to FU3 (coefficient = 0.19, P < .001) in all participants with no significant differences between groups. A significant increase in the proportion of individuals meeting the HEPA recommendations (self-reported) was observed in all participants between baseline and FU3 (OR = 1.47, P = .03), with a higher increase in spontaneous users compared to the randomized groups (interaction between FU3 and spontaneous users, OR = 2.95, P = .02). There were no increases in physical activity over time in any group for objectively measured physical activity. A significant relation was found between time spent on the tailored intervention and changes in self-reported physical activity between baseline and FU3 (coefficient = 1.13, P = .03, intervention group and spontaneous users combined). However, this association was no longer significant when adjusting for stage of change. In a real-life setting, Active-online was not more effective than a nontailored website in increasing physical activity levels in volunteers from the general population. Further research may investigate ways of integrating Web-based physical activity interventions in a wider context, for example, primary care or workplace health promotion.

Using Rasch motor FIM individual growth curves to inform clinical decisions for persons with paraplegia.

PubMed

Pretz, C R; Kozlowski, A J; Charlifue, S; Chen, Y; Heinemann, A W

2014-09-01

A longitudinal retrospective study. To better understand individual-level temporal change in functional status for participants with paraplegia in the National Spinal Cord Injury Database (NSCID), as measured by Rasch Transformed Motor Functional Indepedence Measure (FIM) scores. Multicenter/Multistate longitudinal study across the United States. Non-linear random effects modeling, that is, individual growth curve analysis of retrospective data obtained from the National Institute on Disability and Rehabilitation Research (NIDRR) NSCID. We generated non-linear individual level trajectories of recovery for Rasch Transformed Motor FIM scores that rise rapidly from inpatient rehabilitation admission to a plateau. Trajectories are based on relationships between growth parameters and patient and injury factors: race, gender, level of education at admission, age at injury, neurological level at discharge, American Spinal Injury Association Impairment Scale (AIS) at discharge, days from injury to first system inpatient rehabilitation admission, rehabilitation length of stay, marital status and etiology. On the basis of study results, an interactive tool was developed to represent individual level longitudinal outcomes as trajectories based upon an individual's given baseline characteristics, that is, information supplied by the covariates and provides a robust description of temporal change for those with paraplegia within the NSCID. This methodology allows researchers and clinicians to generate and better understand patient-specific trajectories through the use of an automated interactive tool where a nearly countless number of longitudinal paths of recovery can be explored. Projected trajectories holds promise in facilitating planning for inpatient and outpatient services, which could positively impact long term outcomes.

Evaluation of individual and group grief and trauma interventions for children post disaster.

PubMed

Salloum, Alison; Overstreet, Stacy

2008-07-01

This study evaluated a community-based grief and trauma intervention for children conducted postdisaster. Fifty six children (7 to 12 years old) who reported moderate to severe levels of symptoms of posttraumatic stress were randomly assigned to group or individual treatment. Treatment consisted of a manualized 10-session grief- and trauma-focused intervention and a parent meeting. Measures of disaster-related exposure, posttraumatic stress symptoms, depression, traumatic grief, and distress were administered at preintervention, postintervention, and 3 weeks postintervention. There was a significant decrease in all outcome measures over time, and there were no differences in outcomes between children who participated in group intervention and those who participated in individual intervention. Results suggest that this intervention using either treatment modality may be effective for addressing childhood grief and trauma postdisaster.

Fibrin clot structure remains unaffected in young, healthy individuals after transient exposure to diesel exhaust

PubMed Central

2010-01-01

Exposure to urban particulate matter has been associated with an increased risk of cardiovascular disease and thrombosis. We studied the effects of transient exposure to diesel particles on fibrin clot structure of 16 healthy individuals (age 21- 44). The subjects were randomly exposed to diesel exhaust and filtered air on two separate occasions. Blood samples were collected before exposure, and 2 and 6 hours after exposure. There were no significant changes on clot permeability, maximum turbidity, lag time, fibre diameter, fibre density and fibrinogen level between samples taken after diesel exhaust exposure and samples taken after filtered air exposure. These data show that there are no prothrombotic changes in fibrin clot structure in young, healthy individuals exposed to diesel exhaust. PMID:20565709

Effect of ethnicity on HbA1c levels in individuals without diabetes: Systematic review and meta-analysis

PubMed Central

Freitas, Priscila Aparecida Correa; Gross, Jorge Luiz

2017-01-01

Aims/Hypothesis Disparities in HbA1c levels have been observed among ethnic groups. Most studies were performed in patients with diabetes mellitus (DM), which may interfere with results due to the high variability of glucose levels. We conducted a systematic review and meta-analysis to investigate the effect of ethnicity on HbA1c levels in individuals without DM. Methods This is a systematic review with meta-analysis. We searched MEDLINE and EMBASE up to September 2016. Studies published after 1996, performed in adults without DM, reporting HbA1c results measured by certified/standardized methods were included. A random effects model was used and the effect size was presented as weighted HbA1c mean difference (95% CI) between different ethnicities as compared to White ethnicity. Results Twelve studies met the inclusion criteria, totalling data from 49,238 individuals. There were significant differences between HbA1c levels in Blacks [0.26% (2.8 mmol/mol); 95% CI 0.18 to 0.33 (2.0 to 3.6), p <0.001; I2 = 90%, p <0.001], Asians [0.24% (2.6 mmol/mol); 95% CI 0.16 to 0.33 (1.7 to 3.6), p <0.001; I2 = 80%, p = 0.0006] and Latinos [0.08% (0.9 mmol/mol); IC 95% 0.06 to 0.10 (0.7 to 1.1); p <0.001; I2 = 0%; p = 0.72] when compared to Whites. Conclusions/Interpretation This meta-analysis shows that, in individuals without DM, HbA1c values are higher in Blacks, Asians, and Latinos when compared to White persons. Although small, these differences might have impact on the use of a sole HbA1c point to diagnose DM in all ethnic populations. PMID:28192447

A multilevel model for cardiovascular disease prevalence in the US and its application to micro area prevalence estimates.

PubMed

Congdon, Peter

2009-01-30

Estimates of disease prevalence for small areas are increasingly required for the allocation of health funds according to local need. Both individual level and geographic risk factors are likely to be relevant to explaining prevalence variations, and in turn relevant to the procedure for small area prevalence estimation. Prevalence estimates are of particular importance for major chronic illnesses such as cardiovascular disease. A multilevel prevalence model for cardiovascular outcomes is proposed that incorporates both survey information on patient risk factors and the effects of geographic location. The model is applied to derive micro area prevalence estimates, specifically estimates of cardiovascular disease for Zip Code Tabulation Areas in the USA. The model incorporates prevalence differentials by age, sex, ethnicity and educational attainment from the 2005 Behavioral Risk Factor Surveillance System survey. Influences of geographic context are modelled at both county and state level, with the county effects relating to poverty and urbanity. State level influences are modelled using a random effects approach that allows both for spatial correlation and spatial isolates. To assess the importance of geographic variables, three types of model are compared: a model with person level variables only; a model with geographic effects that do not interact with person attributes; and a full model, allowing for state level random effects that differ by ethnicity. There is clear evidence that geographic effects improve statistical fit. Geographic variations in disease prevalence partly reflect the demographic composition of area populations. However, prevalence variations may also show distinct geographic 'contextual' effects. The present study demonstrates by formal modelling methods that improved explanation is obtained by allowing for distinct geographic effects (for counties and states) and for interaction between geographic and person variables. Thus an appropriate methodology to estimate prevalence at small area level should include geographic effects as well as person level demographic variables.

A multilevel model for cardiovascular disease prevalence in the US and its application to micro area prevalence estimates

PubMed Central

Congdon, Peter

2009-01-01

Background Estimates of disease prevalence for small areas are increasingly required for the allocation of health funds according to local need. Both individual level and geographic risk factors are likely to be relevant to explaining prevalence variations, and in turn relevant to the procedure for small area prevalence estimation. Prevalence estimates are of particular importance for major chronic illnesses such as cardiovascular disease. Methods A multilevel prevalence model for cardiovascular outcomes is proposed that incorporates both survey information on patient risk factors and the effects of geographic location. The model is applied to derive micro area prevalence estimates, specifically estimates of cardiovascular disease for Zip Code Tabulation Areas in the USA. The model incorporates prevalence differentials by age, sex, ethnicity and educational attainment from the 2005 Behavioral Risk Factor Surveillance System survey. Influences of geographic context are modelled at both county and state level, with the county effects relating to poverty and urbanity. State level influences are modelled using a random effects approach that allows both for spatial correlation and spatial isolates. Results To assess the importance of geographic variables, three types of model are compared: a model with person level variables only; a model with geographic effects that do not interact with person attributes; and a full model, allowing for state level random effects that differ by ethnicity. There is clear evidence that geographic effects improve statistical fit. Conclusion Geographic variations in disease prevalence partly reflect the demographic composition of area populations. However, prevalence variations may also show distinct geographic 'contextual' effects. The present study demonstrates by formal modelling methods that improved explanation is obtained by allowing for distinct geographic effects (for counties and states) and for interaction between geographic and person variables. Thus an appropriate methodology to estimate prevalence at small area level should include geographic effects as well as person level demographic variables. PMID:19183458

The effectiveness of foot orthotics in improving postural control in individuals with chronic ankle instability: a critically appraised topic.

PubMed

Gabriner, Michael L; Braun, Brittany A; Houston, Megan N; Hoch, Matthew C

2015-02-01

Chronic ankle instability (CAI) is a condition commonly experienced by physically active individuals. It has been suggested that foot orthotics may increase a CAI patient's postural control. For patients with CAI, is there evidence to suggest that an orthotic intervention will help improve postural control? The literature was searched for studies of level 2 evidence or higher that investigated the effects of foot orthotics on postural control in patients with CAI. The search of the literature produced 5 possible studies for inclusion; 2 studies met the inclusion criteria and were included. One randomized controlled trial and 1 outcomes study were included. Foot orthotics appear to be effective at improving postural control in patients with CAI. There is moderate evidence to support the use of foot orthotics in the treatment of CAI to help improve postural control. There is grade B evidence that foot orthotics help improve postural control in people with CAI. The Centre of Evidence Based Medicine recommends a grade of B for level 2 evidence with consistent findings.

A person based formula for allocating commissioning funds to general practices in England: development of a statistical model.

PubMed

Dixon, Jennifer; Smith, Peter; Gravelle, Hugh; Martin, Steve; Bardsley, Martin; Rice, Nigel; Georghiou, Theo; Dusheiko, Mark; Billings, John; Lorenzo, Michael De; Sanderson, Colin

2011-11-22

To develop a formula for allocating resources for commissioning hospital care to all general practices in England based on the health needs of the people registered in each practice Multivariate prospective statistical models were developed in which routinely collected electronic information from 2005-6 and 2006-7 on individuals and the areas in which they lived was used to predict their costs of hospital care in the next year, 2007-8. Data on individuals included all diagnoses recorded at any inpatient admission. Models were developed on a random sample of 5 million people and validated on a second random sample of 5 million people and a third sample of 5 million people drawn from a random sample of practices. All general practices in England as of 1 April 2007. All NHS inpatient admissions and outpatient attendances for individuals registered with a general practice on that date. All individuals registered with a general practice in England at 1 April 2007. Power of the statistical models to predict the costs of the individual patient or each practice's registered population for 2007-8 tested with a range of metrics (R(2) reported here). Comparisons of predicted costs in 2007-8 with actual costs incurred in the same year were calculated by individual and by practice. Models including person level information (age, sex, and ICD-10 codes diagnostic recorded) and a range of area level information (such as socioeconomic deprivation and supply of health facilities) were most predictive of costs. After accounting for person level variables, area level variables added little explanatory power. The best models for resource allocation could predict upwards of 77% of the variation in costs at practice level, and about 12% at the person level. With these models, the predicted costs of about a third of practices would exceed or undershoot the actual costs by 10% or more. Smaller practices were more likely to be in these groups. A model was developed that performed well by international standards, and could be used for allocations to practices for commissioning. The best formulas, however, could predict only about 12% of the variation in next year's costs of most inpatient and outpatient NHS care for each individual. Person-based diagnostic data significantly added to the predictive power of the models.

High Power Distance Enhances Employees' Preference for Likable Managers: A Resource Dependency Perspective

PubMed Central

Wei, Cong; Sun, Xiaomin; Liu, Jia; Zhou, Chunfang; Xue, Gang

2017-01-01

Is a manager's likability important from an employee's perspective? Research results in this field are scant and inconsistent. The current study explored employees' response to managers' likability and the moderating effect of power distance at both the cultural and individual levels. In study 1, following the countercultural priming experimental paradigm proposed by Van den Bos et al. (2013), 121 college students from China (a high power distance culture) and 99 college students from Denmark (a low power distance culture) were randomly assigned to either a countercultural (experimental) condition or a control condition. All participants were required to complete a manager selection task using the zero-acquaintance paradigm to measure their preference for likable managers. The results confirmed the moderating role of power distance at the cultural level. Study 2 further explored the moderating effect of power distance orientation at the individual level, as well as the boundary condition of the degree of resource dependence from the employee's perspective. One hundred and three Chinese participants with work experience were randomly assigned to either the subordinate perspective (high resource dependence) or the HR department perspective (low resource dependence) condition and completed the same task as in study 1. The results suggested that high power distance-oriented participants demonstrate stronger preference for likable manager candidates than do low power distance-oriented participants. In addition, these findings hold only when employees expect a high resource dependence relation with the manager. Theoretical and practical implications of the research findings and future research directions were discussed. PMID:28119654

Controlled assessment of the efficacy of occlusal stabilization splints on sleep bruxism.

PubMed

van der Zaag, Jacques; Lobbezoo, Frank; Wicks, Darrel J; Visscher, Corine M; Hamburger, Hans L; Naeije, Machiel

2005-01-01

To assess the efficacy of occlusal stabilization splints in the management of sleep bruxism (SB) in a double-blind, parallel, controlled, randomized clinical trial. Twenty-one participants were randomly assigned to an occlusal splint group (n = 11; mean age = 34.2 +/- 13.1 years) or a palatal splint (ie, an acrylic palatal coverage) group (n = 10; mean age = 34.9 +/- 11.2 years). Two polysomnographic recordings that included bilateral masseter electromyographic activity were made: one prior to treatment, the other after a treatment period of 4 weeks. The number of bruxism episodes per hour of sleep (Epi/h), the number of bursts per hour (Bur/h), and the bruxism time index (ie, the percentage of total sleep time spent bruxing) were established as outcome variables at a 10% maximum voluntary contraction threshold level. A general linear model was used to test both the effects between splint groups and within the treatment phase as well as their interaction for each outcome variable. Neither occlusal stabilization splints nor palatal splints had an influence on the SB outcome variables or on the sleep variables measured on a group level. In individual cases, variable outcomes were found: Some patients had an increase (33% to 48% of the cases), while others showed no change (33% to 48%) or a decrease (19% to 29%) in SB outcome variables. The absence of significant group effects of splints in the management of SB indicates that caution is required when splints are indicated, apart from their role in the protection against dental wear. The application of splints should therefore be considered at the individual patient level.

Effect of Sugar-Free and Regular Toothpaste on Salivary Glucose and pH among Type 2 Diabetes- A Randomized Crossover Trial.

PubMed

Kapadia, Junaid; Dodamani, Arun; Baviskar, Priya; Karibasappa, G N; Pathak, Parag; Bezalwar, Abhishek

2017-07-01

Diabetes is one of the most prevalent diseases of mankind having general as well as oral health manifestations. Also, there is an increase of salivary glucose level in diabetic, inducing saccharolytic bacteria in saliva which can have adverse effects on oral tissue. To assess and compare the effect of sugar-free toothpaste on salivary glucose and pH among Type 2 diabetic and non-diabetic individuals. A randomized controlled-crossover study was carried out on 30 Type 2 diabetic (Group A) and 45 non-diabetic (Group B) subjects. In first half of study, subjects in Group A and Group B were intervened with sugar-free and regular toothpaste respectively. Salivary glucose and pH was assessed before and after brushing at interval of one week for a period of four weeks. In second half, toothpastes were switched over between the groups, after sufficient washout period. Salivary glucose and pH were assessed again in the same manner for both the groups. The data was subjected to paired t-test and unpaired t-test for intragroup and intergroup comparison respectively. Salivary glucose level was significantly reduced and salivary pH was increased significantly (p<0.001) in both groups with sugar free toothpaste when compared to regular toothpaste. Sugar free toothpaste showed beneficial effect on salivary glucose level and salivary pH level on diabetes and non-diabetes population.

Effect of Sugar-Free and Regular Toothpaste on Salivary Glucose and pH among Type 2 Diabetes- A Randomized Crossover Trial

PubMed Central

Dodamani, Arun; Baviskar, Priya; Karibasappa, GN; Pathak, Parag; Bezalwar, Abhishek

2017-01-01

Introduction Diabetes is one of the most prevalent diseases of mankind having general as well as oral health manifestations. Also, there is an increase of salivary glucose level in diabetic, inducing saccharolytic bacteria in saliva which can have adverse effects on oral tissue. Aim To assess and compare the effect of sugar-free toothpaste on salivary glucose and pH among Type 2 diabetic and non-diabetic individuals. Materials and Methods A randomized controlled-crossover study was carried out on 30 Type 2 diabetic (Group A) and 45 non-diabetic (Group B) subjects. In first half of study, subjects in Group A and Group B were intervened with sugar-free and regular toothpaste respectively. Salivary glucose and pH was assessed before and after brushing at interval of one week for a period of four weeks. In second half, toothpastes were switched over between the groups, after sufficient washout period. Salivary glucose and pH were assessed again in the same manner for both the groups. The data was subjected to paired t-test and unpaired t-test for intragroup and intergroup comparison respectively. Results Salivary glucose level was significantly reduced and salivary pH was increased significantly (p<0.001) in both groups with sugar free toothpaste when compared to regular toothpaste. Conclusion Sugar free toothpaste showed beneficial effect on salivary glucose level and salivary pH level on diabetes and non-diabetes population. PMID:28893048

Determining individual variation in growth and its implication for life-history and population processes using the empirical Bayes method.

PubMed

Vincenzi, Simone; Mangel, Marc; Crivelli, Alain J; Munch, Stephan; Skaug, Hans J

2014-09-01

The differences in demographic and life-history processes between organisms living in the same population have important consequences for ecological and evolutionary dynamics. Modern statistical and computational methods allow the investigation of individual and shared (among homogeneous groups) determinants of the observed variation in growth. We use an Empirical Bayes approach to estimate individual and shared variation in somatic growth using a von Bertalanffy growth model with random effects. To illustrate the power and generality of the method, we consider two populations of marble trout Salmo marmoratus living in Slovenian streams, where individually tagged fish have been sampled for more than 15 years. We use year-of-birth cohort, population density during the first year of life, and individual random effects as potential predictors of the von Bertalanffy growth function's parameters k (rate of growth) and L∞ (asymptotic size). Our results showed that size ranks were largely maintained throughout marble trout lifetime in both populations. According to the Akaike Information Criterion (AIC), the best models showed different growth patterns for year-of-birth cohorts as well as the existence of substantial individual variation in growth trajectories after accounting for the cohort effect. For both populations, models including density during the first year of life showed that growth tended to decrease with increasing population density early in life. Model validation showed that predictions of individual growth trajectories using the random-effects model were more accurate than predictions based on mean size-at-age of fish.

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

PubMed

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

2017-10-01

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

Stress reduction at the work-family interface: positive parenting and self-efficacy as mechanisms of change in Workplace Triple P.

PubMed

Hartung, Doreen; Hahlweg, Kurt

2011-01-01

Workplace Triple P (WPTP) is a group-based parenting skills training specifically designed to meet the needs of employed parents. Several randomized controlled trials have demonstrated the training's efficacy. This study examined possible mechanisms of change that account for the stress reduction effects of this parenting skills training at the work-family interface. It was hypothesized that reductions in dysfunctional parenting (DP) behavior and increases in parental self-efficacy would mediate the stress-reducing effects of WPTP. The mediator effects were analyzed in a German pre- and postcompleter sample (N = 97 parents; 74 mothers and 23 fathers; treatment condition: n = 42 parents; waitlist-control condition n = 55 parents). The results indicate that individual stress- (IS) level reductions were mediated by decreased levels of DP. In addition, changes in IS levels mediated the effects of the training on work-related stress. The discussion focuses on the importance of understanding mechanisms of change to effectively implement interventions at the work-family interface.

Links between fear of humans, stress and survival support a non-random distribution of birds among urban and rural habitats

PubMed Central

Rebolo-Ifrán, Natalia; Carrete, Martina; Sanz-Aguilar, Ana; Rodríguez-Martínez, Sol; Cabezas, Sonia; Marchant, Tracy A.; Bortolotti, Gary R.; Tella, José L.

2015-01-01

Urban endocrine ecology aims to understand how organisms cope with new sources of stress and maintain allostatic load to thrive in an increasingly urbanized world. Recent research efforts have yielded controversial results based on short-term measures of stress, without exploring its fitness effects. We measured feather corticosterone (CORTf, reflecting the duration and amplitude of glucocorticoid secretion over several weeks) and subsequent annual survival in urban and rural burrowing owls. This species shows high individual consistency in fear of humans (i.e., flight initiation distance, FID), allowing us to hypothesize that individuals distribute among habitats according to their tolerance to human disturbance. FIDs were shorter in urban than in rural birds, but CORTf levels did not differ, nor were correlated to FIDs. Survival was twice as high in urban as in rural birds and links with CORTf varied between habitats: while a quadratic relationship supports stabilizing selection in urban birds, high predation rates may have masked CORTf-survival relationship in rural ones. These results evidence that urban life does not constitute an additional source of stress for urban individuals, as shown by their near identical CORTf values compared with rural conspecifics supporting the non-random distribution of individuals among habitats according to their behavioural phenotypes. PMID:26348294

Links between fear of humans, stress and survival support a non-random distribution of birds among urban and rural habitats.

PubMed

Rebolo-Ifrán, Natalia; Carrete, Martina; Sanz-Aguilar, Ana; Rodríguez-Martínez, Sol; Cabezas, Sonia; Marchant, Tracy A; Bortolotti, Gary R; Tella, José L

2015-09-08

Urban endocrine ecology aims to understand how organisms cope with new sources of stress and maintain allostatic load to thrive in an increasingly urbanized world. Recent research efforts have yielded controversial results based on short-term measures of stress, without exploring its fitness effects. We measured feather corticosterone (CORTf, reflecting the duration and amplitude of glucocorticoid secretion over several weeks) and subsequent annual survival in urban and rural burrowing owls. This species shows high individual consistency in fear of humans (i.e., flight initiation distance, FID), allowing us to hypothesize that individuals distribute among habitats according to their tolerance to human disturbance. FIDs were shorter in urban than in rural birds, but CORTf levels did not differ, nor were correlated to FIDs. Survival was twice as high in urban as in rural birds and links with CORTf varied between habitats: while a quadratic relationship supports stabilizing selection in urban birds, high predation rates may have masked CORTf-survival relationship in rural ones. These results evidence that urban life does not constitute an additional source of stress for urban individuals, as shown by their near identical CORTf values compared with rural conspecifics supporting the non-random distribution of individuals among habitats according to their behavioural phenotypes.

Experimental evaluation of fingerprint verification system based on double random phase encoding

NASA Astrophysics Data System (ADS)

Suzuki, Hiroyuki; Yamaguchi, Masahiro; Yachida, Masuyoshi; Ohyama, Nagaaki; Tashima, Hideaki; Obi, Takashi

2006-03-01

We proposed a smart card holder authentication system that combines fingerprint verification with PIN verification by applying a double random phase encoding scheme. In this system, the probability of accurate verification of an authorized individual reduces when the fingerprint is shifted significantly. In this paper, a review of the proposed system is presented and preprocessing for improving the false rejection rate is proposed. In the proposed method, the position difference between two fingerprint images is estimated by using an optimized template for core detection. When the estimated difference exceeds the permissible level, the user inputs the fingerprint again. The effectiveness of the proposed method is confirmed by a computational experiment; its results show that the false rejection rate is improved.

Competency-Based Training and Worker Turnover in Community Supports for People With IDD: Results From a Group Randomized Controlled Study.

PubMed

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-06-01

Turnover among direct support professionals (DSPs) in community support settings for individuals with intellectual and developmental disabilities (IDD) has been regarded as a challenge since tracking of this workforce began in the 1980s. This study utilized a group randomized controlled design to test the effects of a competency-based training intervention for DSPs on site-level turnover rates over a one year period. Results suggested that, compared with the control group, sites receiving the training intervention experienced a significant decrease in annual turnover, when multiple factors were controlled. Implications, including the importance of considering quality training as a long term organizational investment and intervention to reduce turnover, are discussed.

Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis.

PubMed

Nascimento, Lucas R; Teixeira-Salmela, Luci F; Souza, Ricardo B; Resende, Renan A

2018-01-01

Study Design Systematic review with meta-analysis. Background The addition of hip strengthening to knee strengthening for persons with patellofemoral pain has the potential to optimize treatment effects. There is a need to systematically review and pool the current evidence in this area. Objective To examine the efficacy of hip strengthening, associated or not with knee strengthening, to increase strength, reduce pain, and improve activity in individuals with patellofemoral pain. Methods A systematic review of randomized and/or controlled trials was performed. Participants in the reviewed studies were individuals with patellofemoral pain, and the experimental intervention was hip and knee strengthening. Outcome data related to muscle strength, pain, and activity were extracted from the eligible trials and combined in a meta-analysis. Results The review included 14 trials involving 673 participants. Random-effects meta-analyses revealed that hip and knee strengthening decreased pain (mean difference, -3.3; 95% confidence interval [CI]: -5.6, -1.1) and improved activity (standardized mean difference, 1.4; 95% CI: 0.03, 2.8) compared to no training/placebo. In addition, hip and knee strengthening was superior to knee strengthening alone for decreasing pain (mean difference, -1.5; 95% CI: -2.3, -0.8) and improving activity (standardized mean difference, 0.7; 95% CI: 0.2, 1.3). Results were maintained beyond the intervention period. Meta-analyses showed no significant changes in strength for any of the interventions. Conclusion Hip and knee strengthening is effective and superior to knee strengthening alone for decreasing pain and improving activity in persons with patellofemoral pain; however, these outcomes were achieved without a concurrent change in strength. Level of Evidence Therapy, level 1a-. J Orthop Sports Phys Ther 2018;48(1):19-31. Epub 15 Oct 2017. doi:10.2519/jospt.2018.7365.

Learning by (video) example: a randomized study of communication skills training for end-of-life and error disclosure family care conferences.

PubMed

Schmitz, Connie C; Braman, Jonathan P; Turner, Norman; Heller, Stephanie; Radosevich, David M; Yan, Yelena; Miller, Jane; Chipman, Jeffrey G

2016-11-01

Teaching residents to lead end of life (EOL) and error disclosure (ED) conferences is important. We developed and tested an intervention using videotapes of EOL and error disclosure encounters from previous Objective Structured Clinical Exams. Residents (n = 72) from general and orthopedic surgery programs at 2 sites were enrolled. Using a prospective, pre-post, block group design with stratified randomization, we hypothesized the treatment group would outperform the control on EOL and ED cases. We also hypothesized that online course usage would correlate positively with post-test scores. All residents improved (pre-post). At the group level, treatment effects were insignificant, and post-test performance was unrelated to course usage. At the subgroup level for EOL, low performers assigned to treatment scored higher than controls at post-test; and within the treatment group, post graduate year 3 residents outperformed post graduate year ​1 residents. To be effective, online curricula illustrating communication behaviors need face-to-face interaction, individual role play with feedback and discussion. Copyright © 2016 Elsevier Inc. All rights reserved.

Individual contributions, provision point mechanisms and project cost information effects on contingent values: Findings from a field validity test.

PubMed

Christantoni, Maria; Damigos, Dimitris

2018-05-15

In many instances, Contingent Valuation practitioners rely on voluntary monetary contributions, despite the fact that they are deemed to be neither incentive compatible in theory nor demand revealing in practice. The reason is that they are suitable for most field applications and offer benefits that may outweigh their drawbacks. This paper endeavors to contribute to the literature by exploring the effect of donation payments with differing incentive structures and information levels on contingent values and on respondents' uncertainty regarding the donations declared. To this end, a field survey was conducted using a sample of 332 respondents who were randomly assigned to one of three different mechanisms: (1) individual contribution (hereinafter CVM treatment); (2) individual contribution with provision point mechanism (PPM), where the total cost of the project is unknown (hereinafter PPM treatment); and (3) individual contribution with PPM, where the total cost of the project is known (hereinafter PPM-INF treatment). The results indicate that there are no statistically significant differences in willingness to pay (WTP) estimates between the CVM and PPM treatments nor between the PPM and the PPM-INF treatments. The results also indicate that the PPM has a positive effect on respondents' certainty level, but there is no evidence that the certainty level is affected by the project information cost. The results are mixed compared to previous research efforts. Thus, further tests are necessary in field comparisons and under different information environments before any definite recommendations can be made. Copyright © 2017 Elsevier B.V. All rights reserved.

Exploring the impact of high intensity interval training on adolescents' objectively measured physical activity: Findings from a randomized controlled trial.

PubMed

Costigan, Sarah A; Ridgers, Nicola D; Eather, Narelle; Plotnikoff, Ronald C; Harris, Nigel; Lubans, David R

2018-05-01

High Intensity Interval Training (HIIT) may be effective for accumulating VPA. However, the contribution of HIIT to overall physical activity is unknown. Our primary aim was to explore the impact of school-based HIIT on physical activity. The secondary aim was to explore within-individual changes in physical activity after participating in HIIT. Participants [n = 65; 15.8(0.6)years] were randomized to a HIIT or control group. Intervention groups participated in three HIIT sessions/week. GENEActiv accelerometers assessed objective physical activity at baseline and week-one, to detect changes in MPA and VPA. Intervention effects were examined using linear mixed models and evidence of a change in physical activity (i.e., compensation) were examined using multilevel linear regression models. The group-by-time interaction effects for MPA and VPA were small and moderate, respectively. Adjusted difference between groups for VPA was 1.70 min/day, 95%CI -1.96 to 5.36; p = 0.354; d = 0.55). Embedding HIIT within the school-day had a moderate effect on VPA compared to controls. Compensation analyses (i.e., individual level) suggested that adolescents were more active on days when they participated in HIIT. Further studies are needed to test the effects of HIIT on adolescents' physical activity over extended time periods.

How do individual-level sociodemographics and neighbourhood-level characteristics influence residential location behaviour in the context of the food and built environment? Findings from 25 years of follow-up in the CARDIA Study.

PubMed

Rummo, Pasquale E; Guilkey, David K; Shikany, James M; Reis, Jared P; Gordon-Larsen, Penny

2017-03-01

Little is known about how diet-related and activity-related amenities relate to residential location behaviour. Understanding these relationships is essential for addressing residential self-selection bias. Using 25 years (6 examinations) of data from the Coronary Artery Risk Development in Young Adults (CARDIA) study (n=11 013 observations) and linked neighbourhood-level data from the 4 CARDIA baseline cities (Birmingham, Alabama; Chicago, Illinois; Minneapolis, Minnesota; Oakland, California, USA), we characterised participants' neighbourhoods as having low, average or high road connectivity and amenities using non-hierarchical cluster analysis. We then used repeated measures multinomial logistic regression with random effects to examine the associations between individual-level sociodemographics and neighbourhood-level characteristics with residential neighbourhood types over the 25-year period, and whether these associations differed by individual-level income. Being female was positively associated with living in neighbourhoods with low (vs high) road connectivity and activity-related and diet-related amenities among high-income individuals only. At all income levels, a higher percentage of neighbourhood white population and neighbourhood population <18 years were associated with living in neighbourhoods with low (vs high) connectivity and amenities. Individual-level race; age; and educational attainment, neighbourhood socioeconomic status and housing prices did not influence residential location behaviour related to neighbourhood connectivity and amenities at any income level. Neighbourhood-level factors appeared to play a comparatively greater role in shaping residential location behaviour than individual-level sociodemographics. Our study is an important step in understanding how residential locational behaviour relates to amenities and physical activity opportunities, and may help mitigate residential self-selection bias in built environment studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effects of blood pressure-lowering treatment on cardiovascular outcomes and mortality: 13 - benefits and adverse events in older and younger patients with hypertension: overview, meta-analyses and meta-regression analyses of randomized trials.

PubMed

Thomopoulos, Costas; Parati, Gianfranco; Zanchetti, Alberto

2018-05-29

There is overwhelming evidence that blood pressure (BP)-lowering treatment can reduce cardiovascular outcomes also in the elderly, but some important aspects influencing medical practice are controversial as sufficient evidence has not been provided by single randomized controlled trials (RCTs), whereas evidence may result from a systematic search and meta-analysis of all available data. The following clinically relevant issues concerning the effects of BP lowering in older and younger individuals have been investigated: differences in benefits; the oldest and the youngest age range for which evidence of BP-lowering effects is available; the SBP level at which BP-lowering treatment should be initiated; the SBP and DBP levels treatment should be aimed at; differences in treatment burdens and harms. A database we previously identified of 72 BP-lowering RCTs in 260 210 patients was searched for separately reported data on older and younger individuals [cutoffs of 65 (primary analyses), 70, 75, 80, 60 and 55 years). The data were further stratified according to the levels of baseline (untreated) BP, and of on-treatment achieved SBP or DBP. Seven fatal and nonfatal outcomes were considered for benefits. Burdens and harms were investigated as permanent treatment discontinuations for adverse events, and hypotension/syncope. Risk ratios and absolute risk changes were calculated by a random effects model. Effects at older and younger ages were compared by heterogeneity test. Thirty-two RCTs provided data on 96 549 patients older than 65 years, and 31 RCTs on 114 009 patients younger than 65 years. All cardiovascular outcomes were significantly reduced by treatment both in older and younger individuals, without significant age-dependent differences in relative risk reduction but with significantly higher absolute risk reductions in older individuals. The extreme age ranges for which evidence of significant benefits of treatment were available was greater than 80 and less than 55 years. Only one RCT provided data on benefits of BP-lowering at age greater than 65 when treatment was initiated at SBP values in the grade 1 range, but more consistent evidence was provided when age was greater than 60 years. Both in patients older and younger than 65 years, significant reductions of cardiovascular outcomes were found at on-treatment SBP less than 140 mmHg and DBP less than 80 mmHg. There was no evidence that treatment discontinuations for adverse events or hypotension/syncope were more frequent at age greater than 65. Antihypertensive treatment should be recommended to all individuals with elevated BP, independent of age. The prudent recommendation to initiate treatment at SBP values 140-159 mmHg is supported at older age defined as greater than 60 years. SBP and DBP values lower than 140 mmHg and, respectively, 80 mmHg can be aimed at with incremental benefits without disproportionate burdens until age 80 years, above which available evidence is for benefits at on-treatment SBP 140-149 mmHg.

A Bereavement Support Group Intervention Is Longitudinally Associated with Salutary Effects on the CD4 Cell Count and Number of Physician Visits

PubMed Central

Goodkin, Karl; Feaster, Daniel J.; Asthana, Deshratn; Blaney, Nancy T.; Kumar, Mahendra; Baldewicz, Teri; Tuttle, Raymond S.; Maher, Kevin J.; Baum, Marianna K.; Shapshak, Paul; Fletcher, Mary Ann

1998-01-01

A randomized, controlled, clinical trial was conducted to examine the impact of a semistructured, 10-week, once weekly, 90-min/session bereavement support group intervention on immunological, neuroendocrine, and clinical health status in human immunodeficiency virus type 1-seropositive (HIV-1+) and HIV-1-seronegative (HIV-1−) homosexual men, compared to a standard of care control condition. A total of 119 homosexual men (74 HIV-1+ and 45 HIV-1−) were assessed at baseline, 10 weeks, and 6 months follow-up. At the 6-month follow-up assessment, the intervention groups exhibited significant beneficial effects compared to controls on changes in CD4 cell, total T-lymphocyte, and total lymphocyte counts, when baseline levels, antiretroviral medication use, CDC stage of disease, and other potentially confounding factors were accounted for. There was no statistically significant effect on the CD4/CD8 ratio or on the CD8 cell count. The effect on CD4 cell count was associated with group attendance and with changes in plasma cortisol level. Plasma cortisol levels decreased significantly among intervention subjects, compared to controls. A significantly reduced number of health care visits over the 6-month follow-up period among the intervention subjects supported the clinical relevance of the immunological changes observed for both HIV-1+ and HIV-1− individuals. These results indicate that behavioral interventions may have salutary immunological and clinical health effects following bereavement among HIV-1-infected individuals. The effect in HIV-1− individuals suggests that this bereavement support group intervention might have similar salutary effects in the general population. Potential effects of such interventions on clinical HIV disease progression are of interest and should be studied. PMID:9605995

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

ERIC Educational Resources Information Center

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

2015-01-01

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

Role of delay-based reward in the spatial cooperation

NASA Astrophysics Data System (ADS)

Wang, Xu-Wen; Nie, Sen; Jiang, Luo-Luo; Wang, Bing-Hong; Chen, Shi-Ming

2017-01-01

Strategy selection in games, a typical decision making, usually brings noticeable reward for players which have discounted value if the delay appears. The discounted value is measure: earning sooner with a small reward or later with a delayed larger reward. Here, we investigate effects of delayed rewards on the cooperation in structured population. It is found that delayed reward supports the spreading of cooperation in square lattice, small-world and random networks. In particular, intermediate reward differences between delays impel the highest cooperation level. Interestingly, cooperative individuals with the same delay time steps form clusters to resist the invasion of defects, and cooperative individuals with lowest delay reward survive because they form the largest clusters in the lattice.

Effects of antecedent exercise on academic engagement and stereotypy during instruction.

PubMed

Neely, Leslie; Rispoli, Mandy; Gerow, Stephanie; Ninci, Jennifer

2015-01-01

Antecedent physical exercise has emerged as a potentially promising treatment for reducing challenging behavior and increasing academic behavior in individuals with autism spectrum disorder (ASD). The purpose of this study was to evaluate the effects of physical exercise conducted prior to instructional sessions (antecedent physical exercise) on academic engagement and stereotypy during instructional sessions for two children diagnosed with ASD. Functional analysis results suggested stereotypy was maintained by automatic reinforcement for both participants. A multielement design was employed to evaluate academic engagement and stereotypy during instructional sessions following randomly sequenced conditions involving either (a) no antecedent exercise, (b) brief durations of antecedent exercise, or (c) antecedent exercise that continued until the participant engaged in a systematically determined behavioral indicator of satiation. Both participants demonstrated higher levels of academic engagement and reduced levels of stereotypy during the instructional sessions which followed antecedent physical exercise that continued until behavioral indicators of satiation occurred. This study replicates previous research suggesting that individuals with ASD may benefit from physical exercise prior to academic instruction and further suggests that the duration of antecedent exercise may be optimally individualized based on behavioral indicators of satiation. © The Author(s) 2014.

Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial.

PubMed

Poulsen, Rie; Fisker, Jonas; Hoff, Andreas; Hjorthøj, Carsten; Eplov, Lene Falgaard

2017-12-02

Common mental disorders are important contributors to the global burden of disease and cause negative effects on both the individual and society. Stress-related disorders influence the individual's workability and cause early retirement pensions in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this group. Integrated vocational and health care services have shown good effects on return to work in other similar welfare contexts. The purpose of the Danish IBBIS (Integreret Behandlings- og BeskæftigelsesIndsats til Sygemeldte) study is to examine the efficacy of (1) a stepped mental health care intervention with individual stress coaching and/or group-based MBSR and (2) an integrated stepped mental health care with individual stress coaching and/or group-based MBSR and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark. This three-armed, parallel-group, randomized superiority trial is set up to investigate the effectiveness of a stepped mental health care intervention and an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of exhaustion disorder, adjustment disorder or distress in Denmark. The trial has an investigator-initiated multicenter design. Six hundred and three patients will be recruited from Danish vocational rehabilitation centers in four municipalities and randomly assigned into three groups: (1) IBBIS mental health care integrated with IBBIS vocational rehabilitation, (2) IBBIS mental health care and standard vocational rehabilitation, and (3) standard mental health care and standard vocational rehabilitation. The primary outcome is register-based return to work at 12 months. The secondary outcome measures are self-assessed level of depression (BDI), anxiety (BAI), distress symptoms (4DSQ), work- and social functioning (WSAS), and register-based recurrent sickness absence. This study will contribute with knowledge on the consequence of the current organizational separation of health care interventions and vocational rehabilitation regarding the individual's process of returning to work after sick leave because of exhaustion disorder, adjustment disorder or distress. If the effect on return to work, symptom level, and recurrent sick leave is different in the intervention groups, this study can contribute with new knowledge on shared care models and the potential for preventing deterioration in stress symptoms, prolonged sick leave, and recurrent sick leave. ClinicalTrials.gov, registration number: NCT02885519 . Retrospectively registered on 15 August 2016). Participants have been included in the IBBIS trial for distress, adjustment disorder and exhaustion disorder since April 2016.

Integration of genotoxicity and population genetic analyses in kangaroo rats (Dipodomys merriami) exposed to radionuclide contamination at the Nevada Test Site, USA

USGS Publications Warehouse

Theodorakis, Christopher W.; Bickham, John W.; Lamb, Trip; Medica, Philip A.; Lyne, T. Barrett

2001-01-01

We examined effects of radionuclide exposure at two atomic blast sites on kangaroo rats (Dipodomys merriami) at the Nevada Test Site, Nevada, USA, using genotoxicity and population genetic analyses. We assessed chromosome damage by micronucleus and flow cytometric assays and genetic variation by randomly amplified polymorphic DNA (RAPD) and mitochondrial DNA (mtDNA) analyses. The RAPD analysis showed no population structure, but mtDNA exhibited differentiation among and within populations. Genotoxicity effects were not observed when all individuals were analyzed. However, individuals with mtDNA haplotypes unique to the contaminated sites had greater chromosomal damage than contaminated-site individuals with haplotypes shared with reference sites. When interpopulation comparisons used individuals with unique haplotypes, one contaminated site had greater levels of chromosome damage than one or both of the reference sites. We hypothesize that shared-haplotype individuals are potential migrants and that unique-haplotype individuals are potential long-term residents. A parsimony approach was used to estimate the minimum number of migration events necessary to explain the haplotype distributions on a phylogenetic tree. The observed predominance of migration events into the contaminated sites supported our migration hypothesis. We conclude the atomic blast sites are ecological sinks and that immigration masks the genotoxic effects of radiation on the resident populations.

Investigating the Associations between Ethnic Networks, Community Social Capital, and Physical Health among Marriage Migrants in Korea.

PubMed

Kim, Harris Hyun-Soo

2018-01-17

This study examines factors associated with the physical health of Korea's growing immigrant population. Specifically, it focuses on the associations between ethnic networks, community social capital, and self-rated health (SRH) among female marriage migrants. For empirical testing, secondary analysis of a large nationally representative sample (NSMF 2009) is conducted. Given the clustered data structure (individuals nested in communities), a series of two-level random intercepts and slopes models are fitted to probe the relationships between SRH and interpersonal (bonding and bridging) networks among foreign-born wives in Korea. In addition to direct effects, cross-level interaction effects are investigated using hierarchical linear modeling. While adjusting for confounders, bridging (inter-ethnic) networks are significantly linked with better health. Bonding (co-ethnic) networks, to the contrary, are negatively associated with immigrant health. Net of individual-level covariates, living in a commuijnity with more aggregate bridging social capital is positively linked with health. Community-level bonding social capital, however, is not a significant predictor. Lastly, two cross-level interaction terms are found. First, the positive relationship between bridging network and health is stronger in residential contexts with more aggregate bridging social capital. Second, it is weaker in communities with more aggregate bonding social capital.

Inferring personal economic status from social network location

NASA Astrophysics Data System (ADS)

Luo, Shaojun; Morone, Flaviano; Sarraute, Carlos; Travizano, Matías; Makse, Hernán A.

2017-05-01

It is commonly believed that patterns of social ties affect individuals' economic status. Here we translate this concept into an operational definition at the network level, which allows us to infer the economic well-being of individuals through a measure of their location and influence in the social network. We analyse two large-scale sources: telecommunications and financial data of a whole country's population. Our results show that an individual's location, measured as the optimal collective influence to the structural integrity of the social network, is highly correlated with personal economic status. The observed social network patterns of influence mimic the patterns of economic inequality. For pragmatic use and validation, we carry out a marketing campaign that shows a threefold increase in response rate by targeting individuals identified by our social network metrics as compared to random targeting. Our strategy can also be useful in maximizing the effects of large-scale economic stimulus policies.

Inferring personal economic status from social network location.

PubMed

Luo, Shaojun; Morone, Flaviano; Sarraute, Carlos; Travizano, Matías; Makse, Hernán A

2017-05-16

It is commonly believed that patterns of social ties affect individuals' economic status. Here we translate this concept into an operational definition at the network level, which allows us to infer the economic well-being of individuals through a measure of their location and influence in the social network. We analyse two large-scale sources: telecommunications and financial data of a whole country's population. Our results show that an individual's location, measured as the optimal collective influence to the structural integrity of the social network, is highly correlated with personal economic status. The observed social network patterns of influence mimic the patterns of economic inequality. For pragmatic use and validation, we carry out a marketing campaign that shows a threefold increase in response rate by targeting individuals identified by our social network metrics as compared to random targeting. Our strategy can also be useful in maximizing the effects of large-scale economic stimulus policies.

Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial.

PubMed

Tan, Xiao; Saarinen, Antti; Mikkola, Tuija M; Tenhunen, Jarkko; Martinmäki, Samu; Rahikainen, Aki; Cheng, Shumei; Eklund, Niklas; Pekkala, Satu; Wiklund, Petri; Munukka, Eveliina; Wen, Xinfei; Cong, Fengyu; Wang, Xi; Zhang, Yajun; Tarkka, Ina; Sun, Yining; Partinen, Markku; Alen, Markku; Cheng, Sulin

2013-07-26

Sleep is essential for normal and healthy living. Lack of good quality sleep affects physical, mental and emotional functions. Currently, the treatments of obesity-related sleep disorders focus more on suppressing sleep-related symptoms pharmaceutically and are often accompanied by side effects. Thus, there is urgent need for alternative ways to combat chronic sleep disorders. This study will investigate underlying mechanisms of the effects of exercise and diet intervention on obesity-related sleep disorders, the role of gut microbiota in relation to poor quality of sleep and day-time sleepiness, as well as the levels of hormones responsible for sleep-wake cycle regulation. Participants consist of 330 (target sample) Finnish men aged 30 to 65 years. Among them, we attempt to randomize 180 (target sample) with sleep disorders into exercise and diet intervention. After screening and physician examination, 101 men with sleep disorders are included and are randomly assigned into three groups: exercise (n = 33), diet (n = 35), and control (n = 33). In addition, we attempt to recruit a target number of 150 healthy men without sleep disorders as the reference group. The exercise group undergoes a six-month individualized progressive aerobic exercise program based on initial fitness level. The diet group follows a six month specific individualized diet program. The control group and reference group are asked to maintain their normal activity and diet during intervention. Measurements are taken before and after the intervention. Primary outcomes include objective sleep measurements by polysomnography and a home-based non-contact sleep monitoring system, and subjective sleep evaluation by questionnaires. Secondary outcome measures include anthropometry, body composition, fitness, sleep disorder-related lifestyle risk factors, composition of gut microbiota and adipose tissue metabolism, as well as specific hormone and neurotranmitter levels and inflammatory biomarkers from venous blood samples. It is expected that the improvement of sleep quality after exercise and diet intervention will be evident both in subjective and objective measures of quality of sleep. Additionally, the change of sleep quality induced by exercise and diet intervention is expected to be related to the changes in specific hormones and inflammatory biomarkers, and in the composition of gut microbiota.

Comparison of the efficacy of saline, local anesthetics, and steroids in epidural and facet joint injections for the management of spinal pain: A systematic review of randomized controlled trials

PubMed Central

Manchikanti, Laxmaiah; Nampiaparampil, Devi E.; Manchikanti, Kavita N.; Falco, Frank J.E.; Singh, Vijay; Benyamin, Ramsin M.; Kaye, Alan D.; Sehgal, Nalini; Soin, Amol; Simopoulos, Thomas T.; Bakshi, Sanjay; Gharibo, Christopher G.; Gilligan, Christopher J.; Hirsch, Joshua A.

2015-01-01

Background: The efficacy of epidural and facet joint injections has been assessed utilizing multiple solutions including saline, local anesthetic, steroids, and others. The responses to these various solutions have been variable and have not been systematically assessed with long-term follow-ups. Methods: Randomized trials utilizing a true active control design were included. The primary outcome measure was pain relief and the secondary outcome measure was functional improvement. The quality of each individual article was assessed by Cochrane review criteria, as well as the criteria developed by the American Society of Interventional Pain Physicians (ASIPP) for assessing interventional techniques. An evidence analysis was conducted based on the qualitative level of evidence (Level I to IV). Results: A total of 31 trials met the inclusion criteria. There was Level I evidence that local anesthetic with steroids was effective in managing chronic spinal pain based on multiple high-quality randomized controlled trials. The evidence also showed that local anesthetic with steroids and local anesthetic alone were equally effective except in disc herniation, where the superiority of local anesthetic with steroids was demonstrated over local anesthetic alone. Conclusion: This systematic review showed equal efficacy for local anesthetic with steroids and local anesthetic alone in multiple spinal conditions except for disc herniation where the superiority of local anesthetic with steroids was seen over local anesthetic alone. PMID:26005584

Translating the link between social identity and health behavior into effective health communication strategies: An experimental application using antismoking advertisements.

PubMed

Moran, Meghan Bridgid; Sussman, Steve

2014-01-01

Social identity is a construct that has been linked to health behavior. Yet, limited research has attempted to translate this relationship into health communication strategies. The current study addresses this gap by examining the efficacy of social identity targeting (constructing ads so that they target a specific group with which an individual identifies) to increase anti-cigarette smoking beliefs among adolescents. Two hundred and fifty one adolescents aged 12-15, randomly selected from a nationally representative sample, completed an online survey. Participants indicated which of 11 peer groups (determined in pre-testing) they most identified with. Each participant was then randomly assigned to view an ad that either did or did not target that group. One week later participants reported level of agreement with two key antismoking beliefs presented in the ad. Multiple regression analyses indicated that if an individual identified with the group targeted by the ad, antismoking beliefs were more strongly endorsed. Based on these findings, we conclude that social identity targeting has the potential to increase the effectiveness of antismoking messages and should be considered when designing antismoking campaigns.

Effectiveness of acupuncture therapy as treatment for tinnitus: a randomized controlled trial.

PubMed

Doi, Marcelo Yugi; Tano, Simone Sayomi; Schultz, Adriane Rocha; Borges, Ricardo; Marchiori, Luciana Lozza de Moraes

2016-01-01

Tinnitus is a subjective sensation of hearing a sound in the absence of an external stimulus, which significantly worsens the quality of life in 15-25% of affected individuals. To assess the effectiveness of acupuncture therapy for tinnitus. Randomized clinical trial ( 2T9T7Q) with 50 participants with tinnitus, divided into two groups: 25 participants in the acupuncture group and 25 participants in the control group. The acupuncture group received acupuncture treatment and the control group received no treatment. After a period of 5 weeks, they were called to perform the final evaluation and the control group received acupuncture treatment for ethical reasons. A statistically significant result was found for the primary outcome, reducing the intensity of tinnitus, with p=0.0001 and the secondary endpoint, showing improvement in quality of life, with p=0.0001. Chinese scalp acupuncture associated with bilateral electroacupuncture demonstrated, in the short term, a statistically significant improvement by reducing the level of tinnitus intensity, as well as improving the quality of life of individuals with tinnitus. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study

PubMed Central

Jiménez-Rejano, J. J.; Chillón-Martínez, R.; Gómez-Benítez, M. A.; De-La-Casa-Almeida, M.

2018-01-01

Background There are a great number of interventions in physiotherapy, but with little evidence of their effectiveness in chronic low back pain. Therefore, this study assesses effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics and the combination of both to decrease pain and lumbar disability while increasing joint mobility and quality of life in patients with chronic nonspecific low back pain. Methods A randomized, single-blinded, controlled, clinical trial with sample (n = 27) was comprised of patients between 20 and 65 years, diagnosed with pain of mechanical origin characterized by having a duration of at least 12 weeks and no serious complications. Each group received 8 interventions of 30 minutes. Results Friedman ANOVA test obtained statistically significant differences of Oswestry, NRS, and Schober variables (p < 0.05) in the three measurements (pretest, posttest 1, and posttest 2), in each individual group. ANOVA Kruskal-Wallis test was used for comparison between groups, and Oswestry Disability values were significantly higher (p = 0.024) in the group receiving both treatments. Conclusion Both individual groups reduce pain levels, improve disability, and increase the flexibility of the lumbar spine. The combination therapy provides greater benefits in terms of lumbar disability. This study is registered on March 8, 2016, with NCT02721914. PMID:29681973

Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study.

PubMed

Bellido-Fernández, L; Jiménez-Rejano, J J; Chillón-Martínez, R; Gómez-Benítez, M A; De-La-Casa-Almeida, M; Rebollo-Salas, M

2018-01-01

There are a great number of interventions in physiotherapy, but with little evidence of their effectiveness in chronic low back pain. Therefore, this study assesses effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics and the combination of both to decrease pain and lumbar disability while increasing joint mobility and quality of life in patients with chronic nonspecific low back pain. A randomized, single-blinded, controlled, clinical trial with sample ( n = 27) was comprised of patients between 20 and 65 years, diagnosed with pain of mechanical origin characterized by having a duration of at least 12 weeks and no serious complications. Each group received 8 interventions of 30 minutes. Friedman ANOVA test obtained statistically significant differences of Oswestry, NRS, and Schober variables ( p < 0.05) in the three measurements (pretest, posttest 1, and posttest 2), in each individual group. ANOVA Kruskal-Wallis test was used for comparison between groups, and Oswestry Disability values were significantly higher ( p = 0.024) in the group receiving both treatments. Both individual groups reduce pain levels, improve disability, and increase the flexibility of the lumbar spine. The combination therapy provides greater benefits in terms of lumbar disability. This study is registered on March 8, 2016, with NCT02721914.

Mindfulness-Based Cognitive Therapy for Individuals Whose Lives Have Been Affected by Cancer: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Foley, Elizabeth; Baillie, Andrew; Huxter, Malcolm; Price, Melanie; Sinclair, Emma

2010-01-01

Objective: This study evaluated the effectiveness of mindfulness-based cognitive therapy (MBCT) for individuals with a diagnosis of cancer. Method: Participants (N = 115) diagnosed with cancer, across site and stage, were randomly allocated to either the treatment or the wait-list condition. Treatment was conducted at 1 site, by a single…

The effectiveness of an intervention to reduce alcohol-related violence in premises licensed for the sale and on-site consumption of alcohol: a randomized controlled trial.

PubMed

Moore, Simon C; Alam, M Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-11-01

Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

The effectiveness of an intervention to reduce alcohol‐related violence in premises licensed for the sale and on‐site consumption of alcohol: a randomized controlled trial

PubMed Central

Alam, M. Fasihul; Heikkinen, Marjukka; Hood, Kerenza; Huang, Chao; Moore, Laurence; Murphy, Simon; Playle, Rebecca; Shepherd, Jonathan; Shovelton, Claire; Sivarajasingam, Vaseekaran; Williams, Anne

2017-01-01

Abstract Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault‐related injury through poor operational practices that, if addressed, could reduce violence. We tested the real‐world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police‐recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow‐up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455‐day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention‐to‐treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20–1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow‐up visits). Conclusion An Environmental Health Practitioner‐led intervention in premises licensed for the sale and on‐site consumption of alcohol resulted in an increase in police recorded violence. PMID:28543914

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

PubMed Central

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

2009-01-01

Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

Outcome of dialectical behaviour therapy for concurrent eating and substance use disorders.

PubMed

Courbasson, Christine; Nishikawa, Yasunori; Dixon, Lauren

2012-09-01

The current study examined the preliminary efficacy of dialectical behaviour therapy (DBT) adapted for concurrent eating disorders (EDs) and substance use disorders (SUDs). A matched randomized controlled trial was carried out with 25 female outpatients diagnosed with concurrent ED and SUD. Participants randomized to the intervention condition received DBT, whereas those randomized to the control condition received treatment as usual (TAU), both for a period of 1 year. A series of measures related to disordered eating, substance use and depression were administered to the participants at the beginning of treatment and at 3, 6, 9 and 12 months into treatment, followed by 3-month and 6-month follow-up assessments. Participants randomized to the DBT condition evidenced a superior retention rate relative to their counterparts in the TAU condition at various study time points, including post-treatment (80% versus 20%) and follow-up (60% versus 20%). Due to the unexpected elevated dropout rates and the worsening of ED-SUD symptomatology in the TAU condition, recruitment efforts were terminated early. Results from the DBT condition revealed that the intervention had a significant positive effect on behavioural and attitudinal features of disordered eating, substance use severity and use, negative mood regulation and depressive symptoms. Finally, increases in participants' perceived ability to regulate and cope with negative emotional states were significantly associated with decreases in emotional eating and increases in levels of confidence in ability to resist urges for substance use. Results suggest that the adapted DBT might hold promise for treating individuals with concurrent ED and SUD. The current study is the first study to report positive effects of DBT on individuals with concurrent eating and substance use disorders. Although the results require replication and extension, they suggest that the DBT may be promising for this population. The results suggest that clinicians treating individuals with concurrent eating and substance use problems should be particularly cautious of poor treatment retention and treatment complications. The results bear upon the highly salient and important issue of whether individuals with concurrent substance use need to be excluded from research studies and treatment programmes. Copyright © 2011 John Wiley & Sons, Ltd.

A cross-sectional study of the effect of health literacy on diabetes prevention and control among elderly individuals with prediabetes in rural China

PubMed Central

Qin, Lulu; Xu, Huilan

2016-01-01

Objectives This study was designed to examine the effect of health literacy on diabetes prevention and control and risk factors for low diabetes health literacy among elderly individuals with prediabetes in rural areas in China. Design setting and participates A cross-sectional survey was conducted among elderly individuals in rural communities in Yiyang City in China. Multi-staged cluster random sampling was used to select 42 areas and 434 individuals with prediabetes who were interviewed using a questionnaire on diabetes health literacy in China. Main outcome measures Participants were asked for general information (age, gender, marital status, history of hyperglycaemia, family history of diabetes mellitus, presence of other diseases and level of education). Binary logistic regression analysis was used to identify risk factors for poor health literacy concerning diabetes prevention and control among elderly subjects with prediabetes. Results The median health literacy score for diabetes prevention and prediabetes control was 10.0 (IQR 7.0–13.0). The level of diabetes health literacy among men was lower than among women (OR 2.831, 95% CI 1.818 to 4.408), and lower among respondents with 1–6 years of education than among those with 6 years or more of education (OR 14.274, 95% CI 5.927 to 34.375). Those with less than 1 year of education had the lowest literacy (OR 31.148, 95% CI 11.661 to 83.204). The level of diabetes health literacy among elderly individuals with prediabetes but no history of hyperglycaemia was lower than among those with a history of hyperglycaemia (OR 2.676, 95% CI 1.101 to 6.504). Conclusions Health literacy concerning diabetes prevention and control among elderly individuals with prediabetes was very low in rural China. Appropriate health education for elderly individuals with low educational levels should be incorporated into diabetes prevention efforts. Trial registration number ChiCTR-IOR-15007033; Results. PMID:27235299

A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents.

PubMed

Kolanowski, Ann; Litaker, Mark; Buettner, Lin; Moeller, Joyel; Costa, Paul T

2011-06-01

To test the main and interactive effects of activities derived from the Need-Driven Dementia-Compromised Behavior model for responding to behavioral symptoms in nursing home residents. Randomized double-blind clinical trial. Nine community-based nursing homes. One hundred twenty-eight cognitively impaired residents randomly assigned to activities adjusted to functional level (FL) (n=32), personality style of interest (PSI) (n=33), functional level and personality style of interest (FL+PSI) (n=31), or active control (AC) (n=32). Three weeks of activities provided twice daily. Agitation, passivity, engagement, affect, and mood assessed from video recordings and real-time observations during baseline, intervention, random times outside of intervention, and 1 week after intervention. All treatments improved outcomes during intervention except mood, which worsened under AC. During intervention the PSI group demonstrated greater engagement, alertness, and attention than the other groups; the FL+PSI group demonstrated greater pleasure. During random times, engagement returned to baseline levels except in the FL group in which it decreased. There was also less agitation and passivity in groups with a component adjusted to PSI. One week after the intervention, mood, anxiety, and passivity improved over baseline; significantly less pleasure was displayed after withdrawal of treatment. The hypothesis that activities adjusted to FL+PSI would improve behavioral outcomes to a greater extent than partially adjusted or nonadjusted activities was partially supported. PSI is a critical component of individualized activity prescription. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

Iterative Usage of Fixed and Random Effect Models for Powerful and Efficient Genome-Wide Association Studies

PubMed Central

Liu, Xiaolei; Huang, Meng; Fan, Bin; Buckler, Edward S.; Zhang, Zhiwu

2016-01-01

False positives in a Genome-Wide Association Study (GWAS) can be effectively controlled by a fixed effect and random effect Mixed Linear Model (MLM) that incorporates population structure and kinship among individuals to adjust association tests on markers; however, the adjustment also compromises true positives. The modified MLM method, Multiple Loci Linear Mixed Model (MLMM), incorporates multiple markers simultaneously as covariates in a stepwise MLM to partially remove the confounding between testing markers and kinship. To completely eliminate the confounding, we divided MLMM into two parts: Fixed Effect Model (FEM) and a Random Effect Model (REM) and use them iteratively. FEM contains testing markers, one at a time, and multiple associated markers as covariates to control false positives. To avoid model over-fitting problem in FEM, the associated markers are estimated in REM by using them to define kinship. The P values of testing markers and the associated markers are unified at each iteration. We named the new method as Fixed and random model Circulating Probability Unification (FarmCPU). Both real and simulated data analyses demonstrated that FarmCPU improves statistical power compared to current methods. Additional benefits include an efficient computing time that is linear to both number of individuals and number of markers. Now, a dataset with half million individuals and half million markers can be analyzed within three days. PMID:26828793

A randomized trial of the effects of an aquatic exercise program on depression, anxiety levels, and functional capacity in of people who suffered an ischemic stroke.

PubMed

Aidar, Felipe J; Jacó de Oliveira, Ricardo; Gama de Matos, Dihogo; Chilibeck, Philip D; de Souza, Raphael F; Carneiro, André L; Machado Reis, Victor

2017-05-09

Aquatic exercise programs are used in rehabilitation and might help to reduce disability after stroke. This was a randomized intervention trial to assess the influence of an aquatic exercise program on people suffering from depression and anxiety after ischemic stroke. Participants were randomized to an experimental group (EG) composed of 19 individuals (51.8 ± 8.5 years; ten males and nine females), and a control group (CG) composed of 17 people (52.7 ± 6.7 years; nine males and eight females). The aquatic exercise program consisted of two sessions per week, each lasting between 45 and 60 minutes and divided into 5 to 10 minutes exercise sections during 12 weeks. The State-Trait Anxiety Inventory (STAI) was used to determine anxiety levels while the Beck Depression Inventory was used as a self-assessment of depression. EG improved measures of depression, anxiety trait and anxiety state between pre- and post-treatment, with no changes in CG. EG improved in all tests related to functional capacity compared to CG. The practice of aquatic exercises promotes improvements in the levels of depression and anxiety in people who suffered an ischemic stroke.

Evaluation of a cognitive behavioural self-help manual for reducing depression: a randomized controlled trial.

PubMed

Songprakun, W; McCann, T V

2012-09-01

The prevalence of depression is increasing in Thailand. We used a randomized controlled trial to examine the effectiveness of a self-help programme in reducing depression in people with depression in Chiang Mai Province in Thailand. Fifty-six individuals diagnosed with moderate depression participated. They were assigned randomly to an intervention (n= 27) or control (n= 29) group. The intervention group were given a self-help manual along with standard care and treatment, while the control group continued to receive standard care and treatment. Both groups were also given a short weekly telephone call. The findings showed statistically significant differences between the groups, and within the intervention group, in their depression levels. Between baseline and post-test, a sharp decrease in depression was evident in the intervention group, whereas the level of depression increased in the control group. Between post-test and follow-up, a decrease was apparent in depression in both groups. However, the intervention group showed a much lower level of depression than the control group. The results support the use of bibliotherapy as an adjunct to mental health nurses' and other professionals' work in caring for people with moderate depression in the community. http://www.ANZCTR.org.au/ACTRN12611000905965.aspx. © 2012 Blackwell Publishing.

Estimating the efficacy of Alcoholics Anonymous without self-selection bias: An instrumental variables re-analysis of randomized clinical trials

PubMed Central

Humphreys, Keith; Blodgett, Janet C.; Wagner, Todd H.

2014-01-01

Background Observational studies of Alcoholics Anonymous’ (AA) effectiveness are vulnerable to self-selection bias because individuals choose whether or not to attend AA. The present study therefore employed an innovative statistical technique to derive a selection bias-free estimate of AA’s impact. Methods Six datasets from 5 National Institutes of Health-funded randomized trials (one with two independent parallel arms) of AA facilitation interventions were analyzed using instrumental variables models. Alcohol dependent individuals in one of the datasets (n = 774) were analyzed separately from the rest of sample (n = 1582 individuals pooled from 5 datasets) because of heterogeneity in sample parameters. Randomization itself was used as the instrumental variable. Results Randomization was a good instrument in both samples, effectively predicting increased AA attendance that could not be attributed to self-selection. In five of the six data sets, which were pooled for analysis, increased AA attendance that was attributable to randomization (i.e., free of self-selection bias) was effective at increasing days of abstinence at 3-month (B = .38, p = .001) and 15-month (B = 0.42, p = .04) follow-up. However, in the remaining dataset, in which pre-existing AA attendance was much higher, further increases in AA involvement caused by the randomly assigned facilitation intervention did not affect drinking outcome. Conclusions For most individuals seeking help for alcohol problems, increasing AA attendance leads to short and long term decreases in alcohol consumption that cannot be attributed to self-selection. However, for populations with high pre-existing AA involvement, further increases in AA attendance may have little impact. PMID:25421504

Estimating the efficacy of Alcoholics Anonymous without self-selection bias: an instrumental variables re-analysis of randomized clinical trials.

PubMed

Humphreys, Keith; Blodgett, Janet C; Wagner, Todd H

2014-11-01

Observational studies of Alcoholics Anonymous' (AA) effectiveness are vulnerable to self-selection bias because individuals choose whether or not to attend AA. The present study, therefore, employed an innovative statistical technique to derive a selection bias-free estimate of AA's impact. Six data sets from 5 National Institutes of Health-funded randomized trials (1 with 2 independent parallel arms) of AA facilitation interventions were analyzed using instrumental variables models. Alcohol-dependent individuals in one of the data sets (n = 774) were analyzed separately from the rest of sample (n = 1,582 individuals pooled from 5 data sets) because of heterogeneity in sample parameters. Randomization itself was used as the instrumental variable. Randomization was a good instrument in both samples, effectively predicting increased AA attendance that could not be attributed to self-selection. In 5 of the 6 data sets, which were pooled for analysis, increased AA attendance that was attributable to randomization (i.e., free of self-selection bias) was effective at increasing days of abstinence at 3-month (B = 0.38, p = 0.001) and 15-month (B = 0.42, p = 0.04) follow-up. However, in the remaining data set, in which preexisting AA attendance was much higher, further increases in AA involvement caused by the randomly assigned facilitation intervention did not affect drinking outcome. For most individuals seeking help for alcohol problems, increasing AA attendance leads to short- and long-term decreases in alcohol consumption that cannot be attributed to self-selection. However, for populations with high preexisting AA involvement, further increases in AA attendance may have little impact. Copyright © 2014 by the Research Society on Alcoholism.

Coexisting with dependence and well-being: the results of a pilot study intervention on 75-99-year-old individuals.

PubMed

Rodríguez-Díaz, M Teresa; Pérez-Marfil, M Nieves; Cruz-Quintana, Francisco

2016-12-01

The objective of this study is to design and implement an intervention program centered on preventing functional dependence. A pre/post quasi-experimental (typical case) design study with a control group was conducted on a group of 75-90-year-old individuals with functional dependence (n = 59) at three nursing homes in Madrid (Spain). The intervention program consists of two types of activities developed simultaneously. Some focused on emotional well-being (nine 90-minute sessions, once per week), whereas others focused on improving participants' physical condition (two 30-minute sessions, twice per week). The simple randomized participants included 59 elderly individuals (Intervention Group = 30, Control Group = 29) (mean age 86.80) [SD, 5. 19]. Fifty-nine participants were analyzed. The results indicate that the program is effective in improving mood, lowering anxiety levels (d = 0.81), and increasing both self-esteem (d = 0.65) and the perception of self-efficacy (d = 1.04). There are improvements in systolic pressure and functional dependence levels are maintained. Linear simple regression (independent variable pre-Barthel) shows that the pre-intervention dependence level can predict self-esteem after the intervention. We have demonstrated that the program is innovative with regard to bio-psychosocial care in elderly individuals, is based on actual practice, and is effective in increasing both self-esteem and self-efficacy. These variables positively affect functional capabilities and delay functional dependence.

Exploring association between statin use and breast cancer risk: an updated meta-analysis.

PubMed

Islam, Md Mohaimenul; Yang, Hsuan-Chia; Nguyen, Phung-Anh; Poly, Tahmina Nasrin; Huang, Chih-Wei; Kekade, Shwetambara; Khalfan, Abdulwahed Mohammed; Debnath, Tonmoy; Li, Yu-Chuan Jack; Abdul, Shabbir Syed

2017-12-01

The benefits of statin treatment for preventing cardiac disease are well established. However, preclinical studies suggested that statins may influence mammary cancer growth, but the clinical evidence is still inconsistent. We, therefore, performed an updated meta-analysis to provide a precise estimate of the risk of breast cancer in individuals undergoing statin therapy. For this meta-analysis, we searched PubMed, the Cochrane Library, Web of Science, Embase, and CINAHL for published studies up to January 31, 2017. Articles were included if they (1) were published in English; (2) had an observational study design with individual-level exposure and outcome data, examined the effect of statin therapy, and reported the incidence of breast cancer; and (3) reported estimates of either the relative risk, odds ratios, or hazard ratios with 95% confidence intervals (CIs). We used random-effect models to pool the estimates. Of 2754 unique abstracts, 39 were selected for full-text review, and 36 studies reporting on 121,399 patients met all inclusion criteria. The overall pooled risks of breast cancer in patients using statins were 0.94 (95% CI 0.86-1.03) in random-effect models with significant heterogeneity between estimates (I 2  = 83.79%, p = 0.0001). However, we also stratified by region, the duration of statin therapy, methodological design, statin properties, and individual stain use. Our results suggest that there is no association between statin use and breast cancer risk. However, observational studies cannot clarify whether the observed epidemiologic association is a causal effect or the result of some unmeasured confounding variable. Therefore, more research is needed.

Differences Between Dual-Method and Non–Dual-Method Protection Use in a Sample of Young African American Women Residing in the Southeastern United States

PubMed Central

Sales, Jessica M.; Latham, Teaniese P.; DiClemente, Ralph J.; Rose, Eve

2013-01-01

Objectives To characterize dual-method protection users and report the prevalence of dual-method use among young adult African American women residing in the Southeastern United States. Design Analysis of baseline data from a randomized controlled trial. Setting A clinic-based sample of young women enrolled in a randomized trial of a human immunodeficiency virus (HIV)–prevention program in Atlanta, Georgia, from June 2005 to June 2007. Participants African American women aged 14 to 20 years who reported unprotected sexual activity in the past 6months. Of the eligible adolescents, 94% (N=701) were enrolled in the study and completed baseline assessments. Outcome Measures Dual-method protection use as well as sociodemographic, individual-level, interpersonal-level, and community-level factors and interpersonal communication skills. Only data from the baseline assessment, before randomization, were used for the analysis. Results A total of 102 participants (14.6%) were classified as dual-method protection users. After controlling for age and clinic, significant differences between dual-method users and non–dual-method users were found for impulsivity, self-esteem, social support, relationship style, partner communication self-efficacy, and fear of condom negotiation. Conclusions Dual-method protection use is low. Identification of factors that differentiate dual-method users from non–dual-method users at the individual, interpersonal, and community levels in this young African American sample suggests that HIV, sexually transmitted disease, and unintended pregnancy risk–reduction programs should address factors at each level, not simply the individual level, and that this may involve structural and/or clinical counseling practice changes in clinics that serve young women, to optimally facilitate dual-method protection use among young African American women in the Southeastern United States. PMID:21135341

Serum Iron Levels and the Risk of Parkinson Disease: A Mendelian Randomization Study

PubMed Central

Gögele, Martin; Lill, Christina M.; Bertram, Lars; Do, Chuong B.; Eriksson, Nicholas; Foroud, Tatiana; Myers, Richard H.; Nalls, Michael; Keller, Margaux F.; Benyamin, Beben; Whitfield, John B.; Pramstaller, Peter P.; Hicks, Andrew A.; Thompson, John R.; Minelli, Cosetta

2013-01-01

Background Although levels of iron are known to be increased in the brains of patients with Parkinson disease (PD), epidemiological evidence on a possible effect of iron blood levels on PD risk is inconclusive, with effects reported in opposite directions. Epidemiological studies suffer from problems of confounding and reverse causation, and mendelian randomization (MR) represents an alternative approach to provide unconfounded estimates of the effects of biomarkers on disease. We performed a MR study where genes known to modify iron levels were used as instruments to estimate the effect of iron on PD risk, based on estimates of the genetic effects on both iron and PD obtained from the largest sample meta-analyzed to date. Methods and Findings We used as instrumental variables three genetic variants influencing iron levels, HFE rs1800562, HFE rs1799945, and TMPRSS6 rs855791. Estimates of their effect on serum iron were based on a recent genome-wide meta-analysis of 21,567 individuals, while estimates of their effect on PD risk were obtained through meta-analysis of genome-wide and candidate gene studies with 20,809 PD cases and 88,892 controls. Separate MR estimates of the effect of iron on PD were obtained for each variant and pooled by meta-analysis. We investigated heterogeneity across the three estimates as an indication of possible pleiotropy and found no evidence of it. The combined MR estimate showed a statistically significant protective effect of iron, with a relative risk reduction for PD of 3% (95% CI 1%–6%; p = 0.001) per 10 µg/dl increase in serum iron. Conclusions Our study suggests that increased iron levels are causally associated with a decreased risk of developing PD. Further studies are needed to understand the pathophysiological mechanism of action of serum iron on PD risk before recommendations can be made. Please see later in the article for the Editors' Summary PMID:23750121

Evaluating the effectiveness of Facebook to impact the knowledge of evidence-based employment practices by individuals with traumatic brain injury: A knowledge translation random control study.

PubMed

Inge, Katherine J; Graham, Carolyn W; McLaughlin, James W; Erickson, Doug; Wehman, Paul; Seward, Hannah E

2017-09-14

Individuals with traumatic brain injury (TBI) experience difficulty with obtaining and maintaining employment post-injury. Although vocational rehabilitation (VR) can be one option to provide individuals with TBI support and services to lead to successful employment outcomes, information about these services can be difficult and confusing to navigate. Providing information on evidence-based employment practices to individuals with TBI through social media could be an effective approach. The objective of this study was to compare the effect of a knowledge translation (KT) strategy and the use of a secret Facebook group, on the knowledge of evidence-based employment research by individuals with traumatic brain injury (TBI). The study used a randomized pretest-posttest control group design. Sixty individuals with TBI were recruited through clubhouse programs in the state where the authors resided as well as through support groups nationally for individuals with TBI, and were randomly assigned to one of two groups. Both groups received information on evidence-based employment practices for individuals with traumatic brain injury (TBI) over a three month period. One group received the information via participation in a secret Facebook group while the comparison group received information as an "e-news" email blast. Participants were assessed pre- and post-intervention with a Likert-scale instrument designed to measure knowledge of evidenced-based employment information for TBI. Both groups gained a significant amount of knowledge between baseline and post-intervention. However, there were no significant differences between groups in knowledge gained at post-intervention. While the study did not identify the most effective means of delivering information to individuals with TBI, it does provide some guidance for future KT research.

The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

PubMed

Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2018-01-01

This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

ERCC1 protein as a guide for individualized therapy of late-stage advanced non-small cell lung cancer.

PubMed

Gao, Zhiqiang; Han, Baohui; Shen, Jie; Gu, Aiqin; Qi, Dajiang; Huang, Jinsu; Shi, Chunlei; Xiong, Liwen; Zhao, Yizhuo; Jiang, Liyan; Wang, Huimin; Chen, Yurong

2011-09-01

Excision repair cross-complementation group 1 (ERCC1) protein has been associated with cisplatin resistance. The objective of this study was to investigate the correlation between ERCC1 protein levels and the therapeutic effect of individualized therapy in advanced non-small cell lung cancer (NSCLC). A total of 190 advanced NSCLC patients were included in this study. Patients were randomized into either the individualized therapy group or the standard therapy group at a ratio of 2:1. Patients in the standard therapy group were treated with either gemcitabine plus cisplatin or vinorelbine plus cisplatin. The expression of ERCC1 protein in lung cancer tissues of patients from the individualized therapy group was detected with immunohistochemistry. Patients with low ERCC1 levels received either gemcitabine plus cisplatin or vinorelbine plus cisplatin, and patients with high levels received gemcitabine plus vinorelbine. The main outcome assessments were response rate (RR), overall survival (OS) and time to progression (TTP). Follow-up data were recorded until September 30, 2010. RR, 1-year survival rate and TTP were not statistically significant. The median survival time was 10.10 months in the standard therapy group (95% CI 8.48-11.92) and 13.59 months in the individualized therapy group (95% CI 11.86-14.74). The difference in median survival time was significantly different between these groups (P=0.036). The median survival time was longer in the individualized group compared to the standard therapy group. ERCC1 protein expression in advanced NSCLC patients, however, was not significantly correlated with RR, OS and TTP in the individualized therapy group. Therefore, this study suggests that ERCC1 protein levels should be assessed in combination with additional biomarkers to determine an optimal index for individualized therapy in advanced NSCLC patients.

Restoring effects of oxytocin on the attentional preference for faces in autism.

PubMed

Kanat, M; Spenthof, I; Riedel, A; van Elst, L T; Heinrichs, M; Domes, G

2017-04-18

Reduced attentional preference for faces and symptoms of social anxiety are common in autism spectrum disorders (ASDs). The neuropeptide oxytocin triggers anxiolytic functions and enhances eye gaze, facial emotion recognition and neural correlates of face processing in ASD. Here we investigated whether a single dose of oxytocin increases attention to faces in ASD. As a secondary question, we explored the influence of social anxiety on these effects. We tested for oxytocin's effects on attention to neutral faces as compared to houses in a sample of 29 autistic individuals and 30 control participants using a dot-probe paradigm with two different presentation times (100 or 500 ms). A single dose of 24 IU oxytocin was administered in a randomized, double-blind placebo-controlled, cross-over design. Under placebo, ASD individuals paid less attention to faces presented for 500 ms than did controls. Oxytocin administration increased the allocation of attention toward faces in ASD to a level observed in controls. Secondary analyses revealed that these oxytocin effects primarily occurred in ASD individuals with high levels of social anxiety who were characterized by attentional avoidance of faces under placebo. Our results confirm a positive influence of intranasal oxytocin on social attention processes in ASD. Further, they suggest that oxytocin may in particular restore the attentional preference for facial information in ASD individuals with high social anxiety. We conclude that oxytocin's anxiolytic properties may partially account for its positive effects on socio-cognitive functioning in ASD, such as enhanced eye gaze and facial emotion recognition.

Restoring effects of oxytocin on the attentional preference for faces in autism

PubMed Central

Kanat, M; Spenthof, I; Riedel, A; van Elst, L T; Heinrichs, M; Domes, G

2017-01-01

Reduced attentional preference for faces and symptoms of social anxiety are common in autism spectrum disorders (ASDs). The neuropeptide oxytocin triggers anxiolytic functions and enhances eye gaze, facial emotion recognition and neural correlates of face processing in ASD. Here we investigated whether a single dose of oxytocin increases attention to faces in ASD. As a secondary question, we explored the influence of social anxiety on these effects. We tested for oxytocin's effects on attention to neutral faces as compared to houses in a sample of 29 autistic individuals and 30 control participants using a dot-probe paradigm with two different presentation times (100 or 500 ms). A single dose of 24 IU oxytocin was administered in a randomized, double-blind placebo-controlled, cross-over design. Under placebo, ASD individuals paid less attention to faces presented for 500 ms than did controls. Oxytocin administration increased the allocation of attention toward faces in ASD to a level observed in controls. Secondary analyses revealed that these oxytocin effects primarily occurred in ASD individuals with high levels of social anxiety who were characterized by attentional avoidance of faces under placebo. Our results confirm a positive influence of intranasal oxytocin on social attention processes in ASD. Further, they suggest that oxytocin may in particular restore the attentional preference for facial information in ASD individuals with high social anxiety. We conclude that oxytocin's anxiolytic properties may partially account for its positive effects on socio-cognitive functioning in ASD, such as enhanced eye gaze and facial emotion recognition. PMID:28418399

Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods.

PubMed

Krupski, Antoinette; Joesch, Jutta M; Dunn, Chris; Donovan, Dennis; Bumgardner, Kristin; Lord, Sarah Peregrine; Ries, Richard; Roy-Byrne, Peter

2012-12-14

A substantial body of research has established the effectiveness of brief interventions for problem alcohol use. Following these studies, national dissemination projects of screening, brief intervention (BI), and referral to treatment (SBIRT) for alcohol and drugs have been implemented on a widespread scale in multiple states despite little existing evidence for the impact of BI on drug use for non-treatment seekers. This article describes the design of a study testing the impact of SBIRT on individuals with drug problems, its contributions to the existing literature, and its potential to inform drug policy. The study is a randomized controlled trial of an SBIRT intervention carried out in a primary care setting within a safety net system of care. Approximately 1,000 individuals presenting for scheduled medical care at one of seven designated primary care clinics who endorse problematic drug use when screened are randomized in a 1:1 ratio to BI versus enhanced care as usual (ECAU). Individuals in both groups are reassessed at 3, 6, 9, and 12 months after baseline. Self-reported drug use and other psychosocial measures collected at each data point are supplemented by urine analysis and public health-related data from administrative databases. This study will contribute to the existing literature by providing evidence for the impact of BI on problem drug use based on a broad range of measures including self-reported drug use, urine analysis, admission to drug abuse treatment, and changes in utilization and costs of health care services, arrests, and death with the intent of informing policy and program planning for problem drug use at the local, state, and national levels. ClinicalTrials.gov NCT00877331.

Evaluating an Organizational-Level Occupational Health Intervention in a Combined Regression Discontinuity and Randomized Control Design.

PubMed

Sørensen, By Ole H

2016-10-01

Organizational-level occupational health interventions have great potential to improve employees' health and well-being. However, they often compare unfavourably to individual-level interventions. This calls for improving methods for designing, implementing and evaluating organizational interventions. This paper presents and discusses the regression discontinuity design because, like the randomized control trial, it is a strong summative experimental design, but it typically fits organizational-level interventions better. The paper explores advantages and disadvantages of a regression discontinuity design with an embedded randomized control trial. It provides an example from an intervention study focusing on reducing sickness absence in 196 preschools. The paper demonstrates that such a design fits the organizational context, because it allows management to focus on organizations or workgroups with the most salient problems. In addition, organizations may accept an embedded randomized design because the organizations or groups with most salient needs receive obligatory treatment as part of the regression discontinuity design. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

No effect of caloric restriction on salivary cortisol levels in overweight men and women.

PubMed

Tam, Charmaine S; Frost, Elizabeth A; Xie, Wenting; Rood, Jennifer; Ravussin, Eric; Redman, Leanne M

2014-02-01

The effect of weight loss by diet or diet and exercise on salivary cortisol levels, a measure of hypothalamic pituitary adrenal activity, in overweight individuals is not known. The objective was to test the hypothesis that 24 weeks of moderate caloric restriction (CR) (25%) by diet or diet and aerobic exercise would alter morning and diurnal salivary cortisol levels. Randomized control trial in an institutional research center. Thirty-five overweight (BMI: 27.8±0.7 kg/m(2)) but otherwise healthy participants (16 M/19 F). Participants were randomized to either calorie restriction (CR: 25% reduction in energy intake, n=12), calorie restriction+exercise (CR+EX: 12.5% reduction in energy intake+12.5% increase in exercise energy expenditure, n=12) or control (healthy weight-maintenance diet, n=11) for 6 months. Salivary cortisol measured at 8:00, 8:30, 11:00, 11:30, 12:30, 13:00, 16:00 and 16:30. Morning cortisol was defined as the mean cortisol concentration at 08:00 and 08:30. Diurnal cortisol was calculated as the mean of the 8 cortisol measures across the day. In the whole cohort, higher morning and diurnal cortisol levels were associated with impaired insulin sensitivity (morning: P=0.004, r(2)=0.24; diurnal: P=0.02, r(2)=0.15). Using mixed model analysis, there was no significant effect of group, time or sex on morning or diurnal cortisol levels. A 10% weight loss with a 25% CR diet alone or with exercise did not impact morning or diurnal salivary cortisol levels. © 2013.

Anxiety moderates the effects of stressor controllability and cognitive reappraisal on distress following aversive exposure: An experimental investigation.

PubMed

Le, Lillian; Moulds, Michelle; Nickerson, Angela

2018-05-08

Emerging evidence suggests that the effectiveness of cognitive reappraisal (CR) depends on different factors, including the individual's psychological wellbeing (e.g., level of anxiety) and the context in which the strategy is used (e.g., stressor controllability). The present study aimed to investigate the emotional (negative affect) and physiological (skin conductance levels) effects of emotion regulation following exposure to controllable versus uncontrollable stress. Ninety-five undergraduate students completed measures assessing anxiety, and were randomly assigned to a condition in which they had (a) control or (b) no control over the viewing duration of distressing film clips, and were then instructed to either (a) cognitively reappraise or (b) ruminate about the clips. There were no significant interactions between controllability, emotion regulation, and pre-post changes in responses. However, individual differences in anxiety moderated the effects of controllability and emotion regulation on distress responses. For participants low in anxiety, CR was related to smaller increases in distress following uncontrollable than controllable stress. This pattern was not observed for those high in anxiety following stress exposure. This study used a non-clinical sample, limiting the generalizability of the findings. These findings indicate that the utility of CR may depend upon contextual factors such as stressor controllability, and individual differences in psychological symptoms. Copyright © 2018 Elsevier Ltd. All rights reserved.

Social network targeting to maximise population behaviour change: a cluster randomised controlled trial.

PubMed

Kim, David A; Hwong, Alison R; Stafford, Derek; Hughes, D Alex; O'Malley, A James; Fowler, James H; Christakis, Nicholas A

2015-07-11

Information and behaviour can spread through interpersonal ties. By targeting influential individuals, health interventions that harness the distributive properties of social networks could be made more effective and efficient than those that do not. Our aim was to assess which targeting methods produce the greatest cascades or spillover effects and hence maximise population-level behaviour change. In this cluster randomised trial, participants were recruited from villages of the Department of Lempira, Honduras. We blocked villages on the basis of network size, socioeconomic status, and baseline rates of water purification, for delivery of two public health interventions: chlorine for water purification and multivitamins for micronutrient deficiencies. We then randomised villages, separately for each intervention, to one of three targeting methods, introducing the interventions to 5% samples composed of either: randomly selected villagers (n=9 villages for each intervention); villagers with the most social ties (n=9); or nominated friends of random villagers (n=9; the last strategy exploiting the so-called friendship paradox of social networks). Participants and data collectors were not aware of the targeting methods. Primary endpoints were the proportions of available products redeemed by the entire population under each targeting method. This trial is registered with ClinicalTrials.gov, number NCT01672580. Between Aug 4, and Aug 14, 2012, 32 villages in rural Honduras (25-541 participants each; total study population of 5773) received public health interventions. For each intervention, nine villages (each with 1-20 initial target individuals) were randomised, using a blocked design, to each of the three targeting methods. In nomination-targeted villages, 951 (74·3%) of 1280 available multivitamin tickets were redeemed compared with 940 (66·2%) of 1420 in randomly targeted villages and 744 (61·0%) of 1220 in indegree-targeted villages. All pairwise differences in redemption rates were significant (p<0·01) after correction for multiple comparisons. Targeting nominated friends increased adoption of the nutritional intervention by 12·2% compared with random targeting (95% CI 6·9-17·9). Targeting the most highly connected individuals, by contrast, produced no greater adoption of either intervention, compared with random targeting. Introduction of a health intervention to the nominated friends of random individuals can enhance that intervention's diffusion by exploiting intrinsic properties of human social networks. This method has the additional advantage of scalability because it can be implemented without mapping the network. Deployment of certain types of health interventions via network targeting, without increasing the number of individuals targeted or the resources used, could enhance the adoption and efficiency of those interventions, thereby improving population health. National Institutes of Health, The Bill & Melinda Gates Foundation, Star Family Foundation, and the Canadian Institutes of Health Research. Copyright © 2015 Elsevier Ltd. All rights reserved.

A Wii Bit of Fun: A Novel Platform to Deliver Effective Balance Training to Older Adults

PubMed Central

Merriman, Niamh A.; Young, William R.; Newell, Fiona N.; Craig, Cathy

2015-01-01

Abstract Background: Falls and fall-related injuries are symptomatic of an aging population. This study aimed to design, develop, and deliver a novel method of balance training, using an interactive game-based system to promote engagement, with the inclusion of older adults at both high and low risk of experiencing a fall. Study Design: Eighty-two older adults (65 years of age and older) were recruited from sheltered accommodation and local activity groups. Forty volunteers were randomly selected and received 5 weeks of balance game training (5 males, 35 females; mean, 77.18 ± 6.59 years), whereas the remaining control participants recorded levels of physical activity (20 males, 22 females; mean, 76.62 ± 7.28 years). The effect of balance game training was measured on levels of functional balance and balance confidence in individuals with and without quantifiable balance impairments. Results: Balance game training had a significant effect on levels of functional balance and balance confidence (P < 0.05). This was further demonstrated in participants who were deemed at high risk of falls. The overall pattern of results suggests the training program is effective and suitable for individuals at all levels of ability and may therefore play a role in reducing the risk of falls. Conclusions: Commercial hardware can be modified to deliver engaging methods of effective balance assessment and training for the older population. PMID:26469308

The Effect of a Multi-Level Intervention on the Initiation of Antiretroviral Therapy (ART) among HIV-Infected Men Who Inject Drugs and Were Diagnosed Late in Thai Nguyen, Vietnam

PubMed Central

Zelaya, Carla E.; Le Minh, Nguyen; Lau, Bryan; Latkin, Carl A.; Viet Ha, Tran; Minh Quan, Vu; Mo, Thi Tran; Sripaipan, Teerada; Davis, Wendy W.; Celentano, David D.; Frangakis, Constantine; Go, Vivian F.

2016-01-01

Background In Vietnam, an estimated 256,000 people are living with HIV, and 58% of HIV-infections reported are among people who inject drugs (PWID). While antiretroviral therapy (ART) is widely available in Vietnam, marginalized hard-to-reach male PWID, demonstrate significantly reduced and delayed access to ART. Methods We investigated the effect of a randomized four-arm multi-level intervention trial on ART initiation among male PWID. Our analysis was conducted among a subset of trial participants (n = 136), who were newly diagnosed as HIV-infected, treatment naïve, and eligible for ART (baseline late diagnosis). The trial arms included: 1, standard of care (HIV testing and counseling); 2, structural-level intervention (door-to-door communications and community video screenings); 3, individual-level intervention (counseling plus group support); and 4, individual-level plus structural-level intervention. In a time-to-event analysis, we used a non-parametric approach for competing risks to estimate cumulative incidence function (CIF) for ART initiation (event of interest) by arm and the difference in CIF for each trial arm as compared to Arm 1. Follow-up was conducted at 6, 12, 18 and 24 months. Data collection occurred from 2009 to 2013. Findings By 24-months, 61.0% initiated ART, and 30.9% had died prior to ART initiation. In the first 6 months, participants in arm 4 (individual plus community intervention) had a 28% (95% confidence interval (CI): 6–50%) increased probability of initiating ART. Despite increasing coverage of ART in all arms throughout follow-up, participants in arm 4 retained a 31% (95% CI: 5–56%) increased probability of initiating ART. The individual and community components of the intervention were only effective when delivered together. Conclusions Marginalized, hard-to-reach men, who do not routinely engage in HIV services, and therefore come into care late, may benefit significantly from both individual counseling and group support, in combination with community-focused stigma reduction, when being referred and attempting to initiate urgently needed ART. PMID:27579772

The Effect of a Multi-Level Intervention on the Initiation of Antiretroviral Therapy (ART) among HIV-Infected Men Who Inject Drugs and Were Diagnosed Late in Thai Nguyen, Vietnam.

PubMed

Zelaya, Carla E; Le Minh, Nguyen; Lau, Bryan; Latkin, Carl A; Viet Ha, Tran; Minh Quan, Vu; Mo, Thi Tran; Sripaipan, Teerada; Davis, Wendy W; Celentano, David D; Frangakis, Constantine; Go, Vivian F

2016-01-01

In Vietnam, an estimated 256,000 people are living with HIV, and 58% of HIV-infections reported are among people who inject drugs (PWID). While antiretroviral therapy (ART) is widely available in Vietnam, marginalized hard-to-reach male PWID, demonstrate significantly reduced and delayed access to ART. We investigated the effect of a randomized four-arm multi-level intervention trial on ART initiation among male PWID. Our analysis was conducted among a subset of trial participants (n = 136), who were newly diagnosed as HIV-infected, treatment naïve, and eligible for ART (baseline late diagnosis). The trial arms included: 1, standard of care (HIV testing and counseling); 2, structural-level intervention (door-to-door communications and community video screenings); 3, individual-level intervention (counseling plus group support); and 4, individual-level plus structural-level intervention. In a time-to-event analysis, we used a non-parametric approach for competing risks to estimate cumulative incidence function (CIF) for ART initiation (event of interest) by arm and the difference in CIF for each trial arm as compared to Arm 1. Follow-up was conducted at 6, 12, 18 and 24 months. Data collection occurred from 2009 to 2013. By 24-months, 61.0% initiated ART, and 30.9% had died prior to ART initiation. In the first 6 months, participants in arm 4 (individual plus community intervention) had a 28% (95% confidence interval (CI): 6-50%) increased probability of initiating ART. Despite increasing coverage of ART in all arms throughout follow-up, participants in arm 4 retained a 31% (95% CI: 5-56%) increased probability of initiating ART. The individual and community components of the intervention were only effective when delivered together. Marginalized, hard-to-reach men, who do not routinely engage in HIV services, and therefore come into care late, may benefit significantly from both individual counseling and group support, in combination with community-focused stigma reduction, when being referred and attempting to initiate urgently needed ART.

One-stage individual participant data meta-analysis models: estimation of treatment-covariate interactions must avoid ecological bias by separating out within-trial and across-trial information.

PubMed

Hua, Hairui; Burke, Danielle L; Crowther, Michael J; Ensor, Joie; Tudur Smith, Catrin; Riley, Richard D

2017-02-28

Stratified medicine utilizes individual-level covariates that are associated with a differential treatment effect, also known as treatment-covariate interactions. When multiple trials are available, meta-analysis is used to help detect true treatment-covariate interactions by combining their data. Meta-regression of trial-level information is prone to low power and ecological bias, and therefore, individual participant data (IPD) meta-analyses are preferable to examine interactions utilizing individual-level information. However, one-stage IPD models are often wrongly specified, such that interactions are based on amalgamating within- and across-trial information. We compare, through simulations and an applied example, fixed-effect and random-effects models for a one-stage IPD meta-analysis of time-to-event data where the goal is to estimate a treatment-covariate interaction. We show that it is crucial to centre patient-level covariates by their mean value in each trial, in order to separate out within-trial and across-trial information. Otherwise, bias and coverage of interaction estimates may be adversely affected, leading to potentially erroneous conclusions driven by ecological bias. We revisit an IPD meta-analysis of five epilepsy trials and examine age as a treatment effect modifier. The interaction is -0.011 (95% CI: -0.019 to -0.003; p = 0.004), and thus highly significant, when amalgamating within-trial and across-trial information. However, when separating within-trial from across-trial information, the interaction is -0.007 (95% CI: -0.019 to 0.005; p = 0.22), and thus its magnitude and statistical significance are greatly reduced. We recommend that meta-analysts should only use within-trial information to examine individual predictors of treatment effect and that one-stage IPD models should separate within-trial from across-trial information to avoid ecological bias. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

The effect of missing data on linkage disequilibrium mapping and haplotype association analysis in the GAW14 simulated datasets

PubMed Central

McCaskie, Pamela A; Carter, Kim W; McCaskie, Simon R; Palmer, Lyle J

2005-01-01

We used our newly developed linkage disequilibrium (LD) plotting software, JLIN, to plot linkage disequilibrium between pairs of single-nucleotide polymorphisms (SNPs) for three chromosomes of the Genetic Analysis Workshop 14 Aipotu simulated population to assess the effect of missing data on LD calculations. Our haplotype analysis program, SIMHAP, was used to assess the effect of missing data on haplotype-phenotype association. Genotype data was removed at random, at levels of 1%, 5%, and 10%, and the LD calculations and haplotype association results for these levels of missingness were compared to those for the complete dataset. It was concluded that ignoring individuals with missing data substantially affects the number of regions of LD detected which, in turn, could affect tagging SNPs chosen to generate haplotypes. PMID:16451612

Inflamed by the flames? The impact of terrorism and war on immunity.

PubMed

Canetti, Daphna; Russ, Eric; Luborsky, Judith; Gerhart, James I; Hobfoll, Stevan E

2014-06-01

The physiological impact on citizens of prolonged exposure to violence and conflict is a crucial, yet underexplored, issue within the political science and biology literature. We examined the effect of high levels of exposure to rocket and terrorist attacks on biological markers of immunity and inflammation in a sample of 92 Israelis. A stratified random sample of individuals was drawn from a pool of subjects in Israel who had previously been interviewed regarding their stress exposure and psychological distress during a period of active rocket and terrorist attacks. These individuals were reinterviewed and blood samples were collected to assess antibodies to cytomegalovirus (CMV antibodies) and C-reactive protein (CRP). Posttraumatic stress disorder (PTSD) was significantly related to CRP, β = .33, p = .034, with body mass index, depression, and exposure to terrorism included in the model. Depression scores were not significantly associated with CRP or CMV antibody levels. In contrast to the established convention that psychological distress is the sole outcome of terrorism exposure, these findings reveal that individuals exposed to terrorism experience higher levels of both PTSD/depression, and inflammation. This study has important ramifications for how policy makers and medical health professionals should formulate public health policies and medically treat individuals living in conflict zones. Copyright © 2014 International Society for Traumatic Stress Studies.

Preferential selection based on strategy persistence and memory promotes cooperation in evolutionary prisoner's dilemma games

NASA Astrophysics Data System (ADS)

Liu, Yuanming; Huang, Changwei; Dai, Qionglin

2018-06-01

Strategy imitation plays a crucial role in evolutionary dynamics when we investigate the spontaneous emergence of cooperation under the framework of evolutionary game theory. Generally, when an individual updates his strategy, he needs to choose a role model whom he will learn from. In previous studies, individuals choose role models randomly from their neighbors. In recent works, researchers have considered that individuals choose role models according to neighbors' attractiveness characterized by the present network topology or historical payoffs. Here, we associate an individual's attractiveness with the strategy persistence, which characterizes how frequently he changes his strategy. We introduce a preferential parameter α to describe the nonlinear correlation between the selection probability and the strategy persistence and the memory length of individuals M into the evolutionary games. We investigate the effects of α and M on cooperation. Our results show that cooperation could be promoted when α > 0 and at the same time M > 1, which corresponds to the situation that individuals are inclined to select their neighbors with relatively higher persistence levels during the evolution. Moreover, we find that the cooperation level could reach the maximum at an optimal memory length when α > 0. Our work sheds light on how to promote cooperation through preferential selection based on strategy persistence and a limited memory length.

Attachment anxiety benefits from security priming: Evidence from working memory performance

PubMed Central

2018-01-01

The present study investigates the relationship between the attachment dimensions (anxious vs. avoidance) and the cognitive performance of individuals, specifically whether the attachment dimensions would predict the working memory (WM) performance. In the n-back task, reflecting the WM capacity, both attachment related and non-attachment related words were used. Participants were randomly assigned into two groups that received either the secure or the neutral subliminal priming. In the secure priming condition, the aim was to induce sense of security by presenting secure attachment words prior to the n-back task performance. In neutral priming condition, neutral words that did not elicit sense of security were presented. Structural equation modeling revealed divergent patterns for attachment anxiety and avoidance dimensions under the different priming conditions. In neutral priming condition, WM performance declined in terms of capacity in the n-back task for individuals who rated higher levels of attachment anxiety. However in the secure priming condition, WM performance was boosted in the n-back task for individuals who rated higher levels of attachment anxiety. In other words, the subliminal priming of the security led to increased WM capacity of individuals who rated higher levels of attachment anxiety. This effect, however, was not observed for higher levels of attachment avoidance. Results are discussed along the lines of hyperactivation and deactivation strategies of the attachment system. PMID:29522549

Neighborhood Availability of Convenience Stores and Diet Quality: Findings From 20 Years of Follow-Up in the Coronary Artery Risk Development in Young Adults Study

PubMed Central

Rummo, Pasquale E.; Meyer, Katie A.; Boone-Heinonen, Janne; Jacobs, David R.; Kiefe, Catarina I.; Lewis, Cora E.; Steffen, Lyn M.

2015-01-01

Objectives. We examined the association between neighborhood convenience stores and diet outcomes for 20 years of the Coronary Artery Risk Development in Young Adults study. Methods. We used dietary data from the Coronary Artery Risk Development in Young Adults study years 1985–1986, 1992–1993, and 2005–2006 (n = 3299; Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA) and geographically and temporally matched neighborhood-level food resource and US Census data. We used random effects repeated measures regression to estimate associations between availability of neighborhood convenience stores with diet outcomes and whether these associations differed by individual-level income. Results. In multivariable-adjusted analyses, greater availability of neighborhood convenience stores was associated with lower diet quality (mean score = 66.3; SD = 13.0) for participants with lower individual-level income (b = −2.40; 95% CI = −3.30, −1.51); associations at higher individual-level income were weaker. We observed similar associations with whole grain consumption across time but no statistically significant associations with consumption of sugar-sweetened beverages, artificially sweetened beverages, snacks, processed meats, fruits, or vegetables. Conclusions. The presence of neighborhood convenience stores may be associated with lower quality diets. Low-income individuals may be most sensitive to convenience store availability. PMID:25790410

Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence.

PubMed

El-Matary, Wael; Dufault, Brenden; Moroz, Stan P; Schellenberg, Jeannine; Bernstein, Charles N

2017-04-01

We aimed to assess levels of education attained, employment, and marital status of adults diagnosed with inflammatory bowel diseases (IBD) during childhood or adolescence, compared with healthy individuals in Canada. We performed a cross-sectional study of adults diagnosed with IBD in childhood or adolescence at Children's Hospital in Winnipeg, Manitoba from January 1978 through December 2007. Participants (n = 112) answered a semi-structured questionnaire on educational achievements, employment, and marital status. Patients were matched for age and sex with random healthy individuals from the 2012 Canadian Community Health Survey (controls, 5 per patient). Conditional binary logistic regression and random-effects ordinal logistic regression models were used for analysis. Patients were followed for a mean duration of 14.3 years (range, 3.1-34.5 years). Persons with IBD were more likely to earn more money per annum and attain a post-secondary school degree or receive a diploma than controls (odds ratio, 1.72; 95% confidence interval, 1.13-2.60; P < .01 and odds ratio, 2.73; 95% confidence interval, 1.48-5.04; P < .01, respectively). There was no significant difference between patients and controls in employment or marital status. Adults diagnosed with IBD during childhood seem to achieve higher education levels than individuals without IBD. This observation should provide reassurance to children with IBD and their parents. ClinicalTrials.gov number: NCT02152241. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Effect of seasonal affective disorder and pathological tanning motives on efficacy of an appearance-focused intervention to prevent skin cancer.

PubMed

Hillhouse, Joel; Turrisi, Rob; Stapleton, Jerod; Robinson, June

2010-05-01

To evaluate the robustness of an appearance-focused intervention to prevent skin cancer in individuals reporting seasonal affective disorder (SAD) symptoms and pathological tanning motives. Randomized, controlled clinical trial. College campus. Four hundred thirty adult female indoor tanners (200 in the intervention group and 230 control participants). A booklet discussing the history of tanning, current tanning norms, UV radiation's effects on skin, recommendations for indoor tanning use focusing on abstinence and harm reduction recommendations, and information on healthier, appearance-enhancing alternatives to tanning. Self-reported attitudes, intentions, and tanning behaviors; pathological tanning motives assessed by a questionnaire developed for this study; and SAD symptoms assessed by the Seasonal Pattern Assessment Questionnaire. Two of the 4 pathological tanning scales, opiatelike reactions to tanning and dissatisfaction with natural skin tone, were significant moderators demonstrating stronger treatment effects for individuals scoring higher on these scales. Treatment effects were equivalently positive (ie, no significant moderator effects) for all levels of SAD symptoms and all levels of the other 2 pathological tanning motive scales (ie, perceiving tanning as a problem and tolerance to the effects of tanning). The appearance-focused skin cancer prevention intervention is robust enough to reduce indoor tanning among tanners who exhibit SAD symptoms or pathological tanning motives. Tailored interventions may address individuals' motivations for tanning and their relation to maladaptive behavior, such as dissatisfaction with appearance or the need for relaxation because of anxiety.

Evolution in fluctuating environments: decomposing selection into additive components of the Robertson-Price equation.

PubMed

Engen, Steinar; Saether, Bernt-Erik

2014-03-01

We analyze the stochastic components of the Robertson-Price equation for the evolution of quantitative characters that enables decomposition of the selection differential into components due to demographic and environmental stochasticity. We show how these two types of stochasticity affect the evolution of multivariate quantitative characters by defining demographic and environmental variances as components of individual fitness. The exact covariance formula for selection is decomposed into three components, the deterministic mean value, as well as stochastic demographic and environmental components. We show that demographic and environmental stochasticity generate random genetic drift and fluctuating selection, respectively. This provides a common theoretical framework for linking ecological and evolutionary processes. Demographic stochasticity can cause random variation in selection differentials independent of fluctuating selection caused by environmental variation. We use this model of selection to illustrate that the effect on the expected selection differential of random variation in individual fitness is dependent on population size, and that the strength of fluctuating selection is affected by how environmental variation affects the covariance in Malthusian fitness between individuals with different phenotypes. Thus, our approach enables us to partition out the effects of fluctuating selection from the effects of selection due to random variation in individual fitness caused by demographic stochasticity. © 2013 The Author(s). Evolution © 2013 The Society for the Study of Evolution.

The Effect of Cognitive Therapy on Structural Social Capital: Results From a Randomized Controlled Trial Among Sexual Violence Survivors in the Democratic Republic of the Congo

PubMed Central

Bolton, Paul A.; Annan, Jeannie; Kaysen, Debra; Robinette, Katie; Cetinoglu, Talita; Wachter, Karin; Bass, Judith K.

2014-01-01

Objectives. We evaluated changes in social capital following group-based cognitive processing therapy (CPT) for female survivors of sexual violence. Methods. We compared CPT with individual support in a cluster-randomized trial in villages in South Kivu province, Democratic Republic of the Congo. Local psychosocial assistants delivered the interventions from April through July 2011. We evaluated differences between CPT and individual support conditions for structural social capital (i.e., time spent with nonkin social network, group membership and participation, and the size of financial and instrumental support networks) and emotional support seeking. We analyzed intervention effects with longitudinal random effects models. Results. We obtained small to medium effect size differences for 2 study outcomes. Women in the CPT villages increased group membership and participation at 6-month follow-up and emotional support seeking after the intervention compared with women in the individual support villages. Conclusions. Results support the efficacy of group CPT to increase dimensions of social capital among survivors of sexual violence in a low-income conflict-affected context. PMID:25033113

Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia.

PubMed

Sakzewski, Leanne; Ziviani, Jenny; Abbott, David F; Macdonell, Richard A L; Jackson, Graeme D; Boyd, Roslyn N

2011-04-01

To determine if constraint-induced movement therapy (CIMT) is more effective than bimanual training (BIM) in improving upper limb activity outcomes for children with congenital hemiplegia in a matched-pairs randomized trial. Sixty-three children (mean age 10.2, SD 2.7, range 5-16 y; 33 males, 30 females), 16 in Manual Ability Classification System level I, 46 level II, and 1 level III and 16 in Gross Motor Function Classification level I, 47 level II) were randomly allocated to either CIMT or BIM group day camps (60 hours over 10 days). The Melbourne Assessment of Unilateral Upper Limb Function assessed unimanual capacity of the impaired limb and Assisting Hand Assessment evaluated bimanual coordination at baseline, 3 and 26 weeks, scored by blinded raters. After concealed random allocation, there was no baseline difference between groups. CIMT had superior outcomes compared with BIM for unimanual capacity at 26 weeks (estimated mean difference [EMD] 4.4, 95% confidence interval [CI] 2.2-6.7; p < 0.001). There was no other significant difference between groups post-intervention. Both groups demonstrated significant improvements in bimanual performance at 3 weeks, with gains maintained by BIM at 26 weeks (EMD 2.3; 95% CI 0.6-4.0; p = 0.008). Interpretation  Overall, there were only small differences between the two training approaches. CIMT yielded greater changes in unimanual capacity of the impaired upper limb compared with BIM. Results generally reflect specificity of practice, with CIMT improving unimanual capacity and BIM improving bimanual performance. Considerable inter-individual variation in response to either intervention was evident. Future research should consider serial sequencing unimanual then BIM approaches to optimize upper limb outcomes for children with congenital hemiplegia. © The Authors. Journal compilation © Mac Keith Press 2011.

Using assessment to individualize early mathematics instruction.

PubMed

Connor, Carol McDonald; Mazzocco, Michèle M M; Kurz, Terri; Crowe, Elizabeth C; Tighe, Elizabeth L; Wood, Taffeta S; Morrison, Frederick J

2018-02-01

Accumulating evidence suggests that assessment-informed personalized instruction, tailored to students' individual skills and abilities, is more effective than more one-size-fits-all approaches. In this study, we evaluate the efficacy of Individualizing Student Instruction in Mathematics (ISI-Math) compared to Reading (ISI-Reading) where classrooms were randomly assigned to ISI-Math or ISI-Reading. The literature on child characteristics X instruction or skill X treatment interaction effects point to the complexities of tailoring instruction for individual students who present with constellations of skills. Second graders received mathematics instruction in small flexible learning groups based on their assessed learning needs. Results of the study (n=32 teachers, 370 students) revealed significant treatment effects on standardized mathematics assessments. With effect sizes (d) of 0.41-0.60, we show that we can significantly improve 2nd graders' mathematics achievement, including for children living in poverty, by using assessment data to individualize the mathematics instruction they receive. The instructional regime, ISI-Math, was implemented by regular classroom teachers and it led to about a 4-month achievement advantage on standardized mathematics tests when compared to students in control classrooms. These results were realized within one school year. Moreover, treatment effects were the same regardless of school-level poverty and students' gender, initial mathematics or vocabulary scores. Copyright © 2017 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

A preliminary, randomized trial of aerobic exercise for alcohol dependence.

PubMed

Brown, Richard A; Abrantes, Ana M; Minami, Haruka; Read, Jennifer P; Marcus, Bess H; Jakicic, John M; Strong, David R; Dubreuil, Mary Ella; Gordon, Alan A; Ramsey, Susan E; Kahler, Christopher W; Stuart, Gregory L

2014-07-01

Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relatively untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n=25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use. Copyright © 2014 Elsevier Inc. All rights reserved.

Individual and group-level job resources and their relationships with individual work engagement

PubMed Central

Füllemann, Désirée; Brauchli, Rebecca; Jenny, Gregor J.; Bauer, Georg F.

2016-01-01

Objectives: This study adds a multilevel perspective to the well-researched individual-level relationship between job resources and work engagement. In addition, we explored whether individual job resources cluster within work groups because of a shared psychosocial environment and investigated whether a resource-rich psychosocial work group environment is beneficial for employee engagement over and above the beneficial effect of individual job resources and independent of their variability within groups. Methods: Data of 1,219 employees nested in 103 work groups were obtained from a baseline employee survey of a large stress management intervention project implemented in six medium and large-sized organizations in diverse sectors. A variety of important job resources were assessed and grouped to an overall job resource factor with three subfactors (manager behavior, peer behavior, and task-related resources). Data were analyzed using multilevel random coefficient modeling. Results: The results indicated that job resources cluster within work groups and can be aggregated to a group-level job resources construct. However, a resource-rich environment, indicated by high group-level job resources, did not additionally benefit employee work engagement but on the contrary, was negatively related to it. Conclusions: On the basis of this unexpected result, replication studies are encouraged and suggestions for future studies on possible underlying within-group processes are discussed. The study supports the presumed value of integrating work group as a relevant psychosocial environment into the motivational process and indicates a need to further investigate emergent processes involved in aggregation procedures across levels. PMID:27108639

Determining Individual Variation in Growth and Its Implication for Life-History and Population Processes Using the Empirical Bayes Method

PubMed Central

Vincenzi, Simone; Mangel, Marc; Crivelli, Alain J.; Munch, Stephan; Skaug, Hans J.

2014-01-01

The differences in demographic and life-history processes between organisms living in the same population have important consequences for ecological and evolutionary dynamics. Modern statistical and computational methods allow the investigation of individual and shared (among homogeneous groups) determinants of the observed variation in growth. We use an Empirical Bayes approach to estimate individual and shared variation in somatic growth using a von Bertalanffy growth model with random effects. To illustrate the power and generality of the method, we consider two populations of marble trout Salmo marmoratus living in Slovenian streams, where individually tagged fish have been sampled for more than 15 years. We use year-of-birth cohort, population density during the first year of life, and individual random effects as potential predictors of the von Bertalanffy growth function's parameters k (rate of growth) and (asymptotic size). Our results showed that size ranks were largely maintained throughout marble trout lifetime in both populations. According to the Akaike Information Criterion (AIC), the best models showed different growth patterns for year-of-birth cohorts as well as the existence of substantial individual variation in growth trajectories after accounting for the cohort effect. For both populations, models including density during the first year of life showed that growth tended to decrease with increasing population density early in life. Model validation showed that predictions of individual growth trajectories using the random-effects model were more accurate than predictions based on mean size-at-age of fish. PMID:25211603

Regression Discontinuity for Causal Effect Estimation in Epidemiology.

PubMed

Oldenburg, Catherine E; Moscoe, Ellen; Bärnighausen, Till

Regression discontinuity analyses can generate estimates of the causal effects of an exposure when a continuously measured variable is used to assign the exposure to individuals based on a threshold rule. Individuals just above the threshold are expected to be similar in their distribution of measured and unmeasured baseline covariates to individuals just below the threshold, resulting in exchangeability. At the threshold exchangeability is guaranteed if there is random variation in the continuous assignment variable, e.g., due to random measurement error. Under exchangeability, causal effects can be identified at the threshold. The regression discontinuity intention-to-treat (RD-ITT) effect on an outcome can be estimated as the difference in the outcome between individuals just above (or below) versus just below (or above) the threshold. This effect is analogous to the ITT effect in a randomized controlled trial. Instrumental variable methods can be used to estimate the effect of exposure itself utilizing the threshold as the instrument. We review the recent epidemiologic literature reporting regression discontinuity studies and find that while regression discontinuity designs are beginning to be utilized in a variety of applications in epidemiology, they are still relatively rare, and analytic and reporting practices vary. Regression discontinuity has the potential to greatly contribute to the evidence base in epidemiology, in particular on the real-life and long-term effects and side-effects of medical treatments that are provided based on threshold rules - such as treatments for low birth weight, hypertension or diabetes.

Randomized clinical trial in healthy individuals on the effect of viscous fiber blend on glucose tolerance when incorporated in capsules or into the carbohydrate or fat component of the meal.

PubMed

Jenkins, Alexandra L; Morgan, Linda M; Bishop, Jacqueline; Jovanovski, Elena; Vuksan, Vladimir

2014-01-01

Addition of viscous fiber to foods has been shown to significantly reduce postprandial glucose excursions. However, palatability issues and the variability in effectiveness due to different methods of administration in food limits it use. This study explores the effectiveness of a viscous fiber blend (VFB) in lowering postprandial glycemia using different methods of incorporation. Two acute, randomized, controlled studies were undertaken: Study 1: Twelve healthy individuals (mean ± SD, age: 36 ± 13 years, body mass index [BMI]: 27 ± 4 kg/m(2)) consumed 8 different breakfasts. All meals consisted of 50 g of available carbohydrate from white bread (WB) and 10 g margarine. Zero, 1, 2, or 4 g of the VFB was baked into WB or mixed with the margarine. Study 2: Thirteen healthy individuals (mean ± SD, age: 39 ± 17 years, BMI: 25 ± 5 kg/m(2)) consumed 6 test meals, consisting of 50 g of available carbohydrate from WB. Six capsules containing either cornstarch or VFB were taken at 4 different time points during the glucose tolerance test. After obtaining a fasting finger-prick blood sample, volunteers consumed the test meal over a 10-minute period. Additional blood samples were taken at 15, 30, 45, 60, 90, and 120 minutes from the start of the meal. For study 2, an additional fasting sample was obtained at -30 minutes. Study 1: Irrespective of VFB dose, glucose levels were lower at 30 and 45 minutes when VFB was mixed into the margarine compared to the control (p < 0.05). Incremental areas under the curve were significantly lower compared to control when 4 g of VFB was mixed into the margarine. Study 2: There was no effect of the VFB on postprandial glucose levels when administered in capsules. Incorporation of VFB into margarine was more effective in lowering postprandial glycemia than when the VFB was baked into bread and no effect when given in capsules.

Pathologic complete response and disease-free survival are not surrogate endpoints for 5-year survival in rectal cancer: an analysis of 22 randomized trials.

PubMed

Petrelli, Fausto; Borgonovo, Karen; Cabiddu, Mary; Ghilardi, Mara; Lonati, Veronica; Barni, Sandro

2017-02-01

We performed a literature-based analysis of randomized clinical trials to assess the pathologic complete response (pCR) (ypT0N0 after neoadjuvant therapy) and 3-year disease-free survival (DFS) as potential surrogate endpoints for 5-year overall survival (OS) in rectal cancer treated with neoadjuvant (chemo)radiotherapy (CT)RT. A systematic literature search of PubMed, EMBASE, the Web of Science, SCOPUS, CINAHL, and the Cochrane Library was performed. Treatment effects on 3-year DFS and 5-year OS were expressed as rates of patients alive (%), and those on pCR as differences in pCR rates (∆ pCR% ). A weighted regression analysis was performed at individual- and trial-level to test the association between treatment effects on surrogate (∆ pCR% and ∆ 3yDFS ) and the main clinical outcome (∆ 5yOS ). Twenty-two trials involving 10,050 patients, were included in the analysis. The individual level surrogacy showed that the pCR% and 3-year DFS were poorly correlated with 5-year OS (R=0.52; 95% CI, 0.31-0.91; P=0.002; and R=0.60; 95% CI, 0.36-1; P=0.002). The trial-level surrogacy analysis confirmed that the two treatment effects on surrogates (∆ pCR% and ∆ 3yDFS ) are not strong surrogates for treatment effects on 5-year OS % (R=0.2; 95% CI, -0.29-0.78; P=0.5 and R=0.64; 95% CI, 0.29-1; P=0.06). These findings were confirmed in neoadjuvant CTRT studies but not in phase III trials were 3-year DFS could still represent a valid surrogate. This analysis does not support the use of pCR and 3-year DFS% as appropriate surrogate endpoints for 5-year OS% in patients with rectal cancer treated with neoadjuvant therapy.

The Influence of Mark-Recapture Sampling Effort on Estimates of Rock Lobster Survival

PubMed Central

Kordjazi, Ziya; Frusher, Stewart; Buxton, Colin; Gardner, Caleb; Bird, Tomas

2016-01-01

Five annual capture-mark-recapture surveys on Jasus edwardsii were used to evaluate the effect of sample size and fishing effort on the precision of estimated survival probability. Datasets of different numbers of individual lobsters (ranging from 200 to 1,000 lobsters) were created by random subsampling from each annual survey. This process of random subsampling was also used to create 12 datasets of different levels of effort based on three levels of the number of traps (15, 30 and 50 traps per day) and four levels of the number of sampling-days (2, 4, 6 and 7 days). The most parsimonious Cormack-Jolly-Seber (CJS) model for estimating survival probability shifted from a constant model towards sex-dependent models with increasing sample size and effort. A sample of 500 lobsters or 50 traps used on four consecutive sampling-days was required for obtaining precise survival estimations for males and females, separately. Reduced sampling effort of 30 traps over four sampling days was sufficient if a survival estimate for both sexes combined was sufficient for management of the fishery. PMID:26990561

Genetic variability and effective population size when local extinction and recolonization of subpopulations are frequent

PubMed Central

Maruyama, Takeo; Kimura, Motoo

1980-01-01

If a population (species) consists of n haploid lines (subpopulations) which reproduce asexually and each of which is subject to random extinction and subsequent replacement, it is shown that, at equilibrium in which mutational production of new alleles and their random extinction balance each other, the genetic diversity (1 minus the sum of squares of allelic frequencies) is given by 2Nev/(1 + 2Nev), where [Formula: see text] in which Ñ is the harmonic mean of the population size per line, n is the number of lines (assumed to be large), λ is the rate of line extinction, and v is the mutation rate (assuming the infinite neutral allele model). In a diploid population (species) consisting of n colonies, if migration takes place between colonies at the rate m (the island model) in addition to extinction and recolonization of colonies, it is shown that effective population size is [Formula: see text] If the rate of colony extinction (λ) is much larger than the migration rate of individuals, the effective population size is greatly reduced compared with the case in which no colony extinctions occur (in which case Ne = nÑ). The stepping-stone type of recolonization scheme is also considered. Bearing of these results on the interpretation of the level of genetic variability at the enzyme level observed in natural populations is discussed from the standpoint of the neutral mutation-random drift hypothesis. PMID:16592920

Alterations of antioxidant status in asymptomatic hypercholesterolemic individuals after resveratrol intake.

PubMed

Apostolidou, C; Adamopoulos, K; Iliadis, S; Kourtidou-Papadeli, C

2015-08-01

High cholesterol is one of the risk factors for atherogenesis, leading to oxidative stress and cardiovascular disease (CVD). The focus of this study was to evaluate the role and the pathways of action of a natural antioxidant, resveratrol, in asymptomatic hypercholesterolemic (AHC) individuals. Forty healthy AHCs and normocholesterolemics (NCs) participated in the study. They received random-order resveratrol and placebo capsules for four weeks. Total antioxidant capacity (TAC), vitamin E and total cholesterol (TC) were measured at baseline and at the end of each intervention. Resveratrol provided a direct antioxidant effect in healthy NC individuals, but in AHC individuals, with a higher demand for antioxidant activity due to higher cholesterol levels, it acted by facilitating an increase in vitamin E. Our findings suggest that resveratrol acts synergistically with other antioxidants against oxidative stress and highlights the importance of hypercholesterolemic individuals consuming natural antioxidants instead of medications to reduce the risk of CVD, while the situation is still reversible.

Promoting Social Nurturance and Positive Social Environments to Reduce Obesity in High Risk Youth

PubMed Central

Wilson, Dawn K.; Sweeney, Allison M.; Kitzman-Ulrich, Heather; Gause, Haylee; St. George, Sara M.

2017-01-01

Nurturing environments within the context of families, schools, and communities all play an important role in enhancing youth’s behavioral choices and health outcomes. The increasing prevalence rates of obesity among youth, especially among low income and ethnic minorities, highlight the need to develop effective and innovative intervention approaches that promote positive supportive environments across different contexts for at risk youth. We propose that the integration of Social Cognitive Theory, Family Systems Theory, and Self-Determination Theory offers a useful framework for understanding how individual, family and social-environmental level factors contribute to the development of nurturing environments. In this paper, we summarize evidence-based randomized controlled trials that integrate positive parenting, motivational, and behavioral skills strategies in different contexts, including primary care, home, community, and school-based settings. Taken together, these studies suggest that youth and parents are most likely to benefit when youth receive individual-level behavioral skills, family-level support and communication, and autonomous motivational support from the broader social environment. Future investigators and health care providers should consider integrating these evidence-based approaches that support the effects of positive social climate-based interventions on promoting healthy eating, physical activity, and weight management in youth. PMID:28229248

Promoting Social Nurturance and Positive Social Environments to Reduce Obesity in High-Risk Youth.

PubMed

Wilson, Dawn K; Sweeney, Allison M; Kitzman-Ulrich, Heather; Gause, Haylee; St George, Sara M

2017-03-01

Nurturing environments within the context of families, schools, and communities all play an important role in enhancing youth's behavioral choices and health outcomes. The increasing prevalence rates of obesity among youth, especially among low income and ethnic minorities, highlight the need to develop effective and innovative intervention approaches that promote positive supportive environments across different contexts for at-risk youth. We propose that the integration of Social Cognitive Theory, Family Systems Theory, and Self-Determination Theory offers a useful framework for understanding how individual, family, and social-environmental-level factors contribute to the development of nurturing environments. In this paper, we summarize evidence-based randomized controlled trials that integrate positive parenting, motivational, and behavioral skills strategies in different contexts, including primary care, home, community, and school-based settings. Taken together, these studies suggest that youth and parents are most likely to benefit when youth receive individual-level behavioral skills, family-level support and communication, and autonomous motivational support from the broader social environment. Future investigators and healthcare providers should consider integrating these evidence-based approaches that support the effects of positive social climate-based interventions on promoting healthy eating, physical activity, and weight management in youth.

A Randomized Controlled Trial to Test the Effectiveness of an Immersive 3D Video Game for Anxiety Prevention among Adolescents

PubMed Central

Scholten, Hanneke; Malmberg, Monique; Lobel, Adam; Engels, Rutger C. M. E.; Granic, Isabela

2016-01-01

Adolescent anxiety is debilitating, the most frequently diagnosed adolescent mental health problem, and leads to substantial long-term problems. A randomized controlled trial (n = 138) was conducted to test the effectiveness of a biofeedback video game (Dojo) for adolescents with elevated levels of anxiety. Adolescents (11–15 years old) were randomly assigned to play Dojo or a control game (Rayman 2: The Great Escape). Initial screening for anxiety was done on 1,347 adolescents in five high schools; only adolescents who scored above the “at-risk” cut-off on the Spence Children Anxiety Survey were eligible. Adolescents’ anxiety levels were assessed at pre-test, post-test, and at three month follow-up to examine the extent to which playing Dojo decreased adolescents’ anxiety. The present study revealed equal improvements in anxiety symptoms in both conditions at follow-up and no differences between Dojo and the closely matched control game condition. Latent growth curve models did reveal a steeper decrease of personalized anxiety symptoms (not of total anxiety symptoms) in the Dojo condition compared to the control condition. Moderation analyses did not show any differences in outcomes between boys and girls nor did age differentiate outcomes. The present results are of importance for prevention science, as this was the first full-scale randomized controlled trial testing indicated prevention effects of a video game aimed at reducing anxiety. Future research should carefully consider the choice of control condition and outcome measurements, address the potentially high impact of participants’ expectations, and take critical design issues into consideration, such as individual- versus group-based intervention and contamination issues. PMID:26816292

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial.

PubMed

Nascimento, L S; Santos, A C; Lucena, Jms; Silva, Lgo; Almeida, Aem; Brasileiro-Santos, M S

2017-06-02

Resistant hypertension is a specific condition that affects approximately 10% of subjects with hypertension, and is characterized by persistently high blood pressure levels even using therapy of three or more antihypertensive agents or with blood pressure control using therapy with four or more antihypertensive agents. Changes in lifestyle, such as physical exercise, are indicated for controlling blood pressure. However, investigating studies about this therapy in individuals with resistant hypertension are few. This is a randomized controlled clinical trial. Forty-eight patients with resistant hypertension will be submitted to perform four short-term interventions: aerobic exercise sessions (mild-, moderate- and high-intensity) and control session, in random order and on separate days. After the short-term sessions, the patients will be randomly allocated into four groups for 8 weeks of follow-up: mild-, moderate- and high-intensity aerobic exercise, and a control group. The primary outcome is the occurrence of blood pressure reduction (office and ambulatory analysis, and acute and chronic effects). Secondary outcomes are autonomic and hemodynamic mechanisms: cardiac and vasomotor autonomic modulation, spontaneous baroreflex sensitivity, forearm blood flow and vascular resistance. The importance of exercise for hypertension has been known for decades, but little is known about the effects on patients with resistant hypertension. This study will help to understand whether different aerobic exercise intensities can induce different responses, as well as by what mechanisms adjustments in blood pressure levels may occur. ClinicalTrials.gov, ID: NCT02670681 . Registered on 28 January 2016 (first version); Brazilian Registry Platform Clinical Trials: protocol RBR-5q24zh . Registered on 24 June 2015.

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

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

The effect of trauma-focused therapy on the altered T cell distribution in individuals with PTSD: evidence from a randomized controlled trial.

PubMed

Morath, Julia; Gola, Hannah; Sommershof, Annette; Hamuni, Gilava; Kolassa, Stephan; Catani, Claudia; Adenauer, Hannah; Ruf-Leuschner, Martina; Schauer, Maggie; Elbert, Thomas; Groettrup, Marcus; Kolassa, Iris-Tatjana

2014-07-01

Posttraumatic stress disorder (PTSD) is associated with a reduced ratio of naïve cytotoxic T lymphocytes, an increased ratio of memory cytotoxic T lymphocytes, and a reduced proportion of FoxP3(+) regulatory T lymphocytes. This study investigated whether these immunological alterations are reversible through an evidence-based psychotherapeutic treatment. Therefore, 34 individuals with PTSD were randomly assigned to either a treatment condition of 12 sessions narrative exposure therapy (NET) or a waitlist control (WLC) group. PTSD symptoms were significantly reduced in the NET group, but not in the WLC group, four months post-therapy (effect size: Hedges' g = -1.61). One year after therapy, PTSD symptoms were improved even further in the NET group compared to baseline (Hedges' g = -1.96). This symptom improvement was mirrored in an increase in the originally reduced proportion of regulatory T cells (Tregs) in the NET group at the one-year follow-up, when comparing subgroups matched for baseline Treg numbers. However, no changes were found for the initially reduced proportion of CD45RA(+)CCR7(+) naïve T lymphocytes. In conclusion, NET was effective in reducing trauma-related PTSD symptoms and had a positive effect on the proportion of Tregs cells, thus demonstrating an effect of psychotherapy on an immunological level. Yet, the shift in the proportion of naïve and memory T lymphocytes in individuals with PTSD, discussed in the literature as a correlate of premature immunosenescence, was not reversible and thus might render these patients permanently more susceptible to infectious diseases. Copyright © 2014 Elsevier Ltd. All rights reserved.

The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: a randomized pilot study.

PubMed

Mertz, Birgitte Goldschmidt; Dunn-Henriksen, Anne Katrine; Kroman, Niels; Johansen, Christoffer; Andersen, Kenneth Geving; Andersson, Michael; Mathiesen, Ulla Breitenstein; Vibe-Petersen, Jette; Dalton, Susanne Oksbjerg; Envold Bidstrup, Pernille

2017-12-01

Our aim was to determine the feasibility and effectiveness of an individual, nurse-navigator intervention for relieving distress, anxiety, depression and health-related quality of life in women who have been treated for breast cancer (BC) and are experiencing moderate-to-severe psychological and physical symptoms. Fifty women with newly diagnosed BC who reported distress (score ≥7 on distress thermometer) before surgery were included consecutively in a pilot study and randomized 1:1 to the intervention or the control group. The intervention comprised repeated screening with patient reported outcome measures and nurse navigation. A total of 66 women who were not distressed (score <7) were followed longitudinally as an observational group. Participants filled in four questionnaires, at baseline, after 6 months and 12 months. The primary outcome was psychological distress and the secondary outcomes were anxiety, depression, health-related quality of life and feasibility of the intervention. Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation and lower levels of distress (mean 2.7 vs. 5.1, p<.01), anxiety (mean 5.1 vs. 7.8, p = .02) and depression (mean 2.2 vs. 4.4, p = .04) after 12 months compared to the control group. No significant effects were seen on health-related quality of life. The study shows promising feasibility of the individually tailored nurse-navigation intervention and while no significant effects were observed after 6 months, we did find statistically significant effects on distress, anxiety and depression 12 months after diagnosis. Our results will assist in developing rehabilitation to the most vulnerable patients.

Individual-based versus aggregate meta-analysis in multi-database studies of pregnancy outcomes: the Nordic example of selective serotonin reuptake inhibitors and venlafaxine in pregnancy.

PubMed

Selmer, Randi; Haglund, Bengt; Furu, Kari; Andersen, Morten; Nørgaard, Mette; Zoëga, Helga; Kieler, Helle

2016-10-01

Compare analyses of a pooled data set on the individual level with aggregate meta-analysis in a multi-database study. We reanalysed data on 2.3 million births in a Nordic register based cohort study. We compared estimated odds ratios (OR) for the effect of selective serotonin reuptake inhibitors (SSRI) and venlafaxine use in pregnancy on any cardiovascular birth defect and the rare outcome right ventricular outflow tract obstructions (RVOTO). Common covariates included maternal age, calendar year, birth order, maternal diabetes, and co-medication. Additional covariates were added in analyses with country-optimized adjustment. Country adjusted OR (95%CI) for any cardiovascular birth defect in the individual-based pooled analysis was 1.27 (1.17-1.39), 1.17 (1.07-1.27) adjusted for common covariates and 1.15 (1.05-1.26) adjusted for all covariates. In fixed effects meta-analyses pooled OR was 1.29 (1.19-1.41) based on crude country specific ORs, 1.19 (1.09-1.29) adjusted for common covariates, and 1.16 (1.06-1.27) for country-optimized adjustment. In a random effects model the adjusted OR was 1.07 (0.87-1.32). For RVOTO, OR was 1.48 (1.15-1.89) adjusted for all covariates in the pooled data set, and 1.53 (1.19-1.96) after country-optimized adjustment. Country-specific adjusted analyses at the substance level were not possible for RVOTO. Results of fixed effects meta-analysis and individual-based analyses of a pooled dataset were similar in this study on the association of SSRI/venlafaxine and cardiovascular birth defects. Country-optimized adjustment attenuated the estimates more than adjustment for common covariates only. When data are sparse pooled data on the individual level are needed for adjusted analyses. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Association of cardiac and vascular changes with ambient PM2.5 in diabetic individuals

PubMed Central

2010-01-01

Background and Objective Exposure to fine airborne particles (PM2.5) has been shown to be responsible for cardiovascular and hematological effects, especially in older people with cardiovascular disease. Some epidemiological studies suggest that individuals with diabetes may be a particularly susceptible population. This study examined effects of short-term exposures to ambient PM2.5 on markers of systemic inflammation, coagulation, autonomic control of heart rate, and repolarization in 22 adults (mean age: 61 years) with type 2 diabetes. Methods Each individual was studied for four consecutive days with daily assessments of plasma levels of blood markers. Cardiac rhythm and electrocardiographic parameters were examined at rest and with 24-hour ambulatory ECG monitors. PM2.5 and meteorological data were measured daily on the rooftop of the patient exam site. Data were analyzed with models adjusting for season, weekday, meteorology, and a random intercept. To identify susceptible subgroups, effect modification was analyzed by clinical characteristics associated with insulin resistance as well as with oxidative stress and by medication intake. Results Interleukin (IL)-6 and tumor necrosis factor alpha showed a significant increase with a lag of two days (percent change of mean level: 20.2% with 95%-confidence interval [6.4; 34.1] and 13.1% [1.9; 24.4], respectively) in association with an increase of 10 μg/m3 in PM2.5. Obese participants as well as individuals with elevated glycosylated hemoglobin, lower adiponectin, higher ferritin or with glutathione S-transferase M1 null genotype showed higher IL-6 effects. Changes in repolarization were found immediately as well as up to four days after exposure in individuals without treatment with a beta-adrenergic receptor blocker. Conclusions Exposure to elevated levels of PM2.5 alters ventricular repolarization and thus may increase myocardial vulnerability to arrhythmias. Exposure to PM2.5 also increases systemic inflammation. Characteristics associated with insulin resistance or with oxidative stress were shown to enhance the association. PMID:20525188

Effects of vibration therapy on hormone response and stress in severely disabled patients: a double-blind randomized placebo-controlled clinical trial.

PubMed

Seco, J; Rodríguez-Pérez, V; López-Rodríguez, A F; Torres-Unda, J; Echevarria, E; Díez-Alegre, M I; Ortega, A; Morán, P; Mendoza-Laíz, N; Abecia Inchaurregui, L C

2015-01-01

To assess the effects of vibration therapy (VT) on quality of life and hormone response in severely disabled patients compared with placebo. A longitudinal prospective, double-blind, randomized placebo-controlled trial, with pre and postintervention assessments. A total of 20 severely disabled individuals were recruited from a National Reference Centre in Spain: 13 (65%) men and 7 (35%) women, 45.5 ± 9.32 years of age (range 41: 22-63). We evaluated their physical stress and state anxiety. No statistically significant changes were found in the socio-psychological variables studied, while in the experimental group state anxiety decreased significantly with p < 0.01 (Z = 2.38; one-tailed p = .009) and, among the biological variables, the level of cortisol fell (p = 0.03). Short periods of exposure to low-frequency and low-amplitude local vibration are a safe and effective mechanical stimulus that can have a positive effect in terms of hormone response. VT can be considered to have an anti-stress effect. © 2013 Association of Rehabilitation Nurses.

Adrenergic System Activation Mediates Changes in Cardiovascular and Psychomotoric Reactions in Young Individuals after Red Bull© Energy Drink Consumption

PubMed Central

Cavka, Ana; Stupin, Marko; Panduric, Ana; Plazibat, Ana; Cosic, Anita; Rasic, Lidija; Debeljak, Zeljko; Martinovic, Goran; Drenjancevic, Ines

2015-01-01

Objectives. To assess the effect of Red Bull© on (1) blood glucose and catecholamine levels, (2) cardiovascular and respiratory function changes before, during, and after exercise, (3) reaction time, (4) cognitive functions, and (5) response to mental stress test and emotions in young healthy individuals (N=38). Methods. Heart rate (HR) and arterial blood pressure (ABP), blood glucose, adrenaline, and noradrenalin plasma levels were measured before and after Red Bull© intake. Participants were subjected to 4 different study protocols by randomized order, before and 30 minutes after consumption of 500 mL of Red Bull©. Results. Mean ABP and HR were significantly increased at rest after Red Bull© intake. Blood glucose level and plasma catecholamine levels significantly increased after Red Bull© consumption. Heart rate, respiration rate, and respiratory flow rate were significantly increased during exercise after Red Bull© consumption compared to control condition. Intake of Red Bull© significantly improved reaction time, performance in immediate memory test, verbal fluency, and subject's attention as well as performance in mental stress test. Conclusion. This study demonstrated that Red Bull© has beneficial effect on some cognitive functions and effect on cardiovascular and respiratory system at rest and during exercise by increasing activity of the sympathetic nervous system. PMID:26124829

Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

PubMed

Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

2016-01-01

Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

Multi-level, cross-sectional study of workplace social capital and smoking among Japanese employees.

PubMed

Suzuki, Etsuji; Fujiwara, Takeo; Takao, Soshi; Subramanian, S V; Yamamoto, Eiji; Kawachi, Ichiro

2010-08-17

Social capital is hypothesized to be relevant to health promotion, and the association between community social capital and cigarette smoking has been examined. Individual-level social capital has been found to be associated with smoking cessation, but evidence remains sparse on the contextual effect of social capital and smoking. Further, evidence remains sparse on the association between smoking and social capital in the workplace, where people are spending an increasing portion of their daily lives. We examined the association between workplace social capital and smoking status among Japanese private sector employees. We employed a two-stage stratified random sampling procedure. Of the total of 1,800 subjects in 60 companies, 1,171 (men/women; 834/337) employees (65.1%) were identified from 46 companies in Okayama in 2007. Workplace social capital was assessed in two dimensions; trust and reciprocity. Company-level social capital was based on inquiring about employee perceptions of trust and reciprocity among co-workers, and then aggregating their responses in order to calculate the proportion of workers reporting mistrust and lack of reciprocity. Multilevel logistic regression analysis was conducted using Markov Chain Monte Carlo methods to explore whether individual- and company-level social capital was associated with smoking. Odds ratios (ORs) and 95% credible intervals (CIs) for current smoking were obtained. Overall, 33.3% of the subjects smoked currently. There was no relationship between individual-level mistrust of others and smoking status. By contrast, one-standard deviation change in company-level mistrust was associated with higher odds of smoking (OR: 1.25, 95% CI: 1.06-1.46) even after controlling for individual-level mistrust, sex, age, occupation, educational attainment, alcohol use, physical activity, body mass index, and chronic diseases. No clear associations were found between lack of reciprocity and smoking both at the individual- and company-level. Company-level mistrust is associated with higher likelihood of smoking among Japanese employees, while individual perceptions of mistrust were not associated. The link between lack of reciprocity and smoking was not supported either at the individual- or company-level. Further studies are warranted to examine the possible link between company-level trust and smoking cessation in the Japanese workplace.

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

PubMed

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

Methodology for Knowledge Synthesis of the Management of Vaccination Pain and Needle Fear.

PubMed

Taddio, Anna; McMurtry, C Meghan; Shah, Vibhuti; Yoon, Eugene W; Uleryk, Elizabeth; Pillai Riddell, Rebecca; Lang, Eddy; Chambers, Christine T; Noel, Melanie; MacDonald, Noni E

2015-10-01

A knowledge synthesis was undertaken to inform the development of a revised and expanded clinical practice guideline about managing vaccination pain in children to include the management of pain across the lifespan and the management of fear in individuals with high levels of needle fear. This manuscript describes the methodological details of the knowledge synthesis and presents the list of included clinical questions, critical and important outcomes, search strategy, and search strategy results. The Grading of Assessments, Recommendations, Development and Evaluation (GRADE) and Cochrane methodologies provided the general framework. The project team voted on clinical questions for inclusion and critically important and important outcomes. A broad search strategy was used to identify relevant randomized-controlled trials and quasi-randomized-controlled trials. Quality of research evidence was assessed using the Cochrane risk of bias tool and quality across studies was assessed using GRADE. Multiple measures of the same construct within studies (eg, observer-rated and parent-rated infant distress) were combined before pooling. The standardized mean difference and 95% confidence intervals (CI) or relative risk and 95% CI was used to express the effects of an intervention. Altogether, 55 clinical questions were selected for inclusion in the knowledge synthesis; 49 pertained to pain management during vaccine injections and 6 pertained to fear management in individuals with high levels of needle fear. Pain, fear, and distress were typically prioritized as critically important outcomes across clinical questions. The search strategy identified 136 relevant studies. This manuscript describes the methodological details of a knowledge synthesis about pain management during vaccination and fear management in individuals with high levels of needle fear. Subsequent manuscripts in this series will present the results for the included questions.

The benefits of ω-3 supplementation depend on adiponectin basal level and adiponectin increase after the supplementation: A randomized clinical trial.

PubMed

Barbosa, Milena Maria de Araújo Lima; Melo, Alexandra Lorenzzi Trinanes Raposo de; Damasceno, Nágila Raquel Teixeira

2017-02-01

The aim of this study was to analyze whether ω-3 supplementation improves cardiometabolic profile in individuals with cardiovascular risk factors and to determine the effect of adiponectin levels on these changes. In this double-blind, placebo-controlled, 2-mo clinical trial, we randomized 80 individuals of both sexes (mean age 52 y) with at least one cardiovascular risk factor (excess weight, hypertension, dyslipidemia, diabetes, or smoking) into two groups: ω-3 (supplemented with 3 g/d of fish oil containing 37% eicosapentaenoic acid and 23% docosahexaenoic acid) and placebo (3 g/d of sunflower oil containing 65% linoleic acid). At baseline and after the intervention, we evaluated serum adiponectin, leptin, lipid profile, apolipoproteins (apo), electronegative low-density lipoprotein (LDL[-]), and glucose metabolism (glucose and insulin). After supplementation, the ω-3 group showed an increase in serum adiponectin. After stratifying the ω-3 group by adiponectin concentration at baseline, participants with lower adiponectin concentration showed a higher reduction of total cholesterol, LDL, LDL/high-density lipoprotein ratio, LDL/apo B, and LDL(-). Individuals with a higher variation of adiponectin concentration after ω-3 supplementation presented with reduced blood glucose. The variation of serum adiponectin induced by ω-3 supplementation was negatively correlated with the Framingham and Adult Treatment Panel IV scores (r = -0.4 and P < 0.05 for both). Adiponectin is shown as one of the mechanisms by which ω-3 improves cardiometabolic profile in persons with cardiovascular risk. Moreover, the benefit varies according to the adiponectin basal level and adiponectin variation after supplementation. Copyright © 2016 Elsevier Inc. All rights reserved.

A mobile phone-based program to promote healthy behaviors among adults with prediabetes: study protocol for a pilot randomized controlled trial.

PubMed

Griauzde, Dina H; Kullgren, Jeffrey T; Liestenfeltz, Brad; Richardson, Caroline; Heisler, Michele

2018-01-01

Rates of participation in Diabetes Prevention Programs (DPPs) are low. This may be due, in part, to low levels of autonomous motivation (i.e., motivation that arises from internal sources and sustains healthy behaviors over time) to prevent type 2 diabetes (T2DM) among many individuals with prediabetes. Mobile health (mHealth) technologies that incorporate principles from the Self-Determination Theory offer an effective and scalable approach to increase autonomous motivation levels. One promising mobile phone-based application is JOOL Health, which aims to help users connect certain health behaviors (e.g., sleep and diet) with personal values in specific life domains (e.g., family and work). The first aim of this study is to estimate whether JOOL Health can increase autonomous motivation to prevent T2DM among individuals with prediabetes who declined DPP participation. The second aim of this pilot study is to examine the intervention's feasibility and acceptability. This is a 12-week, three-arm pilot randomized controlled trial. We will recruit 105 individuals with prediabetes who did not engage in a DPP despite invitation from their health plan to participate in face-to-face or web-based programs at no out-of-pocket-cost. Participants will be randomized to one of three study arms: (1) a group that receives information on prediabetes, evidence-based strategies to decrease progression to T2DM, and a list of resources for mHealth tools for monitoring diet, physical activity, and weight (comparison group); (2) a group that receives the JOOL Health application; and (3) a group that receives the JOOL Health application as well as a Fitbit activity tracker and wireless-enabled scale. Our primary outcome is change in autonomous motivation to prevent T2DM (measured using the Treatment Self-Regulation Questionnaire). We will also collect data related to the intervention's feasibility (recruitment and retention rates) and acceptability (adherence and qualitative experience) as well as changes in psychosocial outcomes, hemoglobin A1c, and weight. To our knowledge, this is the first study that aims to promote positive health behaviors among individuals with prediabetes who previously declined to participate in a DPP. Our results will inform a larger trial to test the effect of JOOL Health on clinically relevant outcomes, including weight loss, physical activity, and DPP engagement. NCT03025607. Registered February 2017.

Household and familial resemblance in risk factors for type 2 diabetes and related cardiometabolic diseases in rural Uganda: a cross-sectional community sample.

PubMed

Nielsen, Jannie; Bahendeka, Silver K; Whyte, Susan R; Meyrowitsch, Dan W; Bygbjerg, Ib C; Witte, Daniel R

2017-09-21

Prevention of type 2 diabetes (T2D) has been successfully established in randomised clinical trials. However, the best methods for the translation of this evidence into effective population-wide interventions remain unclear. To assess whether households could be a target for T2D prevention and screening, we investigated the resemblance of T2D risk factors at household level and by type of familial dyadic relationship in a rural Ugandan community. This cross-sectional household-based study included 437 individuals ≥13 years of age from 90 rural households in south-western Uganda. Resemblance in glycosylated haemoglobin (HbA1c), anthropometry, blood pressure, fitness status and sitting time were analysed using a general mixed model with random effects (by household or dyad) to calculate household intraclass correlation coefficients (ICCs) and dyadic regression coefficients. Logistic regression with household as a random effect was used to calculate the ORs for individuals having a condition or risk factor if another household member had the same condition. The strongest degree of household member resemblances in T2D risk factors was seen in relation to fitness status (ICC=0.24), HbA1c (ICC=0.18) and systolic blood pressure (ICC=0.11). Regarding dyadic resemblance, the highest standardised regression coefficient was seen in fitness status for spouses (0.54, 95% CI 0.32 to 0.76), parent-offspring (0.41, 95% CI 0.28 0.54) and siblings (0.41, 95% CI 0.25 to 0.57). Overall, parent-offspring and sibling pairs were the dyads with strongest resemblance, followed by spouses. The marked degree of resemblance in T2D risk factors at household level and between spouses, parent-offspring and sibling dyads suggest that shared behavioural and environmental factors may influence risk factor levels among cohabiting individuals, which point to the potential of the household setting for screening and prevention of T2D. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A clustered randomized trial of the effects of feedback using academic detailing compared to postal bulletin on prescribing of preventative cardiovascular therapy.

PubMed

Naughton, Corina; Feely, John; Bennett, Kathleen

2007-10-01

Interventions to promote prescribing of preventive therapies in patients with cardiovascular disease (CVD) or diabetes have reported variable success. (i) To evaluate the effect of prescribing feedback on GP practice using academic detailing compared to postal bulletin on prescribing of CVD preventive therapies in patients with CVD or diabetes at 3 and 6 months post intervention and (ii) to evaluate the intervention from a GP's perspective. Volunteer GP practices (n = 98) were randomized to receive individualized prescribing feedback via academic detailing (postal bulletin plus outreach visit) (n = 48) or postal bulletin (n = 50). The proportion of CVD or diabetic patients on statins and antiplatelet agents/warfarin pre- and post-intervention was calculated for each GP practice. Multivariate regression with a random effects model was used to compare differences between the groups adjusting for GP clustering and confounding factors. beta-Coefficients and 95% confidence intervals (CIs) are presented. There was a 3% increase in statin prescribing in CVD patients at 6 months post-intervention for both randomized groups, but there was no statistical difference between the groups (beta = 0.004; 95% CI = -0.01 to 0.02). Statin and antiplatelet/warfarin prescribing also increased in the diabetic population; there was no significant differences between the groups. GPs participating in the project expressed a high level of satisfaction with both interventions. Prescribing of preventive therapies increased in both randomized groups over the study period. But academic detailing did not have an additional effect on changing prescribing over the postal bulletin alone.

Genetic analysis of body weights of individually fed beef bulls in South Africa using random regression models.

PubMed

Selapa, N W; Nephawe, K A; Maiwashe, A; Norris, D

2012-02-08

The aim of this study was to estimate genetic parameters for body weights of individually fed beef bulls measured at centralized testing stations in South Africa using random regression models. Weekly body weights of Bonsmara bulls (N = 2919) tested between 1999 and 2003 were available for the analyses. The model included a fixed regression of the body weights on fourth-order orthogonal Legendre polynomials of the actual days on test (7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, and 84) for starting age and contemporary group effects. Random regressions on fourth-order orthogonal Legendre polynomials of the actual days on test were included for additive genetic effects and additional uncorrelated random effects of the weaning-herd-year and the permanent environment of the animal. Residual effects were assumed to be independently distributed with heterogeneous variance for each test day. Variance ratios for additive genetic, permanent environment and weaning-herd-year for weekly body weights at different test days ranged from 0.26 to 0.29, 0.37 to 0.44 and 0.26 to 0.34, respectively. The weaning-herd-year was found to have a significant effect on the variation of body weights of bulls despite a 28-day adjustment period. Genetic correlations amongst body weights at different test days were high, ranging from 0.89 to 1.00. Heritability estimates were comparable to literature using multivariate models. Therefore, random regression model could be applied in the genetic evaluation of body weight of individually fed beef bulls in South Africa.

Internet peer support for individuals with psychiatric disabilities: A randomized controlled trial.

PubMed

Kaplan, Katy; Salzer, Mark S; Solomon, Phyllis; Brusilovskiy, Eugene; Cousounis, Pamela

2011-01-01

Despite the prevalence of Internet support groups for individuals with mental illnesses little is known about the potential benefits, or harm, of participating in such groups. Therefore, this randomized controlled trial sought to determine the impact of unmoderated, unstructured Internet peer support, similar to what is naturally occurring on the Internet, on the well-being of individuals with psychiatric disabilities. Three hundred individuals resident in the USA diagnosed with a Schizophrenia Spectrum or an Affective Disorder were randomized into one of three conditions: experimental Internet peer support via a listserv, experimental Internet peer support via a bulletin board, or a control condition. Three measurement time points, baseline, 4- and 12 months post-baseline, assessed well-being by examining measures of recovery, quality of life, empowerment, social support, and distress. Time × group interactions in the repeated measures ANOVA showed no differences between conditions on the main outcomes. Post-hoc repeated measures ANOVAs found that those individuals who participated more in Internet peer support reported higher levels of distress than those with less or no participation (p = 0.03). Those who reported more positive experiences with the Internet peer support group also reported higher levels of psychological distress than those reporting less positive experiences (p = 0.01). Study results therefore do not support the hypothesis that participation in an unmoderated, unstructured Internet listserv or bulletin board peer support group for individuals with psychiatric disabilities enhances well-being. Counterintuitive findings demonstrating those who report more positive experiences also experienced higher levels of distress are discussed but we also point to the need for additional research. Future research should explore the various structures, formats, and interventions of Internet support, as well as the content and quality of interactions. Knowledge generated from such research can help to inform policies and guidelines for safely navigating online resources and supports to gain maximum benefit. Copyright © 2010 Elsevier Ltd. All rights reserved.

Effort reward imbalance, and salivary cortisol in the morning.

PubMed

Eller, Nanna Hurwitz; Nielsen, Søren Feodor; Blønd, Morten; Nielsen, Martin Lindhardt; Hansen, Åse Marie; Netterstrøm, Bo

2012-02-01

Effort reward imbalance (ERI) is suggested to increase risk for stress and is hypothesized to increase cortisol levels, especially the awakening cortisol response, ACR. In 2006 and 2008, 480 individuals collected saliva samples at awakening and 30 min post-awakening. Mixed effects models with subject as a random effect and appropriate covariates were used to evaluate associations between the Effort Reward Model, and salivary cortisol at awakening (S0), and ACR. ERI was negatively and significantly associated with S0 for women and positively associated with ACR. S0 and ACR increased significantly from 2006 to 2008. ERI was significantly associated with cortisol levels at awakening (inverse association) for women, and positively associated with ACR. The population experienced a significant increase in morning cortisol levels and ACR from 2006 to 2008, which may originate in a re-organization of the included work places. Copyright © 2011 Elsevier B.V. All rights reserved.

How Random Is Social Behaviour? Disentangling Social Complexity through the Study of a Wild House Mouse Population

PubMed Central

Perony, Nicolas; Tessone, Claudio J.; König, Barbara; Schweitzer, Frank

2012-01-01

Out of all the complex phenomena displayed in the behaviour of animal groups, many are thought to be emergent properties of rather simple decisions at the individual level. Some of these phenomena may also be explained by random processes only. Here we investigate to what extent the interaction dynamics of a population of wild house mice (Mus domesticus) in their natural environment can be explained by a simple stochastic model. We first introduce the notion of perceptual landscape, a novel tool used here to describe the utilisation of space by the mouse colony based on the sampling of individuals in discrete locations. We then implement the behavioural assumptions of the perceptual landscape in a multi-agent simulation to verify their accuracy in the reproduction of observed social patterns. We find that many high-level features – with the exception of territoriality – of our behavioural dataset can be accounted for at the population level through the use of this simplified representation. Our findings underline the potential importance of random factors in the apparent complexity of the mice's social structure. These results resonate in the general context of adaptive behaviour versus elementary environmental interactions. PMID:23209394

The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial.

PubMed

Verhees, Martine W F T; Ceulemans, Eva; Bakermans-Kranenburg, Marian J; van IJzendoorn, Marinus H; de Winter, Simon; Bosmans, Guy

2017-07-14

Lack of trust in parental support is a transdiagnostic risk factor for the development of psychological problems throughout the lifespan. Research suggests that children's cognitive attachment representations and related information processing biases could be an important target for interventions aiming to build trust in the parent-child relationship. A paradigm that can alter these biases and increase trust is that of Cognitive Bias Modification (CBM), during which a target processing bias is systematically trained. Trust-related CBM training effects could possibly be enhanced by oxytocin, a neuropeptide that has been proposed to play an important role in social information processing and social relationships. The present article describes the study protocol for a double-blind randomized controlled trial (RCT) aimed at testing the individual and combined effects of CBM training and oxytocin administration on trust in maternal support. One hundred children (aged 8-12 years) are randomly assigned to one of four intervention conditions. Participants inhale a nasal spray that either contains oxytocin (OT) or a placebo. Additionally, they receive either a CBM training aimed at positively modifying trust-related information processing bias or a neutral placebo training aimed to have no trust-related effects. Main and interaction effects of the interventions are assessed on three levels of trust-related outcome measures: trust-related interpretation bias; self-reported trust; and mother-child interactional behavior. Importantly, side-effects of a single administration of OT in middle childhood are monitored closely to provide further information on the safety of OT administration in this age group. The present RCT is the first study to combine CBM training with oxytocin to test for individual and combined effects on trust in mother. If effective, CBM training and oxytocin could be easily applicable and nonintrusive additions to interventions that target trust in the context of the parent-child relationship. ClinicalTrials.gov, ID: NCT02737254 . Registered on 23 March 2016.

Low thyroid function is not associated with an accelerated deterioration in renal function.

PubMed

Meuwese, Christiaan L; van Diepen, Merel; Cappola, Anne R; Sarnak, Mark J; Shlipak, Michael G; Bauer, Douglas C; Fried, Linda P; Iacoviello, Massimo; Vaes, Bert; Degryse, Jean; Khaw, Kay-Tee; Luben, Robert N; Åsvold, Bjørn O; Bjøro, Trine; Vatten, Lars J; de Craen, Anton J M; Trompet, Stella; Iervasi, Giorgio; Molinaro, Sabrina; Ceresini, Graziano; Ferrucci, Luigi; Dullaart, Robin P F; Bakker, Stephan J L; Jukema, J Wouter; Kearney, Patricia M; Stott, David J; Peeters, Robin P; Franco, Oscar H; Völzke, Henry; Walsh, John P; Bremner, Alexandra; Sgarbi, José A; Maciel, Rui M B; Imaizumi, Misa; Ohishi, Waka; Dekker, Friedo W; Rodondi, Nicolas; Gussekloo, Jacobijn; den Elzen, Wendy P J

2018-04-18

Chronic kidney disease (CKD) is frequently accompanied by thyroid hormone dysfunction. It is currently unclear whether these alterations are the cause or consequence of CKD. This study aimed at studying the effect of thyroid hormone alterations on renal function in cross-sectional and longitudinal analyses in individuals from all adult age groups. Individual participant data (IPD) from 16 independent cohorts having measured thyroid stimulating hormone, free thyroxine levels and creatinine levels were included. Thyroid hormone status was defined using clinical cut-off values. Estimated glomerular filtration rates (eGFR) were calculated by means of the four-variable Modification of Diet in Renal Disease (MDRD) formula. For this IPD meta-analysis, eGFR at baseline and eGFR change during follow-up were computed by fitting linear regression models and linear mixed models in each cohort separately. Effect estimates were pooled using random effects models. A total of 72 856 individuals from 16 different cohorts were included. At baseline, individuals with overt hypothyroidism (n = 704) and subclinical hypothyroidism (n = 3356) had a average (95% confidence interval) -4.07 (-6.37 to -1.78) and -2.40 (-3.78 to -1.02) mL/min/1.73 m2 lower eGFR as compared with euthyroid subjects (n = 66 542). In (subclinical) hyperthyroid subjects (n = 2254), average eGFR was 3.01 (1.50-4.52) mL/min/1.73 m2 higher. During 329 713 patient years of follow-up, eGFR did not decline more rapidly in individuals with low thyroid function compared with individuals with normal thyroid function. Low thyroid function is not associated with a deterioration of renal function. The cross-sectional association may be explained by renal dysfunction causing thyroid hormone alterations.

Fitting milk production curves through nonlinear mixed models.

PubMed

Piccardi, Monica; Macchiavelli, Raúl; Funes, Ariel Capitaine; Bó, Gabriel A; Balzarini, Mónica

2017-05-01

The aim of this work was to fit and compare three non-linear models (Wood, Milkbot and diphasic) to model lactation curves from two approaches: with and without cow random effect. Knowing the behaviour of lactation curves is critical for decision-making in a dairy farm. Knowledge of the model of milk production progress along each lactation is necessary not only at the mean population level (dairy farm), but also at individual level (cow-lactation). The fits were made in a group of high production and reproduction dairy farms; in first and third lactations in cool seasons. A total of 2167 complete lactations were involved, of which 984 were first-lactations and the remaining ones, third lactations (19 382 milk yield tests). PROC NLMIXED in SAS was used to make the fits and estimate the model parameters. The diphasic model resulted to be computationally complex and barely practical. Regarding the classical Wood and MilkBot models, although the information criteria suggest the selection of MilkBot, the differences in the estimation of production indicators did not show a significant improvement. The Wood model was found to be a good option for fitting the expected value of lactation curves. Furthermore, the three models fitted better when the subject (cow) random effect was considered, which is related to magnitude of production. The random effect improved the predictive potential of the models, but it did not have a significant effect on the production indicators derived from the lactation curves, such as milk yield and days in milk to peak.

Group engagement in persons with dementia: The concept and its measurement.

PubMed

Cohen-Mansfield, Jiska; Hai, Tasmia; Comishen, Michael

2017-05-01

Although a few papers documented benefits of group therapeutic activities for individuals with dementia, there is a dearth of studies that have investigated the effects of group activities on persons with dementia. This paper introduces a theoretical framework of studying group therapeutic recreational activity, the Comprehensive Process Model of Group Engagement, and an assessment tool, the Group Observational Measurement of Engagement (GOME). We also report the psychometric properties of this assessment. One hundred and four persons with dementia took part in ten different group activities, with each activity conducted twice at random order so that 20 activities were observed for each group of participants. Following each group activity, research and therapeutic recreation staff members used the GOME assessment to independently rate participants on individual-level measures of attendance duration and engagement, and group level measures (e.g., positive and negative interactions among group members). Reliability and validity analyses comparing observer ratings for each group activity on the individual-level measures of attendance and engagement showed good psychometric properties. Different measures collected on a group level differed with respect to their psychometric quality. We present a theoretical framework to understand group engagement and present measures that could be used in future research and practice. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The Effect of Acclydine in Chronic Fatigue Syndrome: A Randomized Controlled Trial

PubMed Central

The, Gerard K. H; Bleijenberg, Gijs; van der Meer, Jos W. M

2007-01-01

Objectives: It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio). Design: A randomized, placebo-controlled, double-blind clinical trial. Setting: Radboud University Nijmegen Medical Centre, The Netherlands. Participants: Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals. Intervention: Acclydine or placebo for 14 wk. Outcome measures: Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis. Results: There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI −4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI −201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio −0.5 (95% CI −2.8 to +1.7, p = 0.63). Conclusion: We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS. PMID:17525791

The hypocholesterolemic effect of an antacid containing aluminum hydroxide.

PubMed

Sperber, A D; Henkin, Y; Zuili, I; Bearman, J E; Shany, S

1991-12-01

To evaluate the efficacy, safety, and hypocholesterolemic effect of an aluminum hydroxide-containing antacid in hypercholesterolemic individuals. A prospective, randomized, double-masked, placebo-controlled phase of 2 months' duration, followed by an open-design treatment phase of 2 months' duration and a washout phase of 2 months' duration. Family practice clinics of two rural communities (kibbutzim) in Israel. Fifty-six men and women with hypercholesterolemia (type IIa or IIb). Fifty individuals completed the study. After 2 months of dietary modification (low-fat, low-cholesterol diet), the participants were randomized into two matched groups. Group 1 (28 participants) was treated for 2 months with a chewable antacid tablet containing simethicone, magnesium hydroxide, and 113 mg of aluminum hydroxide per tablet, at a dose of two tablets four times daily. Group 2 (22 participants) was given a similar number of placebo tablets for 2 months. During the following 2 months, both groups received the antacid at the above dose. Lipoprotein levels were evaluated at baseline and every 2 months thereafter for 6 months. Compared with pretreatment levels, Group 1 experienced a decrease in low-density lipoprotein cholesterol (LDL-C) of 9.8% after 2 months (p less than 0.001) and 18.5% after 4 months (p less than 0.001). Compared with Group 2, the decrease in LDL-C in Group 1 was 6.2% at the end of the 2-month double-masked, placebo phase. Although the high-density lipoprotein cholesterol (HDL-C) was also reduced in Group 1 at the end of 4 months of therapy (10.2%), the HDL-C/LDL-C ratio increased by 13% during the same interval (p less than 0.05). The treatment was well tolerated, with minimal side effects. An aluminum hydroxide-containing antacid reduces LDL-C in hypercholesterolemic individuals. Although HDL-C was also reduced to a lesser extent, the overall atherogenic index was improved. Further studies should be conducted to evaluate the long-term safety and efficacy of antacids containing aluminum hydroxide in hypercholesterolemic patients.

The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial.

PubMed

The, Gerard K H; Bleijenberg, Gijs; van der Meer, Jos W M

2007-05-18

It is unclear whether insulin-like growth factor (IGF) function is involved in the pathophysiology of chronic fatigue syndrome (CFS). Unpublished data and reports in patient organization newsletters suggest that Acclydine, a food supplement, could be effective in the treatment of CFS by increasing biologically active IGF1 levels. Here we aimed to measure the IGF1 and IGF binding protein (IGFBP) 3 status of CFS patients compared to age- and gender-matched neighborhood controls, and to assess the effect of Acclydine on fatigue severity, functional impairment, and biologically active IGF1 level (IGFBP3/IGF1 ratio). A randomized, placebo-controlled, double-blind clinical trial. Radboud University Nijmegen Medical Centre, The Netherlands. Fifty-seven adult patients who fulfilled the US Centers for Disease Control and Prevention criteria for CFS. IGF status of 22 CFS patients was compared to that of 22 healthy age- and gender-matched neighborhood control individuals. Acclydine or placebo for 14 wk. Outcomes were fatigue severity (Checklist Individual Strength, subscale fatigue severity [CIS-fatigue]), functional impairment (Sickness Impact Profile-8 [SIP-8]), and biologically active IGF1 serum concentrations. Analyses were on an intention-to-treat basis. There was no difference in IGF status in 22 CFS patients compared to healthy age- and gender-matched control individuals. Treatment with Acclydine did not result in significant differences compared with the placebo group on any of the outcome measures: CIS-fatigue +1.1 (95% CI -4.4 to +6.5, p = 0.70), SIP-8 +59.1 (95% CI -201.7 to +319.8, p = 0.65), and IGFBP3/IGF1 ratio -0.5 (95% CI -2.8 to +1.7, p = 0.63). We found no differences in IGF1 status in CFS patients compared to healthy matched neighborhood controls. In addition, the results of this clinical trial do not demonstrate any benefit of Acclydine over placebo in the treatment of CFS.

A dynamic spatio-temporal model for spatial data

USGS Publications Warehouse

Hefley, Trevor J.; Hooten, Mevin B.; Hanks, Ephraim M.; Russell, Robin; Walsh, Daniel P.

2017-01-01

Analyzing spatial data often requires modeling dependencies created by a dynamic spatio-temporal data generating process. In many applications, a generalized linear mixed model (GLMM) is used with a random effect to account for spatial dependence and to provide optimal spatial predictions. Location-specific covariates are often included as fixed effects in a GLMM and may be collinear with the spatial random effect, which can negatively affect inference. We propose a dynamic approach to account for spatial dependence that incorporates scientific knowledge of the spatio-temporal data generating process. Our approach relies on a dynamic spatio-temporal model that explicitly incorporates location-specific covariates. We illustrate our approach with a spatially varying ecological diffusion model implemented using a computationally efficient homogenization technique. We apply our model to understand individual-level and location-specific risk factors associated with chronic wasting disease in white-tailed deer from Wisconsin, USA and estimate the location the disease was first introduced. We compare our approach to several existing methods that are commonly used in spatial statistics. Our spatio-temporal approach resulted in a higher predictive accuracy when compared to methods based on optimal spatial prediction, obviated confounding among the spatially indexed covariates and the spatial random effect, and provided additional information that will be important for containing disease outbreaks.

Determining the effectiveness of the third person interview in the level of insight psychotic patients.

PubMed

Mehdizadeh, Mahsa; Rezaei, Omid; Dolatshahi, Behrouz

2016-11-30

The goal of this study was to determine the effectiveness of the third person interview in increasing the level of insight and cooperation in psychotic patients. We used a quasi-experimental posttest design with an alternative method group. A number of 40 individuals with a definite diagnosis of psychosis were selected using a simple random sampling, and were put randomly in an experimental group (third person interview) and an alternative control group (clinical interview). The results indicated that using the third person interview, the insight level of the psychotic patients increased in all dimensions of insight, except awareness of flat or blunted affect and awareness of unsociability. The results of the independent t-test samples showed no significant difference in cooperation between the two groups of psychotic patients. It seems that the ability to consider one's mental viewpoint from other's, is dependent on the relative ability of psychotic patients to represent other's mental states (theory of mind). But, psychotic patients have severe impairment in the ability to represent their own mental states, resulting in an impairment in the recognition of their mental disorder, psychotic symptoms, the need for therapy, and social consequences of their mental disorder. Copyright © 2016. Published by Elsevier Ireland Ltd.

Manual physical therapy and exercise versus supervised home exercise in the management of patients with inversion ankle sprain: a multicenter randomized clinical trial.

PubMed

Cleland, Joshua A; Mintken, Paul E; McDevitt, Amy; Bieniek, Melanie L; Carpenter, Kristin J; Kulp, Katherine; Whitman, Julie M

2013-01-01

Randomized clinical trial. To compare the effectiveness of manual therapy and exercise (MTEX) to a home exercise program (HEP) in the management of individuals with an inversion ankle sprain. An in-clinic exercise program has been found to yield similar outcomes as an HEP for individuals with an inversion ankle sprain. However, no studies have compared an MTEX approach to an HEP. Patients with an inversion ankle sprain completed the Foot and Ankle Ability Measure (FAAM) activities of daily living subscale, the FAAM sports subscale, the Lower Extremity Functional Scale, and the numeric pain rating scale. Patients were randomly assigned to either an MTEX or an HEP treatment group. Outcomes were collected at baseline, 4 weeks, and 6 months. The primary aim (effects of treatment on pain and disability) was examined with a mixed-model analysis of variance. The hypothesis of interest was the 2-way interaction (group by time). Seventy-four patients (mean ± SD age, 35.1 ± 11.0 years; 48.6% female) were randomized into the MTEX group (n = 37) or the HEP group (n = 37). The overall group-by-time interaction for the mixed-model analysis of variance was statistically significant for the FAAM activities of daily living subscale (P<.001), FAAM sports subscale (P<.001), Lower Extremity Functional Scale (P<.001), and pain (P ≤.001). Improvements in all functional outcome measures and pain were significantly greater at both the 4-week and 6-month follow-up periods in favor of the MTEX group. The results suggest that an MTEX approach is superior to an HEP in the treatment of inversion ankle sprains. Registered at clinicaltrials.gov (NCT00797368). Therapy, level 1b-.

ADVANCE--Action in Diabetes and Vascular Disease: patient recruitment and characteristics of the study population at baseline.

PubMed

2005-07-01

The primary aim of ADVANCE is to determine the effects on macrovascular and microvascular disease of blood pressure lowering (with an ACE inhibitor-diuretic combination), irrespective of initial blood pressure level; and of intensive glucose lowering, in high-risk individuals with Type 2 diabetes. The study is a 2 x 2 factorial randomized controlled trial. Following 6 weeks on active perindopril-indapamide combination, eligible participants were randomized to perindopril/indapamide (initially 2.0/0.625 mg daily, increasing to 4.0/1.25 mg daily after 3 months) or matching placebo; and to an intensive gliclazide MR-based glucose control regimen aiming for a haemoglobin A1c (HbA1c) value of 6.5% or lower, or local standard therapy. The study is being conducted in 215 centres in 20 countries within Australasia, Asia, Europe and North America. Recruitment commenced in June 2001 and was completed in March 2003, with the inclusion of 11,140 randomized participants. Fifty-seven per cent of participants are male and the mean age at baseline was 66 years. On average, the diagnosis of diabetes was made 8 years before study entry. At baseline 32 and 10% of patients had a history of macrovascular and microvascular disease, respectively. The mean blood pressure at baseline was 145/81 mmHg; the mean HbA1c concentration was 7.5%. While blood pressure and HbA1c values were broadly similar, certain characteristics of randomized participants varied between countries. With successful worldwide recruitment completed, ADVANCE should provide reliable and broadly generalizable results on the effects of routine blood pressure lowering and intensive glucose control in high-risk individuals with Type 2 diabetes.

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

PubMed

Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

2016-04-27

Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

A randomized controlled trial of physical activity with individual goal-setting and volunteer mentors to overcome sedentary lifestyle in older adults at risk of cognitive decline: the INDIGO trial protocol.

PubMed

Cox, Kay L; Cyarto, Elizabeth V; Etherton-Beer, Christopher; Ellis, Kathryn A; Alfonso, Helman; Clare, Linda; Liew, Danny; Ames, David; Flicker, Leon; Almeida, Osvaldo P; LoGiudice, Dina; Lautenschlager, Nicola T

2017-09-13

Increasing physical activity (PA) effectively in those who are inactive is challenging. For those who have subjective memory complaints (SMC) or mild cognitive impairment (MCI) this is a greater challenge necessitating the need for more engaging and innovative approaches. The primary aim of this trial is to determine whether a home-based 6-month PA intervention with individual goal-setting and peer mentors (GM-PA) can significantly increase PA levels in insufficiently active older adults at increased risk of developing Alzheimer's disease (AD). Community living 60-80 year olds with SMC or MCI who do not engage in more than 60 min per week of moderate intensity PA will be recruited from memory clinics and the community via media advertisements to participate in this randomized, single-blind controlled trial. All participants will receive an individually tailored home-based PA program of 150 min of moderate intensity walking/week for 6 months. The intervention group will undertake individual goal-setting and behavioral education workshops with mentor support via telephone (GM-PA). Those randomized to the control group will have standard education workshops and Physical Activity Liaison (PAL) contact via telephone (CO-PA). Increase in PA is the primary outcome, fitness, cognitive, personality, demographic and clinical parameters will be measured and a health economic analysis performed. A saliva sample will be collected for APOE e4 genotyping. All participants will have a goal-setting interview to determine their PA goals. Active volunteers aged 50-85 years will be recruited from the community randomized and trained to provide peer support as mentors (intervention group) or PALS (control group) for the 6-month intervention. Mentors and PALS will have PA, exercise self-efficacy and mentoring self-efficacy measured. Participants in both groups are asked to attend 3 workshops in 6 months. At the first workshop, they will meet their allocated Mentor or PAL who will deliver their respective programs and support via 6 telephone calls during the intervention. If the GM-PA program is successful in increasing the PA levels of the target group it will potentially provide another strategy and community resource that can be translated into practice. Australia New Zealand Clinical Trials Registry ACTRN12613001181796 . (29/10/2013) retrospectively registered.

Immediate effects of Pilates based therapeutic exercise on postural control of young individuals with non-specific low back pain: A randomized controlled trial.

PubMed

Lopes, Susana; Correia, Christophe; Félix, Gonçalo; Lopes, Mário; Cruz, Ana; Ribeiro, Fernando

2017-10-01

Low back pain affects the person's ability to keep balance, especially in challenging conditions. The purpose of this study was to determine the immediate effects of Pilates exercises on postural sway and dynamic balance of young individuals with non-specific low back pain. Controlled laboratory design. Forty-six participants with non-specific low back pain were randomized to a Pilates (n=23, 10 males; age: 21.8±3.2years) and a control group (n=23, 9 males; age: 22.8±3.6years). Postural sway was assessed with a force platform and dynamic balance with the Star Excursion Balance Test, before and after the intervention or rest period. To assess postural sway, participants stood still on an unstable surface set on the force plate for 90s, with eyes closed. The intervention lasted 20min and consisted on four Pilates exercises: single leg stretch (level 1), pelvic press (level 1), swimming (level 1) and kneeling opposite arm and leg reach. At baseline, no differences were found between groups. The Pilates group improved in all the postural sway values (area of CoP: 11.5±3.4 to 9.7±2.7cm 2 , p=0.002 and CoP velocity: 2.8±0.6 to 2.3±0.5cm/s, p<0.001) and in the Star Excursion Balance Test. Control group only improved in CoP velocity, however, this improvement was significantly inferior compared to the Pilates group. Pilates exercises immediately improved postural sway and dynamic balance in young adults with non-specific low back pain. Copyright © 2017 Elsevier Ltd. All rights reserved.

Tocotrienol rich fraction supplementation improved lipid profile and oxidative status in healthy older adults: A randomized controlled study

PubMed Central

2011-01-01

Background Vitamin E supplements containing tocotrienols are now being recommended for optimum health but its effects are scarcely known. The objective was to determine the effects of Tocotrienol Rich Fraction (TRF) supplementation on lipid profile and oxidative status in healthy older individuals at a dose of 160 mg/day for 6 months. Methods Sixty-two subjects were recruited from two age groups: 35-49 years (n = 31) and above 50 years (n = 31), and randomly assigned to receive either TRF or placebo capsules for six months. Blood samples were obtained at 0, 3rd and 6th months. Results HDL-cholesterol in the TRF-supplemented group was elevated after 6 months (p < 0.01). Protein carbonyl contents were markedly decreased (p < 0.001), whereas AGE levels were lowered in the > 50 year-old group (p < 0.05). Plasma levels of total vitamin E particularly tocopherols were significantly increased in the TRF-supplemented group after 3 months (p < 0.01). Plasma total tocotrienols were only increased in the > 50 year-old group after receiving 6 months of TRF supplementation. Changes in enzyme activities were only observed in the > 50 year-old group. SOD activity was decreased after 3 (p < 0.05) and 6 (p < 0.05) months of TRF supplementation whereas CAT activity was decreased after 3 (p < 0.01) and 6 (p < 0.05) months in the placebo group. GPx activity was increased at 6 months for both treatment and placebo groups (p < 0.05). Conclusion The observed improvement of plasma cholesterol, AGE and antioxidant vitamin levels as well as the reduced protein damage may indicate a restoration of redox balance after TRF supplementation, particularly in individuals over 50 years of age. PMID:21702918

Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial.

PubMed

Ferrando, Carlos; Suarez-Sipmann, Fernando; Tusman, Gerardo; León, Irene; Romero, Esther; Gracia, Estefania; Mugarra, Ana; Arocas, Blanca; Pozo, Natividad; Soro, Marina; Belda, Francisco J

2017-01-01

Low tidal volume (VT) during anesthesia minimizes lung injury but may be associated to a decrease in functional lung volume impairing lung mechanics and efficiency. Lung recruitment (RM) can restore lung volume but this may critically depend on the post-RM selected PEEP. This study was a randomized, two parallel arm, open study whose primary outcome was to compare the effects on driving pressure of adding a RM to low-VT ventilation, with or without an individualized post-RM PEEP in patients without known previous lung disease during anesthesia. Consecutive patients scheduled for major abdominal surgery were submitted to low-VT ventilation (6 ml·kg-1) and standard PEEP of 5 cmH2O (pre-RM, n = 36). After 30 min estabilization all patients received a RM and were randomly allocated to either continue with the same PEEP (RM-5 group, n = 18) or to an individualized open-lung PEEP (OL-PEEP) (Open Lung Approach, OLA group, n = 18) defined as the level resulting in maximal Cdyn during a decremental PEEP trial. We compared the effects on driving pressure and lung efficiency measured by volumetric capnography. OL-PEEP was found at 8±2 cmH2O. 36 patients were included in the final analysis. When compared with pre-RM, OLA resulted in a 22% increase in compliance and a 28% decrease in driving pressure when compared to pre-RM. These parameters did not improve in the RM-5. The trend of the DP was significantly different between the OLA and RM-5 groups (p = 0.002). VDalv/VTalv was significantly lower in the OLA group after the RM (p = 0.035). Lung recruitment applied during low-VT ventilation improves driving pressure and lung efficiency only when applied as an open-lung strategy with an individualized PEEP in patients without lung diseases undergoing major abdominal surgery. ClinicalTrials.gov NCT02798133.

Social aggregation in pea aphids: experiment and random walk modeling.

PubMed

Nilsen, Christa; Paige, John; Warner, Olivia; Mayhew, Benjamin; Sutley, Ryan; Lam, Matthew; Bernoff, Andrew J; Topaz, Chad M

2013-01-01

From bird flocks to fish schools and ungulate herds to insect swarms, social biological aggregations are found across the natural world. An ongoing challenge in the mathematical modeling of aggregations is to strengthen the connection between models and biological data by quantifying the rules that individuals follow. We model aggregation of the pea aphid, Acyrthosiphon pisum. Specifically, we conduct experiments to track the motion of aphids walking in a featureless circular arena in order to deduce individual-level rules. We observe that each aphid transitions stochastically between a moving and a stationary state. Moving aphids follow a correlated random walk. The probabilities of motion state transitions, as well as the random walk parameters, depend strongly on distance to an aphid's nearest neighbor. For large nearest neighbor distances, when an aphid is essentially isolated, its motion is ballistic with aphids moving faster, turning less, and being less likely to stop. In contrast, for short nearest neighbor distances, aphids move more slowly, turn more, and are more likely to become stationary; this behavior constitutes an aggregation mechanism. From the experimental data, we estimate the state transition probabilities and correlated random walk parameters as a function of nearest neighbor distance. With the individual-level model established, we assess whether it reproduces the macroscopic patterns of movement at the group level. To do so, we consider three distributions, namely distance to nearest neighbor, angle to nearest neighbor, and percentage of population moving at any given time. For each of these three distributions, we compare our experimental data to the output of numerical simulations of our nearest neighbor model, and of a control model in which aphids do not interact socially. Our stochastic, social nearest neighbor model reproduces salient features of the experimental data that are not captured by the control.

The association of personality traits and coping styles according to stress level

PubMed Central

Afshar, Hamid; Roohafza, Hamid Reza; Keshteli, Ammar Hassanzadeh; Mazaheri, Mina; Feizi, Awat; Adibi, Peyman

2015-01-01

Background: Some personality traits and coping styles could be as risk factors in stressful situations. This study aimed to investigate the association of personality traits and coping styles according to the stress level. Meterials and Methods: This cross-sectional study was performed in 2011. A total of 4628 individuals over 20 years were selected by random sampling from nonacademic employees that working in 50 different centers across Isfahan province. Data were collected using 12-item General Health Questionnaire (GHQ-12), Big Five Personality Inventory Short Form and coping strategies scale, and individuals were divided into high and low-stress groups in term of GHQ-12. To analyze the data, a binary logistic regression analysis was conducted. Results: Mean age of participants was 36.3 ± 7.91 years and 56.26% (2604) of them were female. Neuroticism with adjusting covariates of demographic characteristics and the rest of personality traits was a risk factor for stress level with odds ratios (OR) OR:1.24; but other personality traits were protective. Also, active coping styles were protective factors for OR of stress level with adjusting covariates of demographic characteristics and the rest of coping styles, and positive reinterpretation and growth was the most effective of coping style with OR:0.84. Conclusion: Some personality traits are associated with passive copings and cause high-stress level. So, it could be concluded that improve and strengthen effective coping strategies in individual with maladaptive traits should be considered as a crucial component of prevention and control programs of stress. PMID:26109990

Food security among individuals experiencing homelessness and mental illness in the At Home/Chez Soi Trial.

PubMed

O'Campo, Patricia; Hwang, Stephen W; Gozdzik, Agnes; Schuler, Andrée; Kaufman-Shriqui, Vered; Poremski, Daniel; Lazgare, Luis Ivan Palma; Distasio, Jino; Belbraouet, Slimane; Addorisio, Sindi

2017-08-01

Individuals experiencing homelessness are particularly vulnerable to food insecurity. The At Home/Chez Soi study provides a unique opportunity to first examine baseline levels of food security among homeless individuals with mental illness and second to evaluate the effect of a Housing First (HF) intervention on food security in this population. At Home/Chez Soi was a 2-year randomized controlled trial comparing the effectiveness of HF compared with usual care among homeless adults with mental illness, stratified by level of need for mental health services (high or moderate). Logistic regressions tested baseline associations between food security (US Food Security Survey Module), study site, sociodemographic variables, duration of homelessness, alcohol/substance use, physical health and service utilization. Negative binomial regression determined the impact of the HF intervention on achieving levels of high or marginal food security over an 18-month follow-up period (6 to 24 months). Community settings at five Canadian sites (Moncton, Montreal, Toronto, Winnipeg and Vancouver). Homeless adults with mental illness (n 2148). Approximately 41 % of our sample reported high or marginal food security at baseline, but this figure varied with gender, age, mental health issues and substance use problems. High need participants who received HF were more likely to achieve marginal or high food security than those receiving usual care, but only at the Toronto and Moncton sites. Our large multi-site study demonstrated low levels of food security among homeless experiencing mental illness. HF showed promise for improving food security among participants with high levels of need for mental health services, with notable site differences.

Immediate changes in widespread pressure pain sensitivity, neck pain, and cervical range of motion after cervical or thoracic thrust manipulation in patients with bilateral chronic mechanical neck pain: a randomized clinical trial.

PubMed

Martínez-Segura, Raquel; De-la-Llave-Rincón, Ana I; Ortega-Santiago, Ricardo; Cleland, Joshua A; Fernández-de-Las-Peñas, César

2012-09-01

Randomized clinical trial. To compare the effects of cervical versus thoracic thrust manipulation in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity, neck pain, and cervical range of motion (CROM). Evidence suggests that spinal interventions can stimulate descending inhibitory pain pathways. To our knowledge, no study has investigated the neurophysiological effects of thoracic thrust manipulation in individuals with bilateral chronic mechanical neck pain, including widespread changes on pressure sensitivity. Ninety patients (51% female) were randomly assigned to 1 of 3 groups: cervical thrust manipulation on the right, cervical thrust manipulation on the left, or thoracic thrust manipulation. Pressure pain thresholds (PPTs) over the C5-6 zygapophyseal joint, lateral epicondyle, and tibialis anterior muscle, neck pain (11-point numeric pain rating scale), and cervical spine range of motion (CROM) were collected at baseline and 10 minutes after the intervention by an assessor blinded to the treatment allocation of the patients. Mixed-model analyses of covariance were used to examine the effects of the treatment on each outcome variable, with group as the between-subjects variable, time and side as the within-subject variables, and gender as the covariate. The primary analysis was the group-by-time interaction. No significant interactions were found with the mixed-model analyses of covariance for PPT level (C5-6, P>.210; lateral epicondyle, P>.186; tibialis anterior muscle, P>.268), neck pain intensity (P = .923), or CROM (flexion, P = .700; extension, P = .387; lateral flexion, P>.672; rotation, P>.192) as dependent variables. All groups exhibited similar changes in PPT, neck pain, and CROM (all, P<.001). Gender did not influence the main effects or the interaction effects in the analyses of the outcomes (P>.10). The results of the current randomized clinical trial suggest that cervical and thoracic thrust manipulation induce similar changes in PPT, neck pain intensity, and CROM in individuals with bilateral chronic mechanical neck pain. However, changes in PPT and CROM were small and did not surpass their respective minimal detectable change values. Further, because we did not include a control group, we cannot rule out a placebo effect of the thrust interventions on the outcomes. Therapy, level 1b.J Orthop Sports Phys Ther 2012;42(9):806-814, Epub 18 June 2012. doi:10.2519/jospt.2012.4151.

Income Levels and Response to Contingency Management for Smoking Cessation.

PubMed

López-Núñez, Carla; Secades-Villa, Roberto; Peña-Suárez, Elsa; Fernández-Artamendi, Sergio; Weidberg, Sara

2017-06-07

Contingency management (CM) has demonstrated its efficacy in treating many drug addictions, including nicotine. However, one of the most commonly perceived limitations with regard to its dissemination into community settings is whether this protocol could be equally effective for treating patients across different income levels. This study aimed to examine whether individuals' income levels affect treatment success in a cognitive behavioral treatment (CBT) that included a voucher-based CM protocol for smoking cessation. A total of 92 treatment-seeking smokers in a community setting were randomly assigned to a CBT group (N = 49) or to a CBT plus CM group (N = 43). The CM procedure included a voucher program through which smoking abstinence was reinforced on a schedule of escalating magnitude of reinforcement with a reset contingency. We analyzed the impact of self-reported monthly income, alone and in combination with treatment condition, on short-term (treatment retention) and long-term (self-reported number of days of continuous smoking abstinence at 6-month follow-up) results. Income had no effect on treatment retention and continuous abstinence outcomes at 6-month follow-up in either treatment condition. Treatment modality emerged as the only significant predictor of treatment success. Our findings suggest that treatment-seeking smokers from the general population respond equally well to CM regardless of their income levels. The results of this randomized controlled trial support the generalizability of this evidenced-based program into community settings.

Simvastatin Treatment Does Not Affect Serum Vitamin D Concentrations in Patients with Dyslipidemia: A Randomized Double-blind Placebo-controlled Cross-over Trial.

PubMed

Mazidi, Mohsen; Rokni, Haleh; Sahebkar, Amir Hossein; Mohammadi, Akram; Ghayour-Mobarhan, Majid; Ferns, Gordon A

2016-01-01

Hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) are antihyperlipidemic drugs with an established efficacy in stabilizing atherosclerotic plaques and preventing atherogenesis and reducing cardiovascular events. The purpose of this study was to determine the effect of simvastatin on serum Vitamin D status in dyslipidemic patients as Vitamin D status has an impact on monocyte/macrophage function and may also contribute to cardiovascular risk. Selected individuals (n = 102) were treated with simvastatin (40 mg/day), or matching placebo in a randomized, double-blind, placebo-controlled, crossover trial. Each treatment period (with simvastatin or placebo) lasted for 30 days and was separated by a 2-week washout phase. Serum Vitamin D concentration was assessed pre- and post-treatment. Seventy-seven completed the trial, noncompliance with the study protocol and drug intolerance or relocation were the causes for drop-out. No significant carry-over effect was observed for the assessed parameters. There was a reduction in the serum levels of low-density lipoprotein cholesterol (P < 0.001), total cholesterol (P < 0.001), and triglycerides (P < 0.05). Nevertheless, simvastatin therapy did not significantly affect serum level of high-density lipoprotein cholesterol and Vitamin D level (P > 0.05). Short-term treatment with simvastatin (40 mg/day) does not have a significant affect on serum levels of Vitamin D.

Effects of stigma-reducing conditions on intention to seek psychological help among Korean college students with anxious-ambivalent attachment.

PubMed

Nam, Suk Kyung; Choi, Seong In; Lee, Sang Min

2015-05-01

This study aimed to examine whether stigma-reducing conditions (i.e., random assignment of participants to hypothetical scenarios with varying levels of stigma) effectively increase intention to seek help for Korean college students with anxious-ambivalent attachment style, depending on previous counseling experience. Three hundred thirty Korean college students participated and were randomly assigned to either a low or a high stigma-reducing manipulative condition group. Each group was provided with three possible strategies to reduce stigma: the location of a counseling center, contact with a mental health patient, and the media portrayal of mental illness. In the high-stigma group, the strategies were described in a way that was highly stigmatizing. In the other group, the 3 strategies were created in a way that was not as stigmatizing. In order to examine the effect of stigma-reducing scenarios through the conditions, participants were also instructed to remember a previous or current stressful situation before responding to the questionnaire. The results of multivariate analysis of variance showed a 3-way interaction effect (i.e., level of stigma based on stigma manipulative condition, level of attachment anxiety, and previous counseling experience) on the intentions score when the "contact" and the "media" strategies were applied. The results indicated that individuals who have a higher level of attachment anxiety and a previous experience of counseling were more sensitive to the stigma-reducing manipulative condition. These results highlight the importance of the "contact" and "media" strategies in reducing stigma of seeking counseling for mental health services. (c) 2015 APA, all rights reserved).

The Neighbourhood Effects on Health and Well-being (NEHW) study.

PubMed

O'Campo, Patricia; Wheaton, Blair; Nisenbaum, Rosane; Glazier, Richard H; Dunn, James R; Chambers, Catharine

2015-01-01

Many cross-sectional studies of neighbourhood effects on health do not employ strong study design elements. The Neighbourhood Effects on Health and Well-being (NEHW) study, a random sample of 2412 English-speaking Toronto residents (age 25-64), utilises strong design features for sampling neighbourhoods and individuals, characterising neighbourhoods using a variety of data sources, measuring a wide range of health outcomes, and for analysing cross-level interactions. We describe here methodological issues that shaped the design and analysis features of the NEHW study to ensure that, while a cross-sectional sample, it will advance the quality of evidence emerging from observational studies. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial.

PubMed

Herpich, Carolina Marciela; Leal-Junior, Ernesto Cesar Pinto; Amaral, Ana Paula; Tosato, Juliana de Paiva; Glória, Igor Phillip dos Santos; Garcia, Marília Barbosa Santos; Barbosa, Bruno Roberto Borges; El Hage, Yasmin; Arruda, Éric Edmur Camargo; Gomes, Cid Ándre Fidelis de Paula; Rodrigues, Monique Sampaio; de Sousa, Dowglas Fernando Magalhães; de Carvalho, Paulo de Tarso Camillo; Bussadori, Sandra Kalil; Gonzalez, Tabajara de Oliveira; Politti, Fabiano; Biasotto-Gonzalez, Daniela Aparecida

2014-12-16

According to the International Association for the Study of Pain (IASP), the term temporomandibular disorder (TMD) regards a subgroup of orofacial pain, the symptoms of which include pain or discomfort in the temporomandibular joint, ears, masticatory muscles and neck on one or both sides, as well as joint sounds, limited mandibular movements or mandibular deviation and difficulties chewing. Phototherapy, such as low-level laser therapy (LLLT) and light-emitting diode (LED) therapy, is one of the resources used to treatment muscle pain. Thus, there is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (LLLT and LED) in the same apparatus. The aim of the proposed study is to evaluate the effects of four different doses of phototherapy on pain, activity of the masticatory muscles (masseter and bilateral anterior temporal) and joint mobility in individuals with temporomandibular disorder. A further aim is to determine the cumulative effect 24 and 48 hours after a single session. A placebo-controlled, double-blind, randomized, clinical trial will be carried out involving 72 women between 18 and 40 years of age with a diagnosis of myogenous TMD. The participants will then be randomly allocated to four groups totaling 18 individuals per group. Three groups will be submitted to a single session of phototherapy with different light sources, and one group will receive placebo therapy: Group A (2.62 Joules); Group B (5.24 Joules); Group C (7.86 Joules); and Group D (0 Joules). The following assessment tools will be administered on four separate occasions (baseline and immediately after, 24 h after and 48 h after phototherapy). Pain intensity will be assessed using the visual analog scale for pain, while pain thresholds will be determined using algometer, and electromyographic (EMG) analysis on the masseter and anterior temporal muscles. The study will contribute to the practice of the evidence-based use of phototherapy in individuals with a myogenous TMD. Data will be published after the study is completed. This study is registered with the Brazilian Registry of Clinical Trials, NCT02018770, date of registration: 7 December 2013.

Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society

PubMed Central

Shinnar, Shlomo; Gloss, David; Alldredge, Brian; Arya, Ravindra; Bainbridge, Jacquelyn; Bare, Mary; Bleck, Thomas; Dodson, W. Edwin; Garrity, Lisa; Jagoda, Andy; Lowenstein, Daniel; Pellock, John; Riviello, James; Sloan, Edward; Treiman, David M.

2016-01-01

CONTEXT: The optimal pharmacologic treatment for early convulsive status epilepticus is unclear. OBJECTIVE: To analyze efficacy, tolerability and safety data for anticonvulsant treatment of children and adults with convulsive status epilepticus and use this analysis to develop an evidence-based treatment algorithm. DATA SOURCES: Structured literature review using MEDLINE, Embase, Current Contents, and Cochrane library supplemented with article reference lists. STUDY SELECTION: Randomized controlled trials of anticonvulsant treatment for seizures lasting longer than 5 minutes. DATA EXTRACTION: Individual studies were rated using predefined criteria and these results were used to form recommendations, conclusions, and an evidence-based treatment algorithm. RESULTS: A total of 38 randomized controlled trials were identified, rated and contributed to the assessment. Only four trials were considered to have class I evidence of efficacy. Two studies were rated as class II and the remaining 32 were judged to have class III evidence. In adults with convulsive status epilepticus, intramuscular midazolam, intravenous lorazepam, intravenous diazepam and intravenous phenobarbital are established as efficacious as initial therapy (Level A). Intramuscular midazolam has superior effectiveness compared to intravenous lorazepam in adults with convulsive status epilepticus without established intravenous access (Level A). In children, intravenous lorazepam and intravenous diazepam are established as efficacious at stopping seizures lasting at least 5 minutes (Level A) while rectal diazepam, intramuscular midazolam, intranasal midazolam, and buccal midazolam are probably effective (Level B). No significant difference in effectiveness has been demonstrated between intravenous lorazepam and intravenous diazepam in adults or children with convulsive status epilepticus (Level A). Respiratory and cardiac symptoms are the most commonly encountered treatment-emergent adverse events associated with intravenous anticonvulsant drug administration in adults with convulsive status epilepticus (Level A). The rate of respiratory depression in patients with convulsive status epilepticus treated with benzodiazepines is lower than in patients with convulsive status epilepticus treated with placebo indicating that respiratory problems are an important consequence of untreated convulsive status epilepticus (Level A). When both are available, fosphenytoin is preferred over phenytoin based on tolerability but phenytoin is an acceptable alternative (Level A). In adults, compared to the first therapy, the second therapy is less effective while the third therapy is substantially less effective (Level A). In children, the second therapy appears less effective and there are no data about third therapy efficacy (Level C). The evidence was synthesized into a treatment algorithm. CONCLUSIONS: Despite the paucity of well-designed randomized controlled trials, practical conclusions and an integrated treatment algorithm for the treatment of convulsive status epilepticus across the age spectrum (infants through adults) can be constructed. Multicenter, multinational efforts are needed to design, conduct and analyze additional randomized controlled trials that can answer the many outstanding clinically relevant questions identified in this guideline. PMID:26900382

Benchmarking dairy herd health status using routinely recorded herd summary data.

PubMed

Parker Gaddis, K L; Cole, J B; Clay, J S; Maltecca, C

2016-02-01

Genetic improvement of dairy cattle health through the use of producer-recorded data has been determined to be feasible. Low estimated heritabilities indicate that genetic progress will be slow. Variation observed in lowly heritable traits can largely be attributed to nongenetic factors, such as the environment. More rapid improvement of dairy cattle health may be attainable if herd health programs incorporate environmental and managerial aspects. More than 1,100 herd characteristics are regularly recorded on farm test-days. We combined these data with producer-recorded health event data, and parametric and nonparametric models were used to benchmark herd and cow health status. Health events were grouped into 3 categories for analyses: mastitis, reproductive, and metabolic. Both herd incidence and individual incidence were used as dependent variables. Models implemented included stepwise logistic regression, support vector machines, and random forests. At both the herd and individual levels, random forest models attained the highest accuracy for predicting health status in all health event categories when evaluated with 10-fold cross-validation. Accuracy (SD) ranged from 0.61 (0.04) to 0.63 (0.04) when using random forest models at the herd level. Accuracy of prediction (SD) at the individual cow level ranged from 0.87 (0.06) to 0.93 (0.001) with random forest models. Highly significant variables and key words from logistic regression and random forest models were also investigated. All models identified several of the same key factors for each health event category, including movement out of the herd, size of the herd, and weather-related variables. We concluded that benchmarking health status using routinely collected herd data is feasible. Nonparametric models were better suited to handle this complex data with numerous variables. These data mining techniques were able to perform prediction of health status and could add evidence to personal experience in herd management. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

A person based formula for allocating commissioning funds to general practices in England: development of a statistical model

PubMed Central

Smith, Peter; Gravelle, Hugh; Martin, Steve; Bardsley, Martin; Rice, Nigel; Georghiou, Theo; Dusheiko, Mark; Billings, John; Lorenzo, Michael De; Sanderson, Colin

2011-01-01

Objectives To develop a formula for allocating resources for commissioning hospital care to all general practices in England based on the health needs of the people registered in each practice Design Multivariate prospective statistical models were developed in which routinely collected electronic information from 2005-6 and 2006-7 on individuals and the areas in which they lived was used to predict their costs of hospital care in the next year, 2007-8. Data on individuals included all diagnoses recorded at any inpatient admission. Models were developed on a random sample of 5 million people and validated on a second random sample of 5 million people and a third sample of 5 million people drawn from a random sample of practices. Setting All general practices in England as of 1 April 2007. All NHS inpatient admissions and outpatient attendances for individuals registered with a general practice on that date. Subjects All individuals registered with a general practice in England at 1 April 2007. Main outcome measures Power of the statistical models to predict the costs of the individual patient or each practice’s registered population for 2007-8 tested with a range of metrics (R2 reported here). Comparisons of predicted costs in 2007-8 with actual costs incurred in the same year were calculated by individual and by practice. Results Models including person level information (age, sex, and ICD-10 codes diagnostic recorded) and a range of area level information (such as socioeconomic deprivation and supply of health facilities) were most predictive of costs. After accounting for person level variables, area level variables added little explanatory power. The best models for resource allocation could predict upwards of 77% of the variation in costs at practice level, and about 12% at the person level. With these models, the predicted costs of about a third of practices would exceed or undershoot the actual costs by 10% or more. Smaller practices were more likely to be in these groups. Conclusions A model was developed that performed well by international standards, and could be used for allocations to practices for commissioning. The best formulas, however, could predict only about 12% of the variation in next year’s costs of most inpatient and outpatient NHS care for each individual. Person-based diagnostic data significantly added to the predictive power of the models. PMID:22110252

The Demand for, and Impact of, Learning HIV Status

PubMed Central

Thornton, Rebecca L.

2011-01-01

This paper evaluates an experiment in which individuals in rural Malawi were randomly assigned monetary incentives to learn their HIV results after being tested. Distance to the HIV results centers was also randomly assigned. Without any incentive, 34 percent of the participants learned their HIV results. However, even the smallest incentive doubled that share. Using the randomly assigned incentives and distance from results centers as instruments for the knowledge of HIV status, sexually active HIV-positive individuals who learned their results are three times more likely to purchase condoms two months later than sexually active HIV-positive individuals who did not learn their results; however, HIV-positive individuals who learned their results purchase only two additional condoms than those who did not. There is no significant effect of learning HIV-negative status on the purchase of condoms. PMID:21687831

Genetic predictors of response to serotonergic and noradrenergic antidepressants in major depressive disorder: a genome-wide analysis of individual-level data and a meta-analysis.

PubMed

Tansey, Katherine E; Guipponi, Michel; Perroud, Nader; Bondolfi, Guido; Domenici, Enrico; Evans, David; Hall, Stephanie K; Hauser, Joanna; Henigsberg, Neven; Hu, Xiaolan; Jerman, Borut; Maier, Wolfgang; Mors, Ole; O'Donovan, Michael; Peters, Tim J; Placentino, Anna; Rietschel, Marcella; Souery, Daniel; Aitchison, Katherine J; Craig, Ian; Farmer, Anne; Wendland, Jens R; Malafosse, Alain; Holmans, Peter; Lewis, Glyn; Lewis, Cathryn M; Stensbøl, Tine Bryan; Kapur, Shitij; McGuffin, Peter; Uher, Rudolf

2012-01-01

It has been suggested that outcomes of antidepressant treatment for major depressive disorder could be significantly improved if treatment choice is informed by genetic data. This study aims to test the hypothesis that common genetic variants can predict response to antidepressants in a clinically meaningful way. The NEWMEDS consortium, an academia-industry partnership, assembled a database of over 2,000 European-ancestry individuals with major depressive disorder, prospectively measured treatment outcomes with serotonin reuptake inhibiting or noradrenaline reuptake inhibiting antidepressants and available genetic samples from five studies (three randomized controlled trials, one part-randomized controlled trial, and one treatment cohort study). After quality control, a dataset of 1,790 individuals with high-quality genome-wide genotyping provided adequate power to test the hypotheses that antidepressant response or a clinically significant differential response to the two classes of antidepressants could be predicted from a single common genetic polymorphism. None of the more than half million genetic markers significantly predicted response to antidepressants overall, serotonin reuptake inhibitors, or noradrenaline reuptake inhibitors, or differential response to the two types of antidepressants (genome-wide significance p<5×10(-8)). No biological pathways were significantly overrepresented in the results. No significant associations (genome-wide significance p<5×10(-8)) were detected in a meta-analysis of NEWMEDS and another large sample (STAR*D), with 2,897 individuals in total. Polygenic scoring found no convergence among multiple associations in NEWMEDS and STAR*D. No single common genetic variant was associated with antidepressant response at a clinically relevant level in a European-ancestry cohort. Effects specific to particular antidepressant drugs could not be investigated in the current study. Please see later in the article for the Editors' Summary.

Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

2005-01-01

This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

Depression Symptoms Among Homeless Smokers: Effect of Motivational Interviewing.

PubMed

Robinson, Cendrine D; Rogers, Charles R; Okuyemi, Kolawole S

2016-08-23

Tobacco use is higher among homeless individuals than the general population. Homeless individuals are also more likely to have symptoms of depression. Depression symptoms may add to the burden of homelessness by increasing psychological distress and serve as a barrier to quitting smoking. The primary goal of this study is to assess the impact of depression symptoms on psychological distress in homeless smokers. The effect of depression symptoms on abstinence and the effect of Motivational Interviewing (MI) on cessation among smokers is also explored. Homeless smokers (N = 430) enrolled in a smoking cessation study were randomized to Motivational Interviewing (MI) or standard care (SC). Participants received nicotine replacement therapy and were followed for 26 weeks. Participants were categorized into a depression symptoms (DS) group or control group using the Patient Health Questionnaire-9. Between group differences of perceived stress, hopelessness, confidence, craving and abstinence were assessed at weeks 8 and 26. The interaction between depression symptoms (levels: DS and control) and the intervention (levels: MI and SC) was also assessed. Homeless smokers in the DS group reported higher levels of hopelessness, perceived stress, and craving. There was no effect of DS status on abstinence at week 8 or week 26. There was no significant interaction between depression symptoms (DS vs. Control) and the intervention (MI vs. SC). Despite reporting greater psychological distress, homeless smokers with depression symptoms in this sample had abstinence levels similar to the control group. Future research should explore protective factors among depressed smokers.

High Dose Atorvastatin Decreases Cellular Markers of Immune Activation Without Affecting HIV-1 RNA Levels: Results of a Double-Blind Randomized Placebo Controlled Clinical Trial

DTIC Science & Technology

2011-02-15

M A J O R A R T I C L E High Dose Atorvastatin Decreases Cellular Markers of Immune Activation without Affecting HIV-1 RNA Levels: Results of a... atorvastatin on HIV-1 RNA (primary objective) and cellular markers of immune activation (secondary objective). HIV-infected individuals not receiving...antiretroviral therapy were randomized to receive either 8 weeks of atorvastatin (80 mg) or placebo daily. After a 4–6 week washout phase, participants

Contemporary multilevel analysis of the effectiveness of water fluoridation in Australia.

PubMed

Do, Loc; Spencer, A John

2015-02-01

Water fluoridation was extended in Queensland, Australia, across 2009-2011. A research program was commenced to inform the rationale for and the outcome of this program, to estimate the effectiveness of water fluoridation in preventing caries and to predict changes in caries experience as a result of the extension of fluoridation. Queensland children were selected through a stratified random sample selection in 2010-2012. Oral epidemiological examinations provided individual-level outcomes for decayed, missing or filled primary or permanent tooth surfaces: dmfs (among 5-8-year-olds) and DMFS (9-14-year-olds). Explanatory factors at the individual-level, school-level and area-level fluoridation status were derived. Data were weighted to represent the population. Three-level multilevel multivariable models were sequentially specified for negative binomial distribution of dmfs/DMFS to estimate rate ratios (RR). The effectiveness of area-level water fluoridation was evaluated in the full models controlling for other factors. Data from 2,214 5-8 year-olds and 3,186 9-14 year-olds from 207 schools in 16 areas were analysed. Queensland's average dmfs was 4.23 and DMFS 1.47. The lowest levels of dental caries were observed in long-term fluoridated Townsville. In the full models, Townsville children had significantly lower caries experience (RR for dmfs: 0.61 (95%CI: 0.44-0.82); RR for DMFS 0.60 (95%CI: 0.42-0.88)) compared with children in non-fluoridated areas. Comparison of caries experience of children at the time of the extension of water fluoridation supported the rationale for this population health measure. © 2014 Public Health Association of Australia.

Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: A randomized, placebo-controlled pilot study

PubMed Central

Liu, Alice; Kim, Sun H.; Ariel, Danit; Abbasi, Fahim; Lamendola, Cindy; Cardell, James; Xu, Shiming; Patel, Shailja; Tomasso, Vanessa; Mojaddidi, Hafasa; Grove, Kaylene; Tsao, Philip S.; Kushida, Clete A.; Reaven, Gerald M.

2016-01-01

Background High fasting insulin levels have been reported to predict development of observed apneas, suggesting that insulin resistance may contribute to the pathogenesis of obstructive sleep apnea (OSA). The study aim was to determine whether enhancing insulin sensitivity in individuals with OSA would improve sleep measures. Patients/Methods Insulin-resistant, nondiabetic individuals with untreated OSA were randomized (2:1) to pioglitazone (45mg/day) or placebo for 8 weeks in this single-blind study. All individuals had repeat measurements pertaining to sleep (overnight polysomnography and Functional Outcomes of Sleep Questionnaire) and insulin action (insulin suppression test). Results Forty-five overweight/obese men and women with moderate/severe OSA were randomized to pioglitazone (n=30) or placebo (n=15). Although insulin sensitivity increased 31% among pioglitazone-treated as compared to no change among individuals receiving placebo ((p<0.001 for between-group difference), no improvements in quantitative or qualitative sleep measurements were observed. Conclusions Pioglitazone administration increased insulin sensitivity in otherwise untreated individuals with OSA, without any change in polysomnographic sleep measures over an 8-week period. These findings do not support a causal role for insulin resistance in the pathogenesis of OSA. PMID:27544837

Dietary protein intake, energy deficit, and nitrogen balance in normal-weight adults: a randomized controlled

USDA-ARS?s Scientific Manuscript database

Consuming protein at levels higher than the recommended dietary allowance (RDA) may be metabolically advantageous for overweight and obese individuals attempting weight loss. However, the dose-response characteristics that define the optimal level of dietary protein necessary to sustain measures of...

Estimating energy expenditure from heart rate in older adults: a case for calibration.

PubMed

Schrack, Jennifer A; Zipunnikov, Vadim; Goldsmith, Jeff; Bandeen-Roche, Karen; Crainiceanu, Ciprian M; Ferrucci, Luigi

2014-01-01

Accurate measurement of free-living energy expenditure is vital to understanding changes in energy metabolism with aging. The efficacy of heart rate as a surrogate for energy expenditure is rooted in the assumption of a linear function between heart rate and energy expenditure, but its validity and reliability in older adults remains unclear. To assess the validity and reliability of the linear function between heart rate and energy expenditure in older adults using different levels of calibration. Heart rate and energy expenditure were assessed across five levels of exertion in 290 adults participating in the Baltimore Longitudinal Study of Aging. Correlation and random effects regression analyses assessed the linearity of the relationship between heart rate and energy expenditure and cross-validation models assessed predictive performance. Heart rate and energy expenditure were highly correlated (r=0.98) and linear regardless of age or sex. Intra-person variability was low but inter-person variability was high, with substantial heterogeneity of the random intercept (s.d. =0.372) despite similar slopes. Cross-validation models indicated individual calibration data substantially improves accuracy predictions of energy expenditure from heart rate, reducing the potential for considerable measurement bias. Although using five calibration measures provided the greatest reduction in the standard deviation of prediction errors (1.08 kcals/min), substantial improvement was also noted with two (0.75 kcals/min). These findings indicate standard regression equations may be used to make population-level inferences when estimating energy expenditure from heart rate in older adults but caution should be exercised when making inferences at the individual level without proper calibration.

Assessing variation in life-history tactics within a population using mixture regression models: a practical guide for evolutionary ecologists.

PubMed

Hamel, Sandra; Yoccoz, Nigel G; Gaillard, Jean-Michel

2017-05-01

Mixed models are now well-established methods in ecology and evolution because they allow accounting for and quantifying within- and between-individual variation. However, the required normal distribution of the random effects can often be violated by the presence of clusters among subjects, which leads to multi-modal distributions. In such cases, using what is known as mixture regression models might offer a more appropriate approach. These models are widely used in psychology, sociology, and medicine to describe the diversity of trajectories occurring within a population over time (e.g. psychological development, growth). In ecology and evolution, however, these models are seldom used even though understanding changes in individual trajectories is an active area of research in life-history studies. Our aim is to demonstrate the value of using mixture models to describe variation in individual life-history tactics within a population, and hence to promote the use of these models by ecologists and evolutionary ecologists. We first ran a set of simulations to determine whether and when a mixture model allows teasing apart latent clustering, and to contrast the precision and accuracy of estimates obtained from mixture models versus mixed models under a wide range of ecological contexts. We then used empirical data from long-term studies of large mammals to illustrate the potential of using mixture models for assessing within-population variation in life-history tactics. Mixture models performed well in most cases, except for variables following a Bernoulli distribution and when sample size was small. The four selection criteria we evaluated [Akaike information criterion (AIC), Bayesian information criterion (BIC), and two bootstrap methods] performed similarly well, selecting the right number of clusters in most ecological situations. We then showed that the normality of random effects implicitly assumed by evolutionary ecologists when using mixed models was often violated in life-history data. Mixed models were quite robust to this violation in the sense that fixed effects were unbiased at the population level. However, fixed effects at the cluster level and random effects were better estimated using mixture models. Our empirical analyses demonstrated that using mixture models facilitates the identification of the diversity of growth and reproductive tactics occurring within a population. Therefore, using this modelling framework allows testing for the presence of clusters and, when clusters occur, provides reliable estimates of fixed and random effects for each cluster of the population. In the presence or expectation of clusters, using mixture models offers a suitable extension of mixed models, particularly when evolutionary ecologists aim at identifying how ecological and evolutionary processes change within a population. Mixture regression models therefore provide a valuable addition to the statistical toolbox of evolutionary ecologists. As these models are complex and have their own limitations, we provide recommendations to guide future users. © 2016 Cambridge Philosophical Society.

The effect of need supportive text messages on motivation and physical activity behaviour.

PubMed

Kinnafick, Florence-Emilie; Thøgersen-Ntoumani, Cecilie; Duda, Joan

2016-08-01

Few short messaging service (SMS) studies to support behaviour change have used a theoretical underpinning. Using a self-determination theory perspective, we explored the effects of need supportive (NS) SMS on physical activity in 65 (BMI = 24.06 kg/m(2), SD = 5.49; M = 25.76 years, SD = 10.23) insufficiently active individuals embarking on an existing exercise programme. For 10 weeks participants were randomised to an intervention group (NS) or control group (neutral). SMS were sent twice weekly, randomly, via an online SMS service. Mixed design ANCOVA and MANCOVA analyses of measures taken at baseline, mid and post intervention revealed increased levels of perceived autonomy support and psychological need satisfaction in the intervention group post intervention. Both groups reported increases in intrinsic motivation from pre to post intervention. Moderate intensity physical activity was greater in the intervention than the control group at 4-month post intervention with control group returning to baseline levels. Findings provide preliminary causal evidence to support the use of NS SMS to optimise physical activity behaviour change in individuals who are insufficiently active.

Analysis of a Split-Plot Experimental Design Applied to a Low-Speed Wind Tunnel Investigation

NASA Technical Reports Server (NTRS)

Erickson, Gary E.

2013-01-01

A procedure to analyze a split-plot experimental design featuring two input factors, two levels of randomization, and two error structures in a low-speed wind tunnel investigation of a small-scale model of a fighter airplane configuration is described in this report. Standard commercially-available statistical software was used to analyze the test results obtained in a randomization-restricted environment often encountered in wind tunnel testing. The input factors were differential horizontal stabilizer incidence and the angle of attack. The response variables were the aerodynamic coefficients of lift, drag, and pitching moment. Using split-plot terminology, the whole plot, or difficult-to-change, factor was the differential horizontal stabilizer incidence, and the subplot, or easy-to-change, factor was the angle of attack. The whole plot and subplot factors were both tested at three levels. Degrees of freedom for the whole plot error were provided by replication in the form of three blocks, or replicates, which were intended to simulate three consecutive days of wind tunnel facility operation. The analysis was conducted in three stages, which yielded the estimated mean squares, multiple regression function coefficients, and corresponding tests of significance for all individual terms at the whole plot and subplot levels for the three aerodynamic response variables. The estimated regression functions included main effects and two-factor interaction for the lift coefficient, main effects, two-factor interaction, and quadratic effects for the drag coefficient, and only main effects for the pitching moment coefficient.

Testing moderation in network meta-analysis with individual participant data

PubMed Central

Dagne, Getachew A.; Brown, C. Hendricks; Howe, George; Kellam, Sheppard G.; Liu, Lei

2016-01-01

Summary Meta-analytic methods for combining data from multiple intervention trials are commonly used to estimate the effectiveness of an intervention. They can also be extended to study comparative effectiveness, testing which of several alternative interventions is expected to have the strongest effect. This often requires network meta-analysis (NMA), which combines trials involving direct comparison of two interventions within the same trial and indirect comparisons across trials. In this paper, we extend existing network methods for main effects to examining moderator effects, allowing for tests of whether intervention effects vary for different populations or when employed in different contexts. In addition, we study how the use of individual participant data (IPD) may increase the sensitivity of NMA for detecting moderator effects, as compared to aggregate data NMA that employs study-level effect sizes in a meta-regression framework. A new network meta-analysis diagram is proposed. We also develop a generalized multilevel model for NMA that takes into account within- and between-trial heterogeneity, and can include participant-level covariates. Within this framework we present definitions of homogeneity and consistency across trials. A simulation study based on this model is used to assess effects on power to detect both main and moderator effects. Results show that power to detect moderation is substantially greater when applied to IPD as compared to study-level effects. We illustrate the use of this method by applying it to data from a classroom-based randomized study that involved two sub-trials, each comparing interventions that were contrasted with separate control groups. PMID:26841367

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

PubMed

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

2017-11-20

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

Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

PubMed

Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

2013-11-20

Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient-level intervention, and 58.9% (95% CI: 54.7% to 63.1%) receiving both practice- and patient-level interventions (patient-level intervention versus control, P < 0.001). The benefit of the patient-level intervention was seen in both strata. The extra cost of the intervention was $26.43CAN (95% CI: $16 to $44) per additional action met. A Prevention Practitioner can improve the implementation of clinically important prevention and screening for chronic diseases in a cost-effective manner.

Effects of coarse-graining on fluctuations in gene expression

NASA Astrophysics Data System (ADS)

Pedraza, Juan; Paulsson, Johan

2008-03-01

Many cellular components are present in such low numbers per cell that random births and deaths of individual molecules can cause significant `noise' in concentrations. But biochemical events do not necessarily occur in steps of individual molecules. Some processes are greatly randomized when synthesis or degradation occurs in large bursts of many molecules in a short time interval. Conversely, each birth or death of a macromolecule could involve several small steps, creating a memory between individual events. Here we present generalized theory for stochastic gene expression, formulating the variance in protein abundance in terms of the randomness of the individual events, and discuss the effective coarse-graining of the molecular hardware. We show that common molecular mechanisms produce gestation and senescence periods that can reduce noise without changing average abundances, lifetimes, or any concentration-dependent control loops. We also show that single-cell experimental methods that are now commonplace in cell biology do not discriminate between qualitatively different stochastic principles, but that this in turn makes them better suited for identifying which components introduce fluctuations.

Does the Neighborhood Area of Residence Influence Non-Attendance in an Urban Mammography Screening Program? A Multilevel Study in a Swedish City

PubMed Central

Lagerlund, Magdalena; Merlo, Juan; Vicente, Raquel Pérez; Zackrisson, Sophia

2015-01-01

Background and aim The public health impact of population-based mammography screening programs depends on high participation rates. Thus, monitoring participation rates, as well as understanding and considering the factors influencing attendance, is important. With the goal to acquire information on the appropriate level of intervention for increasing screening participation our study aimed to (1) examine whether, over and above individual factors, the neighborhood of residence influences a woman’s mammography non-attendance, and (2) evaluate, whether knowing a woman’s neighborhood of residence would be sufficient to predict non-attendance. Methods We analyze all women invited to mammography screening in 2005–09, residing in the city of Malmö, Sweden. Information regarding mammography screening attendance was linked to data on area of residence, demographic and socioeconomic characteristics available from Statistics Sweden. The influence of individual and neighborhood factors was assessed by multilevel logistic regression analysis with 29,901 women nested within 212 neighborhoods. Results The prevalence of non-attendance among women was 18.3%. After adjusting for individual characteristics, the prevalence in the 212 neighborhoods was 3.6%. Neighborhood of residence had little influence on non-attendance. The multilevel analysis indicates that 8.4% of the total individual differences in the propensity of non-attendance were at the neighborhood level. However, when adjusting for specific individual characteristics this general contextual effect decreased to 1.8%. This minor effect was explained by the sociodemographic characteristic of the neighborhoods. The discriminatory accuracy of classifying women according to their non-attendance was 0.747 when considering only individual level variables, and 0.760 after including neighborhood level as a random effect. Conclusion Our results suggest that neighborhoods of residence in Malmö, Sweden (as defined by small-area market statistics (SAMS) areas) do not condition women’s participation in population based mammography screening. Thus, interventions should be directed to the whole city and target women with a higher risk of non-attendance. PMID:26460609

Effect of individualized goal-setting on college biology students' locus of control

NASA Astrophysics Data System (ADS)

Schafer, John E.

This study investigated the effect of Individualized Goal-Setting A-T, relative to Classic A-T, on a student's locus of control (generalized and academic). This study also examined the effect of pretesting, relative to no pretesting, on a student's locus of control. Sixty students in an introductory, Audio-Tutorial, college zoology course were randomly assigned to treatment and control groups. Control groups (Classic A-T) completed the course in the usual manner. Treatment groups (IGS A-T) completed the course in the usual manner with one exception. That is, they used a different format for Optional Minicourse mastery. This new format released greater control to students over means as well as ends of minicourse mastery. Data were collected through use of the Solomon Four-Group design, with two levels of treatment (Classic A-T, IGS A-T) and two levels of pretesting (pretest, no pretest). Instruments included the Rotter I-E and Schafer Academic I-E Locus of Control Scales. Posttest scores were analyzed by a 2 × 2 multivariate analysis of variance (MANOVA).The following conclusions were made (p < 0.10).1IGS A-T, relative to Classic A-T, has no significant effect on a student's locus of control.2Pretesting, relative to no pretesting, has no significant effect on posttest locus of control.

Handling Correlations between Covariates and Random Slopes in Multilevel Models

ERIC Educational Resources Information Center

Bates, Michael David; Castellano, Katherine E.; Rabe-Hesketh, Sophia; Skrondal, Anders

2014-01-01

This article discusses estimation of multilevel/hierarchical linear models that include cluster-level random intercepts and random slopes. Viewing the models as structural, the random intercepts and slopes represent the effects of omitted cluster-level covariates that may be correlated with included covariates. The resulting correlations between…

Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

PubMed Central

Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

2015-01-01

Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

Mental health impact of social capital interventions: a systematic review.

PubMed

Flores, Elaine C; Fuhr, Daniela C; Bayer, Angela M; Lescano, Andres G; Thorogood, Nicki; Simms, Victoria

2018-02-01

Mental disorders are a major contributor to the global burden of disease and disability, and can be extremely costly at both individual and community level. Social capital, (SC) defined as an individual's social relationships and participation in community networks, may lower the risk of mental disorders while increasing resilience capacity, adaptation and recovery. SC interventions may be a cost-effective way of preventing and ameliorating these conditions. However, the impact of these SC interventions on mental health still needs research. We conducted a systematic review of SC-based interventions to investigate their effect on mental health outcomes from controlled, quasi-experimental studies or pilot trials. We searched twelve academic databases, three clinical trials registries, hand-searched references and contacted field experts. Studies' quality was assessed with the Cochrane Risk of Bias tools for randomized and non-randomized studies. Seven studies were included in the review, published between 2006 and 2016. There was substantial heterogeneity in the definitions of both SC and mental disorders among the studies, preventing us from calculating pooled effect sizes. The interventions included community engagement and educative programs, cognitive processing therapy and sociotherapy for trauma survivors, and neighbourhood projects. There are paucity of SC interventions investigating the effect on mental health outcomes. This study showed that both SC scores and mental health outcomes improved over time but there was little evidence of benefit compared to control groups in the long term. Further high-quality trials are needed, especially among adverse populations to assess sustainability of effect.

Bayesian adjustment for measurement error in continuous exposures in an individually matched case-control study.

PubMed

Espino-Hernandez, Gabriela; Gustafson, Paul; Burstyn, Igor

2011-05-14

In epidemiological studies explanatory variables are frequently subject to measurement error. The aim of this paper is to develop a Bayesian method to correct for measurement error in multiple continuous exposures in individually matched case-control studies. This is a topic that has not been widely investigated. The new method is illustrated using data from an individually matched case-control study of the association between thyroid hormone levels during pregnancy and exposure to perfluorinated acids. The objective of the motivating study was to examine the risk of maternal hypothyroxinemia due to exposure to three perfluorinated acids measured on a continuous scale. Results from the proposed method are compared with those obtained from a naive analysis. Using a Bayesian approach, the developed method considers a classical measurement error model for the exposures, as well as the conditional logistic regression likelihood as the disease model, together with a random-effect exposure model. Proper and diffuse prior distributions are assigned, and results from a quality control experiment are used to estimate the perfluorinated acids' measurement error variability. As a result, posterior distributions and 95% credible intervals of the odds ratios are computed. A sensitivity analysis of method's performance in this particular application with different measurement error variability was performed. The proposed Bayesian method to correct for measurement error is feasible and can be implemented using statistical software. For the study on perfluorinated acids, a comparison of the inferences which are corrected for measurement error to those which ignore it indicates that little adjustment is manifested for the level of measurement error actually exhibited in the exposures. Nevertheless, a sensitivity analysis shows that more substantial adjustments arise if larger measurement errors are assumed. In individually matched case-control studies, the use of conditional logistic regression likelihood as a disease model in the presence of measurement error in multiple continuous exposures can be justified by having a random-effect exposure model. The proposed method can be successfully implemented in WinBUGS to correct individually matched case-control studies for several mismeasured continuous exposures under a classical measurement error model.

Community-based randomized controlled trial of diabetes prevention study for high-risk individuals of type 2 diabetes: lifestyle intervention using web-based system.

PubMed

Cha, Seon-Ah; Lim, Sun-Young; Kim, Kook-Rye; Lee, Eun-Young; Kang, Borami; Choi, Yoon-Hee; Yoon, Kun-Ho; Ahn, Yu-Bae; Lee, Jin-Hee; Ko, Seung-Hyun

2017-05-05

The trend of increasing numbers of patients with type 2 diabetes emphasizes the need for active screening of high-risk individuals and intensive lifestyle modification (LSM). The community-based Korean Diabetes Prevention Study (C-KDPS) is a randomized controlled clinical trial to prevent type 2 diabetes by intensive LSM using a web-based program. The two public healthcare centers in Korea are involved, and 420 subjects are being recruited for 6 months and will be followed up for 22 months. The participants are allocated randomly to intensive LSM (18 individual sessions for 24 weeks) and usual care (control group). The major goals of the C-KDPS lifestyle intervention program are: 1) a minimum of 5-7% loss of initial body weight in 6 months and maintenance of this weight loss, 2) increased physical activity (≥ 150 min/week of moderate intensity activity), 3) balanced healthy eating, and 4) quitting smoking and alcohol with stress management. The web-based program includes education contents, video files, visit schedules, and inter-communicable keeping track sites. Primary outcomes are the diagnoses of newly developed diabetes. A 75-g oral glucose tolerance test with hemoglobin A1c level determination and cardiovascular risk factor assessment is scheduled at 6, 12, 18, and 22 months. Active screening of high-risk individuals and an effective LSM program are an essential prerequisite for successful diabetes prevention. We hope that our C-KDPS program can reduce the incidence of newly developed type 2 diabetes and be implemented throughout the country, merging community-based public healthcare resources and a web-based system. Clinical Research Information Service (CRIS), Republic of Korea (No. KCT0001981 ). Date of registration; July 28, 2016.

Individual patient data meta-analysis of antiplatelet regimens after noncardioembolic stroke or TIA: rationale and design.

PubMed

Greving, Jacoba P; Diener, Hans-Christoph; Csiba, László; Hacke, Werner; Kappelle, L Jaap; Koudstaal, Peter J; Leys, Didier; Mas, Jean-Louis; Sacco, Ralph L; Sivenius, Juhani; Algra, Ale

2015-10-01

The Cerebrovascular Antiplatelet Trialists' Collaborative Group was formed to obtain and analyze individual patient data from the major randomized trials of common antiplatelet regimens after cerebral ischemia. Although the risk of stroke can be reduced by antiplatelet drugs, there continues to be uncertainty about the balance of risk and benefits of different antiplatelet regimens for an individual patient. Our aim is to provide clinicians with a thorough evidence-based answer on these therapeutic alternatives. We have identified six large randomized trials and plan to meta-analyze the data on an individual patient level. In total, these trials have enrolled 46 948 patients with cerebral ischemia. Uniquely, the Cerebrovascular Antiplatelet Trialists' Collaborative Group has secured access to the individual data of all of these trials, with the participation of key investigators and pharmaceutical companies. Our principal objective includes deriving a reliable estimate of the efficacy of different antiplatelet regimens on key outcomes including serious vascular events, major ischemic events, major bleeding, and intracranial hemorrhage. We propose to redefine composite outcome events, if necessary, to achieve comparability. Further, we aim to build and validate prognostic models for the risk of major bleeding and intracranial hemorrhage and to build a decision model that may support evidence-based decision making about which antiplatelet regimen would be most effective in different risk groups of patients. This paper outlines inclusion criteria, outcome measures, baseline characteristics, and planned statistical analysis. © 2015 World Stroke Organization.

Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial

PubMed Central

Campbell, Melissa; Decker, Kathleen P.; Kruk, Kerry; Deaver, Sarah P.

2018-01-01

This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans (N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist–Military Version and Beck Depression Inventory–II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions. PMID:29332989

Association of Genetic Variants Related to Serum Calcium Levels With Coronary Artery Disease and Myocardial Infarction.

PubMed

Larsson, Susanna C; Burgess, Stephen; Michaëlsson, Karl

2017-07-25

Serum calcium has been associated with cardiovascular disease in observational studies and evidence from randomized clinical trials indicates that calcium supplementation, which raises serum calcium levels, may increase the risk of cardiovascular events, particularly myocardial infarction. To evaluate the potential causal association between genetic variants related to elevated serum calcium levels and risk of coronary artery disease (CAD) and myocardial infarction using mendelian randomization. The analyses were performed using summary statistics obtained for single-nucleotide polymorphisms (SNPs) identified from a genome-wide association meta-analysis of serum calcium levels (N = up to 61 079 individuals) and from the Coronary Artery Disease Genome-wide Replication and Meta-analysis Plus the Coronary Artery Disease Genetics (CardiogramplusC4D) consortium's 1000 genomes-based genome-wide association meta-analysis (N = up to 184 305 individuals) that included cases (individuals with CAD and myocardial infarction) and noncases, with baseline data collected from 1948 and populations derived from across the globe. The association of each SNP with CAD and myocardial infarction was weighted by its association with serum calcium, and estimates were combined using an inverse-variance weighted meta-analysis. Genetic risk score based on genetic variants related to elevated serum calcium levels. Co-primary outcomes were the odds of CAD and myocardial infarction. Among the mendelian randomized analytic sample of 184 305 individuals (60 801 CAD cases [approximately 70% with myocardial infarction] and 123 504 noncases), the 6 SNPs related to serum calcium levels and without pleiotropic associations with potential confounders were estimated to explain about 0.8% of the variation in serum calcium levels. In the inverse-variance weighted meta-analysis (combining the estimates of the 6 SNPs), the odds ratios per 0.5-mg/dL increase (about 1 SD) in genetically predicted serum calcium levels were 1.25 (95% CI, 1.08-1.45; P = .003) for CAD and 1.24 (95% CI, 1.05-1.46; P = .009) for myocardial infarction. A genetic predisposition to higher serum calcium levels was associated with increased risk of CAD and myocardial infarction. Whether the risk of CAD associated with lifelong genetic exposure to increased serum calcium levels can be translated to a risk associated with short-term to medium-term calcium supplementation is unknown.

Foliar sprays of citric acid and salicylic acid alter the pattern of root acquisition of some minerals in sweet basil (Ocimum basilicum L.)

PubMed Central

Ghazijahani, Noushin; Hadavi, Ebrahim; Jeong, Byoung R.

2014-01-01

The effect of foliar application of two levels of citric acid (CA; 0 and 7 mM) and two levels of salicylic acid (SA; 0 and 1 mM) combined with two levels of nutrient solution strength (full strength and half strength) on mineral acquisition by sweet basil were investigated. The experiment was conducted in a randomized block design arrangement with three replications. SA alone reduced the plant height and thickened the stem. Plants supplied with a full strength solution had a ticker stem, produced more biomass, and showed higher values of Fv/Fm. Some changes in the uptake pattern of some nutrients, especially boron and sulfur, were noticed. Higher boron concentrations in leaves were in plants sprayed with a combination of 7 mM CA and 1 mM of SA. Applying combination of CA and SA was more effective than using them individually that suggests an effective synergism between them. PMID:25400645

A Methodological Study of a Computer-Managed Instructional Program in High School Physics.

ERIC Educational Resources Information Center

Denton, Jon James

The purpose of this study was to develop and evaluate an instructional model which utilized the computer to produce individually prescribed instructional guides in physics at the secondary school level. The sample consisted of three classes. Of these, two were randomly selected to serve as the treatment groups, e.g., individualized instruction and…

The Use of Group versus Individual Settings for Assessing Student Achievement in Kindergarten and First Grade.

ERIC Educational Resources Information Center

Atkins-Burnett, Sally; Rowan, Brian; Correnti, Richard

This paper reports on an experiment examining the consequences of assessing kindergarten and first-grade students' academic achievement in group versus individualized assessment settings. Students (n=442) blocked by classroom and grade level were randomly assigned to one of two assessment modes: a small group setting with 8 other students from…

Sensitivity Analysis of Mixed Models for Incomplete Longitudinal Data

ERIC Educational Resources Information Center

Xu, Shu; Blozis, Shelley A.

2011-01-01

Mixed models are used for the analysis of data measured over time to study population-level change and individual differences in change characteristics. Linear and nonlinear functions may be used to describe a longitudinal response, individuals need not be observed at the same time points, and missing data, assumed to be missing at random (MAR),…

Improving Students' Report Writing Quality in an EAP Context: Group versus Individual

ERIC Educational Resources Information Center

Ali, Holi Ibrahim Holi

2012-01-01

This paper looks into report writing quality on both individual and group bases in an EAP context. A total of 100 EFL students at post foundation level in a University College in Oman, and 15 EFL teachers were selected randomly. Questionnaires were administered to investigate their perceptions and experiences with report writing quality on…

Physical appearance anxiety impedes the therapeutic effects of video feedback in high socially anxious individuals.

PubMed

Orr, Elizabeth M J; Moscovitch, David A

2014-01-01

Video feedback (VF) interventions effectively reduce social anxiety symptoms and negative self-perception, particularly when they are preceded by cognitive preparation (CP) and followed by cognitive review. In the current study, we re-examined data from a study on the efficacy of a novel VF intervention for individuals high in social anxiety to test the hypothesis that physical appearance anxiety would moderate the effects of VF. Data were analyzed from 68 socially anxious participants who performed an initial public speech, and were randomly assigned to an Elaborated VF condition (VF plus cognitive preparation and cognitive review), a Standard VF condition (VF plus cognitive preparation) or a No VF condition (exposure alone), and then performed a second speech. As hypothesized, when appearance concerns were low, both participants who received Elaborated and Standard VF were significantly less anxious during speech 2 than those in the No VF condition. However, when levels of appearance concern were high, neither Elaborated nor Standard VF reduced anxiety levels during speech 2 beyond the No VF condition. Results from our analog sample suggest the importance of tailoring treatment protocols to accommodate the idiosyncratic concerns of socially anxious patients.

Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial.

PubMed

Gunn, Jane; Wachtler, Caroline; Fletcher, Susan; Davidson, Sandra; Mihalopoulos, Cathrine; Palmer, Victoria; Hegarty, Kelsey; Coe, Amy; Murray, Elizabeth; Dowrick, Christopher; Andrews, Gavin; Chondros, Patty

2017-07-20

Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care. The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group. To our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system. Australian New Zealand Clinical Trials Registry (ANZCTR 12616000537459 ). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data.

Enhanced mood and psychomotor performance by a caffeine-containing energy capsule in fatigued individuals.

PubMed

Childs, Emma; de Wit, Harriet

2008-02-01

Caffeine produces mild psychostimulant effects that may be particularly evident in individuals whose mood or performance is impaired by sleep restriction or caffeine withdrawal. Caffeinated energy drinks have been shown to improve energy and cognition but expectancy effects cannot be ruled out in these studies. Very few studies have examined the effects of caffeine-containing energy capsules upon behavioral and subjective measures. This study compared the effects of a caffeine-containing (200 mg) supplement (CAF) or placebo in capsule form after prolonged wakefulness, in participants who varied in their level of habitual caffeine use. Thirty-five healthy volunteers (16 male, 19 female) participated in two experimental sessions in which they remained awake between 5 p.m. and 5 a.m. At 3:30 a.m. they consumed CAF or placebo in random order under double-blind conditions. Participants completed subjective effects questionnaires and performed computerized attention tasks before and after consuming capsules. Heart rate and blood pressure were monitored at regular intervals. Compared to measures at 5 p.m., participants reported more tiredness and mood disturbance at 3 a.m., and exhibited longer reaction times and more attentional lapses. Heavier caffeine consumers exhibited the greatest decreases in Profile of Mood States (POMS) Vigor. CAF produced stimulant-like effects and significantly improved mood and reaction times upon the tasks. These effects did not vary with level of habitual caffeine consumption. These findings indicate that consumption of a caffeine-containing food supplement improves subjective state and cognitive performance in fatigued individuals that is likely a result of its caffeine content. 2008 APA

Tuberculosis Control in South African Gold Mines: Mathematical Modeling of a Trial of Community-Wide Isoniazid Preventive Therapy

PubMed Central

Vynnycky, Emilia; Sumner, Tom; Fielding, Katherine L.; Lewis, James J.; Cox, Andrew P.; Hayes, Richard J.; Corbett, Elizabeth L.; Churchyard, Gavin J.; Grant, Alison D.; White, Richard G.

2015-01-01

A recent major cluster randomized trial of screening, active disease treatment, and mass isoniazid preventive therapy for 9 months during 2006–2011 among South African gold miners showed reduced individual-level tuberculosis incidence but no detectable population-level impact. We fitted a dynamic mathematical model to trial data and explored 1) factors contributing to the lack of population-level impact, 2) the best-achievable impact if all implementation characteristics were increased to the highest level achieved during the trial (“optimized intervention”), and 3) how tuberculosis might be better controlled with additional interventions (improving diagnostics, reducing treatment delay, providing isoniazid preventive therapy continuously to human immunodeficiency virus–positive people, or scaling up antiretroviral treatment coverage) individually and in combination. We found the following: 1) The model suggests that a small proportion of latent infections among human immunodeficiency virus–positive people were cured, which could have been a key factor explaining the lack of detectable population-level impact. 2) The optimized implementation increased impact by only 10%. 3) Implementing additional interventions individually and in combination led to up to 30% and 75% reductions, respectively, in tuberculosis incidence after 10 years. Tuberculosis control requires a combination prevention approach, including health systems strengthening to minimize treatment delay, improving diagnostics, increased antiretroviral treatment coverage, and effective preventive treatment regimens. PMID:25792607