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

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…

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

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…

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 Central

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

2016-01-01

Objectives 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. Design 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. Setting This study was conducted in primary care units in selected provinces in Poland. Participants 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. Results 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. Conclusions Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. PMID:27927665

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/.

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…

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...

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.

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.

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…

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

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.

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.

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

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.

A manual-based phenomenological art therapy for individuals diagnosed with moderate to severe depression (PATd): A randomized controlled study.

PubMed

Blomdahl, Christina; Guregård, Suzanne; Rusner, Marie; Wijk, Helle

2018-05-14

This study investigated the effects of manual-based Phenomenological Art Therapy for individuals living with depression in addition to treatment as usual (PATd/TAU) compared with only treatment as usual (TAU) for individuals diagnosed with moderate to severe depression. 79 adults (men = 29.1%) were included in this randomized-controlled-trial (RCT), multicenter study in Sweden with an intention-to-treat design. Participants were randomized into either the PATd/TAU-group (n = 43) or TAU-group (n = 36). Data were collected at baseline and at end of treatment. The main outcomes were depression levels and self-esteem. Secondary outcomes were suicide ideation and sickness absence. The PATd/TAU-group showed a significant decrease of depression levels. The PATd/TAU-group returned to work to a higher degree than the TAU-group. Self-esteem significantly improved in both groups. Suicide ideation was unaffected. Manual-based PATd works as expected, being an effective treatment, and contributes to recovery for individuals with moderate to severe depression. This outcome needs to be confirmed and its long-term effects examined in further studies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

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.

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.

Testing Models for the Contributions of Genes and Environment to Developmental Change in Adolescent Depression

PubMed Central

Eaves, Lindon J.; Maes, Hermine; Silberg, Judy L.

2015-01-01

We tested two models to identify the genetic and environmental processes underlying longitudinal changes in depression among adolescents. The first assumes that observed changes in covariance structure result from the unfolding of inherent, random individual differences in the overall levels and rates of change in depression over time (random growth curves). The second assumes that observed changes are due to time-specific random effects (innovations) accumulating over time (autoregressive effects). We found little evidence of age-specific genetic effects or persistent genetic innovations. Instead, genetic effects are consistent with a gradual unfolding in the liability to depression and rates of change with increasing age. Likewise, the environment also creates significant individual differences in overall levels of depression and rates of change. However, there are also time-specific environmental experiences that persist with fidelity. The implications of these differing genetic and environmental mechanisms in the etiology of depression are considered. PMID:25894924

Testing Models for the Contributions of Genes and Environment to Developmental Change in Adolescent Depression.

PubMed

Gillespie, Nathan A; Eaves, Lindon J; Maes, Hermine; Silberg, Judy L

2015-07-01

We tested two models to identify the genetic and environmental processes underlying longitudinal changes in depression among adolescents. The first assumes that observed changes in covariance structure result from the unfolding of inherent, random individual differences in the overall levels and rates of change in depression over time (random growth curves). The second assumes that observed changes are due to time-specific random effects (innovations) accumulating over time (autoregressive effects). We found little evidence of age-specific genetic effects or persistent genetic innovations. Instead, genetic effects are consistent with a gradual unfolding in the liability to depression and rates of change with increasing age. Likewise, the environment also creates significant individual differences in overall levels of depression and rates of change. However, there are also time-specific environmental experiences that persist with fidelity. The implications of these differing genetic and environmental mechanisms in the etiology of depression are considered.

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.

Baseline adjustments for binary data in repeated cross-sectional cluster randomized trials.

PubMed

Nixon, R M; Thompson, S G

2003-09-15

Analysis of covariance models, which adjust for a baseline covariate, are often used to compare treatment groups in a controlled trial in which individuals are randomized. Such analysis adjusts for any baseline imbalance and usually increases the precision of the treatment effect estimate. We assess the value of such adjustments in the context of a cluster randomized trial with repeated cross-sectional design and a binary outcome. In such a design, a new sample of individuals is taken from the clusters at each measurement occasion, so that baseline adjustment has to be at the cluster level. Logistic regression models are used to analyse the data, with cluster level random effects to allow for different outcome probabilities in each cluster. We compare the estimated treatment effect and its precision in models that incorporate a covariate measuring the cluster level probabilities at baseline and those that do not. In two data sets, taken from a cluster randomized trial in the treatment of menorrhagia, the value of baseline adjustment is only evident when the number of subjects per cluster is large. We assess the generalizability of these findings by undertaking a simulation study, and find that increased precision of the treatment effect requires both large cluster sizes and substantial heterogeneity between clusters at baseline, but baseline imbalance arising by chance in a randomized study can always be effectively adjusted for. Copyright 2003 John Wiley & Sons, Ltd.

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

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…

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.

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.

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

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

The effect of message frame in anti-smoking public service announcements on cognitive response and attitude toward smoking.

PubMed

Shen, Lijiang

2010-01-01

This study investigated whether and how message frames in anti-smoking public service announcements (PSAs) affect individuals' cognition and attitude toward smoking. Individuals in a sample of 315 participants were randomly assigned to one of three experimental framing conditions: (a) health consequence, (b) secondhand smoke, and (c) industry manipulation. Each participant viewed four PSAs in a random order within a particular message frame. The study found strong evidence for the application effect in framing. The accessibility effect in framing was found to be conditional on message frame. Individuals' cognition on health consequence of smoking and on industry manipulation predicted their attitude toward smoking, but not cognition on secondhand smoke. The three frames also led to different patterns of affective responses that can be a basis for persuasion. Implications for message framing effect and anti-smoking campaigns were discussed.

Scale of reference bias and the evolution of health.

PubMed

Groot, Wim

2003-09-01

The analysis of subjective measures of well-being-such as self-reports by individuals about their health status is frequently hampered by the problem of scale of reference bias. A particular form of scale of reference bias is age norming. In this study we corrected for scale of reference bias by allowing for individual specific effects in an equation on subjective health. A random effects ordered response model was used to analyze scale of reference bias in self-reported health measures. The results indicate that if we do not control for unobservable individual specific effects, the response to a subjective health state measure suffers from age norming. Age norming can be controlled for by a random effects estimation technique using longitudinal data. Further, estimates are presented on the rate of depreciation of health. Finally, simulations of life expectancy indicate that the estimated model provides a reasonably good fit of the true life expectancy.

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

PubMed

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

2017-08-01

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

Effect of PTSD diagnosis and contingency management procedures on cocaine use in dually cocaine and opioid-dependent individuals maintained on LAAM: A retrospective analysis

PubMed Central

Mancino, M.; McGaugh, J.; Feldman, Z.; Poling, J.; Oliveto, A.

2012-01-01

This randomized clinical trial retrospectively examined the effect of Post Traumatic Stress Disorder (PTSD) and contingency management (CM) on cocaine use in opioid and cocaine dependent individuals maintained on high or low-dose LAAM randomly assigned to CM or a yoked-control condition. Cocaine-positive urines decreased more rapidly over time in those without PTSD versus those with PTSD in the non-contingency condition. In participants with PTSD, CM resulted in fewer cocaine positive urines compared to the non-contingent condition. This suggests that CM may help improve the potentially worse outcomes in opioid-and cocaine dependent individuals with PTSD compared to those without PTSD. PMID:20163389

A Poisson approach to the validation of failure time surrogate endpoints in individual patient data meta-analyses.

PubMed

Rotolo, Federico; Paoletti, Xavier; Burzykowski, Tomasz; Buyse, Marc; Michiels, Stefan

2017-01-01

Surrogate endpoints are often used in clinical trials instead of well-established hard endpoints for practical convenience. The meta-analytic approach relies on two measures of surrogacy: one at the individual level and one at the trial level. In the survival data setting, a two-step model based on copulas is commonly used. We present a new approach which employs a bivariate survival model with an individual random effect shared between the two endpoints and correlated treatment-by-trial interactions. We fit this model using auxiliary mixed Poisson models. We study via simulations the operating characteristics of this mixed Poisson approach as compared to the two-step copula approach. We illustrate the application of the methods on two individual patient data meta-analyses in gastric cancer, in the advanced setting (4069 patients from 20 randomized trials) and in the adjuvant setting (3288 patients from 14 randomized trials).

Older Adults' Strategic Behavior: Effects of Individual versus Collaborative Cognitive Training

ERIC Educational Resources Information Center

Saczynski, Jane; Margrett, Jennifer; Willis, Sherry

2004-01-01

Changes in strategic behavior were examined in older married couples participating in a cognitive intervention study. Participants were randomly assigned to: Questionnaire Control, Individual Training, or Collaborative Training. Trained participants completed inductive reasoning training sessions at home individually or as a couple. Participants…

Effect of Salsalate on Insulin Action, Secretion, and Clearance in Nondiabetic, Insulin-Resistant Individuals: A Randomized, Placebo-Controlled Study

PubMed Central

Liu, Alice; Ariel, Danit; Abbasi, Fahim; Lamendola, Cindy; Grove, Kaylene; Tomasso, Vanessa; Ochoa, Hector; Reaven, Gerald

2014-01-01

OBJECTIVE Salsalate treatment has been shown to improve glucose homeostasis, but the mechanism remains unclear. The aim of this study was to evaluate the effect of salsalate treatment on insulin action, secretion, and clearance rate in nondiabetic individuals with insulin resistance. RESEARCH DESIGN AND METHODS This was a randomized (2:1), single-blind, placebo-controlled study of salsalate (3.5 g daily for 4 weeks) in nondiabetic individuals with insulin resistance. All individuals had measurement of glucose tolerance (75-g oral glucose tolerance test), steady-state plasma glucose (SSPG; insulin suppression test), and insulin secretion and clearance rate (graded-glucose infusion test) before and after treatment. RESULTS Forty-one individuals were randomized to salsalate (n = 27) and placebo (n = 14). One individual from each group discontinued the study. Salsalate improved fasting (% mean change −7% [95% CI −10 to −14] vs. 1% [−3 to 5], P = 0.005) but not postprandial glucose concentration compared with placebo. Salsalate also lowered fasting triglyceride concentration (−25% [−34 to −15] vs. −6% [−26 to 14], P = 0.04). Salsalate had no effect on SSPG concentration or insulin secretion rate but significantly decreased insulin clearance rate compared with placebo (−23% [−30 to −16] vs. 3% [−10 to 15], P < 0.001). Salsalate was well tolerated, but four individuals needed a dose reduction due to symptoms. CONCLUSIONS Salsalate treatment in nondiabetic, insulin-resistant individuals improved fasting, but not postprandial, glucose and triglyceride concentration. These improvements were associated with a decrease in insulin clearance rate without change in insulin action or insulin secretion. PMID:24963111

Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

PubMed Central

Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

2011-01-01

Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

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

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

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

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers

PubMed Central

Achey, Meredith A.; Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Ziman, Nathan; Aldred, Jason; Carter, Julie; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Mari, Zoltan; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Bull, Michael T.; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy; Anderson, Lauren; Singer, Carlos; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Cooper, Jessica; Webb, Sydney; Dhall, Rohit; Hassan, Anhar; Weis, Delana; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Smith, Joseph; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2016-01-01

Abstract Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. PMID:26886406

The Living Arrangement Dynamics of Sick, Elderly Individuals

ERIC Educational Resources Information Center

Dostie, Benoit; Leger, Pierre Thomas

2005-01-01

We model the dynamics associated with living-arrangement decisions of sick elderly individuals. Using the Panel Study of Income Dynamics? Parental Health Supplement, we construct the complete living-arrangement histories of elderly individuals in need of care. We use a simultaneous random-effects competing-risks model to analyze the impact of…

Inhaled Cannabis for Chronic Neuropathic Pain: A Meta-analysis of Individual Patient Data.

PubMed

Andreae, Michael H; Carter, George M; Shaparin, Naum; Suslov, Kathryn; Ellis, Ronald J; Ware, Mark A; Abrams, Donald I; Prasad, Hannah; Wilsey, Barth; Indyk, Debbie; Johnson, Matthew; Sacks, Henry S

2015-12-01

Chronic neuropathic pain, the most frequent condition affecting the peripheral nervous system, remains underdiagnosed and difficult to treat. Inhaled cannabis may alleviate chronic neuropathic pain. Our objective was to synthesize the evidence on the use of inhaled cannabis for chronic neuropathic pain. We performed a systematic review and a meta-analysis of individual patient data. We registered our protocol with PROSPERO CRD42011001182. We searched in Cochrane Central, PubMed, EMBASE, and AMED. We considered all randomized controlled trials investigating chronic painful neuropathy and comparing inhaled cannabis with placebo. We pooled treatment effects following a hierarchical random-effects Bayesian responder model for the population-averaged subject-specific effect. Our evidence synthesis of individual patient data from 178 participants with 405 observed responses in 5 randomized controlled trials following patients for days to weeks provides evidence that inhaled cannabis results in short-term reductions in chronic neuropathic pain for 1 in every 5 to 6 patients treated (number needed to treat = 5.6 with a Bayesian 95% credible interval ranging between 3.4 and 14). Our inferences were insensitive to model assumptions, priors, and parameter choices. We caution that the small number of studies and participants, the short follow-up, shortcomings in allocation concealment, and considerable attrition limit the conclusions that can be drawn from the review. The Bayes factor is 332, corresponding to a posterior probability of effect of 99.7%. This novel Bayesian meta-analysis of individual patient data from 5 randomized trials suggests that inhaled cannabis may provide short-term relief for 1 in 5 to 6 patients with neuropathic pain. Pragmatic trials are needed to evaluate the long-term benefits and risks of this treatment. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women

DTIC Science & Technology

2004-10-01

This study is a randomized clinical trial comparing two types of individual psychotherapy for treating PTSD in 384 female veterans and active duty...Exposure therapy will be more effective than Present Centered Therapy for the treatment of PTSD in female veterans and active duty personnel. The study has entered the randomized phase. There are no conclusions to date.

Game-Based Learning as a Vehicle to Teach First Aid Content: A Randomized Experiment

ERIC Educational Resources Information Center

Charlier, Nathalie; De Fraine, Bieke

2013-01-01

Background: Knowledge of first aid (FA), which constitutes lifesaving treatments for injuries or illnesses, is important for every individual. In this study, we have set up a group-randomized controlled trial to assess the effectiveness of a board game for learning FA. Methods: Four class groups (120 students) were randomly assigned to 2…

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.

Extensions of Existing Methods for Use with a New Class of Experimental Designs Useful when There Is Treatment Effect Contamination

ERIC Educational Resources Information Center

Rhoads, Christopher

2011-01-01

Researchers planning a randomized field trial to evaluate the effectiveness of an educational intervention often face the following dilemma. They plan to recruit schools to participate in their study. The question is, "Should the researchers randomly assign individuals (either students or teachers, depending on the intervention) within schools to…

How Much Do the Effects of Education and Training Programs Vary across Sites? Evidence from Past Multisite Randomized Trials

ERIC Educational Resources Information Center

Weiss, Michael J.; Bloom, Howard S.; Verbitsky-Savitz, Natalya; Gupta, Himani; Vigil, Alma E.; Cullinan, Daniel N.

2017-01-01

Multisite trials, in which individuals are randomly assigned to alternative treatment arms within sites, offer an excellent opportunity to estimate the cross-site average effect of treatment assignment (intent to treat or ITT) "and" the amount by which this impact varies across sites. Although both of these statistics are substantively…

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

ERIC Educational Resources Information Center

Bettinger, Eric P.; Baker, Rachel B.

2014-01-01

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

Using a Random Dependent Group Contingency to Increase On-Task Behaviors of High School Students with High Incidence Disabilities

ERIC Educational Resources Information Center

Williamson, Brenda D.; Campbell-Whatley, Gloria D.; Lo, Ya-yu

2009-01-01

Group contingencies have the advantages of encouraging individual students to collectively feel responsible for appropriate and inappropriate classroom behaviors and have shown effectiveness in improving students' behavior. The purpose of this study was to investigate the effects of a random dependent group contingency on the on-task behaviors of…

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

NASA Technical Reports Server (NTRS)

Kundic, Tomislav; Wambsganss, Joachim

1993-01-01

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

Effects of Situated Learning on Students' Knowledge Acquisition: An Individual Differences Perspective

ERIC Educational Resources Information Center

Zheng, Robert

2010-01-01

This study focuses on the effects of situated learning on students' knowledge acquisition by investigating the influence of individual differences in such learning. Seventy-nine graduates were recruited from an educational department and were assigned to situated learning and traditional learning based on a randomized block design. Results…

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

Effect of Aromatherapy Massage on Agitation and Depressive Mood in Individuals With Dementia.

PubMed

Yang, Ya-Ping; Wang, Chi-Jane; Wang, Jing-Jy

2016-09-01

The current study examined the effects of aromatherapy massage on alleviating agitation and depressive mood in individuals with dementia. A randomized controlled trial and repeated measures design was conducted. A total of 59 participants were randomly assigned to intervention or control groups. The intervention group received aromatherapy massage once per week for 8 weeks. Results indicated no significant changes over time in overall agitation for either group, but agitation decreased from Week 1 to Week 5 for the intervention group. In addition, the overall depressive symptoms decreased significantly over time for the intervention group compared to the control group (p < 0.001). However, changes in agitation within 24 hours following aromatherapy massage showed some significant changes in Weeks 5 and 9. Aromatherapy massage can be an effective and safe intervention to alleviate specific agitated behaviors and depressive mood in individuals with dementia. [Journal of Gerontological Nursing, 42(9), 38-46.]. Copyright 2016, SLACK Incorporated.

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

Bioequivalence of saxagliptin/dapagliflozin fixed-dose combination tablets compared with coadministration of the individual tablets to healthy subjects.

PubMed

Vakkalagadda, Blisse; Vetter, Marion L; Rana, Jignasa; Smith, Charles H; Huang, Jian; Karkas, Jennifer; Boulton, David W; LaCreta, Frank

2015-12-01

Saxagliptin and dapagliflozin are individually indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The bioequivalence of saxagliptin/dapagliflozin 2.5/5 mg and 5/10 mg fixed-dose combination (FDC) tablets compared with coadministration of the individual tablets and the food effect on both strengths of saxagliptin/dapagliflozin FDCs were evaluated in this open-label, randomized, single-dose crossover study. Healthy subjects were randomized to saxagliptin 2.5 mg + dapagliflozin 5 mg fasted, 2.5/5 mg FDC fasted, 2.5/5 mg FDC fed (Cohort 1) or saxagliptin 5 mg + dapagliflozin 10 mg fasted, 5/10 mg FDC fasted, 5/10 mg FDC fed (Cohort 2). Serial blood samples for pharmacokinetics of saxagliptin and dapagliflozin were obtained predose and up to 60 h postdose. Bioequivalence of FDC tablets versus individual components was concluded if the 90% CIs for FDC to individual component geometric mean ratios of C max, AUC 0-T, and AUC inf of both analytes were between 0.80 and 1.25. Seventy-two subjects were randomized; 71 (98.6%) completed the study. Saxagliptin/dapagliflozin 2.5/5 mg and 5/10 mg FDC tablets were bioequivalent to the individual tablets administered concomitantly. Food had no clinically meaningful effect on saxagliptin or dapagliflozin overall systemic exposure. Saxagliptin/dapagliflozin FDC tablets were bioequivalent to coadministration of the individual components in healthy subjects under fasted conditions and food had no clinically meaningful effect on bioavailability.

Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors

PubMed Central

2013-01-01

Background Effective interventions to improve quality of life of cancer survivors are essential. Numerous randomized controlled trials have evaluated the effects of physical activity or psychosocial interventions on health-related quality of life of cancer survivors, with generally small sample sizes and modest effects. Better targeted interventions may result in larger effects. To realize such targeted interventions, we must determine which interventions that are presently available work for which patients, and what the underlying mechanisms are (that is, the moderators and mediators of physical activity and psychosocial interventions). Individual patient data meta-analysis has been described as the ‘gold standard’ of systematic review methodology. Instead of extracting aggregate data from study reports or from authors, the original research data are sought directly from the investigators. Individual patient data meta-analyses allow for adequate statistical analysis of intervention effects and moderators of such effects. Here, we report the rationale and design of the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) Consortium. The primary aim of POLARIS is 1) to conduct meta-analyses based on individual patient data to evaluate the effect of physical activity and psychosocial interventions on the health-related quality of life of cancer survivors; 2) to identify important demographic, clinical, personal, or intervention-related moderators of the effect; and 3) to build and validate clinical prediction models identifying the most relevant predictors of intervention success. Methods/Design We will invite investigators of randomized controlled trials that evaluate the effects of physical activity and/or psychosocial interventions on health-related quality of life compared with a wait-list, usual care or attention control group among adult cancer survivors to join the POLARIS consortium and share their data for use in pooled analyses that will address the proposed aims. We are in the process of identifying eligible randomized controlled trials through literature searches in four databases. To date, we have identified 132 eligible and unique trials. Discussion The POLARIS consortium will conduct the first individual patient data meta-analyses in order to generate evidence essential to targeting physical activity and psychosocial programs to the individual survivor’s characteristics, capabilities, and preferences. Registration PROSPERO: International prospective register of systematic reviews, CRD42013003805 PMID:24034173

Efficacy of individualized social competence training for children with oppositional defiant disorders/conduct disorders: a randomized controlled trial with an active control group.

PubMed

Goertz-Dorten, Anja; Benesch, Christina; Berk-Pawlitzek, Emel; Faber, Martin; Hautmann, Christopher; Hellmich, Martin; Lindenschmidt, Timo; Schuh, Lioba; Stadermann, Rahel; Doepfner, Manfred

2018-03-28

Patient-focused cognitive-behavioral therapy in children with aggressive behavior, which uses group-based social skills training, has resulted in significant reductions in behavioral problems, with effect sizes in the small-to-medium range. However, effects of individually delivered treatments and effects on aggressive behavior and comorbid conditions rated from different perspectives, child functional impairment, child quality of life, parent-child relationship, and parental psychopathology have rarely been assessed. In a randomized controlled trial, 91 boys aged 6-12 years with a diagnosis of oppositional defiant disorder/conduct disorder and peer-related aggression were randomized to receive individually delivered social competence training (Treatment Program for Children with Aggressive Behavior, THAV) or to an active control involving group play that included techniques to activate resources and the opportunity to train prosocial interactions in groups (PLAY). Outcome measures were rated by parents, teachers, or clinicians. Mostly moderate treatment effects for THAV compared to PLAY were found in parent ratings and/or clinician ratings on aggressive behavior, comorbid symptoms, psychosocial impairment, quality of life, parental stress, and negative expressed emotions. In teacher ratings, significant effects were found for ADHD symptoms and prosocial behavior only. THAV is a specifically effective intervention for boys aged 6-12 years with oppositional defiant disorder/conduct disorder and peer-related aggressive behavior as rated by parents and clinicians.

Continuing or Temporarily Stopping Prestroke Antihypertensive Medication in Acute Stroke: An Individual Patient Data Meta-Analysis.

PubMed

Woodhouse, Lisa J; Manning, Lisa; Potter, John F; Berge, Eivind; Sprigg, Nikola; Wardlaw, Joanna; Lees, Kennedy R; Bath, Philip M; Robinson, Thompson G

2017-05-01

Over 50% of patients are already taking blood pressure-lowering therapy on hospital admission for acute stroke. An individual patient data meta-analysis from randomized controlled trials was undertaken to determine the effect of continuation versus temporarily stopping preexisting antihypertensive medication in acute stroke. Key databases were searched for trials against the following inclusion criteria: randomized design; stroke onset ≤48 hours; investigating the effect of continuation versus stopping prestroke antihypertensive medication; and follow-up of ≥2 weeks. Two randomized controlled trials were identified and included in this meta-analysis of individual patient data from 2860 patients with ≤48 hours of acute stroke. Risk of bias in each study was low. In adjusted logistic regression and multiple regression analyses (using random effects), we found no significant association between continuation of prestroke antihypertensive therapy (versus stopping) and risk of death or dependency at final follow-up: odds ratio 0.96 (95% confidence interval, 0.80-1.14). No significant associations were found between continuation (versus stopping) of therapy and secondary outcomes at final follow-up. Analyses for death and dependency in prespecified subgroups revealed no significant associations with continuation versus temporarily stopping therapy, with the exception of patients randomized ≤12 hours, in whom a difference favoring stopping treatment met statistical significance. We found no significant benefit with continuation of antihypertensive treatment in the acute stroke period. Therefore, there is no urgency to administer preexisting antihypertensive therapy in the first few hours or days after stroke, unless indicated for other comorbid conditions. © 2017 American Heart Association, Inc.

Immediate combined effect of gastrocnemius stretching and sustained talocrural joint mobilization in individuals with limited ankle dorsiflexion: A randomized controlled trial.

PubMed

Kang, Min-Hyeok; Oh, Jae-Seop; Kwon, Oh-Yun; Weon, Jong-Hyuk; An, Duk-Hyun; Yoo, Won-Gyu

2015-12-01

Although gastrocnemius stretching and talocrural joint mobilization have been suggested as effective interventions to address limited ankle dorsiflexion passive range of motion (DF PROM), the effects of a combination of the two interventions have not been identified. The aim of the present study was to compare the effects of gastrocnemius stretching combined with joint mobilization and gastrocnemius stretching alone. A randomized controlled trial. In total, 24 individuals with limited ankle DF PROM were randomized to undergo gastrocnemius stretching combined with joint mobilization (12 feet in 12 individuals) or gastrocnemius stretching alone (12 feet in 12 individuals) for 5 min. Ankle kinematics during gait (time to heel-off and ankle DF before heel-off), ankle DF PROM, posterior talar glide, and displacement of the myotendinous junction (MTJ) of the gastrocnemius were assessed before and after the interventions. The groups were compared using two-way repeated measures analysis of variance. Greater increases in the time to heel-off and ankle DF before heel-off during gait and posterior talar glide were observed in the stretching combined with joint mobilization group versus the stretching alone group. Ankle DF PROM and displacement of the MTJ of the gastrocnemius were increased significantly after the interventions in both groups, with no significant difference between them. These findings suggest that gastrocnemius stretching with joint mobilization needs to be considered to improve ankle kinematics during gait. Copyright © 2015 Elsevier Ltd. All rights reserved.

Randomized controlled trial of parent-enhanced CBT compared with individual CBT for obsessive-compulsive disorder in young people.

PubMed

Reynolds, Shirley A; Clark, Sarah; Smith, Holly; Langdon, Peter E; Payne, Ruth; Bowers, Gemma; Norton, Elisabeth; McIlwham, Harriet

2013-12-01

Obsessive-compulsive disorder (OCD) in young people can be effectively treated with Cognitive Behavior Therapy (CBT). Practice guidelines in the United Kingdom recommend that CBT be delivered with parental or family involvement; however, there is no evidence from randomized trials that this enhances effectiveness. The aim of this trial was to assess if CBT with high parental involvement was more effective than CBT with low parental involvement (individual CBT) in reducing symptoms of OCD. Fifty young people ages 12-17 years with OCD were randomly allocated to individual CBT or parent-enhanced CBT. In parent-enhanced CBT parents attended all treatment sessions; in individual CBT, parents attended only Sessions 1, 7, and the final session. Participants received up to 14 sessions of CBT. Data were analyzed using intent-to-treat and per-protocol methods. The primary outcome measure was the Children's Yale-Brown Obsessive Compulsion Scale (Scahill et al., 1997). Both forms of CBT significantly reduced symptoms of OCD and anxiety. Change in OCD symptoms was maintained at 6 months. Per-protocol analysis suggested that parent-enhanced CBT may be associated with significantly larger reductions in anxiety symptoms. High and low parental involvement in CBT for OCD in young people were both effective, and there was no evidence that 1 method of delivery was superior on the primary outcome measure. However, this study was small. Future trials should be adequately powered and examine interactions with the age of the young person and comorbid anxiety disorders.

Markov and semi-Markov switching linear mixed models used to identify forest tree growth components.

PubMed

Chaubert-Pereira, Florence; Guédon, Yann; Lavergne, Christian; Trottier, Catherine

2010-09-01

Tree growth is assumed to be mainly the result of three components: (i) an endogenous component assumed to be structured as a succession of roughly stationary phases separated by marked change points that are asynchronous among individuals, (ii) a time-varying environmental component assumed to take the form of synchronous fluctuations among individuals, and (iii) an individual component corresponding mainly to the local environment of each tree. To identify and characterize these three components, we propose to use semi-Markov switching linear mixed models, i.e., models that combine linear mixed models in a semi-Markovian manner. The underlying semi-Markov chain represents the succession of growth phases and their lengths (endogenous component) whereas the linear mixed models attached to each state of the underlying semi-Markov chain represent-in the corresponding growth phase-both the influence of time-varying climatic covariates (environmental component) as fixed effects, and interindividual heterogeneity (individual component) as random effects. In this article, we address the estimation of Markov and semi-Markov switching linear mixed models in a general framework. We propose a Monte Carlo expectation-maximization like algorithm whose iterations decompose into three steps: (i) sampling of state sequences given random effects, (ii) prediction of random effects given state sequences, and (iii) maximization. The proposed statistical modeling approach is illustrated by the analysis of successive annual shoots along Corsican pine trunks influenced by climatic covariates. © 2009, The International Biometric Society.

Multimedia Learning and Individual Differences: Mediating the Effects of Working Memory Capacity with Segmentation

ERIC Educational Resources Information Center

Lusk, Danielle L.; Evans, Amber D.; Jeffrey, Thomas R.; Palmer, Keith R.; Wikstrom, Chris S.; Doolittle, Peter E.

2009-01-01

Research in multimedia learning lacks an emphasis on individual difference variables, such as working memory capacity (WMC). The effects of WMC and the segmentation of multimedia instruction were examined by assessing the recall and application of low (n = 66) and high (n = 67) working memory capacity students randomly assigned to either a…

Individualizing duration of antibiotic therapy in community-acquired pneumonia.

PubMed

Aliberti, Stefano; Ramirez, Julio; Giuliani, Fabio; Wiemken, Timothy; Sotgiu, Giovanni; Tedeschi, Sara; Carugati, Manuela; Valenti, Vincenzo; Marchioni, Marco; Camera, Marco; Piro, Roberto; Del Forno, Manuela; Milani, Giuseppe; Faverio, Paola; Richeldi, Luca; Deotto, Martina; Villani, Massimiliano; Voza, Antonio; Tobaldini, Eleonora; Bernardi, Mauro; Bellone, Andrea; Bassetti, Matteo; Blasi, Francesco

2017-08-01

International experts suggest tailoring antibiotic duration in community-acquired pneumonia (CAP) according to patients' characteristics. We aimed to assess the effectiveness of an individualized approach to antibiotic duration based on time in which CAP patients reach clinical stability during hospitalization. In a multicenter, non-inferiority, randomized, controlled trial hospitalized adult patients with CAP reaching clinical stability within 5 days after hospitalization were randomized to a standard vs. individualized antibiotic duration. In the Individualized group, antibiotics were discontinued 48 h after the patient reached clinical stability, with at least five days of total antibiotic treatment. Early failure within 30 days was the primary composite outcome. 135 patients were randomized to the Standard group and 125 to the Individualized group. The trial was interrupted by the safety committee because of an apparent inferiority of the Individualized group over the Standard treatment: 14 (11.2%) patients in the Individualized group experienced early failure vs. 10 (7.4%) patients in the Standard group, p = 0.200, at the intention-to-treat analysis. 30-day mortality rate was four-time higher in the Individualized group than the Standard group. Shortening antibiotic duration according to patients' characteristics still remains an open question. Copyright © 2017 Elsevier Ltd. All rights reserved.

Associating a product with a luxury brand label modulates neural reward processing and favors choices in materialistic individuals.

PubMed

Audrin, Catherine; Ceravolo, Leonardo; Chanal, Julien; Brosch, Tobias; Sander, David

2017-11-23

The present study investigated the extent to which luxury vs. non-luxury brand labels (i.e., extrinsic cues) randomly assigned to items and preferences for these items impact choice, and how this impact may be moderated by materialistic tendencies (i.e., individual characteristics). The main objective was to investigate the neural correlates of abovementioned effects using functional magnetic resonance imaging. Behavioural results showed that the more materialistic people are, the more they choose and like items labelled with luxury brands. Neuroimaging results revealed the implication of a neural network including the dorsolateral and ventromedial prefrontal cortex and the orbitofrontal cortex that was modulated by the brand label and also by the participants' preference. Most importantly, items with randomly assigned luxurious brand labels were preferentially chosen by participants and triggered enhanced signal in the caudate nucleus. This effect increased linearly with materialistic tendencies. Our results highlight the impact of brand-item association, although random in our study, and materialism on preference, relying on subparts of the brain valuation system for the integration of extrinsic cues, preferences and individual characteristics.

Normalcy of food intake in patients with head and neck cancer supported by combined dietary counseling and swallowing therapy: A randomized clinical trial.

PubMed

van den Berg, Manon G A; Kalf, Johanna G; Hendriks, Jan C M; Takes, Robert P; van Herpen, Carla M L; Wanten, Geert J A; Drenth, Joost P H; Kaanders, Johannes H A M; Merkx, Matthias A W

2016-04-01

Dysphagia resulting in altered food intake is common among patients with head and neck cancer. This randomized trial investigated the effect of combined individual dietary counseling with individualized swallowing therapy (intervention) compared to individual dietary counseling (control) on normalcy of food intake (NFI). Patients with stage II to IV head and neck cancer treated with postoperative (chemo)radiation were randomly assigned to this study. NFI, dysphagia severity, social eating, and nutritional status were measured at the start of treatment and in weeks 6, 10, 18, and 30. One hundred twenty patients, 60 in each group, were recruited. No overall estimated difference was detected for NFI, dysphagia severity, social eating, or nutritional status. At week 10, the intervention group slightly improved dysphagia recovery 0.6 (95% confidence interval [CI] = 0.1-1.1). This difference diminished by week 30. Adding individualized swallowing therapy to individual dietary counseling did not improve NFI but slightly accelerate swallowing recovery. © 2015 Wiley Periodicals, Inc. Head Neck 38: E198-E206, 2016. © 2015 Wiley Periodicals, Inc.

The Implications of "Contamination" for Experimental Design in Education

ERIC Educational Resources Information Center

Rhoads, Christopher H.

2011-01-01

Experimental designs that randomly assign entire clusters of individuals (e.g., schools and classrooms) to treatments are frequently advocated as a way of guarding against contamination of the estimated average causal effect of treatment. However, in the absence of contamination, experimental designs that randomly assign intact clusters to…

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…

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

PubMed Central

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

2013-01-01

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 treated for two years. Comprehensive data on cognition and employment were collected annually. Results Individuals treated with CET were significantly more likely to be competitively employed, had greater earnings from employment, and were more satisfied with their employment status by the end of treatment compared to EST recipients. Mediator analyses revealed that improvements in both social and non-social cognition mediated the CET effects on employment. Conclusion CET can help facilitate employment in early schizophrenia, by addressing the cognitive impairments that limit functioning in the disorder. Inclusion of cognitive rehabilitation in social work practice can support more optimal functional recovery from schizophrenia. PMID:23885163

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.

Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

PubMed

Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

2015-06-18

Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

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

Identification of Patients Expected to Benefit from Electronic Alerts for Acute Kidney Injury.

PubMed

Biswas, Aditya; Parikh, Chirag R; Feldman, Harold I; Garg, Amit X; Latham, Stephen; Lin, Haiqun; Palevsky, Paul M; Ugwuowo, Ugochukwu; Wilson, F Perry

2018-06-07

Electronic alerts for heterogenous conditions such as AKI may not provide benefit for all eligible patients and can lead to alert fatigue, suggesting that personalized alert targeting may be useful. Uplift-based alert targeting may be superior to purely prognostic-targeting of interventions because uplift models assess marginal treatment effect rather than likelihood of outcome. This is a secondary analysis of a clinical trial of 2278 adult patients with AKI randomized to an automated, electronic alert system versus usual care. We used three uplift algorithms and one purely prognostic algorithm, trained in 70% of the data, and evaluated the effect of targeting alerts to patients with higher scores in the held-out 30% of the data. The performance of the targeting strategy was assessed as the interaction between the model prediction of likelihood to benefit from alerts and randomization status. The outcome of interest was maximum relative change in creatinine from the time of randomization to 3 days after randomization. The three uplift score algorithms all gave rise to a significant interaction term, suggesting that a strategy of targeting individuals with higher uplift scores would lead to a beneficial effect of AKI alerting, in contrast to the null effect seen in the overall study. The prognostic model did not successfully stratify patients with regards to benefit of the intervention. Among individuals in the high uplift group, alerting was associated with a median reduction in change in creatinine of -5.3% ( P =0.03). In the low uplift group, alerting was associated with a median increase in change in creatinine of +5.3% ( P =0.005). Older individuals, women, and those with a lower randomization creatinine were more likely to receive high uplift scores, suggesting that alerts may benefit those with more slowly developing AKI. Uplift modeling, which accounts for treatment effect, can successfully target electronic alerts for AKI to those most likely to benefit, whereas purely prognostic targeting cannot. Copyright © 2018 by the American Society of Nephrology.

Direct versus indirect and individual versus group modes of language therapy for children with primary language impairment: principal outcomes from a randomized controlled trial and economic evaluation.

PubMed

Boyle, James M; McCartney, Elspeth; O'Hare, Anne; Forbes, John

2009-01-01

Many school-age children with language impairments are enrolled in mainstream schools and receive indirect language therapy, but there have been, to the authors' knowledge, no previous controlled studies comparing the outcomes and costs of direct and indirect intervention delivered by qualified therapists and therapy assistants, and each delivery mode offered to children individually or in groups. To investigate the relative effectiveness of indirect and direct intervention therapy modes delivered individually or in groups for children with primary language impairment. A multi-centre randomized controlled trial investigated 161 children with primary language impairment aged 6-11 years randomized to a usual-therapy control group or to direct individual, indirect individual, direct group or indirect group therapy modes. Intervention was delivered three times a week for 30-40-min sessions in mainstream schools over 15 weeks. Language performance was assessed at baseline, post-therapy and at 12 months. Cost analysis was based on salary and travel costs for intervention modes and usual therapy. Compared with controls, children receiving project therapy made short-term improvements in expressive (p = 0.031), but not receptive, language immediately following intervention. Children with specific expressive language delay were more likely to show improvement than those with mixed receptive-expressive difficulties. The four project therapy modes did not differ on primary language outcomes (all p-values>0.392) and there were no further improvements evident at follow-up. Indirect group therapy was the least costly mode, with direct individual therapy the most costly. Intervention in this age group can be effective for expressive language and can be delivered equally effectively though speech and language therapy assistants and to children in groups.

Methods for sample size determination in cluster randomized trials

PubMed Central

Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

2015-01-01

Background: The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. Methods: We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. Results: We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. Conclusions: There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. PMID:26174515

Testing self-regulation interventions to increase walking using factorial randomized N-of-1 trials.

PubMed

Sniehotta, Falko F; Presseau, Justin; Hobbs, Nicola; Araújo-Soares, Vera

2012-11-01

To investigate the suitability of N-of-1 randomized controlled trials (RCTs) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory (goal setting and self-monitoring) for promoting walking in healthy adult volunteers. A series of N-of-1 RCTs in 10 normal and overweight adults ages 19-67 (M = 36.9 years). We randomly allocated 60 days within each individual to text message-prompted daily goal-setting and/or self-monitoring interventions in accordance with a 2 (step-count goal prompt vs. alternative goal prompt) × 2 (self-monitoring: open vs. blinded Omron-HJ-113-E pedometer) factorial design. Aggregated data were analyzed using random intercept multilevel models. Single cases were analyzed individually. The primary outcome was daily pedometer step counts over 60 days. Single-case analyses showed that 4 participants significantly increased walking: 2 on self-monitoring days and 2 on goal-setting days, compared with control days. Six participants did not benefit from the interventions. In aggregated analyses, mean step counts were higher on goal-setting days (8,499.9 vs. 7,956.3) and on self-monitoring days (8,630.3 vs. 7,825.9). Multilevel analyses showed a significant effect of the self-monitoring condition (p = .01), the goal-setting condition approached significance (p = .08), and there was a small linear increase in walking over time (p = .03). N-of-1 randomized trials are a suitable means to test behavioral interventions in individual participants.

Rational group decision making: A random field Ising model at T = 0

NASA Astrophysics Data System (ADS)

Galam, Serge

1997-02-01

A modified version of a finite random field Ising ferromagnetic model in an external magnetic field at zero temperature is presented to describe group decision making. Fields may have a non-zero average. A postulate of minimum inter-individual conflicts is assumed. Interactions then produce a group polarization along one very choice which is however randomly selected. A small external social pressure is shown to have a drastic effect on the polarization. Individual bias related to personal backgrounds, cultural values and past experiences are introduced via quenched local competing fields. They are shown to be instrumental in generating a larger spectrum of collective new choices beyond initial ones. In particular, compromise is found to results from the existence of individual competing bias. Conflict is shown to weaken group polarization. The model yields new psychosociological insights about consensus and compromise in groups.

Social Stories: Mechanisms of Effectiveness in Increasing Game Play Skills in Children Diagnosed with Autism Spectrum Disorder Using a Pretest Posttest Repeated Measures Randomized Control Group Design

ERIC Educational Resources Information Center

Quirmbach, Linda M.; Lincoln, Alan J.; Feinberg-Gizzo, Monica J.; Ingersoll, Brooke R.; Andrews, Siri M.

2009-01-01

An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A…

The Effects of Student Coaching in College: An Evaluation of a Randomized Experiment in Student Mentoring. NBER Working Paper No. 16881

ERIC Educational Resources Information Center

Bettinger, Eric; Baker, Rachel

2011-01-01

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

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

PubMed

Hazlett-Stevens, Holly; Oren, Yelena

2017-06-01

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

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

Cognitive Reappraisal Self-Efficacy Mediates the Effects of Individual Cognitive-Behavioral Therapy for Social Anxiety Disorder

ERIC Educational Resources Information Center

Goldin, Philippe R.; Ziv, Michal; Jazaieri, Hooria; Werner, Kelly; Kraemer, Helena; Heimberg, Richard G.; Gross, James J.

2012-01-01

Objective: To examine whether changes in cognitive reappraisal self-efficacy (CR-SE) mediate the effects of individually administered cognitive-behavioral therapy (I-CBT) for social anxiety disorder (SAD) on severity of social anxiety symptoms. Method: A randomized controlled trial in which 75 adult patients (21-55 years of age; 53% male; 57%…

The effect of occupational therapy in patients with chronic obstructive pulmonary disease: A randomized controlled trial.

PubMed

Martinsen, Unni; Bentzen, Hege; Holter, Morag Kelly; Nilsen, Tove; Skullerud, Hallvard; Mowinckel, Petter; Kjeken, Ingvild

2017-03-01

Aim The main aim of this study was to evaluate the effect of individualized occupational therapy in patients with chronic obstructive pulmonary disease (COPD). Additionally, the authors wanted to explore the occupational problems experienced in daily life by individuals with COPD. Methods A total of 52 patients were randomly assigned to the intervention group (occupational therapy) or control group (treatment as usual). The primary outcome was assessed using the Canadian Occupational Performance Measure (COPM), and participants were assessed at baseline and after four and 12 months. Results There were no treatment effects on occupational performance or satisfaction with performance, as measured by the COPM. However, we found a significant effect in favour of the intervention group at exertion when performing an individually chosen activity, and in the activity dimension of St George's Respiratory Questionnaire. A total of 595 occupational problems were reported, most frequently within mobility, active recreation, and household management. Conclusions The results show that, compared with the usual care, individualized occupational therapy did not improve occupational performance or satisfaction with performance. Small but significant changes in activity performance in favour of the intervention group were found in some of the secondary outcomes.

Effects of beta-blocker therapy on mortality in patients with heart failure. A systematic overview of randomized controlled trials.

PubMed

Doughty, R N; Rodgers, A; Sharpe, N; MacMahon, S

1997-04-01

Several randomized trials have reported that beta-blocker therapy improves left ventricular function and reduces the rate of hospitalization in patients with congestive heart failure. However, most trials were individually too small to assess reliably the effects of treatment on mortality. In these circumstances a systematic overview of all trials of beta-blocker therapy in patients with congestive heart failure may provide the most reliable guide to treatment effects. Details were sought from all completed randomized trials of oral beta-blocker therapy in patients with heart failure of any aetiology. In particular, data on mortality were sought from all randomized patients for the scheduled treatment period. The typical effect of treatment on mortality was estimated from an overview in which the results of all individual trials were combined using standard statistical methods. Twenty-four randomized trials, involving 3141 patients with stable congestive heart failure were identified. Complete data on mortality were obtained from all studies, and a total of 297 deaths were documented during an average of 13 months of follow-up. Overall, there was a 31% reduction in the odds of death among patients assigned a beta-blocker (95% confidence interval 11 to 46%, 2P = 0.0035), representing an absolute reduction in mean annual mortality from 9.7% to 7.5%. The effects on mortality of vasodilating beta-blockers (47% reduction SD 15), principally carvedilol, were non-significantly greater (2P = 0.09) than those of standard agents (18% reduction SD 15), principally metoprolol. Beta-blocker therapy is likely to reduce mortality in patients with heart failure. However, large-scale, long-term randomized trials are still required to confirm and quantify more precisely the benefit suggested by this overview.

A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery.

PubMed

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

2004-12-01

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 (> or = 6 months) were summarized with random effects models. Intervention effects for smoking cessation were significant at posttreatment and comparable for participants in addictions treatment and recovery; however, intervention effects for smoking cessation were nonsignificant at long-term follow-up. Smoking cessation interventions provided during addictions treatment were associated with a 25% increased likelihood of long-term abstinence from alcohol and illicit drugs. Short-term smoking cessation effects look promising, but innovative strategies are needed for long-term cessation. Contrary to previous concerns, smoking cessation interventions during addictions treatment appeared to enhance rather than compromise long-term sobriety. Copyright 2004 APA.

Effects of creatine supplementation on cognitive function of healthy individuals: A systematic review of randomized controlled trials.

PubMed

Avgerinos, Konstantinos I; Spyrou, Nikolaos; Bougioukas, Konstantinos I; Kapogiannis, Dimitrios

2018-07-15

Creatine is a supplement used by sportsmen to increase athletic performance by improving energy supply to muscle tissues. It is also an essential brain compound and some hypothesize that it aids cognition by improving energy supply and neuroprotection. The aim of this systematic review is to investigate the effects of oral creatine administration on cognitive function in healthy individuals. A search of multiple electronic databases was performed for the identification of randomized clinical trials (RCTs) examining the cognitive effects of oral creatine supplementation in healthy individuals. Six studies (281 individuals) met our inclusion criteria. Generally, there was evidence that short term memory and intelligence/reasoning may be improved by creatine administration. Regarding other cognitive domains, such as long-term memory, spatial memory, memory scanning, attention, executive function, response inhibition, word fluency, reaction time and mental fatigue, the results were conflicting. Performance on cognitive tasks stayed unchanged in young individuals. Vegetarians responded better than meat-eaters in memory tasks but for other cognitive domains no differences were observed. Oral creatine administration may improve short-term memory and intelligence/reasoning of healthy individuals but its effect on other cognitive domains remains unclear. Findings suggest potential benefit for aging and stressed individuals. Since creatine is safe, future studies should include larger sample sizes. It is imperative that creatine should be tested on patients with dementias or cognitive impairment. Copyright © 2018 Elsevier Inc. All rights reserved.

Anabolic steroids for the treatment of weight loss in HIV-infected individuals.

PubMed

Johns, K; Beddall, M J; Corrin, R C

2005-10-19

Individuals with HIV infection often lose weight during the course of their disease. Furthermore, low serum concentrations of testosterone are common in individuals with HIV infection, particularly those with weight loss. Treatment of weight loss with anabolic steroids in HIV-infected individuals may be beneficial. Our objectives were to assess the efficacy and safety of anabolic steroids for the treatment of weight loss in adults with HIV infection. We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, AIDSLINE, AIDSearch, EMBASE, CINAHL, Current Contents, and the National Library of Medicine Gateway Abstracts for controlled trials up to April 2005. We also searched the bibliographies of the identified studies and review the articles. In addition, pharmaceutical manufacturers of anabolic steroids were contacted. Randomized controlled trials that compared the use of an anabolic steroid to placebo to treat weight loss in adults with HIV were included. Randomized controlled trials that compared the use of anabolic steroids to placebo for the treatment of weight loss in adults with HIV were selected. Change from baseline in lean body mass or in body weight was reported as on outcome measure. Two reviewers independently assessed the trials for quality of randomization, blinding, withdrawals, and adequacy of allocation concealment. For continuous data, weighted mean differences (WMD) were calculated. For dichotomous outcomes, risk differences, were calculated. Because of uncertainty as to whether consistent true effects exist in such different populations and treatments, the authors decided a priori to use random effects models for all outcomes. Thirteen trials met the inclusion criteria. Two hundred ninety-four individuals randomized to anabolic steroid therapy and 238 individuals randomized to placebo were included in the analysis of efficacy for change from baseline in lean body mass. Three hundred forty-three individuals randomized to anabolic steroid and 286 randomized to placebo were included in the analysis of efficacy for change from baseline in body weight. The mean methodologic quality of the included studies was 4.1, of a maximum 5 points. Although significant heterogeneity was present for both outcomes, the average change in lean body mass was 1.3 kg (95% CI: 0.6, 2.0), while the average change in total body weight was 1.1 kg (95% CI: 0.3, 2.0). A total of eight deaths occurred during the treatment period; four in the anabolic steroid treatment groups and four in the placebo-treatment groups (risk difference 0.00, 95% CI -0.03, 0.03). The risk difference for withdrawals or discontinuations of study medication due to adverse events was 0.00 (95% CI: -0.02, 0.03). Although the results of the trials were heterogeneous, on average, the administration of anabolic steroids appeared to result in a small increase in both lean body mass and body weight as compared with placebo. While these results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, due to limitations, treatment recommendations cannot be made. Further information is required regarding the long-term benefit and adverse effects of anabolic steroid use, the specific populations for which anabolic steroid therapy may be most beneficial, and the optimal regime. In addition, the correlation of improvement in lean body mass with more clinically relevant endpoints, such as physical functioning and survival, needs to be determined.

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.

Predictors for Physical Activity in Adolescent Girls Using Statistical Shrinkage Techniques for Hierarchical Longitudinal Mixed Effects Models

PubMed Central

Grant, Edward M.; Young, Deborah Rohm; Wu, Tong Tong

2015-01-01

We examined associations among longitudinal, multilevel variables and girls’ physical activity to determine the important predictors for physical activity change at different adolescent ages. The Trial of Activity for Adolescent Girls 2 study (Maryland) contributed participants from 8th (2009) to 11th grade (2011) (n=561). Questionnaires were used to obtain demographic, and psychosocial information (individual- and social-level variables); height, weight, and triceps skinfold to assess body composition; interviews and surveys for school-level data; and self-report for neighborhood-level variables. Moderate to vigorous physical activity minutes were assessed from accelerometers. A doubly regularized linear mixed effects model was used for the longitudinal multilevel data to identify the most important covariates for physical activity. Three fixed effects at the individual level and one random effect at the school level were chosen from an initial total of 66 variables, consisting of 47 fixed effects and 19 random effects variables, in additional to the time effect. Self-management strategies, perceived barriers, and social support from friends were the three selected fixed effects, and whether intramural or interscholastic programs were offered in middle school was the selected random effect. Psychosocial factors and friend support, plus a school’s physical activity environment, affect adolescent girl’s moderate to vigorous physical activity longitudinally. PMID:25928064

Peer Influence on Aggressive Behavior, Smoking, and Sexual Behavior: A Study of Randomly-assigned College Roommates.

PubMed

Li, Yi; Guo, Guang

2016-09-01

Identifying casual peer influence is a long-standing challenge to social scientists. Using data from a natural experiment of randomly-assigned college roommates (N = 2,059), which removes the threat of friend selection, we investigate peer effects on aggressive behavior, smoking, and concurrent sexual partnering. The findings suggest that the magnitude and direction of peer influence depend on predisposition, gender, and the nature of the behavior. Peer effects on individuals predisposed toward a given behavior tend to be larger than peer effects on individuals without such a predisposition. We find that the influence of roommates on aggressive behavior is more pronounced among male students than among female students; roommate effects on smoking are negative among female students and male students who did not smoke before college. For concurrent sexual partnering, a highly private behavior, we find no evidence of peer effects. © American Sociological Association 2016.

Comparison of Cognitive Orientation to daily Occupational Performance and conventional occupational therapy on occupational performance in individuals with stroke: A randomized controlled trial.

PubMed

Ahn, Si-Nae; Yoo, Eun-Young; Jung, Min-Ye; Park, Hae-Yean; Lee, Ji-Yeon; Choi, Yoo-Im

2017-01-01

Cognitive Orientation to daily Occupational Performance (CO-OP) approach based on cognitive strategy in occupational therapy. To investigate the effects of CO-OP approach on occupational performance in individuals with hemiparetic stroke. This study was designed as a 5-week, randomized, single-blind. Forty-three participants who had a diagnosis of first stroke were enrolled in this study. The participants were randomly assigned to the experimental group (n = 20) or the control group (n = 23). The experimental group conducted CO-OP approach while the control group conducted conventional occupational therapy based on occupational performance components. This study measured Canadian Occupational Performance Measure (COPM) and Performance Quality Rating Scale (PQRS). Outcome measurements were performed at baseline and post-intervention. After training, the scores of COPM and PQRS in trained task were significantly higher for the score in the experimental group than the control group. In addition, the non-trained task was significantly higher for the score in the experimental group than the control group in COPM and the PQRS. This study suggests that the CO-OP approach is beneficial effects on the occupational performance to improvement in individuals with hemiparetic stroke, and have positive effects on generalization and transfer of acquired skills.

A multilevel model to estimate the within- and the between-center components of the exposure/disease association in the EPIC study.

PubMed

Sera, Francesco; Ferrari, Pietro

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence.

Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial.

PubMed

Givon, Noa; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

2016-04-01

To investigate the feasibility of using video-games in a group setting and to compare the effectiveness of video-games as a group intervention to a traditional group intervention for improving physical activity in individuals with chronic stroke. A single-blind randomized controlled trial with evaluations pre and post a 3-month intervention, and at 3-month follow-up. Compliance (session attendance), satisfaction and adverse effects were feasibility measures. Grip strength and gait speed were measures of physical activity. Hip accelerometers quantified steps/day and the Action Research Arm Test assessed the functional ability of the upper extremity. Forty-seven community-dwelling individuals with chronic stroke (29-78 years) were randomly allocated to receive video-game (N=24) or traditional therapy (N=23) in a group setting. There was high treatment compliance for both interventions (video-games-78%, traditional therapy-66%), but satisfaction was rated higher for the video-game (93%) than the traditional therapy (71%) (χ(2)=4.98, P=0.026). Adverse effects were not reported in either group. Significant improvements were demonstrated in both groups for gait speed (F=3.9, P=0.02), grip strength of the weaker (F=6.67, P=0.002) and stronger hands (F=7.5, P=0.001). Daily steps and functional ability of the weaker hand did not increase in either group. Using video-games in a small group setting is feasible, safe and satisfying. Video-games improve indicators of physical activity of individuals with chronic stroke. © The Author(s) 2015.

Statistical controversies in clinical research: an initial evaluation of a surrogate end point using a single randomized clinical trial and the Prentice criteria

PubMed Central

Heller, G.

2015-01-01

Surrogate end point research has grown in recent years with the increasing development and usage of biomarkers in clinical research. Surrogacy analysis is derived through randomized clinical trial data and it is carried out at the individual level and at the trial level. A common surrogate analysis at the individual level is the application of the Prentice criteria. An approach for the evaluation of the Prentice criteria is discussed, with a focus on its most difficult component, the determination of whether the treatment effect is captured by the surrogate. An interpretation of this criterion is illustrated using data from a randomized clinical trial in prostate cancer. PMID:26254442

Why caution is recommended with post-hoc individual patient matching for estimation of treatment effect in parallel-group randomized controlled trials: the case of acute stroke trials.

PubMed

Jafari, Nahid; Hearne, John; Churilov, Leonid

2013-11-10

A post-hoc individual patient matching procedure was recently proposed within the context of parallel group randomized clinical trials (RCTs) as a method for estimating treatment effect. In this paper, we consider a post-hoc individual patient matching problem within a parallel group RCT as a multi-objective decision-making problem focussing on the trade-off between the quality of individual matches and the overall percentage of matching. Using acute stroke trials as a context, we utilize exact optimization and simulation techniques to investigate a complex relationship between the overall percentage of individual post-hoc matching, the size of the respective RCT, and the quality of matching on variables highly prognostic for a good functional outcome after stroke, as well as the dispersion in these variables. It is empirically confirmed that a high percentage of individual post-hoc matching can only be achieved when the differences in prognostic baseline variables between individually matched subjects within the same pair are sufficiently large and that the unmatched subjects are qualitatively different to the matched ones. It is concluded that the post-hoc individual matching as a technique for treatment effect estimation in parallel-group RCTs should be exercised with caution because of its propensity to introduce significant bias and reduce validity. If used with appropriate caution and thorough evaluation, this approach can complement other viable alternative approaches for estimating the treatment effect. Copyright © 2013 John Wiley & Sons, Ltd.

Effectiveness of Caregiver Training in Mindfulness-Based Positive Behavior Support (MBPBS) vs. Training-as-Usual (TAU): A Randomized Controlled Trial

PubMed Central

Singh, Nirbhay N.; Lancioni, Giulio E.; Karazsia, Bryan T.; Chan, Jeffrey; Winton, Alan S. W.

2016-01-01

Caregivers of individuals with intellectual and developmental disabilities (IDD) often end up having their medical and psychological well-being compromised due to the stressful nature of caregiving, especially when those in their care engage in aggressive behavior. In this study, we provided caregivers with mindfulness-based training to enable them to better manage their psychological well-being and, through this, to also enhance specific indices of quality of life of the individuals in their care. Thus, the aim of the present study was to evaluate in a randomized controlled trial (RCT) the comparative effectiveness of Mindfulness-Based Positive Behavior Support (MBPBS) and Training-as-Usual (TAU) for caregivers in a congregate care facility for individuals with severe and profound IDD. The comparative effects of the two training conditions were assessed in terms of caregiver variables care recipient variable (number of aggressive events), and agency variables Results showed that MBPBS was significantly more effective than TAU in enabling the caregivers to manage their perceived psychological stress, and to reduce the use of physical restraints and stat medications for aggressive behavior of the individuals in their care. In addition, there were significant reductions in aggressive events by the individuals in their care, 1:1 staffing of individuals with aggressive behavior, and staff turnover. Furthermore, the MBPBS training was significantly more cost-effective than the TAU training. If replicated in future RCT studies, MBPBS may provide an effective means of enhancing socially acceptable bidirectional engagement of caregivers and care recipients within a person-centered context. PMID:27766088

Stimulant Treatment Reduces Lapses in Attention among Children with ADHD: The Effects of Methylphenidate on Intra-Individual Response Time Distributions

ERIC Educational Resources Information Center

Spencer, Sarah V.; Hawk, Larry W., Jr.; Richards, Jerry B.; Shiels, Keri; Pelham, William E., Jr.; Waxmonsky, James G.

2009-01-01

Recent research has suggested that intra-individual variability in reaction time (RT) distributions of children with ADHD is characterized by a particularly large rightward skew that may reflect lapses in attention. The purpose of the study was to provide the first randomized, placebo-controlled test of the effects of the stimulant methylphenidate…

Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial.

PubMed

Dumoulin, Chantale; Morin, Mélanie; Mayrand, Marie-Hélène; Tousignant, Michel; Abrahamowicz, Michal

2017-11-16

Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT. The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages. Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice. ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

On Estimation of the Survivor Average Causal Effect in Observational Studies when Important Confounders are Missing Due to Death

PubMed Central

Egleston, Brian L.; Scharfstein, Daniel O.; MacKenzie, Ellen

2008-01-01

We focus on estimation of the causal effect of treatment on the functional status of individuals at a fixed point in time t* after they have experienced a catastrophic event, from observational data with the following features: (1) treatment is imposed shortly after the event and is non-randomized, (2) individuals who survive to t* are scheduled to be interviewed, (3) there is interview non-response, (4) individuals who die prior to t* are missing information on pre-event confounders, (5) medical records are abstracted on all individuals to obtain information on post-event, pre-treatment confounding factors. To address the issue of survivor bias, we seek to estimate the survivor average causal effect (SACE), the effect of treatment on functional status among the cohort of individuals who would survive to t* regardless of whether or not assigned to treatment. To estimate this effect from observational data, we need to impose untestable assumptions, which depend on the collection of all confounding factors. Since pre-event information is missing on those who die prior to t*, it is unlikely that these data are missing at random (MAR). We introduce a sensitivity analysis methodology to evaluate the robustness of SACE inferences to deviations from the MAR assumption. We apply our methodology to the evaluation of the effect of trauma center care on vitality outcomes using data from the National Study on Costs and Outcomes of Trauma Care. PMID:18759833

Comparing Ways of Altering Parent-Child Interaction.

ERIC Educational Resources Information Center

Kogan, Kate L.; Tyler, Nancy B.

This study tests the effectiveness of 2 approaches to parenting instruction for parents of preschool developmentally delayed children aged 3 through 5. Sixty parent/child pairs were randomly assigned to 1 of 3 groups: (1) individual parenting instruction only, (2) individual plus group instruction, and (3) comparison group with no instruction.…

Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

PubMed Central

Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

2015-01-01

Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

Testing cardiovascular drug safety and efficacy in randomized trials.

PubMed

FitzGerald, Garret A

2014-03-28

Randomized trials provide the gold standard evidence on which rests the decision to approve novel therapeutics for clinical use. They are large and expensive and provide average but unbiased estimates of efficacy and risk. Concern has been expressed about how unrepresentative populations and conditions that pertain in randomized trials might be of the real world, including concerns about the homogeneity of the biomedical and adherence characteristics of volunteers entered into such trials, the dose and constancy of drug administration and the mixture of additional medications that are restricted in such trials but might influence outcome in practice. A distinction has been drawn between trials that establish efficacy and those that demonstrate effectiveness, drugs that patients actually consume in the real world for clinical benefit. However, randomized controlled trials remain the gold standard for establishing efficacy and the testing of effectiveness with less rigorous approaches is a secondary, albeit important consideration. Despite this, there is an appreciation that average results may conceal considerable interindividual variation in drug response, leading to a failure to appreciate clinical value or risk in subsets of patients. Thus, attempts are now being made to individualize risk estimates by modulating those derived from large randomized trials with the individual baseline risk estimates based on demographic and biological criteria-the individual Numbers Needed to Treat to obtain a benefit, such as a life saved. Here, I will consider some reasons why large phase 3 trials-by far the most expensive element of drug development-may fail to address the unmet medical needs, which should justify such effort and investment.

Estimation of breeding values using selected pedigree records.

PubMed

Morton, Richard; Howarth, Jordan M

2005-06-01

Fish bred in tanks or ponds cannot be easily tagged individually. The parentage of any individual may be determined by DNA fingerprinting, but is sufficiently expensive that large numbers cannot be so finger-printed. The measurement of the objective trait can be made on a much larger sample relatively cheaply. This article deals with experimental designs for selecting individuals to be finger-printed and for the estimation of the individual and family breeding values. The general setup provides estimates for both genetic effects regarded as fixed or random and for fixed effects due to known regressors. The family effects can be well estimated when even very small numbers are finger-printed, provided that they are the individuals with the most extreme phenotypes.

A randomized controlled study of exposure therapy as aftercare for alcohol use disorder: study protocol.

PubMed

Mellentin, Angelina Isabella; Nielsen, Bent; Nielsen, Anette Søgaard; Yu, Fei; Stenager, Elsebeth

2016-04-21

It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapses when discharged from treatment and confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on exposing individuals to alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aims of the study are: 1) to investigate whether CET aftercare delivered via a smartphone or in group sessions increases the effect of Cognitive Behavioural Treatment in groups of alcohol dependent individuals; 2) to investigate whether CET as a smartphone application is as or more effective than CET group therapy, and 3) to investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual. The study will be implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized into one of the three following aftercare groups after concluding primary treatment: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Aftercare as Usual. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to the control group (3). Individuals in the CET groups are given the opportunity to practise coping strategies during exposure to alcohol stimuli before being unavoidably confronted with alcohol and associated stimuli in real life. Thus, CET may help prevent patients from relapsing after concluding treatment, and in the long term. Moreover, the CET application has the potential to improve AUD treatment and continuing care by offering psychological treatment whenever and wherever the patient finds it convenient. ClinicalTrials.gov ID: NCT02298751 Registration date: 6 November 2014.

Effects of mixing in threshold models of social behavior

NASA Astrophysics Data System (ADS)

Akhmetzhanov, Andrei R.; Worden, Lee; Dushoff, Jonathan

2013-07-01

We consider the dynamics of an extension of the influential Granovetter model of social behavior, where individuals are affected by their personal preferences and observation of the neighbors’ behavior. Individuals are arranged in a network (usually the square lattice), and each has a state and a fixed threshold for behavior changes. We simulate the system asynchronously by picking a random individual and we either update its state or exchange it with another randomly chosen individual (mixing). We describe the dynamics analytically in the fast-mixing limit by using the mean-field approximation and investigate it mainly numerically in the case of finite mixing. We show that the dynamics converge to a manifold in state space, which determines the possible equilibria, and show how to estimate the projection of this manifold by using simulated trajectories, emitted from different initial points. We show that the effects of considering the network can be decomposed into finite-neighborhood effects, and finite-mixing-rate effects, which have qualitatively similar effects. Both of these effects increase the tendency of the system to move from a less-desired equilibrium to the “ground state.” Our findings can be used to probe shifts in behavioral norms and have implications for the role of information flow in determining when social norms that have become unpopular in particular communities (such as foot binding or female genital cutting) persist or vanish.

Effect of food prices on the prevalence of obesity among young adults.

PubMed

Han, E; Powell, L M

2011-03-01

To examine the extent to which various food prices were associated with the obesity status of young adults. Retrospective cohort study of 6537 men and 5324 women in the USA using panel data from the Monitoring the Future Surveys (1992-2003), which were merged with two food-at-home and one food-away-from-home price measures from the American Chamber of Commerce Researchers Association. Longitudinal individual random effect and fixed effect models were estimated. This study found that food prices did not have a significant effect on the prevalence of obesity among young female adults. For young adult men, an individual random effect estimator suggested that a 10% increase in the price of fast food was associated with a 13.2% decrease in the probability of obesity, but this effect lost its economic and statistical significance once individual fixed effects were controlled for in the estimation. Overall, the results imply that observed time-varying individual characteristics, such as working status, marital status and school enrolment status, may over-ride the effect of changes in food prices for young adults. More research employing longitudinal data is necessary to determine if food subsidies or taxes, particularly soft drink and fast food taxes or subsidies for fruit and vegetables, could be effective policy measures to curtail the increasing prevalence of obesity among young adults. Copyright © 2010 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Epidemic spreading on random surfer networks with optimal interaction radius

NASA Astrophysics Data System (ADS)

Feng, Yun; Ding, Li; Hu, Ping

2018-03-01

In this paper, the optimal control problem of epidemic spreading on random surfer heterogeneous networks is considered. An epidemic spreading model is established according to the classification of individual's initial interaction radii. Then, a control strategy is proposed based on adjusting individual's interaction radii. The global stability of the disease free and endemic equilibrium of the model is investigated. We prove that an optimal solution exists for the optimal control problem and the explicit form of which is presented. Numerical simulations are conducted to verify the correctness of the theoretical results. It is proved that the optimal control strategy is effective to minimize the density of infected individuals and the cost associated with the adjustment of interaction radii.

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.

The Effectiveness of an Individualized Learning Method of Instruction When Compared to the Lecture-Discussion Method. A Research Report of a Graduate Study.

ERIC Educational Resources Information Center

Oen, Urban T.; Sweany, H. Paul

To compare the effectiveness of individualized and lecture-discussion methods with a non-instruction (Control) method in developing turfgrass competencies in 11th and 12th grade students as measured by achievement in a battery of tests, teachers from 29 Michigan schools were randomly placed in three groups and attended workshops where they were…

Individualized functional restoration as an adjunct to advice for lumbar disc herniation with associated radiculopathy. A preplanned subgroup analysis of a randomized controlled trial.

PubMed

Hahne, Andrew J; Ford, Jon J; Hinman, Rana S; Richards, Matthew C; Surkitt, Luke D; Chan, Alexander Y P; Slater, Sarah L; Taylor, Nicholas F

2017-03-01

Physical therapy is commonly sought by people with lumbar disc herniation and associated radiculopathy. It is unclear whether physical therapy is effective for this population. To determine the effectiveness of physical therapist-delivered individualized functional restoration as an adjunct to guideline-based advice in people with lumbar disc herniation and associated radiculopathy. This is a preplanned subgroup analysis of a multicenter parallel group randomized controlled trial. The study included 54 participants with clinical features of radiculopathy (6-week to 6-month duration) and imaging showing a lumbar disc herniation. Primary outcomes were activity limitation (Oswestry Disability Index) and separate 0-10 numerical pain rating scales for leg pain and back pain. Measures were taken at baseline and at 5, 10, 26, and 52 weeks. The participants were randomly allocated to receive either individualized functional restoration incorporating advice (10 sessions) or guideline-based advice alone (2 sessions) over a 10-week period. Treatment was administered by 11 physical therapists at private clinics in Melbourne, Australia. Between-group differences for activity limitation favored the addition of individualized functional restoration to advice alone at 10 weeks (7.7, 95% confidence interval [CI] 0.3-15.1) and 52 weeks (8.2, 95% CI 0.7-15.6), as well as back pain at 10 weeks (1.4, 95% CI 0.2-2.7). There were no significant differences between groups for leg pain at any follow-up. Several secondary outcomes also favored individualized functional restoration over advice. In participants with lumbar disc herniation and associated radiculopathy, an individualized functional restoration program incorporating advice led to greater reduction in activity limitation at 10- and 52-week follow-ups compared with guideline-based advice alone. Although back pain was significantly reduced at 10 weeks with individualized functional restoration, this effect was not maintained at later timepoints, and there were no significant effects on leg pain, relative to guideline-based advice. Copyright © 2016 Elsevier Inc. All rights reserved.

Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial.

PubMed

Wilks, Chelsey; Yin, Qingqing; Ang, Sin Yee; Matsumiya, Brandon; Lungu, Anita; Linehan, Marsha

2017-10-25

The need to develop effective and accessible interventions for suicidal individuals engaging in heavy episodic drinking (HED) cannot be understated. While the link between alcohol use and suicidality is a complex one that remains to be elucidated, emotion dysregulation may play a key role in alcohol-related suicide risk in these individuals. In the current study, an 8-week Internet-delivered dialectical behavior therapy (DBT) skills training intervention was developed and preliminarily evaluated for suicidal individuals who engage in HED to regulate emotions. The aim of the study is to evaluate the feasibility and effectiveness of the therapist-assisted and Internet-delivered intervention, and to inform the design of a subsequent full-scale study. The study was a pilot randomized controlled trial comparing participants receiving immediate-treatment (n=30) to waitlist controls (n=29) over a period of 16 weeks. Intervention effects will be assessed longitudinally using hierarchical linear modeling and generalized estimating equations, along with analyses of effect sizes and clinically significant change. The primary outcomes are suicidal ideation, alcohol problems, and emotion dysregulation. Secondary outcomes include alcohol-related consequences, reasons for living, skills use, and depression. The trial is ongoing. A total of 60 individuals returned their informed consent and were randomized, of whom 59 individuals were intended to treat. A total of 50 participants in the study were retained through the 16-week enrollment. There is a dearth of evidence-based treatment for individuals presenting with high risk and complex behaviors. Furthermore, computerized interventions may provide a beneficial alternative to traditional therapies. The particular clinical features and treatment needs of suicidal individuals who also engage in HED constitute key domains for further investigation that are needed to consolidate the design of appropriate interventions for this high-risk population. Clinicaltrials.gov NCT02932241; https://clinicaltrials.gov/ct2/show/NCT02932241 (Archived by WebCite at http://www.webcitation.org/6uJHdQsC2). ©Chelsey Wilks, Qingqing Yin, Sin Yee Ang, Brandon Matsumiya, Anita Lungu, Marsha Linehan. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.10.2017.

Immediate effects of adding mental practice to physical practice on the gait of individuals with Parkinson's disease: Randomized clinical trial.

PubMed

Santiago, Lorenna Marques de Melo; de Oliveira, Daniel Antunes; de Macêdo Ferreira, Louise Gabriella Lopes; de Brito Pinto, Hyanne Yasmim; Spaniol, Ana Paula; de Lucena Trigueiro, Larissa Coutinho; Ribeiro, Tatiana Souza; de Sousa, Angélica Vieira Cavalcanti; Piemonte, Maria Elisa Pimentel; Lindquist, Ana Raquel Rodrigues

2015-01-01

Mental practice has shown benefits in the rehabilitation of neurological patients, however, there is no evidence of immediate effects on gait of individuals with Parkinson's disease. Determine the effects of mental practice activity added to physical practice on the gait of individuals with Idiopathic Parkinson's Disease (IPD). 20 patients classified with stage 2 and 3, according to the Hoehn and Yahr scale were randomized into 2 groups. The experimental group (N = 10) was submitted to a single session of mental practice and physical practice gait protocol and the control group (N = 10) only to physical practice. The primary outcomes were stride length and total stance and swing time. Secondary outcomes were hip range of motion, velocity and mobility. Subjects were reassessed 10 minutes, 1 day and 7 days after the end of the session. There was no statistically significant difference between the groups. An intragroup difference was observed in velocity, stride length, hip range of motion, and mobility, as well as total stance and swing time. These results were also observed on follow-ups. Mental practice did not have a greater effect on the gait of individuals with IPD than physical practice, after a single session.

A new approach to hierarchical data analysis: Targeted maximum likelihood estimation for the causal effect of a cluster-level exposure.

PubMed

Balzer, Laura B; Zheng, Wenjing; van der Laan, Mark J; Petersen, Maya L

2018-01-01

We often seek to estimate the impact of an exposure naturally occurring or randomly assigned at the cluster-level. For example, the literature on neighborhood determinants of health continues to grow. Likewise, community randomized trials are applied to learn about real-world implementation, sustainability, and population effects of interventions with proven individual-level efficacy. In these settings, individual-level outcomes are correlated due to shared cluster-level factors, including the exposure, as well as social or biological interactions between individuals. To flexibly and efficiently estimate the effect of a cluster-level exposure, we present two targeted maximum likelihood estimators (TMLEs). The first TMLE is developed under a non-parametric causal model, which allows for arbitrary interactions between individuals within a cluster. These interactions include direct transmission of the outcome (i.e. contagion) and influence of one individual's covariates on another's outcome (i.e. covariate interference). The second TMLE is developed under a causal sub-model assuming the cluster-level and individual-specific covariates are sufficient to control for confounding. Simulations compare the alternative estimators and illustrate the potential gains from pairing individual-level risk factors and outcomes during estimation, while avoiding unwarranted assumptions. Our results suggest that estimation under the sub-model can result in bias and misleading inference in an observational setting. Incorporating working assumptions during estimation is more robust than assuming they hold in the underlying causal model. We illustrate our approach with an application to HIV prevention and treatment.

Assessment and model guided cancer screening promotion by village doctors in China: a randomized controlled trial protocol.

PubMed

Feng, Rui; Shen, Xingrong; Chai, Jing; Chen, Penglai; Cheng, Jing; Liang, Han; Zhao, Ting; Sha, Rui; Li, Kaichun; Wang, Debin

2015-10-12

Proven cost-effectiveness contrasted by low uptake of cancer screening (CS) calls for new methodologies promoting the service. Contemporary interventions in this regard relies primarily on strategies targeting general or specific groups with limited attention being paid to individualized approaches. This trial tests a novel package promoting CS utilization via continuous and tailored counseling delivered by primary caregivers. It aims at demonstrating that high risk individuals in the intervention arm will, compared to those in the delayed intervention condition, show increased use of CS service. The trial adopts a quasi-randomized controlled trial design and involves 2160 high risk individuals selected, via rapid and detailed risk assessments, from about 72,000 farmers aged 35+ in 36 administrative villages randomized into equal intervention and delayed intervention arms. The CS intervention package uses: a) village doctors and village clinics to deliver personalized and thus relatively sophisticated CS counseling; b) two-stage risk assessment models in identifying high risk individuals to focus the intervention on the most needed; c) standardized operation procedures to guide conduct of counseling; d) real-time effectiveness and quality monitoring to leverage continuous improvement; e) web-based electronic system to enable prioritizing complex determinants of CS uptake and tailoring counseling sessions to the changing needs of individual farmers. The intervention arm receives baseline and semiannual follow up evaluations plus CS counseling for 5 years; while the delayed intervention arm, only the same baseline and follow-up evaluations for the first 5 years and CS counseling starting from the 6th year if the intervention proved effective. Evaluation measures include: CS uptake by high risk farmers and changes in their knowledge, perceptions and self-efficacy about CS. Given the complexity and heterogeneity in the determinant system of individual CS service seeking behavior, personalized interventions may prove to be an effective strategy. The current trial distinguishes itself from previous ones in that it not only adopts a personalized strategy but also introduces a package of pragmatic solutions based on proven theories for tackling potential barriers and incorporating key success factors in a synergetic way toward low cost, effective and sustainable CS promotion. ISRCTN33269053.

A randomized controlled trial of a transdiagnostic Internet intervention for individuals with panic and phobias - One size fits all.

PubMed

Schröder, Johanna; Jelinek, Lena; Moritz, Steffen

2017-03-01

Many individuals with anxiety disorders do not receive professional treatment. Internet interventions have shown to be effective in the treatment of anxiety. The present randomized controlled trial was designed to examine the effectiveness of a short-term (4-week) Internet intervention in treating panic disorder, agoraphobia, social anxiety disorder, and specific phobias ('ConfID'). We addressed the questions of whether this transdiagnostic program would affect these disorders to varying degrees and whether there would be moderators of effectiveness. Adults who were recruited in online forums for anxiety underwent an online baseline assessment (N = 179) and were randomized either to the intervention group (ConfID) or the control group (care as usual). Online post-assessment took place 4 weeks later. The primary outcome was assessed with the Beck Anxiety Inventory (BAI); the secondary outcomes targeted the disorder-specific symptoms, depression, and somatization. Participants in the intervention group showed a significantly stronger anxiety reduction compared to participants receiving care as usual (small-to-medium effect size between groups in intention-to-treat analysis). The treatment effect was similar for the different disorders and was moderated by participants' attitudes towards Internet interventions. Secondary outcomes yielded effect sizes in the medium range. Moderate treatment adherence, lack of measures beyond online self-reports, and unavailability of long-term results. The study provides further evidence that transdiagnostic Internet interventions are promising in reducing the existing treatment gap in individuals with panic disorder and phobias. Results extend previous findings by showing that significant effects can also be reached by comprehensive short-term programs and that the effects might be moderated by participants' attitudes towards Internet interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Double-Blind, Randomized Pilot Trial of Chromium Picolinate for Overweight Individuals with Binge-Eating Disorder: Effects on Glucose Regulation.

PubMed

Sala, Margarita; Breithaupt, Lauren; Bulik, Cynthia M; Hamer, Robert M; La Via, Maria C; Brownley, Kimberly A

2017-03-04

Chromium treatment has been shown to improve glucose regulation in some populations. The purpose of this study was to evaluate whether chromium picolinate (CrPic) supplementation improves glucose regulation in overweight individuals with binge-eating disorder (BED). In this double-blinded randomized pilot trial, participants (N = 24) were randomized to high (HIGH, 1000 mcg/day, n = 8) or moderate (MOD, 600 mcg/day, n = 9) dose of CrPic or placebo (PL, n = 7) for 6 months. Participants completed an oral glucose tolerance test (OGTT) at baseline, 3 months, and 6 months. Fixed effects models were used to estimate mean change in glucose area under the curve (AUC), insulin AUC , and insulin sensitivity index (ISI). Results revealed a significant group and time interaction (p < 0.04) for glucose AUC , with glucose AUC increasing significantly in the PL group (p < 0.02) but decreasing significantly in the MOD group (p < 0.03) at 6 months. Insulin AUC increased significantly over time (main effect, p < 0.02), whereas ISI decreased significantly over time (main effect, p < 0.03). As anticipated, a moderate dose of CrPic was associated with improved glycemic control, whereas PL was associated with decreased glycemic control. It was unexpected that the improved glycemic control seen in the MOD dose group was not seen in the HIGH dose group. However, although participants randomized to the HIGH dose group did not have improved glycemic control, they had better glycemic control than participants randomized to the PL group. These findings support the need for larger trials.

Hypothesis testing in clinical trials.

PubMed

Green, S B

2000-08-01

In designing and analyzing any clinical trial, two issues related to patient heterogeneity must be considered: (1) the effect of chance and (2) the effect of bias. These issues are addressed by enrolling adequate numbers of patients in the study and using randomization for treatment assignment. An "intention-to-treat" analysis of outcome data includes all individuals randomized and counted in the group to which they are randomized. There is an increased risk of spurious results with a greater number of subgroup analyses, particularly when these analyses are data derived. Factorial designs are sometimes appropriate and can lead to efficiencies by addressing more than one comparison of interventions in a single trial.

A Multilevel Model to Estimate the Within- and the Between-Center Components of the Exposure/Disease Association in the EPIC Study

PubMed Central

2015-01-01

In a multicenter study, the overall relationship between exposure and the risk of cancer can be broken down into a within-center component, which reflects the individual level association, and a between-center relationship, which captures the association at the aggregate level. A piecewise exponential proportional hazards model with random effects was used to evaluate the association between dietary fiber intake and colorectal cancer (CRC) risk in the EPIC study. During an average follow-up of 11.0 years, 4,517 CRC events occurred among study participants recruited in 28 centers from ten European countries. Models were adjusted by relevant confounding factors. Heterogeneity among centers was modelled with random effects. Linear regression calibration was used to account for errors in dietary questionnaire (DQ) measurements. Risk ratio estimates for a 10 g/day increment in dietary fiber were equal to 0.90 (95%CI: 0.85, 0.96) and 0.85 (0.64, 1.14), at the individual and aggregate levels, respectively, while calibrated estimates were 0.85 (0.76, 0.94), and 0.87 (0.65, 1.15), respectively. In multicenter studies, over a straightforward ecological analysis, random effects models allow information at the individual and ecologic levels to be captured, while controlling for confounding at both levels of evidence. PMID:25785729

Sudden Gains in Cognitive Therapy and Interpersonal Therapy for Social Anxiety Disorder

ERIC Educational Resources Information Center

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

2013-01-01

Objective: 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). Method: Participants were 67 individuals with SAD who received 16 treatment sessions. Symptom severity at each session…

Tailoring Messages to Individual Differences in Monitoring-Blunting Styles to Increase Fruit and Vegetable Intake

ERIC Educational Resources Information Center

Williams-Piehota, Pamela; Latimer, Amy E.; Katulak, Nicole A.; Cox, Ashley; Silvera, Stephanie A. N.; Mowad, Linda; Salovey, Peter

2009-01-01

Objective: To examine whether messages matched to individuals' monitoring-blunting coping styles (MBCS) are more effective in increasing fruit and vegetable intake than mismatched messages. MBCS refers to the tendency to either attend to and amplify, or distract oneself from and minimize threatening information. Design/Setting: Randomly assigned…

JobTIPS: A Transition to Employment Program for Individuals with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Strickland, Dorothy C.; Coles, Claire D.; Southern, Louise B.

2013-01-01

This study evaluated the effectiveness of an internet accessed training program that included Theory of Mind-based guidance, video models, visual supports, and virtual reality practice sessions in teaching appropriate job interview skills to individuals with high functioning Autism Spectrum Disorders. In a randomized study, twenty-two youth, ages…

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

PubMed Central

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

2010-01-01

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

A Multisite Randomized Trial of a Cognitive Skills Program for Male Mentally Disordered Offenders: Violence and Antisocial Behavior Outcomes

ERIC Educational Resources Information Center

Cullen, Alexis E.; Clarke, Amory Y.; Kuipers, Elizabeth; Hodgins, Sheilagh; Dean, Kimberlie; Fahy, Tom

2012-01-01

Objective: Despite a large evidence base indicating that cognitive skills programs can reduce reoffending in individuals without mental illness, there have been no randomized controlled trials (RCTs) to determine their effectiveness in mentally disordered offenders (MDOs). In the first RCT of a cognitive skills program for MDOs, we aimed to…

Competency-Based Training and Worker Turnover in Community Supports for People with IDD: Results from a Group Randomized Controlled Study

ERIC Educational Resources Information Center

Bogenschutz, Matthew; Nord, Derek; Hewitt, Amy

2015-01-01

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…

Optimal Design in Three-Level Block Randomized Designs with Two Levels of Nesting: An ANOVA Framework with Random Effects

ERIC Educational Resources Information Center

Konstantopoulos, Spyros

2013-01-01

Large-scale experiments that involve nested structures may assign treatment conditions either to subgroups such as classrooms or to individuals such as students within subgroups. Key aspects of the design of such experiments include knowledge of the variance structure in higher levels and the sample sizes necessary to reach sufficient power to…

Effects of omega-3 fatty acid supplementation on mood and emotional information processing in recovered depressed individuals.

PubMed

Antypa, Niki; Smelt, August H M; Strengholt, Annette; Van der Does, A J Willem

2012-05-01

Beneficial effects of omega-3 fatty acids have been reported for several psychiatric disorders, particularly for depression. Association studies show a relationship between omega-3 intake and depression risk. Meta-analyses of clinical trials have shown a moderate effect of supplementation on depressive symptoms, but not on normal mood states. Few studies have investigated effects on cognition. The purpose of this study was to examine effects of omega-3 supplements on cognition and mood of recovered depressed individuals. Seventy-one participants were randomized to receive either omega-3 or placebo for four weeks in a randomized double-blind design. Results showed small effects of omega-3 supplementation on aspects of emotional decision-making and on self-reported states of depression and tension. Some of the effects were confounded by learning effects. No significant effects were observed on memory, attention, cognitive reactivity and depressive symptoms. While inconclusive, the present findings may indicate that omega-3 supplementation has selective effects on emotional cognition and mood in recovered depressed participants.

The Minicommunity Design to Assess Indirect Effects of Vaccination.

PubMed

Halloran, M Elizabeth

2012-08-01

We propose the minicommunity design to estimate indirect effects of vaccination. Establishing indirect effects of vaccination in unvaccinated subpopulations could have important implications for global vaccine policies. In the minicommunity design, the household or other small transmission unit serves as the cluster in which to estimate indirect effects of vaccination, similar to studies in larger communities to estimate indirect, total, and overall effects. Examples from the literature include studies in small transmission units to estimate indirect effects of pertussis, pneumococcal, influenza, and cholera vaccines. We characterize the minicommunity design by several methodologic considerations, including the assignment mechanism, ascertainment, the role of transmission outside the transmission unit, and the relation of the size of the transmission unit to number of people vaccinated. The minicommunity study for indirect effects is contrasted with studies to estimate vaccine effects on infectiousness and protective effects under conditions of household exposure within small transmission units. The minicommunity design can be easily implemented in individually randomized studies by enrolling and following-up members of households of the randomized individuals. The methodology for the minicommunity design for estimating indirect effects of vaccination deserves much future research.

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 cost-effectiveness of cash versus lottery incentives for a web-based, stated-preference community survey.

PubMed

Gajic, Aleksandra; Cameron, David; Hurley, Jeremiah

2012-12-01

We present the results of a randomized experiment to test the effectiveness and cost-effectiveness of response incentives for a stated-preference survey of a general community population. The survey was administered using a mixed-mode approach, in which community members were invited to participate using a traditional mailed letter using contact information for a representative sample of the community; but individuals completed the survey via the web, which exploited the advantages of electronic capture. Individuals were randomized to four incentive groups: (a) no incentive, (b) prepaid cash incentive ($2), (c) a low lottery (10 prizes of $25) and (d) a high lottery (2 prizes of $250). Letters of invitation were mailed to 3,000 individuals. In total, 405 individuals (14.4%) contacted the website and 277 (9.8%) provided complete responses. The prepaid cash incentive generated the highest contact and response rates (23.3 and 17.3%, respectively), and no incentive generated the lowest (9.1 and 5.7%, respectively). The high lottery, however, was the most cost-effective incentive for obtaining completed surveys: compared with no incentive, the incremental cost-effectiveness ratio (ICER) per completed survey for high lottery was $13.89; for prepaid cash, the ICER was $18.29. This finding suggests that the preferred response incentive for community-based, stated-preference surveys is a lottery with a small number of large prizes.

Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data.

PubMed

Gyöngyösi, Mariann; Wojakowski, Wojciech; Lemarchand, Patricia; Lunde, Ketil; Tendera, Michal; Bartunek, Jozef; Marban, Eduardo; Assmus, Birgit; Henry, Timothy D; Traverse, Jay H; Moyé, Lemuel A; Sürder, Daniel; Corti, Roberto; Huikuri, Heikki; Miettinen, Johanna; Wöhrle, Jochen; Obradovic, Slobodan; Roncalli, Jérome; Malliaras, Konstantinos; Pokushalov, Evgeny; Romanov, Alexander; Kastrup, Jens; Bergmann, Martin W; Atsma, Douwe E; Diederichsen, Axel; Edes, Istvan; Benedek, Imre; Benedek, Theodora; Pejkov, Hristo; Nyolczas, Noemi; Pavo, Noemi; Bergler-Klein, Jutta; Pavo, Imre J; Sylven, Christer; Berti, Sergio; Navarese, Eliano P; Maurer, Gerald

2015-04-10

The meta-Analysis of Cell-based CaRdiac study is the first prospectively declared collaborative multinational database, including individual data of patients with ischemic heart disease treated with cell therapy. We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI), including individual patient data from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252). The primary end point was freedom from combined major adverse cardiac and cerebrovascular events (including all-cause death, AMI recurrance, stroke, and target vessel revascularization). The secondary end point was freedom from hard clinical end points (death, AMI recurrence, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy end points included changes in end-diastolic volume, end-systolic volume, and ejection fraction, analyzed with random-effects meta-analyses and ANCOVA. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on major adverse cardiac and cerebrovascular events (14.0% versus 16.3%; hazard ratio, 0.86; 95% confidence interval, 0.63-1.18) or death (1.4% versus 2.1%) or death/AMI recurrence/stroke (2.9% versus 4.7%) was identified in comparison with controls. No changes in ejection fraction (mean difference: 0.96%; 95% confidence interval, -0.2 to 2.1), end-diastolic volume, or systolic volume were observed compared with controls. These results were not influenced by anterior AMI location, reduced baseline ejection fraction, or the use of MRI for assessing left ventricular parameters. This meta-analysis of individual patient data from randomized trials in patients with recent AMI revealed that intracoronary cell therapy provided no benefit, in terms of clinical events or changes in left ventricular function. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591. © 2015 American Heart Association, Inc.

The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

PubMed

Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

2018-07-01

Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

PubMed Central

2011-01-01

Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033 PMID:21767413

The effect of magnesium supplementation on blood pressure in individuals with insulin resistance, prediabetes, or noncommunicable chronic diseases: a meta-analysis of randomized controlled trials.

PubMed

Dibaba, Daniel T; Xun, Pengcheng; Song, Yiqing; Rosanoff, Andrea; Shechter, Michael; He, Ka

2017-09-01

Background: To our knowledge, the effect of magnesium supplementation on blood pressure (BP) in individuals with preclinical or noncommunicable diseases has not been previously investigated in a meta-analysis, and the findings from randomized controlled trials (RCTs) have been inconsistent. Objective: We sought to determine the pooled effect of magnesium supplementation on BP in participants with preclinical or noncommunicable diseases. Design: We identified RCTs that were published in English before May 2017 that examined the effect of magnesium supplementation on BP in individuals with preclinical or noncommunicable diseases through PubMed, ScienceDirect, Cochrane, clinicaltrials.gov, SpringerLink, and Google Scholar databases as well as the reference lists from identified relevant articles. Random- and fixed-effects models were used to estimate the pooled standardized mean differences (SMDs) with 95% CIs in changes in BP from baseline to the end of the trial in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) between the magnesium-supplementation group and the control group. Results: Eleven RCTs that included 543 participants with follow-up periods that ranged from 1 to 6 mo (mean: 3.6 mo) were included in this meta-analysis. The dose of elemental magnesium that was used in the trials ranged from 365 to 450 mg/d. All studies reported BP at baseline and the end of the trial. The weighted overall effects indicated that the magnesium-supplementation group had a significantly greater reduction in both SBP (SMD: -0.20; 95% CI: -0.37, -0.03) and DBP (SMD: -0.27; 95% CI: -0.52, -0.03) than did the control group. Magnesium supplementation resulted in a mean reduction of 4.18 mm Hg in SBP and 2.27 mm Hg in DBP. Conclusion: The pooled results suggest that magnesium supplementation significantly lowers BP in individuals with insulin resistance, prediabetes, or other noncommunicable chronic diseases. © 2017 American Society for Nutrition.

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.

Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

PubMed

Sveinsdottir, Vigdis; Løvvik, Camilla; Fyhn, Tonje; Monstad, Karin; Ludvigsen, Kari; Øverland, Simon; Reme, Silje Endresen

2014-11-18

Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders, and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment. Based on a more innovative place-and-train approach, Individual Placement and Support (IPS) involves supported employment in real-life competitive work settings, and has shown great promise for patients with severe mental illness. The study is a multicenter Randomized Controlled Trial (RCT) of IPS in a Norwegian context, involving an effect evaluation, a process evaluation, and a cost/benefit analysis. IPS will be compared to high quality treatment as usual (TAU), with labor market participation and educational activity at 12 months post inclusion as the primary outcome. The primary outcome will be measured using register data, and the project will also include complete follow-up up to 4 years after inclusion for long-term outcome data. Secondary outcomes include mental health status, disability and quality of life, collected through survey questionnaires at baseline, and after 6 and 12 months. Participants will include patients undergoing treatment for moderate to severe mental illness who are either unemployed or on sickness or social benefits. The estimated total sample size of 400-500 will be randomly assigned to the interventions. To be eligible, participants must have an expressed desire to work, and sufficient Norwegian reading and writing skills to fill out the questionnaires. The Effect Evaluation of Individual Placement and Support (IPS) will be one of the largest randomized controlled trials to date investigating the effectiveness of IPS on competitive employment, and the first study to evaluate the effectiveness of IPS for patients with moderate to severe mental illness within a Norwegian context. Clinicaltrials.gov: NCT01964092 . Registered October 16th, 2013.

Effect of tree nuts on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials.

PubMed

Viguiliouk, Effie; Kendall, Cyril W C; Blanco Mejia, Sonia; Cozma, Adrian I; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H; Augustin, Livia S A; Chiavaroli, Laura; Leiter, Lawrence A; de Souza, Russell J; Jenkins, David J A; Sievenpiper, John L

2014-01-01

Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes. MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR. Two independent reviewer's extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI's. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = -0.07% [95% CI:-0.10, -0.03%]; P = 0.0003) and fasting glucose (MD = -0.15 mmol/L [95% CI: -0.27, -0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts. Majority of trials were of short duration and poor quality. Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates. ClinicalTrials.gov NCT01630980.

Effect of Tree Nuts on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Dietary Trials

PubMed Central

Viguiliouk, Effie; Kendall, Cyril W. C.; Blanco Mejia, Sonia; Cozma, Adrian I.; Ha, Vanessa; Mirrahimi, Arash; Jayalath, Viranda H.; Augustin, Livia S. A.; Chiavaroli, Laura; Leiter, Lawrence A.; de Souza, Russell J.; Jenkins, David J. A.; Sievenpiper, John L.

2014-01-01

Background Tree nut consumption has been associated with reduced diabetes risk, however, results from randomized trials on glycemic control have been inconsistent. Objective To provide better evidence for diabetes guidelines development, we conducted a systematic review and meta-analysis of randomized controlled trials to assess the effects of tree nuts on markers of glycemic control in individuals with diabetes. Data Sources MEDLINE, EMBASE, CINAHL, and Cochrane databases through 6 April 2014. Study Selection Randomized controlled trials ≥3 weeks conducted in individuals with diabetes that compare the effect of diets emphasizing tree nuts to isocaloric diets without tree nuts on HbA1c, fasting glucose, fasting insulin, and HOMA-IR. Data Extraction and Synthesis Two independent reviewer’s extracted relevant data and assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% CI’s. Heterogeneity was assessed (Cochran Q-statistic) and quantified (I2). Results Twelve trials (n = 450) were included. Diets emphasizing tree nuts at a median dose of 56 g/d significantly lowered HbA1c (MD = −0.07% [95% CI:−0.10, −0.03%]; P = 0.0003) and fasting glucose (MD = −0.15 mmol/L [95% CI: −0.27, −0.02 mmol/L]; P = 0.03) compared with control diets. No significant treatment effects were observed for fasting insulin and HOMA-IR, however the direction of effect favoured tree nuts. Limitations Majority of trials were of short duration and poor quality. Conclusions Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes, supporting their inclusion in a healthy diet. Owing to the uncertainties in our analyses there is a need for longer, higher quality trials with a focus on using nuts to displace high-glycemic index carbohydrates. Trial Registration ClinicalTrials.gov NCT01630980 PMID:25076495

Neighborhood Effects in a Behavioral Randomized Controlled Trial

PubMed Central

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

2015-01-01

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

Determination of the influence of dispersion pattern of pesticide-resistant individuals on the reliability of resistance estimates using different sampling plans.

PubMed

Shah, R; Worner, S P; Chapman, R B

2012-10-01

Pesticide resistance monitoring includes resistance detection and subsequent documentation/ measurement. Resistance detection would require at least one (≥1) resistant individual(s) to be present in a sample to initiate management strategies. Resistance documentation, on the other hand, would attempt to get an estimate of the entire population (≥90%) of the resistant individuals. A computer simulation model was used to compare the efficiency of simple random and systematic sampling plans to detect resistant individuals and to document their frequencies when the resistant individuals were randomly or patchily distributed. A patchy dispersion pattern of resistant individuals influenced the sampling efficiency of systematic sampling plans while the efficiency of random sampling was independent of such patchiness. When resistant individuals were randomly distributed, sample sizes required to detect at least one resistant individual (resistance detection) with a probability of 0.95 were 300 (1%) and 50 (10% and 20%); whereas, when resistant individuals were patchily distributed, using systematic sampling, sample sizes required for such detection were 6000 (1%), 600 (10%) and 300 (20%). Sample sizes of 900 and 400 would be required to detect ≥90% of resistant individuals (resistance documentation) with a probability of 0.95 when resistant individuals were randomly dispersed and present at a frequency of 10% and 20%, respectively; whereas, when resistant individuals were patchily distributed, using systematic sampling, a sample size of 3000 and 1500, respectively, was necessary. Small sample sizes either underestimated or overestimated the resistance frequency. A simple random sampling plan is, therefore, recommended for insecticide resistance detection and subsequent documentation.

Extensively Parameterized Mutation-Selection Models Reliably Capture Site-Specific Selective Constraint.

PubMed

Spielman, Stephanie J; Wilke, Claus O

2016-11-01

The mutation-selection model of coding sequence evolution has received renewed attention for its use in estimating site-specific amino acid propensities and selection coefficient distributions. Two computationally tractable mutation-selection inference frameworks have been introduced: One framework employs a fixed-effects, highly parameterized maximum likelihood approach, whereas the other employs a random-effects Bayesian Dirichlet Process approach. While both implementations follow the same model, they appear to make distinct predictions about the distribution of selection coefficients. The fixed-effects framework estimates a large proportion of highly deleterious substitutions, whereas the random-effects framework estimates that all substitutions are either nearly neutral or weakly deleterious. It remains unknown, however, how accurately each method infers evolutionary constraints at individual sites. Indeed, selection coefficient distributions pool all site-specific inferences, thereby obscuring a precise assessment of site-specific estimates. Therefore, in this study, we use a simulation-based strategy to determine how accurately each approach recapitulates the selective constraint at individual sites. We find that the fixed-effects approach, despite its extensive parameterization, consistently and accurately estimates site-specific evolutionary constraint. By contrast, the random-effects Bayesian approach systematically underestimates the strength of natural selection, particularly for slowly evolving sites. We also find that, despite the strong differences between their inferred selection coefficient distributions, the fixed- and random-effects approaches yield surprisingly similar inferences of site-specific selective constraint. We conclude that the fixed-effects mutation-selection framework provides the more reliable software platform for model application and future development. © The Author 2016. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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.

Small individual loans and mental health: a randomized controlled trial among South African adults

PubMed Central

Fernald, Lia CH; Hamad, Rita; Karlan, Dean; Ozer, Emily J; Zinman, Jonathan

2008-01-01

Background In the developing world, access to small, individual loans has been variously hailed as a poverty-alleviation tool – in the context of "microcredit" – but has also been criticized as "usury" and harmful to vulnerable borrowers. Prior studies have assessed effects of access to credit on traditional economic outcomes for poor borrowers, but effects on mental health have been largely ignored. Methods Applicants who had previously been rejected (n = 257) for a loan (200% annual percentage rate – APR) from a lender in South Africa were randomly assigned to a "second-look" that encouraged loan officers to approve their applications. This randomized encouragement resulted in 53% of applicants receiving a loan they otherwise would not have received. All subjects were assessed 6–12 months later with questions about demographics, socio-economic status, and two indicators of mental health: the Center for Epidemiologic Studies – Depression Scale (CES-D) and Cohen's Perceived Stress scale. Intent-to-treat analyses were calculated using multinomial probit regressions. Results Randomization into receiving a "second look" for access to credit increased perceived stress in the combined sample of women and men; the findings were stronger among men. Credit access was associated with reduced depressive symptoms in men, but not women. Conclusion Our findings suggest that a mechanism used to reduce the economic stress of extremely poor individuals can have mixed effects on their experiences of psychological stress and depressive symptomatology. Our data support the notion that mental health should be included as a measure of success (or failure) when examining potential tools for poverty alleviation. Further longitudinal research is needed in South Africa and other settings to understand how borrowing at high interest rates affects gender roles and daily life activities. CCT: ISRCTN 10734925 PMID:19087316

Small individual loans and mental health: a randomized controlled trial among South African adults.

PubMed

Fernald, Lia C H; Hamad, Rita; Karlan, Dean; Ozer, Emily J; Zinman, Jonathan

2008-12-16

In the developing world, access to small, individual loans has been variously hailed as a poverty-alleviation tool - in the context of "microcredit" - but has also been criticized as "usury" and harmful to vulnerable borrowers. Prior studies have assessed effects of access to credit on traditional economic outcomes for poor borrowers, but effects on mental health have been largely ignored. Applicants who had previously been rejected (n = 257) for a loan (200% annual percentage rate - APR) from a lender in South Africa were randomly assigned to a "second-look" that encouraged loan officers to approve their applications. This randomized encouragement resulted in 53% of applicants receiving a loan they otherwise would not have received. All subjects were assessed 6-12 months later with questions about demographics, socio-economic status, and two indicators of mental health: the Center for Epidemiologic Studies - Depression Scale (CES-D) and Cohen's Perceived Stress scale. Intent-to-treat analyses were calculated using multinomial probit regressions. Randomization into receiving a "second look" for access to credit increased perceived stress in the combined sample of women and men; the findings were stronger among men. Credit access was associated with reduced depressive symptoms in men, but not women. Our findings suggest that a mechanism used to reduce the economic stress of extremely poor individuals can have mixed effects on their experiences of psychological stress and depressive symptomatology. Our data support the notion that mental health should be included as a measure of success (or failure) when examining potential tools for poverty alleviation. Further longitudinal research is needed in South Africa and other settings to understand how borrowing at high interest rates affects gender roles and daily life activities. CCT: ISRCTN 10734925.

Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain: a randomized controlled trial.

PubMed

Roche-Leboucher, Ghislaine; Petit-Lemanac'h, Audrey; Bontoux, Luc; Dubus-Bausière, Valérie; Parot-Shinkel, Elsa; Fanello, Serge; Penneau-Fontbonne, Dominique; Fouquet, Natacha; Legrand, Erick; Roquelaure, Yves; Richard, Isabelle

2011-12-15

Randomized parallel group comparative trial with a 1-year follow-up period. To compare in a population of patients with chronic low back pain, the effectiveness of a functional restoration program (FRP), including intensive physical training and a multidisciplinary approach, with an outpatient active physiotherapy program at 1-year follow-up. Controlled studies conducted in the United States and in Northern Europe showed a benefit of FRPs, especially on return to work. Randomized studies have compared these programs with standard care. A previously reported study presented the effectiveness at 6 months of both functional restoration and active physiotherapy, with a significantly greater reduction of sick-leave days for functional restoration. A total of 132 patients with low back pain were randomized to either FRP (68 patients) or active individual therapy (64 patients). One patient did not complete the FRP; 19 patients were lost to follow-up (4 in the FRP group and 15 in the active individual treatment group). The number of sick-leave days in 2 years before the program was similar in both groups (180 ± 135.1 days in active individual treatment vs. 185 ± 149.8 days in FRP, P = 0.847). In both groups, at 1-year follow-up, intensity of pain, flexibility, trunk muscle endurance, Dallas daily activities and work and leisure scores, and number of sick-leave days were significantly improved compared with baseline. The number of sick-leave days was significantly lower in the FRP group. Both programs are efficient in reducing disability and sick-leave days. The FRP is significantly more effective in reducing sick-leave days. Further analysis is required to determine if this overweighs the difference in costs of both programs.

The Multigroup Multilevel Categorical Latent Growth Curve Models

ERIC Educational Resources Information Center

Hung, Lai-Fa

2010-01-01

Longitudinal data describe developmental patterns and enable predictions of individual changes beyond sampled time points. Major methodological issues in longitudinal data include modeling random effects, subject effects, growth curve parameters, and autoregressive residuals. This study embedded the longitudinal model within a multigroup…

Comparing the Effectiveness of Individual Coaching, Self-Coaching, and Group Training: How Leadership Makes the Difference

PubMed Central

Losch, Sabine; Traut-Mattausch, Eva; Mühlberger, Maximilian D.; Jonas, Eva

2016-01-01

Few empirical studies have used a randomized controlled design to evaluate the impact of coaching, and there are even fewer that have compared coaching with other interventions. In the current field study, we investigated the relative effectiveness of coaching as an intervention to reduce procrastination. In a randomized controlled study, participants (N = 84) were assigned to an individual coaching, a self-coaching, a group training, or a control group condition. Results indicate that individual coaching and group training were effective in reducing procrastination and facilitating goal attainment. Individual coaching created a high degree of satisfaction and was superior in helping participants attaining their goals, whereas group training successfully promoted the acquisition of relevant knowledge. The results for the self-coaching condition show that independently performing exercises without being supported by a coach is not sufficient for high goal attainment. Moreover, mediation analysis show that a coach’s transformational and transactional leadership behavior influenced participants’ perceived autonomy support and intrinsic motivation, resulting in beneficial coaching outcomes. The results may guide the selection of appropriate human resource development methods: If there is a general need to systematically prepare employees to perform on specific tasks, group training seems appropriate due to lower costs. However, when certain aspects of working conditions or individual development goals are paramount, coaching might be indicated. However, further research is needed to compare the relative effectiveness of coaching with other interventions in different contexts. PMID:27199857

Comparing the Effectiveness of Individual Coaching, Self-Coaching, and Group Training: How Leadership Makes the Difference.

PubMed

Losch, Sabine; Traut-Mattausch, Eva; Mühlberger, Maximilian D; Jonas, Eva

2016-01-01

Few empirical studies have used a randomized controlled design to evaluate the impact of coaching, and there are even fewer that have compared coaching with other interventions. In the current field study, we investigated the relative effectiveness of coaching as an intervention to reduce procrastination. In a randomized controlled study, participants (N = 84) were assigned to an individual coaching, a self-coaching, a group training, or a control group condition. Results indicate that individual coaching and group training were effective in reducing procrastination and facilitating goal attainment. Individual coaching created a high degree of satisfaction and was superior in helping participants attaining their goals, whereas group training successfully promoted the acquisition of relevant knowledge. The results for the self-coaching condition show that independently performing exercises without being supported by a coach is not sufficient for high goal attainment. Moreover, mediation analysis show that a coach's transformational and transactional leadership behavior influenced participants' perceived autonomy support and intrinsic motivation, resulting in beneficial coaching outcomes. The results may guide the selection of appropriate human resource development methods: If there is a general need to systematically prepare employees to perform on specific tasks, group training seems appropriate due to lower costs. However, when certain aspects of working conditions or individual development goals are paramount, coaching might be indicated. However, further research is needed to compare the relative effectiveness of coaching with other interventions in different contexts.

Using Multigroup-Multiphase Latent State-Trait Models to Study Treatment-Induced Changes in Intra-Individual State Variability: An Application to Smokers' Affect.

PubMed

Geiser, Christian; Griffin, Daniel; Shiffman, Saul

2016-01-01

Sometimes, researchers are interested in whether an intervention, experimental manipulation, or other treatment causes changes in intra-individual state variability. The authors show how multigroup-multiphase latent state-trait (MG-MP-LST) models can be used to examine treatment effects with regard to both mean differences and differences in state variability. The approach is illustrated based on a randomized controlled trial in which N = 338 smokers were randomly assigned to nicotine replacement therapy (NRT) vs. placebo prior to quitting smoking. We found that post quitting, smokers in both the NRT and placebo group had significantly reduced intra-individual affect state variability with respect to the affect items calm and content relative to the pre-quitting phase. This reduction in state variability did not differ between the NRT and placebo groups, indicating that quitting smoking may lead to a stabilization of individuals' affect states regardless of whether or not individuals receive NRT.

Using Multigroup-Multiphase Latent State-Trait Models to Study Treatment-Induced Changes in Intra-Individual State Variability: An Application to Smokers' Affect

PubMed Central

Geiser, Christian; Griffin, Daniel; Shiffman, Saul

2016-01-01

Sometimes, researchers are interested in whether an intervention, experimental manipulation, or other treatment causes changes in intra-individual state variability. The authors show how multigroup-multiphase latent state-trait (MG-MP-LST) models can be used to examine treatment effects with regard to both mean differences and differences in state variability. The approach is illustrated based on a randomized controlled trial in which N = 338 smokers were randomly assigned to nicotine replacement therapy (NRT) vs. placebo prior to quitting smoking. We found that post quitting, smokers in both the NRT and placebo group had significantly reduced intra-individual affect state variability with respect to the affect items calm and content relative to the pre-quitting phase. This reduction in state variability did not differ between the NRT and placebo groups, indicating that quitting smoking may lead to a stabilization of individuals' affect states regardless of whether or not individuals receive NRT. PMID:27499744

Implantable miniature telescope (IMT) for vision loss due to end-stage age-related macular degeneration.

PubMed

Gupta, Amisha; Lam, Jessica; Custis, Peter; Munz, Stephen; Fong, Donald; Koster, Marguerite

2018-05-30

Age-related macular degeneration (AMD) causes progressive and irreversible damage to the retina, resulting in loss of central vision. AMD is the third leading cause of irreversible visual impairment worldwide and the leading cause of blindness in industrialized countries. Since AMD is more common in older individuals, the number of affected individuals will increase significantly as the population ages. The implantable miniature telescope (IMT) is an ophthalmic device developed to improve vision in individuals who have lost vision due to AMD. Once implanted, the IMT is used to enlarge objects in the central visual field and focus them onto healthy areas of the retina not affected by AMD, allowing individuals to recognize objects that they otherwise could not see. It is unclear whether and how much the IMT can improve vision in individuals with end-stage AMD. To assess the effectiveness and safety of the IMT in improving visual acuity and quality of life in people with late or advanced AMD. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 11); Ovid MEDLINE; Embase.com; PubMed; LILACS; AMED; Web of Science Conference Proceedings Citation Index-Science; OpenSIGLE; the metaRegister of Controlled Trials (mRCT) (last searched 27 June 2014); ClinicalTrials.gov; the ICTRP and the US Food and Drug Administration (FDA) Medical Devices database. The date of the search was 2 November 2017, with the exception of mRCT which is no longer in service. We planned to include randomized controlled trials (RCTs) and quasi-randomized trials that compared the IMT versus no IMT. Two review authors independently assessed all studies for inclusion, using standard methodological procedures expected by Cochrane. Our search yielded 1042 unique records. We removed irrelevant studies after screening titles and abstracts, and evaluated five full-text reports from four studies; three were non-randomized studies. There was one ongoing RCT that compared the OriLens intraocular telescope with standard low vision training in eyes with end-stage AMD. Results for this study are expected in 2020. We found no RCT or quasi-RCT and can draw no conclusion about the effectiveness and safety of the IMT in improving visual acuity in individuals with late or advanced AMD. Since the IMT is typically implanted monocularly based upon which eye has better best-corrected distance visual acuity, randomization between eyes within an individual may not be acceptable. Studies are needed that compare outcomes between individuals randomized to the device versus individuals not implanted, at least during study follow-up, who serve as controls.

Shape of a ponytail and the statistical physics of hair fiber bundles.

PubMed

Goldstein, Raymond E; Warren, Patrick B; Ball, Robin C

2012-02-17

A general continuum theory for the distribution of hairs in a bundle is developed, treating individual fibers as elastic filaments with random intrinsic curvatures. Applying this formalism to the iconic problem of the ponytail, the combined effects of bending elasticity, gravity, and orientational disorder are recast as a differential equation for the envelope of the bundle, in which the compressibility enters through an "equation of state." From this, we identify the balance of forces in various regions of the ponytail, extract a remarkably simple equation of state from laboratory measurements of human ponytails, and relate the pressure to the measured random curvatures of individual hairs.

Comparing the Effects of Multisensory Stimulation and Individualized Music Sessions on Elderly People with Severe Dementia: A Randomized Controlled Trial.

PubMed

Sánchez, Alba; Maseda, Ana; Marante-Moar, M Pilar; de Labra, Carmen; Lorenzo-López, Laura; Millán-Calenti, José Carlos

2016-03-08

The objective of this study was to compare the effects of a multisensory stimulation environment (MSSE) and individualized music sessions on agitation, emotional and cognitive status, and dementia severity in a sample of institutionalized patients with severe dementia. Twenty-two participants with a diagnosis of severe or very severe dementia were randomly assigned to two groups: MSSE and individualized music sessions. Both groups participated in two 30-min weekly sessions over 16 weeks. Outcomes were agitation (Cohen-Mansfield Agitation Inventory, CMAI), mood (Cornell Scale for Depression in Dementia, CSDD), anxiety (Rating Anxiety in Dementia, RAID), cognitive function (Severe Mini-Mental State Examination, SMMSE), and the overall severity of dementia (Bedford Alzheimer Nursing Severity Scale, BANS-S). They were assessed at baseline (pre-trial), in the middle (mid-trial), at the end of the intervention (post-trial), and 8 weeks after the intervention (follow-up). Patients in the MSSE group showed significant improvement in their RAID and BANS-S scores compared with the individualized music group post- versus pre-trial. With regard to agitation, there was improvement during the intervention in both the MSSE and individualized music groups in the CMAI total score after 16 weeks of intervention, with no significant differences between the groups. The results suggest that MSSE could have better effects on anxiety symptoms and dementia severity in comparison with individualized music sessions in elderly patients with severe dementia.

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.

Effective Reading Comprehension in EFL Contexts: Individual and Collaborative Concept Mapping Strategies

ERIC Educational Resources Information Center

Riahi, Zahra; Pourdana, Natasha

2017-01-01

The present study attempted to investigate the possible impacts of Individual Concept Mapping (ICM) and Collaborative Concept Mapping (CCM) strategies on Iranian EFL learners' reading comprehension. For this purpose, 90 pre-intermediate female language learners ranged between 12 to 17 years of age were selected to randomly assign into ICM, CCM and…

An individual-tree dbh-total height model with random plot effects for shortleaf pine

Treesearch

Chakra B. Budhathoki; Thomas B. Lynch; James M. Guldin

2007-01-01

Individual tree measurements were available from over 200 permanent plots established during 1985-1987 and later remeasured in naturally regenerated stands of shortleaf pine (Pinus echinata Mill.) in western Arkansas and eastern Oklahoma. The objective of this study was to model shortleaf pine growth in natural stands for the region. As a major...

Careless and Random Responding on Clinical and Research Measures in the Addictions: A Concerning Problem and Investigation of Their Detection

ERIC Educational Resources Information Center

Meyer, Joseph F.; Faust, Kyle A.; Faust, David; Baker, Aaron M.; Cook, Nathan E.

2013-01-01

Even when relatively infrequent, careless and random responding (C/RR) can have robust effects on individual and group data and thereby distort clinical evaluations and research outcomes. Given such potential adverse impacts and the broad use of self-report measures when appraising addictions and addictive behavior, the detection of C/RR can…

Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

ERIC Educational Resources Information Center

Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

2016-01-01

In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

Standardized versus Individualized Acupuncture for Chronic Low Back Pain: A Randomized Controlled Trial

PubMed Central

Pach, Daniel; Yang-Strobel, Xiaoli; Lüdtke, Rainer; Icke, Katja; Brinkhaus, Benno; Witt, Claudia M.

2013-01-01

We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (−33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017. PMID:24288556

A Long-Term Intensive Lifestyle Intervention and Physical Function: the Look AHEAD Movement and Memory Study

PubMed Central

Houston, Denise K.; Leng, Xiaoyan; Bray, George A.; Hergenroeder, Andrea L.; Hill, James O.; Jakicic, John M.; Johnson, Karen C.; Neiberg, Rebecca H.; Marsh, Anthony P.; Rejeski, W. Jack; Kritchevsky, Stephen B.

2014-01-01

OBJECTIVE To assess the long-term effects of an intensive lifestyle intervention on physical function using a randomized post-test design in the Look AHEAD trial. METHODS Overweight and obese (BMI ≥25 kg/m2) middle-aged and older adults (aged 45–76 years at enrollment) with type 2 diabetes (n=964) at four clinics in Look AHEAD, a trial evaluating an intensive lifestyle intervention (ILI) designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including an expanded short physical performance battery (SPPBexp), 20-m and 400-m walk, and grip and knee extensor strength 8 years post-randomization, during the trial’s weight maintenance phase. RESULTS Eight years post-randomization, individuals randomized to ILI had better SPPBexp scores (adjusted mean (SE) difference: 0.055 (0.022), p=0.01) and faster 20-m and 400-m walk speeds (0.032 (0.012) m/sec, p=0.01, and 0.025 (0.011) m/sec, p=0.02, respectively) compared to those randomized to DSE. Achieved weight loss greatly attenuated the group differences in physical function and the intervention effect was no longer significant. CONCLUSIONS An intensive lifestyle intervention has long-term benefits for mobility function in overweight and obese middle-aged and older individuals with type 2 diabetes. PMID:25452229

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.

Effect of virtual reality training on walking distance and physical fitness in individuals with Parkinson's disease.

PubMed

de Melo, Gileno Edu Lameira; Kleiner, Ana Francisca Rozin; Lopes, Jamile Benite Palma; Dumont, Arislander Jonathan Lopes; Lazzari, Roberta Delasta; Galli, Manuela; Oliveira, Claudia Santos

2018-04-07

To evaluate the effects of gait training with virtual reality (VR) on walking distance and physical fitness in individuals with Parkinson's Disease (PD). Thirty-seven individuals with PD participated in this prospective, randomized, controlled clinical trial. They were randomly allocated to a control group submitted to conventional training (n = 12), a treadmill group submitted to gait training on a treadmill (n = 13) and a VR group submitted to gait training using the XboxTM (n = 12). Clinical measures, gait variables and the Six-Minute Walk Test (6MWT) were evaluated: pre-intervention, after one intervention session, post-intervention and follow up (30 days after intervention). The VR and treadmill groups travelled longer distances on the 6MWT and had faster gait speed in comparison to the control group. The VR and treadmill groups demonstrated an increase in pre-6MWT HR. The VR group had more intense HR after the first session and throughout training, but these gains were not maintained at the follow-up. The present findings demonstrate that gait training with a VR program is as effective as treadmill training with regard to gains in walking distance and improvements in temporal gait variables in individuals with PD.

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

Evaluation of a hepatitis B lay health worker intervention for Chinese Americans and Canadians.

PubMed

Taylor, Vicky M; Hislop, T Gregory; Tu, Shin-Ping; Teh, Chong; Acorda, Elizabeth; Yip, Mei-Po; Woodall, Erica; Yasui, Yutaka

2009-06-01

Hepatitis B testing is recommended for immigrants from countries where hepatitis B infection is endemic. However, only about one-half of Chinese in North America have received hepatitis B testing. We conducted a randomized controlled trial to evaluate the effectiveness of a hepatitis B lay health worker intervention for Chinese Americans/Canadians. Four hundred and sixty individuals who had never been tested for hepatitis B were identified from community-based surveys of Chinese conducted in Seattle, Washington, and Vancouver, British Columbia. These individuals were randomly assigned to receive a hepatitis B lay health worker intervention or a direct mailing of physical activity educational materials. Follow-up surveys were completed 6 months after randomization. Self-reported hepatitis B testing was verified through medical records review. A total of 319 individuals responded to the follow-up survey (69% response rate). Medical records data verified hepatitis B testing since randomization for 9 (6%) of the 142 experimental group participants and 3 (2%) of the 177 control group participants (P = 0.04). At follow-up, a higher proportion of individuals in the experimental arm than individuals in the control arm knew that hepatitis B can be spread by razors (P < 0.001) and during sexual intercourse (P = 0.07). Our findings suggest that lay health worker interventions can impact hepatitis B-related knowledge. However, our hepatitis B lay health worker intervention had a very limited impact on hepatitis B testing completion. Future research should evaluate other intervention approaches to improving hepatitis B testing rates among Chinese in North America.

Evaluation of a Hepatitis B Lay Health Worker Intervention for Chinese Americans and Canadians

PubMed Central

Taylor, Vicky M.; Hislop, T. Gregory; Tu, Shin-Ping; Teh, Chong; Acorda, Elizabeth; Yip, Mei-Po; Woodall, Erica; Yasui, Yutaka

2009-01-01

Hepatitis B testing is recommended for immigrants from countries where hepatitis B infection is endemic. However, only about one-half of Chinese in North America have received hepatitis B testing. We conducted a randomized controlled trial to evaluate the effectiveness of a hepatitis B lay health worker intervention for Chinese Americans/Canadians. Four hundred and sixty individuals who had never been tested for hepatitis B were identified from community-based surveys of Chinese conducted in Seattle, Washington, and Vancouver, British Columbia. These individuals were randomly assigned to receive a hepatitis B lay health worker intervention or a direct mailing of physical activity educational materials. Follow-up surveys were completed six months after randomization. Self-reported hepatitis B testing was verified through medical records review. A total of 319 individuals responded to the follow-up survey (69% response rate). Medical records data verified hepatitis B testing since randomization for nine (6%) of the 142 experimental group participants and three (2%) of the 177 control group participants (p=0.04). At follow-up, a higher proportion of individuals in the experimental arm than individuals in the control arm knew that hepatitis B can be spread by razors (p<0.001) and during sexual intercourse (p=0.07). Our findings suggest that lay health worker interventions can impact hepatitis B-related knowledge. However, our hepatitis B lay health worker intervention had a very limited impact on hepatitis B testing completion. Future research should evaluate other intervention approaches to improving hepatitis B testing rates among Chinese in North America. PMID:19127416

The effects of providing periodontal disease risk information on psychological outcomes - a randomized controlled trial.

PubMed

Asimakopoulou, Koula; Newton, Jonathon Tim; Daly, Blánaid; Kutzer, Yvonne; Ide, Mark

2015-04-01

In a two arm randomized controlled trial this study compared the effects of a routine periodontal assessment consultation versus a routine consultation + individualized risk assessment communication intervention on patient thoughts and emotions about periodontal disease. Adults (N = 102) with moderate/advanced chronic periodontitis referred to a Periodontology Department of a large UK dental school, completed psychological measures before a periodontal assessment and again at the end of the visit. Intervention participants received an individualized calculation of their periodontal disease risk using PreViser Risk Calculator in addition to their routine assessment consultation. In routine care, patients' thoughts about periodontal disease seriousness (p < 0.001) and susceptibility (p < 0.03) increased post-consultation and participants felt more positive (p < 0.02) about periodontal disease. These effects were also seen in intervention participants. Additionally, the individualized risk communication intervention led to patients reporting i) periodontal disease treatment as more effective than they did pre-consultation (p < 0.001), ii) feeling more confident in their ability to adhere to treatment as seen in increases in self-efficacy (p < 0.05) and iii) higher intentions to adhere to periodontal management (p < 0.03). Individualized periodontal disease risk communication influences psychological variables that underpin adherence with periodontal instructions. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial

PubMed Central

Wardle, Margaret C.; Marcus, Benjamin A.; de Wit, Harriet

2015-01-01

Polydrug use is common, and might occur because certain individuals experience positive effects from several different drugs during early stages of use. This study examined individual differences in subjective responses to single oral doses of d-amphetamine, alcohol, and delta-9-tetrahydrocannabinol (THC) in healthy social drinkers. Each of these drugs produces feelings of well-being in at least some individuals, and we hypothesized that subjective responses to these drugs would be positively correlated. We also examined participants’ drug responses in relation to personality traits associated with drug use. In this initial, exploratory study, 24 healthy, light drug users (12 male, 12 female), aged 21–31 years, participated in a fully within-subject, randomized, counterbalanced design with six 5.5-hour sessions in which they received d-amphetamine (20mg), alcohol (0.8 g/kg), or THC (7.5 mg), each paired with a placebo session. Participants rated the drugs’ effects on both global measures (e.g. feeling a drug effect at all) and drug-specific measures. In general, participants’ responses to the three drugs were unrelated. Unexpectedly, “wanting more” alcohol was inversely correlated with “wanting more” THC. Additionally, in women, but not in men, “disliking” alcohol was negatively correlated with “disliking” THC. Positive alcohol and amphetamine responses were related, but only in individuals who experienced a stimulant effect of alcohol. Finally, high trait constraint (or lack of impulsivity) was associated with lower reports of liking alcohol. No personality traits predicted responses across multiple drug types. Generally, these findings do not support the idea that certain individuals experience greater positive effects across multiple drug classes, but instead provide some evidence for a “drug of choice” model, in which individuals respond positively to certain classes of drugs that share similar subjective effects, and dislike other types of drugs. Trial Registration ClinicalTrials.gov NCT02485158 PMID:26513587

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.

Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics

PubMed Central

2009-01-01

Background Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. Methods Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. Discussion A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms. Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication. Trial Registration NCT00260663 PMID:20003515

10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Random drug and alcohol testing of individuals who have applied for authorization. 26.67 Section 26.67 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Granting and Maintaining Authorization § 26.67 Random drug and alcohol testing of individuals who...

Supported employment: cost-effectiveness across six European sites

PubMed Central

Knapp, Martin; Patel, Anita; Curran, Claire; Latimer, Eric; Catty, Jocelyn; Becker, Thomas; Drake, Robert E; Fioritti, Angelo; Kilian, Reinhold; Lauber, Christoph; Rössler, Wulf; Tomov, Toma; van Busschbach, Jooske; Comas-Herrera, Adelina; White, Sarah; Wiersma, Durk; Burns, Tom

2013-01-01

A high proportion of people with severe mental health problems are unemployed but would like to work. Individual Placement and Support (IPS) offers a promising approach to establishing people in paid employment. In a randomized controlled trial across six European countries, we investigated the economic case for IPS for people with severe mental health problems compared to standard vocational rehabilitation. Individuals (n=312) were randomized to receive either IPS or standard vocational services and followed for 18 months. Service use and outcome data were collected. Cost-effectiveness analysis was conducted with two primary outcomes: additional days worked in competitive settings and additional percentage of individuals who worked at least 1 day. Analyses distinguished country effects. A partial cost-benefit analysis was also conducted. IPS produced better outcomes than alternative vocational services at lower cost overall to the health and social care systems. This pattern also held in disaggregated analyses for five of the six European sites. The inclusion of imputed values for missing cost data supported these findings. IPS would be viewed as more cost-effective than standard vocational services. Further analysis demonstrated cost-benefit arguments for IPS. Compared to standard vocational rehabilitation services, IPS is, therefore, probably cost-saving and almost certainly more cost-effective as a way to help people with severe mental health problems into competitive employment. PMID:23471803

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.

Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial.

PubMed

Lai, Zhangqi; Wang, Xueqiang; Lee, Seullee; Hou, Xihe; Wang, Lin

2017-09-20

Knee osteoarthritis (KOA) is a leading cause of public disability. Neuromuscular function contributes to the development and/or progression of KOA. Whole body vibration (WBV) exercise improve the neuromuscular function of patients with neurological disorders and even that of older patients with limited exercise options. Therefore, WBV exercise may offer an efficient and alternative treatment for individuals with KOA. However, the effects of WBV training on the neuromuscular function of individuals with KOA remain unclear. Therefore, this study attempts to investigate the effect of a 12-week WBV exercise on the neuromuscular function of individuals with KOA. We will conduct a prospective, single-blind randomized controlled trial on 180 KOA patients. Participants will be randomly assigned to the WBV exercise, lower extremity resistance training, and health education groups. The WBV exercise group will participate in a 12-week WBV training. The lower extremity resistance training group will undergo a 12-week lower extremity resistance training of both lower limbs. The control group will receive health education for 12 weeks. After the intervention, the participants will be followed up for 3 months with no active intervention. Primary outcome measures will include anthropometric measurements, gait analysis during walking and stair climbing, muscle strength test of the knee and ankle, proprioception test of the knee and ankle, and neuromuscular response of the leg muscles. Secondary outcome measures will include self-reported pain and physical functional capacity, and physical performance measures. Furthermore, adverse events will be recorded and analyzed. If any participant withdraws from the trial, intention-to-treat analysis will be performed. Important features of this trial mainly include intervention setting, outcome measure selection, and study duration. This study is intended for estimating the effect of WBV intervention on neuromuscular control outcomes. Study results may provide evidence to support the beneficial effects of WBV exercise on the physical performance and neuromuscular control of individuals with KOA to fill the research gap on the efficacy of WBV. Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009234 . Registered on 21 September 2016.

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

PubMed

Liu, Xian; Engel, Charles C

2012-12-20

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

Exposure to inequality affects support for redistribution.

PubMed

Sands, Melissa L

2017-01-24

The distribution of wealth in the United States and countries around the world is highly skewed. How does visible economic inequality affect well-off individuals' support for redistribution? Using a placebo-controlled field experiment, I randomize the presence of poverty-stricken people in public spaces frequented by the affluent. Passersby were asked to sign a petition calling for greater redistribution through a "millionaire's tax." Results from 2,591 solicitations show that in a real-world-setting exposure to inequality decreases affluent individuals' willingness to redistribute. The finding that exposure to inequality begets inequality has fundamental implications for policymakers and informs our understanding of the effects of poverty, inequality, and economic segregation. Confederate race and socioeconomic status, both of which were randomized, are shown to interact such that treatment effects vary according to the race, as well as gender, of the subject.

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.

Improvement of spontaneous language in stroke patients with chronic aphasia treated with music therapy: a randomized controlled trial.

PubMed

Raglio, Alfredo; Oasi, Osmano; Gianotti, Marta; Rossi, Agnese; Goulene, Karine; Stramba-Badiale, Marco

2016-01-01

The aim of this research is to evaluate the effects of active music therapy (MT) based on free-improvisation (relational approach) in addition to speech language therapy (SLT) compared with SLT alone (communicative-pragmatic approach: Promoting Aphasic's Communicative Effectiveness) in stroke patients with chronic aphasia. The experimental group (n = 10) was randomized to 30 MT individual sessions over 15 weeks in addition to 30 SLT individual sessions while the control group (n = 10) was randomized to only 30 SLT sessions during the same period. Psychological and speech language assessment were made before (T0) and after (T1) the treatments. The study shows a significant improvement in spontaneous speech in the experimental group (Aachener Aphasie subtest: p = 0.020; Cohen's d = 0.35); the 50% of the experimental group showed also an improvement in vitality scores of Short Form Health Survey (chi-square test = 4.114; p = 0.043). The current trial highlights the possibility that the combined use of MT and SLT can lead to a better result in the rehabilitation of patients with aphasia than SLT alone.

Effects of whole body vibration training on postural control in older individuals: a 1 year randomized controlled trial.

PubMed

Bogaerts, An; Verschueren, Sabine; Delecluse, Christophe; Claessens, Albrecht L; Boonen, Steven

2007-07-01

This randomized controlled trial investigated the effects of a 12 month whole body vibration training program on postural control in healthy older adults. Two hundred and twenty people were randomly assigned to a whole body vibration group (n=94), a fitness group (n=60) or a control group (n=66). The whole body vibration and fitness groups trained three times a week for 1 year. The vibration group performed exercises on a vibration platform and the fitness group performed cardiovascular, strength, balance and stretching exercises. Balance was measured using dynamic computerized posturography at baseline and after 6 and 12 months. Whole body vibration training was associated with reduced falls frequency on a moving platform when vision was disturbed and improvements in the response to toes down rotations at the ankle induced by the moving platform. The fitness group showed reduced falls frequency on the moving surface when vision was disturbed. Thus, whole body vibration training may improve some aspects of postural control in community dwelling older individuals.

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

Effect of Amalaki rasayana on DNA damage and repair in randomized aged human individuals.

PubMed

Vishwanatha, Udupi; Guruprasad, Kanive P; Gopinath, Puthiya M; Acharya, Raviraj V; Prasanna, Bokkasa V; Nayak, Jayakrishna; Ganesh, Rajeshwari; Rao, Jayalaxmi; Shree, Rashmi; Anchan, Suchitra; Raghu, Kothanahalli S; Joshi, Manjunath B; Paladhi, Puspendu; Varier, Panniampilly M; Muraleedharan, Kollath; Muraleedharan, Thrikovil S; Satyamoorthy, Kapaettu

2016-09-15

Preparations from Phyllanthus emblica called Amalaki rasayana is used in the Indian traditional medicinal system of Ayurveda for healthy living in elderly. The biological effects and its mechanisms are not fully understood. Since the diminishing DNA repair is the hallmark of ageing, we tested the influence of Amalaki rasayana on recognized DNA repair activities in healthy aged individuals. Amalaki rasayana was prepared fresh and healthy aged randomized human volunteers were administrated with either rasayana or placebo for 45 days strictly as per the traditional text. The DNA repair was analyzed in peripheral blood mononuclear cells before and after rasayana administration and after 45 days post-rasayana treatment regimen. UVC-induced DNA strand break repair (DSBR) based on extent of DNA unwinding by fluorometric analysis, nucleotide excision repair (NER) by flow cytometry and constitutive base excision repair (BER) by gap filling method were analyzed. Amalaki rasayana administration stably maintained/enhanced the DSBR in aged individuals. There were no adverse side effects. Further, subjects with different body mass index showed differential DNA strand break repair capacity. No change in unscheduled DNA synthesis during NER and BER was observed between the groups. Intake of Amalaki rasayana by aged individuals showed stable maintenance of DNA strand break repair without toxic effects. However, there was no change in nucleotide and base excision repair activities. Results warrant further studies on the effects of Amalaki rasayana on DSBR activities. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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.

Consumption of high-fat meal containing cheese compared with vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomized controlled cross-over study

USDA-ARS?s Scientific Manuscript database

Dietary recommendations suggest decreased consumption of SFA to minimize CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomized...

Individualizing Student Instruction Precisely: Effects of Child by Instruction Interactions on First Graders’ Literacy Development

PubMed Central

Connor, Carol McDonald; Piasta, Shayne B.; Fishman, Barry; Glasney, Stephanie; Schatschneider, Christopher; Crowe, Elizabeth; Underwood, Phyllis; Morrison, Frederick J.

2009-01-01

Recent findings demonstrate that the most effective reading instruction may vary with children’s language and literacy skills. These child X instruction interactions imply that individualizing instruction would be a potent strategy for improving students’ literacy. A cluster-randomized control field trial, conducted in 10 high-moderate poverty schools, examined effects of individualizing literacy instruction. The instruction each first grader received (n=461 in 47 classrooms, mean age = 6.7 years), fall, winter and spring, was recorded. Comparing intervention-recommended amounts of instruction with observed amounts revealed that intervention teachers individualized instruction more precisely than did comparison teachers. Importantly, the more precisely children received recommended amounts of instruction, the stronger was their literacy skill growth. Results provide strong evidence of child X instruction interaction effects on literacy outcomes. PMID:19236394

A Comparison of the Effects of Individualized Science Instruction with Traditional Science Instruction in Junior High School.

ERIC Educational Resources Information Center

Heffernan, Daniel F.

The Intermediate Science Curriculum Study (ISCS), operationally defined to be an individualized program, and the New York State Science Syllabus, defined to be the traditional program, were used as methods of instruction with 104 eighth-grade pupils. The students were randomly organized into groups according to the Solomon Four-Group Design.…

A Meta-Analytic Review of the Efficacy of Physical Exercise Interventions on Cognition in Individuals with Autism Spectrum Disorder and ADHD

ERIC Educational Resources Information Center

Tan, Beron W. Z.; Pooley, Julie A.; Speelman, Craig P.

2016-01-01

This review evaluates the efficacy of using physical exercise interventions on improving cognitive functions in individuals with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). This review includes a meta-analysis based on a random-effects model of data reported in 22 studies with 579 participants aged…

The Effects of the Maryland Online Individualized Education Program Goal Wizard on Writing Standards Based Annual Goals

ERIC Educational Resources Information Center

Lewis, Kimberly A.

2011-01-01

The purpose of this study was to examine the efficacy of the Maryland Online Individualized Education Program Goal Wizard on writing standards based annual goals. Specifically, 100 novice special education teachers form a large urban school system in Maryland were randomly assigned to one of two groups. The experimental group received one…

Efficiency of prompt quarantine measures on a susceptible-infected-removed model in networks.

PubMed

Hasegawa, Takehisa; Nemoto, Koji

2017-08-01

This study focuses on investigating the manner in which a prompt quarantine measure suppresses epidemics in networks. A simple and ideal quarantine measure is considered in which an individual is detected with a probability immediately after it becomes infected and the detected one and its neighbors are promptly isolated. The efficiency of this quarantine in suppressing a susceptible-infected-removed (SIR) model is tested in random graphs and uncorrelated scale-free networks. Monte Carlo simulations are used to show that the prompt quarantine measure outperforms random and acquaintance preventive vaccination schemes in terms of reducing the number of infected individuals. The epidemic threshold for the SIR model is analytically derived under the quarantine measure, and the theoretical findings indicate that prompt executions of quarantines are highly effective in containing epidemics. Even if infected individuals are detected with a very low probability, the SIR model under a prompt quarantine measure has finite epidemic thresholds in fat-tailed scale-free networks in which an infected individual can always cause an outbreak of a finite relative size without any measure. The numerical simulations also demonstrate that the present quarantine measure is effective in suppressing epidemics in real networks.

Efficiency of prompt quarantine measures on a susceptible-infected-removed model in networks

NASA Astrophysics Data System (ADS)

Hasegawa, Takehisa; Nemoto, Koji

2017-08-01

This study focuses on investigating the manner in which a prompt quarantine measure suppresses epidemics in networks. A simple and ideal quarantine measure is considered in which an individual is detected with a probability immediately after it becomes infected and the detected one and its neighbors are promptly isolated. The efficiency of this quarantine in suppressing a susceptible-infected-removed (SIR) model is tested in random graphs and uncorrelated scale-free networks. Monte Carlo simulations are used to show that the prompt quarantine measure outperforms random and acquaintance preventive vaccination schemes in terms of reducing the number of infected individuals. The epidemic threshold for the SIR model is analytically derived under the quarantine measure, and the theoretical findings indicate that prompt executions of quarantines are highly effective in containing epidemics. Even if infected individuals are detected with a very low probability, the SIR model under a prompt quarantine measure has finite epidemic thresholds in fat-tailed scale-free networks in which an infected individual can always cause an outbreak of a finite relative size without any measure. The numerical simulations also demonstrate that the present quarantine measure is effective in suppressing epidemics in real networks.

Cooperation and stability through periodic impulses.

PubMed

Zhang, Bo-Yu; Cressman, Ross; Tao, Yi

2010-03-29

Basic games, where each individual chooses between two strategies, illustrate several issues that immediately emerge from the standard approach that applies strategic reasoning, based on rational decisions, to predict population behavior where no rationality is assumed. These include how mutual cooperation (which corresponds to the best outcome from the population perspective) can evolve when the only individually rational choice is to defect, illustrated by the Prisoner's Dilemma (PD) game, and how individuals can randomize between two strategies when neither is individually rational, illustrated by the Battle of the Sexes (BS) game that models male-female conflict over parental investment in offspring. We examine these questions from an evolutionary perspective where the evolutionary dynamics includes an impulsive effect that models sudden changes in collective population behavior. For the PD game, we show analytically that cooperation can either coexist with defection or completely take over the population, depending on the strength of the impulse. By extending these results for the PD game, we also show that males and females each evolve to a single strategy in the BS game when the impulsive effect is strong and that weak impulses stabilize the randomized strategies of this game.

Neighborhood effects in a behavioral randomized controlled trial.

PubMed

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

2014-11-01

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

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.

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.

Quantifying the evolution of individual scientific impact.

PubMed

Sinatra, Roberta; Wang, Dashun; Deville, Pierre; Song, Chaoming; Barabási, Albert-László

2016-11-04

Despite the frequent use of numerous quantitative indicators to gauge the professional impact of a scientist, little is known about how scientific impact emerges and evolves in time. Here, we quantify the changes in impact and productivity throughout a career in science, finding that impact, as measured by influential publications, is distributed randomly within a scientist's sequence of publications. This random-impact rule allows us to formulate a stochastic model that uncouples the effects of productivity, individual ability, and luck and unveils the existence of universal patterns governing the emergence of scientific success. The model assigns a unique individual parameter Q to each scientist, which is stable during a career, and it accurately predicts the evolution of a scientist's impact, from the h-index to cumulative citations, and independent recognitions, such as prizes. Copyright © 2016, American Association for the Advancement of Science.

Effect of magnesium supplementation on lipid profile: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Simental-Mendía, Luis E; Simental-Mendía, Mario; Sahebkar, Amirhossein; Rodríguez-Morán, Martha; Guerrero-Romero, Fernando

2017-05-01

We performed a meta-analysis of randomized controlled trials (RCTs) in order to evaluate the effect of oral magnesium supplementation on lipid profile of both diabetic and non-diabetic individuals. PubMed-Medline, SCOPUS, Web of Science, and Google Scholar databases were searched (from inception to February 23, 2016) to identify RCTs evaluating the effect of magnesium on lipid concentrations. A random-effects model and generic inverse variance method were used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. A weighted random-effects meta-regression was performed to evaluate the impact of potential confounders on lipid concentrations. Magnesium treatment was not found to significantly affect plasma concentrations of any of the lipid indices including total cholesterol (WMD 0.03 mmol/L, 95% CI -0.11, 0.16, p = 0.671), LDL-C (WMD -0.01 mmol/L, 95% CI -0.13, 0.11, p = 0.903), HDL-C (WMD 0.03 mmol/L, 95% CI -0.003, 0.06, p = 0.076), and triglycerides concentrations (WMD -0.10 mmol/L, 95% CI -0.25, 0.04, p = 0.149). In a subgroup analysis comparing studies with and without diabetes, no difference was observed between subgroups in terms of changes in plasma total cholesterol (p = 0.924), LDL-C (p = 0.161), HDL-C (p = 0.822), and triglyceride (p = 0.162) concentrations. Results of the present meta-analysis indicated that magnesium supplementation showed no significant effects on the lipid profile of either diabetic or non-diabetic individuals.

Guided training relative to direct skill training for individuals with cognitive impairments after stroke: a pilot randomized trial

PubMed Central

Skidmore, Elizabeth R.; Butters, Meryl; Whyte, Ellen; Grattan, Emily; Shen, Jennifer; Terhorst, Lauren

2016-01-01

Objective To examine the effects of direct skill training and guided training for promoting independence after stroke. Design Single-blind randomized pilot study. Setting Inpatient rehabilitation facility. Participants Forty-three participants in inpatient rehabilitation with acute stroke and cognitive impairments. Interventions Participants were randomized to receive direct skill training (n=22, 10 sessions as adjunct to usual inpatient rehabilitation) or guided training (n=21, same dose). Main Outcome Measure The Functional Independence Measure assessed independence at baseline, rehabilitation discharge, and months 3, 6, and 12. Results Linear mixed models (random intercept, other effects fixed) revealed a significant intervention by time interaction (F4,150=5.11, p<0.001), a significant main effect of time (F4,150=49.25, p<0.001), and a significant effect of stroke severity (F1,150=34.46, p<.001). There was no main effect of intervention (F1,150=0.07, p=0.79). Change in Functional Independence Measures scores was greater for the DIRECT group at rehabilitation discharge (effect size of between group differences, d=0.28) and greater for the GUIDE group at months 3 (d=0.16), 6 (d=0.39), and 12 (d=0.53). The difference between groups in mean 12 month change scores was 10.57 points. Conclusions Guided training, provided in addition to usual care, offered a small advantage in the recovery of independence, relative to direct skill training. Future studies examining guided training in combination with other potentially potent intervention elements may further advise best practices in rehabilitation for individuals with cognitive impairments after acute stroke. PMID:27794487

New oral anticoagulants in patients with cancer: current state of evidence.

PubMed

Sardar, Partha; Chatterjee, Saurav; Herzog, Eyal; Pekler, Gerald; Mushiyev, Savi; Pastori, Luciano J; Visco, Ferdinand; Aronow, Wilbert S

2015-01-01

Effectiveness of new oral anticoagulants (NOAC) in patients with cancer is not clearly defined. There remain concerns of doubtful benefit and chances of potential harm with newer agents. In this meta-analysis, we evaluated the efficacy and safety of NOAC in patients with cancer. PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 01, 2001 through February 28, 2013. Randomized controlled trials reporting efficacy and safety data of NOACs (rivaroxaban, dabigatran, and apixaban) with control (low-molecular-weight heparin/vitamin K antagonists/placebo) for patients with cancer were included. Primary efficacy outcome was venous thromboembolism (VTE) or VTE-related death, and primary safety outcome was clinically relevant bleeding. We used random-effects models. Six trials randomized 19,832 patients, and 1197 patients had cancer. Risk of VTE or VTE-related death was not significantly different with NOAC versus control [odds ratio (OR), 0.80; 95% confidence interval (CI), 0.39-1.65] in patients with cancer. Separate analysis for individual effects showed similar results for rivaroxaban (OR, 1.08; 95% CI, 0.60-1.94) and dabigatran (OR, 0.91; 95% CI, 0.21-3.91). Clinically relevant bleeding was not higher with NOAC compared with control (OR, 1.49; 95% CI, 0.82-2.71); individual effect of rivaroxaban showed similar results. No statistically significant difference of efficacy and safety with NOAC was found between patients with and without cancer. Rivaroxaban might be equally effective and safe as vitamin K antagonist in patients with cancer. Dabigatran is as effective as comparator; however, safety profile of dabigatran is unknown. Randomized trials of new anticoagulants specific to the cancer population are necessary, and NOAC also need to be evaluated against low-molecular-weight heparin.

Support or competition? How online social networks increase physical activity: A randomized controlled trial.

PubMed

Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Becker, Joshua; Herbert, Natalie; Centola, Damon

2016-12-01

To identify what features of online social networks can increase physical activity, we conducted a 4-arm randomized controlled trial in 2014 in Philadelphia, PA. Students (n = 790, mean age = 25.2) at an university were randomly assigned to one of four conditions composed of either supportive or competitive relationships and either with individual or team incentives for attending exercise classes. The social comparison condition placed participants into 6-person competitive networks with individual incentives. The social support condition placed participants into 6-person teams with team incentives. The combined condition with both supportive and competitive relationships placed participants into 6-person teams, where participants could compare their team's performance to 5 other teams' performances. The control condition only allowed participants to attend classes with individual incentives. Rewards were based on the total number of classes attended by an individual, or the average number of classes attended by the members of a team. The outcome was the number of classes that participants attended. Data were analyzed using multilevel models in 2014. The mean attendance numbers per week were 35.7, 38.5, 20.3, and 16.8 in the social comparison, the combined, the control, and the social support conditions. Attendance numbers were 90% higher in the social comparison and the combined conditions (mean = 1.9, SE = 0.2) in contrast to the two conditions without comparison (mean = 1.0, SE = 0.2) (p = 0.003). Social comparison was more effective for increasing physical activity than social support and its effects did not depend on individual or team incentives.

The Mothers and Toddlers Program, an attachment-based parenting intervention for substance using women: Post-treatment results from a randomized clinical pilot

PubMed Central

Suchman, Nancy E.; DeCoste, Cindy; Castiglioni, Nicole; McMahon, Thomas J.; Rounsaville, Bruce; Mayes, Linda

2010-01-01

This is a report of post-treatment findings from a completed randomized pilot study testing the preliminary efficacy of The Mothers and Toddlers Program (MTP), a 12 week attachment-based individual parenting therapy for mothers enrolled in substance abuse treatment and caring for children ages birth to 36 months. Forty-seven mothers were randomized to MTP versus the Parent Education Program (PE) – a comparison intervention providing individual case management and child guidance brochures. At post-treatment, MTP mothers demonstrated better reflective functioning in the Parent Development Interview, representational coherence and sensitivity, and caregiving behavior than PE mothers. Partial support was also found for proposed mechanisms of change in the MTP model. Together, preliminary findings suggest that attachment-based interventions may be more effective than traditional parent training for enhancing relationships between substance using women and their young children. PMID:20730641

The Effects of Consultation on Individualized Education Program Outcomes for Young Children With Autism: The Collaborative Model for Promoting Competence and Success

PubMed Central

Ruble, Lisa A.; Dalrymple, Nancy J.; McGrew, John H.

2011-01-01

The effects of a teacher consultation intervention were examined—namely, the collaborative model for promoting competence and success (COMPASS), which was designed to improve objectives of individualized education programs for children with autism. The intervention consists of an initial parent–teacher consultation, followed by four teacher consultations across the school year. Thirty-five teachers and a randomly selected child with autism (M age = 6.1 years) from each classroom participated. Compared to the nonintervention teacher–child dyads, the intervention teacher–child dyads showed improvements in individualized education program objectives, with a large effect size (d = 1.51). PMID:21691449

High- and low-frequency transcutaneous electrical nerve stimulation does not reduce experimental pain in elderly individuals

PubMed Central

Bergeron-Vézina, Kayla; Corriveau, Hélène; Martel, Marylie; Harvey, Marie-Philippe; Léonard, Guillaume

2015-01-01

Abstract Despite its widespread clinical use, the efficacy of transcutaneous electrical nerve stimulation (TENS) remains poorly documented in elderly individuals. In this randomized, double-blind crossover study, we compared the efficacy of high-frequency (HF), low-frequency (LF), and placebo (P) TENS in a group of 15 elderly adults (mean age: 67 ± 5 years). The effect of HF-, LF-, and P-TENS was also evaluated in a group of 15 young individuals (26 ± 5 years; same study design) to validate the effectiveness of the TENS protocols that were used in the elderly group. Each participant came to the laboratory on 3 separate occasions to receive, in random order, HF-, LF-, and P-TENS. Pain intensity and pain perception thresholds were assessed before, during, and after TENS, using an experimental heat pain paradigm. For the young group, there was a significant decrease in pain intensity during and after HF- and LF-TENS when compared with baseline, with both HF- and LF-TENS being superior to P-TENS. In the older group, HF- and LF-TENS did not reduce pain when compared with baseline and no difference was observed between the 2 active TENS sessions and P-TENS. High-frequency, LF-, and P-TENS all increased pain thresholds in young individuals, whereas in older individuals, only LF-TENS increased pain thresholds. Taken together, these results suggest that TENS is effective in young, but not in older, individuals. Future studies should be conducted to confirm these results in pain populations and to identify strategies that could enhance the effect of TENS in the elderly. PMID:26101836

Randomized Trial on the Effects of Attentional Focus on Motor Training of the Upper Extremity Using Robotics With Individuals After Chronic Stroke.

PubMed

Kim, Grace J; Hinojosa, Jim; Rao, Ashwini K; Batavia, Mitchell; O'Dell, Michael W

2017-10-01

To compare the long-term effects of external focus (EF) and internal focus (IF) of attention after 4 weeks of arm training. Randomized, repeated-measures, mixed analysis of variance. Outpatient clinic. Individuals with stroke and moderate-to-severe arm impairment living in the community (N=33; withdrawals: n=3). Four-week arm training protocol on a robotic device (12 sessions). Joint independence, Fugl-Meyer Assessment, and Wolf Motor Function Test measured at baseline, discharge, and 4-week follow-up. There were no between-group effects for attentional focus. Participants in both groups improved significantly on all outcome measures from baseline to discharge and maintained those changes at 4-week follow-up regardless of group assignment (joint independence EF condition: F 1.6,45.4 =17.74; P<.0005; partial η 2 =.39; joint independence IF condition: F 2,56 =18.66; P<.0005; partial η 2 =.40; Fugl-Meyer Assessment: F 2,56 =27.83; P<.0005; partial η 2 =.50; Wolf Motor Function Test: F 2,56 =14.05; P<.0005; partial η 2 =.35). There were no differences in retention of motor skills between EF and IF participants 4 weeks after arm training, suggesting that individuals with moderate-to-severe arm impairment may not experience the advantages of an EF found in healthy individuals. Attentional focus is most likely not an active ingredient for retention of trained motor skills for individuals with moderate-to-severe arm impairment, whereas dosage and intensity of practice appear to be pivotal. Future studies should investigate the long-term effects of attentional focus for individuals with mild arm impairment. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of Antimicrobial Therapy after Extraction of Impacted Mandibular Third Molar: A Randomized Clinical Trial.

PubMed

Rabi, A; Maheshwari, Rahul; Srinivasan, Bhuvaneshwari; Warad, Lata P; Suvarna, C C; Tank, Kartik S

2018-01-01

The present study was conducted with the aim of evaluating the effectiveness of antimicrobial therapy following extraction of an impacted mandibular third molar. This randomized controlled trial was conducted on a total of 60 patients who were randomly assigned into three groups: Group I individuals were given 625 mg of combined amoxicillin and clavulanic acid tablet; 625 mg of combined amoxicillin and clavulanic acid tablet + 400 mg metronidazole tablet was given to group II individuals; whereas group III individuals were assigned no treatment. All the individuals underwent surgical extraction of impacted mandibular third molars under strict aseptic techniques, with minimal trauma to the surrounding tissues. Mouth opening in millimeters was recorded postoperatively using Vernier calipers on the 1st, 3rd, 5th, and 7th days. A 4-point visual analog scale (VAS) was used for assessing postoperative pain. Patient satisfaction was further assessed in a subjective manner using a graded scale from "very satisfied" to "very unsatisfied". The present study included individuals between the ages of 20 and 35 years. Group II individuals showed slightly better satisfaction than the other group individuals. There was no statistically significant difference between the mean age of groups. It was observed that on day 3, the number of individuals with severe pain was slightly reduced in the group I compared with group III individuals. On day 5, participants with no pain were significantly more in group II followed by group I. Furthermore, there was a statistically significant difference between the study groups with respect to mouth opening on days 3 and 5. It was concluded from this trial that the administration of postoperative antimicrobials showed no significant differences in the degree of postoperative complications that occur following the surgical extraction of impacted mandibular third molars. Antimicrobial drugs are routinely used to reduce the chances of surgical site infection, either preopera-tively or postoperatively. Therefore, the clinicians should have sound knowledge about choosing the better antimicrobial drug after the extraction of impacted third molars.

Randomized controlled trial of exercise interventions to improve sleep quality and daytime sleepiness in individuals with multiple sclerosis: A pilot study.

PubMed

Siengsukon, Catherine F; Aldughmi, Mayis; Kahya, Melike; Bruce, Jared; Lynch, Sharon; Ness Norouzinia, Abigail; Glusman, Morgan; Billinger, Sandra

2016-01-01

Nearly 70% of individuals with multiple sclerosis (MS) experience sleep disturbances. Increasing physical activity in people with MS has been shown to produce a moderate improvement in sleep quality, and exercise has been shown to improve sleep quality in non-neurologically impaired adults. The purpose of this pilot randomized controlled trial study was to examine the effect of two exercise interventions on sleep quality and daytime sleepiness in individuals with MS. Twenty-eight individuals with relapsing-remitting or secondary progressive MS were randomized into one of two 12-week exercise interventions: a supervised, moderate-intensity aerobic exercise (AE) program or an unsupervised, low-intensity walking and stretching (WS) program. Only individuals who were ≥ 70% compliant with the programs were included in analysis ( n  = 12 AE; n  = 10 WS). Both groups demonstrated a moderate improvement in sleep quality, although only the improvement by the WS group was statistically significant. Only the AE group demonstrated a significant improvement in daytime sleepiness. Change in sleep quality and daytime sleepiness was not correlated with disease severity or with change in cardiovascular fitness, depression, or fatigue. The mechanisms for improvement in sleep quality and daytime sleepiness need further investigation, but may be due to introduction of zeitgebers to improve circadian rhythm.

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.

Effects of quercetin supplementation on endurance performance and maximal oxygen consumption: a meta-analysis.

PubMed

Pelletier, Denis M; Lacerte, Guillaume; Goulet, Eric D B

2013-02-01

Lately, the effect of quercetin supplementation (QS) on endurance performance (EP) and maximal oxygen consumption (VO2max) has been receiving much scientific and media attention. Therefore, a meta-analysis was performed to determine QS's ergogenic value on these variables. Studies were located with database searches (PubMed and SPORTDiscus) and cross-referencing. Outcomes represent mean percentage changes in EP (measured via power output) and VO2max between QS and placebo. Random-effects model meta-regression, mixed-effects model analog to the ANOVA, random-effects weighted mean effect summary, and magnitude-based inferences analyses were used to delineate the effects of QS. Seven research articles (representing 288 subjects) were included, producing 4 VO2max and 10 EP effect estimates. Mean QS daily intake and duration were, respectively, 960 ± 127 mg and 26 ± 24 d for the EP outcome and 1,000 ± 0 mg and 8 ± 23 d for the VO2max outcome. EP was assessed during exercise with a mean duration of 79 ± 82 min. Overall, QS improved EP by 0.74% (95% CI: 0.10-1.39, p = .02) compared with placebo. However, only in untrained individuals (0.83% ± 0.78%, p = .02) did QS significantly improve EP (trained individuals: 0.09% ± 2.15%, p = .92). There was no relationship between QS duration and EP (p = .69). Overall, QS increased VO2max by 1.94% (95% CI: 0.30-3.59, p = .02). Magnitude-based inferences suggest that the effect of QS on EP and VO2max is likely to be trivial for both trained and untrained individuals. In conclusion, this meta-analysis indicates that QS is unlikely to prove ergogenic for aerobic-oriented exercises in trained and untrained individuals.

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.

Infectious disease control using contact tracing in random and scale-free networks

PubMed Central

Kiss, Istvan Z; Green, Darren M; Kao, Rowland R

2005-01-01

Contact tracing aims to identify and isolate individuals that have been in contact with infectious individuals. The efficacy of contact tracing and the hierarchy of traced nodes—nodes with higher degree traced first—is investigated and compared on random and scale-free (SF) networks with the same number of nodes N and average connection K. For values of the transmission rate larger than a threshold, the final epidemic size on SF networks is smaller than that on corresponding random networks. While in random networks new infectious and traced nodes from all classes have similar average degrees, in SF networks the average degree of nodes that are in more advanced stages of the disease is higher at any given time. On SF networks tracing removes possible sources of infection with high average degree. However a higher tracing effort is required to control the epidemic than on corresponding random networks due to the high initial velocity of spread towards the highly connected nodes. An increased latency period fails to significantly improve contact tracing efficacy. Contact tracing has a limited effect if the removal rate of susceptible nodes is relatively high, due to the fast local depletion of susceptible nodes. PMID:16849217

Citalopram Intervention for Hostility: Results of a Randomized Clinical Trial

ERIC Educational Resources Information Center

Kamarck, Thomas W.; Haskett, Roger F.; Muldoon, Matthew; Flory, Janine D.; Anderson, Barbara; Bies, Robert; Pollock, Bruce; Manuck, Stephen B.

2009-01-01

Hostility is associated with an increased risk for cardiovascular disease (CVD). Because central serotonin may modulate aggression, we might expect selective serotonin reuptake inhibitors (SSRIs) to be effective in reducing hostility. Such effects have never been examined in individuals scoring high on hostility who are otherwise free from major…

Effects of Strategy Training and Incentives on Students' Performance, Confidence, and Calibration

ERIC Educational Resources Information Center

Gutierrez, Antonio P.; Schraw, Gregory

2015-01-01

This study examined the effect of strategy instruction and incentives on performance, confidence, and calibration accuracy. Individuals (N = 107) in randomly assigned treatment groups received a multicomponent strategy instruction intervention, financial incentives for high performance, or both. The authors predicted that incentives would improve…

Effect of personalized nutrition on health-related behavior change: evidence from the Food4Me randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Background - Optimal nutritional choices are linked with better health but most current interventions to improve diet have limited effect. We tested the hypothesis that providing personalized nutrition (PN) advice based on collected information on individual diet and lifestyle, phenotype or genotype...

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

PubMed

Shteingart, Hanan; Loewenstein, Yonatan

2016-01-01

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

Individual analyses of Lévy walk in semi-free ranging Tonkean macaques (Macaca tonkeana).

PubMed

Sueur, Cédric; Briard, Léa; Petit, Odile

2011-01-01

Animals adapt their movement patterns to their environment in order to maximize their efficiency when searching for food. The Lévy walk and the Brownian walk are two types of random movement found in different species. Studies have shown that these random movements can switch from a Brownian to a Lévy walk according to the size distribution of food patches. However no study to date has analysed how characteristics such as sex, age, dominance or body mass affect the movement patterns of an individual. In this study we used the maximum likelihood method to examine the nature of the distribution of step lengths and waiting times and assessed how these distributions are influenced by the age and the sex of group members in a semi free-ranging group of ten Tonkean macaques. Individuals highly differed in their activity budget and in their movement patterns. We found an effect of age and sex of individuals on the power distribution of their step lengths and of their waiting times. The males and old individuals displayed a higher proportion of longer trajectories than females and young ones. As regards waiting times, females and old individuals displayed higher rates of long stationary periods than males and young individuals. These movement patterns resembling random walks can probably be explained by the animals moving from one location to other known locations. The power distribution of step lengths might be due to a power distribution of food patches in the enclosure while the power distribution of waiting times might be due to the power distribution of the patch sizes.

MIXREG: a computer program for mixed-effects regression analysis with autocorrelated errors.

PubMed

Hedeker, D; Gibbons, R D

1996-05-01

MIXREG is a program that provides estimates for a mixed-effects regression model (MRM) for normally-distributed response data including autocorrelated errors. This model can be used for analysis of unbalanced longitudinal data, where individuals may be measured at a different number of timepoints, or even at different timepoints. Autocorrelated errors of a general form or following an AR(1), MA(1), or ARMA(1,1) form are allowable. This model can also be used for analysis of clustered data, where the mixed-effects model assumes data within clusters are dependent. The degree of dependency is estimated jointly with estimates of the usual model parameters, thus adjusting for clustering. MIXREG uses maximum marginal likelihood estimation, utilizing both the EM algorithm and a Fisher-scoring solution. For the scoring solution, the covariance matrix of the random effects is expressed in its Gaussian decomposition, and the diagonal matrix reparameterized using the exponential transformation. Estimation of the individual random effects is accomplished using an empirical Bayes approach. Examples illustrating usage and features of MIXREG are provided.

A randomized controlled trial assessing the effectiveness of strategies delivering low vision rehabilitation: design and baseline characteristics of study participants.

PubMed

Christy, Beula; Keeffe, Jill E; Nirmalan, Praveen K; Rao, Gullapalli N

2010-08-01

To design a randomized controlled trial (RCT) to compare the effectiveness of four different strategies to deliver low vision rehabilitation services. The four arms of the RCT comprised-center based rehabilitation, home based rehabilitation, a mix of center based and home based rehabilitation, and center based rehabilitation with home based non interventional supplementary visits by rehabilitation workers. Outcomes were assessed 9 months after baseline and included measuring changes in adaptation to age-related vision loss, quality of life, impact of vision impairment and effectiveness of low vision rehabilitation training. The socio-demographic and vision characteristics of the sample in each of the 4 arms were compared to ensure that outcomes are not associated with differences between the groups. Four hundred and thirty six individuals were enrolled in the study; 393 individuals completed the study. One-fifth of participants were children aged 8 to 16 years. At baseline, socio-demographic and clinical characteristics were similar between individuals in the four arms of the trial. Socio-demographic and clinical characteristics did not differ significantly, except for age, between the 393 individuals who completed the trial and the 43 individuals who dropped out of the study. Twenty six (60.46%) of the forty three drop outs were from the center based arm of the trial. Information from this trial has the potential to shape policy and practice pertaining to low vision rehabilitation services.

Individual behavioural counselling for smoking cessation.

PubMed

Lancaster, Tim; Stead, Lindsay F

2017-03-31

Individual counselling from a smoking cessation specialist may help smokers to make a successful attempt to stop smoking. The review addresses the following hypotheses:1. Individual counselling is more effective than no treatment or brief advice in promoting smoking cessation.2. Individual counselling is more effective than self-help materials in promoting smoking cessation.3. A more intensive counselling intervention is more effective than a less intensive intervention. We searched the Cochrane Tobacco Addiction Group Specialized Register for studies with counsel* in any field in May 2016. Randomized or quasi-randomized trials with at least one treatment arm consisting of face-to-face individual counselling from a healthcare worker not involved in routine clinical care. The outcome was smoking cessation at follow-up at least six months after the start of counselling. Both authors extracted data in duplicate. We recorded characteristics of the intervention and the target population, method of randomization and completeness of follow-up. We used the most rigorous definition of abstinence in each trial, and biochemically-validated rates where available. In analysis, we assumed that participants lost to follow-up continued to smoke. We expressed effects as a risk ratio (RR) for cessation. Where possible, we performed meta-analysis using a fixed-effect (Mantel-Haenszel) model. We assessed the quality of evidence within each study using the Cochrane 'Risk of bias' tool and the GRADE approach. We identified 49 trials with around 19,000 participants. Thirty-three trials compared individual counselling to a minimal behavioural intervention. There was high-quality evidence that individual counselling was more effective than a minimal contact control (brief advice, usual care, or provision of self-help materials) when pharmacotherapy was not offered to any participants (RR 1.57, 95% confidence interval (CI) 1.40 to 1.77; 27 studies, 11,100 participants; I 2 = 50%). There was moderate-quality evidence (downgraded due to imprecision) of a benefit of counselling when all participants received pharmacotherapy (nicotine replacement therapy) (RR 1.24, 95% CI 1.01 to 1.51; 6 studies, 2662 participants; I 2 = 0%). There was moderate-quality evidence (downgraded due to imprecision) for a small benefit of more intensive counselling compared to brief counselling (RR 1.29, 95% CI 1.09 to 1.53; 11 studies, 2920 participants; I 2 = 48%). None of the five other trials that compared different counselling models of similar intensity detected significant differences. There is high-quality evidence that individually-delivered smoking cessation counselling can assist smokers to quit. There is moderate-quality evidence of a smaller relative benefit when counselling is used in addition to pharmacotherapy, and of more intensive counselling compared to a brief counselling intervention.

Portraying mental illness and drug addiction as treatable health conditions: effects of a randomized experiment on stigma and discrimination.

PubMed

McGinty, Emma E; Goldman, Howard H; Pescosolido, Bernice; Barry, Colleen L

2015-02-01

Despite significant advances in treatment, stigma and discrimination toward persons with mental illness and drug addiction have remained constant in past decades. Prior work suggests that portraying other stigmatized health conditions (i.e., HIV/AIDS) as treatable can improve public attitudes toward those affected. Our study compared the effects of vignettes portraying persons with untreated and symptomatic versus successfully treated and asymptomatic mental illness and drug addiction on several dimensions of public attitudes about these conditions. We conducted a survey-embedded randomized experiment using a national sample (N = 3940) from an online panel. Respondents were randomly assigned to read one of ten vignettes. Vignette one was a control vignette, vignettes 2-5 portrayed individuals with untreated schizophrenia, depression, prescription pain medication addiction and heroin addiction, and vignettes 6-10 portrayed successfully treated individuals with the same conditions. After reading the randomly assigned vignette, respondents answered questions about their attitudes related to mental illness or drug addiction. Portrayals of untreated and symptomatic schizophrenia, depression, and heroin addiction heightened negative public attitudes toward persons with mental illness and drug addiction. In contrast, portrayals of successfully treated schizophrenia, prescription painkiller addiction, and heroin addiction led to less desire for social distance, greater belief in the effectiveness of treatment, and less willingness to discriminate against persons with these conditions. Portrayal of persons with successfully treated mental illness and drug addiction is a promising strategy for reducing stigma and discrimination toward persons with these conditions and improving public perceptions of treatment effectiveness. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effectiveness of and Dropout from Outpatient Cognitive Behavioral Therapy for Adult Unipolar Depression: A Meta-Analysis of Nonrandomized Effectiveness Studies

ERIC Educational Resources Information Center

Hans, Eva; Hiller, Wolfgang

2013-01-01

Objective: The primary aim of this study was to assess the overall effectiveness of and dropout from individual and group outpatient cognitive behavioral therapy (CBT) for adults with a primary diagnosis of unipolar depressive disorder in routine clinical practice. Method: We conducted a random effects meta-analysis of 34 nonrandomized…

Disentangling the Relative Influence of Schools and Neighborhoods on Adolescents’ Risk for Depressive Symptoms

PubMed Central

Milliren, Carly E.; Evans, Clare R.; Subramanian, S. V.; Richmond, Tracy K.

2015-01-01

Objectives. Although schools and neighborhoods influence health, little is known about their relative importance, or the influence of one context after the influence of the other has been taken into account. We simultaneously examined the influence of each setting on depression among adolescents. Methods. Analyzing data from wave 1 (1994–1995) of the National Longitudinal Study of Adolescent Health, we used cross-classified multilevel modeling to examine between-level variation and individual-, school-, and neighborhood-level predictors of adolescent depressive symptoms. Also, we compared the results of our cross-classified multilevel models (CCMMs) with those of a multilevel model wherein either school or neighborhood was excluded. Results. In CCMMs, the school-level random effect was significant and more than 3 times the neighborhood-level random effect, even after individual-level characteristics had been taken into account. Individual-level indicators (e.g., race/ethnicity, socioeconomic status) were associated with depressive symptoms, but there was no association with either school- or neighborhood-level fixed effects. The between-level variance in depressive symptoms was driven largely by schools as opposed to neighborhoods. Conclusions. Schools appear to be more salient than neighborhoods in explaining variation in depressive symptoms. Future work incorporating cross-classified multilevel modeling is needed to understand the relative effects of schools and neighborhoods. PMID:25713969

Individual music therapy for agitation in dementia: an exploratory randomized controlled trial.

PubMed

Ridder, Hanne Mette O; Stige, Brynjulf; Qvale, Liv Gunnhild; Gold, Christian

2013-01-01

Agitation in nursing home residents with dementia leads to increase in psychotropic medication, decrease in quality of life, and to patient distress and caregiver burden. Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been methodologically insufficient. The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes, and to explore its effect on psychotropic medication and quality of life. In a crossover trial, 42 participants with dementia were randomized to a sequence of six weeks of individual music therapy and six weeks of standard care. Outcome measures included agitation, quality of life and medication. Agitation disruptiveness increased during standard care and decreased during music therapy. The difference at -6.77 (95% CI (confidence interval): -12.71, -0.83) was significant (p = 0.027), with a medium effect size (0.50). The prescription of psychotropic medication increased significantly more often during standard care than during music therapy (p = 0.02). This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia. The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample.

Social stories: mechanisms of effectiveness in increasing game play skills in children diagnosed with autism spectrum disorder using a pretest posttest repeated measures randomized control group design.

PubMed

Quirmbach, Linda M; Lincoln, Alan J; Feinberg-Gizzo, Monica J; Ingersoll, Brooke R; Andrews, Siri M

2009-02-01

An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A total of 45 children diagnosed with Autism Spectrum Disorder (ASD) ages 7-14 were randomly assigned to standard, directive, or control story conditions. Results demonstrated that the standard and directive story formats were equally as effective in eliciting, generalizing and maintaining the targeted social skills in participants who had prior game play experience and Verbal Comprehension Index (VCI) scores from the WISC-IV intelligence test in the borderline range or above.

Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

PubMed Central

Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

2011-01-01

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression. PMID:19687192

Eliminating Survivor Bias in Two-stage Instrumental Variable Estimators.

PubMed

Vansteelandt, Stijn; Walter, Stefan; Tchetgen Tchetgen, Eric

2018-07-01

Mendelian randomization studies commonly focus on elderly populations. This makes the instrumental variables analysis of such studies sensitive to survivor bias, a type of selection bias. A particular concern is that the instrumental variable conditions, even when valid for the source population, may be violated for the selective population of individuals who survive the onset of the study. This is potentially very damaging because Mendelian randomization studies are known to be sensitive to bias due to even minor violations of the instrumental variable conditions. Interestingly, the instrumental variable conditions continue to hold within certain risk sets of individuals who are still alive at a given age when the instrument and unmeasured confounders exert additive effects on the exposure, and moreover, the exposure and unmeasured confounders exert additive effects on the hazard of death. In this article, we will exploit this property to derive a two-stage instrumental variable estimator for the effect of exposure on mortality, which is insulated against the above described selection bias under these additivity assumptions.

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.

Designing Studies That Would Address the Multilayered Nature of Health Care

PubMed Central

Pennell, Michael; Rhoda, Dale; Hade, Erinn M.; Paskett, Electra D.

2010-01-01

We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates. PMID:20386057

Lessons Learned from Community-Led Recruitment of Immigrants and Refugee Participants for a Randomized, Community-Based Participatory Research Study.

PubMed

Hanza, Marcelo M; Goodson, Miriam; Osman, Ahmed; Porraz Capetillo, Maria D; Hared, Abdullah; Nigon, Julie A; Meiers, Sonja J; Weis, Jennifer A; Wieland, Mark L; Sia, Irene G

2016-10-01

Ethnic minorities remain underrepresented in clinical trials despite efforts to increase their enrollment. Although community-based participatory research (CBPR) approaches have been effective for conducting research studies in minority and socially disadvantaged populations, protocols for CBPR recruitment design and implementation among immigrants and refugees have not been well described. We used a community-led and community-implemented CBPR strategy for recruiting 45 Hispanic, Somali, and Sudanese families (160 individuals) to participate in a large, randomized, community-based trial aimed at evaluating a physical activity and nutrition intervention. We achieved 97.7 % of our recruitment goal for families and 94.4 % for individuals. Use of a CBPR approach is an effective strategy for recruiting immigrant and refugee participants for clinical trials. We believe the lessons we learned during the process of participatory recruitment design and implementation will be helpful for others working with these populations.

At the Frontiers of Modeling Intensive Longitudinal Data: Dynamic Structural Equation Models for the Affective Measurements from the COGITO Study.

PubMed

Hamaker, E L; Asparouhov, T; Brose, A; Schmiedek, F; Muthén, B

2018-04-06

With the growing popularity of intensive longitudinal research, the modeling techniques and software options for such data are also expanding rapidly. Here we use dynamic multilevel modeling, as it is incorporated in the new dynamic structural equation modeling (DSEM) toolbox in Mplus, to analyze the affective data from the COGITO study. These data consist of two samples of over 100 individuals each who were measured for about 100 days. We use composite scores of positive and negative affect and apply a multilevel vector autoregressive model to allow for individual differences in means, autoregressions, and cross-lagged effects. Then we extend the model to include random residual variances and covariance, and finally we investigate whether prior depression affects later depression scores through the random effects of the daily diary measures. We end with discussing several urgent-but mostly unresolved-issues in the area of dynamic multilevel modeling.

Epidemic spreading on random surfer networks with infected avoidance strategy

NASA Astrophysics Data System (ADS)

Feng, Yun; Ding, Li; Huang, Yun-Han; Guan, Zhi-Hong

2016-12-01

In this paper, we study epidemic spreading on random surfer networks with infected avoidance (IA) strategy. In particular, we consider that susceptible individuals’ moving direction angles are affected by the current location information received from infected individuals through a directed information network. The model is mainly analyzed by discrete-time numerical simulations. The results indicate that the IA strategy can restrain epidemic spreading effectively. However, when long-distance jumps of individuals exist, the IA strategy’s effectiveness on restraining epidemic spreading is heavily reduced. Finally, it is found that the influence of the noises from information transferring process on epidemic spreading is indistinctive. Project supported in part by the National Natural Science Foundation of China (Grant Nos. 61403284, 61272114, 61673303, and 61672112) and the Marine Renewable Energy Special Fund Project of the State Oceanic Administration of China (Grant No. GHME2013JS01).

Seed weight - seedling size correlation in coastal Douglas-fir: genetic and environmental components.

Treesearch

Frank C. Sorensen; Robert K. Campbell

1992-01-01

The effect of seed weight on nursery seedling height was analyzed in two experiments. In expt. 1, 16 seeds per family from 111 families were individually weighed and sown in autumn. In expt. 2, a second group of 16 seeds were individually weighed and stratified and sown in spring. Four-tree noncontiguous family plots were randomly assigned to two densities in two...

The Remle Project: A Study Utilizing the iPad with Families of Individuals Diagnosed with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Vasquez-Terry, Teresa LaDoan

2013-01-01

The purpose of The REMLE Project was to develop a best practices model for using the iPad as an assistive technology device with families of individuals with Autism Spectrum Disorder. Implementation of a double-blind, randomized control trial during a six-week intervention utilizing the iPad was measured for effectiveness in empowerment, social…

Effect of personalized nutrition on health-related behaviour change: evidence from the Food4Me European randomized controlled trial.

PubMed

Celis-Morales, Carlos; Livingstone, Katherine M; Marsaux, Cyril Fm; Macready, Anna L; Fallaize, Rosalind; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Walsh, Marianne C; Navas-Carretero, Santiago; San-Cristobal, Rodrigo; Tsirigoti, Lydia; Lambrinou, Christina P; Mavrogianni, Christina; Moschonis, George; Kolossa, Silvia; Hallmann, Jacqueline; Godlewska, Magdalena; Surwillo, Agnieszka; Traczyk, Iwona; Drevon, Christian A; Bouwman, Jildau; van Ommen, Ben; Grimaldi, Keith; Parnell, Laurence D; Matthews, John Ns; Manios, Yannis; Daniel, Hannelore; Martinez, J Alfredo; Lovegrove, Julie A; Gibney, Eileen R; Brennan, Lorraine; Saris, Wim Hm; Gibney, Mike; Mathers, John C

2017-04-01

Optimal nutritional choices are linked with better health, but many current interventions to improve diet have limited effect. We tested the hypothesis that providing personalized nutrition (PN) advice based on information on individual diet and lifestyle, phenotype and/or genotype would promote larger, more appropriate, and sustained changes in dietary behaviour. : Adults from seven European countries were recruited to an internet-delivered intervention (Food4Me) and randomized to: (i) conventional dietary advice (control) or to PN advice based on: (ii) individual baseline diet; (iii) individual baseline diet plus phenotype (anthropometry and blood biomarkers); or (iv) individual baseline diet plus phenotype plus genotype (five diet-responsive genetic variants). Outcomes were dietary intake, anthropometry and blood biomarkers measured at baseline and after 3 and 6 months' intervention. At baseline, mean age of participants was 39.8 years (range 18-79), 59% of participants were female and mean body mass index (BMI) was 25.5 kg/m 2 . From the enrolled participants, 1269 completed the study. Following a 6-month intervention, participants randomized to PN consumed less red meat [-5.48 g, (95% confidence interval:-10.8,-0.09), P  = 0.046], salt [-0.65 g, (-1.1,-0.25), P  = 0.002] and saturated fat [-1.14 % of energy, (-1.6,-0.67), P  < 0.0001], increased folate [29.6 µg, (0.21,59.0), P  = 0.048] intake and had higher Healthy Eating Index scores [1.27, (0.30, 2.25), P  = 0.010) than those randomized to the control arm. There was no evidence that including phenotypic and phenotypic plus genotypic information enhanced the effectiveness of the PN advice. Among European adults, PN advice via internet-delivered intervention produced larger and more appropriate changes in dietary behaviour than a conventional approach. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association

Effectiveness of individual resource-oriented joint protection education in people with rheumatoid arthritis. A randomized controlled trial.

PubMed

Niedermann, Karin; de Bie, Rob A; Kubli, Regula; Ciurea, Adrian; Steurer-Stey, Claudia; Villiger, Peter M; Büchi, Stefan

2011-01-01

the modern joint protection (JP) concept for people with rheumatoid arthritis (RA) is an active coping strategy to improve daily tasks and role performance by changing working methods and using assistive devices. Effective group JP education includes psycho-educational interventions. The Pictorial Representation of Illness and Self Measure (PRISM) is an interactive hands-on-tool, assessing (a) the individual's perceived burden of illness and (b) relevant individual resources. Both issues are important for intrinsic motivation to take action and change behaviour. This study compared individual conventional JP education (C-JP) with PRISM-based JP education (PRISM-JP). an assessor-blinded multicentre randomized controlled trial, including four JP education sessions over 3 weeks, with assessments at baseline and 3 months. in total 53 RA patients participated. At 3 months, the PRISM-JP (n=26) participants did significantly better compared to the C-JP participants (n=27) in JP behaviour (p=0.02 and p=0.008 when corrected for baseline values), Arthritis Self-efficacy (ASES, p=0.015) and JP self-efficacy (JP-SES, p=0.047). Within-group analysis also showed less hand pain (p<0.001) in PRISM-JP group. PRISM-JP more effectively supported learning of JP methods, with meaningful occupations, resource activation and self-efficacy acting as important mediators. PRISM improved patient-clinician communication and is feasible for occupational therapy. 2010 Elsevier Ireland Ltd. All rights reserved.

Exits in order: How crowding affects particle lifetimes

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

Penington, Catherine J.; Simpson, Matthew J.; Baker, Ruth E.

2016-06-28

Diffusive processes are often represented using stochastic random walk frameworks. The amount of time taken for an individual in a random walk to intersect with an absorbing boundary is a fundamental property that is often referred to as the particle lifetime, or the first passage time. The mean lifetime of particles in a random walk model of diffusion is related to the amount of time required for the diffusive process to reach a steady state. Mathematical analysis describing the mean lifetime of particles in a standard model of diffusion without crowding is well known. However, the lifetime of agents inmore » a random walk with crowding has received much less attention. Since many applications of diffusion in biology and biophysics include crowding effects, here we study a discrete model of diffusion that incorporates crowding. Using simulations, we show that crowding has a dramatic effect on agent lifetimes, and we derive an approximate expression for the mean agent lifetime that includes crowding effects. Our expression matches simulation results very well, and highlights the importance of crowding effects that are sometimes overlooked.« less

Effect of Active Music Therapy and Individualized Listening to Music on Dementia: A Multicenter Randomized Controlled Trial.

PubMed

Raglio, Alfredo; Bellandi, Daniele; Baiardi, Paola; Gianotti, Marta; Ubezio, Maria Chiara; Zanacchi, Elisa; Granieri, Enrico; Imbriani, Marcello; Stramba-Badiale, Marco

2015-08-01

To assess the effects of active music therapy (MT) and individualized listening to music (LtM) on behavioral and psychological symptoms of dementia (BPSDs) in persons with dementia (PWDs). Randomized controlled trial. Nine Italian institutions. Persons with moderate to severe dementia and BPSDs (N = 120) were randomized to one of three treatments. All groups received standard care (SC), and two groups attended 20 individualized MT or LtM sessions, twice a week, in addition to SC. The Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Cornell-Brown Scale for Quality of Life in Dementia (CBS-QoL) were administered before treatment, after treatment, and at follow-up to evaluate behavioral and psychological outcomes. A specific coding scheme (Music Therapy Check List-Dementia) was used to evaluate the MT process. Behavioral assessment did not show significant differences between groups. All groups showed a reduction over time in NPI global score (P ≤ .001), CSDD (P = .001), and CBS-QoL (P = .01). The NPI global score fell 28% in the MT group, 12% in the LtM group, and 21% in the SC group at the end of treatment. An exploratory post hoc analysis showed similar within-group improvements for the NPI Delusion, Anxiety, and Disinhibition subscales. In the MT group, communication and relationships between the music therapists and PWDs showed a positive albeit nonsignificant trend during treatment. The addition of MT or LtM to standard care did not have a significant effect on BPSDs in PWDs. Further studies on the effects of the integration of standard care with different types of music interventions on BPSD in PWD are warranted. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

Details of a prospective protocol for a collaborative meta-analysis of individual participant data from all randomized trials of intravenous rt-PA vs. control: statistical analysis plan for the Stroke Thrombolysis Trialists' Collaborative meta-analysis.

PubMed

2013-06-01

Thrombolysis with intravenous alteplase is both effective and safe when administered to particular types of patient within 4·5 hours of having an ischemic stroke. However, the extent to which effects might vary in different types of patient is uncertain. We describe the protocol for an updated individual patient data meta-analysis of trials of intravenous alteplase, including results from the recently reported third International Stroke Trial, in which a wide range of patients enrolled up to six-hours after stroke onset were randomized to alteplase vs. control. This protocol will specify the primary outcome for efficacy, specified prior to knowledge of the results from the third International Stroke Trial, as the proportion of patients having a 'favorable' stroke outcome, defined by modified Rankin Score 0-1 at final follow-up at three- to six-months. The primary analysis will be to estimate the extent to which the known benefit of alteplase on modified Rankin Score 0-1 diminishes with treatment delay, and the extent to which it is independently modified by age and stroke severity. Key secondary outcomes include effect of alteplase on death within 90 days; analyses of modified Rankin Score using ordinal, rather than dichotomous, methods; and effects of alteplase on symptomatic intracranial hemorrhage, fatal intracranial hemorrhage, symptomatic ischemic brain edema and early edema, effacement and/or midline shift. This collaborative meta-analysis of individual participant data from all randomized trials of intravenous alteplase vs. control will demonstrate how the known benefits of alteplase on ischemic stroke outcome vary across different types of patient. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Social capital and health-purely a question of context?

PubMed

Giordano, Giuseppe Nicola; Ohlsson, Henrik; Lindström, Martin

2011-07-01

Debate still surrounds which level of analysis (individual vs. contextual) is most appropriate to investigate the effects of social capital on health. Applying multilevel ecometric analyses to British Household Panel Survey data, we estimated fixed and random effects between five individual-, household- and small area-level social capital indicators and general health. We further compared the variance in health attributable to each level using intraclass correlations. Our results demonstrate that association between social capital and health depends on indicator type and level investigated, with one quarter of total individual-level health variance found at the household level. However, individual-level social capital variables and other health determinants appear to influence contextual-level variance the most. Copyright © 2011 Elsevier Ltd. All rights reserved.

Randomized Effectiveness Study of Four Therapeutic Strategies for TMJ Closed Lock

PubMed Central

Schiffman, E.L.; Look, J.O.; Hodges, J.S.; Swift, J.Q.; Decker, K.L.; Hathaway, K.M.; Templeton, R.B.; Fricton, J.R.

2008-01-01

For individuals with temporomandibular joint (TMJ) disc displacement without reduction with limited mouth opening (closed lock), interventions vary from minimal treatment to surgery. In a single-blind trial, 106 individuals with TMJ closed lock were randomized among medical management, rehabilitation, arthroscopic surgery with post-operative rehabilitation, or arthroplasty with post-operative rehabilitation. Evaluations at baseline, 3, 6, 12, 18, 24, and 60 months used the Craniomandibular Index (CMI) and Symptom Severity Index (SSI) for jaw function and TMJ pain respectively. Using an intention-to-treat analysis, we observed no between-group difference at any follow-up for CMI (p ≥ 0.33) or SSI (p ≥ 0.08). Both outcomes showed within-group improvement (p < 0.0001) for all groups. The findings of this study suggest that primary treatment for individuals with TMJ closed lock should consist of medical management or rehabilitation. The use of this approach will avoid unnecessary surgical procedures. PMID:17189464

Preventing intimate partner violence via the Internet: A randomized controlled trial of emotion-regulation and conflict-management training for individuals with aggression problems.

PubMed

Hesser, Hugo; Axelsson, Sandra; Bäcke, Victoria; Engstrand, Jonna; Gustafsson, Tina; Holmgren, Elin; Jeppsson, Ulrika; Pollack, Maria; Nordén, Kjell; Rosenqvist, Dan; Andersson, Gerhard

2017-09-01

The aim of this randomized controlled trial was to investigate the effect of an Internet-delivered cognitive behaviour therapy (iCBT), which incorporated emotion-regulation and conflict-resolution techniques, on intimate partner violence (IPV). Another aim was to test the theoretical underpinnings of the treatment model using mediation analysis. Sixty-five participants with aggression problems in intimate adult relationships were recruited from the community and were randomly assigned to iCBT or to a monitored waitlist control. Participants were assessed with standardized self-report measures of IPV or aggression (Multidimensional Measure of Emotional Abuse, Revised Conflict Tactics Scale, and Aggression Questionnaire), relationship quality (Dyadic Adjustment Scale), anxiety or depression symptomatology (Patient Health Questionnaire; Generalized Anxiety Disorder Screener), at pretreatment, posttreatment (8 weeks), and 1-year follow-up. Process variables (subscales of Dysfunctional and Emotional Regulation Scale and Anger Rumination Scale) were assessed weekly over the active treatment phase. Robust linear regression analysis of all randomized participants showed significant treatment effects on emotional abuse relative to control at postassessment. Mediation analysis using growth curve modeling revealed that the treatment effect was partially mediated by changes in emotion-regulation ability. Controlled effects on secondary outcomes were also observed. Analyses of uncontrolled effects indicted that gains on IPV were maintained at 1-year follow-up. iCBT focusing on enhancing conflict-resolution skills and emotion-regulation ability has the potential to reduce IPV among self-recruited individuals with mild forms of abusive behaviour in intimate relationships. Emotion-regulation ability is potentially a key therapeutic process of change. Internet-delivered clinician-guided cognitive behaviour therapy is a viable treatment option for reducing intimate partner violence among self-recruited individuals with mild forms of abusive behaviour. For persons who display patterns of frequent and severe violence, other treatments are most likely needed. Emotion-regulation training is potentially a key therapeutic component that ought to be incorporated in interventions targeting IPV. Copyright © 2017 John Wiley & Sons, Ltd.

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.

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

Individual variation behind the evolution of cooperation.

PubMed

Barta, Zoltán

2016-02-05

Life on Earth has two remarkable properties. The first is variation: even apart from the vast number of extant species, there are considerable differences between individuals within a single species. The second property is cooperation. It is surprising that until recently the interactions between these two properties have rarely been addressed from an evolutionary point of view. Here, I concentrate on how inter-individual differences influence the evolution of cooperation. First, I deal with cases where individuality is maintained by random processes like mutation or phenotypic noise. Second, I examine when differences in state cause differences in behaviour. Finally, I investigate the effects of individual role specialization. Variation can be important in several ways. Increased random variation can change the expectation about cooperativeness of future partners, altering behaviour in a current relationship. Differences in state may serve as a book-keeping mechanism that is necessary for the evolution of reciprocity. If the cost of cooperation can depend on state then strategic regulation of state makes it possible to coerce partners to cooperate. If conditions force individuals to specialize, cooperation becomes more valuable. My review of theoretical models suggests that variation plays an important role in the evolution of cooperation. © 2016 The Author(s).

Assessment of the effect of population and diary sampling methods on estimation of school-age children exposure to fine particles.

PubMed

Che, W W; Frey, H Christopher; Lau, Alexis K H

2014-12-01

Population and diary sampling methods are employed in exposure models to sample simulated individuals and their daily activity on each simulation day. Different sampling methods may lead to variations in estimated human exposure. In this study, two population sampling methods (stratified-random and random-random) and three diary sampling methods (random resampling, diversity and autocorrelation, and Markov-chain cluster [MCC]) are evaluated. Their impacts on estimated children's exposure to ambient fine particulate matter (PM2.5 ) are quantified via case studies for children in Wake County, NC for July 2002. The estimated mean daily average exposure is 12.9 μg/m(3) for simulated children using the stratified population sampling method, and 12.2 μg/m(3) using the random sampling method. These minor differences are caused by the random sampling among ages within census tracts. Among the three diary sampling methods, there are differences in the estimated number of individuals with multiple days of exposures exceeding a benchmark of concern of 25 μg/m(3) due to differences in how multiday longitudinal diaries are estimated. The MCC method is relatively more conservative. In case studies evaluated here, the MCC method led to 10% higher estimation of the number of individuals with repeated exposures exceeding the benchmark. The comparisons help to identify and contrast the capabilities of each method and to offer insight regarding implications of method choice. Exposure simulation results are robust to the two population sampling methods evaluated, and are sensitive to the choice of method for simulating longitudinal diaries, particularly when analyzing results for specific microenvironments or for exposures exceeding a benchmark of concern. © 2014 Society for Risk Analysis.

Modeling of contact tracing in social networks

NASA Astrophysics Data System (ADS)

Tsimring, Lev S.; Huerta, Ramón

2003-07-01

Spreading of certain infections in complex networks is effectively suppressed by using intelligent strategies for epidemic control. One such standard epidemiological strategy consists in tracing contacts of infected individuals. In this paper, we use a recently introduced generalization of the standard susceptible-infectious-removed stochastic model for epidemics in sparse random networks which incorporates an additional (traced) state. We describe a deterministic mean-field description which yields quantitative agreement with stochastic simulations on random graphs. We also discuss the role of contact tracing in epidemics control in small-world and scale-free networks. Effectiveness of contact tracing grows as the rewiring probability is reduced.

Effectiveness of personalized and interactive health risk calculators: a randomized trial.

PubMed

Harle, Christopher A; Downs, Julie S; Padman, Rema

2012-01-01

Risk calculators are popular websites that provide individualized disease risk assessments to the public. Little is known about their effect on risk perceptions and health behavior. This study sought to test whether risk calculator features-namely, personalized estimates of one's disease risk and feedback about the effects of risk-mitigating behaviors-improve risk perceptions and motivate healthy behavior. A web-based experimental study using simple randomization was conducted to compare the effects of 3 prediabetes risk communication websites. Setting The study was conducted in the context of ongoing health promotion activities sponsored by a university's human resources office. Patients Participants were adult university employees. Intervention The control website presented nonindividualized risk information. The personalized noninteractive website presented individualized risk calculations. The personalized interactive website presented individualized risk calculations and feedback about the effects of hypothetical risk-mitigating behaviors. Measurements Pre- and postintervention risk perceptions were measured in absolute and relative terms. Health behavior was measured by assessing participant interest in follow-up preventive health services. On average, risk perceptions decreased by 2%. There was no general effect of personalization or interactivity in aligning subjective risk perceptions with objective risk calculations or in increasing healthy behaviors. However, participants who previously overestimated their risk reduced their perceptions by 16%. This was a significantly larger change than the 2% increase by participants who underestimated their risk. Limitations Results may not generalize to different populations, different diseases, or longer-term outcomes. Compared to nonpersonalized information, individualized risk calculators had little positive effect on prediabetes risk perception accuracy or health behavior. Risk perception accuracy was improved in people who receive relatively "good news" about risk rather than "bad news."

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.

Psychology of Fragrance Use: Perception of Individual Odor and Perfume Blends Reveals a Mechanism for Idiosyncratic Effects on Fragrance Choice

PubMed Central

Lenochová, Pavlína; Vohnoutová, Pavla; Roberts, S. Craig; Oberzaucher, Elisabeth; Grammer, Karl; Havlíček, Jan

2012-01-01

Cross-culturally, fragrances are used to modulate body odor, but the psychology of fragrance choice has been largely overlooked. The prevalent view is that fragrances mask an individual's body odor and improve its pleasantness. In two experiments, we found positive effects of perfume on body odor perception. Importantly, however, this was modulated by significant interactions with individual odor donors. Fragrances thus appear to interact with body odor, creating an individually-specific odor mixture. In a third experiment, the odor mixture of an individual's body odor and their preferred perfume was perceived as more pleasant than a blend of the same body odor with a randomly-allocated perfume, even when there was no difference in pleasantness between the perfumes. This indicates that fragrance use extends beyond simple masking effects and that people choose perfumes that interact well with their own odor. Our results provide an explanation for the highly individual nature of perfume choice. PMID:22470479

Psychology of fragrance use: perception of individual odor and perfume blends reveals a mechanism for idiosyncratic effects on fragrance choice.

PubMed

Lenochová, Pavlína; Vohnoutová, Pavla; Roberts, S Craig; Oberzaucher, Elisabeth; Grammer, Karl; Havlíček, Jan

2012-01-01

Cross-culturally, fragrances are used to modulate body odor, but the psychology of fragrance choice has been largely overlooked. The prevalent view is that fragrances mask an individual's body odor and improve its pleasantness. In two experiments, we found positive effects of perfume on body odor perception. Importantly, however, this was modulated by significant interactions with individual odor donors. Fragrances thus appear to interact with body odor, creating an individually-specific odor mixture. In a third experiment, the odor mixture of an individual's body odor and their preferred perfume was perceived as more pleasant than a blend of the same body odor with a randomly-allocated perfume, even when there was no difference in pleasantness between the perfumes. This indicates that fragrance use extends beyond simple masking effects and that people choose perfumes that interact well with their own odor. Our results provide an explanation for the highly individual nature of perfume choice.

Effects of street traffic noise in the night

NASA Technical Reports Server (NTRS)

Wehrli, B.; Nemecek, J.; Turrian, V.; Hoffman, R.; Wanner, H.

1980-01-01

The relationship between automobile traffic noise and the degree of disturbance experience experienced at night was explored through a random sample survey of 1600 individuals in rural and urban areas. The data obtained were used to establish threshold values.

The Effects of an Inference-Making Strategy Taught with and without Goal Setting

ERIC Educational Resources Information Center

Reed, Deborah K.; Lynn, Devon

2016-01-01

This quasi-experimental study examined the effects of a strategy for making text-dependent inferences--with and without embedded self-regulation skills--on the reading comprehension of 24 middle-grade students with disabilities. Classes were randomly assigned to receive the inference intervention only (IO), inference + individual goal setting…

Effects of Directed Written Disclosure on Grief and Distress Symptoms among Bereaved Individuals

ERIC Educational Resources Information Center

Lichtenthal, Wendy G.; Cruess, Dean G.

2010-01-01

Bereavement-specific written disclosure trials have generally demonstrated null effects, but these studies have not directed the focus of writing. This randomized controlled trial compared directed writing that focused on either sense-making or benefit-finding, both associated with adjustment to loss, to traditional, non-directed emotional…

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…

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.

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.

A randomized controlled trial of water-based exercise for cardiovascular fitness in individuals with chronic stroke

PubMed Central

Chu, Kelly S; Eng, Janice J; Dawson, Andrew S; Harris, Jocelyn E.; Ozkaplan, Atila; Gylfadóttir, Sif

2011-01-01

Objective To evaluate the effect of an 8-week water-based exercise program (experimental group) over an upper extremity function program (control group) to increase cardiovascular fitness within a community setting for individuals with stroke. Design Single-blind randomized controlled trial Setting Public community centre Participants 12 community-dwelling individuals who have had a stroke with mild to moderate motor deficits; volunteer sample Intervention Experimental and control groups participated in group exercise programs undertaken in one hour sessions, three times per week for 8 weeks. The experimental group undertook chest deep water exercises at targeted heart rates. The control group performed arm and hand exercises while sitting. Main Outcome Measures The primary outcome measure was cardiovascular fitness (VO2max). Secondary measures were maximal workload, muscle strength, gait speed, and the Berg Balance Score. Results The experimental group attained significant improvements over the control group in cardiovascular fitness, maximal workload, gait speed, and paretic lower extremity muscle strength. The relatively short program (8 weeks) of water-based exercise resulted in a large improvement (22%) in cardiovascular fitness in a small group of individuals with stroke with relatively high function. Conclusions A water-based exercise program can be undertaken in the community as a group program and may be an effective means to promote fitness in individuals with stroke. PMID:15179638

The Effectiveness of Family-Based Cognitive-Behavior Grief Therapy to Prevent Complicated Grief in Relatives of Suicide Victims: The Mediating Role of Suicide Ideation

ERIC Educational Resources Information Center

de Groot, Marieke; Neeleman, Jan; van der Meer, Klaas; Burger, Huibert

2010-01-01

Grief interventions are more effective for high risk individuals. The presence of suicide ideation following suicide bereavement was examined to determine whether it indicates a high risk status. Using data from a randomized controlled trial (n = 122) on the effectiveness of cognitive-behavior therapy, the effect of suicide ideation on the…

Leveraging contact network structure in the design of cluster randomized trials.

PubMed

Harling, Guy; Wang, Rui; Onnela, Jukka-Pekka; De Gruttola, Victor

2017-02-01

In settings like the Ebola epidemic, where proof-of-principle trials have provided evidence of efficacy but questions remain about the effectiveness of different possible modes of implementation, it may be useful to conduct trials that not only generate information about intervention effects but also themselves provide public health benefit. Cluster randomized trials are of particular value for infectious disease prevention research by virtue of their ability to capture both direct and indirect effects of intervention, the latter of which depends heavily on the nature of contact networks within and across clusters. By leveraging information about these networks-in particular the degree of connection across randomized units, which can be obtained at study baseline-we propose a novel class of connectivity-informed cluster trial designs that aim both to improve public health impact (speed of epidemic control) and to preserve the ability to detect intervention effects. We several designs for cluster randomized trials with staggered enrollment, in each of which the order of enrollment is based on the total number of ties (contacts) from individuals within a cluster to individuals in other clusters. Our designs can accommodate connectivity based either on the total number of external connections at baseline or on connections only to areas yet to receive the intervention. We further consider a "holdback" version of the designs in which control clusters are held back from re-randomization for some time interval. We investigate the performance of these designs in terms of epidemic control outcomes (time to end of epidemic and cumulative incidence) and power to detect intervention effect, by simulating vaccination trials during an SEIR-type epidemic outbreak using a network-structured agent-based model. We compare results to those of a traditional Stepped Wedge trial. In our simulation studies, connectivity-informed designs lead to a 20% reduction in cumulative incidence compared to comparable traditional study designs, but have little impact on epidemic length. Power to detect intervention effect is reduced in all connectivity-informed designs, but "holdback" versions provide power that is very close to that of a traditional Stepped Wedge approach. Incorporating information about cluster connectivity in the design of cluster randomized trials can increase their public health impact, especially in acute outbreak settings. Using this information helps control outbreaks-by minimizing the number of cross-cluster infections-with very modest cost in terms of power to detect effectiveness.

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.

The effect of test kit provision, and individual and family education on the uptake rates of fecal occult blood test in an Asian population: a randomized controlled trial.

PubMed

Ha, Tam Cam; Yong, Sook Kwin; Yeoh, Kheng-Wei; Kamberakis, Kay; Yeo, Richard Ming Chert; Koh, Gerald Choon-Huat

2014-11-01

The purpose of the study was to investigate whether fecal occult blood test (FOBT) home-delivery and individual education or combined with family education increases FOBT uptake rates in Singapore. This is a randomized controlled intervention study of Singaporean residents aged 50 years and above, conducted in May 2012 till May 2013. Eligible individuals in randomly selected households were screened, and one member was randomly selected and allocated to one of the four arms: Group A (individual and family education, FOBT kits provided), Group B (individual education only, FOBT kits provided), Group C (no education, FOBT kits provided) and Group D (no education or FOBT kits provided). Overall response rate was 74.7 %. The FOBT return rates for groups A, B, C and D were 24.5 % [CI 16.2-34.4 %], 25.3 % [CI 16.4-36.0 %], 10.7 % [CI 4.7-19.9 %] and 2.2 % [CI 0.3-7.7 %], respectively. Respondents who were provided education and home-delivered FOBT kits were 15 times more likely to return FOBT kits [Group A: OR 15.0 (3.4-66.2); Group B: OR 15.5 (3.5-68.8)] and those provided with home-delivered FOBT without education were five times more likely to return FOBT kits [Group C: OR 5.8 (1.2-28.3)] than those without education and FOBT kits (Group D). There was no significant difference in return of FOBT kits whether education was provided to subject with or without a family member. Home delivery of FOBT kits increased FOBT return rates and individual education combined with home-delivered FOBT increased FOBT return rates even further. However, additional combination with family education did not increase FOBT rates further.

General practice performance in referral for suspected cancer: influence of number of cases and case-mix on publicly reported data.

PubMed

Murchie, P; Chowdhury, A; Smith, S; Campbell, N C; Lee, A J; Linden, D; Burton, C D

2015-05-26

Publicly available data show variation in GPs' use of urgent suspected cancer (USC) referral pathways. We investigated whether this could be due to small numbers of cancer cases and random case-mix, rather than due to true variation in performance. We analysed individual GP practice USC referral detection rates (proportion of the practice's cancer cases that are detected via USC) and conversion rates (proportion of the practice's USC referrals that prove to be cancer) in routinely collected data from GP practices in all of England (over 4 years) and northeast Scotland (over 7 years). We explored the effect of pooling data. We then modelled the effects of adding random case-mix to practice variation. Correlations between practice detection rate and conversion rate became less positive when data were aggregated over several years. Adding random case-mix to between-practice variation indicated that the median proportion of poorly performing practices correctly identified after 25 cancer cases were examined was 20% (IQR 17 to 24) and after 100 cases was 44% (IQR 40 to 47). Much apparent variation in GPs' use of suspected cancer referral pathways can be attributed to random case-mix. The methods currently used to assess the quality of GP-suspected cancer referral performance, and to compare individual practices, are misleading. These should no longer be used, and more appropriate and robust methods should be developed.

Effectiveness of a Theory-Based Risk Reduction HIV Prevention Program for Rural Vietnamese Adolescents

ERIC Educational Resources Information Center

Kaljee, Linda M.; Genberg, Becky; Riel, Rosemary; Cole, Matthew; Tho, Le Huu; Thoa, Le Thi Kim; Stanton, Bonita; Li, Xiaoming; Minh, Tuong Tan

2005-01-01

As of April 2003, 64,801 HIV cases have been documented in Vietnam (Policy Project 2003), 53.9% of which are among individuals 20-29 years of age. Although HIV education efforts have increased, there remains a need for proven effective programs. We present findings from a randomized-controlled effectiveness trial of an HIV prevention program for…

Animated Randomness, Avatars, Movement, and Personalization in Risk Graphics

PubMed Central

Fuhrel-Forbis, Andrea; Wijeysundera, Harindra C; Exe, Nicole; Dickson, Mark; Holtzman, Lisa; Kahn, Valerie C; Zikmund-Fisher, Brian J

2014-01-01

Background Risk communication involves conveying two inherently difficult concepts about the nature of risk: the underlying random distribution of outcomes and how a population-based proportion applies to an individual. Objective The objective of this study was to test whether 4 design factors in icon arrays—animated random dispersal of risk events, avatars to represent an individual, personalization (operationalized as choosing the avatar’s color), and a moving avatar—might help convey randomness and how a given risk applies to an individual, thereby better aligning risk perceptions with risk estimates. Methods A diverse sample of 3630 adults with no previous heart disease or stroke completed an online nested factorial experiment in which they entered personal health data into a risk calculator that estimated 10-year risk of cardiovascular disease based on a robust and validated model. We randomly assigned them to view their results in 1 of 10 risk graphics that used different combinations of the 4 design factors. We measured participants’ risk perceptions as our primary outcome, as well as behavioral intentions and recall of the risk estimate. We also assessed subjective numeracy, whether or not participants knew anyone who had died of cardiovascular causes, and whether or not they knew their blood pressure and cholesterol as potential moderators. Results Animated randomness was associated with better alignment between risk estimates and risk perceptions (F 1,3576=6.12, P=.01); however, it also led to lower scores on healthy lifestyle intentions (F 1,3572=11.1, P<.001). Using an avatar increased risk perceptions overall (F 1,3576=4.61, P=.03) and most significantly increased risk perceptions among those who did not know a particular person who had experienced the grave outcomes of cardiovascular disease (F 1,3576=5.88, P=.02). Using an avatar also better aligned actual risk estimates with intentions to see a doctor (F 1,3556=6.38, P=.01). No design factors had main effects on recall, but animated randomness was associated with better recall for those at lower risk and worse recall for those at higher risk (F 1,3544=7.06, P=.01). Conclusions Animated randomness may help people better understand the random nature of risk. However, in the context of cardiovascular risk, such understanding may result in lower healthy lifestyle intentions. Therefore, whether or not to display randomness may depend on whether one’s goal is to persuade or to inform. Avatars show promise for helping people grasp how population-based statistics map to an individual case. PMID:24642037

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.

Health behaviour change interventions for couples: A systematic review.

PubMed

Arden-Close, Emily; McGrath, Nuala

2017-05-01

Partners are a significant influence on individuals' health, and concordance in health behaviours increases over time in couples. Several theories suggest that couple-focused interventions for health behaviour change may therefore be more effective than individual interventions. A systematic review of health behaviour change interventions for couples was conducted. Systematic search methods identified randomized controlled trials (RCTs) and non-randomized interventions of health behaviour change for couples with at least one member at risk of a chronic physical illness, published from 1990-2014. We identified 14 studies, targeting the following health behaviours: cancer prevention (6), obesity (1), diet (2), smoking in pregnancy (2), physical activity (1) and multiple health behaviours (2). In four out of seven trials couple-focused interventions were more effective than usual care. Of four RCTs comparing a couple-focused intervention to an individual intervention, two found that the couple-focused intervention was more effective. The studies were heterogeneous, and included participants at risk of a variety of illnesses. In many cases the intervention was compared to usual care for an individual or an individual-focused intervention, which meant the impact of the couplebased content could not be isolated. Three arm studies could determine whether any added benefits of couple-focused interventions are due to adding the partner or specific content of couple-focused interventions. Statement of contribution What is already known on this subject? Health behaviours and health behaviour change are more often concordant across couples than between individuals in the general population. Couple-focused interventions for chronic conditions are more effective than individual interventions or usual care (Martire, Schulz, Helgeson, Small, & Saghafi, ). What does this study add? Identified studies targeted a variety of health behaviours, with few studies in any one area. Further assessment of the effectiveness of couple-focused versus individual interventions for those at risk is needed. Three-arm study designs are needed to determine benefits of targeting couples versus couple-focused intervention content. © 2017 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of the British Psychological Society.

Multilevel Analysis Methods for Partially Nested Cluster Randomized Trials

ERIC Educational Resources Information Center

Sanders, Elizabeth A.

2011-01-01

This paper explores multilevel modeling approaches for 2-group randomized experiments in which a treatment condition involving clusters of individuals is compared to a control condition involving only ungrouped individuals, otherwise known as partially nested cluster randomized designs (PNCRTs). Strategies for comparing groups from a PNCRT in the…

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.

Effect of Yoga Based Lifestyle Intervention on Patients With Knee Osteoarthritis: A Randomized Controlled Trial

PubMed Central

Deepeshwar, Singh; Tanwar, Monika; Kavuri, Vijaya; Budhi, Rana B.

2018-01-01

Objective: To investigate the effect of integrated approach of yoga therapy (IAYT) intervention in individual with knee Osteoarthritis. Design: Randomized controlled clincial trail. Participants: Sixty-six individual prediagnosed with knee osteoarthritis aged between 30 and 75 years were randomized into two groups, i.e., Yoga (n = 31) and Control (n = 35). Yoga group received IAYT intervention for 1 week at yoga center of S-VYASA whereas Control group maintained their normal lifestyle. Outcome measures: The Falls Efficacy Scale (FES), Handgrip Strength test (left hand LHGS and right hand RHGS), Timed Up and Go Test (TUG), Sit-to-Stand (STS), and right & left extension and flexion were measured on day 1 and day 7. Results: There were a significant reduction in TUG (p < 0.001), Right (p < 0.001), and Left Flexion (p < 0.001) whereas significant improvements in LHGS (p < 0.01), and right extension (p < 0.05) & left extension (p < 0.001) from baseline in Yoga group. Conclusion: IAYT practice showed an improvement in TUG, STS, HGS, and Goniometer test, which suggest improved muscular strength, flexibility, and functional mobility. CTRI Registration Number: http://ctri.nic.in/Clinicaltrials, identifier CTRI/2017/10/010141. PMID:29867604

Analysis of baseline, average, and longitudinally measured blood pressure data using linear mixed models.

PubMed

Hossain, Ahmed; Beyene, Joseph

2014-01-01

This article compares baseline, average, and longitudinal data analysis methods for identifying genetic variants in genome-wide association study using the Genetic Analysis Workshop 18 data. We apply methods that include (a) linear mixed models with baseline measures, (b) random intercept linear mixed models with mean measures outcome, and (c) random intercept linear mixed models with longitudinal measurements. In the linear mixed models, covariates are included as fixed effects, whereas relatedness among individuals is incorporated as the variance-covariance structure of the random effect for the individuals. The overall strategy of applying linear mixed models decorrelate the data is based on Aulchenko et al.'s GRAMMAR. By analyzing systolic and diastolic blood pressure, which are used separately as outcomes, we compare the 3 methods in identifying a known genetic variant that is associated with blood pressure from chromosome 3 and simulated phenotype data. We also analyze the real phenotype data to illustrate the methods. We conclude that the linear mixed model with longitudinal measurements of diastolic blood pressure is the most accurate at identifying the known single-nucleotide polymorphism among the methods, but linear mixed models with baseline measures perform best with systolic blood pressure as the outcome.

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

Transport properties of random media: A new effective medium theory

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

Busch, K.; Soukoulis, C.M.

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

Virtual reality-based training improves community ambulation in individuals with stroke: a randomized controlled trial.

PubMed

Yang, Yea-Ru; Tsai, Meng-Pin; Chuang, Tien-Yow; Sung, Wen-Hsu; Wang, Ray-Yau

2008-08-01

This is a single blind randomized controlled trial to examine the effect of virtual reality-based training on the community ambulation in individuals with stroke. Twenty subjects with stroke were assigned randomly to either the control group (n=9) or the experimental group (n=11). Subjects in the control group received the treadmill training. Subjects in the experimental group underwent the virtual reality-based treadmill training. Walking speed, community walking time, walking ability questionnaire (WAQ), and activities-specific balance confidence (ABC) scale were evaluated. Subjects in the experimental group improved significantly in walking speed, community walking time, and WAQ score at posttraining and 1-month follow-up periods. Their ABC score also significantly increased at posttraining but did not maintain at follow-up period. Regarding the between-group comparisons, the experimental group improved significantly more than control group in walking speed (P=0.03) and community walking time (P=0.04) at posttraining period and in WAQ score (P=0.03) at follow-up period. Our results support the perceived benefits of gait training programs that incorporate virtual reality to augment the community ambulation of individuals with stroke.

Doing better by getting worse: posthypnotic amnesia improves random number generation.

PubMed

Terhune, Devin Blair; Brugger, Peter

2011-01-01

Although forgetting is often regarded as a deficit that we need to control to optimize cognitive functioning, it can have beneficial effects in a number of contexts. We examined whether disrupting memory for previous numerical responses would attenuate repetition avoidance (the tendency to avoid repeating the same number) during random number generation and thereby improve the randomness of responses. Low suggestible and low dissociative and high dissociative highly suggestible individuals completed a random number generation task in a control condition, following a posthypnotic amnesia suggestion to forget previous numerical responses, and in a second control condition following the cancellation of the suggestion. High dissociative highly suggestible participants displayed a selective increase in repetitions during posthypnotic amnesia, with equivalent repetition frequency to a random system, whereas the other two groups exhibited repetition avoidance across conditions. Our results demonstrate that temporarily disrupting memory for previous numerical responses improves random number generation.

Doing Better by Getting Worse: Posthypnotic Amnesia Improves Random Number Generation

PubMed Central

Terhune, Devin Blair; Brugger, Peter

2011-01-01

Although forgetting is often regarded as a deficit that we need to control to optimize cognitive functioning, it can have beneficial effects in a number of contexts. We examined whether disrupting memory for previous numerical responses would attenuate repetition avoidance (the tendency to avoid repeating the same number) during random number generation and thereby improve the randomness of responses. Low suggestible and low dissociative and high dissociative highly suggestible individuals completed a random number generation task in a control condition, following a posthypnotic amnesia suggestion to forget previous numerical responses, and in a second control condition following the cancellation of the suggestion. High dissociative highly suggestible participants displayed a selective increase in repetitions during posthypnotic amnesia, with equivalent repetition frequency to a random system, whereas the other two groups exhibited repetition avoidance across conditions. Our results demonstrate that temporarily disrupting memory for previous numerical responses improves random number generation. PMID:22195022

Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial.

PubMed

van den Akker, Lizanne E; Beckerman, Heleen; Collette, Emma H; Twisk, Jos Wr; Bleijenberg, Gijs; Dekker, Joost; Knoop, Hans; de Groot, Vincent

2017-10-01

Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. In a multi-center, assessor-masked, randomized controlled trial, participants with severe MS-related fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Between-group analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: -6.7 (95% confidence interval (CI) = -10.7; -2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = -3.6; 4.4)). No clinically relevant effects were found on societal participation. Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term.

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

Effectiveness and Patient Acceptability of Stellate Ganglion Block (SGB) for Treatment of Posttraumatic Stress Disorder (PTSD) Symptoms among Active Duty Military Members

DTIC Science & Technology

PTSD) symptoms. We will conduct two parallel studies: a randomized, controlled trial (RCT) to evaluate the effectiveness of SGB for treating PTSD, and a...study, individuals enrolled in the RCT will be asked to participate either in a focus group or an interview with their spouse. In addition, we will...conduct focus groups and key informant interviews with providers: those who refer individuals to the study, and those who provide SGB to service members.

CBT4BN versus CBTF2F: Comparison of Online versus Face-To-FaceTreatment for Bulimia Nervosa

PubMed Central

Bulik, Cynthia M.; Marcus, Marsha D.; Zerwas, Stephanie; Levine, Michele D.; Hofmeier, Sara; Trace, Sara E.; Hamer, Robert M.; Zimmer, Benjamin; Moessner, Markus; Kordy, Hans

2012-01-01

Cognitive-behavioral therapy (CBT) is currently the “gold standard” for treatment of bulimia nervosa (BN), and is effective for approximately 40–60% of individuals receiving treatment; however, the majority of individuals in need of care do not have access to CBT. New strategies for service delivery of CBT and for maximizing maintenance of treatment benefits are critical for improving our ability to treat BN. This clinical trial is comparing an Internet-based version of CBT (CBT4BN) in which group intervention is conducted via therapeutic chat group with traditional group CBT (CBTF2F) for BN conducted via face-to-face therapy group. The purpose of the trial is to determine whether manualized CBT delivered via the Internet is not inferior to the gold standard of manualized group CBT. In this two-site randomized controlled trial, powered for non-inferiority analyses, 180 individuals with BN are being randomized to either CBT4BN or CBTF2F. We hypothesize that CBT4BN will not be inferior to CBTF2F and that participants will value the convenience of an online intervention. If not inferior, CBT4BN may be a cost-effective approach to service delivery for individuals requiring treatment for BN. PMID:22659072

Modeling Grade IV Gas Emboli using a Limited Failure Population Model with Random Effects

NASA Technical Reports Server (NTRS)

Thompson, Laura A.; Conkin, Johnny; Chhikara, Raj S.; Powell, Michael R.

2002-01-01

Venous gas emboli (VGE) (gas bubbles in venous blood) are associated with an increased risk of decompression sickness (DCS) in hypobaric environments. A high grade of VGE can be a precursor to serious DCS. In this paper, we model time to Grade IV VGE considering a subset of individuals assumed to be immune from experiencing VGE. Our data contain monitoring test results from subjects undergoing up to 13 denitrogenation test procedures prior to exposure to a hypobaric environment. The onset time of Grade IV VGE is recorded as contained within certain time intervals. We fit a parametric (lognormal) mixture survival model to the interval-and right-censored data to account for the possibility of a subset of "cured" individuals who are immune to the event. Our model contains random subject effects to account for correlations between repeated measurements on a single individual. Model assessments and cross-validation indicate that this limited failure population mixture model is an improvement over a model that does not account for the potential of a fraction of cured individuals. We also evaluated some alternative mixture models. Predictions from the best fitted mixture model indicate that the actual process is reasonably approximated by a limited failure population model.

Quality of surgical randomized controlled trials for acute cholecystitis: assessment based on CONSORT and additional check items.

PubMed

Shikata, Satoru; Nakayama, Takeo; Yamagishi, Hisakazu

2008-01-01

In this study, we conducted a limited survey of reports of surgical randomized controlled trials, using the consolidated standards of reporting trials (CONSORT) statement and additional check items to clarify problems in the evaluation of surgical reports. A total of 13 randomized trials were selected from two latest review articles on biliary surgery. Each randomized trial was evaluated according to 28 quality measures that comprised items from the CONSORT statement plus additional items. Analysis focused on relationships between the quality of each study and the estimated effect gap ("pooled estimate in meta-analysis" -- "estimated effect of each study"). No definite relationships were found between individual study quality and the estimated effect gap. The following items could have been described but were not provided in almost all the surgical RCT reports: "clearly defined outcomes"; "details of randomization"; "participant flow charts"; "intention-to-treat analysis"; "ancillary analyses"; and "financial conflicts of interest". The item, "participation of a trial methodologist in the study" was not found in any of the reports. Although the quality of reporting trials is not always related to a biased estimation of treatment effect, the items used for quality measures must be described to enable readers to evaluate the quality and applicability of the reporting. Further development of an assessment tool is needed for items specific to surgical randomized controlled trials.

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.

Impact of lifestyle interventions on depressive symptoms in individuals at-risk of, or with, type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Cezaretto, A; Ferreira, S R G; Sharma, S; Sadeghirad, B; Kolahdooz, F

2016-08-01

Depression affects one in four individuals with type 2 diabetes mellitus (T2DM). The impact of T2DM lifestyle interventions on depression is unclear. The aim of this analysis was to examine the influence of lifestyle interventions on depressive symptoms scores in individuals at-risk of or with T2DM. Major bibliographic databases were searched for studies published in English from 1990 to 2015. Meta-analysis was conducted by random-effects model. Nineteen studies were included in the meta-analyses. A significant reduction in depression scores was shown for lifestyle interventions in the pooled analysis (Standardized Mean Difference (SMD): -0.165; 95%CI: -0.265, -0.064; I(2):67.9%) and when limited to individuals with T2DM (SMD: -0.202; 95%CI: -0.288, -0.079; I(2):72.5%). In subgroup analyses the most effective intervention methods were face-to-face individual consultations (SMD: -0.241; 95%CI: -0.403, -0.078, I(2): 50.8%) with a duration of ≤6 months (SMD: -0.203; 95%CI: -0.381, -0.026, I(2):59.9%). Interventions were most effective when delivered four times a month (SMD: -0.247; 95%CI: -0.441, -0.053, I(2):76.3%). Lifestyle interventions were effective in improving depression among people with T2DM. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

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

Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial.

PubMed

King, Laurie A; Wilhelm, Jennifer; Chen, Yiyi; Blehm, Ron; Nutt, John; Chen, Zunqiu; Serdar, Andrea; Horak, Fay B

2015-10-01

Comparative studies of exercise interventions for people with Parkinson disease (PD) rarely considered how one should deliver the intervention. The objective of this study was to compare the success of exercise when administered by (1) home exercise program, (2) individualized physical therapy, or (3) a group class. We examined if common comorbidities associated with PD impacted success of each intervention. Fifty-eight people (age = 63.9 ± 8 years) with PD participated. People were randomized into (1) home exercise program, (2) individual physical therapy, or (3) group class intervention. All arms were standardized and based on the Agility Boot Camp exercise program for PD, 3 times per week for 4 weeks. The primary outcome measure was the 7-item Physical Performance Test. Other measures of balance, gait, mobility, quality of life, balance confidence, depressions, apathy, self-efficacy and UPDRS-Motor, and activity of daily living scores were included. Only the individual group significantly improved in the Physical Performance Test. The individual exercise showed the most improvements in functional and balance measures, whereas the group class showed the most improvements in gait. The home exercise program improved the least across all outcomes. Several factors effected success, particularly for the home group. An unsupervised, home exercise program is the least effective way to deliver exercise to people with PD, and individual and group exercises have differing benefits. Furthermore, people with PD who also have other comorbidities did better in a program directly supervised by a physical therapist.Video Abstract available for additional insights from the authors (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A112).

Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial

PubMed Central

Ferrer, Assumpta; Formiga, Francesc; Sanz, Héctor; de Vries, Oscar J; Badia, Teresa; Pujol, Ramón

2014-01-01

Background The purpose of this study was to assess the effectiveness of a multifactorial intervention to reduce falls among the oldest-old people, including individuals with cognitive impairment or comorbidities. Methods A randomized, single-blind, parallel-group clinical trial was conducted from January 2009 to December 2010 in seven primary health care centers in Baix Llobregat (Barcelona). Of 696 referred people who were born in 1924, 328 were randomized to an intervention group or a control group. The intervention model used an algorithm and was multifaceted for both patients and their primary care providers. Primary outcomes were risk of falling and time until falls. Data analyses were by intention-to-treat. Results Sixty-five (39.6%) subjects in the intervention group and 48 (29.3%) in the control group fell during follow-up. The difference in the risk of falls was not significant (relative risk 1.28, 95% confidence interval [CI] 0.94–1.75). Cox regression models with time from randomization to the first fall were not significant. Cox models for recurrent falls showed that intervention had a negative effect (hazard ratio [HR] 1.46, 95% CI 1.03–2.09) and that functional impairment (HR 1.42, 95% CI 0.97–2.12), previous falls (HR 1.09, 95% CI 0.74–1.60), and cognitive impairment (HR 1.08, 95% CI 0.72–1.60) had no effect on the assessment. Conclusion This multifactorial intervention among octogenarians, including individuals with cognitive impairment or comorbidities, did not result in a reduction in falls. A history of previous falls, disability, and cognitive impairment had no effect on the program among the community-dwelling subjects in this study. PMID:24596458

Zoster vaccination is associated with a reduction of zoster in elderly patients with chronic kidney disease.

PubMed

Langan, Sinéad M; Thomas, Sara L; Smeeth, Liam; Margolis, David J; Nitsch, Dorothea

2016-12-01

Growing epidemiological evidence demonstrates increased zoster risks in people with chronic kidney disease (CKD). Study objectives were to determine zoster vaccine effectiveness in individuals with CKD in pragmatic use. A population-based cohort study was undertaken in a 5% random sample of US Medicare from 2007 to 2009 involving 766 330 eligible individuals aged ≥65 years who were (29 785) and were not (736 545) exposed to the zoster vaccine. Incidence rates for zoster in vaccinated and unvaccinated individuals and hazard ratios for zoster comparing vaccinated with unvaccinated were determined for individuals with CKD. Time-updated Cox proportional hazards models were used, adjusting for relevant confounders. CKD was present in 183 762 (24%) of individuals (15% of vaccinees). Adjusted vaccine effectiveness [95% confidence intervals (CIs)] in individuals with CKD was 0.49 (0.36-0.65). The adjusted vaccine effectiveness in participants with both CKD and diabetes mellitus was 0.46 (95% CI 0.09-0.68). Vaccine effectiveness estimates were similar to those previously reported for the general population [vaccine effectiveness 0.48 (95% CI 0.39-0.56)]. Zoster vaccine is effective against incident zoster in older individuals with CKD. Extra efforts are warranted to increase vaccine uptake in individuals with CKD given the known low uptake in these higher risk individuals. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA.

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.

Tryptophan for the sleeping disorder and mental symptom of new-type drug dependence: A randomized, double-blind, placebo-controlled trial.

PubMed

Wang, Dongming; Li, Wenzhen; Xiao, Yang; He, Wulong; Wei, Weiquan; Yang, Longyu; Yu, Jincong; Song, Fujian; Wang, Zengzhen

2016-07-01

New-type drugs are popular with adolescents and could lead to psychiatry disorders, but no medications have been proven to be effective for these disorders of new-type drug dependence. We aimed to evaluate the efficacy of tryptophan on sleeping disorders and mental symptoms in detoxified individuals with new-type drug dependence. This randomized, placebo-controlled trial included 80 detoxified individuals with new-type drug dependence, recruited successively from a Compulsory Residential Drug Abstinence Institution in Wuhan, China, from April 2012 to November 2012. Eligible participants were randomly allocated to be treated with tryptophan (1000 mg/d, n = 40) or placebo (n = 40) for 2 weeks. The sleeping disorders and mental symptoms were assessed using Athens Insomnia Scale and Symptom Check-List-90 at baseline and 2 weeks. Results were analyzed according to the "intention-to-treat" approach. Forty-five participants completed the 2-week study, 24 in the tryptophan group and 21 in the placebo group. There were no statistically significant differences in baseline characteristics between groups and the treatment adherence was similar between groups. The reduction in the Athens Insomnia Scale score in the tryptophan group was significantly greater than that in the placebo group (P = 0.017). However, no significant differences were found in Symptom Check-List-90 scores (either by individual dimension or the overall score) between groups (all P > 0.05). The frequency of adverse events was similar and no serious adverse events were reported during the study. Tryptophan was unlikely to be effective for mental symptoms, but could alleviate sleep disorders in short term among detoxified individuals with new-type drug dependence. Future large-scale trials are required to confirm findings from this study.

Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

PubMed

Motie, Marjan; Evangelista, Lorraine S; Horwich, Tamara; Hamilton, Michele; Lombardo, Dawn; Cooper, Dan M; Galassetti, Pietro R; Fonarow, Gregg C

2013-11-01

There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS. © 2013 Elsevier Inc. All rights reserved.

The effects of aquatic therapy on mobility of individuals with neurological diseases: a systematic review.

PubMed

Marinho-Buzelli, Andresa R; Bonnyman, Alison M; Verrier, Mary C

2015-08-01

To summarize evidence on the effects of aquatic therapy on mobility in individuals with neurological diseases. MEDLINE, EMBASE, PsycInfo, CENTRAL, CINAHL, SPORTDiscus, PEDro, PsycBITE and OT Seeker were searched from inception to 15 September 2014. Hand-searching of reference lists was performed in the selected studies. The search included randomized controlled trials and quasi-experimental studies that investigated the use of aquatic therapy and its effect on mobility of adults with neurological diseases. One reviewer screened titles and abstracts of retrieved studies from the search strategy. Two reviewers independently examined the full texts and conducted the study selection, data extraction and quality assessment. A narrative synthesis of data was applied to summarize information from included studies. The Downs and Black Scale was used to assess methodological quality. A total of 116 articles were obtained for full text eligibility. Twenty studies met the specified inclusion criteria: four Randomized Controlled Trials (RCTs), four non-randomized studies and 12 before-and-after tests. Two RCTs (30 patients with stroke in the aquatic therapy groups), three non-randomized studies and three before-and-after studies showed "fair" evidence that aquatic therapy increases dynamic balance in participants with some neurological disorders. One RCT (seven patients with stroke in the aquatic therapy group) and two before-and-after tests (20 patients with multiple sclerosis) demonstrated "fair" evidence on improvement of gait speed after aquatic therapy. Our synthesis showed "fair" evidence supporting the use of aquatic therapy to improve dynamic balance and gait speed in adults with certain neurological conditions. © The Author(s) 2014.

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.

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.

A multidisciplinary TBI inpatient rehabilitation programme for active duty service members as part of a randomized clinical trial.

PubMed

Braverman, S E; Spector, J; Warden, D L; Wilson, B C; Ellis, T E; Bamdad, M J; Salazar, A M

1999-06-01

To design and describe an effective rehabilitation programme for use in an ongoing trial on the efficacy of multidisciplinary brain injury rehabilitation for moderately head injury military service members. Treatment arm of a randomized control trial. US military tertiary care hospital inpatient rehabilitation programme. Sixty seven active duty military with moderate to severe TBI who were randomized to the treatment arm of the protocol. Eight week rehabilitation programme combining group and individual therapies with an inpatient milieu-oriented neuropsychological focus. Group therapies included fitness, planning and organization, cognitive skills, work skills, medication, and milieu groups, and community re-entry outings. Individual therapy included neuropsychology, work therapy, occupational therapy, and speech and language pathology. Successful return to work and return to duty. At 1 year follow-up, 64 patients returned to work (96%) and 66% (44/67) returned to duty. The described rehabilitation programme demonstrates one successful effort to rehabilitate active duty military service members with TBI who have the potential to return to duty.

Modelling nematode movement using time-fractional dynamics.

PubMed

Hapca, Simona; Crawford, John W; MacMillan, Keith; Wilson, Mike J; Young, Iain M

2007-09-07

We use a correlated random walk model in two dimensions to simulate the movement of the slug parasitic nematode Phasmarhabditis hermaphrodita in homogeneous environments. The model incorporates the observed statistical distributions of turning angle and speed derived from time-lapse studies of individual nematode trails. We identify strong temporal correlations between the turning angles and speed that preclude the case of a simple random walk in which successive steps are independent. These correlated random walks are appropriately modelled using an anomalous diffusion model, more precisely using a fractional sub-diffusion model for which the associated stochastic process is characterised by strong memory effects in the probability density function.

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.

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.

The Effect of Eating Sea Cucumber Jelly on Candida Load in the Oral Cavity of Elderly Individuals in a Nursing Home

PubMed Central

Yano, Akira; Abe, Akiko; Aizawa, Fumie; Yamada, Hidetoshi; Minami, Kentaro; Matsui, Miki; Kishi, Mitsuo

2013-01-01

We conducted a double-blind randomized controlled study of elderly individuals in a nursing home to investigate the effect of the consumption of jelly containing sea cucumber on their oral Candida load. The jelly contained a hydrolysate of the sea cucumber Stichopus japonicus, which contained triterpene glycosides called holotoxins. The holotoxins worked as a fungicide, and their minimum inhibitory concentrations for Candida albicans were 7 µg/mL. Eight individuals in the nursing home took the sea cucumber jelly for a week and their oral Candida were counted before and after the intervention. Nine individuals took a control jelly without S. japonicus. The sea cucumber jelly showed inhibitory effects on the oral Candida. Thus, daily consumption of the S. japonicus jelly has the potential to reduce the oral Candida load in the elderly in nursing homes. PMID:24335524

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.

Mixed-effects varying-coefficient model with skewed distribution coupled with cause-specific varying-coefficient hazard model with random-effects for longitudinal-competing risks data analysis.

PubMed

Lu, Tao; Wang, Min; Liu, Guangying; Dong, Guang-Hui; Qian, Feng

2016-01-01

It is well known that there is strong relationship between HIV viral load and CD4 cell counts in AIDS studies. However, the relationship between them changes during the course of treatment and may vary among individuals. During treatments, some individuals may experience terminal events such as death. Because the terminal event may be related to the individual's viral load measurements, the terminal mechanism is non-ignorable. Furthermore, there exists competing risks from multiple types of events, such as AIDS-related death and other death. Most joint models for the analysis of longitudinal-survival data developed in literatures have focused on constant coefficients and assume symmetric distribution for the endpoints, which does not meet the needs for investigating the nature of varying relationship between HIV viral load and CD4 cell counts in practice. We develop a mixed-effects varying-coefficient model with skewed distribution coupled with cause-specific varying-coefficient hazard model with random-effects to deal with varying relationship between the two endpoints for longitudinal-competing risks survival data. A fully Bayesian inference procedure is established to estimate parameters in the joint model. The proposed method is applied to a multicenter AIDS cohort study. Various scenarios-based potential models that account for partial data features are compared. Some interesting findings are presented.

Individual music therapy for agitation in dementia: an exploratory randomized controlled trial

PubMed Central

Stige, Brynjulf; Qvale, Liv Gunnhild; Gold, Christian

2013-01-01

Objectives: Agitation in nursing home residents with dementia leads to increase in psychotropic medication, decrease in quality of life, and to patient distress and caregiver burden. Music therapy has previously been found effective in treatment of agitation in dementia care but studies have been methodologically insufficient. The aim of this study was to examine the effect of individual music therapy on agitation in persons with moderate/severe dementia living in nursing homes, and to explore its effect on psychotropic medication and quality of life. Method: In a crossover trial, 42 participants with dementia were randomized to a sequence of six weeks of individual music therapy and six weeks of standard care. Outcome measures included agitation, quality of life and medication. Results: Agitation disruptiveness increased during standard care and decreased during music therapy. The difference at −6.77 (95% CI (confidence interval): −12.71, −0.83) was significant (p = 0.027), with a medium effect size (0.50). The prescription of psychotropic medication increased significantly more often during standard care than during music therapy (p = 0.02). Conclusion: This study shows that six weeks of music therapy reduces agitation disruptiveness and prevents medication increases in people with dementia. The positive trends in relation to agitation frequency and quality of life call for further research with a larger sample. PMID:23621805

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.

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.

Changing Conspiracy Beliefs through Rationality and Ridiculing.

PubMed

Orosz, Gábor; Krekó, Péter; Paskuj, Benedek; Tóth-Király, István; Bőthe, Beáta; Roland-Lévy, Christine

2016-01-01

Conspiracy theory (CT) beliefs can be harmful. How is it possible to reduce them effectively? Three reduction strategies were tested in an online experiment using general and well-known CT beliefs on a comprehensive randomly assigned Hungarian sample ( N = 813): exposing rational counter CT arguments, ridiculing those who hold CT beliefs, and empathizing with the targets of CT beliefs. Several relevant individual differences were measured. Rational and ridiculing arguments were effective in reducing CT, whereas empathizing with the targets of CTs had no effect. Individual differences played no role in CT reduction, but the perceived intelligence and competence of the individual who conveyed the CT belief-reduction information contributed to the success of the CT belief reduction. Rational arguments targeting the link between the object of belief and its characteristics appear to be an effective tool in fighting conspiracy theory beliefs.

Assessing the Warm Glow Effect in Contingent Valuations for Public Libraries

ERIC Educational Resources Information Center

Lee, Soon-Jae; Chung, Hye-Kyung; Jung, Eun-Joo

2010-01-01

This article aims to present evidence of the warm glow effect in a public library setting. More specifically, it tests whether individual respondents with different values for the warm glow component report different values for their willingness to pay (WTP). The data come from a contingent valuation survey conducted on randomly selected citizens…

Effects of the Paraphrasing Strategy on Expository Reading Comprehension of Young Adults with Intellectual Disability

ERIC Educational Resources Information Center

Hua, Youjia; Woods-Groves, Suzanne; Ford, Jeremy W.; Nobles, Kelly A.

2014-01-01

The purpose of the study was to investigate the effectiveness of teaching a three-step paraphrasing strategy on expository reading comprehension of young adults with intellectual disability. Ten learners from a postsecondary education program for individuals with disability participated in the study. They were randomly assigned to the control and…

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…

Effectiveness of Web Quest Strategy in Acquiring Geographic Concepts among Eighth Grade Students in Jordan

ERIC Educational Resources Information Center

AL-Edwan, Zaid Suleiman

2014-01-01

This study aimed at identifying the Effectiveness of using Web Quest Strategy in acquiring the geographic concepts among eighth grade students in Jordan. The study individuals consisted of (119) students in the scholastic year 2013-2014. Four sections were randomly selected from two schools divided into experimental and control groups. They were…

Aggregate and Individual Replication Probability within an Explicit Model of the Research Process

ERIC Educational Resources Information Center

Miller, Jeff; Schwarz, Wolf

2011-01-01

We study a model of the research process in which the true effect size, the replication jitter due to changes in experimental procedure, and the statistical error of effect size measurement are all normally distributed random variables. Within this model, we analyze the probability of successfully replicating an initial experimental result by…

The Effects of Modafinil on Convergent and Divergent Thinking of Creativity: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Mohamed, Ahmed Dahir

2016-01-01

Modafinil is a drug licensed for the treatment of narcolepsy and sleep apnea. Recently, modafinil has been reported to be used as a pharmacological cognitive enhancer by healthy individuals with no psychiatric disorders. This paper reports on a study that investigated the effects of modafinil on divergent and convergent thinking tasks of…

Cost-Effectiveness of Case Management in Substance Abuse Treatment

ERIC Educational Resources Information Center

Saleh, Shadi S.; Vaughn, Thomas; Levey, Samuel; Fuortes, Laurence; Uden-Holmen, Tanya; Hall, James A.

2006-01-01

Objective: The purpose of this study, which is part of a larger clinical trial, was to examine the cost-effectiveness of case management for individuals treated for substance abuse in a residential setting. Method: Clients who agreed to participate were randomly assigned to one of four study groups. Two groups received face-to-face case management…

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.

Effectiveness of dietary supplements in spinal cord injury subjects.

PubMed

Navarrete-Opazo, Angela; Cuitiño, Pilar; Salas, Inés

2017-04-01

Individuals with spinal cord injury (SCI) consume more dietary supplements than the general population. However, there is limited information regarding the clinical effectiveness of dietary supplements in SCI population. To systematically review the effectiveness of dietary supplements for the prevention or treatment of health-related conditions associated with SCI. Randomized or non-randomized controlled clinical trials were selected, comparing the effect of any dose and form of a dietary supplement (defined by the Dietary Supplement Health and Education Act), with either no treatment, placebo, or other medication. Data Sources included the Cochrane Database, DARE, LILACS, CINAHL, EMBASE, MEDLINE, OTSeeker, PEDro, PsycINFO, SpeechBITE, ScienceDirect, Scopus, clinicaltrials.gov, Google Scholar, and OpenGrey. Two reviewers independently classified articles from January 1970 through October 2015, and 18 articles were selected. Due to the heterogeneity of outcome measures across studies, a meta-analysis was not conducted. However, high-quality evidence showed that cranberry supplementation is not effective for prevention of urinary tract infections (UTIs) in SCI. Moderate-quality evidence supported a beneficial effect of vitamin D, alpha-lipoic acid, and omega-3 supplementation, although replication of results is needed. There were conflicting results for the effect of creatine supplementation on improvement of motor outcomes. Low-quality evidence does not permit assessment of the effectiveness of melatonin, whey protein, vitamin C, and Chinese herb in SCI. There is sufficient data suggesting that cranberry supplementation is ineffective for prevention of UTIs in individuals with SCI. There is insufficient data to support or refute the use of any other dietary supplement in individuals with SCI. Copyright © 2016 Elsevier Inc. All rights reserved.

Combined Cognitive and Parent Training Interventions for Adolescents with ADHD and Their Mothers: A Randomized Controlled Trial

PubMed Central

Steeger, Christine M.; Gondoli, Dawn M.; Gibson, Bradley S.; Morrissey, Rebecca A.

2015-01-01

Objective This study examined the individual and combined effects of two non-pharmacological treatments for Attention-Deficit/Hyperactivity Disorder (ADHD): Cogmed working memory training (CWMT) for adolescents, and behavioral parent training (BPT) for mothers. Method Ninety-one adolescents (ages 11–15) and their mothers were randomized to one of four CWMT and BPT treatment and active control (placebo) group combinations of 5-week interventions. At pre- and post-test, mothers and teachers completed rating forms, and adolescents completed neuropsychological measures of working memory (WM). Results Individual intervention effects showed that treatment CWMT significantly improved WM spans, whereas there were no significant differences for treatment or control BPT on reports of parenting-related outcomes. Combined treatment effects indicated an overall pattern of greatest improvements for the control CWMT/treatment BPT group, as compared to the other three groups, on adolescent WM deficit, behavioral regulation problems, and global executive deficit. Most significant effects for outcomes were main effects of improvements over time. Conclusions: Combination CWMT and BPT did not result in increased treatment gains. However, potential effects of combined treatment may have been masked by greater perceived benefits arising from lack of struggle in the non-adaptive, CWMT active control condition. Future combined intervention research should focus on specific, theoretically-driven WM deficits among individuals with ADHD, include possible adaptations to the standard CWMT program, examine effectiveness of cognitive treatments combined with contextual interventions, and utilize appropriate control groups to fully understand the unique and combined effects of interventions. PMID:25731907

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.

Effects of Ganglioside on Working Memory and the Default Mode Network in Individuals with Subjective Cognitive Impairment: A Randomized Controlled Trial.

PubMed

Jeon, Yujin; Kim, Binna; Kim, Jieun E; Kim, Bori R; Ban, Soonhyun; Jeong, Jee Hyang; Kwon, Oran; Rhie, Sandy Jeong; Ahn, Chang-Won; Kim, Jong-Hoon; Jung, Sung Ug; Park, Soo-Hyun; Lyoo, In Kyoon; Yoon, Sujung

2016-01-01

This randomized, double-blind, placebo-controlled trial examined whether the administration of ganglioside, an active ingredient of deer bone extract, can improve working memory performance by increasing gray matter volume and functional connectivity in the default mode network (DMN) in individuals with subjective cognitive impairment. Seventy-five individuals with subjective cognitive impairment were chosen to receive either ganglioside (330[Formula: see text][Formula: see text]g/day or 660[Formula: see text][Formula: see text]g/day) or a placebo for 8 weeks. Changes in working memory performance with treatment of either ganglioside or placebo were assessed as cognitive outcome measures. Using voxel-based morphometry and functional connectivity analyses, changes in gray matter volume and functional connectivity in the DMN were also assessed as brain outcome measures. Improvement in working memory performance was greater in the ganglioside group than in the placebo group. The ganglioside group, relative to the placebo group, showed greater increases in gray matter volume and functional connectivity in the DMN. A significant relationship between increased functional connectivity of the precuneus and improved working memory performance was observed in the ganglioside group. The current findings suggest that ganglioside has cognitive-enhancing effects in individuals with subjective cognitive impairment. Ganglioside-induced increases in gray matter volume and functional connectivity in the DMN may partly be responsible for the potential nootropic effects of ganglioside. The clinical trial was registered with ClinicalTrials.gov (identifier: NCT02379481).

Effect of individualized diabetes education for type 2 diabetes mellitus: a single-center randomized clinical trial.

PubMed

Fan, Min-Hua; Huang, Bing-Tong; Tang, Ying-Chun; Han, Xiu-Hua; Dong, Wei-Wei; Wang, Le-Xin

2016-12-01

To evaluate the effect of individualized education for patients with type 2 diabetes mellitus (T2DM). A total of 280 patients (158 males, mean age 63 ± 10 years) with T2DM were randomly divided into study and control group. Eysenck Personality questionnaire was used to assess the personality of the patients in the study group, which was provided us one-on-one counseling and individualized management plan. Group education was provided to the control group. At the end of the study, the body mass index (21.5±2.5 vs 23.6±1.6 kg/m 2 , P =0.002), waist circumference (83.7±6.4 vs 85.7±7.7 cm, P =0.03), fasting blood glucose (6.0±0.8 vs 6.9±2.1 mmol/L, P =0.004), HbA1c (6.2±0.6% vs 6.9±3.1%, P =0.03), systolic blood pressure (130.1±8.8 vs 135.1±8.4 mmHg, P =0.003),triglyceride (1.21±0.66 vs 1.46±0.58 mmol/L) and low-density lipoprotein (2.36±0.44 vs 2.84±0.64 mmol/L, P =0.03) in the study group was lower than in the control group. Individualized diabetes education is more effective than group education in facilitating the control of type 2 diabetes.

Effects of aerobic dance training on blood pressure in individuals with uncontrolled hypertension on two antihypertensive drugs: a randomized clinical trial.

PubMed

Maruf, Fatai Adesina; Akinpelu, Aderonke Omobonike; Salako, Babatunde Lawal; Akinyemi, Joshua Odunayo

2016-04-01

There is a dearth of reports on possible additive blood pressure (BP)-reducing effect of aerobic exercise on antihypertensive drug in humans. This study investigated the additive BP-reducing effect of aerobic exercise on BP in individuals with uncontrolled hypertension. In this 12-week double-blind study, 120 new-diagnosed individuals with mild-to-moderate hypertension were randomized to receive coamilozide + 5/10 mg of amlodipine + aerobic dance or coamilozide + 5/10 mg of amlodipine alone. Forty-five and 43 participants in exercise and control groups, respectively, completed the 12-week intervention. Addition of aerobic exercise to antihypertensive drug therapy significantly reduced systolic BP (7.1 mm Hg [95% confidence interval: 5.0, 9.3]; P < .001) and diastolic BP (1.7 mm Hg [95% confidence interval: 0.4, 3.0]; P = .009) at 12 weeks. BP control rate differed significantly between exercise (53.9%) and control (35.3%) groups, P < .001. Postintervention, proportion of participants in exercise group who had their number of antihypertensive drug reduced to one (20.3%) differed from that in control group (11.1%); (χ(2) = 11.0; P = .001). Combination of aerobic dance and antihypertensive drugs reduces number of antihypertensive drugs needed to achieve BP control and enhances BP control in individuals with hypertension on two antihypertensive drugs. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

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.

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

Variation in the oxytocin receptor gene moderates the protective effects of a family-based prevention program on telomere length.

PubMed

Smearman, Erica L; Yu, Tianyi; Brody, Gene H

2016-02-01

Parent-child relationships with high conflict and low warmth and support are associated with later adverse behavioral and physiological child outcomes. These outcomes include shorter telomere lengths, the repetitive sequences at the ends of chromosomes that have been utilized as a biomarker for chronic stress. Our research group furthered this by exploring telomere length outcomes following a family-based prevention program and identified reduced telomere shortening 5 years post intervention among those originally exposed to nonsupportive parenting and randomized to the intervention condition. However, not all individuals respond equally, and a growing literature suggests genetic sensitivity to one's environment, with variations in the oxytocin receptor gene (OXTR) potentially influencing this sensitivity. We utilized data from African American youths (mean age 17) randomized to intervention (n = 100) or control condition (n = 91) with baseline assessments of genetic status and nonsupportive parenting, and 5-year follow-up assessments of telomere length. We found a significant three-way interaction between nonsupportive parenting, intervention condition, and OXTR rs53576 genotype. OXTR GG individuals, who are suggested to be more sensitive to their social environment, exhibited significantly more variability, evidencing the shortest telomeres when exposed to nonsupportive parenting and randomized to the control condition, and similar telomere lengths to non at-risk groups when randomized to the intervention. In contrast, those with the A allele showed no statistical difference in telomere lengths across parental and intervention conditions. Subsequent analyses suggest that these findings may be mediated through chronic anger, whereby GG individuals exposed to nonsupportive parenting and randomized to the control condition had a greater increase in chronic anger by study follow-up, compared to those in the intervention, and this change associated with greater telomere shortening. These findings highlight the importance of individual differences and potential role of genetic status in moderating the relationship between environmental contexts and biological outcomes.

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.

Atomoxetine could improve intra-individual variability in drug-naïve adults with attention-deficit/hyperactivity disorder comparably with methylphenidate: A head-to-head randomized clinical trial.

PubMed

Ni, Hsing-Chang; Hwang Gu, Shoou-Lian; Lin, Hsiang-Yuan; Lin, Yu-Ju; Yang, Li-Kuang; Huang, Hui-Chun; Gau, Susan Shur-Fen

2016-05-01

Intra-individual variability in reaction time (IIV-RT) is common in individuals with attention-deficit/hyperactivity disorder (ADHD). It can be improved by stimulants. However, the effects of atomoxetine on IIV-RT are inconclusive. We aimed to investigate the effects of atomoxetine on IIV-RT, and directly compared its efficacy with methylphenidate in adults with ADHD. An 8-10 week, open-label, head-to-head, randomized clinical trial was conducted in 52 drug-naïve adults with ADHD, who were randomly assigned to two treatment groups: immediate-release methylphenidate (n=26) thrice daily (10-20 mg per dose) and atomoxetine once daily (n=26) (0.5-1.2 mg/kg/day). IIV-RT, derived from the Conners' continuous performance test (CCPT), was represented by the Gaussian (reaction time standard error, RTSE) and ex-Gaussian models (sigma and tau). Other neuropsychological functions, including response errors and mean of reaction time, were also measured. Participants received CCPT assessments at baseline and week 8-10 (60.4±6.3 days). We found comparable improvements in performances of CCPT between the immediate-release methylphenidate- and atomoxetine-treated groups. Both medications significantly improved IIV-RT in terms of reducing tau values with comparable efficacy. In addition, both medications significantly improved inhibitory control by reducing commission errors. Our results provide evidence to support that atomoxetine could improve IIV-RT and inhibitory control, of comparable efficacy with immediate-release methylphenidate, in drug-naïve adults with ADHD. Shared and unique mechanisms underpinning these medication effects on IIV-RT awaits further investigation. © The Author(s) 2016.

Sham transcranial electrical stimulation and its effects on corticospinal excitability: a systematic review and meta-analysis.

PubMed

Dissanayaka, Thusharika D; Zoghi, Maryam; Farrell, Michael; Egan, Gary F; Jaberzadeh, Shapour

2018-02-23

Sham stimulation is used in randomized controlled trials (RCTs) to assess the efficacy of active stimulation and placebo effects. It should mimic the characteristics of active stimulation to achieve blinding integrity. The present study was a systematic review and meta-analysis of the published literature to identify the effects of sham transcranial electrical stimulation (tES) - including anodal and cathodal transcranial direct current stimulation (a-tDCS, c-tDCS), transcranial alternating current stimulation (tACS), transcranial random noise stimulation (tRNS) and transcranial pulsed current stimulation (tPCS) - on corticospinal excitability (CSE), compared to baseline in healthy individuals. Electronic databases - PubMed, CINAHL, Scopus, Science Direct and MEDLINE (Ovid) - were searched for RCTs of tES from 1990 to March 2017. Thirty RCTs were identified. Using a random-effects model, meta-analysis of a-tDCS, c-tDCS, tACS, tRNS and tPCS studies showed statistically non-significant pre-post effects of sham interventions on CSE. This review found evidence for statically non-significant effects of sham tES on CSE.

Influence of visual and auditory biofeedback on partial body weight support treadmill training of individuals with chronic hemiparesis: a randomized controlled clinical trial.

PubMed

Brasileiro, A; Gama, G; Trigueiro, L; Ribeiro, T; Silva, E; Galvão, É; Lindquist, A

2015-02-01

Stroke is an important causal factor of deficiency and functional dependence worldwide. To determine the immediate effects of visual and auditory biofeedback, combined with partial body weight supported (PBWS) treadmill training on the gait of individuals with chronic hemiparesis. Randomized controlled trial. Outpatient rehabilitation hospital. Thirty subjects with chronic hemiparesis and ability to walk with some help. Participants were randomized to a control group that underwent only PBWS treadmill training; or experimental I group with visual biofeedback from the display monitor, in the form of symbolic feet as the subject took a step; or experimental group II with auditory biofeedback associated display, using a metronome at 115% of the individual's preferred cadence. They trained for 20 minutes and were evaluated before and after training. Spatio-temporal and angular gait variables were obtained by kinematics from the Qualisys Motion Analysis system. Increases in speed and stride length were observed for all groups over time (speed: F=25.63; P<0.001; stride length: F=27.18; P<0.001), as well as changes in hip and ankle range of motion - ROM (hip ROM: F=14.43; P=0.001; ankle ROM: F=4.76; P=0.038), with no time*groups interaction. Other spatio-temporal and angular parameters remain unchanged. Visual biofeedback and auditory biofeedback had no influence on PBWS treadmill training of individuals with chronic hemiparesis, in short term. Additional studies are needed to determine whether, in long term, the biofeedback will promote additional benefit to the PBWS treadmill training. The findings of this study indicate that visual and auditory biofeedback does not bring immediate benefits on PBWS treadmill training of individuals with chronic hemiparesis. This suggest that, for additional benefits are achieved with biofeedback, effects should be investigated after long-term training, which may determine if some kind of biofeedback is superior to another to improve the hemiparetic gait.

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

PubMed

Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

2014-11-27

Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions. This trial was registered on clinicaltrials.gov on January 8, 2014 [NCT02038959].

An Evaluation of a Behaviorally Based Social Skills Group for Individuals Diagnosed with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Leaf, Justin B.; Leaf, Jeremy A.; Milne, Christine; Taubman, Mitchell; Oppenheim-Leaf, Misty; Torres, Norma; Townley-Cochran, Donna; Leaf, Ronald; McEachin, John; Yoder, Paul

2017-01-01

In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The…

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.

Allowing for uncertainty due to missing continuous outcome data in pairwise and network meta-analysis.

PubMed

Mavridis, Dimitris; White, Ian R; Higgins, Julian P T; Cipriani, Andrea; Salanti, Georgia

2015-02-28

Missing outcome data are commonly encountered in randomized controlled trials and hence may need to be addressed in a meta-analysis of multiple trials. A common and simple approach to deal with missing data is to restrict analysis to individuals for whom the outcome was obtained (complete case analysis). However, estimated treatment effects from complete case analyses are potentially biased if informative missing data are ignored. We develop methods for estimating meta-analytic summary treatment effects for continuous outcomes in the presence of missing data for some of the individuals within the trials. We build on a method previously developed for binary outcomes, which quantifies the degree of departure from a missing at random assumption via the informative missingness odds ratio. Our new model quantifies the degree of departure from missing at random using either an informative missingness difference of means or an informative missingness ratio of means, both of which relate the mean value of the missing outcome data to that of the observed data. We propose estimating the treatment effects, adjusted for informative missingness, and their standard errors by a Taylor series approximation and by a Monte Carlo method. We apply the methodology to examples of both pairwise and network meta-analysis with multi-arm trials. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

PubMed

Jacobs, Jennifer; Williams, Anna-Leila; Girard, Christine; Njike, Valentine Yanchou; Katz, David

2005-10-01

The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). This work was a randomized, double-blind, placebo-controlled trial. This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

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

Massage Therapy for Pain and Function in Patients With Arthritis: A Systematic Review of Randomized Controlled Trials.

PubMed

Nelson, Nicole L; Churilla, James R

2017-09-01

Massage therapy is gaining interest as a therapeutic approach to managing osteoarthritis and rheumatoid arthritis symptoms. To date, there have been no systematic reviews investigating the effects of massage therapy on these conditions. Systematic review was used. The primary aim of this review was to critically appraise and synthesize the current evidence regarding the effects of massage therapy as a stand-alone treatment on pain and functional outcomes among those with osteoarthritis or rheumatoid arthritis. Relevant randomized controlled trials were searched using the electronic databases Google Scholar, MEDLINE, and PEDro. The PEDro scale was used to assess risk of bias, and the quality of evidence was assessed with the GRADE approach. This review found seven randomized controlled trials representing 352 participants who satisfied the inclusion criteria. Risk of bias ranged from four to seven. Our results found low- to moderate-quality evidence that massage therapy is superior to nonactive therapies in reducing pain and improving certain functional outcomes. It is unclear whether massage therapy is more effective than other forms of treatment. There is a need for large, methodologically rigorous randomized controlled trials investigating the effectiveness of massage therapy as an intervention for individuals with arthritis.

Distractive Auditory Stimuli in the Form of Music in Individuals With COPD: A Systematic Review.

PubMed

Lee, Annemarie L; Desveaux, Laura; Goldstein, Roger S; Brooks, Dina

2015-08-01

Music has been used as a distractive auditory stimulus (DAS) in patients with COPD, but its effects are unclear. This systematic review aimed to establish the effect of DAS on exercise capacity, symptoms, and health-related quality of life (HRQOL) under three conditions: (1) during exercise training, (2) during exercise testing, and (3) for symptom management at rest. Randomized controlled or crossover trials as well as cohort studies of DAS during exercise training, during formal exercise testing, and for symptom management among individuals with COPD were identified from a search of seven databases. Two reviewers independently assessed study quality. Weighted mean differences (WMDs) with 95% CIs were calculated using a random-effects model. Thirteen studies (12 of which were randomized controlled or crossover trials) in 415 participants were included. DAS increased exercise capacity when applied over at least 2 months of exercise training (WMD, 98 m; 95% CI, 47-150 m). HRQOL improved only after a training duration of 3 months. Less dyspnea was noted with DAS during exercise training, but this was not consistently observed in short-term exercise testing or as a symptom management strategy at rest. DAS appears to reduce symptoms of dyspnea and fatigue when used during exercise training, with benefits observed in exercise capacity and HRQOL. When applied during exercise testing, the effects on exercise capacity and symptoms and as a strategy for symptom management at rest are inconsistent.

Epidemic transmission on random mobile network with diverse infection periods

NASA Astrophysics Data System (ADS)

Li, Kezan; Yu, Hong; Zeng, Zhaorong; Ding, Yong; Ma, Zhongjun

2015-05-01

The heterogeneity of individual susceptibility and infectivity and time-varying topological structure are two realistic factors when we study epidemics on complex networks. Current research results have shown that the heterogeneity of individual susceptibility and infectivity can increase the epidemic threshold in a random mobile dynamical network with the same infection period. In this paper, we will focus on random mobile dynamical networks with diverse infection periods due to people's different constitutions and external circumstances. Theoretical results indicate that the epidemic threshold of the random mobile network with diverse infection periods is larger than the counterpart with the same infection period. Moreover, the heterogeneity of individual susceptibility and infectivity can play a significant impact on disease transmission. In particular, the homogeneity of individuals will avail to the spreading of epidemics. Numerical examples verify further our theoretical results very well.

[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.

Multilevel mixed effects parametric survival models using adaptive Gauss-Hermite quadrature with application to recurrent events and individual participant data meta-analysis.

PubMed

Crowther, Michael J; Look, Maxime P; Riley, Richard D

2014-09-28

Multilevel mixed effects survival models are used in the analysis of clustered survival data, such as repeated events, multicenter clinical trials, and individual participant data (IPD) meta-analyses, to investigate heterogeneity in baseline risk and covariate effects. In this paper, we extend parametric frailty models including the exponential, Weibull and Gompertz proportional hazards (PH) models and the log logistic, log normal, and generalized gamma accelerated failure time models to allow any number of normally distributed random effects. Furthermore, we extend the flexible parametric survival model of Royston and Parmar, modeled on the log-cumulative hazard scale using restricted cubic splines, to include random effects while also allowing for non-PH (time-dependent effects). Maximum likelihood is used to estimate the models utilizing adaptive or nonadaptive Gauss-Hermite quadrature. The methods are evaluated through simulation studies representing clinically plausible scenarios of a multicenter trial and IPD meta-analysis, showing good performance of the estimation method. The flexible parametric mixed effects model is illustrated using a dataset of patients with kidney disease and repeated times to infection and an IPD meta-analysis of prognostic factor studies in patients with breast cancer. User-friendly Stata software is provided to implement the methods. Copyright © 2014 John Wiley & Sons, Ltd.

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.

Effect of a new moisturizing lotion on immediate and cumulative skin hydration: Two randomized, intra-individual, vehicle- and comparator-controlled studies.

PubMed

Nogueira, Alessandra; Sidou, Farzaneh; Brocard, Sylvie

2011-08-01

Moisturizers increase skin hydration and can serve as adjunctive care in dermatologic conditions such as xerosis, psoriasis vulgaris, atopic dermatitis and ichthyosis, in which dry skin is implicated. A non-irritating hydrating lotion (CDA lotion) was recently developed. We assessed the effect of CDA lotion on skin hydration in two randomized, evaluator-blind and intra-individual comparison studies. After a single application, CDA lotion induced significantly greater hydration than the non-treated control for at least 24 hours (p < 0.001). After 4 days of twice-daily application, compared with the non-treated control, CDA lotion induced significantly greater skin hydration up to 3 days after treatment cessation (p < 0.05) and significant improvement in the clinical skin dryness score up to 7 days after treatment cessation (p < 0.05). The immediate and cumulative hydration effects of CDA lotion were also compared to those of several currently available moisturizing products. In summary, application of CDA lotion increases skin hydration and alleviates the condition of skin dryness.

Randomized Controlled Pilot Trial of a Novel Dissonance-Based Group Treatment for Eating Disorders

PubMed Central

Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S.; Marti, C. Nathan

2015-01-01

Objective Conduct a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Method Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Body Acceptance Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Results Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ2[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = 0.79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). Conclusions This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. PMID:25577189

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

Group Interventions were not Effective for Female Turkish Migrants with Recurrent Depression – Recommendations from a Randomized Controlled Study

PubMed Central

Renner, Walter; Berry, John W.

2010-01-01

We tested group interventions for women with a Turkish migration background living in Austria and suffering from recurrent depression. N = 66 participants were randomized to: (1) Self-Help Groups (SHG), (2) Cognitive Behavior Therapy (CBT) Groups, and (3) a Wait-List (WL) Control condition. Neither SHG nor CBT were superior to WL. On an individual basis, about one third of the participants showed significant improvements with respect to symptoms of depression. Younger women, women with a longer duration of stay in Austria and those who had encountered a higher number of traumatic experiences, showed increased improvement of depressive symptoms. The results suggest that individual treatment by ethnic, female psychotherapists should be preferred to group interventions. PMID:21976784

The Effect of Practice Schedule on Context-Dependent Learning.

PubMed

Lee, Ya-Yun; Fisher, Beth E

2018-03-02

It is well established that random practice compared to blocked practice enhances motor learning. Additionally, while information in the environment may be incidental, learning is also enhanced when an individual performs a task within the same environmental context in which the task was originally practiced. This study aimed to disentangle the effects of practice schedule and incidental/environmental context on motor learning. Participants practiced three finger sequences under either a random or blocked practice schedule. Each sequence was associated with specific incidental context (i.e., color and location on the computer screen) during practice. The participants were tested under the conditions when the sequence-context associations remained the same or were changed from that of practice. When the sequence-context association was changed, the participants who practiced under blocked schedule demonstrated greater performance decrement than those who practiced under random schedule. The findings suggested that those participants who practiced under random schedule were more resistant to the change of environmental context.

Schizophrenia and Violence: Systematic Review and Meta-Analysis

PubMed Central

Fazel, Seena; Gulati, Gautam; Linsell, Louise; Geddes, John R.; Grann, Martin

2009-01-01

Background Although expert opinion has asserted that there is an increased risk of violence in individuals with schizophrenia and other psychoses, there is substantial heterogeneity between studies reporting risk of violence, and uncertainty over the causes of this heterogeneity. We undertook a systematic review of studies that report on associations between violence and schizophrenia and other psychoses. In addition, we conducted a systematic review of investigations that reported on risk of homicide in individuals with schizophrenia and other psychoses. Methods and Findings Bibliographic databases and reference lists were searched from 1970 to February 2009 for studies that reported on risks of interpersonal violence and/or violent criminality in individuals with schizophrenia and other psychoses compared with general population samples. These data were meta-analysed and odds ratios (ORs) were pooled using random-effects models. Ten demographic and clinical variables were extracted from each study to test for any observed heterogeneity in the risk estimates. We identified 20 individual studies reporting data from 18,423 individuals with schizophrenia and other psychoses. In men, ORs for the comparison of violence in those with schizophrenia and other psychoses with those without mental disorders varied from 1 to 7 with substantial heterogeneity (I 2 = 86%). In women, ORs ranged from 4 to 29 with substantial heterogeneity (I 2 = 85%). The effect of comorbid substance abuse was marked with the random-effects ORs of 2.1 (95% confidence interval [CI] 1.7–2.7) without comorbidity, and an OR of 8.9 (95% CI 5.4–14.7) with comorbidity (p<0.001 on metaregression). Risk estimates of violence in individuals with substance abuse (but without psychosis) were similar to those in individuals with psychosis with substance abuse comorbidity, and higher than all studies with psychosis irrespective of comorbidity. Choice of outcome measure, whether the sample was diagnosed with schizophrenia or with nonschizophrenic psychoses, study location, or study period were not significantly associated with risk estimates on subgroup or metaregression analysis. Further research is necessary to establish whether longitudinal designs were associated with lower risk estimates. The risk for homicide was increased in individuals with psychosis (with and without comorbid substance abuse) compared with general population controls (random-effects OR = 19.5, 95% CI 14.7–25.8). Conclusions Schizophrenia and other psychoses are associated with violence and violent offending, particularly homicide. However, most of the excess risk appears to be mediated by substance abuse comorbidity. The risk in these patients with comorbidity is similar to that for substance abuse without psychosis. Public health strategies for violence reduction could consider focusing on the primary and secondary prevention of substance abuse. Please see later in the article for Editors' Summary PMID:19668362

Failure at the top: How power undermines collaborative performance.

PubMed

Hildreth, John Angus D; Anderson, Cameron

2016-02-01

All too commonly, we see groups of leaders fail to accomplish their stated goals when working together--legislators who cannot agree on a bill, heads of state who cannot draft meaningful environmental policy, or boards of trustees who make disastrous decisions for their school. The current research examines whether groups of leaders fail as often as they do in part because of the power each leader is accustomed to possessing among his or her constituents. In multiple studies we found that high power individuals, when working together in groups, performed worse than did other groups: individuals randomly assigned power in an initial task were less creative when they then worked together in groups on a subsequent task (Studies 1A and 4). Individuals with higher power who worked together in groups were also less likely to reach agreement on a difficult negotiation task, whether these groups comprised actual executives from an extant organization (Study 2) or participants randomly assigned power in the laboratory (Study 3). Mediation analyses suggest that groups of high power individuals performed worse because they fought over their relative status in the group, were less focused on the task, and shared information with each other less effectively. However, high power individuals were more effective when working on tasks that required less coordination: they were more creative (Studies 1B and 4) and persisted longer on a difficult task than other groups. Therefore, group processes are the key problem for groups of high power individuals when they work together. (c) 2016 APA, all rights reserved).

Effect of Treatment Education Based on the Roy Adaptation Model on Adjustment of Hemodialysis Patients.

PubMed

Kacaroglu Vicdan, Ayse; Gulseven Karabacak, Bilgi

2016-01-01

The Roy Adaptation Model examines the individual in 4 fields: physiological mode, self-concept mode, role function mode, and interdependence mode. Hemodialysis treatment is associated with the Roy Adaptation Model as it involves fields that might be needed by the individual with chronic renal disease. This research was conducted as randomized controlled experiment with the aim of determining the effect of the education given in accordance with the Roy Adaptation Model on physiological, psychological, and social adaptation of individuals undergoing hemodialysis treatment. This was a random controlled experimental study. The study was conducted at a dialysis center in Konya-Aksehir in Turkey between July 1 and December 31, 2012. The sample was composed of 82 individuals-41 experimental and 41 control. In the second interview, there was a decrease in the systolic blood pressures and body weights of the experimental group, an increase in the scores of functional performance and self-respect, and a decrease in the scores of psychosocial adaptation. In the control group, on the other hand, there was a decrease in the scores of self-respect and an increase in the scores of psychosocial adaptation. The 2 groups were compared in terms of adaptation variables and a difference was determined on behalf of the experimental group. The training that was provided and evaluated for individuals receiving hemodialysis according to 4 modes of the Roy Adaptation Model increased physical, psychological, and social adaptation.

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.

Chemotherapy in advanced ovarian cancer: four systematic meta-analyses of individual patient data from 37 randomized trials. Advanced Ovarian Cancer Trialists' Group.

PubMed Central

Aabo, K.; Adams, M.; Adnitt, P.; Alberts, D. S.; Athanazziou, A.; Barley, V.; Bell, D. R.; Bianchi, U.; Bolis, G.; Brady, M. F.; Brodovsky, H. S.; Bruckner, H.; Buyse, M.; Canetta, R.; Chylak, V.; Cohen, C. J.; Colombo, N.; Conte, P. F.; Crowther, D.; Edmonson, J. H.; Gennatas, C.; Gilbey, E.; Gore, M.; Guthrie, D.; Yeap, B. Y.

1998-01-01

The purpose of this systematic study was to provide an up to date and reliable quantitative summary of the relative benefits of various types of chemotherapy (non-platinum vs platinum, single-agent vs combination and carboplatin vs cisplatin) in the treatment of advanced ovarian cancer. Also, to investigate whether well-defined patient subgroups benefit more or less from cisplatin- or carboplatin-based therapy. Meta-analyses were based on updated individual patient data from all available randomized controlled trials (published and unpublished), including 37 trials, 5667 patients and 4664 deaths. The results suggest that platinum-based chemotherapy is better than non-platinum therapy, show a trend in favour of platinum combinations over single-agent platinum, and suggest that cisplatin and carboplatin are equally effective. There is no good evidence that cisplatin is more or less effective than carboplatin in any particular subgroup of patients. Images Figure 1 Figure 2 Figure 3 PMID:9836481

Mobile Technology Interventions for Asthma Self-Management: Systematic Review and Meta-Analysis

PubMed Central

Schüz, Benjamin; Walters, Julia; Walters, E Haydn

2017-01-01

Background Mobile technology interventions (MTI) are becoming increasingly popular in the management of chronic health behaviors. Most MTI allow individuals to monitor medication use, record symptoms, or store and activate disease-management action plans. Therefore, MTI may have the potential to improve low adherence to medication and action plans for individuals with asthma, which is associated with poor clinical outcomes. Objective A systematic review and meta-analysis were conducted to evaluate the efficacy of MTI on clinical outcomes as well as adherence in individuals with asthma. As the use of evidence-based behavior change techniques (BCT) has been shown to improve intervention effects, we also conducted exploratory analyses to determine the role of BCT and engagement with MTI as moderators of MTI efficacy. Methods We searched electronic databases for randomized controlled trials up until June 2016. Random effect models were used to assess the effect of MTI on clinical outcomes as well as adherence to preventer medication or symptom monitoring. Mixed effects models assessed whether the features of the MTI (ie, use of BCT) and how often a person engaged with MTI moderated the effects of MTI. Results The literature search located 11 studies meeting the inclusion criteria, with 9 providing satisfactory data for meta-analysis. Compared with standard treatment, MTI had moderate to large effect sizes (Hedges g) on medication adherence and clinical outcomes. MTI had no additional effects on adherence or clinical outcomes when compared with paper-based monitoring. No moderator effects were found, and the number of studies was small. A narrative review of the two studies, which are not included in the meta-analysis, found similar results. Conclusions This review indicated the efficacy of MTI for self-management in individuals with asthma and also indicated that MTI appears to be as efficacious as paper-based monitoring. This review also suggested a need for robust studies to examine the effects of BCT use and engagement on MTI efficacy to inform the evidence base for MTI in individuals with asthma. PMID:28465281

Estimating correlation between multivariate longitudinal data in the presence of heterogeneity.

PubMed

Gao, Feng; Philip Miller, J; Xiong, Chengjie; Luo, Jingqin; Beiser, Julia A; Chen, Ling; Gordon, Mae O

2017-08-17

Estimating correlation coefficients among outcomes is one of the most important analytical tasks in epidemiological and clinical research. Availability of multivariate longitudinal data presents a unique opportunity to assess joint evolution of outcomes over time. Bivariate linear mixed model (BLMM) provides a versatile tool with regard to assessing correlation. However, BLMMs often assume that all individuals are drawn from a single homogenous population where the individual trajectories are distributed smoothly around population average. Using longitudinal mean deviation (MD) and visual acuity (VA) from the Ocular Hypertension Treatment Study (OHTS), we demonstrated strategies to better understand the correlation between multivariate longitudinal data in the presence of potential heterogeneity. Conditional correlation (i.e., marginal correlation given random effects) was calculated to describe how the association between longitudinal outcomes evolved over time within specific subpopulation. The impact of heterogeneity on correlation was also assessed by simulated data. There was a significant positive correlation in both random intercepts (ρ = 0.278, 95% CI: 0.121-0.420) and random slopes (ρ = 0.579, 95% CI: 0.349-0.810) between longitudinal MD and VA, and the strength of correlation constantly increased over time. However, conditional correlation and simulation studies revealed that the correlation was induced primarily by participants with rapid deteriorating MD who only accounted for a small fraction of total samples. Conditional correlation given random effects provides a robust estimate to describe the correlation between multivariate longitudinal data in the presence of unobserved heterogeneity (NCT00000125).

Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention 'ReumaUitgedaagd!' for Adults With a Rheumatic Disease: Results of a Usability Study and Design for a Randomized Control Trail.

PubMed

Ammerlaan, Judy W; Mulder, Olga K; de Boer-Nijhof, Nienke C; Maat, Bertha; Kruize, Aike A; van Laar, Jaap; van Os-Medendorp, Harmieke; Geenen, Rinie

2016-06-23

The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.

Predictors and moderators of treatment outcome in a randomized clinical trial for adults with symptoms of bulimia nervosa.

PubMed

Accurso, Erin C; Wonderlich, Stephen A; Crosby, Ross D; Smith, Tracey L; Klein, Marjorie H; Mitchell, James E; Crow, Scott J; Berg, Kelly C; Peterson, Carol B

2016-02-01

This study examined predictors and moderators of outcome in 2 treatments for bulimia nervosa (BN). Eighty adults with BN symptoms at 1 of 2 sites were randomized to 21 sessions of integrative cognitive-affective therapy for BN (ICAT-BN) or enhanced cognitive behavior therapy (CBT-E). Generalized linear models examined predictors and moderators of improvements in bulimic behavior and eating disorder psychopathology at end of treatment (EOT) and 4-month follow-up (FU). At EOT, individuals with higher dietary restraint had greater reductions in bulimic behavior. At FU, individuals with higher weight and shape concern had greater reductions in bulimic behavior, whereas those with greater baseline depression had less improvement in eating disorder psychopathology. Individuals higher in stimulus seeking had greater reductions in bulimic behavior and eating disorder psychopathology at follow up in ICAT-BN than in CBT-E, whereas individuals lower in stimulus seeking had greater reductions in bulimic behavior in CBT-E than in ICAT-BN. Finally, individuals with higher affective lability had greater reductions in eating disorder psychopathology in ICAT-BN than in CBT-E, whereas improvements were comparable across treatments for individuals with lower affective lability. This study identified 3 nonspecific predictors of outcome (i.e., dietary restraint, weight and shape concern, and depression) and 2 moderators (i.e., affective lability and stimulus seeking). All moderator effects emerged at FU rather than at EOT, suggesting that the moderating effects of treatment were not immediately apparent. These results suggest that individuals with higher affective lability and stimulus seeking may benefit more from treatment with a greater focus on affective states and self-regulation. (c) 2016 APA, all rights reserved).

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.

Serological Markers of Sand Fly Exposure to Evaluate Insecticidal Nets against Visceral Leishmaniasis in India and Nepal: A Cluster-Randomized Trial

PubMed Central

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-01-01

Background Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. Methods As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. Results A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83–0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80–1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. Conclusions This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions. PMID:21931871

Serological markers of sand fly exposure to evaluate insecticidal nets against visceral leishmaniasis in India and Nepal: a cluster-randomized trial.

PubMed

Gidwani, Kamlesh; Picado, Albert; Rijal, Suman; Singh, Shri Prakash; Roy, Lalita; Volfova, Vera; Andersen, Elisabeth Wreford; Uranw, Surendra; Ostyn, Bart; Sudarshan, Medhavi; Chakravarty, Jaya; Volf, Petr; Sundar, Shyam; Boelaert, Marleen; Rogers, Matthew Edward

2011-09-01

Visceral leishmaniasis is the world' second largest vector-borne parasitic killer and a neglected tropical disease, prevalent in poor communities. Long-lasting insecticidal nets (LNs) are a low cost proven vector intervention method for malaria control; however, their effectiveness against visceral leishmaniasis (VL) is unknown. This study quantified the effect of LNs on exposure to the sand fly vector of VL in India and Nepal during a two year community intervention trial. As part of a paired-cluster randomized controlled clinical trial in VL-endemic regions of India and Nepal we tested the effect of LNs on sand fly biting by measuring the antibody response of subjects to the saliva of Leishmania donovani vector Phlebotomus argentipes and the sympatric (non-vector) Phlebotomus papatasi. Fifteen to 20 individuals above 15 years of age from 26 VL endemic clusters were asked to provide a blood sample at baseline, 12 and 24 months post-intervention. A total of 305 individuals were included in the study, 68 participants provided two blood samples and 237 gave three samples. A random effect linear regression model showed that cluster-wide distribution of LNs reduced exposure to P. argentipes by 12% at 12 months (effect 0.88; 95% CI 0.83-0.94) and 9% at 24 months (effect 0.91; 95% CI 0.80-1.02) in the intervention group compared to control adjusting for baseline values and pair. Similar results were obtained for P. papatasi. This trial provides evidence that LNs have a limited effect on sand fly exposure in VL endemic communities in India and Nepal and supports the use of sand fly saliva antibodies as a marker to evaluate vector control interventions.

Effects of web-based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial.

PubMed

Imamura, Kotaro; Kawakami, Norito; Tsuno, Kanami; Tsuchiya, Masao; Shimada, Kyoko; Namba, Katsuyuki; Shimazu, Akihito

2017-01-24

The purpose of this randomized, controlled trial was to examine the effects of a psychoeducational information website on improving work engagement among individual workers with low work engagement, where work engagement was measured as a secondary outcome. Participants were recruited from registered members of a web survey site in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Immediately after the baseline survey, the intervention group was invited to study a psychoeducational website called the "UTSMed," which provided general mental health literacy and cognitive behavioral skills. Work engagement was assessed by using the Utrecht Work Engagement Scale at baseline, 1-, and 4-month follow-ups for both intervention and control groups. An exploratory analysis was conducted for a subgroup with low (lower than the median scores) work engagement scores at baseline. A total of 1,236 workers completed the baseline survey. In the low work engagement subgroup, a total of 313 and 300 participants were allocated to an intervention and control group, respectively. In the high work engagement subgroup, 305 and 318 participants were allocated to an intervention and control group, respectively. The program showed a significant effect on work engagement (t = 1.98, P = 0.048) at the 4-month follow-up in the low work engagement subgroup, with a small effect size (d = 0.17). A web-based psychoeducation resource of mental health literacy and cognitive behavioral skills may be effective for improving work engagement among individual workers with low work engagement.

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.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

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.

A meta-analysis of anxiety symptom prevention with cognitive-behavioral interventions.

PubMed

Zalta, Alyson K

2011-06-01

This meta-analysis assessed efficacy of cognitive-behavioral interventions in preventing anxiety symptoms. A systematic review identified 15 independent pretest-posttest randomized or quasi-randomized efficacy trials for analysis. At posttest, intervention groups demonstrated significantly greater symptom reduction compared to control groups resulting in weighted mean effect sizes (Hedges' g) of 0.25 for general anxiety, 0.24 for disorder-specific symptoms, and 0.22 for depression after the removal of outliers. These effects appeared to diminish over 6- and 12-month follow-up. Exploratory moderator analyses indicated that individually administered media interventions were more effective than human-administered group interventions at preventing general anxiety and depression symptoms. Implications of current findings are discussed with attention to existing gaps in the literature.

Processing Time and Question Type in the Comprehension of Compressed Speech with Adjunct Pictures.

ERIC Educational Resources Information Center

Tantiblarphol, Subhreawpun; Hughes, Lawson H.

The effect of adding time for processing compressed speech and the effects of questions that gave adjunct pictures either a redundant or contextual function were investigated. Subjects were 144 fourth- and fifth-grade students randomly assigned to 24 groups. They listened individually to a 20-sentence story at either 225 or 300 words-per-minute…

Randomized Controlled Double-Blind Trial of Optimal Dose Methylphenidate in Children and Adolescents with Severe Attention Deficit Hyperactivity Disorder and Intellectual Disability

ERIC Educational Resources Information Center

Simonoff, Emily; Taylor, Eric; Baird, Gillian; Bernard, Sarah; Chadwick, Oliver; Liang, Holan; Whitwell, Susannah; Riemer, Kirsten; Sharma, Kishan; Sharma, Santvana Pandey; Wood, Nicky; Kelly, Joanna; Golaszewski, Ania; Kennedy, Juliet; Rodney, Lydia; West, Nicole; Walwyn, Rebecca; Jichi, Fatima

2013-01-01

Background: Attention deficit hyperactivity disorder is increased in children with intellectual disability. Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks. Method: One hundred and…

A Correlated Random Effects Model for Nonignorable Missing Data in Value-Added Assessment of Teacher Effects

ERIC Educational Resources Information Center

Karl, Andrew T.; Yang, Yan; Lohr, Sharon L.

2013-01-01

Value-added models have been widely used to assess the contributions of individual teachers and schools to students' academic growth based on longitudinal student achievement outcomes. There is concern, however, that ignoring the presence of missing values, which are common in longitudinal studies, can bias teachers' value-added scores.…

Effects of a Health Behavior Change Model-Based HIV/STI Prevention Intervention on Condom Use among Heterosexual Couples: A Randomized Trial

ERIC Educational Resources Information Center

Harvey, S. Marie; Kraft, Joan Marie; West, Stephen G.; Taylor, Aaron B.; Pappas-DeLuca, Katina A.; Beckman, Linda J.

2009-01-01

This study examines an intervention for heterosexual couples to prevent human immunodeficiency virus/sexually transmitted infections. It also evaluates the effect of the intervention, which is based on current models of health behavior change, on intermediate outcomes (individual and relationship factors) and consistency of condom use. Eligible…

Using a Meta-Analytic Technique to Assess the Relationship between Treatment Intensity and Program Effects in a Cluster-Randomized Trial

ERIC Educational Resources Information Center

Polanin, Joshua R.; Espelage, Dorothy L.

2015-01-01

School bullying and delinquent behaviors are persistent and pervasive problems for schools, and have lasting effects for all individuals involved (Copeland et al., "JAMA Psychiatry" 70:419-426, 2013; Espelage et al., "J Res Adolesc" 24(2):337-349, 2013a). As a result, policymakers and practitioners have attempted to thwart…

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson's disease: study protocol for a randomized controlled feasibility trial.

PubMed

Silva, Keyte Guedes; De Freitas, Tatiana Beline; Doná, Flávia; Ganança, Fernando Freitas; Ferraz, Henrique Ballalai; Torriani-Pasin, Camila; Pompeu, José Eduardo

2017-01-01

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson's disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial attention deficiencies may contribute to the impairment of motor performance during daily activities. There are strong evidences that physical therapy can prevent physical and cognitive decline in individuals with PD. Recently, the European Physiotherapy Guideline (EPG) was developed based on randomized clinical trials about the effectiveness of the physical therapy to improve the functional deficiencies of individuals with PD. The EPG did not include the use of promising new intervention as virtual reality in PD due the lack of studies about its safety, feasibility and effectiveness. Therefore, this study protocol had as objective to evaluate the feasibility, safety and effectiveness of a physical therapy program-based on the European Physiotherapy Guideline (EPG) compared to Kinect-based training on postural control, gait, cognition, and quality of life (QoL) of Individuals with PD. A single-blind, parallel, randomized, controlled feasibility trial will be conducted with a sample of 32 individuals diagnosed with idiopathic PD. Participants will be allocated into control group (CG) and experimental group (EG). The intervention of the CG will be conventional physical therapy, and the intervention of the EG will be a supervised practice of five Kinect games. Both groups will perform 14 sessions of 1 h each one, twice a week over 7 weeks. Process outcomes will be safety, feasibility, adherence, and acceptability. Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. Feasibility will be assessed through the scores of the games recorded in all training sessions. Adherence will be assessed through the participant's attendance. Acceptability will be the motivation of the participants regarding the interventions. Clinical outcomes will be (1) postural control, (2) cognitive function, (3) balance, (4) gait, and (5) QoL. Individuals will be assessed pre- and post-interventions and after 30 days by a blinded evaluator. This protocol will clarify if an intervention based on Kinect games will be feasible, safe, and acceptable for individuals with PD compared to conventional physical therapy. We will verify whether the proposed interventions can improve clinical outcomes as postural control, gait, cognition, and QoL of individuals with PD. Our hypothesis is that both Kinect games and conventional physical therapy will be feasible, safe, and acceptable for individuals with PD and will promote positive clinical effects. The results of this feasibility study will be used to design a future definitive clinical trial. Unique identification number in WHO Trial Registration: U1111-1171-0371. Brazilian Clinical Trial Registration Number RBR-27kqv5, registration date: February, 2016.

Evidence to practice: treatment of anxiety in individuals with autism spectrum disorders

PubMed Central

Lang, Russell; Mahoney, Richard; El Zein, Farah; Delaune, Elizabeth; Amidon, Megan

2011-01-01

Clinical question What treatment improves social interactions and reduces reports of anxiety symptoms in individuals with autism spectrum disorders (ASD) and a co-occurring anxiety disorder? Results Systematic reviews and randomized clinical trials suggest that cognitive behavior therapy in tandem with direct instruction of social skills using applied behavior analysis intervention components may be effective for treating anxiety in individuals with high functioning ASD. For individuals with ASD, an anxiety disorder, and an intellectual disability, systematic desensitization may be effective. Implementation Intervention should emphasize teaching social skills. Reinforcers (ie, rewards based upon the client’s interests) should be used to encourage participation in therapy. Treatment should incorporate visual aides and family involvement. Intervention components involving abstract concepts, visualization, and discussions of emotions are less useful given difficulties in abstract reasoning and communication inherent to ASD. PMID:21326652

Effect of Chocolate and Yerba Mate Phenolic Compounds on Inflammatory and Oxidative Biomarkers in HIV/AIDS Individuals.

PubMed

Petrilli, Aline A; Souza, Suelen J; Teixeira, Andrea M; Pontilho, Patricia M; Souza, José M P; Luzia, Liania A; Rondó, Patricia H C

2016-05-23

Flavonoids in cocoa and yerba mate have a beneficial role on inflammation and oxidative disorders. Their effect on HIV individuals has not been studied yet, despite the high cardiovascular risk of this population. This study investigated the role of cocoa and yerba mate consumption on oxidative and inflammatory biomarkers in HIV+ individuals. A cross-over, placebo-controlled, double-blind, randomized clinical trial was conducted in 92 individuals on antiretroviral therapy for at least six months and at viral suppression. Participants were randomized to receive either 65 g of chocolate or chocolate-placebo or 3 g of yerba mate or mate-placebo for 15 days each, alternating by a washout period of 15 days. At baseline, and at the end of each intervention regimen, data regarding anthropometry, inflammatory, oxidative and immunological parameters were collected. High-sensitivity C-reactive protein, fibrinogen, lipid profile, white blood cell profile and thiobarbituric acid reactive substances were assessed. There was a difference between mean concentrations of HDL-c (ANOVA; p ≤ 0.05) among the different regimens: dark chocolate, chocolate-placebo, yerba mate and mate-placebo. When a paired Student t-test was used for comparisons between mean HDL-c at baseline and after each regimen, the mean concentration of HDL-c was higher after supplementation with dark chocolate (p = 0.008).

Effect of Chocolate and Yerba Mate Phenolic Compounds on Inflammatory and Oxidative Biomarkers in HIV/AIDS Individuals

PubMed Central

Petrilli, Aline A.; Souza, Suelen J.; Teixeira, Andrea M.; Pontilho, Patricia M.; Souza, José M. P.; Luzia, Liania A.; Rondó, Patricia H. C.

2016-01-01

Flavonoids in cocoa and yerba mate have a beneficial role on inflammation and oxidative disorders. Their effect on HIV individuals has not been studied yet, despite the high cardiovascular risk of this population. This study investigated the role of cocoa and yerba mate consumption on oxidative and inflammatory biomarkers in HIV+ individuals. A cross-over, placebo-controlled, double-blind, randomized clinical trial was conducted in 92 individuals on antiretroviral therapy for at least six months and at viral suppression. Participants were randomized to receive either 65 g of chocolate or chocolate-placebo or 3 g of yerba mate or mate-placebo for 15 days each, alternating by a washout period of 15 days. At baseline, and at the end of each intervention regimen, data regarding anthropometry, inflammatory, oxidative and immunological parameters were collected. High-sensitivity C-reactive protein, fibrinogen, lipid profile, white blood cell profile and thiobarbituric acid reactive substances were assessed. There was a difference between mean concentrations of HDL-c (ANOVA; p ≤ 0.05) among the different regimens: dark chocolate, chocolate-placebo, yerba mate and mate-placebo. When a paired Student t-test was used for comparisons between mean HDL-c at baseline and after each regimen, the mean concentration of HDL-c was higher after supplementation with dark chocolate (p = 0.008). PMID:27223302

A qualitative study exploring patients' experiences of standard care or cardiac rehabilitation post minor stroke and transient ischaemic attack.

PubMed

Hillsdon, Kaye M; Kersten, Paula; Kirk, Hayden J S

2013-09-01

To explore individuals' experiences of receiving either standard care or comprehensive cardiac rehabilitation post minor stroke or transient ischaemic attack. A qualitative study using semi-structured interviews, alongside a randomized controlled trial, exploring the effectiveness of comprehensive cardiac rehabilitation compared with standard care. Interviews were transcribed verbatim and subjected to thematic analysis. Individuals' homes. People who have experienced a minor stroke or transient ischaemic attack and who were partaking in a secondary prevention randomized controlled trial (6-7 months post the event, 17 males, five females; mean age 67 years). Not relevant. Not relevant. Four themes were identified: information delivery, comparing oneself with others, psychological impact, attitudes and actions regarding risk factor reduction. Participants indicated a need for improved information delivery, specific to their own risk factors and lifestyle changes. Many experienced psychological impact as a result of their minor stroke. Participants were found to make two types of social comparison; the comparison of self to another affected by stroke, and the comparison of self to cardiac patients. Comprehensive cardiac rehabilitation was reported to have positive effects on people's motivation to exercise. Following a minor stroke, many individuals do not recall information given or risk factors specific to them. Downward comparison with individuals who have had a cardiovascular event led to some underplaying the significance of their minor stroke.

Individual versus group family-focused cognitive-behaviour therapy for childhood anxiety: pilot randomized controlled trial.

PubMed

de Groot, Jules; Cobham, Vanessa; Leong, Joyce; McDermott, Brett

2007-12-01

The aim of the present study was to compare the relative effectiveness of group and individual formats of a family-focused cognitive-behavioural intervention, for the treatment of childhood anxiety disorders. Twenty-nine clinically anxious children aged between 7 and 12 years were randomly allocated to either individual cognitive-behaviour therapy (ICBT) or group cognitive-behaviour therapy (GCBT). At post-treatment assessment 57% of children in the ICBT condition no longer met criteria for any anxiety disorder, compared to 47% of children in the GCBT condition. At 3 month follow up these improvements were retained with some weakening. By the 6 month follow up 50% of children in the ICBT compared to 53% of children in the GCBT condition were anxiety diagnosis free. In terms of questionnaire data, no significant differences were detected between the ICBT and GCBT conditions at any of the follow-up points. However, a significant treatment effect for time was found, with both self-reports and parent reports indicating a significant reduction over time in anxiety symptoms. Overall, results suggest that children with anxiety disorders appear to improve following a family-focused cognitive behavioural intervention, regardless of individual or group administration. The interpretation and potential clinical implications of these findings are discussed, together with the limitations of this study and suggestions for future research.

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.

Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial.

PubMed

Kullgren, Jeffrey T; Troxel, Andrea B; Loewenstein, George; Asch, David A; Norton, Laurie A; Wesby, Lisa; Tao, Yuanyuan; Zhu, Jingsan; Volpp, Kevin G

2013-04-02

Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited. To test the effectiveness of 2 financial incentive designs for promoting weight loss among obese employees. Randomized, controlled trial. (ClinicalTrials.gov: NCT01208350) Children's Hospital of Philadelphia. 105 employees with a body mass index between 30 and 40 kg/m2. 24 weeks of monthly weigh-ins (control group; n = 35); individual incentive, designed as $100 per person per month for meeting or exceeding weight-loss goals (n = 35); and group incentive, designed as $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals (n = 35). Weight loss after 24 weeks (primary outcome) and 36 weeks and changes in behavioral mediators of weight loss (secondary outcomes). Group-incentive participants lost more weight than control participants (mean between-group difference, 4.4 kg [95% CI, 2.0 to 6.7 kg]; P < 0.001) and individual-incentive participants (mean between-group difference, 3.2 kg [CI, 0.9 to 5.5 kg]; P = 0.008). Twelve weeks after incentives ended and after adjustment for 3-group comparisons, group-incentive participants maintained greater weight loss than control group participants (mean between-group difference, 2.9 kg [CI, 0.5 to 5.3 kg]; P = 0.016) but not greater than individual-incentive participants (mean between-group difference, 2.7 kg [CI, 0.4 to 5.0 kg]; P = 0.024). Single employer and short follow-up. A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks. National Institute on Aging.

Differential effects of cardiovascular and resistance exercise on functional mobility in individuals with advanced cancer: a randomized trial.

PubMed

Litterini, Amy J; Fieler, Vickie K; Cavanaugh, James T; Lee, Jeannette Q

2013-12-01

To compare the effects of resistance and cardiovascular exercise on functional mobility in individuals with advanced cancer. Prospective, 2-group pretest-posttest pilot study with randomization to either resistance or cardiovascular exercise mode. Comprehensive community cancer center and a hospital-based fitness facility. Volunteer sample of individuals (N=66; 30 men; 36 women; mean age, 62y) with advanced cancer recruited through the cancer center, palliative care service, rehabilitation department, and a local hospice. Ten weeks of individualized resistance or cardiovascular exercise, prescribed and monitored by oncology-trained exercise personnel. Functional mobility was assessed using the Short Physical Performance Battery (SPPB); self-reported pain and fatigue were assessed secondarily using visual analog scales. Data were analyzed using a split plot 2×2 analysis of variance (α=.05). Fifty-two patients (78.8%) completed the study: 23 (67.7%) of 34 patients in the resistance arm and 29 (90.6%) of 32 patients in the cardiovascular arm. No participant withdrew because of study adverse events. Ten-week outcomes (n=52) included a significant increase in SPPB total score (P<.001), increase in gait speed (P=.001), and reduction in fatigue (P=.05). Although cardiovascular exercise participants had a modestly greater improvement in SPPB total score than resistance training participants (F1,49=4.21, P=.045), the difference was not confirmed in a subsequent intention-to-treat analysis (N=66). Individuals with advanced cancer appear to benefit from exercise for improving functional mobility. Neither resistance nor cardiovascular exercise appeared to have a strong differential effect on outcome. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

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.

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

PubMed Central

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

2015-01-01

Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. PMID:25733677

Garlic extract favorably modifies markers of endothelial function in obese patients -randomized double blind placebo-controlled nutritional intervention.

PubMed

Szulińska, Monika; Kręgielska-Narożna, Matylda; Świątek, Joanna; Styś, Paulina; Kuźnar-Kamińska, Barbara; Jakubowski, Hieronim; Walkowiak, Jarosław; Bogdański, Paweł

2018-06-01

Garlic exerts a range of effects relevant to human health. However, its influence on the endothelium in obese individuals remains unknown. We aimed to determine the effects of garlic extract (GE) on arterial stiffness and markers of endothelial function. Ninety-two subjects were enrolled in this study. The participants were randomly assigned to receive 400 mg of GE or placebo daily for 3 months. The arterial stiffness index (SI) and markers of endothelial function such as high-sensitivity C-reactive protein (hsCRP), cholesterol (total, LDL, HDL), triglycerides, and plasminogen activator inhibitor 1 (PAI-1), as well as total antioxidant status (TAS) were quantified at baseline and the end of study. At the end of study SI (p = 0.01), hsCRP (p < 0.001, PAI-1 (p < 0.001), LDL cholesterol (p < 0.001), and TAS (p < 0.01) were reduced in the GE-supplemented group, but not in the placebo group. This randomized, double-blind, placebo-controlled trial demonstrates that supplementation with GE favorably modifies endothelial biomarkers associated with cardiovascular risk and suggests that GE can be used to suppress chronic inflammation in obese individuals. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Phase transitions in the quadratic contact process on complex networks

NASA Astrophysics Data System (ADS)

Varghese, Chris; Durrett, Rick

2013-06-01

The quadratic contact process (QCP) is a natural extension of the well-studied linear contact process where infected (1) individuals infect susceptible (0) neighbors at rate λ and infected individuals recover (10) at rate 1. In the QCP, a combination of two 1's is required to effect a 01 change. We extend the study of the QCP, which so far has been limited to lattices, to complex networks. We define two versions of the QCP: vertex-centered (VQCP) and edge-centered (EQCP) with birth events 1-0-11-1-1 and 1-1-01-1-1, respectively, where “-” represents an edge. We investigate the effects of network topology by considering the QCP on random regular, Erdős-Rényi, and power-law random graphs. We perform mean-field calculations as well as simulations to find the steady-state fraction of occupied vertices as a function of the birth rate. We find that on the random regular and Erdős-Rényi graphs, there is a discontinuous phase transition with a region of bistability, whereas on the heavy-tailed power-law graph, the transition is continuous. The critical birth rate is found to be positive in the former but zero in the latter.

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 multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan

PubMed Central

Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka

2018-01-01

The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p <0.01), working memory (p = 0.02), verbal fluency (p < 0.01), attention (p < 0.01), and composite score (p < 0.01) on the BACS-J; interest/enjoyment (p < 0.01), value/usefulness (p < 0.01), perceived choice (p < 0.01), and IMI-J total (p < 0.01) on the IMI-J; MMAS-8 score (p < 0.01) compared with the GOT alone. Patients in the GOT+IOT demonstrated significant improvements on the CSQ-8J compared with the GOT alone (p < 0.01). The present findings provide support for the feasibility in implementing an IOT program and its effectiveness for improving cognitive impairment and other outcomes in patients with schizophrenia. PMID:29621261

A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan.

PubMed

Shimada, Takeshi; Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka; Kobayashi, Masayoshi

2018-01-01

The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p <0.01), working memory (p = 0.02), verbal fluency (p < 0.01), attention (p < 0.01), and composite score (p < 0.01) on the BACS-J; interest/enjoyment (p < 0.01), value/usefulness (p < 0.01), perceived choice (p < 0.01), and IMI-J total (p < 0.01) on the IMI-J; MMAS-8 score (p < 0.01) compared with the GOT alone. Patients in the GOT+IOT demonstrated significant improvements on the CSQ-8J compared with the GOT alone (p < 0.01). The present findings provide support for the feasibility in implementing an IOT program and its effectiveness for improving cognitive impairment and other outcomes in patients with schizophrenia.

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

Effects of Concurrent Music Listening on Emotional Processing

ERIC Educational Resources Information Center

Graham, Rodger; Robinson, Johanna; Mulhall, Peter

2009-01-01

Increased processing time for threatening stimuli is a reliable finding in emotional Stroop tasks. This is particularly pronounced among individuals with anxiety disorders and reflects heightened attentional bias for perceived threat. In this repeated measures study, 35 healthy participants completed a randomized series of Stroop tasks involving…

Blocking for Sequential Political Experiments

PubMed Central

Moore, Sally A.

2013-01-01

In typical political experiments, researchers randomize a set of households, precincts, or individuals to treatments all at once, and characteristics of all units are known at the time of randomization. However, in many other experiments, subjects “trickle in” to be randomized to treatment conditions, usually via complete randomization. To take advantage of the rich background data that researchers often have (but underutilize) in these experiments, we develop methods that use continuous covariates to assign treatments sequentially. We build on biased coin and minimization procedures for discrete covariates and demonstrate that our methods outperform complete randomization, producing better covariate balance in simulated data. We then describe how we selected and deployed a sequential blocking method in a clinical trial and demonstrate the advantages of our having done so. Further, we show how that method would have performed in two larger sequential political trials. Finally, we compare causal effect estimates from differences in means, augmented inverse propensity weighted estimators, and randomization test inversion. PMID:24143061

Effects of unipedal standing balance exercise on the prevention of falls and hip fracture among clinically defined high-risk elderly individuals: a randomized controlled trial.

PubMed

Sakamoto, Keizo; Nakamura, Toshitaka; Hagino, Hiroshi; Endo, Naoto; Mori, Satoshi; Muto, Yoshiteru; Harada, Atsushi; Nakano, Tetsuo; Itoi, Eiji; Yoshimura, Mitsuo; Norimatsu, Hiromichi; Yamamoto, Hiroshi; Ochi, Takahiro

2006-10-01

The aim of this study was to assess the effectiveness of the unipedal standing balance exercise for 1 min to prevent falls and hip fractures in high-risk elderly individuals with a randomized controlled trial. This control study was designed as a 6-month intervention trial. Subjects included 553 clinically defined high-risk adults who were living in residences or in the community. They were randomized to an exercise group and a control group. Randomization to the subjects was performed by a table of random numbers. A unipedal standing balance exercise with open eyes was performed by standing on each leg for 1 min three times per day. As a rule, subjects of the exercise group stood on one leg without holding onto any support, but unstable subjects were permitted to hold onto a bar during the exercise time. Falls and hip fractures were reported by nurses, physical therapists, or facility staff with a survey sheet every month. This survey sheet was required every month for both groups. Registered subjects were 553 persons ranging in age from 37 to 102 years (average, 81.6 years of age). Twenty-six subjects dropped out. The number of falls and hip fractures for the 6-month period after the trial for 527 of the 553 subjects for whom related data were available were assessed. The exercise group comprised 315 subjects and the control group included 212 subjects. The cumulative number of falls of the exercise group, with 1 multiple faller omitted, was 118, and the control group recorded 121 falls. A significant intergroup difference was observed. However, the cumulative number of hip fractures was only 1 case in both groups. This difference was not statistically significant. The unipedal standing balance exercise is effective to prevent falls but was not shown to be statistically significant in the prevention of hip fracture in this study.

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial.

PubMed

Levenson, Jessica C; Rollman, Bruce L; Ritterband, Lee M; Strollo, Patrick J; Smith, Kenneth J; Yabes, Jonathan G; Moore, Charity G; Harvey, Allison G; Buysse, Daniel J

2017-06-06

Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

Internet-based interventions for disordered gamblers: study protocol for a randomized controlled trial of online self-directed cognitive-behavioural motivational therapy.

PubMed

Hodgins, David C; Fick, Gordon H; Murray, Robert; Cunningham, John A

2013-01-08

Gambling disorders affect about one percent of adults. Effective treatments are available but only a small proportion of affected individuals will choose to attend formal treatment. As a result, self-directed treatments have also been developed and found effective. Self-directed treatments provide individuals with information and support to initiate a recovery program without attending formal treatment. In previous research we developed an telephone-based intervention package that helps people to be motivated to tackle their gambling problem and to use basic behavioral and cognitive change strategies. The present study will investigate the efficacy of this self-directed intervention offered as a free online resource. The Internet is an excellent modality in which to offer self-directed treatment for gambling problems. The Internet is increasingly accessible to members of the public and is frequently used to access health-related information. Online gambling sites are also becoming more popular gambling platforms. A randomized clinical trial (N=180) will be conducted in which individuals with gambling problems who are not interested in attending formal treatment are randomly assigned to have access to an online self-directed intervention or to a comparison condition. The comparison condition will be an alternative website that offers a self-assessment of gambling involvement and gambling-related problems. The participant's use of the resources and their gambling involvement (days of gambling, dollars loss) and their gambling problems will be tracked for a twelve month follow-up period. The results of this research will be important for informing policy-makers who are developing treatment systems. ISRCTN06220098.

Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men: A Preliminary Randomized Trial.

PubMed

Murphy, Christopher M; Eckhardt, Christopher I; Clifford, Judith M; Lamotte, Adam D; Meis, Laura A

2017-04-01

A randomized clinical trial tested the hypothesis that a flexible, case formulation-based, individual treatment approach integrating motivational interviewing strategies with cognitive-behavioral therapy (ICBT) is more efficacious than a standardized group cognitive-behavioral approach (GCBT) for perpetrators of intimate partner violence (IPV). Forty-two men presenting for services at a community domestic violence agency were randomized to receive 20 sessions of ICBT or a 20-week group cognitive-behavioral therapy (CBT) program. Participants and their relationship partners completed assessments of relationship abuse and relationship functioning at baseline and quarterly follow-ups for 1 year. Treatment uptake and session attendance were significantly higher in ICBT than GCBT. However, contrary to the study hypothesis, GCBT produced consistently equivalent or greater benefits than ICBT. Participant self-reports revealed significant reductions in abusive behavior and injuries across conditions with no differential benefits between conditions. Victim partner reports revealed more favorable outcomes for group treatment, including a statistically significant difference in psychological aggression, and differences exceeding a medium effect size for physical assault, emotional abuse, and partner relationship adjustment. In response to hypothetical relationship scenarios, GCBT was associated with greater reductions than ICBT (exceeding a medium effect) in articulated cognitive distortions and aggressive intentions. Treatment competence ratings suggest that flexible, individualized administration of CBT creates challenges in session agenda setting, homework implementation, and formal aspects of relationship skills training. Although caution is needed in generalizing findings from this small-scale trial, the results suggest that the mutual support and positive social influence available in group intervention may be particularly helpful for IPV perpetrators.

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.

The Effects of Vortioxetine on Cognitive Function in Patients with Major Depressive Disorder: A Meta-Analysis of Three Randomized Controlled Trials

PubMed Central

Harrison, J; Loft, H; Jacobson, W; Olsen, CK

2016-01-01

Background: Management of cognitive deficits in Major Depressive Disorder (MDD) remains an important unmet need. This meta-analysis evaluated the effects of vortioxetine on cognition in patients with MDD. Methods: Random effects meta-analysis was applied to three randomized, double-blind, placebo-controlled 8-week trials of vortioxetine (5–20mg/day) in MDD, and separately to two duloxetine-referenced trials. The primary outcome measure was change in Digit Symbol Substitution Test (DSST) score. Standardized effect sizes (SES) versus placebo (Cohen’s d) were used as input. Path analysis was employed to determine the extent to which changes in DSST were mediated independently of a change in Montgomery-Åsberg Depression Rating Scale (MADRS) score. Meta-analysis was applied to MADRS-adjusted and -unadjusted SES values. Changes on additional cognitive tests were evaluated (source studies only). Results: Before adjustment for MADRS, vortioxetine separated from placebo on DSST score (SES 0.25–0.48; nominal p < 0.05) in all individual trials, and statistically improved DSST performance versus placebo in meta-analyses of the three trials (SES = 0.35; p < 0.0001) and two duloxetine-referenced trials (SES = 0.26; p = 0.001). After adjustment for MADRS, vortioxetine maintained DSST improvement in one individual trial (p = 0.001) and separation from placebo was maintained in meta-analyses of all three trials (SES = 0.24; p < 0.0001) and both duloxetine-referenced trials (SES 0.19; p = 0.01). Change in DSST with duloxetine failed to separate from placebo in individual trials and both meta-analyses. Change in DSST statistically favored vortioxetine versus duloxetine after MADRS adjustment (SES = 0.16; p = 0.04). Conclusions: Vortioxetine, but not duloxetine, significantly improved cognition, independent of depressive symptoms. Vortioxetine represents an important treatment for MDD-related cognitive dysfunction. PMID:27312740

The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

PubMed

Focht, Brian C; Lucas, Alexander R; Grainger, Elizabeth; Simpson, Christina; Thomas-Ahner, Jennifer M; Clinton, Steven K

2014-09-09

Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach, and may offset, or even reverse, the adverse effects accompanying ADT. Unfortunately, the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects. Consequently, the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer. A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care. Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity, dietary behavior, body composition, muscular strength, and quality of life. Outcomes will be obtained at baseline, 2-month, and 3-month assessments by trial personnel blinded to participants' randomization assignment. Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT. ClinicalTrials.gov NCT02050906.

Effects of correcting missing daily feed intake values on the genetic parameters and estimated breeding values for feeding traits in pigs.

PubMed

Ito, Tetsuya; Fukawa, Kazuo; Kamikawa, Mai; Nikaidou, Satoshi; Taniguchi, Masaaki; Arakawa, Aisaku; Tanaka, Genki; Mikawa, Satoshi; Furukawa, Tsutomu; Hirose, Kensuke

2018-01-01

Daily feed intake (DFI) is an important consideration for improving feed efficiency, but measurements using electronic feeder systems contain many missing and incorrect values. Therefore, we evaluated three methods for correcting missing DFI data (quadratic, orthogonal polynomial, and locally weighted (Loess) regression equations) and assessed the effects of these missing values on the genetic parameters and the estimated breeding values (EBV) for feeding traits. DFI records were obtained from 1622 Duroc pigs, comprising 902 individuals without missing DFI and 720 individuals with missing DFI. The Loess equation was the most suitable method for correcting the missing DFI values in 5-50% randomly deleted datasets among the three equations. Both variance components and heritability for the average DFI (ADFI) did not change because of the missing DFI proportion and Loess correction. In terms of rank correlation and information criteria, Loess correction improved the accuracy of EBV for ADFI compared to randomly deleted cases. These findings indicate that the Loess equation is useful for correcting missing DFI values for individual pigs and that the correction of missing DFI values could be effective for the estimation of breeding values and genetic improvement using EBV for feeding traits. © 2017 The Authors. Animal Science Journal published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Animal Science.

The effect of individual enabling and support on empowerment and depression severity in persons with affective disorders: outcome of a randomized control trial.

PubMed

Porter, Susann; Bejerholm, Ulrika

2018-05-01

To evaluate the effect of Individual Enabling and Support (IES) on empowerment and depression severity as compared to Traditional Vocational Rehabilitation (TVR) in people with affective disorders at 12 months follow-up. Additionally, longitudinal changes within the intervention groups and the correlation over time between empowerment and depression severity were evaluated. A single-blind randomized controlled trial of two intervention groups, IES (n = 33) and TVR (n = 28), was performed with measurement points at baseline, 6, and 12 months. Individuals with affective disorders, including depression and bipolar disorder diagnoses were included. The Empowerment Scale and Montgomery-Åsberg Depression Self-Rating Scale were administered, and Intention-To-Treat analysis was applied. The study was registered with the trial number ISRCTN93470551. There was a statistically significant difference between the intervention groups on empowerment and depression severity at 12 months. Within-group analysis showed that IES-participants increased their perceived empowerment and decreased their depression severity between measurement points, this was not seen among TVR-participants. A moderate, inverse relationship was detected between empowerment and depression. IES is more effective in increasing empowerment and decreasing depression severity after a 12-month intervention than is TVR. This study was limited by a small sample size and larger trials in different contexts are needed.

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.

Effect of neuromuscular stimulation and individualized rehabilitation on muscle strength in Intensive Care Unit survivors: A randomized trial.

PubMed

Patsaki, Irini; Gerovasili, Vasiliki; Sidiras, Georgios; Karatzanos, Eleftherios; Mitsiou, Georgios; Papadopoulos, Emmanuel; Christakou, Anna; Routsi, Christina; Kotanidou, Anastasia; Nanas, Serafim

2017-08-01

Intensive Care Unit (ICU) survivors experience muscle weakness leading to restrictions in functional ability. Neuromuscular electrical stimulation (NMES) has been an alternative to exercise in critically ill patients. The aim of our study was to investigate its effects along with individualized rehabilitation on muscle strength of ICU survivors. Following ICU discharge, 128 patients (age: 53±16years) were randomly assigned to daily NMES sessions and individualized rehabilitation (NMES group) or to control group. Muscle strength was assessed by the Medical Research Council (MRC) score and hand grip at hospital discharge. Secondary outcomes were functional ability and hospital length of stay. MRC, handgrip, functional status and hospital length of stay did not differ at hospital discharge between groups (p>0.05). ΔMRC% one and two weeks after ICU discharge tended to be higher in NMES group, while it was significant higher in NMES group of patients with ICU-acquired weakness at two weeks (p=0.05). NMES and personalized physiotherapy in ICU survivors did not result in greater improvement of muscle strength and functional status at hospital discharge. However, in patients with ICU-aw NMES may be effective. The potential benefits of rehabilitation strategies should be explored in larger number of patients in future studies. www.Clinicaltrials.gov: NCT01717833. Copyright © 2017. Published by Elsevier Inc.

Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials.

PubMed

Nordmann, Alain J; Nordmann, Abigail; Briel, Matthias; Keller, Ulrich; Yancy, William S; Brehm, Bonnie J; Bucher, Heiner C

2006-02-13

Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, -3.3 kg; 95% confidence interval [CI], -5.3 to -1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, -1.0 kg; 95% CI, -3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, -22.1 mg/dL [-0.25 mmol/L]; 95% CI, -38.1 to -5.3 mg/dL [-0.43 to -0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). Low-carbohydrate, non-energy-restricted diets appear to be at least as effective as low-fat, energy-restricted diets in inducing weight loss for up to 1 year. However, potential favorable changes in triglyceride and high-density lipoprotein cholesterol values should be weighed against potential unfavorable changes in low-density lipoprotein cholesterol values when low-carbohydrate diets to induce weight loss are considered.

Perspectives: Nanofibers and nanowires for disordered photonics

NASA Astrophysics Data System (ADS)

Pisignano, Dario; Persano, Luana; Camposeo, Andrea

2017-03-01

As building blocks of microscopically non-homogeneous materials, semiconductor nanowires and polymer nanofibers are emerging component materials for disordered photonics, with unique properties of light emission and scattering. Effects found in assemblies of nanowires and nanofibers include broadband reflection, significant localization of light, strong and collective multiple scattering, enhanced absorption of incident photons, synergistic effects with plasmonic particles, and random lasing. We highlight recent related discoveries, with a focus on material aspects. The control of spatial correlations in complex assemblies during deposition, the coupling of modes with efficient transmission channels provided by nanofiber waveguides, and the embedment of random architectures into individually coded nanowires will allow the potential of these photonic materials to be fully exploited, unconventional physics to be highlighted, and next-generation optical devices to be achieved. The prospects opened by this technology include enhanced random lasing and mode-locking, multi-directionally guided coupling to sensors and receivers, and low-cost encrypting miniatures for encoders and labels.

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.

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

Randomized controlled expressive writing pilot in individuals with Parkinson's disease and their caregivers.

PubMed

Cash, Therese Verkerke; Lageman, Sarah K

2015-11-30

Individuals with Parkinson's disease (PD) and their caregivers are at risk for emotional distress and hypercortisolism. Expressive writing is an effective complementary intervention to ameliorate the psychological and physiological effects of chronic illness. This pilot study aimed to evaluate feasibility and preliminary effectiveness of an expressive writing intervention for individuals with PD and their caregivers. Individuals with PD (N = 27) and their caregivers (N = 14) were randomly assigned to expressive (N = 15 patients, eight caregivers) or neutral (N = 12 patients, six caregivers) writing conditions. Cortisol awakening response (CAR), non-motor functioning, quality of life, and performance on tests of cognitive functioning were assessed at baseline, immediate post, 4-month, and 10-month post intervention. Attrition was a challenge as eight patients (29.62 %) and four caregivers (28.57 %) chose to discontinue before beginning the intervention or were lost to follow up prior to completing the intervention or the first follow up visit. Significant reduction in anxiety, marginally significant improvement in depression and caregiver burden, and significant improvements in performance on tests of learning and memory were observed, but these changes did not differ by writing condition. CAR significantly differed over time between patients and caregivers and writing conditions. Some evidence for the feasibility and effectiveness of writing to alleviate hypercortisolism was demonstrated in a small sample of PD patients; however, relatively high attrition rates and the lack of difference between expressive and neutral writing conditions on emotional and neurocognitive outcomes suggests expressive writing procedure modifications may be needed to obtain optimal results for this population. ClinicalTrials.gov, NCT02217735 , Study Start Date: August 30, 2011.

A randomized controlled trial of a supported employment program for persons with long-term mental illness in Hong Kong.

PubMed

Kin Wong, Kenny; Chiu, Rose; Tang, Betty; Mak, Donald; Liu, Joanne; Chiu, Siu Ning

2008-01-01

Supported employment is an evidence-based practice that has proved to be consistently more effective than conventional vocational rehabilitation in helping people with severe mental illness find and sustain competitive employment. Most research on the effectiveness of supported employment comes from the United States. This study examined the effectiveness and applicability of a supported employment program based on the individual placement and support model in a Hong Kong setting. Ninety-two unemployed individuals with long-term mental illness who desired competitive employment were randomly assigned to either a supported employment program or a conventional vocational rehabilitation program and followed up for 18 months. Both vocational and nonvocational outcomes were measured. Over the 18-month study period, compared with participants in the conventional vocational rehabilitation program, those in the supported employment group were more likely to work competitively (70% versus 29%; odds ratio=5.63, 95% confidence interval=2.28-13.84), held a greater number of competitive jobs, earned more income, worked more days, and sustained longer job tenures. Repeated-measures analysis of variance found no substantive differences between participants in the two groups and no significant change from baseline over time for psychiatric symptoms and self-perceived quality of life. Consistent with previous research findings in the United States, the supported employment program was more effective than the conventional vocational rehabilitation program in helping individuals with long-term mental illness find and sustain competitive employment in a Hong Kong setting. The supported employment program based on the individual placement and support model can thus be recommended for wider use in local mental health practice.

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.

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.

Neural signature of tDCS, tPCS and their combination: Comparing the effects on neural plasticity

PubMed Central

Thibaut, Aurore; Russo, Cristina; Morales-Quezada, Leon; Hurtado-Puerto, Aura; Deitos, Alícia; Freedman, Steven; Carvalho, Sandra; Fregni, Felipe

2017-01-01

Transcranial pulsed current stimulation (tPCS) and transcranial direct current stimulation (tDCS) are two noninvasive neuromodulatory brain stimulation techniques whose effects on human brain and behavior have been studied individually. In the present study we aimed to quantify the effects of tDCS and tPCS, individually and in combination, on cortical activity, sensitivity and pain-related assessments in healthy individuals in order to understand their neurophysiological mechanisms and potential applications in clinical populations. A total of 48 healthy individuals participated in this randomized double blind sham controlled study. Participants were randomized to receive a single stimulation session of either: active or sham tPCS and active or sham tDCS. Quantitative electroencephalography (qEEG), sensitivity and pain assessments were used before and after each stimulation session. We observed that tPCS had a higher effect on power, as compared to tDCS, in several bandwidths on various cortical regions: the theta band in the parietal region (p = 0.021), the alpha band in the temporal (p = 0.009), parietal (p = 0.0063), and occipital (p < 0.0001) regions. We found that the combination of tPCS and tDCS significantly decreased power in the low beta bandwidth of the frontal (p = 0.0006), central (p = 0.0001), and occipital (p = 0.0003) regions, when compared to sham stimulation. Additionally, tDCS significantly increased power in high beta over the temporal (p = 0.0015) and parietal (p = 0.0007) regions, as compared to sham. We found no effect on sensitivity or pain-related assessments. We concluded that tPCS and tDCS have different neurophysiological mechanisms, elicit distinct signatures, and that the combination of the two leads to no effect or a decrease on qEEG power. Further studies are required to examine the effects of these techniques on clinical populations in which EEG signatures have been found altered. PMID:27765610

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.

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.

Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority Trial.

PubMed

Tanum, Lars; Solli, Kristin Klemmetsby; Latif, Zill-E-Huma; Benth, Jurate Šaltyte; Opheim, Arild; Sharma-Haase, Kamni; Krajci, Peter; Kunøe, Nikolaj

2017-12-01

To date, extended-release naltrexone hydrochloride has not previously been compared directly with opioid medication treatment (OMT), currently the most commonly prescribed treatment for opioid dependence. To determine whether treatment with extended-release naltrexone will be as effective as daily buprenorphine hydrochloride with naloxone hydrochloride in maintaining abstinence from heroin and other illicit substances in newly detoxified individuals. A 12-week, multicenter, outpatient, open-label randomized clinical trial was conducted at 5 urban addiction clinics in Norway between November 1, 2012, and December 23, 2015; the last follow-up was performed on October 23, 2015. A total of 232 adult opioid-dependent (per DSM-IV criteria) individuals were recruited from outpatient addiction clinics and detoxification units and assessed for eligibility. Intention-to-treat analyses of efficacy end points were performed with all randomized participants. Randomization to either daily oral flexible dose buprenorphine-naloxone, 4 to 24 mg/d, or extended-release naltrexone hydrochloride, 380 mg, administered intramuscularly every fourth week for 12 weeks. Primary end points (protocol) were the randomized clinical trial completion rate, the proportion of opioid-negative urine drug tests, and number of days of use of heroin and other illicit opioids. Secondary end points included number of days of use of other illicit substances. Safety was assessed by adverse event reporting. Of 159 participants, mean (SD) age was 36 (8.6) years and 44 (27.7%) were women. Eighty individuals were randomized to extended-release naltrexone and 79 to buprenorphine-naloxone; 105 (66.0%) completed the trial. Retention in the extended-release naltrexone group was noninferior to the buprenorphine-naloxone group (difference, -0.1; with 95% CI, -0.2 to 0.1; P = .04), with mean (SD) time of 69.3 (25.9) and 63.7 (29.9) days, correspondingly (P = .33, log-rank test). Treatment with extended-release naltrexone showed noninferiority to buprenorphine-naloxone on group proportion of total number of opioid-negative urine drug tests (mean [SD], 0.9 [0.3] and 0.8 [0.4], respectively, difference, 0.1 with 95% CI, -0.04 to 0.2; P < .001) and use of heroin (mean difference, -3.2 with 95% CI, -4.9 to -1.5; P < .001) and other illicit opioids (mean difference, -2.7 with 95% CI, -4.6 to -0.9; P < .001). Superiority analysis showed significantly lower use of heroin and other illicit opioids in the extended-release naltrexone group. No significant differences were found between the treatment groups regarding most other illicit substance use. Extended-release naltrexone was as effective as buprenorphine-naloxone in maintaining short-term abstinence from heroin and other illicit substances and should be considered as a treatment option for opioid-dependent individuals. clinicaltrials.gov Identifier: NCT01717963.

The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial.

PubMed

Weatherwax, Ryan M; Harris, Nigel K; Kilding, Andrew E; Dalleck, Lance C

2016-12-19

There is individual variability to cardiorespiratory fitness (CRF) training, but the underlying cause is not well understood. Traditionally, a standardized approach to exercise prescription has utilized relative percentages of maximal heart rate, heart rate reserve (HRR), maximal oxygen uptake (VO 2 max), or VO 2 reserve to establish exercise intensity. However, this model fails to take into consideration individual metabolic responses to exercise and may attribute to the variability in training responses. It has been proposed that an individualized approach would take into consideration metabolic responses to exercises to increase responsiveness to training. In this randomized control trial, participants will undergo a 12-week exercise intervention using individualized (ventilatory thresholds) and standardized (HRR) methods to prescribe CRF training intensity. Following the intervention, participants will be categorized as responders or non-responders based on changes in maximal aerobic abilities. Participants who are non-responders will complete a second 12-week intervention in a crossover design to determine whether they can become responders with a differing exercise prescription. There are four main research outcomes: (1) determine the cohort-specific technical error to use in the categorization of response rate; (2) determine if an individualized intensity prescription is superior to a standard approach in regards to VO 2 max and cardiometabolic risk factors; (3) investigate the time course changes throughout 12 weeks of CRF training between the two intervention groups; and (4) determine if non-responders can become responders if the exercise prescription is modified. The findings from this research will provide evidence on the effectiveness of individualized exercise prescription related to training responsiveness of VO 2 max and cardiometabolic risk factors compared to a standardized approach and further our understanding of individual exercise responses. If the individualized approach proposed is deemed effective, it may change the way exercise specialists prescribe exercise intensity to enhance training responsiveness. ClinicalTrials.gov, NCT02868710 . Registered on 15 August 2016.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.

PubMed

Saper, Robert B; Sherman, Karen J; Delitto, Anthony; Herman, Patricia M; Stevans, Joel; Paris, Ruth; Keosaian, Julia E; Cerrada, Christian J; Lemaster, Chelsey M; Faulkner, Carol; Breuer, Maya; Weinberg, Janice

2014-02-26

Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting ≥ 12 weeks and a self-reported average pain intensity of ≥ 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927.

Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. Methods/Design This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18–64 years old with non-specific low back pain lasting ≥12 weeks and a self-reported average pain intensity of ≥4 on a 0–10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. Trial registration This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927. PMID:24568299

Individual eigenvalue distributions of crossover chiral random matrices and low-energy constants of SU(2) × U(1) lattice gauge theory

NASA Astrophysics Data System (ADS)

Yamamoto, Takuya; Nishigaki, Shinsuke M.

2018-02-01

We compute individual distributions of low-lying eigenvalues of a chiral random matrix ensemble interpolating symplectic and unitary symmetry classes by the Nyström-type method of evaluating the Fredholm Pfaffian and resolvents of the quaternion kernel. The one-parameter family of these distributions is shown to fit excellently the Dirac spectra of SU(2) lattice gauge theory with a constant U(1) background or dynamically fluctuating U(1) gauge field, which weakly breaks the pseudoreality of the unperturbed SU(2) Dirac operator. The observed linear dependence of the crossover parameter with the strength of the U(1) perturbations leads to precise determination of the pseudo-scalar decay constant, as well as the chiral condensate in the effective chiral Lagrangian of the AI class.

Experimental Effects and Individual Differences in Linear Mixed Models: Estimating the Relationship between Spatial, Object, and Attraction Effects in Visual Attention

PubMed Central

Kliegl, Reinhold; Wei, Ping; Dambacher, Michael; Yan, Ming; Zhou, Xiaolin

2011-01-01

Linear mixed models (LMMs) provide a still underused methodological perspective on combining experimental and individual-differences research. Here we illustrate this approach with two-rectangle cueing in visual attention (Egly et al., 1994). We replicated previous experimental cue-validity effects relating to a spatial shift of attention within an object (spatial effect), to attention switch between objects (object effect), and to the attraction of attention toward the display centroid (attraction effect), also taking into account the design-inherent imbalance of valid and other trials. We simultaneously estimated variance/covariance components of subject-related random effects for these spatial, object, and attraction effects in addition to their mean reaction times (RTs). The spatial effect showed a strong positive correlation with mean RT and a strong negative correlation with the attraction effect. The analysis of individual differences suggests that slow subjects engage attention more strongly at the cued location than fast subjects. We compare this joint LMM analysis of experimental effects and associated subject-related variances and correlations with two frequently used alternative statistical procedures. PMID:21833292

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

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks. The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective. Current Controlled Trials ISRCTN42856343. Date registered: 21.03.2013.

Food processing and structure impact the metabolizable energy of almonds

USDA-ARS?s Scientific Manuscript database

The measured metabolizable energy (ME) of whole almonds has been shown to be less than predicted by Atwater factors. However, data are lacking on the effects of processing (roasting, chopping or grinding) on the ME of almonds. A 5-period randomized, crossover study in healthy individuals (n=18) was ...

Improving the Short-Term Affect of Grieving Children through Art

ERIC Educational Resources Information Center

Hill, Kaylin E.; Lineweaver, Tara T.

2016-01-01

We evaluated changes in positive and negative affect of grieving children in response to art making compared to another noncreative, non-expressive, but engaging visuospatial task and assessed whether art making was equally or differentially effective in individual versus collaborative settings. We randomly assigned grieving children to one of…

Focus of Attention and Putting Performance.

ERIC Educational Resources Information Center

Boutcher, Stephen H.; Crews, Debra J.

The effect of a preshot attentional/behavioral routine on putting performance was investigated. Subjects were randomly assigned to four groups: (1) Male Routine (MR); (2) Female Routine (FR); (3) Male Control (MC); and (4) Female Control (FC). Subjects in the FR and MR groups were given individualized putting routines which focused on specific…

Randomization Based Privacy Preserving Categorical Data Analysis

ERIC Educational Resources Information Center

Guo, Ling

2010-01-01

The success of data mining relies on the availability of high quality data. To ensure quality data mining, effective information sharing between organizations becomes a vital requirement in today's society. Since data mining often involves sensitive information of individuals, the public has expressed a deep concern about their privacy.…

Effects of microbial inoculum composition on rumen microbial ecology of dairy calves

USDA-ARS?s Scientific Manuscript database

The objective of this study was to determine if microbial inoculum composition affects dairy calf rumen microbial ecology. Holstein bull calves (n=20) were removed from their dam at birth and individually housed in calf hutches with sand bedding. Responses were studied using a randomized complete bl...

Adult Age Differences in Knowledge-Driven Reading

ERIC Educational Resources Information Center

Miller, Lisa M. Soederberg; Stine-Morrow, Elizabeth A. L.; Kirkorian, Heather L.; Conroy, Michelle L.

2004-01-01

The authors investigated the effects of domain knowledge on online reading among younger and older adults. Individuals were randomly assigned to either a domain-relevant (i.e., high-knowledge) or domain-irrelevant (i.e., low-knowledge) training condition. Two days later, participants read target passages on a computer that drew on information…

Moderators of the Intervention Effects for a Dissonance-Based Eating Disorder Prevention Program; Results from an Amalgam of Three Randomized Trials

PubMed Central

Müller, Sina; Stice, Eric

2013-01-01

Objective To investigate factors hypothesized to moderate the effects of a dissonance-based eating disorder prevention program, including initial elevations in thin-ideal internalization, body dissatisfaction, eating disorder symptoms, and older participant age. Method Adolescent female high school and college students with body image concerns (N = 977; M age = 18.6) were randomized to a dissonance-based thin-ideal internalization reduction program or an assessment-only control condition in three prevention trials. Results The intervention produced (a) significantly stronger reductions in thin-ideal internalization for participants with initial elevations in thin-ideal internalization and a threshold/subthreshold DSM-5 eating disorder at baseline, (b) significantly greater reductions in eating disorder symptoms for participants with versus without a DSM-5 eating disorder at baseline, and (c) significantly stronger reductions in body dissatisfaction for late adolescence/young adulthood versus mid-adolescent participants. Baseline body dissatisfaction did not moderate the intervention effects. Conclusion Overall, intervention effects tended to be amplified for individuals with initial elevations in risk factors and a DSM-5 eating disorder at baseline. Results suggest that this prevention program is effective for a broad range of individuals, but is somewhat more beneficial for the subgroups identified in the moderation analyses. PMID:23337181

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.

The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial.

PubMed

Conboy, Lisa; Gerke, Travis; Hsu, Kai-Yin; St John, Meredith; Goldstein, Marc; Schnyer, Rosa

2016-01-01

Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists. This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52) or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52). Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P) and the secondary outcome is the McGill Pain scale. Of the 104 subjects who underwent randomization, 85 completed the protocol (82%). A clinically and statistically significant average improvement of 9.4 points (p = 0.03) in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04) compared to group 2. Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. ClinicalTrials.gov NCT01305811.

Synchronization in Random Pulse Oscillator Networks

NASA Astrophysics Data System (ADS)

Brown, Kevin; Hermundstad, Ann

Motivated by synchronization phenomena in neural systems, we study synchronization of random networks of coupled pulse oscillators. We begin by considering binomial random networks whose nodes have intrinsic linear dynamics. We quantify order in the network spiking dynamics using a new measure: the normalized Lev-Zimpel complexity (LZC) of the nodes' spike trains. Starting from a globally-synchronized state, we see two broad classes of behaviors. In one (''temporally random''), the LZC is high and nodes spike independently with no coherent pattern. In another (''temporally regular''), the network does not globally synchronize but instead forms coherent, repeating population firing patterns with low LZC. No topological feature of the network reliably predicts whether an individual network will show temporally random or regular behavior; however, we find evidence that degree heterogeneity in binomial networks has a strong effect on the resulting state. To confirm these findings, we generate random networks with independently-adjustable degree mean and variance. We find that the likelihood of temporally-random behavior increases as degree variance increases. Our results indicate the subtle and complex relationship between network structure and dynamics.

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

Comparing Web, Group and Telehealth Formats of a Military Parenting Program

DTIC Science & Technology

2017-06-01

directed approaches. Comparative effectiveness will be tested by specifying a non - equivalence hypothesis for group -based and web-facilitated relative...Comparative effectiveness will be tested by specifying a non - equivalence hypothesis fro group based and individualized facilitated relative to self-directed...documents for review and approval. 1a. Finalize human subjects protocol and consent documents for pilot group (N=5 families), and randomized controlled

The Relative Effectiveness of the Use of Static and Dynamic Mechanical Models in Teaching Elementary School Children the Theoretical Concept--The Particle Nature of Matter.

ERIC Educational Resources Information Center

Ziegler, Robert Edward

This study is concerned with determining the relative effectiveness of a static and dynamic theoretical model in teaching elementary school students to use the particle idea of matter when explaining certain physical phenomena. A clinical method of personal individual interview-testing, teaching, and retesting of a random sample population from…

United We Stand? The Effects of a Couple-Coping Intervention on Adjustment to Early Stage Breast or Gynecological Cancer

ERIC Educational Resources Information Center

Scott, Jennifer L.; Halford, W. Kim; Ward, Bruce G.

2004-01-01

Cancer diagnosis affects the psychological well-being of both patients and their partners, and effective coping has been suggested to be a conjoint process of mutual support. Ninety-four married women with early stage cancer and their partners were randomly assigned to couples-based coping training (CanCOPE), individual coping training for the…

Comparative Evaluation of the Efficacy of Probiotic, Herbal and Chlorhexidine Mouthwash on Gingival Health: A Randomized Clinical Trial

PubMed Central

Dodamani, Arun Suresh; Karibasappa, Gundabaktha; Khairnar, Mahesh Ravindra; Naik, Rahul Gaybarao; Jadhav, Harish Chaitram

2017-01-01

Introduction Due to inherent limitations of Chlorhexidine (CHX), search for an effective and potentially safe anti-plaque agent has led to emergence of alternative products. Aim The present study evaluated the comparative efficacy of probiotic, herbal and CHX mouthwashes on gingival health of healthy individuals. Materials and Methods The present study was randomized parallel group controlled trial. A group of 45 healthy subjects in the age group of 18-21 years received complete supragingival scaling at baseline and study variables viz., Oral Hygiene Index – Simplified (OHI-S), Plaque Index (PI) and Gingival Index (GI) were recorded. Subjects were then randomly divided into three groups (15 in each group) and were randomly intervened with three different mouthwashes i.e., HiOra mouthwash, CHX mouthwash and Probiotic mouthwash. Variables were again recorded on the seventh and 14th day after use of mouthwashes and data obtained was subjected to statistical analysis. Results There was no significant difference in the efficacy of CHX, HiOra regular and probiotic mouthwashes on plaque accumulation, gingival health and oral hygiene status. Conclusion Herbal and probiotic mouthwashes can prove to be effective alternatives to CHX with minimal side effects. PMID:28511500

Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists.

PubMed

Rutten, Juliette M T M; Vlieger, Arine M; Frankenhuis, Carla; George, Elvira K; Groeneweg, Michael; Norbruis, Obbe F; Tjon a Ten, Walther; Van Wering, Herbert; Dijkgraaf, Marcel G W; Merkus, Maruschka P; Benninga, Marc A

2014-06-04

Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months.The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. Dutch Trial Register number NTR2725 (date of registration: 1 February 2011).

Gut-directed hypnotherapy in children with irritable bowel syndrome or functional abdominal pain (syndrome): a randomized controlled trial on self exercises at home using CD versus individual therapy by qualified therapists

PubMed Central

2014-01-01

Background Irritable bowel syndrome (IBS) and functional abdominal pain (syndrome) (FAP(S)) are common pediatric disorders, characterized by chronic or recurrent abdominal pain. Treatment is challenging, especially in children with persisting symptoms. Gut-directed hypnotherapy (HT) performed by a therapist has been shown to be effective in these children, but is still unavailable to many children due to costs, a lack of qualified child-hypnotherapists and because it requires a significant investment of time by child and parent(s). Home-based hypnotherapy by means of exercises on CD has been shown effective as well, and has potential benefits, such as lower costs and less time investment. The aim of this randomized controlled trial (RCT) is to compare cost-effectiveness of individual HT performed by a qualified therapist with HT by means of CD recorded self-exercises at home in children with IBS or FAP(S). Methods/Design 260 children, aged 8-18 years with IBS or FAP(S) according to Rome III criteria are included in this currently conducted RCT with a follow-up period of one year. Children are randomized to either 6 sessions of individual HT given by a qualified therapist over a 3-month period or HT through self-exercises at home with CD for 3 months. The primary outcome is the proportion of patients in which treatment is successful at the end of treatment and after one year follow-up. Treatment success is defined as at least 50% reduction in both abdominal pain frequency and intensity scores. Secondary outcomes include adequate relief, cost-effectiveness and effects of both therapies on depression and anxiety scores, somatization scores, QoL, pain beliefs and coping strategies. Discussion If the effectiveness of home-based HT with CD is comparable to, or only slightly lower, than HT by a therapist, this treatment may become an attractive form of therapy in children with IBS or FAP(S), because of its low costs and direct availability. Trial registration Dutch Trial Register number NTR2725 (date of registration: 1 February 2011) PMID:24894077

Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial.

PubMed

Espí-López, G V; Rodríguez-Blanco, C; Oliva-Pascual-Vaca, A; Benítez-Martínez, J C; Lluch, E; Falla, D

2014-12-01

Tension-type headache (TTH) is the most common type of primary headache however there is no clear evidence as to which specific treatment is most effective or whether combined treatment is more effective than individual treatments. To assess the effectiveness of manual therapy techniques, applied to the suboccipital region, on aspects of disability in a sample of patients with tension-type headache. Randomized Controlled Trial. Specialized centre for headache treatment. Seventy-six (62 women) patients (age: 39.9 ± 10.9 years) with episodic chronic TTH. Patients were randomly divided into four treatment groups: 1) suboccipital soft tissue inhibition; 2) occiput-atlas-axis manipulation; 3) combined treatment of both techniques; 4) control. Four sessions were applied over 4 weeks and disability was assessed before and after treatment using the Headache Disability Inventory (HDI). Headache frequency, severity and the functional and emotional subscales of the questionnaire were assessed. Photophobia, phonophobia and pericranial tenderness were also monitored. Headache frequency was significantly reduced with the manipulative and combined treatment (P<0.05), and the severity and functional subscale of the HDI changed in all three treatment groups (P<0.05). Manipulation treatment also reduced the score on the emotional subscale of the HDI (P<0.05). The combined intervention showed a greater effect at reducing the overall HDI score compared to the group that received suboccipital soft tissue inhibition and to the control group (both P<0.05). In addition, photophobia, phonophobia and pericranial tenderness only improved in the group receiving combined therapy (P<0.05). When given individually, suboccipital soft tissue inhibition and occiput-atlas-axis manipulation resulted in changes in different parameters related to the disability caused by TTH. However, when the two treatments were combined, effectiveness was noted for all aspects of disability and other symptoms including photophobia, phonophobia and pericranial tenderness. Although individual manual therapy treatments showed a positive change in headache features, measures of photophobia, photophobia and pericranial tenderness only improved in the group that received the combined treatment suggesting that combined treatment is the most appropriate for symptomatic relief of TTH.

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

PubMed

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

2015-06-01

Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1.15-4.53]) and CDS + coaching arm (adjusted odds ratio, 2.60 [95% CI, 1.25-5.41]) and higher use of HEDIS codes for nutrition or physical activity counseling (CDS arm, 45%; CDS + coaching arm, 25%; P < .001 compared with usual care arm). An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families resulted in improved childhood BMI. Both interventions improved the quality of care for childhood obesity. clinicaltrials.gov Identifier: NCT01537510.

Glucocorticoid-induced hyperglycaemia in respiratory disease: a systematic review and meta-analysis.

PubMed

Breakey, S; Sharp, S J; Adler, A I; Challis, B G

2016-12-01

The relative risk of glucocorticoid-induced hyperglycaemia is poorly quantified. We undertook a meta-analysis to estimate the association between glucocorticoid treatment and hyperglycaemia, overall and separately in individuals with and without diabetes and underlying respiratory disease. We searched electronic databases for clinical trials of adults randomized to either glucocorticoid treatment or placebo. Eight articles comprising 2121 participants were identified. We performed a random effects meta-analysis to determine relative risks for the associations between glucocorticoid use and both hyperglycaemia and starting hypoglycaemic therapy. In all individuals, the relative risk of hyperglycaemia comparing glucocorticoid treatment with placebo was 1.72 [95% confidence interval (CI) 1.50-2.04; p < .001]. The relative risks in individuals with and those without diabetes were 2.10 (95% CI 0.92-5.02; p = .079) and 1.50 (95% CI 0.79-2.86; p = .22), respectively. In all individuals, the relative risk of hyperglycaemia requiring initiation of hypoglycaemic therapy, comparing glucocorticoid treatment with placebo, was 1.73 (95% CI 1.40-2.14; p < .001). In conclusion, glucocorticoid therapy increases the risk of hyperglycaemia in all individuals with underlying respiratory disease but not when diabetic status is analysed separately. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

The effect of two types of memory training on subjective and objective memory performance in healthy individuals aged 55 years and older: a randomized controlled trial.

PubMed

Valentijn, Susanne A M; van Hooren, Susan A H; Bosma, Hans; Touw, Dory M; Jolles, Jelle; van Boxtel, Martin P J; Ponds, Rudolf W H M

2005-04-01

The objective of the study was to examine the effectiveness of two types of memory training (collective and individual), compared to control (waiting list), on memory performance. Participants were 139 community-dwelling older individuals recruited through media advertisements asking for people with subjective memory complaints to participate in a study. Data were collected at baseline, and at 1 week and 4 months after the intervention. Training efficacy was assessed using measures of subjective and objective memory performance. After the intervention, participants in the collective training group reported more stability in memory functioning and had fewer feelings of anxiety and stress about memory functioning. In addition, positive effects were found on objective memory functioning. Compared with the other two groups, the collective training group participants had an improved recall of a previously learned word list. Compared to controls, participants in the individual training group reported fewer feelings of anxiety and stress in relation to memory functioning.

Multivitamin/multimineral supplements for cancer prevention: implications for primary care practice.

PubMed

Hardy, Mary L; Duvall, Karen

2015-01-01

There is a popular belief that multivitamin and mineral (MVM) supplements can help prevent cancer and other chronic diseases. Studies evaluating the effects of MVM supplements on cancer risk have largely been observational, with considerable methodologic limitations, and with conflicting results. We review evidence from the few available randomized, controlled trials that assessed the effects of supplements containing individual vitamins, a combination of a few select vitamins, or complete MVM supplements, with a focus on the recent Physicians' Health Study II (PHS II). PHS II is a landmark trial that followed generally healthy middle-aged and older men (mean age 64 years) who were randomized to daily MVM supplementation for a mean duration of 11 years. Men taking MVMs experienced a statistically significant 8% reduction in incidence of total cancer (hazard ratio [HR]: 0.92; 95% confidence interval [CI]: 0.86-0.998; p = 0.04). Men with a history of cancer derived an even greater benefit: cancer incidence was 27% lower with MVM supplementation versus placebo in this subgroup (HR: 0.73; 95% CI: 0.56-0.96; p = 0.02). Positive results of PHS II contrast with randomized studies of individual vitamins or small combinations of vitamins, which have largely shown a neutral effect, and in some cases, an adverse effect, on cancer risk. The results of PHS II may have a considerable public health impact, potentially translating to prevention of approximately 68 000 cancers per year if all men were to use similar supplements, and to an even greater benefit with regard to secondary prevention of cancer.

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

PubMed

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

2015-01-01

To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Linear mixed model for heritability estimation that explicitly addresses environmental variation.

PubMed

Heckerman, David; Gurdasani, Deepti; Kadie, Carl; Pomilla, Cristina; Carstensen, Tommy; Martin, Hilary; Ekoru, Kenneth; Nsubuga, Rebecca N; Ssenyomo, Gerald; Kamali, Anatoli; Kaleebu, Pontiano; Widmer, Christian; Sandhu, Manjinder S

2016-07-05

The linear mixed model (LMM) is now routinely used to estimate heritability. Unfortunately, as we demonstrate, LMM estimates of heritability can be inflated when using a standard model. To help reduce this inflation, we used a more general LMM with two random effects-one based on genomic variants and one based on easily measured spatial location as a proxy for environmental effects. We investigated this approach with simulated data and with data from a Uganda cohort of 4,778 individuals for 34 phenotypes including anthropometric indices, blood factors, glycemic control, blood pressure, lipid tests, and liver function tests. For the genomic random effect, we used identity-by-descent estimates from accurately phased genome-wide data. For the environmental random effect, we constructed a covariance matrix based on a Gaussian radial basis function. Across the simulated and Ugandan data, narrow-sense heritability estimates were lower using the more general model. Thus, our approach addresses, in part, the issue of "missing heritability" in the sense that much of the heritability previously thought to be missing was fictional. Software is available at https://github.com/MicrosoftGenomics/FaST-LMM.

Cost-Effectiveness Analysis of a Navigation Program for Colorectal Cancer Screening to Reduce Social Health Inequalities: A French Cluster Randomized Controlled Trial.

PubMed

De Mil, Rémy; Guillaume, Elodie; Guittet, Lydia; Dejardin, Olivier; Bouvier, Véronique; Pornet, Carole; Christophe, Véronique; Notari, Annick; Delattre-Massy, Hélène; De Seze, Chantal; Peng, Jérôme; Launoy, Guy; Berchi, Célia

2018-06-01

Patient navigation programs to increase colorectal cancer (CRC) screening adherence have become widespread in recent years, especially among deprived populations. To evaluate the cost-effectiveness of the first patient navigation program in France. A total of 16,250 participants were randomized to either the usual screening group (n = 8145) or the navigation group (n = 8105). Navigation consisted of personalized support provided by social workers. A cost-effectiveness analysis of navigation versus usual screening was conducted from the payer perspective in the Picardy region of northern France. We considered nonmedical direct costs in the analysis. Navigation was associated with a significant increase of 3.3% (24.4% vs. 21.1%; P = 0.003) in participation. The increase in participation was higher among affluent participants (+4.1%; P = 0.01) than among deprived ones (+2.6%; P = 0.07). The cost per additional individual screened by navigation compared with usual screening (incremental cost-effectiveness ratio) was €1212 globally and €1527 among deprived participants. Results were sensitive to navigator wages and to the intervention effectiveness whose variations had the greatest impact on the incremental cost-effectiveness ratio. Patient navigation aiming at increasing CRC screening participation is more efficient among affluent individuals. Nevertheless, when the intervention is implemented for the entire population, social inequalities in CRC screening adherence increase. To reduce social inequalities, patient navigation should therefore be restricted to deprived populations, despite not being the most cost-effective strategy, and accepted to bear a higher extra cost per additional individual screened. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: a pragmatic randomized controlled trial.

PubMed

Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

2013-01-01

Restorative home care services are short-term and aimed at maximizing a person's ability to live independently. They are multidimensional and often include an exercise program to improve strength, mobility, and balance. The aim of this study was to determine whether a lifestyle exercise program would be undertaken more often and result in greater functional gains than the current structured exercise program delivered as part of a restorative home care service for older adults. A pragmatic randomized controlled trial was conducted in an organization with an established restorative home care service. Individuals who were to have an exercise program as part of their service were randomized to receive either a lifestyle and functional exercise program called LiFE (as this was a new program, the intervention) or the structured exercise program currently being used in the service (control). Exercise data collected by the individuals throughout and pre and post intervention testing was used to measure balance, strength, mobility, falls efficacy, vitality, function, and disability. There was no difference between the groups in the amounts of exercise undertaken during the 8-week intervention period. Outcome measurement indicated that the LiFE program was as effective, and on 40% of the measures, more effective, than the structured exercise program. Organizations delivering restorative home care services that include an exercise component should consider whether LiFE rather than the exercise program they are currently using could help their clients achieve better outcomes.

Cognitive-behaviour therapy for post-traumatic stress in schizophrenia. A randomized controlled trial.

PubMed

Steel, C; Hardy, A; Smith, B; Wykes, T; Rose, S; Enright, S; Hardcastle, M; Landau, S; Baksh, M F; Gottlieb, J D; Rose, D; Mueser, K T

2017-01-01

There is limited evidence for effective interventions in the treatment of post-traumatic stress symptoms within individuals diagnosed with schizophrenia. Clinicians have concerns about using exposure treatments with this patient group. The current trial was designed to evaluate a 16-session cognitive restructuring programme, without direct exposure, for the treatment of post-traumatic stress symptoms specifically within individuals diagnosed with schizophrenia. A multicentre randomized controlled single-blinded trial with assessments at 0 months, 6 months (post-treatment) and 12 months (follow-up) was conducted. A total of 61 participants diagnosed with schizophrenia and exhibiting post-traumatic stress symptoms were recruited. Those randomized to treatment were offered up to 16 sessions of cognitive-behaviour therapy (CBT, including psychoeducation, breathing training and cognitive restructuring) over a 6-month period, with the control group offered routine clinical services. The main outcome was blind rating of post-traumatic stress symptoms using the Clinician Administered PTSD Scale for Schizophrenia. Secondary outcomes were psychotic symptoms as measured by the Positive and Negative Symptom Scale and the Psychotic Symptom Rating Scale. Both the treatment and control groups experienced a significant decrease in post-traumatic stress symptoms over time but there was no effect of the addition of CBT on either the primary or secondary outcomes. The current trial did not demonstrate any effect in favour of CBT. Cognitive restructuring programmes may require further adaptation to promote emotional processing of traumatic memories within people diagnosed with a psychotic disorder.

Moderators of smoking cessation outcomes in a randomized-controlled trial of varenicline versus placebo.

PubMed

Littlewood, Rae A; Claus, Eric D; Wilcox, Claire E; Mickey, Jessica; Arenella, Pamela B; Bryan, Angela D; Hutchison, Kent E

2017-12-01

Varenicline has gained a reputation as the optimal intervention for treatment resistant smokers, yet more than half of those who try it do not succeed. To better understand individual differences in the effectiveness of varenicline, this study evaluates the effectiveness of varenicline for smoking cessation in a double-blind, placebo-controlled, randomized clinical trial and examines the influence of psychological factors on treatment outcome. Two hundred five cigarette smokers interested in quitting were randomly assigned to 12 weeks of varenicline or placebo. Outcomes examined were CO-confirmed continuous abstinence for the past month, average number of cigarettes smoked per day, and 7-day point prevalence. Varenicline-treated participants were more likely than placebo to achieve continuous abstinence at the end of treatment (OR = 3.29; RR = 2.62), and 7-day point prevalence rates showed an effect of medication at each time point. Participants in both groups significantly reduced their smoking during the course of treatment and follow-up, and the medication by visit interaction was significant in the expected direction. Impulsivity and personality style emerged as moderators of the relationship between medication condition and treatment outcome. In addition to replicating efficacy results for varenicline versus placebo, the present study shows that the efficacy of pharmacotherapy is influenced by psychological factors. In an era where pharmacotherapy is often perceived as the "silver bullet," we are reminded that smoking cessation is a dynamic process and intervention must be adaptable to address individual differences.

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

Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial.

PubMed

Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H

2016-04-01

To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Randomized controlled pilot trial of a novel dissonance-based group treatment for eating disorders.

PubMed

Stice, Eric; Rohde, Paul; Butryn, Meghan; Menke, Katharine S; Marti, C Nathan

2015-02-01

The authors conducted a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Young women with a DSM-5 eating disorder (N = 72) were randomized to an 8-week dissonance-based Counter Attitudinal Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ(2)[6] = 34.1, p < .001), producing large effects for thin-ideal internalization (d = .79), body dissatisfaction (d = 1.14), and blinded interview-assessed eating disorder symptoms (d = .95), and medium effects for dissonance regarding perpetuating the thin ideal (d = .65) and negative affect (d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

Individual patient meta-analysis of exercise training effects on systemic brain natriuretic peptide expression in heart failure.

PubMed

Smart, N A; Meyer, T; Butterfield, J A; Faddy, S C; Passino, C; Malfatto, G; Jonsdottir, S; Sarullo, F; Wisloff, U; Vigorito, C; Giallauria, F

2012-06-01

Brain natriuretic peptide (BNP) predicts exercise performance and exercise training may modulate BNP and its N-terminal portion (NT-pro-BNP), we therefore conducted an individual patient analysis of exercise training effects on BNP and NT-pro-BNP. To use an individual patient meta-analysis to relate changes in BNP, NT-pro-BNP, and peak VO(2); to link these changes to volume parameters of exercise training programmes (intensity etc.); and to identify patient characteristics likely to lead to greater improvements in BNP, NT-pro-BNP, and peak VO(2). Individual patient meta-analysis. A systematic search was conducted of Medline (Ovid), Embase.com, Cochrane Central Register of Controlled Trials, and CINAHL (until July 2008) to identify randomized controlled trials of aerobic and/or resistance exercise training in systolic heart failure patients measuring BNP and/or NT-pro-BNP. Primary outcome measures were change in BNP, NT-pro-BNP, and peak VO2. Subanalyses were conducted to identify (1) patient groups that benefit most and (2) exercise programme parameters enhancing favourable changes in primary outcome measures. Ten randomized controlled studies measuring BNP or NT-pro-BNP met eligibility criteria, authors provided individual patient data for 565 patients (313 exercise and 252 controls). Exercise training had favourable effects on BNP (-28.3%, p < 0.0001), NT-pro-BNP (-37.4%, p = < 0.0001), and peak VO(2) (17.8%, p < 0.0001). The analysis showed a significant change in primary outcome measures; moreover, change in BNP (r = -0.31, p < 0.0001) and NT-pro-BNP (r = -0.22, p < 0.0001) were correlated with peak VO(2) change. Exercise training has favourable effects on BNP, NT-pro-BNP, and peak VO(2) in heart failure patients and BNP/NT-pro-BNP changes were correlated with peak VO(2) changes.

Evolutionary Ensemble for In Silico Prediction of Ames Test Mutagenicity

NASA Astrophysics Data System (ADS)

Chen, Huanhuan; Yao, Xin

Driven by new regulations and animal welfare, the need to develop in silico models has increased recently as alternative approaches to safety assessment of chemicals without animal testing. This paper describes a novel machine learning ensemble approach to building an in silico model for the prediction of the Ames test mutagenicity, one of a battery of the most commonly used experimental in vitro and in vivo genotoxicity tests for safety evaluation of chemicals. Evolutionary random neural ensemble with negative correlation learning (ERNE) [1] was developed based on neural networks and evolutionary algorithms. ERNE combines the method of bootstrap sampling on training data with the method of random subspace feature selection to ensure diversity in creating individuals within an initial ensemble. Furthermore, while evolving individuals within the ensemble, it makes use of the negative correlation learning, enabling individual NNs to be trained as accurate as possible while still manage to maintain them as diverse as possible. Therefore, the resulting individuals in the final ensemble are capable of cooperating collectively to achieve better generalization of prediction. The empirical experiment suggest that ERNE is an effective ensemble approach for predicting the Ames test mutagenicity of chemicals.

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.

The health policy implications of individual adaptive behavior responses to smog pollution in urban China.

PubMed

Ban, Jie; Zhou, Lian; Zhang, Yi; Brooke Anderson, G; Li, Tiantian

2017-09-01

Smog pollution is a serious public health issue in urban China, where it is associated with public health through a range of respiratory and cardiovascular illnesses. Despite the negative health impacts of smog pollution, individual adaptive behaviors are poorly understood. This knowledge gap hinders the development of effective public policy to support and encourage the adoption of individual adaptive and mitigating behaviors to smog pollution. A questionnaire survey of 1141 randomly sampled individuals in a typical PM 2.5 -polluted Chinese city was designed to establish smog concerns and behavior changes during smog events. The results demonstrate a variety of behavior responses associated with risk perception, experience of smog, age, and gender of respondents. An understanding of these variations is critical to the development of effective public policy and ultimately to the improvement of public health in cities affected by smog. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

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.

Effect of signal jitter on the spectrum of rotor impulsive noise

NASA Technical Reports Server (NTRS)

Brooks, Thomas F.

1987-01-01

The effect of randomness or jitter of the acoustic waveform on the spectrum of rotor impulsive noise is studied because of its importance for data interpretation. An acoustic waveform train is modelled representing rotor impulsive noise. The amplitude, shape, and period between occurrences of individual pulses are allowed to be randomized assuming normal probability distributions. Results, in terms of the standard deviations of the variable quantities, are given for the autospectrum as well as special processed spectra designed to separate harmonic and broadband rotor noise components. Consideration is given to the effect of accuracy in triggering or keying to a rotor one per revolution signal. An example is given showing the resultant spectral smearing at the high frequencies due to the pulse signal period variability.

Effect of signal jitter on the spectrum of rotor impulsive noise

NASA Technical Reports Server (NTRS)

Brooks, Thomas F.

1988-01-01

The effect of randomness or jitter of the acoustic waveform on the spectrum of rotor impulsive noise is studied because of its importance for data interpretation. An acoustic waveform train is modeled representing rotor impulsive noise. The amplitude, shape, and period between occurrences of individual pulses are allowed to be randomized assuming normal probability distributions. Results, in terms of the standard deviations of the variable quantities, are given for the autospectrum as well as special processed spectra designed to separate harmonic and broadband rotor noise components. Consideration is given to the effect of accuracy in triggering or keying to a rotor one per revolution signal. An example is given showing the resultant spectral smearing at the high frequencies due to the pulse signal period variability.

Social patterns revealed through random matrix theory

NASA Astrophysics Data System (ADS)

Sarkar, Camellia; Jalan, Sarika

2014-11-01

Despite the tremendous advancements in the field of network theory, very few studies have taken weights in the interactions into consideration that emerge naturally in all real-world systems. Using random matrix analysis of a weighted social network, we demonstrate the profound impact of weights in interactions on emerging structural properties. The analysis reveals that randomness existing in particular time frame affects the decisions of individuals rendering them more freedom of choice in situations of financial security. While the structural organization of networks remains the same throughout all datasets, random matrix theory provides insight into the interaction pattern of individuals of the society in situations of crisis. It has also been contemplated that individual accountability in terms of weighted interactions remains as a key to success unless segregation of tasks comes into play.

Impact of an Educational Program to Reduce Healthcare Resources in Community-Acquired Pneumonia: The EDUCAP Randomized Controlled Trial

PubMed Central

Simonetti, Antonella; Jiménez-Martínez, Emilio; Molero, Lorena; González-Samartino, Maribel; Castillo, Elena; Juvé-Udina, María-Eulalia; Alcocer, María-Jesús; Hernández, Carme; Buera, María-Pilar; Roel, Asunción; Abad, Emilia; Zabalegui, Adelaida; Ricart, Pilar; Gonzalez, Anna; Isla, Pilar; Dorca, Jordi; Garcia-Vidal, Carolina

2015-01-01

Background Additional healthcare visits and rehospitalizations after discharge are frequent among patients with community-acquired pneumonia (CAP) and have a major impact on healthcare costs. We aimed to determine whether the implementation of an individualized educational program for hospitalized patients with CAP would decrease subsequent healthcare visits and readmissions within 30 days of hospital discharge. Methods A multicenter, randomized trial was conducted from January 1, 2011 to October 31, 2014 at three hospitals in Spain. We randomly allocated immunocompetent adults patients hospitalized for CAP to receive either an individualized educational program or conventional information before discharge. The educational program included recommendations regarding fluid intake, adherence to drug therapy and preventive vaccines, knowledge and management of the disease, progressive adaptive physical activity, and counseling for alcohol and smoking cessation. The primary trial endpoint was a composite of the frequency of additional healthcare visits and rehospitalizations within 30 days of hospital discharge. Intention-to-treat analysis was performed. Results We assigned 102 patients to receive the individualized educational program and 105 to receive conventional information. The frequency of the composite primary end point was 23.5% following the individualized program and 42.9% following the conventional information (difference, -19.4%; 95% confidence interval, -6.5% to -31.2%; P = 0.003). Conclusions The implementation of an individualized educational program for hospitalized patients with CAP was effective in reducing subsequent healthcare visits and rehospitalizations within 30 days of discharge. Such a strategy may help optimize available healthcare resources and identify post-acute care needs in patients with CAP. Trial Registration Controlled-Trials.com ISRCTN39531840 PMID:26460907

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.

Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial.

PubMed

Davenport, Todd E; Kulig, Kornelia; Fisher, Beth E

2010-10-19

Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. http://www.clinicaltrials.gov identifier NCT00888498.

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

A manual-based individual therapy to improve metacognition in schizophrenia: protocol of a multi-center RCT

PubMed Central

2014-01-01

Background Metacognitive dysfunction has been widely recognized as a feature of schizophrenia. As it is linked with deficits in several aspects of daily life functioning, improvement of metacognition may lead to improvement in functioning. Individual psychotherapy might be a useful form of treatment to improve metacognition in patients with schizophrenia; multiple case reports and a pilot study show promising results. The present study aims to measure the effectiveness of an individual, manual-based therapy (Metacognitive Reflection and Insight Therapy, MERIT) in improving metacognition in patients with schizophrenia. We also want to examine if improvement in metacognitive abilities is correlated with improvements in aspects of daily life functioning namely social functioning, experience of symptoms, quality of life, depression, work readiness, insight and experience of stigma. Methods/Design MERIT is currently evaluated in a multicenter randomized controlled trial. Thirteen therapists in six mental health institutions in the Netherlands participate in this study. Patients are randomly assigned to either MERIT or the control condition: treatment as usual (TAU). Discussion If proven effective, MERIT can be a useful addition to the care for schizophrenia patients. The design brings along some methodological difficulties, these issues are addressed in the discussion of this paper. Trial registration Current Controlled Trials: ISRCTN16659871. PMID:24490942

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.

Improving executive function deficits by playing interactive video-games: secondary analysis of a randomized controlled trial for individuals with chronic stroke.

PubMed

Rozental-Iluz, Clara; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

2016-08-01

Executive function deficits negatively impact independence and participation in everyday life of individuals with chronic stroke. Therefore, it is important to explore therapeutic interventions to improve executive functions. The aim of this study was to determine the effectiveness of a 3-month interactive video-game group intervention compared to a traditional motor group intervention for improving executive functions in individuals with chronic stroke. This study is a secondary analysis of a single-blind randomized controlled trial for improving factors related to physical activity of individuals with chronic stroke. Assessments were administered pre and post the intervention and at 3-month follow-up by assessors blind to treatment allocation. Thirty-nine individuals with chronic stroke with executive function deficits participated in an interactive video-game group intervention (N.=20) or a traditional group intervention (N.=19). The intervention included two 1-hour group sessions per week for three months, either playing video-games or performing traditional exercises/activities. Executive function deficits were assessed using The Trail Making Test (Parts A and B) and by two performance-based assessments; the Bill Paying Task from the Executive Function Performance Test (EFPT) and the Executive Function Route-Finding Task (EFRT). Following intervention, scores for the Bill Paying Task (EFPT) decreased by 27.5% and 36.6% for the participants in the video-game and traditional intervention, respectively (F=17.3, P<0.000) and continued to decrease in the video-game group with small effect sizes. Effect size was small to medium for the TMT-B (F=0.003, P=0.954) and EFRT (F=1.2, P=0.28), without any statistical significance difference. Interactive video-games provide combined cognitive-motor stimulation and therefore have potential to improve executive functioning of individuals with chronic stroke. Further research is needed. These findings highlight the potential of utilizing interactive video-games in a small group for keeping these individuals active, while maintaining and improving executive functioning especially for individuals with chronic stroke, who have completed their formal rehabilitation.

10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... for one or more random tests after any applicable requirement for pre-access testing in §§ 26.65 or 26... individual for any pre-access testing that may be required under §§ 26.65 or 26.69, and thereafter, the... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

Code of Federal Regulations, 2014 CFR

2014-01-01

... for one or more random tests after any applicable requirement for pre-access testing in § 26.65 or... individual for any pre-access testing that may be required under § 26.65 or § 26.69, and thereafter, the... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

Code of Federal Regulations, 2012 CFR

2012-01-01

... for one or more random tests after any applicable requirement for pre-access testing in §§ 26.65 or 26... individual for any pre-access testing that may be required under §§ 26.65 or 26.69, and thereafter, the... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

10 CFR 26.67 - Random drug and alcohol testing of individuals who have applied for authorization.

Code of Federal Regulations, 2013 CFR

2013-01-01

... for one or more random tests after any applicable requirement for pre-access testing in §§ 26.65 or 26... individual for any pre-access testing that may be required under §§ 26.65 or 26.69, and thereafter, the... other entity relies on drug and alcohol tests that were conducted before the individual applied for...

Individual Optimal Frequency in Whole-Body Vibration: Effect of Protocol, Joint Angle, and Fatiguing Exercise.

PubMed

Carlucci, Flaminia; Felici, Francesco; Piccinini, Alberto; Haxhi, Jonida; Sacchetti, Massimo

2016-12-01

Carlucci, F, Felici, F, Piccinini, A, Haxhi, J, and Sacchetti, M. Individual optimal frequency in whole-body vibration: effect of protocol, joint angle, and fatiguing exercise. J Strength Cond Res 30(12): 3503-3511, 2016-Recent studies have shown the importance of individualizing the vibration intervention to produce greater effects on the neuromuscular system in less time. The purpose of this study was to assess the individual optimal vibration frequency (OVF) corresponding to the highest muscle activation (RMSmax) during vibration at different frequencies, comparing different protocols. Twenty-nine university students underwent 3 continuous (C) and 2 random (R) different vibrating protocols, maintaining a squat position on a vibration platform. The C protocol lasted 50 seconds and involved the succession of ascending frequencies from 20 to 55 Hz, every 5 seconds. The same protocol was performed twice, having the knee angle at 120° (C) and 90° (C90), to assess the effect of joint angle and after a fatiguing squatting exercise (CF) to evaluate the influence of fatigue on OVF assessment. In the random protocols, vibration time was 20 seconds with a 2-minute (R2) and a 4-minute (R4) pauses between tested frequencies. Muscle activation and OVF values did not differ significantly in the C, R2, and R4 protocols. RMSmax was higher in C90 (p < 0.001) and in CF (p = 0.04) compared with the C protocol. Joint angle and fatiguing exercise had no effect on OVF. In conclusion, the shorter C protocol produced similar myoelectrical activity in the R2 and the R4 protocols, and therefore, it could be equally valid in identifying the OVF with considerable time efficiency. Knee joint angle and fatiguing exercise had an effect on surface electromyography response during vibration but did not affect OVF identification significantly.

Spreading Effect of tDCS in Individuals with Attention-Deficit/Hyperactivity Disorder as Shown by Functional Cortical Networks: A Randomized, Double-Blind, Sham-Controlled Trial.

PubMed

Cosmo, Camila; Ferreira, Cândida; Miranda, José Garcia Vivas; do Rosário, Raphael Silva; Baptista, Abrahão Fontes; Montoya, Pedro; de Sena, Eduardo Pondé

2015-01-01

Transcranial direct current stimulation (tDCS) is known to modulate spontaneous neural network excitability. The cognitive improvement observed in previous trials raises the potential of this technique as a possible therapeutic tool for use in attention-deficit/hyperactivity disorder (ADHD) population. However, to explore the potential of this technique as a treatment approach, the functional parameters of brain connectivity and the extent of its effects need to be more fully investigated. The aim of this study was to investigate a functional cortical network (FCN) model based on electroencephalographic activity for studying the dynamic patterns of brain connectivity modulated by tDCS and the distribution of its effects in individuals with ADHD. Sixty ADHD patients participated in a parallel, randomized, double-blind, sham-controlled trial. Individuals underwent a single session of sham or anodal tDCS at 1 mA of current intensity over the left dorsolateral prefrontal cortex for 20 min. The acute effects of stimulation on brain connectivity were assessed using the FCN model based on electroencephalography activity. Comparing the weighted node degree within groups prior to and following the intervention, a statistically significant difference was found in the electrodes located on the target and correlated areas in the active group (p < 0.05), while no statistically significant results were found in the sham group (p ≥ 0.05; paired-sample Wilcoxon signed-rank test). Anodal tDCS increased functional brain connectivity in individuals with ADHD compared to data recorded in the baseline resting state. In addition, although some studies have suggested that the effects of tDCS are selective, the present findings show that its modulatory activity spreads. Further studies need to be performed to investigate the dynamic patterns and physiological mechanisms underlying the modulatory effects of tDCS. ClinicalTrials.gov NCT01968512.

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

PubMed

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

2017-04-01

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

The effect of D-cycloserine on subliminal cue exposure in spider fearful individuals.

PubMed

Gutner, Cassidy A; Weinberger, Joel; Hofmann, Stefan G

2012-01-01

Research on D-cycloserine (DCS) has demonstrated a significant effect on symptom reduction in human studies that utilized conventional exposure-based approaches. Recent studies have offered promising results for targeting fears through subliminal paradigms. In this double-blind, randomized placebo-controlled study, 45 spider fearful individuals received DCS or placebo pills prior to completing a subliminal cue exposure task to images of spiders. Participants completed self-report questionnaires and a behavioral approach task to a live caged tarantula. After repeated exposure to subliminal spider cues, participants in the DCS group reported a greater reduction in disgust than individuals in the placebo group. No difference was observed in fear ratings. These findings suggest that DCS augments the reduction in disgust in spider fearful subjects after subliminal exposure to spider cues.

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.

The effective propagation constants of SH wave in composites reinforced by dispersive parallel nanofibers

NASA Astrophysics Data System (ADS)

Qiang, FangWei; Wei, PeiJun; Li, Li

2012-07-01

In the present paper, the effective propagation constants of elastic SH waves in composites with randomly distributed parallel cylindrical nanofibers are studied. The surface stress effects are considered based on the surface elasticity theory and non-classical interfacial conditions between the nanofiber and the host are derived. The scattering waves from individual nanofibers embedded in an infinite elastic host are obtained by the plane wave expansion method. The scattering waves from all fibers are summed up to obtain the multiple scattering waves. The interactions among random dispersive nanofibers are taken into account by the effective field approximation. The effective propagation constants are obtained by the configurational average of the multiple scattering waves. The effective speed and attenuation of the averaged wave and the associated dynamical effective shear modulus of composites are numerically calculated. Based on the numerical results, the size effects of the nanofibers on the effective propagation constants and the effective modulus are discussed.

Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury: a 16-week randomized controlled trial.

PubMed

Bakkum, A J T; de Groot, S; Stolwijk-Swüste, J M; van Kuppevelt, D J; van der Woude, L H V; Janssen, T W J

2015-05-01

This is an open randomized controlled trial. The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI). The study was conducted in two rehabilitation centers with a specialized SCI unit. Twenty individuals (SCI⩾8 years) were randomly assigned to a hybrid cycle (voluntary arm exercise combined with functional electrical stimulation (FES)-induced leg exercise) or a handcycle group. During 16 weeks, both groups trained twice a week for 30 min at 65-75% heart rate reserve. Outcome measures obtained before, during and after the program were fitness (peak power output, peak oxygen consumption), submaximal VO2 and heart rate (HR), resting HR, wheelchair skill performance time score) and physical activity (distance travelled in wheelchair and Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) score). Changes were examined using a two-factor mixed-measures analysis of variance. For all fitness parameters, except for submaximal VO2, no interaction effects were found. The hybrid cycle group showed a decrease in VO2 over time in contrast to the handcycle group (P=0.045). An overall reduction in HRrest (5±2 b.p.m.; P=0.03) and overall increase in PASIPD score (6.5±2.1; P=0.002) were found after 16 weeks of training. No overall training effects were found for the other fitness and activity outcome measures. In the current study, hybrid cycling and handcycling showed similar effects on fitness and physical activity, indicating that there seem to be no additional benefits of the FES-induced leg exercise over handcycle training alone.

Effects of web-based stress and depression literacy intervention on improving work engagement among workers with low work engagement: An analysis of secondary outcome of a randomized controlled trial

PubMed Central

Imamura, Kotaro; Kawakami, Norito; Tsuno, Kanami; Tsuchiya, Masao; Shimada, Kyoko; Namba, Katsuyuki; Shimazu, Akihito

2016-01-01

Objective: The purpose of this randomized, controlled trial was to examine the effects of a psychoeducational information website on improving work engagement among individual workers with low work engagement, where work engagement was measured as a secondary outcome. Methods: Participants were recruited from registered members of a web survey site in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Immediately after the baseline survey, the intervention group was invited to study a psychoeducational website called the "UTSMed," which provided general mental health literacy and cognitive behavioral skills. Work engagement was assessed by using the Utrecht Work Engagement Scale at baseline, 1-, and 4-month follow-ups for both intervention and control groups. An exploratory analysis was conducted for a subgroup with low (lower than the median scores) work engagement scores at baseline. Results: A total of 1,236 workers completed the baseline survey. In the low work engagement subgroup, a total of 313 and 300 participants were allocated to an intervention and control group, respectively. In the high work engagement subgroup, 305 and 318 participants were allocated to an intervention and control group, respectively. The program showed a significant effect on work engagement (t = 1.98, P = 0.048) at the 4-month follow-up in the low work engagement subgroup, with a small effect size (d = 0.17). Conclusion: A web-based psychoeducation resource of mental health literacy and cognitive behavioral skills may be effective for improving work engagement among individual workers with low work engagement. PMID:27885247

Randomized controlled pilot study to compare Homeopathy and Conventional therapy in Acute Otitis Media.

PubMed

Sinha, M N; Siddiqui, V A; Nayak, C; Singh, Vikram; Dixit, Rupali; Dewan, Deepti; Mishra, Alok

2012-01-01

To compare the effectiveness of Homeopathy and Conventional therapy in Acute Otitis Media (AOM). A randomized placebo-controlled parallel group pilot study of homeopathic vs conventional treatment for AOM was conducted in Jaipur, India. Patients were randomized by a computer generated random number list to receive either individualized homeopathic medicines in fifty millesimal (LM) potencies, or conventional treatment including analgesics, antipyretics and anti-inflammatory drugs. Patients who did not improve were prescribed antibiotics at the 3rd day. Outcomes were assessed by the Acute Otitis Media-Severity of Symptoms (AOM-SOS) Scale and Tympanic Membrane Examination over 21 days. 81 patients were included, 80 completed follow-up: 41 for conventional and 40 for homeopathic treatment. In the Conventional group, all 40 (100%) patients were cured, in the Homeopathy group, 38 (95%) patients were cured while 02 (5%) patients were lost to the last two follow-up. By the 3rd day of treatment, 4 patients were cured in Homeopathy group but in Conventional group only one patient was cured. In the Conventional group antibiotics were prescribed in 39 (97.5%), no antibiotics were required in the Homeopathy group. 85% of patients were prescribed six homeopathic medicines. Individualized homeopathy is an effective conventional treatment in AOM, there were no significant differences between groups in the main outcome. Symptomatic improvement was quicker in the Homeopathy group, and there was a large difference in antibiotic requirements, favouring homeopathy. Further work on a larger scale should be conducted. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Work-focused cognitive behavioral intervention for psychological complaints in patients on sick leave due to work-related stress: Results from a randomized controlled trial.

PubMed

Dalgaard, Vita Ligaya; Andersen, Lars Peter Sønderbo; Andersen, Johan Hviid; Willert, Morten Vejs; Carstensen, Ole; Glasscock, David John

2017-08-22

Work-related stress is a global problem with negative implications for individuals and society. The purpose of the current study was to evaluate a stress management intervention for patients on sick leave due to work-related stress complaints using a three-armed randomized controlled design. Participants were patients referred from three municipalities to the regional Department of Occupational Medicine. Inclusion criteria were: 1) sick leave due to work-related stress complaints, 2) a diagnosis of adjustment disorder or reactions to severe stress (ICD 10 code: F43,2 - F 43,9 not PTSD) or mild depressive episode (F 32.0). Through a double randomization procedure patients (n = 163) were randomized to either an intervention group (n = 58), a 'control group A' receiving a clinical examination (n = 56), or 'control group B' (n = 49) receiving no offers at the department. The intervention comprised six sessions of individual cognitive behavioral therapy and the offer of a small workplace intervention. Questionnaire data were analyzed with multivariate repeated measurements analysis. Primary outcomes assessed were perceived stress and general mental health. Secondary outcomes were sleep quality and cognitive failures. Follow-up was at four and 10 months after baseline. Complaints were significantly reduced in all groups over time. No group effects were observed between the intervention group and control group A that was clinically assessed. Significant group effects were found for perceived stress and memory when comparing the intervention group to group B, but most likely not due to an intervention effect. Psychological complaints improved substantially over time in all groups, but there was no significant treatment effect on any outcomes when the intervention group was compared to control group A that received a clinical assessment. ISRCTN ISRCTN91404229. Registered 03 August 2012 (retrospectively registered).