Photodynamic Therapy for Actinic Keratoses: A Randomized Prospective Non-sponsored Cost-effectiveness Study of Daylight-mediated Treatment Compared with Light-emitting Diode Treatment.

PubMed

Neittaanmäki-Perttu, Noora; Grönroos, Mari; Karppinen, Toni; Snellman, Erna; Rissanen, Pekka

2016-02-01

Daylight-mediated photodynamic therapy (DL-PDT) is considered as effective as conventional PDT using artificial light (light-emitting diode (LED)-PDT) for treatment of actinic keratoses (AK). This randomized prospective non-sponsored study assessed the cost-effectiveness of DL-PDT compared with LED-PDT. Seventy patients with 210 AKs were randomized to DL-PDT or LED-PDT groups. Effectiveness was assessed at 6 months. The costs included societal costs and private costs, including the time patients spent in treatment. Results are presented as incremental cost-effectiveness ratio (ICER). The total costs per patient were significantly lower for DL-PDT (€132) compared with LED-PDT (€170), giving a cost saving of €38 (p = 0.022). The estimated probabilities for patients' complete response were 0.429 for DL-PDT and 0.686 for LED-PDT; a difference in probability of being healed of 0.257. ICER showed a monetary gain of €147 per unit of effectiveness lost. DL-PDT is less costly and less effective than LED-PDT. In terms of cost-effectiveness analysis, DL-PDT provides lower value for money compared with LED-PDT.

Contextual interference effect on perceptual-cognitive skills training.

PubMed

Broadbent, David P; Causer, Joe; Ford, Paul R; Williams, A Mark

2015-06-01

Contextual interference (CI) effect predicts that a random order of practice for multiple skills is superior for learning compared to a blocked order. We report a novel attempt to examine the CI effect during acquisition and transfer of anticipatory judgments from simulation training to an applied sport situation. Participants were required to anticipate tennis shots under either a random practice schedule or a blocked practice schedule. Response accuracy was recorded for both groups in pretest, during acquisition, and on a 7-d retention test. Transfer of learning was assessed through a field-based tennis protocol that attempted to assess performance in an applied sport setting. The random practice group had significantly higher response accuracy scores on the 7-d laboratory retention test compared to the blocked group. Moreover, during the transfer of anticipatory judgments to an applied sport situation, the decision times of the random practice group were significantly lower compared to the blocked group. The CI effect extends to the training of anticipatory judgments through simulation techniques. Furthermore, we demonstrate for the first time that the CI effect increases transfer of learning from simulation training to an applied sport task, highlighting the importance of using appropriate practice schedules during simulation training.

The Effects of Attrition on Baseline Comparability in Randomized Experiments in Education: A Meta-Analysis

ERIC Educational Resources Information Center

Valentine, Jeffrey C.; McHugh, Cathleen M.

2007-01-01

Using meta-analysis, randomized experiments in education that either clearly did or clearly did not experience student attrition were examined for the baseline comparability of groups. Results from 35 studies suggested that after attrition, the observed measures of baseline comparability of groups did not differ more than would be expected given…

Neither fixed nor random: weighted least squares meta-analysis.

PubMed

Stanley, T D; Doucouliagos, Hristos

2015-06-15

This study challenges two core conventional meta-analysis methods: fixed effect and random effects. We show how and explain why an unrestricted weighted least squares estimator is superior to conventional random-effects meta-analysis when there is publication (or small-sample) bias and better than a fixed-effect weighted average if there is heterogeneity. Statistical theory and simulations of effect sizes, log odds ratios and regression coefficients demonstrate that this unrestricted weighted least squares estimator provides satisfactory estimates and confidence intervals that are comparable to random effects when there is no publication (or small-sample) bias and identical to fixed-effect meta-analysis when there is no heterogeneity. When there is publication selection bias, the unrestricted weighted least squares approach dominates random effects; when there is excess heterogeneity, it is clearly superior to fixed-effect meta-analysis. In practical applications, an unrestricted weighted least squares weighted average will often provide superior estimates to both conventional fixed and random effects. Copyright © 2015 John Wiley & Sons, Ltd.

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.

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

A self-help book is better than sleep hygiene advice for insomnia: a randomized controlled comparative study.

PubMed

Bjorvatn, Bjørn; Fiske, Eldbjørg; Pallesen, Ståle

2011-12-01

The objective was to compare the effects of two types of written material for insomnia in a randomized trial with follow-up after three months. Insomniacs were recruited through newspaper advertisements to a web-based survey with validated questionnaires about sleep, anxiety, depression, and use of sleep medications. A self-help book focusing on cognitive behavioral therapy for insomnia was compared to standard sleep hygiene advice; 77 and 78 participants were randomized to self-help book or sleep hygiene advice, respectively. The response rate was 81.9%. The self-help book gave significantly better scores on the sleep questionnaires compared to sleep hygiene advice. The proportion using sleep medications was reduced in the self-help book group, whereas it was increased in the sleep hygiene group. Compared to pre-treatment, the self-help book improved scores on the sleep (effect sizes 0.61-0.62) and depression (effect size 0.18) scales, whereas the sleep hygiene advice improved scores on some sleep scales (effect sizes 0.24-0.28), but worsened another (effect size -0.36). In addition, sleep hygiene advice increased the number of days per week where they took sleep medications (effect size -0.50). To conclude, in this randomized controlled trial, the self-help book improved sleep and reduced the proportion using sleep medications compared to sleep hygiene advice. The self-help book is an efficient low-threshold intervention, which is cheap and easily available for patients suffering from insomnia. Sleep hygiene advice also improved sleep at follow-up, but increased sleep medication use. Thus, caution is warranted when sleep hygiene advice are given as a single treatment. © 2011 The Authors. Scandinavian Journal of Psychology © 2011 The Scandinavian Psychological Associations.

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.

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

PubMed

Flory, James; Karlawish, Jason

2012-12-01

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

Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence?

PubMed Central

Kehlet, Henrik; Aasvang, Eske Kvanner

2015-01-01

Regional anesthesia for knee and hip arthroplasty may have favorable outcome effects compared with general anesthesia by effectively blocking afferent input, providing initial postoperative analgesia, reducing endocrine metabolic responses, and providing sympathetic blockade with reduced bleeding and less risk of thromboembolic complications but with undesirable effects on lower limb motor and urinary bladder function. Old randomized studies supported the use of regional anesthesia with fewer postoperative pulmonary and thromboembolic complications, and this has been supported by recent large non-randomized epidemiological database cohort studies. In contrast, the data from newer randomized trials are conflicting, and recent studies using modern general anesthetic techniques may potentially support the use of general versus spinal anesthesia. In summary, the lack of properly designed large randomized controlled trials comparing modern general anesthesia and spinal anesthesia for knee and hip arthroplasty prevents final recommendations and calls for prospective detailed studies in this clinically important field. PMID:26918127

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

PubMed

Hernán, Miguel A; Robins, James M

2016-04-15

Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. © The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

PubMed

Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

2017-02-01

Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow-up at 12 months was <2%. The 12-month method continuation probabilities were 63.3% (95% confidence interval, 58.9-67.3) (preference short-acting reversible contraception), 53.0% (95% confidence interval, 45.7-59.8) (randomized short-acting reversible contraception), and 77.8% (95% confidence interval, 71.0-83.2) (randomized long-acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12-month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1-8.7) (preference short-acting reversible contraception), 7.7% (95% confidence interval, 3.3-12.1) (randomized short-acting reversible contraception), and 0.7% (95% confidence interval, 0.0-4.7) (randomized long-acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short-acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short-acting reversible contraception randomized group and short-acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy-eight percent of randomized long-acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short-acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). Even in a typical population of women who presented to initiate or continue short-acting reversible contraception, long-acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long-acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short-acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short-acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual-care preference group. Benefits of increased voluntary uptake of long-acting reversible contraception may extend to wider populations than previously thought. Copyright © 2016 Elsevier Inc. All rights reserved.

The solid fat content of stearic acid-rich fats determines their postprandial effects.

PubMed

Berry, Sarah E E; Miller, George J; Sanders, Thomas A B

2007-06-01

The process of randomization is used commercially to harden fats as an alternative to partial hydrogenation, but its effects on cardiovascular disease risk factors are uncertain. The objective was to compare the chronic and acute effects of randomization of a fat rich in 1,3-distearyl, 2-oleyl glycerol on fasting and postprandial lipids, glucose, insulin, and activated clotting factor VII (FVIIa) concentrations. A crossover design study in 16 men compared fasting and postprandial lipid, glucose, insulin, and FVIIa concentrations at baseline and after a 3-wk diet providing 30 g unrandomized or randomized shea butter and sunflower oil blends (SSOBs), both of which contained approximately 50% stearic acid. Fecal fat excretion was measured during each dietary period. Postprandial changes were assessed after the consumption of meals providing 50 g test fat. A subsequent study compared postprandial changes after the consumption of an oleic acid-rich sunflower oil meal and an unrandomized SSOB meal. Both SSOBs were well digested and absorbed. Randomization did not affect fasting or postprandial lipid, glucose, insulin, or FVIIa concentrations. Compared with the oleic acid-rich meal, the unrandomized SSOB resulted in 53% lower postprandial lipemia, 23% higher hepatic lipase activity, and a 25% lower postprandial increase in FVIIa concentration. The solid fat contents at 37 degrees C were 22%, 41%, and 0% with the unrandomized SSOB, randomized SSOB, and oleic acid-rich meals, respectively. Stearic acid-rich triacylglycerol in both unrandomized and randomized forms does not adversely affect lipid risk factors for cardiovascular disease. The high proportion of solid fat at 37 degrees C may explain the decreased postprandial lipemic response.

A Gompertzian model with random effects to cervical cancer growth

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

Mazlan, Mazma Syahidatul Ayuni; Rosli, Norhayati

2015-05-15

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

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

ERIC Educational Resources Information Center

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

2012-01-01

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

Diagnostics of Robust Growth Curve Modeling Using Student's "t" Distribution

ERIC Educational Resources Information Center

Tong, Xin; Zhang, Zhiyong

2012-01-01

Growth curve models with different types of distributions of random effects and of intraindividual measurement errors for robust analysis are compared. After demonstrating the influence of distribution specification on parameter estimation, 3 methods for diagnosing the distributions for both random effects and intraindividual measurement errors…

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.

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

PubMed Central

2011-01-01

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

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

ERIC Educational Resources Information Center

Hoelzle, Braden R.

2012-01-01

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

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

ERIC Educational Resources Information Center

Kjøbli, John; Bjørnebekk, Gunnar

2013-01-01

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

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

ERIC Educational Resources Information Center

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

2014-01-01

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

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

PubMed Central

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

2016-01-01

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

Random regression analyses using B-splines functions to model growth from birth to adult age in Canchim cattle.

PubMed

Baldi, F; Alencar, M M; Albuquerque, L G

2010-12-01

The objective of this work was to estimate covariance functions using random regression models on B-splines functions of animal age, for weights from birth to adult age in Canchim cattle. Data comprised 49,011 records on 2435 females. The model of analysis included fixed effects of contemporary groups, age of dam as quadratic covariable and the population mean trend taken into account by a cubic regression on orthogonal polynomials of animal age. Residual variances were modelled through a step function with four classes. The direct and maternal additive genetic effects, and animal and maternal permanent environmental effects were included as random effects in the model. A total of seventeen analyses, considering linear, quadratic and cubic B-splines functions and up to seven knots, were carried out. B-spline functions of the same order were considered for all random effects. Random regression models on B-splines functions were compared to a random regression model on Legendre polynomials and with a multitrait model. Results from different models of analyses were compared using the REML form of the Akaike Information criterion and Schwarz' Bayesian Information criterion. In addition, the variance components and genetic parameters estimated for each random regression model were also used as criteria to choose the most adequate model to describe the covariance structure of the data. A model fitting quadratic B-splines, with four knots or three segments for direct additive genetic effect and animal permanent environmental effect and two knots for maternal additive genetic effect and maternal permanent environmental effect, was the most adequate to describe the covariance structure of the data. Random regression models using B-spline functions as base functions fitted the data better than Legendre polynomials, especially at mature ages, but higher number of parameters need to be estimated with B-splines functions. © 2010 Blackwell Verlag GmbH.

A Bayesian ridge regression analysis of congestion's impact on urban expressway safety.

PubMed

Shi, Qi; Abdel-Aty, Mohamed; Lee, Jaeyoung

2016-03-01

With the rapid growth of traffic in urban areas, concerns about congestion and traffic safety have been heightened. This study leveraged both Automatic Vehicle Identification (AVI) system and Microwave Vehicle Detection System (MVDS) installed on an expressway in Central Florida to explore how congestion impacts the crash occurrence in urban areas. Multiple congestion measures from the two systems were developed. To ensure more precise estimates of the congestion's effects, the traffic data were aggregated into peak and non-peak hours. Multicollinearity among traffic parameters was examined. The results showed the presence of multicollinearity especially during peak hours. As a response, ridge regression was introduced to cope with this issue. Poisson models with uncorrelated random effects, correlated random effects, and both correlated random effects and random parameters were constructed within the Bayesian framework. It was proven that correlated random effects could significantly enhance model performance. The random parameters model has similar goodness-of-fit compared with the model with only correlated random effects. However, by accounting for the unobserved heterogeneity, more variables were found to be significantly related to crash frequency. The models indicated that congestion increased crash frequency during peak hours while during non-peak hours it was not a major crash contributing factor. Using the random parameter model, the three congestion measures were compared. It was found that all congestion indicators had similar effects while Congestion Index (CI) derived from MVDS data was a better congestion indicator for safety analysis. Also, analyses showed that the segments with higher congestion intensity could not only increase property damage only (PDO) crashes, but also more severe crashes. In addition, the issues regarding the necessity to incorporate specific congestion indicator for congestion's effects on safety and to take care of the multicollinearity between explanatory variables were also discussed. By including a specific congestion indicator, the model performance significantly improved. When comparing models with and without ridge regression, the magnitude of the coefficients was altered in the existence of multicollinearity. These conclusions suggest that the use of appropriate congestion measure and consideration of multicolilnearity among the variables would improve the models and our understanding about the effects of congestion on traffic safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

ERIC Educational Resources Information Center

Schroder, Kerstin E. E.

2011-01-01

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

Comparative effectiveness research in cancer with observational data.

PubMed

Giordano, Sharon H

2015-01-01

Observational studies are increasingly being used for comparative effectiveness research. These studies can have the greatest impact when randomized trials are not feasible or when randomized studies have not included the population or outcomes of interest. However, careful attention must be paid to study design to minimize the likelihood of selection biases. Analytic techniques, such as multivariable regression modeling, propensity score analysis, and instrumental variable analysis, also can also be used to help address confounding. Oncology has many existing large and clinically rich observational databases that can be used for comparative effectiveness research. With careful study design, observational studies can produce valid results to assess the benefits and harms of a treatment or intervention in representative real-world populations.

Cryopreservation of human embryos by vitrification or slow freezing: which one is better?

PubMed

Kolibianakis, Efstratios M; Venetis, Christos A; Tarlatzis, Basil C

2009-06-01

To summarize the available evidence from randomized controlled trials comparing vitrification versus slow freezing for cryopreservation of human embryos. Vitrification, as compared with slow freezing, appears to be better in terms of postthawing survival rates both for cleavage-stage embryos [odds ratio (OR): 6.35, 95% confidence interval (CI): 1.14-35.26, random effects model] and for blastocysts (OR: 4.09, 95% CI: 2.45-6.84, random effects model). Furthermore, postthawing blastocyst development of embryos cryopreserved in the cleavage stage is significantly higher with vitrification as compared with slow freezing (OR: 1.56, 95% CI: 1.07-2.27, fixed effects model). No significant difference in clinical pregnancy rates per transfer could be detected between the two cryopreservation methods (OR: 1.66, 95% CI: 0.98-2.79). Currently, vitrification does not appear to be associated with an increased probability of pregnancy. However, a significant advantage of vitrification over slow freezing in terms of postthawing survival rates is present for embryos cryopreserved both at the cleavage and at the blastocyst stages. The above conclusions are based on limited data, and thus further properly designed randomized controlled trials are needed.

Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

PubMed Central

2014-01-01

Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

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

ERIC Educational Resources Information Center

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

2005-01-01

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

Comparing three knowledge communication strategies - Diffusion, Dissemination and Translation - through randomized controlled studies.

PubMed

Lane, Joseph P; Stone, Vathsala I

2015-01-01

This paper describes a series of three randomized controlled case studies comparing the effectiveness of three strategies for communicating new research-based knowledge (Diffusion, Dissemination, Translation), to different Assistive Technology (AT) stakeholder groups. Pre and post intervention measures for level of knowledge use (unaware, aware, interested, using) via the LOKUS instrument, assessed the relative effectiveness of the three strategies. The latter two approaches were both more effective than diffusion but also equally effective. The results question the value added by tailoring research findings to specific audiences, and instead supports the critical yet neglected role for relevance in determining knowledge use by stakeholders.

The Modern Design of Experiments for Configuration Aerodynamics: A Case Study

NASA Technical Reports Server (NTRS)

DeLoach, Richard

2006-01-01

The effects of slowly varying and persisting covariate effects on the accuracy and precision of experimental result is reviewed, as is the rationale for run-order randomization as a quality assurance tactic employed in the Modern Design of Experiments (MDOE) to defend against such effects. Considerable analytical complexity is introduced by restrictions on randomization in configuration aerodynamics tests because they involve hard-to-change configuration variables that cannot be randomized conveniently. Tradeoffs are examined between quality and productivity associated with varying degrees of rigor in accounting for such randomization restrictions. Certain characteristics of a configuration aerodynamics test are considered that may justify a relaxed accounting for randomization restrictions to achieve a significant reduction in analytical complexity with a comparably negligible adverse impact on the validity of the experimental results.

To compare growth outcomes and cost-effectiveness of "Kangaroo ward care" with "intermediate intensive care" in stable extremely low birth weight infants: randomized control trial.

PubMed

Sharma, Deepak; Murki, Srinivas; Pratap, Oleti Tejo

2017-07-01

To compare growth outcome and cost-effectiveness of "Kangaroo ward care" (KWC) with "Intermediate intensive care" (IIC) in stable extremely low birth weight (ELBW) infants. This is secondary analysis of the study and we analyzed 62 ELBW infants, 33 were randomized to KWC and 29 to IIC once the infant reached a weight of 1150 g. Infants in the KWC group were shifted to the Kangaroo ward immediately after randomization and in the IIC group received IIC care till they attain a weight of 1250 g before shifting to Kangaroo ward. The gain in weight (g/day), length (cm/week), and head circumference (cm/week) were comparable between the two groups. The mean weight, length, and head circumference were comparable at term gestational age. The infants in KWC group were shifted five days earlier to Kangaroo ward when compared to IIC group. The cost-effective analysis using "top-down" and "bottom-up" accounting method showed that there was significant reduction of hospital and parents expenditure in KWC group (p < 0.001) with approximate saving of 452 USD for each patient in the KWC group. Early shifting of ELBW infants for KWC is very efficacious and cost-effective intervention when compared to IIC. (CTRI/2014/05/004625).

Bias in Observational Studies of Prevalent Users: Lessons for Comparative Effectiveness Research From a Meta-Analysis of Statins

PubMed Central

Danaei, Goodarz; Tavakkoli, Mohammad; Hernán, Miguel A.

2012-01-01

Randomized clinical trials (RCTs) are usually the preferred strategy with which to generate evidence of comparative effectiveness, but conducting an RCT is not always feasible. Though observational studies and RCTs often provide comparable estimates, the questioning of observational analyses has recently intensified because of randomized-observational discrepancies regarding the effect of postmenopausal hormone replacement therapy on coronary heart disease. Reanalyses of observational data that excluded prevalent users of hormone replacement therapy led to attenuated discrepancies, which begs the question of whether exclusion of prevalent users should be generally recommended. In the current study, the authors evaluated the effect of excluding prevalent users of statins in a meta-analysis of observational studies of persons with cardiovascular disease. The pooled, multivariate-adjusted mortality hazard ratio for statin use was 0.77 (95% confidence interval (CI): 0.65, 0.91) in 4 studies that compared incident users with nonusers, 0.70 (95% CI: 0.64, 0.78) in 13 studies that compared a combination of prevalent and incident users with nonusers, and 0.54 (95% CI: 0.45, 0.66) in 13 studies that compared prevalent users with nonusers. The corresponding hazard ratio from 18 RCTs was 0.84 (95% CI: 0.77, 0.91). It appears that the greater the proportion of prevalent statin users in observational studies, the larger the discrepancy between observational and randomized estimates. PMID:22223710

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

ERIC Educational Resources Information Center

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

2016-01-01

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

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

PubMed

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

2006-01-01

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

The Effects of Including Observed Means or Latent Means as Covariates in Multilevel Models for Cluster Randomized Trials

ERIC Educational Resources Information Center

Aydin, Burak; Leite, Walter L.; Algina, James

2016-01-01

We investigated methods of including covariates in two-level models for cluster randomized trials to increase power to detect the treatment effect. We compared multilevel models that included either an observed cluster mean or a latent cluster mean as a covariate, as well as the effect of including Level 1 deviation scores in the model. A Monte…

Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled Pilot Study in a Swine Model

DTIC Science & Technology

2014-11-01

ORIGINAL CONTRIBUTION Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant...and chronic pain. Intravenous lipid emulsion (ILE) is a recent antidote for lipophilic drug overdose with unclear effectiveness. ILE has been studied in...Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled

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

ERIC Educational Resources Information Center

Groot, Wim; van den Brink, Henriette Maassen

2003-01-01

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

Efficacy of Virtual Patients in Medical Education: A Meta-Analysis of Randomized Studies

ERIC Educational Resources Information Center

Consorti, Fabrizio; Mancuso, Rosaria; Nocioni, Martina; Piccolo, Annalisa

2012-01-01

A meta-analysis was performed to assess the Effect Size (ES) from randomized studies comparing the effect of educational interventions in which Virtual patients (VPs) were used either as an alternative method or additive to usual curriculum versus interventions based on more traditional methods. Meta-analysis was designed, conducted and reported…

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

ERIC Educational Resources Information Center

Tummers, Marcia; Knoop, Hans; Bleijenberg, Gijs

2010-01-01

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

Extracting the field-effect mobilities of random semiconducting single-walled carbon nanotube networks: A critical comparison of methods

NASA Astrophysics Data System (ADS)

Schießl, Stefan P.; Rother, Marcel; Lüttgens, Jan; Zaumseil, Jana

2017-11-01

The field-effect mobility is an important figure of merit for semiconductors such as random networks of single-walled carbon nanotubes (SWNTs). However, owing to their network properties and quantum capacitance, the standard models for field-effect transistors cannot be applied without modifications. Several different methods are used to determine the mobility with often very different results. We fabricated and characterized field-effect transistors with different polymer-sorted, semiconducting SWNT network densities ranging from low (≈6 μm-1) to densely packed quasi-monolayers (≈26 μm-1) with a maximum on-conductance of 0.24 μS μm-1 and compared four different techniques to evaluate the field-effect mobility. We demonstrate the limits and requirements for each method with regard to device layout and carrier accumulation. We find that techniques that take into account the measured capacitance on the active device give the most reliable mobility values. Finally, we compare our experimental results to a random-resistor-network model.

Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review.

PubMed

Chou, Roger; Dana, Tracy; Bougatsos, Christina; Blazina, Ian; Starmer, Amy J; Reitel, Katie; Buckley, David I

2013-07-02

Pressure ulcers are associated with substantial health burdens but may be preventable. To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk. MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists. Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes. Multiple investigators abstracted and checked study details and quality using predefined criteria. One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions. Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings. More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.

A randomized cross over study comparing the efficacy of two mandibular advancement appliances in the treatment of mild-moderate obstructive sleep apnea.

PubMed

Al-Dharrab, Ayman

2017-11-01

To compare efficacy, side effects, patient compliance, and preference between two types of custom-made mandibular advancement appliances (MAAs) in the treatment of patients with mild to moderate obstructive sleep apnea (OSA). This prospective, randomized, crossover study of 12 patients with mild to moderate OSA compared a titratable and a non-titratable MAA. Each patient was fitted with both appliances in a random order with a washout period of two weeks. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire. All patients underwent overnight home sleep recordings prior to and after the use of each appliance in order to objectively assess sleep quality in terms of the apnea and hypopnea index (AHI), snoring frequency and oxygen desaturation index. Treatment successes (relief of symptoms and/or reduction of AHI to <10/h) were reported with both types of appliances. No compliance failure was reported, and in most patients, the side effects were mild, and improved with time. Both types of oral appliances were effective treatments for patients with mild to moderate OSA, with fewer side effects and higher patient satisfaction.

Effects of soy isoflavone supplements on bone turnover markers in menopausal women: systematic review and meta-analysis of randomized controlled trials.

PubMed

Taku, Kyoko; Melby, Melissa K; Kurzer, Mindy S; Mizuno, Shoichi; Watanabe, Shaw; Ishimi, Yoshiko

2010-08-01

Effects of soy isoflavone supplements on bone turnover markers remain unclear. This up-to-date systematic review and meta-analysis of randomized controlled trials (RCTs) was performed primarily to more completely and precisely clarify the effects on urinary deoxypyridinoline (DPD) and serum bone alkaline phosphatase (BAP) and secondarily to evaluate the effects on other bone turnover markers, compared with placebo in menopausal women. PubMed, CENTRAL, ICHUSHI, and CNKI were searched in June 2009 for relevant studies of RCTs. Data on study design, participants, interventions, and outcomes were extracted and methodological quality of each included trial was assessed. From 3740 identified relevant articles, 10 (887 participants), 10 (1210 participants), and 8 (380 participants) RCTs were selected for meta-analysis of effects on DPD, BAP, and serum osteocalcin (OC), respectively, using Review Manager 5.0.22. Daily ingestion of an average 56 mg soy isoflavones (aglycone equivalents) for 10 weeks to 12 months significantly decreased DPD by 14.1% (95% CI: -26.8% to -1.5%; P=0.03) compared to baseline (heterogeneity: P<0.00001; I(2)=93%; random effects model). The overall effect of soy isoflavones on DPD compared with placebo was a significant decrease of -18.0% (95% CI: -28.4% to -7.7%, P=0.0007; heterogeneity: P=0.0001; I(2)=73%; random effects model). Subgroup analyses and meta-regressions revealed that isoflavone dose and intervention duration did not significantly relate to the variable effects on DPD. Daily supplementation of about 84 mg and 73 mg of soy isoflavones for up to 12 months insignificantly increased BAP by 8.0% (95% CI: -4.2% to 20.2%, P=0.20; heterogeneity: P<0.00001; I(2)=98%) and OC by 10.3% (95% CI: -3.1% to 23.7%, P=0.13; heterogeneity: P=0.002; I(2)=69%) compared with placebo (random effects model), respectively. Soy isoflavone supplements moderately decreased the bone resorption marker DPD, but did not affect bone formation markers BAP and OC in menopausal women. The effects varied between studies, and further studies are needed to address factors relating to the observed effects of soy isoflavones on DPD and to verify effects on other bone turnover markers. Copyright 2010 Elsevier Inc. All rights reserved.

Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

USDA-ARS?s Scientific Manuscript database

Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

A clustered randomized trial of the effects of feedback using academic detailing compared to postal bulletin on prescribing of preventative cardiovascular therapy.

PubMed

Naughton, Corina; Feely, John; Bennett, Kathleen

2007-10-01

Interventions to promote prescribing of preventive therapies in patients with cardiovascular disease (CVD) or diabetes have reported variable success. (i) To evaluate the effect of prescribing feedback on GP practice using academic detailing compared to postal bulletin on prescribing of CVD preventive therapies in patients with CVD or diabetes at 3 and 6 months post intervention and (ii) to evaluate the intervention from a GP's perspective. Volunteer GP practices (n = 98) were randomized to receive individualized prescribing feedback via academic detailing (postal bulletin plus outreach visit) (n = 48) or postal bulletin (n = 50). The proportion of CVD or diabetic patients on statins and antiplatelet agents/warfarin pre- and post-intervention was calculated for each GP practice. Multivariate regression with a random effects model was used to compare differences between the groups adjusting for GP clustering and confounding factors. beta-Coefficients and 95% confidence intervals (CIs) are presented. There was a 3% increase in statin prescribing in CVD patients at 6 months post-intervention for both randomized groups, but there was no statistical difference between the groups (beta = 0.004; 95% CI = -0.01 to 0.02). Statin and antiplatelet/warfarin prescribing also increased in the diabetic population; there was no significant differences between the groups. GPs participating in the project expressed a high level of satisfaction with both interventions. Prescribing of preventive therapies increased in both randomized groups over the study period. But academic detailing did not have an additional effect on changing prescribing over the postal bulletin alone.

Comparing Tailored and Untailored Text Messages for Smoking Cessation: A Randomized Controlled Trial among Adolescent and Young Adult Smokers

ERIC Educational Resources Information Center

Skov-Ettrup, L. S.; Ringgaard, L. W.; Dalum, P.; Flensborg-Madsen, T.; Thygesen, L. C.; Tolstrup, J. S.

2014-01-01

The aim was to compare the effectiveness of untailored text messages for smoking cessation to tailored text messages delivered at a higher frequency. From February 2007 to August 2009, 2030 users of an internet-based smoking cessation program with optional text message support aged 15-25 years were consecutively randomized to versions of the…

Evaluation of some random effects methodology applicable to bird ringing data

USGS Publications Warehouse

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

2002-01-01

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

Review of methodological challenges in comparing the effectiveness of neoadjuvant chemotherapy versus primary debulking surgery for advanced ovarian cancer in the United States.

PubMed

Cole, Ashley L; Austin, Anna E; Hickson, Ryan P; Dixon, Matthew S; Barber, Emma L

2018-05-11

Randomized trials outside the U.S. have found non-inferior survival for neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) for advanced ovarian cancer (AOC). However, these trials reported lower overall survival and lower rates of optimal debulking than U.S. studies, leading to questions about generalizability to U.S. practice, where aggressive debulking is more common. Consequently, comparative effectiveness in the U.S. remains controversial. We reviewed U.S. comparative effectiveness studies of NACT versus PDS for AOC. Here we describe methodological challenges, compare results to trials outside the U.S., and make suggestions for future research. We identified U.S. studies published in 2010 or later that evaluated the comparative effectiveness of NACT versus PDS on survival in AOC through a PubMed search. Two independent reviewers abstracted data from eligible articles. Nine of 230 articles were eligible for review. Methodological challenges included unmeasured confounders, heterogeneous treatment effects, treatment variations over time, and inconsistent measurement of treatment and survival. Whereas some limitations were unavoidable, several limitations noted across studies were avoidable, including conditioning on mediating factors and immortal time introduced by measuring survival beginning from diagnosis. Without trials in the U.S., non-randomized studies are an important source of evidence for the ideal treatment for AOC. However, several methodological challenges exist when assessing the comparative effectiveness of NACT versus PDS in a non-randomized setting. Future observational studies must ensure that treatment is consistent throughout the study period and that treatment groups are comparable. Rapidly-evolving oncology data networks may allow for identification of treatment intent and other important confounders. Copyright © 2018 Elsevier Ltd. All rights reserved.

Selenium and Preeclampsia: a Systematic Review and Meta-analysis.

PubMed

Xu, Min; Guo, Dan; Gu, Hao; Zhang, Li; Lv, Shuyan

2016-06-01

Conflicting results exist between selenium concentration and preeclampsia. The role of selenium in the development of preeclampsia is unclear. We conducted a meta-analysis to compare the blood selenium level in patients with preeclampsia and healthy pregnant women, and to determine the effectiveness of selenium supplementation in preventing preeclampsia. We searched PubMed, ScienceDirect, the Cochrane Library, and relevant references for English language literature up to November 25, 2014. Mean difference from observational studies and relative risk from randomized controlled trials were meta-analyzed by a random-effect model. Thirteen observational studies with 1515 participants and 3 randomized controlled trials with 439 participants were included in the meta-analysis. Using a random-effect model, a statistically significant difference in blood selenium concentration of -6.47 μg/l (95 % confidence interval (CI) -11.24 to -1.7, p = 0.008) was seen after comparing the mean difference of observational studies. In randomized controlled trials, using a random-effect model, the relative risk for preeclampsia was 0.28 (0.09 to 0.84) for selenium supplementation (p = 0.02). Evidence from observational studies indicates an inverse association of blood selenium level and the risk of preeclampsia. Supplementation with selenium significantly reduces the incidence of preeclampsia. However, more prospective clinical trials are required to assess the association between selenium supplementation and preeclampsia and to determine the dose, beginning time, and duration of selenium supplementation.

Transcatheter Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Darmoch, Fahed; Al-Khadra, Yasser; Soud, Mohamad; Fanari, Zaher; Alraies, M Chadi

2018-01-01

Patent foramen ovale (PFO) with atrial septal aneurysm is suggested as an important potential source for cryptogenic strokes. Percutaneous PFO closure to reduce the recurrence of stroke compared to medical therapy has been intensely debated. The aim of this study is to assess whether PFO closure in patients with cryptogenic stroke is safe and effective compared with medical therapy. A search of PubMed, Medline, and Cochrane Central Register from January 2000 through September 2017 for randomized controlled trails (RCT), which compared PFO closure to medical therapy in patients with cryptogenic stroke was conducted. We used the items "PFO or patent foramen ovale", "paradoxical embolism", "PFO closure" and "stroke". Data were pooled for the primary outcome measure using the random-effects model as pooled rate ratio (RR). The primary outcome was reduction in recurrent strokes. Among 282 studies, 5 were selected. Our analysis included 3,440 patients (mean age 45 years, 55% men, mean follow-up 2.9 years), 1,829 in the PFO closure group and 1,611 in the medical therapy group. The I2 heterogeneity test was found to be 48%. A random effects model combining the results of the included studies demonstrated a statistically significant risk reduction in risk of recurrent stroke in the PFO closure group when compared with medical therapy (RR 0.42; 95% CI 0.20-0.91, p = 0.03). Pooled data from 5 large RCTs showed that PFO closure in patients with cryptogenic stroke is safe and effective intervention for prevention of stroke recurrence compared with medical therapy. © 2018 S. Karger AG, Basel.

Understanding and comparisons of different sampling approaches for the Fourier Amplitudes Sensitivity Test (FAST)

PubMed Central

Xu, Chonggang; Gertner, George

2013-01-01

Fourier Amplitude Sensitivity Test (FAST) is one of the most popular uncertainty and sensitivity analysis techniques. It uses a periodic sampling approach and a Fourier transformation to decompose the variance of a model output into partial variances contributed by different model parameters. Until now, the FAST analysis is mainly confined to the estimation of partial variances contributed by the main effects of model parameters, but does not allow for those contributed by specific interactions among parameters. In this paper, we theoretically show that FAST analysis can be used to estimate partial variances contributed by both main effects and interaction effects of model parameters using different sampling approaches (i.e., traditional search-curve based sampling, simple random sampling and random balance design sampling). We also analytically calculate the potential errors and biases in the estimation of partial variances. Hypothesis tests are constructed to reduce the effect of sampling errors on the estimation of partial variances. Our results show that compared to simple random sampling and random balance design sampling, sensitivity indices (ratios of partial variances to variance of a specific model output) estimated by search-curve based sampling generally have higher precision but larger underestimations. Compared to simple random sampling, random balance design sampling generally provides higher estimation precision for partial variances contributed by the main effects of parameters. The theoretical derivation of partial variances contributed by higher-order interactions and the calculation of their corresponding estimation errors in different sampling schemes can help us better understand the FAST method and provide a fundamental basis for FAST applications and further improvements. PMID:24143037

Understanding and comparisons of different sampling approaches for the Fourier Amplitudes Sensitivity Test (FAST).

PubMed

Xu, Chonggang; Gertner, George

2011-01-01

Fourier Amplitude Sensitivity Test (FAST) is one of the most popular uncertainty and sensitivity analysis techniques. It uses a periodic sampling approach and a Fourier transformation to decompose the variance of a model output into partial variances contributed by different model parameters. Until now, the FAST analysis is mainly confined to the estimation of partial variances contributed by the main effects of model parameters, but does not allow for those contributed by specific interactions among parameters. In this paper, we theoretically show that FAST analysis can be used to estimate partial variances contributed by both main effects and interaction effects of model parameters using different sampling approaches (i.e., traditional search-curve based sampling, simple random sampling and random balance design sampling). We also analytically calculate the potential errors and biases in the estimation of partial variances. Hypothesis tests are constructed to reduce the effect of sampling errors on the estimation of partial variances. Our results show that compared to simple random sampling and random balance design sampling, sensitivity indices (ratios of partial variances to variance of a specific model output) estimated by search-curve based sampling generally have higher precision but larger underestimations. Compared to simple random sampling, random balance design sampling generally provides higher estimation precision for partial variances contributed by the main effects of parameters. The theoretical derivation of partial variances contributed by higher-order interactions and the calculation of their corresponding estimation errors in different sampling schemes can help us better understand the FAST method and provide a fundamental basis for FAST applications and further improvements.

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.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients.

PubMed

Krieger, Janice L; Neil, Jordan M; Strekalova, Yulia A; Sarge, Melanie A

2017-03-01

Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. © The Author 2016. Published by Oxford University Press.

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients

PubMed Central

Neil, Jordan M.; Strekalova, Yulia A.; Sarge, Melanie A.

2017-01-01

Abstract Background: Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs. Methods: Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided. Results: Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001). Conclusions: The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes. PMID:27794035

Quality of Life and Aesthetic Plastic Surgery: A Systematic Review and Meta-analysis.

PubMed

Dreher, Rodrigo; Blaya, Carolina; Tenório, Juliana L C; Saltz, Renato; Ely, Pedro B; Ferrão, Ygor A

2016-09-01

Quality of life (QoL) is an important outcome in plastic surgery. However, authors use different scales to address this subject, making it difficult to compare the outcomes. To address this discrepancy, the aim of this study was to perform a systematic review and a random effect meta-analysis. The search was made in two electronic databases (LILACS and PUBMED) using Mesh and non-Mesh terms related to aesthetic plastic surgery and QoL. We performed qualitative and quantitative analyses of the gathered data. We calculated a random effect meta-analysis with Der Simonian and Laird as variance estimator to compare pre- and postoperative QoL standardized mean difference. To check if there is difference between aesthetic surgeries, we compared reduction mammoplasty to other aesthetic surgeries. Of 1,715 identified, 20 studies were included in the qualitative analysis and 16 went through quantitative analysis. The random effect of all aesthetic surgeries shows that QoL improved after surgery. Reduction mammoplasty has improved QoL more than other procedures in social functioning and physical functioning domains. Aesthetic plastic surgery increases QoL. Reduction mammoplasty seems to have better improvement compared with other aesthetic surgeries.

Individualizing drug dosage with longitudinal data.

PubMed

Zhu, Xiaolu; Qu, Annie

2016-10-30

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

Counterintuitive Effects of Online Feedback in Middle School Math: Results from a Randomized Controlled Trial in ASSISTments

ERIC Educational Resources Information Center

McGuire, Patrick; Tu, Shihfen; Logue, Mary Ellin; Mason, Craig A.; Ostrow, Korinn

2017-01-01

This study compared the effects of three different feedback formats provided to sixth grade mathematics students within a web-based online learning platform, ASSISTments. A sample of 196 students were randomly assigned to one of three conditions: (1) text-based feedback; (2) image-based feedback; and (3) correctness only feedback. Regardless of…

A Randomized Trial Comparison of the Effects of Verbal and Pictorial Naturalistic Communication Strategies on Spoken Language for Young Children with Autism

ERIC Educational Resources Information Center

Schreibman, Laura; Stahmer, Aubyn C.

2014-01-01

Presently there is no consensus on the specific behavioral treatment of choice for targeting language in young nonverbal children with autism. This randomized clinical trial compared the effectiveness of a verbally-based intervention, Pivotal Response Training (PRT) to a pictorially-based behavioral intervention, the Picture Exchange Communication…

Beneficial effects of zinc supplementation on head circumference of Nepalese infants and toddlers: a randomized controlled trial.

PubMed

Surkan, P J; Shankar, M; Katz, J; Siegel, E H; Leclerq, S C; Khatry, S K; Stoltzfus, R J; Tielsch, J M

2012-07-01

To assess the effects of micronutrient supplementation on head circumference of rural Nepali infants and children. We used a randomized controlled trial to assess the effects of micronutrient supplementation on head circumference in 569 rural Nepali infants and children aged 4-17 months. Children were randomized to: (1) zinc, (2) iron-folic acid, (3) zinc plus iron-folic acid or (4) a placebo group. Data on head circumference were collected during five visits at ∼3 month intervals over the course of a year. We calculated change in head circumference in treatment groups receiving zinc and iron comparing the first and fifth visits as well as used generalized estimating equations (GEE) to take advantage of data from all points in time. Models were adjusted for covariates unbalanced in the randomization and for baseline head circumference. Estimating differences in head circumference between baseline and visit 5, children in the zinc treatment group showed smaller decreases in head circumference z-score compared with placebo (adjusted β=0.13, 95% confidence interval (CI): 0.03 to 0.23). Using GEE, zinc treatment was associated with 0.11 (95% CI: 0.05 to 0.17) decrease in the rate of decline in head circumference z-score across visits as compared with placebo. Iron-folic acid supplementation was not associated with head circumference z-scores when comparing visits 1 with 5 or including data across all visits in adjusted models. Our results suggest that zinc supplementation confers a beneficial effect on the rate of head growth in Nepali infants.

Comparative Effectiveness Research in Oncology

PubMed Central

2013-01-01

Although randomized controlled trials represent the gold standard for comparative effective research (CER), a number of additional methods are available when randomized controlled trials are lacking or inconclusive because of the limitations of such trials. In addition to more relevant, efficient, and generalizable trials, there is a need for additional approaches utilizing rigorous methodology while fully recognizing their inherent limitations. CER is an important construct for defining and summarizing evidence on effectiveness and safety and comparing the value of competing strategies so that patients, providers, and policymakers can be offered appropriate recommendations for optimal patient care. Nevertheless, methodological as well as political and social challenges for CER remain. CER requires constant and sophisticated methodological oversight of study design and analysis similar to that required for randomized trials to reduce the potential for bias. At the same time, if appropriately conducted, CER offers an opportunity to identify the most effective and safe approach to patient care. Despite rising and unsustainable increases in health care costs, an even greater challenge to the implementation of CER arises from the social and political environment questioning the very motives and goals of CER. Oncologists and oncology professional societies are uniquely positioned to provide informed clinical and methodological expertise to steer the appropriate application of CER toward critical discussions related to health care costs, cost-effectiveness, and the comparative value of the available options for appropriate care of patients with cancer. PMID:23697601

A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Coll, Joseph R; Schoen, Sarah A

2007-01-01

A pilot randomized controlled trial (RCT) of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) was conducted with children who had sensory modulation disorders (SMDs). This study evaluated the effectiveness of three treatment groups. In addition, sample size estimates for a large scale, multisite RCT were calculated. Twenty-four children with SMD were randomly assigned to one of three treatment conditions; OT-SI, Activity Protocol, and No Treatment. Pretest and posttest measures of behavior, sensory and adaptive functioning, and physiology were administered. The OT-SI group, compared to the other two groups, made significant gains on goal attainment scaling and on the Attention subtest and the Cognitive/Social composite of the Leiter International Performance Scale-Revised. Compared to the control groups, OT-SI improvement trends on the Short Sensory Profile, Child Behavior Checklist, and electrodermal reactivity were in the hypothesized direction. Findings suggest that OT-SI may be effective in ameliorating difficulties of children with SMD.

A Randomized Controlled Trial Comparing Botulinum Toxin A Dosage in the Upper Extremity of Children with Spasticity

ERIC Educational Resources Information Center

Kawamura, Anne; Campbell, Kent; Lam-Damji, Sophie; Fehlings, Darcy

2007-01-01

This study compared the effects of low and high doses of botulinum toxin A (BTX-A) to improve upper extremity function. Thirty-nine children (22 males, 17 females) with a mean age of 6 years 2 months (SD 2y 9mo) diagnosed with spastic hemiplegia or triplegia were enrolled into this double-blind, randomized controlled trial. The high-dose group…

Pharmacologic intervention for retained placenta: a systematic review and meta-analysis.

PubMed

Duffy, James M N; Mylan, Sophie; Showell, Marian; Wilson, Matthew J A; Khan, Khalid S

2015-03-01

To assess the effectiveness and safety of pharmacologic interventions for the treatment of retained placenta (when the placenta remains undelivered after 30 minutes of active management of the third stage of labor). We searched: 1) Cochrane Central Register of Controlled Trials (CENTRAL), 2) Cochrane Pregnancy and Childbirth Group's Trials Register, 3) EMBASE, and 4) MEDLINE from inception to June 2014. Randomized controlled trials comparing a pharmacologic intervention(s) with a placebo for the treatment of retained placenta were included. Sixteen randomized controlled trials, including 1,683 participants, were included. Study characteristics and quality were recorded. The meta-analysis was based on random-effects methods for pooled data. There were no statistically significant differences in the requirement to perform manual removal of a placenta in patients treated with oxytocin (55% compared with 60%; relative risk [RR] 0.86, 95% confidence interval [CI] 0.73-1.02; 10 randomized controlled trials [RCTs]), prostaglandins (44% compared with 55%; RR 0.82, 95% CI 0.58-1.15; four RCTs), nitroglycerin (85% compared with 80%; RR 1.06, 95% CI 0.80-1.41; one RCT), or oxytocin and nitroglycerin (52% compared with 79%; RR 0.23, 95% CI 0.01-8.48; two RCTs) compared with placebo. There was limited reporting of secondary outcomes. As opposed to the use of oxytocin as part of the active management of the third stage of labor that has been shown to diminish bleeding in the third stage, once the diagnosis of retained placenta has been made, no pharmacologic treatment has been shown to be effective. When retained placenta is diagnosed, immediate manual removal of the placenta should be considered. PROSPERO International Prospective Register of Systematic Reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42014010641.

Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

PubMed

Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

2014-02-01

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single Enantiomer (+)-Mefloquine Compared with Racemic Mefloquine in Healthy Persons

PubMed Central

Tansley, Robert; Lotharius, Julie; Priestley, Anthony; Bull, Fiona; Duparc, Stephan; Möhrle, Jörg

2010-01-01

Racemic mefloquine is a highly effective antimalarial whose clinical utility has been compromised by its association with neuropsychiatric and gastrointestinal side effects. It is hypothesized that the cause of the side effects may reside in the (−) enantiomer. We sought to compare the safety, tolerability and pharmacokinetic profile of (+)-mefloquine with racemic mefloquine in a randomized, ascending-dose, double-blind, active and placebo-controlled, parallel cohort study in healthy male and female adult volunteers. Although differing in its manifestations, both study drugs displayed a substantially worse tolerability profile compared with placebo. The systemic clearance was slower for (−)-mefloquine than (+)-mefloquine. Thus, (+)-mefloquine has a different safety and tolerability profile compared with racemic mefloquine but its global safety profile is not superior and replacement of the currently used antimalarial drug with (+)-mefloquine is not warranted. PMID:21118921

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

NASA Astrophysics Data System (ADS)

Witteveen, Jeroen A. S.; Bijl, Hester

2009-10-01

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

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

PubMed

Krishnamoorthy, K; Mathew, Thomas; Peng, Jie

2016-11-01

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

Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Crossover Study Evaluating the Abuse Potential of the Antiepileptic Drug Lacosamide in Healthy Recreational Drug Users.

PubMed

Schoedel, Kerri A; Andreas, Jens-Otto; Doty, Pamela; Eckhardt, Klaus; Sellers, Edward M

2017-12-01

This phase 1, randomized, double-blind, placebo- and active comparator-controlled crossover study assessed the abuse potential of the antiepileptic drug, lacosamide. After a qualification phase, 38 healthy, recreational central nervous system-depressant users were randomized to treatment sequences comprising single oral therapeutic (200 mg) and supratherapeutic (800 mg) doses of lacosamide, alprazolam (1.5 and 3 mg), and placebo. Subjective effects were assessed for 24 hours following each dose using a range of scales, with a 5- to 9-day washout between treatments. Mean subjective effects for 200 mg lacosamide were statistically similar to placebo and significantly lower than with alprazolam for most end points. Lacosamide 800 mg elicited transient, statistically significant positive effects compared with placebo, but also persistent Bad Drug Effects including statistically greater maximum effect (Emax) scores for Nausea and Dysphoria compared with other treatments (P < 0.0002). Consistent with this, the 800 mg lacosamide dose showed a significantly lower "at this moment" Drug Liking visual analog scale (VAS) Emax compared with 3 mg alprazolam, but was not different from 1.5 mg alprazolam (73.1/100, 85.4/100, and 78.9/100, respectively, where 50 is neutral). Overall Drug Liking VAS and Take Drug Again VAS Emax for 800 mg lacosamide were not significantly different from placebo and were lower than those for both alprazolam doses (P < 0.0001). These results suggest that in recreational central nervous system-depressant users, lacosamide has detectable abuse-related subjective effects, but a relatively low potential for abuse compared with alprazolam. These findings contributed toward placement of lacosamide into Schedule V of the US Controlled Substances Act.

Comparative Effectiveness of Medication versus Cognitive-Behavioral Therapy in a Randomized Controlled Trial of Low-Income Young Minority Women with Depression

ERIC Educational Resources Information Center

Siddique, Juned; Chung, Joyce Y.; Brown, C. Hendricks; Miranda, Jeanne

2012-01-01

Objective: To examine whether there are latent trajectory classes in response to treatment and whether they moderate the effects of medication versus psychotherapy. Method: Data come from a 1-year randomized controlled trial of 267 low-income, young (M = 29 years), minority (44% Black, 50% Latina, 6% White) women with current major depression…

Implementing Mother Tongue Instruction in the Real World: Results from a Medium-Scale Randomized Controlled Trial in Kenya

ERIC Educational Resources Information Center

Piper, Benjamin; Zuilkowski, Stephanie S.; Ong'ele, Salome

2016-01-01

Research in sub-Saharan Africa investigating the effect of mother tongue (MT) literacy instruction at medium scale is limited. A randomized controlled trial of MT literacy instruction was implemented in 2013 and 2014 as part of the Primary Math and Reading (PRIMR) Initiative in Kenya. We compare the effect of two treatment groups--the base PRIMR…

A randomized clinical trial to compare the immediate effects of seated thoracic manipulation and targeted supine thoracic manipulation on cervical spine flexion range of motion and pain.

PubMed

Karas, Steve; Olson Hunt, Megan J

2014-05-01

Randomized clinical trial. To determine the effectiveness of seated thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and flexion range of motion (ROM). There is evidence that thoracic spine manipulation is an effective treatment for patients with cervical spine pain. This evidence includes a variety of techniques to manipulate the thoracic spine. Although each of them is effective, no research has compared techniques to determine which produces the best outcomes. A total of 39 patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion ROM measures were taken before and after the intervention. Pain reduction (post-treatment-pre-treatment) was significantly greater in those patients receiving the targeted supine thoracic manipulation compared to the seated thoracic manipulation (P<0.05). Although not significant, we did observe greater improvement in flexion ROM in the targeted supine thoracic manipulation group. The results of this study indicate that a targeted supine thoracic manipulation may be more effective in reducing cervical spine pain and improving cervical flexion ROM than a seated thoracic manipulation. Future studies should include a variety of patients and physical therapists (PTs) to validate our findings.

Mortality risk of darbepoetin alfa versus epoetin alfa in patients with CKD: systematic review and meta-analysis.

PubMed

Wilhelm-Leen, Emilee R; Winkelmayer, Wolfgang C

2015-07-01

Epoetin alfa (EPO) and darbepoetin alfa (DPO) are erythropoiesis-stimulating agents that are widely and interchangeably used for the treatment of anemia in patients with advanced chronic kidney disease and end-stage renal disease. No study has specifically compared the risks of hard study outcomes between EPO and DPO, including mortality. Systematic review of the literature and meta-analysis. Patients enrolled in randomized trials comparing EPO versus DPO for the treatment of anemia in adults with chronic kidney disease, including those requiring dialysis. We conducted a systematic search of the literature (PubMed, CENTRAL, SCOPUS, and EMBASE, all years) and industry resources, using predefined search terms and data abstraction tools. We then summarized key characteristics and findings of these trials and performed a random-effects meta-analysis of trials with at least 3 months' duration to identify the summary OR of mortality between patients randomly assigned to DPO versus EPO. DPO versus EPO. All-cause mortality. We identified 9 trials that met the stated inclusion criteria. Overall, 2,024 patients were included in the meta-analysis, of whom 126 died during follow-up, which ranged from 20 to 52 weeks. We found no significant difference in mortality between patients randomly assigned to DPO versus EPO (OR, 1.33; 95% CI, 0.88-2.01). No treatment heterogeneity across studies was detected (Q statistic=4.60; P=0.8). Generalizability to nontrial populations is uncertain. Few trials directly comparing DPO and EPO have been conducted and follow-up was limited. In aggregate, no effect of specific erythropoiesis-stimulating agent on mortality was identified, but the confidence limits were wide and remained compatible with considerable harm from DPO. Absent adequately powered randomized trials, observational postmarketing comparative effectiveness studies comparing these erythropoiesis-stimulating agents are required to better characterize the long-term safety profiles of these agents. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2014-01-01

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

A Comparative Study on Power Point Presentation and Traditional Lecture Method in Material Understandability, Effectiveness and Attitude

ERIC Educational Resources Information Center

Sewasew, Daniel; Mengestle, Missaye; Abate, Gebeyehu

2015-01-01

The aim of this study was to compare PPT and traditional lecture method in material understandability, effectiveness and attitude among university students. Comparative descriptive survey research design was employed to answer the research questions raised. Four hundred and twenty nine participants were selected randomly using stratified sampling…

Cognitive-Behavioral Treatment versus an Active Control for Children and Adolescents with Anxiety Disorders: A Randomized Trial

ERIC Educational Resources Information Center

Hudson, Jennifer L.; Rapee, Ronald M.; Deveney, Charise; Schniering, Carolyn A.; Lyneham, Heidi J.; Bavopoulos, Nataly

2009-01-01

Specific delivery of cognitive-behavioral skills is more effective in treating childhood anxiety compared to treatment that contains only nonspecific therapy factors. The findings are based on a randomized trial involving 112 children aged 7-16 years.

Testing homogeneity in Weibull-regression models.

PubMed

Bolfarine, Heleno; Valença, Dione M

2005-10-01

In survival studies with families or geographical units it may be of interest testing whether such groups are homogeneous for given explanatory variables. In this paper we consider score type tests for group homogeneity based on a mixing model in which the group effect is modelled as a random variable. As opposed to hazard-based frailty models, this model presents survival times that conditioned on the random effect, has an accelerated failure time representation. The test statistics requires only estimation of the conventional regression model without the random effect and does not require specifying the distribution of the random effect. The tests are derived for a Weibull regression model and in the uncensored situation, a closed form is obtained for the test statistic. A simulation study is used for comparing the power of the tests. The proposed tests are applied to real data sets with censored data.

Optical characterization of randomly microrough surfaces covered with very thin overlayers using effective medium approximation and Rayleigh-Rice theory

NASA Astrophysics Data System (ADS)

Ohlídal, Ivan; Vohánka, Jiří; Čermák, Martin; Franta, Daniel

2017-10-01

The modification of the effective medium approximation for randomly microrough surfaces covered by very thin overlayers based on inhomogeneous fictitious layers is formulated. The numerical analysis of this modification is performed using simulated ellipsometric data calculated using the Rayleigh-Rice theory. The system used to perform this numerical analysis consists of a randomly microrough silicon single crystal surface covered with a SiO2 overlayer. A comparison to the effective medium approximation based on homogeneous fictitious layers is carried out within this numerical analysis. For ellipsometry of the system mentioned above the possibilities and limitations of both the effective medium approximation approaches are discussed. The results obtained by means of the numerical analysis are confirmed by the ellipsometric characterization of two randomly microrough silicon single crystal substrates covered with native oxide overlayers. It is shown that the effective medium approximation approaches for this system exhibit strong deficiencies compared to the Rayleigh-Rice theory. The practical consequences implied by these results are presented. The results concerning the random microroughness are verified by means of measurements performed using atomic force microscopy.

Effective comparative analysis of protein-protein interaction networks by measuring the steady-state network flow using a Markov model.

PubMed

Jeong, Hyundoo; Qian, Xiaoning; Yoon, Byung-Jun

2016-10-06

Comparative analysis of protein-protein interaction (PPI) networks provides an effective means of detecting conserved functional network modules across different species. Such modules typically consist of orthologous proteins with conserved interactions, which can be exploited to computationally predict the modules through network comparison. In this work, we propose a novel probabilistic framework for comparing PPI networks and effectively predicting the correspondence between proteins, represented as network nodes, that belong to conserved functional modules across the given PPI networks. The basic idea is to estimate the steady-state network flow between nodes that belong to different PPI networks based on a Markov random walk model. The random walker is designed to make random moves to adjacent nodes within a PPI network as well as cross-network moves between potential orthologous nodes with high sequence similarity. Based on this Markov random walk model, we estimate the steady-state network flow - or the long-term relative frequency of the transitions that the random walker makes - between nodes in different PPI networks, which can be used as a probabilistic score measuring their potential correspondence. Subsequently, the estimated scores can be used for detecting orthologous proteins in conserved functional modules through network alignment. Through evaluations based on multiple real PPI networks, we demonstrate that the proposed scheme leads to improved alignment results that are biologically more meaningful at reduced computational cost, outperforming the current state-of-the-art algorithms. The source code and datasets can be downloaded from http://www.ece.tamu.edu/~bjyoon/CUFID .

Zhen gan xi feng decoction, a traditional chinese herbal formula, for the treatment of essential hypertension: a systematic review of randomized controlled trials.

PubMed

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use.

Perinatal and Hemodynamic Evaluation of Sildenafil Citrate for Preeclampsia Treatment: A Randomized Controlled Trial.

PubMed

Trapani, Alberto; Gonçalves, Luis Flavio; Trapani, Thamyris Finger; Vieira, Simone; Pires, Marilen; Pires, Maria Marlene de Souza

2016-08-01

To evaluate whether therapy with sildenafil citrate prolongs gestation in women with preeclampsia. In a randomized double-blind, placebo-controlled trial, 100 singleton pregnancies with preeclampsia between 24 and 33 weeks of gestation were randomized to 50 mg oral sildenafil citrate every 8 hours or placebo. The primary outcome was prolongation of pregnancy from randomization to delivery. Secondary outcomes were changes in resistance indices of uterine, umbilical, and middle cerebral arteries by Doppler, fetal and maternal complications, and adverse neonatal outcomes. Power analysis estimated that to detect a difference of 5 days in pregnancy duration, 43 patients would have to be randomized to each group. From June 2013 to October 2015, 50 patients were randomized to each group. Pregnancy duration was on average 4 days longer (14.4 days, 95% confidence interval [CI] 12.5-16.6 days compared with 10.4 days, 95% CI 8.4-12.3 days, P=.008) and percent reduction in pulsatility indices of uterine and umbilical arteries higher (22.5% and 18.5%, compared with placebo 2.1% and 2.5%, P<.001) for patients treated with sildenafil compared with placebo. Maternal blood pressure before and 24 hours after randomization was lower with sildenafil (sildenafil: 100.3±5.6 mm Hg compared with 116.4±5.1 mm Hg, P<.05; placebo: 110.6±6.2 mm Hg compared with 114.7±6.5 mm Hg, P=.21). There was no difference in perinatal morbidity, mortality, or adverse effects between groups. Therapy with sildenafil citrate was associated with pregnancy prolongation of approximately 4 days compared with placebo in women with preeclampsia. Brazilian Registry of Clinical Trials, www.ensaiosclinicos.gov.br, RBR-8qj4p5.

Analysis on pseudo excitation of random vibration for structure of time flight counter

NASA Astrophysics Data System (ADS)

Wu, Qiong; Li, Dapeng

2015-03-01

Traditional computing method is inefficient for getting key dynamical parameters of complicated structure. Pseudo Excitation Method(PEM) is an effective method for calculation of random vibration. Due to complicated and coupling random vibration in rocket or shuttle launching, the new staging white noise mathematical model is deduced according to the practical launch environment. This deduced model is applied for PEM to calculate the specific structure of Time of Flight Counter(ToFC). The responses of power spectral density and the relevant dynamic characteristic parameters of ToFC are obtained in terms of the flight acceptance test level. Considering stiffness of fixture structure, the random vibration experiments are conducted in three directions to compare with the revised PEM. The experimental results show the structure can bear the random vibration caused by launch without any damage and key dynamical parameters of ToFC are obtained. The revised PEM is similar with random vibration experiment in dynamical parameters and responses are proved by comparative results. The maximum error is within 9%. The reasons of errors are analyzed to improve reliability of calculation. This research provides an effective method for solutions of computing dynamical characteristic parameters of complicated structure in the process of rocket or shuttle launching.

Implantable Cardioverter Defibrillators for Primary Prevention of Mortality in Patients With Nonischemic Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Stavrakis, Stavros; Asad, Zain; Reynolds, Dwight

2017-06-01

Implantable cardioverter defibrillators (ICDs) improve survival in patients with heart failure due to ischemic cardiomyopathy, but their benefit in nonischemic cardiomyopathy (NICM) has been recently questioned. We performed a meta-analysis of randomized clinical trials to examine the effect of ICDs on total mortality and arrhythmic death in patients with NICM. We also examined the impact of age and cardiac resynchronization therapy (CRT) on the relative effect of ICD compared to control. We searched the MEDLINE and EMBASE databases for randomized trials evaluating the effect of ICD versus control in patients with NICM. Hazard ratios (HR) with 95% confidence interval (CI) were calculated using a random effects model. Six trials involving 2,967 patients were included (ICD, n = 1,553; control, n = 1,414). Based on the pooled estimate across the six studies, the use of ICD was associated with a significant reduction in total mortality (HR = 0.78, 95% CI 0.66-0.92; P = 0.003), as well as arrhythmic death (HR = 0.46, 95% CI 0.29-0.71; P = 0.0005) compared to control. ICD decreased total mortality in younger patients compared to control (HR = 0.63, 95% CI 0.46-0.86; P = 0.004), but not in older patients (HR = 0.97, 95% CI 0.56-1.68; P = 0.92). In patients with CRT, ICD reduced total mortality compared to control (HR = 0.78, 95% CI 0.65-0.95; P = 0.02), but not in patients with CRT (HR = 0.71, 95% CI 0.40-1.26). ICDs decrease total mortality and arrhythmic deaths in patients with NICM. The benefit of ICD appears to be dependent on age and concomitant use of CRT. © 2017 Wiley Periodicals, Inc.

Cost-effectiveness of a mild compared with a standard strategy for IVF: a randomized comparison using cumulative term live birth as the primary endpoint.

PubMed

Polinder, S; Heijnen, E M E W; Macklon, N S; Habbema, J D F; Fauser, B J C M; Eijkemans, M J C

2008-02-01

BACKGROUND Conventional ovarian stimulation and the transfer of two embryos in IVF exhibits an inherent high probability of multiple pregnancies, resulting in high costs. We evaluated the cost-effectiveness of a mild compared with a conventional strategy for IVF. METHODS Four hundred and four patients were randomly assigned to undergo either mild ovarian stimulation/GnRH antagonist co-treatment combined with single embryo transfer, or standard stimulation/GnRH agonist long protocol and the transfer of two embryos. The main outcome measures are total costs of treatment within a 12 months period after randomization, and the relationship between total costs and proportion of cumulative pregnancies resulting in term live birth within 1 year of randomization. RESULTS Despite a significantly increased average number of IVF cycles (2.3 versus 1.7; P < 0.001), lower average total costs over a 12-month period (8333 versus euro10 745; P = 0.006) were observed using the mild strategy. This was mainly due to higher costs of the obstetric and post-natal period for the standard strategy, related to multiple pregnancies. The costs per pregnancy leading to term live birth were euro19 156 in the mild strategy and euro24 038 in the standard. The incremental cost-effectiveness ratio of the standard strategy compared with the mild strategy was euro185 000 per extra pregnancy leading to term live birth. CONCLUSIONS Despite an increased mean number of IVF cycles within 1 year, from an economic perspective, the mild treatment strategy is more advantageous per term live birth. It is unlikely, over a wide range of society's willingness-to-pay, that the standard treatment strategy is cost-effective, compared with the mild strategy.

A Comparative Study of Randomized Constraint Solvers for Random-Symbolic Testing

NASA Technical Reports Server (NTRS)

Takaki, Mitsuo; Cavalcanti, Diego; Gheyi, Rohit; Iyoda, Juliano; dAmorim, Marcelo; Prudencio, Ricardo

2009-01-01

The complexity of constraints is a major obstacle for constraint-based software verification. Automatic constraint solvers are fundamentally incomplete: input constraints often build on some undecidable theory or some theory the solver does not support. This paper proposes and evaluates several randomized solvers to address this issue. We compare the effectiveness of a symbolic solver (CVC3), a random solver, three hybrid solvers (i.e., mix of random and symbolic), and two heuristic search solvers. We evaluate the solvers on two benchmarks: one consisting of manually generated constraints and another generated with a concolic execution of 8 subjects. In addition to fully decidable constraints, the benchmarks include constraints with non-linear integer arithmetic, integer modulo and division, bitwise arithmetic, and floating-point arithmetic. As expected symbolic solving (in particular, CVC3) subsumes the other solvers for the concolic execution of subjects that only generate decidable constraints. For the remaining subjects the solvers are complementary.

Optimizing the delivery of contraceptives in low- and middle-income countries through task shifting: a systematic review of effectiveness and safety.

PubMed

Polus, Stephanie; Lewin, Simon; Glenton, Claire; Lerberg, Priya M; Rehfuess, Eva; Gülmezoglu, A Metin

2015-04-01

To assess the effectiveness and safety of task shifting for the delivery of injectable contraceptives, contraceptive implants, intrauterine devices (IUDs), tubal ligation and vasectomy in low- and middle-income countries. Multiple electronic databases were searched up to 25 May 2012 for studies which had assessed the delivery of contraceptives by health workers with lower levels of training, compared to delivery by health workers usually assigned this role, or compared to no organized provision of contraceptives. We included randomized controlled trials, non-randomized controlled trials, controlled before-after studies, and interrupted time series. Data were extracted using a standard form and the certainty of the evidence found was assessed using GRADE. We identified six randomized controlled trials published between 1977 and 1995 that assessed the safety and effectiveness of task shifting for the delivery of long-term contraceptives. Two studies assessed IUD insertion by nurses compared to doctors, two assessed IUD insertion by auxiliary nurse-midwives compared to doctors, one assessed tubal ligation by midwives compared to doctors, and one assessed the delivery of vasectomy by medical students compared to doctors. In general, little or no difference was found in contraceptive outcomes between cadres. Study design limitations and the low number of eligible studies, however, allow only limited conclusions to be drawn. The findings indicate that task shifting for the delivery of long-term contraceptives may be a safe and effective approach to increasing access to contraception. Further research is needed because the certainty of the evidence identified is variable.

YOCAS©® Yoga Reduces Self-reported Memory Difficulty in Cancer Survivors in a Nationwide Randomized Clinical Trial: Investigating Relationships Between Memory and Sleep.

PubMed

Janelsins, Michelle C; Peppone, Luke J; Heckler, Charles E; Kesler, Shelli R; Sprod, Lisa K; Atkins, James; Melnik, Marianne; Kamen, Charles; Giguere, Jeffrey; Messino, Michael J; Mohile, Supriya G; Mustian, Karen M

2016-09-01

Background Interventions are needed to alleviate memory difficulty in cancer survivors. We previously showed in a phase III randomized clinical trial that YOCAS©® yoga-a program that consists of breathing exercises, postures, and meditation-significantly improved sleep quality in cancer survivors. This study assessed the effects of YOCAS©® on memory and identified relationships between memory and sleep. Survivors were randomized to standard care (SC) or SC with YOCAS©® . 328 participants who provided data on the memory difficulty item of the MD Anderson Symptom Inventory are included. Sleep quality was measured using the Pittsburgh Sleep Quality Index. General linear modeling (GLM) determined the group effect of YOCAS©® on memory difficulty compared with SC. GLM also determined moderation of baseline memory difficulty on postintervention sleep and vice versa. Path modeling assessed the mediating effects of changes in memory difficulty on YOCAS©® changes in sleep and vice versa. YOCAS©® significantly reduced memory difficulty at postintervention compared with SC (mean change: yoga=-0.60; SC=-0.16; P<.05). Baseline memory difficulty did not moderate the effects of postintervention sleep quality in YOCAS©® compared with SC. Baseline sleep quality did moderate the effects of postintervention memory difficulty in YOCAS©® compared with SC (P<.05). Changes in sleep quality was a significant mediator of reduced memory difficulty in YOCAS©® compared with SC (P<.05); however, changes in memory difficulty did not significantly mediate improved sleep quality in YOCAS©® compared with SC. In this large nationwide trial, YOCAS©® yoga significantly reduced patient-reported memory difficulty in cancer survivors. © The Author(s) 2015.

Radioiodine therapy versus antithyroid drugs in Graves' disease: a meta-analysis of randomized controlled trials.

PubMed

Wang, Junqi; Qin, Lan

2016-06-27

This meta-analysis was performed to compare radioiodine therapy with antithyroid drugs in terms of clinical outcomes, including development or worsening of ophthalmopathy, hyperthyroid cure rate, hypothyroidism, relapse rate and adverse events. Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, SinoMed and National Knowledge Infrastructure, China, were systematically reviewed to compare the effects of radioiodine therapy with antithyroid drugs in patients with Graves' disease. Results were expressed as risk ratio with 95% confidence intervals (CIs) and weighted mean differences with 95% CIs. Pooled estimates were performed using a fixed-effects model or random-effects model, depending on the heterogeneity among studies. 17 RCTs involving 4024 patients met the inclusion criteria and were included. Results showed that radioiodine treatment has increased risk in new ophthalmopathy, development or worsening of ophthalmopathy and hypothyroidism. Whereas, compared with antithyroid drugs, radioiodine treatment seems to have a higher hyperthyroid cure rate, lower recurrence rate and lower incidence of adverse events. Radioiodine therapy is associated with a higher hyperthyroid cure rate and lower relapse rate compared with antithyroid drugs. However, it also increases the risk of ophthalmopathy and hypothyroidism. Considering that antithyroid drug treatment can be associated with unsatisfactory control of hyperthyroidism, we would recommend radioiodine therapy as the treatment of choice for patients with Graves' disease.

Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.

PubMed

Rodriguez, Alfredo E; Rodriguez-Granillo, Alfredo M; Antoniucci, David; Mieres, Juan; Fernandez-Pereira, Carlos; Rodriguez-Granillo, Gaston A; Santaera, Omar; Rubilar, Bibiana; Palacios, Igor F; Serruys, Patrick W

2012-09-01

The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy. OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown. In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test. At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS. Copyright © 2011 Wiley Periodicals, Inc.

Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

PubMed

Barnhoorn, Karlijn; Staal, J Bart; van Dongen, Robert Tm; Frölke, Jan Paul M; Klomp, Frank P; van de Meent, Henk; Adang, Eddy; Nijhuis-van der Sanden, Maria Wg

2018-06-01

To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. Randomized controlled trial with 9 months follow-up. Patients were recruited from hospitals and general practitioners in the region around a university hospital. A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

The efficacy and safety of selective leukocytapheresis in the treatment of ulcerative colitis: a meta-analysis.

PubMed

Zhu, Mingming; Xu, Xitao; Nie, Fang; Tong, Jinlu; Xiao, Shudong; Ran, Zhihua

2011-08-01

The use of selective leukocytapheresis for the treatment of ulcerative colitis (UC) has been evaluated in several open and controlled trials, with varying outcomes. A meta-analysis was performed to better assess the efficacy and safety of selective leukocytapheresis as supplemental therapy compared with conventional pharmacotherapy in patients with UC. All randomized trials comparing selective leukocytapheresis supplementation with conventional pharmacotherapy were included from electronic databases and reference lists. A meta-analysis that pooled the outcome effects of leukocytapheresis and pharmacotherapy was performed. A fixed effect model or random effect model was selected depending on the heterogeneity test of the trials. Nine randomized controlled trials met the inclusion criteria contributing a total of 686 participants. Compared with conventional pharmacotherapy, leukocytapheresis supplementation presented a significant benefit in promoting a response rate (OR, 2.88, 95% CI: 1.60-5.18) and remission rate (OR, 2.04; 95% CI, 1.36-3.07) together with significant higher steroid-sparing effects (OR, 10.49; 95% CI, 3.44-31.93) in patients with active moderate-to-severe UC by intention-to-treat analysis. Leukocytapheresis was more effective in maintaining clinical remission for asymptomatic UC patients than conventional therapy (OR, 8.14; 95% CI, 2.22-29.90). The incidence of mild-moderate adverse effects was much less frequent in the leukocytapheresis groups than conventional pharmacotherapy groups (OR, 0.16; 95% CI, 0.04-0.60). Few severe adverse events were observed. Current data indicate that leukocytapheresis supplementation may be more efficacious on improving response and remission rates and tapering corticosteroid dosage with excellent tolerability and safety than conventional pharmacotherapy in patients with UC. In addition, more high-quality randomized controlled trials are required to confirm the higher efficacy of leukocytapheresis in patients with UC.

Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

PubMed

Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

2011-11-01

Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

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…

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Randomized Control Trials on the Dynamic Geometry Approach

ERIC Educational Resources Information Center

Jiang, Zhonghong; White, Alexander; Rosenwasser, Alana

2011-01-01

The project reported here is conducting repeated randomized control trials of an approach to high school geometry that utilizes Dynamic Geometry (DG) software to supplement ordinary instructional practices. It compares effects of that intervention with standard instruction that does not make use of computer drawing/exploration tools. The basic…

Object Interest in Autism Spectrum Disorder: A Treatment Comparison

ERIC Educational Resources Information Center

McDuffie, Andrea S.; Lieberman, Rebecca G.; Yoder, Paul J.

2012-01-01

A randomized control trial comparing two social communication treatments for children with autism spectrum disorder examined the effect of treatment on object interest. Thirty-two children, 18-60 months, were randomly assigned to the Picture Exchange Communication System (PECS) or Responsive Education and Prelinguistic Milieu Teaching (RPMT)…

The effect of interference on temporal order memory for random and fixed sequences in nondemented older adults.

PubMed

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

2012-05-21

Two experiments tested the effect of temporal interference on order memory for fixed and random sequences in young adults and nondemented older adults. The results demonstrate that temporal order memory for fixed and random sequences is impaired in nondemented older adults, particularly when temporal interference is high. However, temporal order memory for fixed sequences is comparable between older adults and young adults when temporal interference is minimized. The results suggest that temporal order memory is less efficient and more susceptible to interference in older adults, possibly due to impaired temporal pattern separation.

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

Modeling and Predicting the Stress Relaxation of Composites with Short and Randomly Oriented Fibers

PubMed Central

Obaid, Numaira; Sain, Mohini

2017-01-01

The addition of short fibers has been experimentally observed to slow the stress relaxation of viscoelastic polymers, producing a change in the relaxation time constant. Our recent study attributed this effect of fibers on stress relaxation behavior to the interfacial shear stress transfer at the fiber-matrix interface. This model explained the effect of fiber addition on stress relaxation without the need to postulate structural changes at the interface. In our previous study, we developed an analytical model for the effect of fully aligned short fibers, and the model predictions were successfully compared to finite element simulations. However, in most industrial applications of short-fiber composites, fibers are not aligned, and hence it is necessary to examine the time dependence of viscoelastic polymers containing randomly oriented short fibers. In this study, we propose an analytical model to predict the stress relaxation behavior of short-fiber composites where the fibers are randomly oriented. The model predictions were compared to results obtained from Monte Carlo finite element simulations, and good agreement between the two was observed. The analytical model provides an excellent tool to accurately predict the stress relaxation behavior of randomly oriented short-fiber composites. PMID:29053601

Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

ERIC Educational Resources Information Center

Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

2016-01-01

A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

NASA Astrophysics Data System (ADS)

Chaibub Neto, Elias

2016-11-01

Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

Effects of Random Circuit Fabrication Errors on Small Signal Gain and on Output Phase In a Traveling Wave Tube

NASA Astrophysics Data System (ADS)

Rittersdorf, I. M.; Antonsen, T. M., Jr.; Chernin, D.; Lau, Y. Y.

2011-10-01

Random fabrication errors may have detrimental effects on the performance of traveling-wave tubes (TWTs) of all types. A new scaling law for the modification in the average small signal gain and in the output phase is derived from the third order ordinary differential equation that governs the forward wave interaction in a TWT in the presence of random error that is distributed along the axis of the tube. Analytical results compare favorably with numerical results, in both gain and phase modifications as a result of random error in the phase velocity of the slow wave circuit. Results on the effect of the reverse-propagating circuit mode will be reported. This work supported by AFOSR, ONR, L-3 Communications Electron Devices, and Northrop Grumman Corporation.

Analysis of Machine Learning Techniques for Heart Failure Readmissions.

PubMed

Mortazavi, Bobak J; Downing, Nicholas S; Bucholz, Emily M; Dharmarajan, Kumar; Manhapra, Ajay; Li, Shu-Xia; Negahban, Sahand N; Krumholz, Harlan M

2016-11-01

The current ability to predict readmissions in patients with heart failure is modest at best. It is unclear whether machine learning techniques that address higher dimensional, nonlinear relationships among variables would enhance prediction. We sought to compare the effectiveness of several machine learning algorithms for predicting readmissions. Using data from the Telemonitoring to Improve Heart Failure Outcomes trial, we compared the effectiveness of random forests, boosting, random forests combined hierarchically with support vector machines or logistic regression (LR), and Poisson regression against traditional LR to predict 30- and 180-day all-cause readmissions and readmissions because of heart failure. We randomly selected 50% of patients for a derivation set, and a validation set comprised the remaining patients, validated using 100 bootstrapped iterations. We compared C statistics for discrimination and distributions of observed outcomes in risk deciles for predictive range. In 30-day all-cause readmission prediction, the best performing machine learning model, random forests, provided a 17.8% improvement over LR (mean C statistics, 0.628 and 0.533, respectively). For readmissions because of heart failure, boosting improved the C statistic by 24.9% over LR (mean C statistic 0.678 and 0.543, respectively). For 30-day all-cause readmission, the observed readmission rates in the lowest and highest deciles of predicted risk with random forests (7.8% and 26.2%, respectively) showed a much wider separation than LR (14.2% and 16.4%, respectively). Machine learning methods improved the prediction of readmission after hospitalization for heart failure compared with LR and provided the greatest predictive range in observed readmission rates. © 2016 American Heart Association, Inc.

A Double-Blind Randomized Controlled Trial Comparing Epidural Clonidine vs Bupivacaine for Pain Control During and After Lower Abdominal Surgery

PubMed Central

Abd-Elsayed, Alaa A.; Guirguis, Maged; DeWood, Mark S.; Zaky, Sherif S.

2015-01-01

Background Alpha-2 adrenergic agonists produce safe and effective analgesia, but most investigations studying the analgesic effect of alpha-2 adrenoceptor agonists postoperatively included previous or concomitant administration of other analgesics. Because clonidine potentiates the effect of these drugs, its own intrinsic analgesic effect has been difficult to establish. This study was designed to compare the intraoperative and postoperative effects of epidural clonidine vs bupivacaine for patients undergoing lower abdominal surgery. Methods This randomized controlled trial included 40 patients aged 18-50 who were scheduled for elective lower abdominal surgery. Patients were randomly divided into 2 groups. Group I (n=20) received epidural clonidine; Group II (n=20) received epidural bupivacaine. Intraoperative and postoperative hemodynamics, pain scores, and complications were monitored. Results Mean pain scores were significantly lower in Group I compared to Group II (1.5 ± 0.5 compared to 3.4 ± 1.0, respectively) in the first 12 hours after surgery. Sedation was more prominent in Group I until 9 hours after surgery. Opioid requirements were significantly lower in Group I. Respiratory rate was similar in the 2 groups. Group I had larger decreases from baseline in systolic blood pressure and diastolic blood pressure than Group II. Heart rate in Group I was reduced from baseline, while it was increased in Group II. Less postoperative nausea and vomiting, urinary retention, pruritus, and shivering were observed in Group I. Conclusion Compared to bupivacaine, epidural clonidine provided effective intraoperative and postoperative analgesia in selected patients, resulting in a decreased intravenous pain medication requirement and prolonged duration of analgesia after epidural infusion was discontinued. PMID:26130975

Cost-effectiveness of early interventions for non-specific low back pain: a randomized controlled study investigating medical yoga, exercise therapy and self-care advice.

PubMed

Aboagye, Emmanuel; Karlsson, Malin Lohela; Hagberg, Jan; Jensen, Irene

2015-02-01

To evaluate the cost-effectiveness of medical yoga as an early intervention compared with evidence-based exercise therapy and self-care advice for non-specific low back pain. Randomized controlled trial with a cost-effectiveness analysis. A total of 159 participants randomized into the medical yoga group (n = 52), the exercise therapy group (n = 52) and the self-care advice group (n = 55). The health outcome measure EQ-5D was applied to measure quality of life data combined with cost data collected from treatment groups from baseline to 12 months follow-up. Outcome measure was health-related quality of life (HRQL). Incremental cost per quality adjusted life year (QALY) was also calculated. Cost-effectiveness analysis was conducted primarily from the societal and employer perspectives. Medical yoga is cost-effective compared with self-care advice if an employer considers the significant improvement in the HRQL of an employee with low back pain justifies the additional cost of treatment (i.e. in this study EUR 150). From a societal perspective, medical yoga is a cost-effective treatment compared with exercise therapy and self-care advice if an additional QALY is worth EUR 11,500. Sensitivity analysis suggests that medical yoga is more cost-effective than its alternatives. Six weeks of uninterrupted medical yoga thera-py is a cost-effective early intervention for non-specific low back pain, when treatment recommendations are adhered to.

Random electric field instabilities of relaxor ferroelectrics

NASA Astrophysics Data System (ADS)

Arce-Gamboa, José R.; Guzmán-Verri, Gian G.

2017-06-01

Relaxor ferroelectrics are complex oxide materials which are rather unique to study the effects of compositional disorder on phase transitions. Here, we study the effects of quenched cubic random electric fields on the lattice instabilities that lead to a ferroelectric transition and show that, within a microscopic model and a statistical mechanical solution, even weak compositional disorder can prohibit the development of long-range order and that a random field state with anisotropic and power-law correlations of polarization emerges from the combined effect of their characteristic dipole forces and their inherent charge disorder. We compare and reproduce several key experimental observations in the well-studied relaxor PbMg1/3Nb2/3O3-PbTiO3.

Telephone-based continuing care counseling in substance abuse treatment: economic analysis of a randomized trial

PubMed Central

Daley, Marilyn C.; Neuman, Matthew J.; Blaakman, Aaron P.; McKay, James R.

2016-01-01

Purpose To investigate whether telephone-based continuing care (TEL) is a promising alternative to traditional face-to-face counseling for clients in treatment for substance abuse. Methods Patients with alcohol and/or cocaine dependence who had completed a 4-week intensive outpatient program were randomly assigned through urn randomization into one of three 12-week interventions: standard continuing care (STD), in-person relapse prevention (RP), or telephone-based continuing care (TEL). This study performed cost, cost-effectiveness, and cost-benefit analyses of TEL and RP compared to STD, using results from the randomized clinical trial with two years of follow up (359 participants). In addition, the study examined the potential moderating effect of baseline patient costs on economic outcomes. Results The study found that TEL was less expensive per client from the societal perspective ($569) than STD ($870) or RP ($1,684). TEL also was also significantly more effective, with an abstinence rate of 57.1% compared to 46.7% for STD (p<0.05). Thus TEL dominated STD, with a highly favorable negative incremental cost-effectiveness ratio (−$1,400 per abstinent year). TEL also proved favorable under a benefit-cost perspective. Conclusions TEL proved to be a cost-effective and cost-beneficial contributor to long-term recovery over two years. Because TEL dominated STD care interventions, wider adoption should be considered. PMID:26718395

Telephone-based continuing care counseling in substance abuse treatment: Economic analysis of a randomized trial.

PubMed

Shepard, Donald S; Daley, Marilyn C; Neuman, Matthew J; Blaakman, Aaron P; McKay, James R

2016-02-01

To investigate whether telephone-based continuing care (TEL) is a promising alternative to traditional face-to-face counseling for clients in treatment for substance abuse. Patients with alcohol and/or cocaine dependence who had completed a 4-week intensive outpatient program were randomly assigned through urn randomization into one of three 12-week interventions: standard continuing care (STD), in-person relapse prevention (RP), or telephone-based continuing care (TEL). This study performed cost, cost-effectiveness, and cost-benefit analyses of TEL and RP compared to STD, using results from the randomized clinical trial with two years of follow up (359 participants). In addition, the study examined the potential moderating effect of baseline patient costs on economic outcomes. The study found that TEL was less expensive per client from the societal perspective ($569) than STD ($870) or RP ($1684). TEL also was also significantly more effective, with an abstinence rate of 57.1% compared to 46.7% for STD (p<0.05). Thus TEL dominated STD, with a highly favorable negative incremental cost-effectiveness ratio (-$1400 per abstinent year). TEL also proved favorable under a benefit-cost perspective. TEL proved to be a cost-effective and cost-beneficial contributor to long-term recovery over two years. Because TEL dominated STD care interventions, wider adoption should be considered. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Mindfulness-based stress reduction for treating chronic headache: A systematic review and meta-analysis.

PubMed

Anheyer, Dennis; Leach, Matthew J; Klose, Petra; Dobos, Gustav; Cramer, Holger

2018-01-01

Background Mindfulness-based stress reduction/cognitive therapy are frequently used for pain-related conditions, but their effects on headache remain uncertain. This review aimed to assess the efficacy and safety of mindfulness-based stress reduction/cognitive therapy in reducing the symptoms of chronic headache. Data sources and study selection MEDLINE/PubMed, Scopus, CENTRAL, and PsychINFO were searched to 16 June 2017. Randomized controlled trials comparing mindfulness-based stress reduction/cognitive therapy with usual care or active comparators for migraine and/or tension-type headache, which assessed headache frequency, duration or intensity as a primary outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Tool. Results Five randomized controlled trials (two on tension-type headache; one on migraine; two with mixed samples) with a total of 185 participants were included. Compared to usual care, mindfulness-based stress reduction/cognitive therapy did not improve headache frequency (three randomized controlled trials; standardized mean difference = 0.00; 95% confidence interval = -0.33,0.32) or headache duration (three randomized controlled trials; standardized mean difference = -0.08; 95% confidence interval = -1.03,0.87). Similarly, no significant difference between groups was found for pain intensity (five randomized controlled trials; standardized mean difference = -0.78; 95% confidence interval = -1.72,0.16). Conclusions Due to the low number, small scale and often high or unclear risk of bias of included randomized controlled trials, the results are imprecise; this may be consistent with either an important or negligible effect. Therefore, more rigorous trials with larger sample sizes are needed.

AFRESh: an adaptive framework for compression of reads and assembled sequences with random access functionality.

PubMed

Paridaens, Tom; Van Wallendael, Glenn; De Neve, Wesley; Lambert, Peter

2017-05-15

The past decade has seen the introduction of new technologies that lowered the cost of genomic sequencing increasingly. We can even observe that the cost of sequencing is dropping significantly faster than the cost of storage and transmission. The latter motivates a need for continuous improvements in the area of genomic data compression, not only at the level of effectiveness (compression rate), but also at the level of functionality (e.g. random access), configurability (effectiveness versus complexity, coding tool set …) and versatility (support for both sequenced reads and assembled sequences). In that regard, we can point out that current approaches mostly do not support random access, requiring full files to be transmitted, and that current approaches are restricted to either read or sequence compression. We propose AFRESh, an adaptive framework for no-reference compression of genomic data with random access functionality, targeting the effective representation of the raw genomic symbol streams of both reads and assembled sequences. AFRESh makes use of a configurable set of prediction and encoding tools, extended by a Context-Adaptive Binary Arithmetic Coding scheme (CABAC), to compress raw genetic codes. To the best of our knowledge, our paper is the first to describe an effective implementation CABAC outside of its' original application. By applying CABAC, the compression effectiveness improves by up to 19% for assembled sequences and up to 62% for reads. By applying AFRESh to the genomic symbols of the MPEG genomic compression test set for reads, a compression gain is achieved of up to 51% compared to SCALCE, 42% compared to LFQC and 44% compared to ORCOM. When comparing to generic compression approaches, a compression gain is achieved of up to 41% compared to GNU Gzip and 22% compared to 7-Zip at the Ultra setting. Additionaly, when compressing assembled sequences of the Human Genome, a compression gain is achieved up to 34% compared to GNU Gzip and 16% compared to 7-Zip at the Ultra setting. A Windows executable version can be downloaded at https://github.com/tparidae/AFresh . tom.paridaens@ugent.be. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Lingual vs. labial fixed orthodontic appliances: systematic review and meta-analysis of treatment effects.

PubMed

Papageorgiou, Spyridon N; Gölz, Lina; Jäger, Andreas; Eliades, Theodore; Bourauel, Christoph

2016-04-01

The aim of this systematic review was to compare the therapeutic and adverse effects of lingual and labial orthodontic fixed appliances from clinical trials on human patients in an evidence-based manner. Randomized and prospective non-randomized clinical trials comparing lingual and labial appliances were included. Risk of bias within and across studies was assessed using the Cochrane tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Random-effects meta-analyses were conducted, followed by subgroup and sensitivity analyses. Six electronic databases were searched from inception to July 2015, without limitations. A total of 13 papers pertaining to 11 clinical trials were included with a total of 407 (34% male/66% female) patients. Compared with labial appliances, lingual appliances were associated with increased overall oral discomfort, increased speech impediment (measured using auditory analysis), worse speech performance assessed by laypersons, increased eating difficulty, and decreased intermolar width. On the other hand, lingual appliances were associated with increased intercanine width and significantly decreased anchorage loss of the maxillary first molar during space closure. Based on existing trials, there is insufficient evidence to make robust recommendations for lingual fixed orthodontic appliances regarding their therapeutic or adverse effects, as the quality of evidence was low. © 2016 Eur J Oral Sci.

A Randomized Comparative Trial on the Therapeutic Efficacy of Topical Aloe vera and Calendula officinalis on Diaper Dermatitis in Children

PubMed Central

Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

2012-01-01

Introduction. Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of Aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Methods. Sixty-six infants with DD (aged < 3 years) were randomized to receive either Aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Results. Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to Aloe group (P = 0.001). No adverse effect was reported from either of the medications. Discussion. The evidence from this study suggests that topical Aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants. PMID:22606064

A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children.

PubMed

Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

2012-01-01

Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Sixty-six infants with DD (aged < 3 years) were randomized to receive either aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications. The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

Therapeutic Plasma Transfusion in Bleeding Patients: A Systematic Review.

PubMed

Levy, Jerrold H; Grottke, Oliver; Fries, Dietmar; Kozek-Langenecker, Sibylle

2017-04-01

Plasma products, including fresh frozen plasma, are administered extensively in a variety of settings from massive transfusion to vitamin K antagonist reversal. Despite the widespread use of plasma as a hemostatic agent in bleeding patients, its effect in comparison with other available choices of hemostatic therapies is unclear. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed Central, and databases of ongoing trials for randomized controlled trials that assessed the efficacy and/or safety of therapeutic plasma as an intervention to treat bleeding patients compared with other interventions or placebo. Of 1243 unique publications retrieved in our initial search, no randomized controlled trials were identified. Four nonrandomized studies described the effect of therapeutic plasma in bleeding patients; however, data gathered from these studies did not allow for comparison with other therapeutic interventions primarily as a result of the low number of patients and the use of different (or lack of) comparators. We identified two ongoing trials investigating the efficacy and safety of therapeutic plasma, respectively; however, no data have been released as yet. Although plasma is used extensively in the treatment of bleeding patients, evidence from randomized controlled trials comparing its effect with those of other therapeutic interventions is currently lacking.

Longitudinal Changes in Menopausal Symptoms Comparing Women Randomized to Low-Dose Oral Conjugated Estrogens or Transdermal Estradiol Plus Micronized Progesterone Versus Placebo: the Kronos Early Estrogen Prevention Study (KEEPS)

PubMed Central

Santoro, Nanette; Allshouse, Amanda; Neal-Perry, Genevieve; Pal, Lubna; Lobo, Rogerio A.; Naftolin, Frederick; Black, Dennis M.; Brinton, Eliot A.; Budoff, Matthew J.; Cedars, Marcelle I.; Dowling, N. Maritza; Dunn, Mary; Gleason, Carey E.; Hodis, Howard N.; Isaac, Barbara; Magnani, Maureen; Manson, JoAnn E.; Miller, Virginia M.; Taylor, Hugh S.; Wharton, Whitney; Wolff, Erin; Zepeda, Viola; Harman, S. Mitchell

2016-01-01

Objective To compare the efficacy of two forms of menopausal hormone therapy in alleviating vasomotor symptoms, insomnia, and irritability in early menopausal women over four years. Methods 727 women, aged 42–58, within three years of their final menstrual period were randomized to receive oral conjugated estrogens (o-CEE) 0.45 mg (n=230) or transdermal estradiol (t-E2) 50mcg (n=225; both with micronized progesterone 200mg for 12 days each month), or placebos (PBO; n=275). Menopausal symptoms were recorded at screening and at 6, 12, 24, 36 and 48 months post-randomization. Differences in proportions of women with symptoms at baseline and at each followup timepoint were compared by treatment arm using exact chi-square tests in an intent-to-treat (ITT) analysis. Differences in treatment effect by race/ethnicity and body mass index (BMI) were tested using generalized linear mixed effects modeling. Results Moderate-to-severe hot flashes (from 44% at baseline to 28.3% for PBO, 7.4% for t-E2 and 4.2% for o-CEE) and night sweats (from 35% at baseline to 19% for PBO, 5.3% for t-E2 and 4.7% for o-CEE) were reduced significantly by 6 months in women randomized to either active hormone compared to PBO (P<0.001 for both symptoms), with no significant differences between the active treatment arms. Insomnia and irritability decreased from baseline to 6 months post randomization in all groups. There was an intermittent reduction in insomnia in both active treatment arms vs PBO, with o-CEE more effective than PBO at 36 and 48 months (p=0.002mad 0.05) and t-E2 more effective than PBO at 48 months (p=0.004). Neither hormone treatment significantly affected irritability compared to PBO. Symptom relief for active treatment vs PBO was not significantly modified by BMI or race/ethnicity. Conclusions Recently-menopausal women had similar and substantial reductions in hot flashes and night sweats with lower than conventional doses of oral or transdermal estrogen. These reductions were sustained over 4 years. Insomnia was intermittently reduced compared to placebo for both hormone regimens. PMID:27779568

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.

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

Meta-analysis of randomized controlled trials on risk of myocardial infarction from the use of oral direct thrombin inhibitors.

PubMed

Artang, Ramin; Rome, Eric; Nielsen, Jørn Dalsgaard; Vidaillet, Humberto J

2013-12-15

Dabigatran has been associated with greater risk of myocardial infarction (MI) than warfarin. It is unknown whether the increased risk is unique to dabigatran, an adverse effect shared by other oral direct thrombin inhibitors (DTIs), or the result of a protective effect of warfarin against MI. To address these questions, we systematically searched MEDLINE and performed a meta-analysis on randomized trials that compared oral DTIs with warfarin for any indication with end point of MIs after randomization. We furthermore performed a secondary meta-analysis on atrial fibrillation stroke prevention trials with alternative anticoagulants compared with warfarin with end point of MIs after randomization. A total of 11 trials (39,357 patients) that compared warfarin to DTIs (dabigatran, ximelagatran, and AZD0837) were identified. In these trials, patients treated with oral DTIs were more likely to experience an MI than their counterparts treated with warfarin (285 of 23,333 vs 133 of 16,024, odds ratio 1.35, 95% confidence interval 1.10 to 1.66, p = 0.005). For secondary analysis, 8 studies (69,615 patients) were identified that compared warfarin with alternative anticoagulant including factor Xa inhibitors, DTIs, aspirin, and clopidogrel. There was no significant advantage in the rate of MIs with the use of warfarin versus comparators (odds ratio 1.06, 95% confidence interval 0.85 to 1.34, p = 0.59). In conclusion, our data suggest that oral DTIs were associated with increased risk of MI. This increased risk appears to be a class effect of these agents, not a specific phenomenon unique to dabigatran or protective effect of warfarin. These findings support the need for enhanced postmarket surveillance of oral DTIs and other novel agents. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2009-06-01

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

Decisions with Uncertain Consequences—A Total Ordering on Loss-Distributions

PubMed Central

König, Sandra; Schauer, Stefan

2016-01-01

Decisions are often based on imprecise, uncertain or vague information. Likewise, the consequences of an action are often equally unpredictable, thus putting the decision maker into a twofold jeopardy. Assuming that the effects of an action can be modeled by a random variable, then the decision problem boils down to comparing different effects (random variables) by comparing their distribution functions. Although the full space of probability distributions cannot be ordered, a properly restricted subset of distributions can be totally ordered in a practically meaningful way. We call these loss-distributions, since they provide a substitute for the concept of loss-functions in decision theory. This article introduces the theory behind the necessary restrictions and the hereby constructible total ordering on random loss variables, which enables decisions under uncertainty of consequences. Using data obtained from simulations, we demonstrate the practical applicability of our approach. PMID:28030572

The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials.

PubMed

Liu, Hua; Zeng, Chao; Gao, Shu-guang; Yang, Tuo; Luo, Wei; Li, Yu-sheng; Xiong, Yi-lin; Sun, Jin-peng; Lei, Guang-hua

2013-10-01

A meta-analysis was conducted to examine the effect of mud therapy on pain relief in patients with knee osteoarthritis (OA). A detailed search of PubMed®/MEDLINE® was undertaken to identify randomized controlled trials and prospective comparative studies published before 9 March 2013 that compared mud therapy with control group treatments in patients with knee OA. A quantitative meta-analysis of seven studies (410 patients) was performed. There was a significant difference between the groups in the visual analogue scale pain score (standardized mean difference [SMD] -0.73) and Western Ontario and McMaster Universities Osteoarthritis Index pain score (SMD -0.30), with differences in favour of mud therapy. Mud therapy is a favourable option for pain relief in patients with knee OA. Additional high-quality randomized controlled trials need to be conducted to explore this issue further and to confirm this conclusion.

Effects of glucose and ethylene on root hair initiation and elongation in lettuce (Lactuca sativa L.) seedlings.

PubMed

Harigaya, Wakana; Takahashi, Hidenori

2018-05-01

Root hair formation occurs in lettuce seedlings after transfer to an acidic medium (pH 4.0). This process requires cortical microtubule (CMT) randomization in root epidermal cells and the plant hormone ethylene. We investigated the interaction between ethylene and glucose, a new signaling molecule in plants, in lettuce root development, with an emphasis on root hair formation. Dark-grown seedlings were used to exclude the effect of photosynthetically produced glucose. In the dark, neither root hair formation nor the CMT randomization preceding it occurred, even after transfer to the acidic medium (pH 4.0). Adding 1-aminocyclopropane-1-carboxylic-acid (ACC) to the medium rescued the induction, while adding glucose did not. Although CMT randomization occurred when glucose was applied together with ACC, it was somewhat suppressed compared to that in ACC-treated seedlings. This was not due to a decrease in the speed of randomization, but due to lowering of the maximum degree of randomization. Despite the negative effect of glucose on ACC-induced CMT randomization, the density and length of ACC-induced root hairs increased when glucose was also added. The hair-cell length of the ACC-treated seedlings was comparable to that in the combined-treatment seedlings, indicating that the increase in hair density caused by glucose results from an increase in the root hair number. Furthermore, quantitative RT-PCR revealed that glucose suppressed ethylene signaling. These results suggest that glucose has a negative and positive effect on the earlier and later stages of root hair formation, respectively, and that the promotion of the initiation and elongation of root hairs by glucose may be mediated in an ethylene-independent manner.

Two Universality Classes for the Many-Body Localization Transition

NASA Astrophysics Data System (ADS)

Khemani, Vedika; Sheng, D. N.; Huse, David A.

2017-08-01

We provide a systematic comparison of the many-body localization (MBL) transition in spin chains with nonrandom quasiperiodic versus random fields. We find evidence suggesting that these belong to two separate universality classes: the first dominated by "intrinsic" intrasample randomness, and the second dominated by external intersample quenched randomness. We show that the effects of intersample quenched randomness are strongly growing, but not yet dominant, at the system sizes probed by exact-diagonalization studies on random models. Thus, the observed finite-size critical scaling collapses in such studies appear to be in a preasymptotic regime near the nonrandom universality class, but showing signs of the initial crossover towards the external-randomness-dominated universality class. Our results provide an explanation for why exact-diagonalization studies on random models see an apparent scaling near the transition while also obtaining finite-size scaling exponents that strongly violate Harris-Chayes bounds that apply to disorder-driven transitions. We also show that the MBL phase is more stable for the quasiperiodic model as compared to the random one, and the transition in the quasiperiodic model suffers less from certain finite-size effects.

Comparing Inspiratory Resistive Muscle Training with Incentive Spirometry on Rehabilitation of COPD Patients.

PubMed

Heydari, Abbas; Farzad, Marjan; Ahmadi hosseini, Seyed-hossein

2015-01-01

To examine the effect of incentive spirometry in pulmonary rehabilitation of chronic obstructive pulmonary disease (COPD) patients and compare its efficacy with inspiratory resistive muscle training (IMT) technique. Randomized controlled trial. Thirty patients with COPD, from a general hospital in Mashhad, Iran, were randomly assigned to two study groups. All subjects trained daily in two 15-minute sessions, 4 days a week, for 4 weeks. Respiratory function tests were compared before interventions and at the end of weeks 2 and 4. Both techniques improved the mean values of all respiratory function tests (p≤.01). The IMT technique was more effective to improve MVV and PImax (p≤.05). PEFR was better improved in the incentive spirometry group (p≤.05). There was no significant difference for other spirometric parameters between two groups. Incentive spirometry can be considered as an effective component for pulmonary rehabilitation in COPD patients. © 2013 Association of Rehabilitation Nurses.

Beam combining and SBS suppression in white noise and pseudo-random modulated amplifiers

NASA Astrophysics Data System (ADS)

Anderson, Brian; Flores, Angel; Holten, Roger; Ehrenreich, Thomas; Dajani, Iyad

2015-03-01

White noise phase modulation (WNS) and pseudo-random binary sequence phase modulation (PRBS) are effective techniques for mitigation of nonlinear effects such as stimulated Brillouin scattering (SBS); thereby paving the way for higher power narrow linewidth fiber amplifiers. However, detailed studies comparing both coherent beam combination and the SBS suppression of these phase modulation schemes have not been reported. In this study an active fiber cutback experiment is performed comparing the enhancement factor of a PRBS and WNS broadened seed as a function of linewidth and fiber length. Furthermore, two WNS and PRBS modulated fiber lasers are coherently combined to measure and compare the fringe visibility and coherence length as a function of optical path length difference. Notably, the discrete frequency comb of PRBS modulation provides a beam combining re-coherence effect where the lasers periodically come back into phase. Significantly, this may reduce path length matching complexity in coherently combined fiber laser systems.

Use of simulation to compare the performance of minimization with stratified blocked randomization.

PubMed

Toorawa, Robert; Adena, Michael; Donovan, Mark; Jones, Steve; Conlon, John

2009-01-01

Minimization is an alternative method to stratified permuted block randomization, which may be more effective at balancing treatments when there are many strata. However, its use in the regulatory setting for industry trials remains controversial, primarily due to the difficulty in interpreting conventional asymptotic statistical tests under restricted methods of treatment allocation. We argue that the use of minimization should be critically evaluated when designing the study for which it is proposed. We demonstrate by example how simulation can be used to investigate whether minimization improves treatment balance compared with stratified randomization, and how much randomness can be incorporated into the minimization before any balance advantage is no longer retained. We also illustrate by example how the performance of the traditional model-based analysis can be assessed, by comparing the nominal test size with the observed test size over a large number of simulations. We recommend that the assignment probability for the minimization be selected using such simulations. Copyright (c) 2008 John Wiley & Sons, Ltd.

Design and Rationale for a Randomized Controlled Trial to Reduce Readmissions among Patients with Depressive Symptoms

PubMed Central

Mitchell, Suzanne E.; Martin, Jessica M.; Krizman, Katherine; Sadikova, Ekaterina; Culpepper, Larry; Stewart, Sabrina K.; Brown, Jennifer Rose; Jack, Brian W.

2016-01-01

Background The Re-Engineered Discharge (Project RED) reduces 30-day readmission rates by 30 percent. However, our data indicates that for patients displaying depressive symptoms during hospitalization, Project RED is less effective in preventing unplanned readmission. We aim to examine the effectiveness of RED-D, a modified brief Cognitive behavioral therapy (CBT) protocol delivered as a post-discharge extension of the Re-Engineered Discharge, in reducing 30-day readmissions rates and emergency department (ED) use as well as depressive symptoms for medical patients with comorbid depressive symptoms. Methods This paper details the study design and implementation of an ongoing, federally funded randomized controlled trial of our post-discharge mental health intervention, RED-D, compared to the RED plus usual care. This research has two primary objectives: (1) to determine whether RED-D delivered telephonically by a mental health professional immediately following discharge is effective in reducing hospital readmission and emergency department use for patients displaying depressive symptoms during their inpatient stay, and (2) to examine whether this approach yields a clinically significant reduction in depressive symptoms. We intend to recruit 1200 participants randomized to our intervention, RED-D (n=600), and to RED plus usual care (n=600). Conclusions Hospitalized patients with depressive symptoms are at increased risk for 30-day readmission. We aim to conduct a randomized clinical trial to evaluate the comparative effectiveness of RED-D, our post-discharge modified brief CBT intervention compared to RED alone in reducing readmissions and depressive symptoms for this at-risk population. PMID:26343332

Design and rationale for a randomized controlled trial to reduce readmissions among patients with depressive symptoms.

PubMed

Mitchell, Suzanne E; Martin, Jessica M; Krizman, Katherine; Sadikova, Ekaterina; Culpepper, Larry; Stewart, Sabrina K; Brown, Jennifer Rose; Jack, Brian W

2015-11-01

The Re-Engineered Discharge (Project RED) reduces 30-day readmission rates by 30%. However, our data indicates that for patients displaying depressive symptoms during hospitalization, Project RED is less effective in preventing unplanned readmission. We aim to examine the effectiveness of RED-D, a modified brief Cognitive behavioral therapy (CBT) protocol delivered as a post-discharge extension of the Re-Engineered Discharge, in reducing 30-day readmissions rates and emergency department (ED) use as well as depressive symptoms for medical patients with comorbid depressive symptoms. This paper details the study design and implementation of an ongoing, federally funded randomized controlled trial of our post-discharge mental health intervention, RED-D, compared to the RED plus usual care. This research has two primary objectives: (1) to determine whether RED-D delivered telephonically by a mental health professional immediately following discharge is effective in reducing hospital readmission and emergency department use for patients displaying depressive symptoms during their inpatient stay, and (2) to examine whether this approach yields a clinically significant reduction in depressive symptoms. We intend to recruit 1200 participants randomized to our intervention, RED-D (n=600), and to RED plus usual care (n=600). Hospitalized patients with depressive symptoms are at increased risk for 30-day readmission. We aim to conduct a randomized clinical trial to evaluate the comparative effectiveness of RED-D, our post-discharge modified brief CBT intervention compared to RED alone in reducing readmissions and depressive symptoms for this at-risk population. Copyright © 2015 Elsevier Inc. All rights reserved.

A randomized clinical trial to compare the immediate effects of seated thoracic manipulation and targeted supine thoracic manipulation on cervical spine flexion range of motion and pain

PubMed Central

Karas, Steve; Olson Hunt, Megan J

2014-01-01

Design Randomized clinical trial. Objectives To determine the effectiveness of seated thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and flexion range of motion (ROM). There is evidence that thoracic spine manipulation is an effective treatment for patients with cervical spine pain. This evidence includes a variety of techniques to manipulate the thoracic spine. Although each of them is effective, no research has compared techniques to determine which produces the best outcomes. Methods A total of 39 patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion ROM measures were taken before and after the intervention. Results Pain reduction (post-treatment–pre-treatment) was significantly greater in those patients receiving the targeted supine thoracic manipulation compared to the seated thoracic manipulation (P<0.05). Although not significant, we did observe greater improvement in flexion ROM in the targeted supine thoracic manipulation group. The results of this study indicate that a targeted supine thoracic manipulation may be more effective in reducing cervical spine pain and improving cervical flexion ROM than a seated thoracic manipulation. Future studies should include a variety of patients and physical therapists (PTs) to validate our findings. PMID:24976754

Comparative Effectiveness of Mesalamine, Sulfasalazine, Corticosteroids, and Budesonide for the Induction of Remission in Crohn's Disease: A Bayesian Network Meta-analysis.

PubMed

Coward, Stephanie; Kuenzig, M Ellen; Hazlewood, Glen; Clement, Fiona; McBrien, Kerry; Holmes, Rebecca; Panaccione, Remo; Ghosh, Subrata; Seow, Cynthia H; Rezaie, Ali; Kaplan, Gilaad G

2017-03-01

Induction treatment of mild-to-moderate Crohn's disease is controversial. To compare the induction of remission between different doses of mesalamine, sulfasalazine, corticosteroids, and budesonide for active Crohn's disease. We identified randomized controlled trials from existing Cochrane reviews and an updated literature search in Medline, EMBASE, and CENTRAL to November 2015. We included randomized controlled trials (n = 22) in adult patients with Crohn's disease that compared budesonide, sulfasalazine, mesalamine, or corticosteroids with placebo or each other, for the induction of remission (8-17 wks). Mesalamine (above and below 2.4 g/d) and budesonide (above and below 6 mg/d) were stratified into low and high doses. Our primary outcome was remission, defined as a Crohn's Disease Activity Index score <150. A Bayesian random-effects network meta-analysis was performed on the proportion in remission. Corticosteroids (odds ratio [OR] = 3.80; 95% credible interval [CrI]: 2.48-5.66), high-dose budesonide (OR = 2.96; 95% CrI: 2.06-4.30), and high-dose mesalamine (OR = 2.29; 95% CrI: 1.58-3.33) were superior to placebo. Corticosteroids were similar to high-dose budesonide (OR = 1.21; 95% CrI: 0.84-1.76), but more effective than high-dose mesalamine (OR = 1.83; 95% CrI: 1.16-2.88). Sulfasalazine was not significantly superior to any therapy including placebo. Randomized controlled trials that use a strict definition of induction of remission and disease severity at enrollment to assess effectiveness in treating mild-to-moderate Crohn's disease are limited. Corticosteroids and high-dose budesonide were effective treatments for inducing remission in mild-to-moderate Crohn's disease. High-dose mesalamine is an option among patients preferring to avoid steroids.

Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

DTIC Science & Technology

2010-09-30

a novel hypocretiniorexin antagonist, almorexant (ALM), to a standard hypnotic , zolpidem (ZOL), and placebo (PBO) on neurocognitive performance at...Placebo-Controlled, Randomized, Parallel- Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic ...Group Study Comparing the Effect of a Novel HypocretiniOrexin Antagonist (Almorexant) Versus a Standard Hypnotic (Zolpidem) and Placebo on

Comparing the Effects of Teen Mentors to Adult Teachers on Child Lifestyle Behaviors and Health Outcomes in Appalachia

ERIC Educational Resources Information Center

Smith, Laureen H.; Holloman, Christopher

2013-01-01

Childhood obesity prevalence rates in the United States are the highest in the rural Appalachian areas. Teens mentoring younger children to reverse obesity health risks are an understudied approach. This randomized-controlled trial compared the effects of two curriculum delivery methods and assessed the mediating effects of the number of sessions…

The Effects of a Computerized Study Program on the Acquisition of Science Vocabulary

ERIC Educational Resources Information Center

Rollins, Karen F.

2012-01-01

The following study examined the difference in science vocabulary acquisition comparing computer-assisted learning and a traditional study review sheet. Fourth and fifth grade students from a suburban school in central Texas were randomly selected and randomly assigned to either experimental group or control group. Both groups were given a…

Tic Reduction with Risperidone Versus Pimozide in a Randomized, Double-Blind, Crossover Trial

ERIC Educational Resources Information Center

Gilbert, Donald L.; Batterson, J. Robert; Sethuraman, Gopalan; Sallee, Floyd R.

2004-01-01

Objective: To compare the tic suppression, electrocardiogram (ECG) changes, weight gain, and side effect profiles of pimozide versus risperidone in children and adolescents with tic disorders. Method: This was a randomized, double-blind, crossover (evaluable patient analysis) study. Nineteen children aged 7 to 17 years with Tourette's or chronic…

Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. DESIGN: Multicenter, single blinded randomized trial (Lifestyle Interventions and ...

Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

ERIC Educational Resources Information Center

Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

2016-01-01

Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

Comparison of random regression models with Legendre polynomials and linear splines for production traits and somatic cell score of Canadian Holstein cows.

PubMed

Bohmanova, J; Miglior, F; Jamrozik, J; Misztal, I; Sullivan, P G

2008-09-01

A random regression model with both random and fixed regressions fitted by Legendre polynomials of order 4 was compared with 3 alternative models fitting linear splines with 4, 5, or 6 knots. The effects common for all models were a herd-test-date effect, fixed regressions on days in milk (DIM) nested within region-age-season of calving class, and random regressions for additive genetic and permanent environmental effects. Data were test-day milk, fat and protein yields, and SCS recorded from 5 to 365 DIM during the first 3 lactations of Canadian Holstein cows. A random sample of 50 herds consisting of 96,756 test-day records was generated to estimate variance components within a Bayesian framework via Gibbs sampling. Two sets of genetic evaluations were subsequently carried out to investigate performance of the 4 models. Models were compared by graphical inspection of variance functions, goodness of fit, error of prediction of breeding values, and stability of estimated breeding values. Models with splines gave lower estimates of variances at extremes of lactations than the model with Legendre polynomials. Differences among models in goodness of fit measured by percentages of squared bias, correlations between predicted and observed records, and residual variances were small. The deviance information criterion favored the spline model with 6 knots. Smaller error of prediction and higher stability of estimated breeding values were achieved by using spline models with 5 and 6 knots compared with the model with Legendre polynomials. In general, the spline model with 6 knots had the best overall performance based upon the considered model comparison criteria.

The Effects of Cognitive Therapy Versus ‘Treatment as Usual’ in Patients with Major Depressive Disorder

PubMed Central

Jakobsen, Janus Christian; Lindschou Hansen, Jane; Storebø, Ole Jakob; Simonsen, Erik; Gluud, Christian

2011-01-01

Background Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy may be an effective treatment option for major depressive disorder, but the effects have only had limited assessment in systematic reviews. Methods/Principal Findings Cochrane systematic review methodology, with meta-analyses and trial sequential analyses of randomized trials, are comparing the effects of cognitive therapy versus ‘treatment as usual’ for major depressive disorder. To be included the participants had to be older than 17 years with a primary diagnosis of major depressive disorder. Altogether, we included eight trials randomizing a total of 719 participants. All eight trials had high risk of bias. Four trials reported data on the 17-item Hamilton Rating Scale for Depression and four trials reported data on the Beck Depression Inventory. Meta-analysis on the data from the Hamilton Rating Scale for Depression showed that cognitive therapy compared with ‘treatment as usual’ significantly reduced depressive symptoms (mean difference −2.15 (95% confidence interval −3.70 to −0.60; P<0.007, no heterogeneity)). However, meta-analysis with both fixed-effect and random-effects model on the data from the Beck Depression Inventory (mean difference with both models −1.57 (95% CL −4.30 to 1.16; P = 0.26, I2 = 0) could not confirm the Hamilton Rating Scale for Depression results. Furthermore, trial sequential analysis on both the data from Hamilton Rating Scale for Depression and Becks Depression Inventory showed that insufficient data have been obtained. Discussion Cognitive therapy might not be an effective treatment for major depressive disorder compared with ‘treatment as usual’. The possible treatment effect measured on the Hamilton Rating Scale for Depression is relatively small. More randomized trials with low risk of bias, increased sample sizes, and broader more clinically relevant outcomes are needed. PMID:21829664

Post Hoc Analyses of Randomized Clinical Trial for the Effect of Clopidogrel Added to Aspirin on Kidney Function.

PubMed

Ikeme, Jesse C; Pergola, Pablo E; Scherzer, Rebecca; Shlipak, Michael G; Benavente, Oscar R; Peralta, Carmen A

2017-07-07

Despite the high burden of CKD, few specific therapies are available that can halt disease progression. In animal models, clopidogrel has emerged as a potential therapy to preserve kidney function. The effect of clopidogrel on kidney function in humans has not been established. The Secondary Prevention of Small Subcortical Strokes Study randomized participants with prior lacunar stroke to treatment with aspirin or aspirin plus clopidogrel. We compared annual eGFR decline and incidence of rapid eGFR decline (≥30% from baseline) using generalized estimating equations and interval-censored proportional hazards regression, respectively. We also stratified our analyses by baseline eGFR, systolic BP target, and time after randomization. At randomization, median age was 62 (interquartile range, 55-71) years old; 36% had a history of diabetes, 90% had hypertension, and the median eGFR was 81 (interquartile range, 65-94) ml/min per 1 m 2 . Persons receiving aspirin plus clopidogrel had an average annual change in kidney function of -1.39 (95% confidence interval, -1.15 to -1.62) ml/min per 1.73 m 2 per year compared with -1.52 (95% confidence interval, -1.30 to -1.74) ml/min per 1.73 m 2 per year among persons receiving aspirin only ( P =0.42). Rapid kidney function decline occurred in 21% of participants receiving clopidogrel plus aspirin compared with 22% of participants receiving aspirin plus placebo (hazard ratio, 0.94; 95% confidence interval, 0.79 to 1.10; P =0.42). Findings did not vary by baseline eGFR, time after randomization, or systolic BP target (all P values for interaction were >0.3). We found no effect of clopidogrel added to aspirin compared with aspirin alone on kidney function decline among persons with prior lacunar stroke. Copyright © 2017 by the American Society of Nephrology.

Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials.

PubMed

Carpenter, Joseph K; Andrews, Leigh A; Witcraft, Sara M; Powers, Mark B; Smits, Jasper A J; Hofmann, Stefan G

2018-06-01

The purpose of this study was to examine the efficacy of cognitive behavioral therapy (CBT) for anxiety-related disorders based on randomized placebo-controlled trials. We included 41 studies that randomly assigned patients (N = 2,843) with acute stress disorder, generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) to CBT or a psychological or pill placebo condition. Findings demonstrated moderate placebo-controlled effects of CBT on target disorder symptoms (Hedges' g = 0.56), and small to moderate effects on other anxiety symptoms (Hedges' g = 0.38), depression (Hedges' g = 0.31), and quality of life (Hedges' g = 0.30). Response rates in CBT compared to placebo were associated with an odds ratio of 2.97. Effects on the target disorder were significantly stronger for completer samples than intent-to-treat samples, and for individuals compared to group CBT in SAD and PTSD studies. Large effect sizes were found for OCD, GAD, and acute stress disorder, and small to moderate effect sizes were found for PTSD, SAD, and PD. In PTSD studies, dropout rates were greater in CBT (29.0%) compared to placebo (17.2%), but no difference in dropout was found across other disorders. Interventions primarily using exposure strategies had larger effect sizes than those using cognitive or cognitive and behavioral techniques, though this difference did not reach significance. Findings demonstrate that CBT is a moderately efficacious treatment for anxiety disorders when compared to placebo. More effective treatments are especially needed for PTSD, SAD, and PD. © 2018 Wiley Periodicals, Inc.

Survival After Neoadjuvant and Adjuvant Treatments Compared to Surgery Alone for Resectable Esophageal Carcinoma: A Network Meta-analysis.

PubMed

Pasquali, Sandro; Yim, Guang; Vohra, Ravinder S; Mocellin, Simone; Nyanhongo, Donald; Marriott, Paul; Geh, Ju Ian; Griffiths, Ewen A

2017-03-01

This network meta-analysis compared overall survival after neoadjuvant or adjuvant chemotherapy (CT), radiotherapy (RT), or combinations of both (chemoradiotherapy, CRT) or surgery alone to identify the most effective approach. The optimal treatment for resectable esophageal cancer is unknown. A search for randomized controlled trials reporting on neoadjuvant and adjuvant therapies was conducted. Using a network meta-analysis, treatments were ranked based on their effectiveness for improving survival. In 33 eligible randomized controlled trials, 6072 patients were randomized to receive either surgery alone (N = 2459) or neoadjuvant CT (N = 1332), RT (N = 58), and CRT (N = 1196) followed by surgery or surgery followed by adjuvant CT (N = 542), RT (N = 383), and CRT (N = 102). Twenty-one comparisons were generated. Neoadjuvant CRT followed by surgery compared with surgery alone was the only treatment to significantly improve survival [hazard ratio (HR) = 0.77, 95% confidence interval (CI): 0.68-0.87]. When trials were grouped considering neoadjuvant and adjuvant therapies and surgery alone, neoadjuvant therapies combined with surgery compared with surgery alone showed a survival advantage (HR = 0.83, 95% CI 0.76-0.90), whereas surgery along with adjuvant therapies showed no significant survival advantage (HR = 0.87, 95% CI 0.67-1.14). A subgroup analysis of neoadjuvant therapies showed a superior effectiveness of neoadjuvant CRT and surgery compared with surgery alone (HR = 0.77, 95% CI 0.68-0.87). This network meta-analysis showed neoadjuvant CRT followed by surgery to be the most effective strategy in improving survival of resectable esophageal cancer. Resources should be focused on developing the most effective neoadjuvant CRT regimens for both adenocarcinomas and squamous cell carcinomas of the esophagus.

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

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials. © The Author(s) 2014.

Rifampicin versus streptomycin for brucellosis treatment in humans: A meta-analysis of randomized controlled trials.

PubMed

Meng, Fanjie; Pan, Xiangpo; Tong, Wenzhen

2018-01-01

Brucellosis is a zoonotic disease with a high morbidity in developing countries, but there the optimal treatment is not yet determined. Therefore, the development of a simple and effective treatment is important. The aim of this study was to summarize the available evidences and compare rifampicin with streptomycin in human brucellosis with doxycycline as background regimen. We systematically searched PubMed, EmBase, and the Cochrane Library from their inception up through December 2016. We included studies with a randomized controlled design that evaluated the effect of streptomycin compared with rifampicin in human brucellosis patients who received doxycycline therapy as background regimen. The overall failure and relapse were summarized using random-effects model. Our meta-analysis included 1,383 patients with brucellosis from 14 trials. We found that patients who received rifampicin therapy had a higher risk of overall failure (RR: 2.36; 95% CI: 1.72-3.23; P<0.001) and relapse (RR: 2.74; 95% CI: 1.80-4.19; P<0.001) compared with streptomycin. Results of the sensitivity analysis were consistent with the overall analysis. Subgroup analysis indicated that mean age of the patients and percentage of male participants might influence the treatment effects. Furthermore, no publication bias was detected. The findings of this study indicated that rifampicin therapy significantly increased the risk of overall failure and relapse compared with streptomycin. Hence, it can be recommended to patients with human brucellosis receiving streptomycin therapy.

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.

Effect of soothing-liver and nourishing-heart acupuncture on early selective serotonin reuptake inhibitor treatment onset for depressive disorder and related indicators of neuroimmunology: a randomized controlled clinical trial.

PubMed

Liu, Yi; Feng, Hui; Mo, Yali; Gao, Jingfang; Mao, Hongjing; Song, Mingfen; Wang, Shengdong; Yin, Yan; Liu, Wenjuan

2015-10-01

To observe the effect of soothing-liver and nourishing-heart acupuncture on selective serotonin reuptake inhibitor (SSRIs) treatment effect onset in patients with depressive disorder and related indicators of neuroimmunology. Overall, 126 patients with depressive disorder were randomly divided into a medicine and acupuncture-medicine group using a random number table. Patients were treated for 6 consecutive weeks. The two groups were evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS) and Side Effects Rating Scale (SERS) to assess the effect of the soothing-liver and nourishing-heart acupuncture method on early onset of SSRI treatment effect. Changes in serum 5-hydroxytryptamine (5-HT) and inflammatory cytokines before and after treatment were recorded and compared between the medicine group and the acupuncture-medicine group. The acupuncture-medicine group had significantly lower MADRS scores at weeks 1, 2, 4, and 6 after treatment compared with the medicine group (P < 0.01). The acupuncture group had significantly lower SERS scores at weeks 1, 2, 4, and 6 after treatment compared with the medicine group (P < 0.01). At 6 weeks after treatment, serum 5-HT in the acupuncture-medicine group was significantly higher compared with the medicine group (P < 0.01). Interleukin-6 (IL-6) in the acupuncture-medicine group was significantly lower than that in the medicine group (P < 0.01), whereas there was no significant difference in IL-1β between the groups (P > 0.05). Anti-inflammatory cytokines IL-4 and IL-10 were significantly higher in the acupuncture-medicine group compared with the medicine group (P < 0.01, P < 0.05, respectively). The soothing-liver and nourishing-heart acupuncture method can effectively accelerate the onset of SSRI effects when treating depressive disorder and can significantly reduce the adverse reactions of SSRIs. Moreover, acupuncture can enhance serum 5-HT and regulate the balance of pro-inflammatory cytokines and anti-inflammatory cytokines.

Zhen Gan Xi Feng Decoction, a Traditional Chinese Herbal Formula, for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

PubMed Central

Xiong, Xingjiang; Yang, Xiaochen; Feng, Bo; Liu, Wei; Duan, Lian; Gao, Ao; Li, Haixia; Ma, Jizheng; Du, Xinliang; Li, Nan; Wang, Pengqian; Su, Kelei; Chu, Fuyong; Zhang, Guohao; Li, Xiaoke; Wang, Jie

2013-01-01

Objectives. To assess the clinical effectiveness and adverse effects of Zhen Gan Xi Feng Decoction (ZGXFD) for essential hypertension (EH). Methods. Five major electronic databases were searched up to August 2012 to retrieve any potential randomized controlled trials designed to evaluate the clinical effectiveness of ZGXFD for EH reported in any language, with main outcome measure as blood pressure (BP). Results. Six randomized trials were included. Methodological quality of the trials was evaluated as generally low. Four trials compared prescriptions based on ZGXFD with antihypertensive drugs. Meta-analysis showed that ZGXFD was more effective in BP control and TCM syndrome and symptom differentiation (TCM-SSD) scores than antihypertensive drugs. Two trials compared the combination of modified ZGXFD plus antihypertensive drugs with antihypertensive drugs. Meta-analysis showed that there is significant beneficial effect on TCM-SSD scores. However, no significant effect on BP was found. The safety of ZGXFD is still uncertain. Conclusions. ZGXFD appears to be effective in improving blood pressure and hypertension-related symptoms for EH. However, the evidence remains weak due to poor methodological quality of the included studies. More rigorous trials are warranted to support their clinical use. PMID:23573163

Melatonin for Atypical Antipsychotic-Induced Metabolic Adverse Effects: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Kamath, Ashwin; Rather, Zahoor Ahmad

2018-01-01

The objective of our study was to determine the effect of melatonin administration on atypical antipsychotic-induced metabolic adverse effects in patients with psychiatric disorders. A systematic search was performed in PUBMED, Cochrane Library, Scopus, Web of Science, and EBSCOhost electronic databases. Randomized controlled trials studying the effect of melatonin on antipsychotic-induced metabolic adverse effects were identified and subjected to meta-analysis. Four studies were included in the meta-analysis, including 57 patients on melatonin and 61 patients on placebo. Melatonin produced a significant decrease in the diastolic blood pressure compared with placebo (mean difference = -4.44 [95% CI, -7.00 to -1.88]; p = 0.0007; I 2 = 13%), but not the systolic blood pressure (mean difference = -4.23 [95% CI, -8.11 to -0.36]; p = 0.03; I 2 = 0%). Although a decrease in the body mass index was seen in the melatonin group, the difference was not significant in the random-effects analysis model. To conclude, in patients on atypical antipsychotics, melatonin at a dose of up to 5 mg/day for a treatment duration of up to 12 weeks attenuated the rise in diastolic blood pressure compared with placebo but had no significant effects on other metabolic parameters.

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

PubMed

Ghidey, Wendimagegn; Lesaffre, Emmanuel; Verbeke, Geert

2010-12-01

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

Comparative Effectiveness of Two Walking Interventions on Participation, Step Counts, and Health.

PubMed

Smith-McLallen, Aaron; Heller, Debbie; Vernisi, Kristin; Gulick, Diana; Cruz, Samantha; Snyder, Richard L

2017-03-01

To (1) compare the effects of two worksite-based walking interventions on employee participation rates; (2) compare average daily step counts between conditions, and; (3) examine the effects of increases in average daily step counts on biometric and psychologic outcomes. We conducted a cluster-randomized trial in which six employer groups were randomly selected and randomly assigned to condition. Four manufacturing worksites and two office-based worksite served as the setting. A total of 474 employees from six employer groups were included. A standard walking program was compared to an enhanced program that included incentives, feedback, competitive challenges, and monthly wellness workshops. Walking was measured by self-reported daily step counts. Survey measures and biometric screenings were administered at baseline and 3, 6, and 9 months after baseline. Analysis used linear mixed models with repeated measures. During 9 months, participants in the enhanced condition averaged 726 more steps per day compared with those in the standard condition (p < .001). A 1000-step increase in average daily steps was associated with significant weight loss for both men (-3.8 lbs.) and women (-2.1 lbs.), and reductions in body mass index (-0.41 men, -0.31 women). Higher step counts were also associated with improvements in mood, having more energy, and higher ratings of overall health. An enhanced walking program significantly increases participation rates and daily step counts, which were associated with weight loss and reductions in body mass index.

Systematic review: proton pump inhibitors (PPIs) for the healing of reflux oesophagitis - a comparison of esomeprazole with other PPIs.

PubMed

Edwards, S J; Lind, T; Lundell, L

2006-09-01

No randomized controlled trial has compared all the licensed standard dose proton pump inhibitors in the healing of reflux oesophagitis. To compare the effectiveness of esomeprazole with licensed standard dose proton pump inhibitors for healing of reflux oesophagitis (i.e. lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg). Systematic review of CENTRAL, BIOSIS, EMBASE and MEDLINE for randomized controlled trials in patients with reflux oesophagitis. Searching was completed in February 2005. Data on endoscopic healing rates at 4 and 8 weeks were extracted and re-analysed if not analysed by intention-to-treat. Meta-analysis was conducted using a fixed effects model. Of 133 papers identified in the literature search, six were of sufficient quality to be included in the analysis. No studies were identified comparing rabeprazole with esomeprazole. A meta-analysis of healing rates of esomeprazole 40 mg compared with standard dose proton pump inhibitors gave the following results: at 4 weeks [relative risk (RR) 0.92; 95% CI: 0.90, 0.94; P < 0.00001], and 8 weeks (RR 0.95; 95% CI: 0.94, 0.97; P < 0.00001). Publication bias did not have a significant impact on the results. The results were robust to changes in the inclusion/exclusion criteria and using a random effects model. Esomeprazole consistently demonstrates higher healing rates when compared with standard dose proton pump inhibitors.

Effects of Transcranial Direct Current Stimulation, Transcranial Pulsed Current Stimulation, and Their Combination on Brain Oscillations in Patients with Chronic Visceral Pain: A Pilot Crossover Randomized Controlled Study.

PubMed

Thibaut, Aurore; Russo, Cristina; Hurtado-Puerto, Aura Maria; Morales-Quezada, Jorge Leon; Deitos, Alícia; Petrozza, John Christopher; Freedman, Steven; Fregni, Felipe

2017-01-01

Chronic visceral pain (CVP) syndromes are persistently painful disorders with a remarkable lack of effective treatment options. This study aimed at evaluating the effects of different neuromodulation techniques in patients with CVP on cortical activity, through electreocephalography (EEG) and on pain perception, through clinical tests. A pilot crossover randomized controlled study. Out-patient. Adults with CVP (>3 months). Participants received four interventions in a randomized order: (1) transcranial pulsed current stimulation (tPCS) and active transcranial direct current stimulation (tDCS) combined, (2) tPCS alone, (3) tDCS alone, and (4) sham condition. Resting state quantitative electroencephalography (qEEG) and pain assessments were performed before and after each intervention. Results were compared with a cohort of 47 healthy controls. We enrolled six patients with CVP for a total of 21 visits completed. Compared with healthy participants, patients with CVP showed altered cortical activity characterized by increased power in theta, alpha and beta bands, and a significant reduction in the alpha/beta ratio. Regarding tES, the combination of tDCS with tPCS had no effect on power in any of the bandwidths, nor brain regions. Comparing tPCS with tDCS alone, we found that tPCS induced higher increase in power within the theta and alpha bandwidths. This study confirms that patients with CVP present abnormal EEG-indexed cortical activity compared with healthy controls. Moreover, we showed that combining two types of neurostimulation techniques had no effect, whereas the two interventions, when applied individually, have different neural signatures.

Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial.

PubMed

Balappanavar, Aswini Y; Sardana, Varun; Singh, Malkeet

2013-01-01

The aim of this study was to evaluate and compare the effectiveness of 0.5% tea, 2% neem, and 0.2% chlorhexidine mouthwashes on oral health. A randomized blinded controlled trial with 30 healthy human volunteers of age group 18-25 years was carried out. The subjects were randomly assigned to 3 groups i.e., group A - 0.2% chlorhexidine gluconate (bench mark control), Group B - 2% neem, and group C - 0.5% tea of 10 subjects per group. Plaque accumulation and gingival condition were recorded using plaque index and gingival index. Oral hygiene was assessed by simplified oral hygiene index (OHIS). Salivary pH was assessed by indikrom pH strips. Plaque, gingival, and simplified OHI scores as well as salivary pH were recorded at baseline, immediately after 1 st rinse, after 1 week, 2 nd week, and 3 rd week. The 3 rd week was skipped for group A. Mean plaque and gingival scores were reduced over the 3 week trial period for experimental and control groups. Anti-plaque effectiveness was observed in all groups and the highest being in group C (P < 0.05). Neem and tea showed comparative effectiveness on gingiva better than chlorhexidine (P < 0.05). The salivary pH rise was sustained and significant in Group B and C compared to Group A. Oral hygiene improvement was better appreciated in Group B and Group C. The effectiveness of 0.5% tea was more compared to 2% neem and 0.2% chlorhexidine mouth rinse.

Radioiodine therapy versus antithyroid drugs in Graves' disease: a meta-analysis of randomized controlled trials

PubMed Central

Qin, Lan

2016-01-01

Objective: This meta-analysis was performed to compare radioiodine therapy with antithyroid drugs in terms of clinical outcomes, including development or worsening of ophthalmopathy, hyperthyroid cure rate, hypothyroidism, relapse rate and adverse events. Methods: Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, SinoMed and National Knowledge Infrastructure, China, were systematically reviewed to compare the effects of radioiodine therapy with antithyroid drugs in patients with Graves' disease. Results were expressed as risk ratio with 95% confidence intervals (CIs) and weighted mean differences with 95% CIs. Pooled estimates were performed using a fixed-effects model or random-effects model, depending on the heterogeneity among studies. Results: 17 RCTs involving 4024 patients met the inclusion criteria and were included. Results showed that radioiodine treatment has increased risk in new ophthalmopathy, development or worsening of ophthalmopathy and hypothyroidism. Whereas, compared with antithyroid drugs, radioiodine treatment seems to have a higher hyperthyroid cure rate, lower recurrence rate and lower incidence of adverse events. Conclusion: Radioiodine therapy is associated with a higher hyperthyroid cure rate and lower relapse rate compared with antithyroid drugs. However, it also increases the risk of ophthalmopathy and hypothyroidism. Advances in knowledge: Considering that antithyroid drug treatment can be associated with unsatisfactory control of hyperthyroidism, we would recommend radioiodine therapy as the treatment of choice for patients with Graves' disease. PMID:27266544

Therapeutic effects of nandrolone and testosterone in adult male HIV patients with AIDS wasting syndrome (AWS): a randomized, double-blind, placebo-controlled trial.

PubMed

Sardar, Partha; Jha, Ayan; Roy, Deeptarka; Majumdar, Uddalak; Guha, Pradipta; Roy, Sabyasachi; Banerjee, Ramtanu; Banerjee, Amit Kumar; Bandyopadhyay, Dipanjan

2010-01-01

We aimed to compare therapeutic effects of intramuscular (IM) nandrolone decanoate and IM testosterone enanthate in male HIV patients with AIDS wasting syndrome (AWS) with placebo control. In this randomized, double-blind, placebo-controlled, 12-week trial, 104 patients with AWS who satisfied our inclusion criteria were randomly allotted in a 2:2:1 ratio to the 3 intervention groups: nandrolone, testosterone, and placebo. We administered 150 mg nandrolone and 250 mg testosterone (both IM, biweekly). The primary outcome measure was a comparison of absolute change in weight at 12 weeks between the nandrolone decanoate, testosterone, and placebo groups. Intent-to-treat analysis was done. The nandrolone group recorded maximum mean increase in weight (3.20 kg; post hoc P < .01 compared to placebo). Body mass index (BMI) of subjects in the nandrolone group had a significantly greater increase (mean = 1.28) compared to both testosterone (post hoc P < .05) and placebo (post hoc P < .01). Waist circumference and triceps skinfold thickness of patients on nandrolone showed similar results. Nandrolone also ensured a better quality of life. Patients with low testosterone level (<3 ng/mL) benefited immensely from nandrolone therapy, which increased their weight and BMI significantly compared to placebo (P < .05). Our trial demonstrates the superior therapeutic effects of nandrolone in male AWS patients, including the androgen deficient.

Genomic-Enabled Prediction Kernel Models with Random Intercepts for Multi-environment Trials.

PubMed

Cuevas, Jaime; Granato, Italo; Fritsche-Neto, Roberto; Montesinos-Lopez, Osval A; Burgueño, Juan; Bandeira E Sousa, Massaine; Crossa, José

2018-03-28

In this study, we compared the prediction accuracy of the main genotypic effect model (MM) without G×E interactions, the multi-environment single variance G×E deviation model (MDs), and the multi-environment environment-specific variance G×E deviation model (MDe) where the random genetic effects of the lines are modeled with the markers (or pedigree). With the objective of further modeling the genetic residual of the lines, we incorporated the random intercepts of the lines ([Formula: see text]) and generated another three models. Each of these 6 models were fitted with a linear kernel method (Genomic Best Linear Unbiased Predictor, GB) and a Gaussian Kernel (GK) method. We compared these 12 model-method combinations with another two multi-environment G×E interactions models with unstructured variance-covariances (MUC) using GB and GK kernels (4 model-method). Thus, we compared the genomic-enabled prediction accuracy of a total of 16 model-method combinations on two maize data sets with positive phenotypic correlations among environments, and on two wheat data sets with complex G×E that includes some negative and close to zero phenotypic correlations among environments. The two models (MDs and MDE with the random intercept of the lines and the GK method) were computationally efficient and gave high prediction accuracy in the two maize data sets. Regarding the more complex G×E wheat data sets, the prediction accuracy of the model-method combination with G×E, MDs and MDe, including the random intercepts of the lines with GK method had important savings in computing time as compared with the G×E interaction multi-environment models with unstructured variance-covariances but with lower genomic prediction accuracy. Copyright © 2018 Cuevas et al.

Genomic-Enabled Prediction Kernel Models with Random Intercepts for Multi-environment Trials

PubMed Central

Cuevas, Jaime; Granato, Italo; Fritsche-Neto, Roberto; Montesinos-Lopez, Osval A.; Burgueño, Juan; Bandeira e Sousa, Massaine; Crossa, José

2018-01-01

In this study, we compared the prediction accuracy of the main genotypic effect model (MM) without G×E interactions, the multi-environment single variance G×E deviation model (MDs), and the multi-environment environment-specific variance G×E deviation model (MDe) where the random genetic effects of the lines are modeled with the markers (or pedigree). With the objective of further modeling the genetic residual of the lines, we incorporated the random intercepts of the lines (l) and generated another three models. Each of these 6 models were fitted with a linear kernel method (Genomic Best Linear Unbiased Predictor, GB) and a Gaussian Kernel (GK) method. We compared these 12 model-method combinations with another two multi-environment G×E interactions models with unstructured variance-covariances (MUC) using GB and GK kernels (4 model-method). Thus, we compared the genomic-enabled prediction accuracy of a total of 16 model-method combinations on two maize data sets with positive phenotypic correlations among environments, and on two wheat data sets with complex G×E that includes some negative and close to zero phenotypic correlations among environments. The two models (MDs and MDE with the random intercept of the lines and the GK method) were computationally efficient and gave high prediction accuracy in the two maize data sets. Regarding the more complex G×E wheat data sets, the prediction accuracy of the model-method combination with G×E, MDs and MDe, including the random intercepts of the lines with GK method had important savings in computing time as compared with the G×E interaction multi-environment models with unstructured variance-covariances but with lower genomic prediction accuracy. PMID:29476023

Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial.

PubMed

Li, Juan; Ng, Ernest Hung Yu; Stener-Victorin, Elisabet; Hu, Zhenxing; Shao, Xiaoguang; Wang, Haiyan; Li, Meifang; Lai, Maohua; Xie, Changcai; Su, Nianjun; Yu, Chuyi; Liu, Jia; Wu, Taixiang; Ma, Hongxia

2017-03-09

Our prospective pilot study of acupuncture affecting insulin sensitivity on polycystic ovary syndrome (PCOS) combined with insulin resistance (IR) showed that acupuncture had a significant effect on improving the insulin sensitivity of PCOS. But there is still no randomized controlled trial to determine the effect of acupuncture on the insulin sensitivity in women with PCOS and IR. In this article, we present the protocol of a randomized controlled trial to compare the effect of true acupuncture on the insulin sensitivity of these patients compared with metformin and sham acupuncture. Acupuncture may be an effective therapeutic alternative that is superior to metformin and sham acupuncture in improving the insulin sensitivity of PCOS combined with IR. This study is a multi-center, controlled, double-blind, and randomized clinical trial aiming to evaluate the effect of acupuncture on the insulin sensitivity in PCOS combined with IR. In total 342 patients diagnosed with PCOS and IR will be enrolled. Participants will be randomized to one of the three groups: (1) true acupuncture + metformin placebo; (2) sham acupuncture + metformin, and (3) sham acupuncture + metformin placebo. Participants and assessors will be blinded. The acupuncture intervention will be given 3 days per week for a total of 48 treatment sessions during 4 months. Metformin (0.5 g per pill) or placebo will be given, three times per day, and for 4 months. Primary outcome measures are changes in homeostasis model assessment of insulin resistance (HOMA-IR) and improvement rate of HOMA-IR by oral glucose tolerance test (OGTT) and insulin releasing test (Ins). Secondary outcome measures are homeostasis model assessment-β (HOMA-β), area under the curve for glucose and insulin, frequency of regular menstrual cycles and ovulation, body composition, metabolic profile, hormonal profile, questionnaires, side effect profile, and expectation and credibility of treatment. Outcome measures are collected at baseline, at the end of treatments, and 3 months after the last acupuncture treatment. On completion of the screening visit, randomization will be conducted using a central randomization system. This study will investigate the effects of acupuncture on the insulin sensitivity of PCOS and IR women compared with metformin and sham acupuncture. We will test whether true acupuncture with needles placed in skeletal muscles and stimulated manually and by electrical stimulation is more effective than metformin and sham acupuncture with superficial needle placement with no manual or electrical stimulation in improving the insulin sensitivity in PCOS women with IR. ClinicalTrials.gov, NCT02491333 ; Chinese Clinical Trial Registry, ChiCTR-ICR-15006639. Registered on 24 June 2015.

Randomized Trial of the Effect of Four Second-Generation Antipsychotics and One First-Generation Antipsychotic on Cigarette Smoking, Alcohol, and Drug Use in Chronic Schizophrenia.

PubMed

Mohamed, Somaia; Rosenheck, Robert A; Lin, Haiqun; Swartz, Marvin; McEvoy, Joseph; Stroup, Scott

2015-07-01

No large-scale randomized trial has compared the effect of different second-generation antipsychotic drugs and any first-generation drug on alcohol, drug and nicotine use in patients with schizophrenia. The Clinical Antipsychotic Trial of Intervention Effectiveness study randomly assigned 1432 patients formally diagnosed with schizophrenia to four second-generation antipsychotic drugs (olanzapine, risperidone quetiapine, and ziprasidone) and one first-generation antipsychotic (perphenazine) and followed them for up to 18 months. Secondary outcome data documented cigarettes smoked in the past week and alcohol and drug use severity ratings. At baseline, 61% of patients smoked, 35% used alcohol, and 23% used illicit drugs. Although there were significant effects of time showing reduction in substance use over the 18 months (all p < 0.0001), this study found no evidence that any antipsychotic was robustly superior to any other in a secondary analysis of data on substance use outcomes from a large 18-month randomized schizophrenia trial.

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

PubMed

Gardiner, Paula; Lestoquoy, Anna Sophia; Gergen-Barnett, Katherine; Penti, Brian; White, Laura F; Saper, Robert; Fredman, Lisa; Stillman, Sarah; Lily Negash, N; Adelstein, Pamela; Brackup, Ivy; Farrell-Riley, Christine; Kabbara, Karim; Laird, Lance; Mitchell, Suzanne; Bickmore, Timothy; Shamekhi, Ameneh; Liebschutz, Jane M

2017-03-01

Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills. Copyright © 2016 Elsevier Inc. All rights reserved.

Methods to Limit Attrition in Longitudinal Comparative Effectiveness Trials: Lessons from the Lithium Use for Bipolar Disorder (LiTMUS) Study

PubMed Central

Sylvia, Louisa G.; Reilly-Harrington, Noreen A.; Leon, Andrew C.; Kansky, Christine I.; Ketter, Terence A.; Calabrese, Joseph R.; Thase, Michael E.; Bowden, Charles L.; Friedman, Edward S.; Ostacher, Michael J.; Iosifescu, Dan V.; Severe, Joanne; Nierenberg, Andrew A.

2013-01-01

Background High attrition rates which occur frequently in longitudinal clinical trials of interventions for bipolar disorder limit the interpretation of results. Purpose The aim of this article is to present design approaches that limited attrition in the Lithium Use for Bipolar Disorder (LiTMUS) Study. Methods LiTMUS was a 6-month randomized, longitudinal multi-site comparative effectiveness trial that examined bipolar participants who were at least mildly ill. Participants were randomized to either low to moderate doses of lithium or no lithium, in addition to other treatments needed for mood stabilization administered in a guideline-informed, empirically supported, and personalized fashion (N=283). Results Components of the study design that may have contributed to the low attrition rate of the study included use of: (1) an intent-to-treat design; (2) a randomized adjunctive single-blind design; (3) participant reimbursement; (4) intent-to-attend the next study visit (includes a discussion of attendance obstacles when intention is low); (5) quality care with limited participant burden; and (6) target windows for study visits. Limitations Site differences and the effectiveness and tolerability data have not been analyzed yet. Conclusions These components of the LiTMUS study design may have reduced the probability of attrition which would inform the design of future randomized clinical effectiveness trials. PMID:22076437

A randomized and placebo-controlled study to compare the skin-lightening efficacy and safety of lignin peroxidase cream vs. 2% hydroquinone cream.

PubMed

Mauricio, Tess; Karmon, Yoram; Khaiat, Alain

2011-12-01

  Historically, the most effective treatments for skin lightening have contained hydroquinone. However, there is a need for an effective alternative.   The purpose of this study was to evaluate the skin-lightening efficacy and safety of lignin peroxidase (LIP) creams using a regimen of both day and night products compared with twice-daily application of 2% hydroquinone cream and placebo in Asian women.   This was a randomized, double-blind, placebo-controlled, split-face, single-center study of 51 patients. Patients were randomized to receive day and night LIP cream on one randomly selected side of their face and either 2% hydroquinone cream or placebo on the other.   A statistically significant change from baseline in the melanin index was observed in LIP-treated skin, with a mean reduction of 7.6% (P < 0.001) on Day 31. Conversely, hydroquinone and placebo did not provide a statistically significant lightening effect when instrumentally measured. Dermatologist scoring demonstrated a significant improvement in overall fairness as early as 8 days after treatment initiation in the LIP-treated group, which was not observed in the other groups. Overall, patients preferred the LIP creams.   The application of day/night LIP cream provided a significantly more rapid and observable skin-lightening effect than hydroquinone 2% cream or placebo. © 2011 Wiley Periodicals, Inc.

Simulation of diffuse-charge capacitance in electric double layer capacitors

NASA Astrophysics Data System (ADS)

Sun, Ning; Gersappe, Dilip

2017-01-01

We use a Lattice Boltzmann Model (LBM) in order to simulate diffuse-charge dynamics in Electric Double Layer Capacitors (EDLCs). Simulations are carried out for both the charge and the discharge processes on 2D systems of complex random electrode geometries (pure random, random spheres and random fibers). The steric effect of concentrated solutions is considered by using a Modified Poisson-Nernst-Planck (MPNP) equations and compared with regular Poisson-Nernst-Planck (PNP) systems. The effects of electrode microstructures (electrode density, electrode filler morphology, filler size, etc.) on the net charge distribution and charge/discharge time are studied in detail. The influence of applied potential during discharging process is also discussed. Our studies show how electrode morphology can be used to tailor the properties of supercapacitors.

A health economic outcome evaluation of an internet-based mobile-supported stress management intervention for employees.

PubMed

Ebert, David Daniel; Kählke, Fanny; Buntrock, Claudia; Berking, Matthias; Smit, Filip; Heber, Elena; Baumeister, Harald; Funk, Burkhardt; Riper, Heleen; Lehr, Dirk

2018-03-01

Objective This study aimed to estimate and evaluate the cost-effectiveness and cost-benefit of a guided internet- and mobile-supported occupational stress-management intervention (iSMI) for employees from the employer's perspective alongside a randomized controlled trial. Methods A sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale, PSS-10 ≥22) was randomly assigned either to the iSMI or a waitlist control (WLC) group with unrestricted access to treatment as usual. The iSMI consisted of seven sessions of problem-solving and emotion-regulation techniques and one booster session. Self-report data on symptoms of perceived stress and economic data were assessed at baseline, and at six months following randomization. A cost-benefit analysis (CBA) and a cost-effectiveness analysis (CEA) with symptom-free status as the main outcome from the employer's perspective was carried out. Statistical uncertainty was estimated using bootstrapping (N=5000). Results The CBA yielded a net-benefit of EUR181 [95% confidence interval (CI) -6043-1042] per participant within the first six months following randomization. CEA showed that at a willingness-to-pay ceiling of EUR0, EUR1000, EUR2000 for one additional symptom free employee yielded a 67%, 90%, and 98% probability, respectively, of the intervention being cost-effective compared to the WLC. Conclusion The iSMI was cost-effective when compared to WLC and even lead to cost savings within the first six months after randomization. Offering stress-management interventions can present good value for money in occupational healthcare.

Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness.

PubMed

Cohen, Steven P; Peterlin, B Lee; Fulton, Larry; Neely, Edward T; Kurihara, Connie; Gupta, Anita; Mali, Jimmy; Fu, Diana C; Jacobs, Michael B; Plunkett, Anthony R; Verdun, Aubrey J; Stojanovic, Milan P; Hanling, Steven; Constantinescu, Octav; White, Ronald L; McLean, Brian C; Pasquina, Paul F; Zhao, Zirong

2015-12-01

Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline -2.743 ± 2.487 vs -1.377 ± 1.970; P < 0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.

Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness

PubMed Central

Cohen, Steven P.; Peterlin, B. Lee; Fulton, Larry; Neely, Edward T.; Kurihara, Connie; Gupta, Anita; Mali, Jimmy; Fu, Diana C.; Jacobs, Michael B.; Plunkett, Anthony R.; Verdun, Aubrey J.; Stojanovic, Milan P.; Hanling, Steven; Constantinescu, Octav; White, Ronald L.; McLean, Brian C.; Pasquina, Paul F.; Zhao, Zirong

2015-01-01

Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. Forty-two participants were randomized to receive local anesthetic and saline, and three 120 second cycles of PRF per targeted nerve, and 39 were randomized to receive local anesthetic mixed with deposteroid and 3 rounds of sham PRF. Patients, treating physicians, and evaluators were blinded to interventions. The PRF group experienced a greater reduction in the primary outcome measure, average occipital pain at 6 weeks (mean change from baseline −2.743 ± 2.487 vs −1.377 ± 1.970; P <0.001), than the steroid group, which persisted through the 6-month follow-up. Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline−1.925 ± 3.204 vs−0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline −2.738 ± 2.753 vs −1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures. PMID:26447705

Disease Mapping of Zero-excessive Mesothelioma Data in Flanders

PubMed Central

Neyens, Thomas; Lawson, Andrew B.; Kirby, Russell S.; Nuyts, Valerie; Watjou, Kevin; Aregay, Mehreteab; Carroll, Rachel; Nawrot, Tim S.; Faes, Christel

2016-01-01

Purpose To investigate the distribution of mesothelioma in Flanders using Bayesian disease mapping models that account for both an excess of zeros and overdispersion. Methods The numbers of newly diagnosed mesothelioma cases within all Flemish municipalities between 1999 and 2008 were obtained from the Belgian Cancer Registry. To deal with overdispersion, zero-inflation and geographical association, the hurdle combined model was proposed, which has three components: a Bernoulli zero-inflation mixture component to account for excess zeros, a gamma random effect to adjust for overdispersion and a normal conditional autoregressive random effect to attribute spatial association. This model was compared with other existing methods in literature. Results The results indicate that hurdle models with a random effects term accounting for extra-variance in the Bernoulli zero-inflation component fit the data better than hurdle models that do not take overdispersion in the occurrence of zeros into account. Furthermore, traditional models that do not take into account excessive zeros but contain at least one random effects term that models extra-variance in the counts have better fits compared to their hurdle counterparts. In other words, the extra-variability, due to an excess of zeros, can be accommodated by spatially structured and/or unstructured random effects in a Poisson model such that the hurdle mixture model is not necessary. Conclusions Models taking into account zero-inflation do not always provide better fits to data with excessive zeros than less complex models. In this study, a simple conditional autoregressive model identified a cluster in mesothelioma cases near a former asbestos processing plant (Kapelle-op-den-Bos). This observation is likely linked with historical local asbestos exposures. Future research will clarify this. PMID:27908590

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

PubMed Central

Churilov, Leonid

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting. PMID:29659631

Disease mapping of zero-excessive mesothelioma data in Flanders.

PubMed

Neyens, Thomas; Lawson, Andrew B; Kirby, Russell S; Nuyts, Valerie; Watjou, Kevin; Aregay, Mehreteab; Carroll, Rachel; Nawrot, Tim S; Faes, Christel

2017-01-01

To investigate the distribution of mesothelioma in Flanders using Bayesian disease mapping models that account for both an excess of zeros and overdispersion. The numbers of newly diagnosed mesothelioma cases within all Flemish municipalities between 1999 and 2008 were obtained from the Belgian Cancer Registry. To deal with overdispersion, zero inflation, and geographical association, the hurdle combined model was proposed, which has three components: a Bernoulli zero-inflation mixture component to account for excess zeros, a gamma random effect to adjust for overdispersion, and a normal conditional autoregressive random effect to attribute spatial association. This model was compared with other existing methods in literature. The results indicate that hurdle models with a random effects term accounting for extra variance in the Bernoulli zero-inflation component fit the data better than hurdle models that do not take overdispersion in the occurrence of zeros into account. Furthermore, traditional models that do not take into account excessive zeros but contain at least one random effects term that models extra variance in the counts have better fits compared to their hurdle counterparts. In other words, the extra variability, due to an excess of zeros, can be accommodated by spatially structured and/or unstructured random effects in a Poisson model such that the hurdle mixture model is not necessary. Models taking into account zero inflation do not always provide better fits to data with excessive zeros than less complex models. In this study, a simple conditional autoregressive model identified a cluster in mesothelioma cases near a former asbestos processing plant (Kapelle-op-den-Bos). This observation is likely linked with historical local asbestos exposures. Future research will clarify this. Copyright © 2016 Elsevier Inc. All rights reserved.

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study.

PubMed

Chiam, Elizabeth; Bellomo, Rinaldo; Churilov, Leonid; Weinberg, Laurence

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting.

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.

Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

PubMed

Carlson, Linda E; Zelinski, Erin L; Speca, Michael; Balneaves, Lynda G; Jones, Jennifer M; Santa Mina, Daniel; Wayne, Peter M; Campbell, Tavis S; Giese-Davis, Janine; Faris, Peter; Zwicker, Jennifer; Patel, Kamala; Beattie, Tara L; Cole, Steve; Toivonen, Kirsti; Nation, Jill; Peng, Philip; Thong, Bruce; Wong, Raimond; Vohra, Sunita

2017-08-01

A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics. The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system. Copyright © 2017 Elsevier Inc. All rights reserved.

Acute dark chocolate and cocoa ingestion and endothelial function: a randomized controlled crossover trial.

PubMed

Faridi, Zubaida; Njike, Valentine Yanchou; Dutta, Suparna; Ali, Ather; Katz, David L

2008-07-01

Studies suggest cardioprotective benefits of dark chocolate containing cocoa. This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults. Randomized, placebo-controlled, single-blind crossover trial of 45 healthy adults [mean age: 53 y; mean body mass index (in kg/m(2)): 30]. In phase 1, subjects were randomly assigned to consume a solid dark chocolate bar (containing 22 g cocoa powder) or a cocoa-free placebo bar (containing 0 g cocoa powder). In phase 2, subjects were randomly assigned to consume sugar-free cocoa (containing 22 g cocoa powder), sugared cocoa (containing 22 g cocoa powder), or a placebo (containing 0 g cocoa powder). Solid dark chocolate and liquid cocoa ingestion improved endothelial function (measured as flow-mediated dilatation) compared with placebo (dark chocolate: 4.3 +/- 3.4% compared with -1.8 +/- 3.3%; P < 0.001; sugar-free and sugared cocoa: 5.7 +/- 2.6% and 2.0 +/- 1.8% compared with -1.5 +/- 2.8%; P < 0.001). Blood pressure decreased after the ingestion of dark chocolate and sugar-free cocoa compared with placebo (dark chocolate: systolic, -3.2 +/- 5.8 mm Hg compared with 2.7 +/- 6.6 mm Hg; P < 0.001; and diastolic, -1.4 +/- 3.9 mm Hg compared with 2.7 +/- 6.4 mm Hg; P = 0.01; sugar-free cocoa: systolic, -2.1 +/- 7.0 mm Hg compared with 3.2 +/- 5.6 mm Hg; P < 0.001; and diastolic: -1.2 +/- 8.7 mm Hg compared with 2.8 +/- 5.6 mm Hg; P = 0.014). Endothelial function improved significantly more with sugar-free than with regular cocoa (5.7 +/- 2.6% compared with 2.0 +/- 1.8%; P < 0.001). The acute ingestion of both solid dark chocolate and liquid cocoa improved endothelial function and lowered blood pressure in overweight adults. Sugar content may attenuate these effects, and sugar-free preparations may augment them.

A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.

PubMed

Piccini, Jonathan P; Connolly, Stuart J; Abraham, William T; Healey, Jeff S; Steinberg, Benjamin A; Al-Khalidi, Hussein R; Dignacco, Patricia; van Veldhuisen, Dirk J; Sauer, William H; White, Michel; Wilton, Stephen B; Anand, Inder S; Dufton, Christopher; Marshall, Debra A; Aleong, Ryan G; Davis, Gordon W; Clark, Richard L; Emery, Laura L; Bristow, Michael R

2018-05-01

Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. The Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Metoprolol Succinate for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure (GENETIC-AF) trial is a multicenter, randomized, double-blinded "seamless" phase 2B/3 trial of bucindolol hydrochloride versus metoprolol succinate, for the prevention of symptomatic AF/AFL in patients with reduced ejection fraction heart failure (HFrEF). Patients with pre-existing HFrEF and recent history of symptomatic AF are eligible for enrollment and genotype screening, and if they are ADRB1 Arg389Arg, eligible for randomization. A total of approximately 200 patients will comprise the phase 2B component and if pre-trial assumptions are met, 620 patients will be randomized at approximately 135 sites to form the Phase 3 population. The primary endpoint is the time to recurrence of symptomatic AF/AFL or mortality over a 24-week follow-up period, and the trial will continue until 330 primary endpoints have occurred. GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. (ClinicalTrials.govNCT01970501). Copyright © 2017 Elsevier Inc. All rights reserved.

An in silico approach helped to identify the best experimental design, population, and outcome for future randomized clinical trials.

PubMed

Bajard, Agathe; Chabaud, Sylvie; Cornu, Catherine; Castellan, Anne-Charlotte; Malik, Salma; Kurbatova, Polina; Volpert, Vitaly; Eymard, Nathalie; Kassai, Behrouz; Nony, Patrice

2016-01-01

The main objective of our work was to compare different randomized clinical trial (RCT) experimental designs in terms of power, accuracy of the estimation of treatment effect, and number of patients receiving active treatment using in silico simulations. A virtual population of patients was simulated and randomized in potential clinical trials. Treatment effect was modeled using a dose-effect relation for quantitative or qualitative outcomes. Different experimental designs were considered, and performances between designs were compared. One thousand clinical trials were simulated for each design based on an example of modeled disease. According to simulation results, the number of patients needed to reach 80% power was 50 for crossover, 60 for parallel or randomized withdrawal, 65 for drop the loser (DL), and 70 for early escape or play the winner (PW). For a given sample size, each design had its own advantage: low duration (parallel, early escape), high statistical power and precision (crossover), and higher number of patients receiving the active treatment (PW and DL). Our approach can help to identify the best experimental design, population, and outcome for future RCTs. This may be particularly useful for drug development in rare diseases, theragnostic approaches, or personalized medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

Metacognitive therapy versus cognitive behavioural therapy for depression: a randomized pilot study.

PubMed

Jordan, Jennifer; Carter, Janet D; McIntosh, Virginia V W; Fernando, Kumari; Frampton, Christopher M A; Porter, Richard J; Mulder, Roger T; Lacey, Cameron; Joyce, Peter R

2014-10-01

Metacognitive therapy (MCT) is one of the newer developments within cognitive therapy. This randomized controlled pilot study compared independently applied MCT with cognitive behavioural therapy (CBT) in outpatients with depression to explore the relative speed and efficacy of MCT, ahead of a planned randomized controlled trial. A total of 48 participants referred for outpatient therapy were randomized to up to 12 weeks of MCT or CBT. Key outcomes were reduction in depressive symptoms at week 4 and week 12, measured using the independent-clinician-rated Quick Inventory of Depressive Symptomatology16. Intention-to-treat and completer analyses as well as additional methods of reporting outcome of depression are presented. Both therapies were effective in producing clinically significant change in depressive symptoms, with moderate-to-large effect sizes obtained. No differences were detected between therapies in overall outcome or early change on clinician-rated or self-reported measures. Post-hoc analyses suggest that MCT may have been adversely affected by greater comorbidity. In this large pilot study conducted independently of MCT's developers, MCT was an effective treatment for outpatients with depression, with similar results overall to CBT. Insufficient power and imbalanced comorbidity limit conclusions regarding comparative efficacy so further studies of MCT and CBT are required. © The Royal Australian and New Zealand College of Psychiatrists 2014.

Artemisinin derivatives for treating severe malaria.

PubMed

McIntosh, H M; Olliaro, P

2000-01-01

Artemisinin derivatives may have advantages over quinoline drugs for treating severe malaria since they are fast acting and effective against quinine resistant malaria parasites. The objective of this review was to assess the effects of artemisinin drugs for severe and complicated falciparum malaria in adults and children. We searched the Cochrane Infectious Diseases Group trials register, Cochrane Controlled Trials Register, Medline, Embase, Science Citation Index, Lilacs, African Index Medicus, conference abstracts and reference lists of articles. We contacted organisations, researchers in the field and drug companies. Randomised and pseudo-randomised trials comparing artemisinin drugs (rectal, intramuscular or intravenous) with standard treatment, or comparisons between artemisinin derivatives in adults or children with severe or complicated falciparum malaria. Eligibility, trial quality assessment and data extraction were done independently by two reviewers. Study authors were contacted for additional information. Twenty three trials are included, allocation concealment was adequate in nine. Sixteen trials compared artemisinin drugs with quinine in 2653 patients. Artemisinin drugs were associated with better survival (mortality odds ratio 0.61, 95% confidence interval 0.46 to 0.82, random effects model). In trials where concealment of allocation was adequate (2261 patients), this was barely statistically significant (odds ratio 0.72, 95% CI 0.54 to 0.96, random effects model). In 1939 patients with cerebral malaria, mortality was also lower with artemisinin drugs overall (odds ratio 0.63, 95% CI 0.44 to 0.88, random effects model). The difference was not significant however when only trials reporting adequate concealment of allocation were analysed (odds ratio 0.78, 95% CI 0.55 to 1.10, random effects model) based on 1607 patients. No difference in neurological sequelae was shown. Compared with quinine, artemisinin drugs showed faster parasite clearance from the blood and similar adverse effects. The evidence suggests that artemisinin drugs are no worse than quinine in preventing death in severe or complicated malaria. No artemisinin derivative appears to be better than the others.

A randomized, controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine (Tylenol 3) after outpatient breast surgery.

PubMed

Mitchell, Alex; McCrea, Patrick; Inglis, Karen; Porter, Geoffrey

2012-11-01

The combination of acetaminophen, codeine, and caffeine (Tylenol 3, T3) is a standard postoperative analgesia after breast surgery despite the adverse effects and variable efficacy of narcotics. This study compared the efficacy of a nonnarcotic approach (acetaminophen and ibuprofen; AcIBU) to T3 after outpatient breast surgery. This double-blind randomized equivalence trial involved patients undergoing outpatient breast surgery. Patients were randomized (stratified by procedure type) to receive AcIBU or T3 four times daily for 7 days, or until free of pain. Pain intensity, measured four times daily by the visual analog scale, was the primary outcome; secondary outcomes were pain relief with analgesic, days until freedom from pain, adverse effects, discontinuation of drug as a result of adverse effects, and patient satisfaction. There were 71 patients randomized to AcIBU and 70 patients to T3. Repeated measures analysis showed no significant difference in average pain intensity over 7 days (AcIBU 19.9 mm vs. T3 20.6 mm; P = 0.78). Similarly, there was no significant difference in pain relief with analgesic (P = 0.46). Although no difference in the incidence of adverse effects was observed (P = 0.94), discontinuation of the study drug as a result of adverse effects was more common with T3 (19 % vs. 6 %; P = 0.018). No significant differences were identified in days until freedom from pain or patient satisfaction; 92 % of AcIBU and 89 % of T3 patients were satisfied with their pain control (P = 0.55). AcIBU is a safe, effective method of pain control after outpatient breast surgery. Compared to T3, it provides at least equivalent analgesia and has a more tolerable adverse effect profile.

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

PubMed

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

2017-12-01

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

Single versus double embryo transfer: cost-effectiveness analysis alongside a randomized clinical trial.

PubMed

Fiddelers, Audrey A A; van Montfoort, Aafke P A; Dirksen, Carmen D; Dumoulin, John C M; Land, Jolande A; Dunselman, Gerard A J; Janssen, J Marij; Severens, Johan L; Evers, Johannes L H

2006-08-01

Twin pregnancies after IVF are still frequent and are considered high-risk pregnancies leading to high costs. Transferring one embryo can reduce the twin pregnancy rate. We compared cost-effectiveness of one fresh cycle elective single embryo transfer (eSET) versus one fresh cycle double embryo transfer (DET) in an unselected patient population. Patients starting their first IVF cycle were randomized between eSET and DET. Societal costs per couple were determined empirically, from hormonal stimulation up to 42 weeks after embryo transfer. An incremental cost-effectiveness ratio (ICER) was calculated, representing additional costs per successful pregnancy. Successful pregnancy rates were 20.8% for eSET and 39.6% for DET. Societal costs per couple were significantly lower after eSET (7334 euro) compared with DET (10,924 euro). The ICER of DET compared with eSET was 19,096 euro, meaning that each additional successful pregnancy in the DET group will cost 19,096 euro extra. One cycle eSET was less expensive, but also less effective compared to one cycle DET. It depends on the society's willingness to pay for one extra successful pregnancy, whether one cycle DET is preferred from a cost-effectiveness point of view.

Efficacy and side-effect profiles of lactulose, docusate sodium, and sennosides compared to PEG in opioid-induced constipation: a systematic review.

PubMed

Ruston, Teresa; Hunter, Kathleen; Cummings, Greta; Lazarescu, Adriana

2013-01-01

Opioid-induced constipation (OIC) is a side effect of opioid therapy that can affect quality of life, adherence to treatment, and morbidity and possibly mortality. To investigate whether docusate sodium, sennosides, and lactulose have equal efficacy and side effect profiles compared to PEG in the management of OIC in adults. A systematic review was undertaken. Randomized controlled trials of adults taking opioids for cancer or non-cancer pain were considered if they met inclusion criteria. Statistical pooling was not possible as no studies met inclusion criteria. Large, well-powered, randomized controlled trials are feasible. Standard definitions of OIC would assist with the execution of these studies and contribute to their internal and external validity. Further research is strongly encouraged.

A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

ERIC Educational Resources Information Center

Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

2014-01-01

Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

Randomized Controlled Trial of Teaching Methods: Do Classroom Experiments Improve Economic Education in High Schools?

ERIC Educational Resources Information Center

Eisenkopf, Gerald; Sulser, Pascal A.

2016-01-01

The authors present results from a comprehensive field experiment at Swiss high schools in which they compare the effectiveness of teaching methods in economics. They randomly assigned classes into an experimental and a conventional teaching group, or a control group that received no specific instruction. Both teaching treatments improve economic…

Randomized Trial Comparison of Emotion Regulation and Relational Psychotherapies for PTSD with Girls Involved in Delinquency

ERIC Educational Resources Information Center

Ford, Julian D.; Steinberg, Karen L.; Hawke, Josephine; Levine, Joan; Zhang, Wanli

2012-01-01

Posttraumatic stress disorder (PTSD) is prevalent in youth involved in delinquency, but it is often not effectively treated. A randomized clinical trial was conducted comparing the outcomes of an emotion regulation therapy (Trauma Affect Regulation: Guide for Education and Therapy, or TARGET) with a relational supportive therapy (Enhanced…

A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Lerner, Matthew D.; Mikami, Amori Y.

2012-01-01

This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

Conduct Problems and Peer Rejection in Childhood: A Randomized Trial of the Making Choices and Strong Families Programs

ERIC Educational Resources Information Center

Fraser, Mark W.; Day, Steven H.; Galinsky, Maeda J.; Hodges, Vanessa G.; Smokowski, Paul R.

2004-01-01

This article discusses the effectiveness of a multicomponent intervention designed to disrupt developmental processes associated with conduct problems and peer rejection in childhood. Compared with 41 children randomized to a wait list control condition, 45 children in an intervention condition received a social skills training program. At the…

Effectiveness of Multidimensional Family Therapy with Higher Severity Substance-Abusing Adolescents: Report from Two Randomized Controlled Trials

ERIC Educational Resources Information Center

Henderson, Craig E.; Dakof, Gayle A.; Greenbaum, Paul E.; Liddle, Howard A.

2010-01-01

Objective: We used growth mixture modeling to examine heterogeneity in treatment response in a secondary analysis of 2 randomized controlled trials testing multidimensional family therapy (MDFT), an established evidence-based therapy for adolescent drug abuse and delinquency. Method: The first study compared 2 evidence-based adolescent substance…

Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

2013-01-01

Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

Multisite Randomized Trial of Behavioral Interventions for Women with Co-Occurring PTSD and Substance Use Disorders

ERIC Educational Resources Information Center

Hien, Denise A.; Wells, Elizabeth A.; Jiang, Huiping; Suarez-Morales, Lourdes; Campbell, Aimee N. C.; Cohen, Lisa R.; Miele, Gloria M.; Killeen, Therese; Brigham, Gregory S.; Zhang, Yulei; Hansen, Cheri; Hodgkins, Candace; Hatch-Maillette, Mary; Brown, Chanda; Kulaga, Agatha; Kristman-Valente, Allison; Chu, Melissa; Sage, Robert; Robinson, James A.; Liu, David; Nunes, Edward V.

2009-01-01

The authors compared the effectiveness of the Seeking Safety group, cognitive-behavioral treatment for substance use disorder and posttraumatic stress disorder (PTSD), to an active comparison health education group (Women's Health Education [WHE]) within the National Institute on Drug Abuse's Clinical Trials Network. The authors randomized 353…

A Randomized Comparison of the Effect of Two Prelinguistic Communication Interventions on the Acquisition of Spoken Communication in Preschoolers with ASD

ERIC Educational Resources Information Center

Yoder, Paul; Stone, Wendy L.

2006-01-01

Purpose: This randomized group experiment compared the efficacy of 2 communication interventions (Responsive Education and Prelinguistic Milieu Teaching [RPMT] and the Picture Exchange Communication System [PECS]) on spoken communication in 36 preschoolers with autism spectrum disorders (ASD). Method: Each treatment was delivered to children for a…

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

ERIC Educational Resources Information Center

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

2004-01-01

The authors compared simultaneous versus sequential approaches to multiple health behavior change in diet, exercise, and cigarette smoking. Female regular smokers (N = 315) randomized to 3 conditions received 16 weeks of behavioral smoking treatment, quit smoking at Week 5, and were followed for 9 months after quit date. Weight management was…

Neuroprotection after a first episode of mania: a randomized controlled maintenance trial comparing the effects of lithium and quetiapine on grey and white matter volume

PubMed Central

Berk, M; Dandash, O; Daglas, R; Cotton, S M; Allott, K; Fornito, A; Suo, C; Klauser, P; Liberg, B; Henry, L; Macneil, C; Hasty, M; McGorry, P; Pantelis, Cs; Yücel, M

2017-01-01

Lithium and quetiapine are effective treatments for bipolar disorder, but their potential neuroprotective effects in humans remain unclear. A single blinded equivalence randomized controlled maintenance trial was conducted in a prospective cohort of first-episode mania (FEM) patients (n=26) to longitudinally compare the putative protective effects of lithium and quetapine on grey and white matter volume. A healthy control sample was also collected (n=20). Using structural MRI scans, voxel-wise grey and white matter volumes at baseline and changes over time in response to treatment were investigated. Patients were assessed at three time points (baseline, 3 and 12-month follow-up), whereas healthy controls were assessed at two time points (baseline and 12-month follow-up). Patients were randomized to lithium (serum level 0.6 mmol l−1, n=20) or quetiapine (flexibly dosed up to 800 mg per day, n=19) monotherapy. At baseline, compared with healthy control subjects, patients with FEM showed reduced grey matter in the orbitofrontal cortex, anterior cingulate, inferior frontal gyrus and cerebellum. In addition, patients had reduced internal capsule white matter volume bilaterally (t1,66>3.20, P<0.01). Longitudinally, there was a significant treatment × time effect only in the white matter of the left internal capsule (F2,112=8.54, P<0.01). Post hoc testing showed that, compared with baseline, lithium was more effective than quetiapine in slowing the progression of white matter volume reduction after 12 months (t1,24=3.76, P<0.01). Our data support the role of lithium but not quetiapine therapy in limiting white matter reduction early in the illness course after FEM. PMID:28117843

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

PubMed

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

2014-05-21

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

Ablative fractional lasers (CO(2) and Er:YAG): a randomized controlled double-blind split-face trial of the treatment of peri-orbital rhytides.

PubMed

Karsai, Syrus; Czarnecka, Agnieszka; Jünger, Michael; Raulin, Christian

2010-02-01

Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO(2) and Er:YAG lasers. The present study compares these modalities in a randomized controlled double-blind split-face study design. Twenty-eight patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO(2) and one with a fractional Er:YAG laser. The evaluation included the profilometric measurement of wrinkle depth, the Fitzpatrick wrinkle score (both before and 3 months after treatment) as well as the assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment). Both modalities showed a roughly equivalent effect. Wrinkle depth and Fitzpatrick score were reduced by approximately 20% and 10%, respectively, with no appreciable difference between lasers. Side effects and discomfort were slightly more pronounced after Er:YAG treatment in the first few days, but in the later course there were more complaints following CO(2) laser treatment. Patient satisfaction was fair and the majority of patients would have undergone the treatment again without a clear preference for either method. According to the present study, a single ablative fractional treatment session has an appreciable yet limited effect on peri-orbital rhytides. When fractional CO(2) and Er:YAG lasers are used in such a manner that there are comparable post-operative healing periods, comparable cosmetic improvement occurs. Multiple sessions may be required for full effect, which cancels out the proposed advantage of fractional methods, that is, fewer side effects and less down time.

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

PubMed

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

2018-06-02

The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand the ability of small primary care practices to improve "ABCS" clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed to assess feasibility of implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) quality improvement (QI) strategies to improve ABCS at practices in Illinois, Indiana, and Wisconsin. We describe the design and randomization of the H3 study. We conducted a two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness study in 226 primary care practices across four "waves" of randomization with a 12-month intervention period, followed by a six-month sustainability period. Randomization controlled imbalance in nine baseline variables through a modified constrained algorithm. Among others, we used initial, unverified estimates of baseline ABCS values. We randomized 112 and 114 practices to POC and POC + PM arms, respectively. Randomization ensured baseline comparability for all nine key variables, including the ABCS measures indicating proportion of patients at the practice level meeting each quality measure. Median(Inner Quartile Range) values were A: 0.78(0.66-0.86) in POC arm vs. 0.77(0.63-0.86) in POC + PM arm, B: 0.64(0.53-0.73) vs. 0.64(0.53-0.75), C: 0.78(0.63-0.86) vs. 0.75(0.64-0.81), S: 0.80(0.65-0.81) vs. 0.79(0.61-0.91). Surrogate estimates for the true ABCS at baseline coupled with the unique randomization logic achieved adequate baseline balance on these outcomes. Similar practice- or cluster-randomized trials may consider adaptations of this design. Final analyses on 12- and 18-month ABCS outcomes for the H3 study are forthcoming. This trial is registered on ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284; https://clinicaltrials.gov/ct2/show/NCT02598284?term=NCT02598284&rank=1). Copyright © 2018 Elsevier Inc. All rights reserved.

How to Prevent Diabetes: MedlinePlus Health Topic

MedlinePlus

... to 10 percent of your current weight. For example, if you weigh 200 pounds, your goal would ... 2 diabetes mellitus: A... Article: Design of a comparative effectiveness randomized controlled trial testing a... Article: Effect ...

THE EFFECTIVENESS OF PILOT PROGRAMS COMPARED TO OTHER PROGRAMS OF VOCATIONAL AGRICULTURE IN TENNESSEE.

ERIC Educational Resources Information Center

LEGG, OTTO

THE OBJECTIVE OF THIS COMPARATIVE STUDY WAS TO EVALUATE THE RELATIVE EFFECTIVENESS OF TENNESSEE VOCATIONAL AGRICULTURE PROGRAMS IN FOUR CATEGORIES -- (1) PILOT SCHOOLS, (2) LIKE-PILOT SCHOOLS OR SCHOOLS RESEMBLING PILOT SCHOOLS, (3) STUDENT TEACHING CENTERS, AND (4) NEGRO SCHOOLS. THE RANDOM SAMPLE INCLUDED 800 STUDENTS FROM 20 SCHOOLS DIVIDED…

The Transfer of Cognitive Speed of Processing Training to Older Adults’ Driving Mobility Across 5 Years

PubMed Central

Edwards, Jerri D.; O’Connor, Melissa L.; Ball, Karlene K.; Wadley, Virginia G.; Vance, David E.

2016-01-01

Objectives. Multilevel models assessed the effects of cognitive speed of processing training (SPT) on older adults’ self-reported driving using intention-to-treat (ITT, randomization to training or control conditions) and dosage (treatment-received via number of training sessions) analyses across 5 years. Method. Participants randomized to SPT (n = 598) were compared with those randomized to either the no-contact control (n = 598) or memory training, which served as an active control (n = 610). Driving mobility (frequency, exposure, and space) was assessed over time. Results. No significant effects were found within the ITT analyses. However, number of SPT sessions did affect driving mobility outcomes. In the full sample (N = 1,806), higher SPT doses were associated with maintained driving frequency as compared with both control groups, but no effects were found for driving exposure or space. Subsample analyses (n = 315) revealed that persons at-risk for mobility declines (i.e., poor initial processing speed) who received additional booster SPT sessions reported greater maintenance of both driving frequency and exposure over time as compared with the no-contact and active control groups. Discussion. These results and prior research indicate that cognitive SPT transfers to prolonged driving mobility among older adults. Future research should investigate the mechanisms behind transfer effects to real-world activities, such as driving. PMID:25878053

Antipyretic effect of ibuprofen in Gabonese children with uncomplicated falciparum malaria: a randomized, double-blind, placebo-controlled trial

PubMed Central

Matsiégui, Pierre-Blaise; Missinou, Michel A; Necek, Magdalena; Mavoungou, Elie; Issifou, Saadou; Lell, Bertrand; Kremsner, Peter G

2008-01-01

Background Antipyretic drugs are widely used in children with fever, though there is a controversy about the benefit of reducing fever in children with malaria. In order to assess the effect of ibuprofen on fever compared to placebo in children with uncomplicated Plasmodium falciparum malaria in Gabon, a randomized double blind placebo controlled trial, was designed. Methods Fifty children between two and seven years of age with uncomplicated malaria were included in the study. For the treatment of fever, all patients "received" mechanical treatment when the temperature rose above 37.5°C. In addition to the mechanical treatment, continuous fanning and cooling blanket, patients were assigned randomly to receive ibuprofen (7 mg/kg body weight, every eight hours) or placebo. Results The fever clearance time using a fever threshold of 37.5°C was similar in children receiving ibuprofen compared to those receiving placebo. The difference was also not statistically significant using a fever threshold of 37.8°C or 38.0°C. However, the fever time and the area under the fever curve were significantly smaller in the ibuprofen group compared to the placebo group. Conclusion Ibuprofen is effective in reducing the time with fever. The effect on fever clearance is less obvious and depends on definition of the fever threshold. Trial registration The trial registration number is: NCT00167713 PMID:18503714

EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

PubMed Central

Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

2015-01-01

Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

Health economic evaluation of patients treated for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter randomized clinical trial of vancomycin and linezolid.

PubMed

Niederman, Michael S; Chastre, Jean; Solem, Caitlyn T; Wan, Yin; Gao, Xin; Myers, Daniela E; Haider, Seema; Li, Jim Z; Stephens, Jennifer M

2014-09-01

Results from studies comparing health care resource use (HCRU), costs of treatment, and cost-effectiveness of linezolid compared with vancomycin therapy in the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published literature. We therefore conducted an analysis to compare the HCRU, costs of treatment, and cost-effectiveness of linezolid compared with vancomycin in the treatment of hospitalized patients with MRSA nosocomial pneumonia using data from a Phase IV clinical trial. The economic effect of moderate to severe adverse events (MSAEs) and the development of renal failure were also evaluated. We performed a post hoc analysis of data from a Phase IV, double-blind, randomized, comparator-controlled, multicenter trial that compared linezolid and vancomycin treatment in patients with MRSA nosocomial pneumonia. HCRU and costs were compared based on treatment, development of MSAEs, and development of renal failure using data from the modified intent-to-treat population. Predictors of costs were evaluated using generalized linear models. A piggyback cost-effectiveness analysis was conducted to assess the incremental cost-effectiveness ratio of linezolid versus vancomycin, given the significantly higher clinical success of linezolid compared with vancomycin found in the trial. Overall, HCRU and costs were similar between the linezolid and vancomycin treatment groups; drug costs were significantly higher and dialysis costs significantly lower for linezolid- compared with vancomycin-treated patients. Total treatment costs were approximately $8000 higher (P = .046) for patients who developed renal failure compared with those who did not. Renal failure occurred more commonly in patients randomized to receive vancomycin (15%) compared with linezolid (4%; P < .001). Region, ventilator-associated pneumonia, clinical failure, and development of renal failure were associated with significantly higher total costs. The point estimate incremental cost-effectiveness ratio for linezolid compared with vancomycin was $16,516 per treatment success, with linezolid dominant in 24% and dominated in <2% of bootstrapped samples. This phase 4 clinical trial conducted in patients with MRSA-confirmed nosocomial pneumonia reveals that linezolid- compared with vancomycin-treated patients had similar HCRU and total overall costs. Fewer patients developed renal failure during the study while taking linezolid compared with vancomycin, and patients with a documented MSAE or renal failure had increased HCRU and costs. In summary, linezolid may be a cost-effective treatment strategy in MRSA-confirmed nosocomial pneumonia. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

On the conservative nature of intragenic recombination

PubMed Central

Drummond, D. Allan; Silberg, Jonathan J.; Meyer, Michelle M.; Wilke, Claus O.; Arnold, Frances H.

2005-01-01

Intragenic recombination rapidly creates protein sequence diversity compared with random mutation, but little is known about the relative effects of recombination and mutation on protein function. Here, we compare recombination of the distantly related β-lactamases PSE-4 and TEM-1 to mutation of PSE-4. We show that, among β-lactamase variants containing the same number of amino acid substitutions, variants created by recombination retain function with a significantly higher probability than those generated by random mutagenesis. We present a simple model that accurately captures the differing effects of mutation and recombination in real and simulated proteins with only four parameters: (i) the amino acid sequence distance between parents, (ii) the number of substitutions, (iii) the average probability that random substitutions will preserve function, and (iv) the average probability that substitutions generated by recombination will preserve function. Our results expose a fundamental functional enrichment in regions of protein sequence space accessible by recombination and provide a framework for evaluating whether the relative rates of mutation and recombination observed in nature reflect the underlying imbalance in their effects on protein function. PMID:15809422

On the conservative nature of intragenic recombination.

PubMed

Drummond, D Allan; Silberg, Jonathan J; Meyer, Michelle M; Wilke, Claus O; Arnold, Frances H

2005-04-12

Intragenic recombination rapidly creates protein sequence diversity compared with random mutation, but little is known about the relative effects of recombination and mutation on protein function. Here, we compare recombination of the distantly related beta-lactamases PSE-4 and TEM-1 to mutation of PSE-4. We show that, among beta-lactamase variants containing the same number of amino acid substitutions, variants created by recombination retain function with a significantly higher probability than those generated by random mutagenesis. We present a simple model that accurately captures the differing effects of mutation and recombination in real and simulated proteins with only four parameters: (i) the amino acid sequence distance between parents, (ii) the number of substitutions, (iii) the average probability that random substitutions will preserve function, and (iv) the average probability that substitutions generated by recombination will preserve function. Our results expose a fundamental functional enrichment in regions of protein sequence space accessible by recombination and provide a framework for evaluating whether the relative rates of mutation and recombination observed in nature reflect the underlying imbalance in their effects on protein function.

Ketoprofen is more effective than diclofenac after oral surgery when used as a preemptive analgesic: a pilot study.

PubMed

Velásquez, Grace Carolaine Esquivel; Santa Cruz, Luis A German; Espinoza, Mario Alberto Isiordia

2014-01-01

To evaluate the preemptive analgesia of ketoprofen in comparison with diclofenac after mandibular third molar surgery. This study was a double-blind, randomized clinical trial. Forty patients were randomized into two treatment groups (each with 20 patients) by using a series of random numbers: group A received ketoprofen 100 mg and group B received diclofenac 75 mg, all intramuscularly. Surgery was done 30 minutes after analgesic treatments. The durations of analgesia, pain intensity, analgesic consumption, and side effects were evaluated. The statistical analysis was done using the chi-square, Student t, Mann-Whitney U, and Log-Rank tests. The duration of analgesia was longer in the ketoprofen group when compared with the diclofenac group. The number of patients taking the first rescue analgesic at 6 hours was lower in the ketoprofen group in comparison with the diclofenac group. Patients who received ketoprofen had lower pain intensity compared with patients who received diclofenac. Intramuscular ketoprofen 100 mg is more effective than intramuscular diclofenac 75 mg after mandibular third molar extraction when used as a preemptive analgesic.

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

PubMed

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

2013-08-01

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

Robot-assisted gait training in multiple sclerosis patients: a randomized trial.

PubMed

Schwartz, Isabella; Sajin, Anna; Moreh, Elior; Fisher, Iris; Neeb, Martin; Forest, Adina; Vaknin-Dembinsky, Adi; Karusis, Dimitrios; Meiner, Zeev

2012-06-01

Preservation of locomotor activity in multiple sclerosis (MS) patients is of utmost importance. Robotic-assisted body weight-supported treadmill training is a promising method to improve gait functions in neurologically impaired patients, although its effectiveness in MS patients is still unknown. To compare the effectiveness of robot-assisted gait training (RAGT) with that of conventional walking treatment (CWT) on gait and generalized functions in a group of stable MS patients. A prospective randomized controlled trial of 12 sessions of RAGT or CWT in MS patients of EDSS score 5-7. Primary outcome measures were gait parameters and the secondary outcomes were functional and quality of life parameters. All tests were performed at baseline, 3 and 6 months post-treatment by a blinded rater. Fifteen and 17 patients were randomly allocated to RAGT and CWT, respectively. Both groups were comparable at baseline in all parameters. As compared with baseline, although some gait parameters improved significantly following the treatment at each time point there was no difference between the groups. Both FIM and EDSS scores improved significantly post-treatment with no difference between the groups. At 6 months, most gait and functional parameters had returned to baseline. Robot-assisted gait training is feasible and safe and may be an effective additional therapeutic option in MS patients with severe walking disabilities.

Mesalazine for the Treatment of Symptomatic Uncomplicated Diverticular Disease of the Colon and for Primary Prevention of Diverticulitis: A Systematic Review of Randomized Clinical Trials.

PubMed

Picchio, Marcello; Elisei, Walter; Brandimarte, Giovanni; Di Mario, Francesco; Malfertheiner, Peter; Scarpignato, Carmelo; Tursi, Antonio

2016-10-01

Symptomatic uncomplicated diverticular disease (SUDD) is a common gastrointestinal disease, because it affects about one fourth of the patient harboring colonic diverticula. To assess the effectiveness of mesalazine in improving symptoms (namely abdominal pain) and in preventing diverticulitis occurrence in patients with SUDD. Only randomized clinical trials (irrespective of language, blinding, or publication status) that compared mesalazine with placebo or any other therapy in SUDD were evaluated. The selected endpoints were symptom relief and diverticulitis occurrence at maximal follow-up. Absolute risk reduction (ARR, with 95% confidence interval) and the number needed to treat were used as measures of the therapeutic effect. Six randomized clinical trials enrolled 1021 patients: 526 patients were treated with mesalazine and 495 with placebo or other therapies. Symptom relief with mesalazine was always larger than that with placebo and other therapies. However, absolute risk reduction was significant only when mesalazine was compared with placebo, a high-fiber diet, and low-dose rifaximin. The incidence of diverticulitis with mesalazine was lower than that observed with placebo and other treatments, being significant only when compared with placebo. Mesalazine is effective in achieving symptom relief and primary prevention of diverticulitis in patients with SUDD.

Pentoxifylline for the treatment of nonalcoholic fatty liver disease: a meta-analysis of randomized double-blind, placebo-controlled studies.

PubMed

Zeng, Tao; Zhang, Cui-Li; Zhao, Xiu-Lan; Xie, Ke-Qin

2014-06-01

Pentoxifylline has been used to treat nonalcoholic fatty liver diseases (NAFLDs) due to its anti-tumor necrosis factor-α effects. We conducted a meta-analysis of randomized, double-blinded, placebo-controlled trials to investigate the effect of pentoxifylline on the biochemical and histological parameters of NAFLD patients. A comprehensive literature search was conducted in the database including PubMed, Embase, ISI web of knowledge, the Cochrane Library, and Google Scholar to identify randomized, double-blind, placebo-controlled clinical trials about the effects of pentoxifylline on NAFLD. The pooled weighted mean difference (WMD) with 95% confidence interval (CI) was calculated to compare the effects of pentoxifylline and placebo. Five well-designed studies were retrieved. Pooled results showed that pentoxifylline significantly reduced the serum alanine transaminase activity (WMD=-27.97; 95% CI: -42.59, -13.34) and aspartate transaminase activity (WMD=-13.97; 95% CI: -23.31, -4.63) in NAFLD patients compared with placebo. In addition, pentoxifylline significantly improved steatosis (WMD=-0.68; 95% CI: -1.01, -0.34), lobular inflammation (WMD=-0.49; 95% CI: -0.86, -0.12), and fibrosis (WMD=-0.60; 95% CI: -0.99, -0.21). Furthermore, pentoxifylline also led to significant reduction in BMI (WMD=-0.51; 95% CI: -0.96, -0.06) and fasting glucose (WMD=-8.97; 95% CI: -14.52, -3.42), but did not significantly affect the serum tumor necrosis factor α and adiponectin levels when compared with placebo. Pentoxifylline could reduce the aminotransferase activities and improve the histological parameters in NAFLD patients. Large well-designed, randomized, placebo-controlled studies are needed to confirm these results.

TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study

PubMed Central

Aniulis, Povilas; Skaudickas, Darijus

2015-01-01

Objectives The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). Methods A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients – using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Results Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact – at 94.5% and SLING-IUFT – at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. Conclusion the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness. PMID:28352711

TVT-Exact and midurethral sling (SLING-IUFT) operative procedures: a randomized study.

PubMed

Aniuliene, Rosita; Aniulis, Povilas; Skaudickas, Darijus

2015-01-01

The aim of the study is to compare results, effectiveness and complications of TVT exact and midurethral sling (SLING-IUFT) operations in the treatment of female stress urinary incontinence (SUI). A single center nonblind, randomized study of women with SUI who were randomized to TVT-Exact and SLING-IUFT was performed by one surgeon from April 2009 to April 2011. SUI was diagnosed on coughing and Valsalva test and urodynamics (cystometry and uroflowmetry) were assessed before operation and 1 year after surgery. This was a prospective randomized study. The follow up period was 12 months. 76 patients were operated using the TVT-Exact operation and 78 patients - using the SLING-IUFT operation. There was no statistically significant differences between groups for BMI, parity, menopausal status and prolapsed stage (no patients had cystocele greater than stage II). Mean operative time was significantly shorter in the SLING-IUFT group (19 ± 5.6 min.) compared with the TVT-Exact group (27 ± 7.1 min.). There were statistically significant differences in the effectiveness of both procedures: TVT-Exact - at 94.5% and SLING-IUFT - at 61.2% after one year. Hospital stay was statistically significantly shorter in the SLING-IUFT group (1. 2 ± 0.5 days) compared with the TVT-Exact group (3.5 ± 1.5 days). Statistically significantly fewer complications occurred in the SLING-IUFT group. the TVT-Exact and SLING-IUFT operations are both effective for surgical treatment of female stress urinary incontinence. The SLING-IUFT involved a shorter operation time and lower complications rate., the TVT-Exact procedure had statistically significantly more complications than the SLING-IUFT operation, but a higher effectiveness.

Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

PubMed Central

Dahabreh, Issa J.; Sheldrick, Radley C.; Paulus, Jessica K.; Chung, Mei; Varvarigou, Vasileia; Jafri, Haseeb; Rassen, Jeremy A.; Trikalinos, Thomas A.; Kitsios, Georgios D.

2012-01-01

Aims Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment–outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. Methods and results We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients’ characteristics, interventions, and outcomes (‘topics’), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. Conclusion For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant. PMID:22711757

Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

PubMed

Mikocka-Walus, Antonina; Hughes, Patrick A; Bampton, Peter; Gordon, Andrea; Campaniello, Melissa A; Mavrangelos, Chris; Stewart, Benjamin J; Esterman, Adrian; Andrews, Jane M

2017-04-01

Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.]. © European Crohn’s and Colitis Organistion (ECCO) 2016.

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

PubMed Central

2013-01-01

Background When study data are clustered, standard regression analysis is considered inappropriate and analytical techniques for clustered data need to be used. For prediction research in which the interest of predictor effects is on the patient level, random effect regression models are probably preferred over standard regression analysis. It is well known that the random effect parameter estimates and the standard logistic regression parameter estimates are different. Here, we compared random effect and standard logistic regression models for their ability to provide accurate predictions. Methods Using an empirical study on 1642 surgical patients at risk of postoperative nausea and vomiting, who were treated by one of 19 anesthesiologists (clusters), we developed prognostic models either with standard or random intercept logistic regression. External validity of these models was assessed in new patients from other anesthesiologists. We supported our results with simulation studies using intra-class correlation coefficients (ICC) of 5%, 15%, or 30%. Standard performance measures and measures adapted for the clustered data structure were estimated. Results The model developed with random effect analysis showed better discrimination than the standard approach, if the cluster effects were used for risk prediction (standard c-index of 0.69 versus 0.66). In the external validation set, both models showed similar discrimination (standard c-index 0.68 versus 0.67). The simulation study confirmed these results. For datasets with a high ICC (≥15%), model calibration was only adequate in external subjects, if the used performance measure assumed the same data structure as the model development method: standard calibration measures showed good calibration for the standard developed model, calibration measures adapting the clustered data structure showed good calibration for the prediction model with random intercept. Conclusion The models with random intercept discriminate better than the standard model only if the cluster effect is used for predictions. The prediction model with random intercept had good calibration within clusters. PMID:23414436

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

PubMed

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

2013-02-15

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

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

PubMed

Sidik, Kurex; Jonkman, Jeffrey N

2005-01-01

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

Memory consolidation and contextual interference effects with computer games.

PubMed

Shewokis, Patricia A

2003-10-01

Some investigators of the contextual interference effect contend that there is a direct relation between the amount of practice and the contextual interference effect based on the prediction that the improvement in learning tasks in a random practice schedule, compared to a blocked practice schedule, increases in magnitude as the amount of practice during acquisition on the tasks increases. Research using computer games in contextual interference studies has yielded a large effect (f = .50) with a random practice schedule advantage during transfer. These investigations had a total of 36 and 72 acquisition trials, respectively. The present study tested this prediction by having 72 college students, who were randomly assigned to a blocked or random practice schedule, practice 102 trials of three computer-game tasks across three days. After a 24-hr. interval, 6 retention and 5 transfer trials were performed. Dependent variables were time to complete an event in seconds and number of errors. No significant differences were found for retention and transfer. These results are discussed in terms of how the amount of practice, task-related factors, and memory consolidation mediate the contextual interference effect.

The Bayesian group lasso for confounded spatial data

USGS Publications Warehouse

Hefley, Trevor J.; Hooten, Mevin B.; Hanks, Ephraim M.; Russell, Robin E.; Walsh, Daniel P.

2017-01-01

Generalized linear mixed models for spatial processes are widely used in applied statistics. In many applications of the spatial generalized linear mixed model (SGLMM), the goal is to obtain inference about regression coefficients while achieving optimal predictive ability. When implementing the SGLMM, multicollinearity among covariates and the spatial random effects can make computation challenging and influence inference. We present a Bayesian group lasso prior with a single tuning parameter that can be chosen to optimize predictive ability of the SGLMM and jointly regularize the regression coefficients and spatial random effect. We implement the group lasso SGLMM using efficient Markov chain Monte Carlo (MCMC) algorithms and demonstrate how multicollinearity among covariates and the spatial random effect can be monitored as a derived quantity. To test our method, we compared several parameterizations of the SGLMM using simulated data and two examples from plant ecology and disease ecology. In all examples, problematic levels multicollinearity occurred and influenced sampling efficiency and inference. We found that the group lasso prior resulted in roughly twice the effective sample size for MCMC samples of regression coefficients and can have higher and less variable predictive accuracy based on out-of-sample data when compared to the standard SGLMM.

Vaccine Effectiveness - How Well Does the Seasonal Flu Vaccine Work?

MedlinePlus

... to determine the benefits of flu vaccination are “observational studies.” “Observational studies” compare the occurrence of flu illness in ... randomized. The measurement of vaccine effects in an observational study is referred to as “effectiveness.” Top of ...

A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

PubMed

Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

2015-01-30

Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

The efficacy of Internet-based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial.

PubMed

Abrahams, Harriët J G; Gielissen, Marieke F M; Donders, Rogier R T; Goedendorp, Martine M; van der Wouw, Agnes J; Verhagen, Constans A H H V M; Knoop, Hans

2017-10-01

Severe fatigue is a common and distressing symptom affecting approximately one in four survivors of breast cancer. The current study examined the efficacy of Internet-based cognitive behavioral therapy (ICBT) for severe fatigue in survivors of breast cancer compared with care as usual (CAU). The authors conducted a parallel-group randomized controlled trial. Severely fatigued, disease-free survivors of breast cancer who had completed cancer treatment at least 3 months previously were eligible. Participants were randomly allocated to ICBT or CAU using computer-generated stratified block randomization. The primary outcome of fatigue severity was assessed at baseline and after 6 months, as were the secondary outcomes of functional impairment, psychological distress, and quality of life. Statistical effects were tested with analyses of covariance (intention-to-treat analysis). Participants were recruited between January 2014 and March 2016 and assigned to ICBT (66 patients) or CAU (66 patients). Compared with the participants who had received CAU, those who had received ICBT reported lower fatigue scores at 6 months (mean difference [Δ], 11.5; 95% confidence interval [95% CI], 7.7-15.3) and a large effect size (Cohen d = 1.0), with the majority of patients (73%) demonstrating clinically significant improvement. ICBT also was found to lead to lower functional impairment (Δ, 297.8; 95% CI, 145.5-450.1) and psychological distress scores (Δ, 5.7; 95% CI, 3.4-7.9) and higher quality-of-life scores (Δ, 11.7; 95% CI, 5.8-17.7) compared with CAU, with medium to large effect sizes (Cohen d = 0.6-0.8). ICBT appears to be effective in reducing severe fatigue and related symptoms and meets the current need for easy accessible and more efficient evidence-based treatment options for severely fatigued survivors of breast cancer. Cancer 2017;123:3825-34. © 2017 American Cancer Society. © 2017 American Cancer Society.

Effects of Six versus Three Times per Week Hemodialysis on Physical Performance, Health, and Functioning: Frequent Hemodialysis Network (FHN) Randomized Trials

PubMed Central

Larive, Brett; Painter, Patricia; Kaysen, George A.; Lindsay, Robert M.; Nissenson, Allen R.; Unruh, Mark L.; Rocco, Michael V.; Chertow, Glenn M.

2012-01-01

Summary Background and objectives Relatively little is known about the effects of hemodialysis frequency on the disability of patients with ESRD. Design, setting, participants, & measurements This study examined changes in physical performance and self-reported physical health and functioning among subjects randomized to frequent (six times per week) compared with conventional (three times per week) hemodialysis in both the Frequent Hemodialysis Network daily (n=245) and nocturnal (n=87) trials. The main outcome measures were adjusted change in scores over 12 months on the short physical performance battery (SPPB), RAND 36-item health survey physical health composite (PHC), and physical functioning subscale (PF) based on the intention to treat principle. Results Overall scores for SPPB, PHC, and PF were poor relative to population norms and in line with other studies in ESRD. In the Daily Trial, subjects randomized to frequent compared with conventional in-center hemodialysis experienced no significant change in SPPB (adjusted mean change of −0.20±0.19 versus −0.41±0.21, P=0.45) but experienced significant improvement in PHC (3.4±0.8 versus 0.4±0.8, P=0.009) and a relatively large change in PF that did not reach statistical significance. In the Nocturnal Trial, there were no significant differences among subjects randomized to frequent compared with conventional hemodialysis in SPPB (adjusted mean change of −0.92±0.44 versus −0.41±0.43, P=0.41), PHC (2.7±1.4 versus 2.1±1.5, P=0.75), or PF (−3.1±3.5 versus 1.1±3.6, P=0.40). Conclusions Frequent in-center hemodialysis compared with conventional in-center hemodialysis improved self-reported physical health and functioning but had no significant effect on objective physical performance. There were no significant effects of frequent nocturnal hemodialysis on the same physical metrics. PMID:22422538

Effects of six versus three times per week hemodialysis on physical performance, health, and functioning: Frequent Hemodialysis Network (FHN) randomized trials.

PubMed

Hall, Yoshio N; Larive, Brett; Painter, Patricia; Kaysen, George A; Lindsay, Robert M; Nissenson, Allen R; Unruh, Mark L; Rocco, Michael V; Chertow, Glenn M

2012-05-01

Relatively little is known about the effects of hemodialysis frequency on the disability of patients with ESRD. This study examined changes in physical performance and self-reported physical health and functioning among subjects randomized to frequent (six times per week) compared with conventional (three times per week) hemodialysis in both the Frequent Hemodialysis Network daily (n=245) and nocturnal (n=87) trials. The main outcome measures were adjusted change in scores over 12 months on the short physical performance battery (SPPB), RAND 36-item health survey physical health composite (PHC), and physical functioning subscale (PF) based on the intention to treat principle. Overall scores for SPPB, PHC, and PF were poor relative to population norms and in line with other studies in ESRD. In the Daily Trial, subjects randomized to frequent compared with conventional in-center hemodialysis experienced no significant change in SPPB (adjusted mean change of -0.20±0.19 versus -0.41±0.21, P=0.45) but experienced significant improvement in PHC (3.4±0.8 versus 0.4±0.8, P=0.009) and a relatively large change in PF that did not reach statistical significance. In the Nocturnal Trial, there were no significant differences among subjects randomized to frequent compared with conventional hemodialysis in SPPB (adjusted mean change of -0.92±0.44 versus -0.41±0.43, P=0.41), PHC (2.7±1.4 versus 2.1±1.5, P=0.75), or PF (-3.1±3.5 versus 1.1±3.6, P=0.40). Frequent in-center hemodialysis compared with conventional in-center hemodialysis improved self-reported physical health and functioning but had no significant effect on objective physical performance. There were no significant effects of frequent nocturnal hemodialysis on the same physical metrics.

A randomized controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine after outpatient general surgery.

PubMed

Mitchell, Alex; van Zanten, Sander Veldhuyzen; Inglis, Karen; Porter, Geoffrey

2008-03-01

Narcotics are used extensively in outpatient general surgery but are often poorly tolerated with variable efficacy. Acetaminophen combined with NSAIDs is a possible alternative. The objective of this study was to compare the efficacy of acetaminophen, codeine, and caffeine (Tylenol No. 3) with acetaminophen and ibuprofen for management of pain after outpatient general surgery procedures. A double-blind randomized controlled trial was performed in patients undergoing outpatient inguinal/umbilical/ventral hernia repair or laparoscopic cholecystectomy. Patients were randomized to receive acetaminophen plus codeine plus caffeine (Tylenol No. 3) or acetaminophen plus ibuprofen (AcIBU) 4 times daily for 7 days or until pain-free. Pain intensity, measured four times daily by visual analogue scale, was the primary outcome. Secondary end points included incidence of side effects, patient satisfaction, number of days until patient was pain-free, and use of alternative analgesia. One hundred forty-six patients were randomized (74 Tylenol No. 3 and 72 AcIBU), and 139 (95%) patients completed the study. No significant differences in mean or maximum daily visual analogue scale scores were identified between the 2 groups, except on postoperative day 2, when pain was improved in AcIBU patients (p = 0.025). During the entire week, mean visual analogue scale score was modestly lower in AcIBU patients (p = 0.018). More patients in the AcIBU group, compared with Tylenol No. 3, were satisfied with their analgesia (83% versus 64%, respectively; p = 0.02). There were more side effects with Tylenol No. 3 (57% versus 41%, p = 0.045), and the discontinuation rate was also higher in Tylenol No. 3-treated patients (11% versus 3%, p = 0.044). When compared with Tylenol No. 3, AcIBU was not an inferior analgesic and was associated with fewer side effects and higher patient satisfaction. AcIBU is an effective, low-cost, and safe alternative to codeine-based narcotic analgesia for outpatient general surgery procedures.

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.

Extract of valerian root (Valeriana officinalis L.) vs. placebo in treatment of obsessive-compulsive disorder: a randomized double-blind study.

PubMed

Pakseresht, Siroos; Boostani, Hatam; Sayyah, Mehdi

2011-10-11

Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric condition. Many herbs with psychotropic effects exist which can have fewer side effects compared to more conventional medications. Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in the world with an effect on GABA. This plant is reported to be safe on humans. Our objective in this study was to compare the efficacy of the extract of Valeriana Officinalis L. with placebo in the treatment of OCD. The study was an 8-week pilot double-blind randomized trial. Thirty-one adult outpatients who met the DSM-IV-TR criteria for OCD based on the structured clinical interview participated in the trial. In this double-blind and randomized trial, patients were randomly assigned to receive either capsule of the extract (765 mg/day) or placebo (30 mg/day) for 8 weeks. The results showed significant difference between the extract and placebo in the end of treatment (P=0.000). Somnolence was the only significant difference between the two groups in terms of observed side effects (P=0.02). The results suggest that Valeriana Officinalis L. has some antiobsessive and compulsive effects. However, further studies are needed to confirm these findings. Psychiatrists often find that many patients cannot tolerate the side effects of psychiatry medicine Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in world with effect on GABA.The results showed significant difference between the extract and placebo in the treatment of OCD. There was also no significant difference between the two groups in terms of observed side effects.

A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants.

PubMed

Goedhart, Paul W; van der Voet, Hilko; Baldacchino, Ferdinando; Arpaia, Salvatore

2014-04-01

Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, available as Supplementary Material, can be used to generate count data having different statistical distributions possibly with excess-zeros. In addition the model employs completely randomized or randomized block experiments, can be used to simulate single or multiple trials across environments, enables genotype by environment interaction by adding random variety effects, and finally includes repeated measures in time following a constant, linear or quadratic pattern in time possibly with some form of autocorrelation. The model also allows to add a set of reference varieties to the GM plants and its comparator to assess the natural variation which can then be used to set limits of concern for equivalence testing. The different count distributions are described in some detail and some examples of how to use the simulation model to study various aspects, including a prospective power analysis, are provided.

A statistical simulation model for field testing of non-target organisms in environmental risk assessment of genetically modified plants

PubMed Central

Goedhart, Paul W; van der Voet, Hilko; Baldacchino, Ferdinando; Arpaia, Salvatore

2014-01-01

Genetic modification of plants may result in unintended effects causing potentially adverse effects on the environment. A comparative safety assessment is therefore required by authorities, such as the European Food Safety Authority, in which the genetically modified plant is compared with its conventional counterpart. Part of the environmental risk assessment is a comparative field experiment in which the effect on non-target organisms is compared. Statistical analysis of such trials come in two flavors: difference testing and equivalence testing. It is important to know the statistical properties of these, for example, the power to detect environmental change of a given magnitude, before the start of an experiment. Such prospective power analysis can best be studied by means of a statistical simulation model. This paper describes a general framework for simulating data typically encountered in environmental risk assessment of genetically modified plants. The simulation model, available as Supplementary Material, can be used to generate count data having different statistical distributions possibly with excess-zeros. In addition the model employs completely randomized or randomized block experiments, can be used to simulate single or multiple trials across environments, enables genotype by environment interaction by adding random variety effects, and finally includes repeated measures in time following a constant, linear or quadratic pattern in time possibly with some form of autocorrelation. The model also allows to add a set of reference varieties to the GM plants and its comparator to assess the natural variation which can then be used to set limits of concern for equivalence testing. The different count distributions are described in some detail and some examples of how to use the simulation model to study various aspects, including a prospective power analysis, are provided. PMID:24834325

Effects of interpretive nutrition labels on consumer food purchases: the Starlight randomized controlled trial.

PubMed

Ni Mhurchu, Cliona; Volkova, Ekaterina; Jiang, Yannan; Eyles, Helen; Michie, Jo; Neal, Bruce; Blakely, Tony; Swinburn, Boyd; Rayner, Mike

2017-03-01

Background: Nutrition labeling is a prominent policy to promote healthy eating. Objective: We aimed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases. Design: In this parallel-group randomized controlled trial, we enrolled household shoppers across New Zealand who owned smartphones and were aged ≥18 y. Eligible participants were randomly assigned (1:1:1) to receive either traffic light labels (TLLs), Health Star Rating labels (HSRs), or a control [nutrition information panel (NIP)]. Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens. The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period, which was measured by using the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC). Results: Between October 2014 and November 2015, 1357 eligible shoppers were randomly assigned to TLL ( n = 459), HSR ( n = 443), or NIP ( n = 455) labels. Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was -0.20 (95% CI: -0.94, 0.54; P = 0.60). The corresponding difference for HSR compared with NIP was -0.60 (95% CI: -1.35, 0.15; P = 0.12). In an exploratory per-protocol analysis of participants who used the labeling intervention more often than average ( n = 423, 31%), those who were assigned to TLL and HSR had significantly better NPSC scores [TLL compared with NIP: -1.33 (95% CI: -2.63, -0.04; P = 0.04); HSR compared with NIP: -1.70 (95% CI: -2.97, -0.43; P = 0.01)]. Shoppers who were randomly assigned to HSR and TLL also found the labels significantly more useful and easy to understand than the NIP (all P values <0.001). Conclusions: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases. However, shoppers who used interpretive labels found them to be significantly more useful and easy to understand, and compared with frequent NIP users, frequent TLL and HSR users had significantly healthier food purchases. This trial was registered at the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366446&isReview=true) as ACTRN12614000644662. © 2017 American Society for Nutrition.

A Network Meta-Analysis Comparing Effects of Various Antidepressant Classes on the Digit Symbol Substitution Test (DSST) as a Measure of Cognitive Dysfunction in Patients with Major Depressive Disorder.

PubMed

Baune, Bernhard T; Brignone, Mélanie; Larsen, Klaus Groes

2018-02-01

Major depressive disorder is a common condition that often includes cognitive dysfunction. A systematic literature review of studies and a network meta-analysis were carried out to assess the relative effect of antidepressants on cognitive dysfunction in major depressive disorder. MEDLINE, Embase, Cochrane, CDSR, and PsychINFO databases; clinical trial registries; and relevant conference abstracts were searched for randomized controlled trials assessing the effects of antidepressants/placebo on cognition. A network meta-analysis comparing antidepressants was conducted using a random effects model. The database search retrieved 11337 citations, of which 72 randomized controlled trials from 103 publications met the inclusion criteria. The review identified 86 cognitive tests assessing the effect of antidepressants on cognitive functioning. However, the Digit Symbol Substitution Test, which targets multiple domains of cognition and is recognized as being sensitive to change, was the only test that was used across 12 of the included randomized controlled trials and that allowed the construction of a stable network suitable for the network meta-analysis. The interventions assessed included selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and other non-selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors. The network meta-analysis using the Digit Symbol Substitution Test showed that vortioxetine was the only antidepressant that improved cognitive dysfunction on the Digit Symbol Substitution Test vs placebo {standardized mean difference: 0.325 (95% CI = 0.120; 0.529, P=.009}. Compared with other antidepressants, vortioxetine was statistically more efficacious on the Digit Symbol Substitution Test vs escitalopram, nortriptyline, and the selective serotonin reuptake inhibitor and tricyclic antidepressant classes. This study highlighted the large variability in measures used to assess cognitive functioning. The findings on the Digit Symbol Substitution Test indicate differential effects of various antidepressants on improving cognitive function in patients with major depressive disorder. © The Author 2017. Published by Oxford University Press on behalf of CINP.

Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial.

PubMed

van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H; Monninkhof, Evelyn M

2016-05-01

We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both interventions was to lose 5 to 6 kg bodyweight by a hypocaloric diet or an exercise program (4 hours/week) combined with a small caloric intake restriction. Outcomes after 16 weeks included serum high-sensitive C-reactive protein (hsCRP), IL6, adiponectin, and leptin. Both intervention groups achieved the target weight loss. Controls remained weight stable. Compared with control, hsCRP decreased with mainly exercise [treatment effect ratio (TER) = 0.64] and borderline statistically significant with diet (TER = 0.77). There was a suggestively larger effect of exercise, directly compared with diet (TER = 0.83). Leptin decreased with both interventions: mainly exercise (TER = 0.55) and diet (TER = 0.59), versus control. Effects attenuated and lost significance after adjusting for change in body fat percentage, and to a lesser extent when adjusting for fitness. No effects were seen on IL6 and adiponectin. A 16-week randomized intervention inducing comparable weight loss by a hypocaloric diet or mainly exercise, resulted in favorable effects on serum hsCRP and leptin. We found a possible more beneficial effect on hsCRP with mainly exercise versus diet. These effects of exercise were established by changes in body fat percentage and physical fitness. A modest amount of weight loss in postmenopausal women reduces hsCRP and leptin levels which might be associated with a lower breast cancer risk. Cancer Epidemiol Biomarkers Prev; 25(5); 799-806. ©2016 AACR. ©2016 American Association for Cancer Research.

Random electric field instabilities of relaxor ferroelectrics

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

Arce-Gamboa, Jose R.; Guzman-Verri, Gian G.

Relaxor ferroelectrics are complex oxide materials which are rather unique to study the effects of compositional disorder on phase transitions. Here, we study the effects of quenched cubic random electric fields on the lattice instabilities that lead to a ferroelectric transition and show that, within a microscopic model and a statistical mechanical solution, even weak compositional disorder can prohibit the development of long-range order and that a random field state with anisotropic and power-law correlations of polarization emerges from the combined effect of their characteristic dipole forces and their inherent charge disorder. As a result, we compare and reproduce severalmore » key experimental observations in the well-studied relaxor PbMg 1/3Nb 2/3O 3–PbTiO 3.« less

Random electric field instabilities of relaxor ferroelectrics

DOE PAGES

Arce-Gamboa, Jose R.; Guzman-Verri, Gian G.

2017-06-13

Relaxor ferroelectrics are complex oxide materials which are rather unique to study the effects of compositional disorder on phase transitions. Here, we study the effects of quenched cubic random electric fields on the lattice instabilities that lead to a ferroelectric transition and show that, within a microscopic model and a statistical mechanical solution, even weak compositional disorder can prohibit the development of long-range order and that a random field state with anisotropic and power-law correlations of polarization emerges from the combined effect of their characteristic dipole forces and their inherent charge disorder. As a result, we compare and reproduce severalmore » key experimental observations in the well-studied relaxor PbMg 1/3Nb 2/3O 3–PbTiO 3.« less

Concordance of Results from Randomized and Observational Analyses within the Same Study: A Re-Analysis of the Women's Health Initiative Limited-Access Dataset.

PubMed

Bolland, Mark J; Grey, Andrew; Gamble, Greg D; Reid, Ian R

2015-01-01

Observational studies (OS) and randomized controlled trials (RCTs) often report discordant results. In the Women's Health Initiative Calcium and Vitamin D (WHI CaD) RCT, women were randomly assigned to CaD or placebo, but were permitted to use personal calcium and vitamin D supplements, creating a unique opportunity to compare results from randomized and observational analyses within the same study. WHI CaD was a 7-year RCT of 1g calcium/400IU vitamin D daily in 36,282 post-menopausal women. We assessed the effects of CaD on cardiovascular events, death, cancer and fracture in a randomized design- comparing CaD with placebo in 43% of women not using personal calcium or vitamin D supplements- and in a observational design- comparing women in the placebo group (44%) using personal calcium and vitamin D supplements with non-users. Incidence was assessed using Cox proportional hazards models, and results from the two study designs deemed concordant if the absolute difference in hazard ratios was ≤0.15. We also compared results from WHI CaD to those from the WHI Observational Study(WHI OS), which used similar methodology for analyses and recruited from the same population. In WHI CaD, for myocardial infarction and stroke, results of unadjusted and 6/8 covariate-controlled observational analyses (age-adjusted, multivariate-adjusted, propensity-adjusted, propensity-matched) were not concordant with the randomized design results. For death, hip and total fracture, colorectal and total cancer, unadjusted and covariate-controlled observational results were concordant with randomized results. For breast cancer, unadjusted and age-adjusted observational results were concordant with randomized results, but only 1/3 other covariate-controlled observational results were concordant with randomized results. Multivariate-adjusted results from WHI OS were concordant with randomized WHI CaD results for only 4/8 endpoints. Results of randomized analyses in WHI CaD were concordant with observational analyses for 5/8 endpoints in WHI CaD and 4/8 endpoints in WHI OS.

Concordance of Results from Randomized and Observational Analyses within the Same Study: A Re-Analysis of the Women’s Health Initiative Limited-Access Dataset

PubMed Central

Bolland, Mark J.; Grey, Andrew; Gamble, Greg D.; Reid, Ian R.

2015-01-01

Background Observational studies (OS) and randomized controlled trials (RCTs) often report discordant results. In the Women’s Health Initiative Calcium and Vitamin D (WHI CaD) RCT, women were randomly assigned to CaD or placebo, but were permitted to use personal calcium and vitamin D supplements, creating a unique opportunity to compare results from randomized and observational analyses within the same study. Methods WHI CaD was a 7-year RCT of 1g calcium/400IU vitamin D daily in 36,282 post-menopausal women. We assessed the effects of CaD on cardiovascular events, death, cancer and fracture in a randomized design- comparing CaD with placebo in 43% of women not using personal calcium or vitamin D supplements- and in a observational design- comparing women in the placebo group (44%) using personal calcium and vitamin D supplements with non-users. Incidence was assessed using Cox proportional hazards models, and results from the two study designs deemed concordant if the absolute difference in hazard ratios was ≤0.15. We also compared results from WHI CaD to those from the WHI Observational Study(WHI OS), which used similar methodology for analyses and recruited from the same population. Results In WHI CaD, for myocardial infarction and stroke, results of unadjusted and 6/8 covariate-controlled observational analyses (age-adjusted, multivariate-adjusted, propensity-adjusted, propensity-matched) were not concordant with the randomized design results. For death, hip and total fracture, colorectal and total cancer, unadjusted and covariate-controlled observational results were concordant with randomized results. For breast cancer, unadjusted and age-adjusted observational results were concordant with randomized results, but only 1/3 other covariate-controlled observational results were concordant with randomized results. Multivariate-adjusted results from WHI OS were concordant with randomized WHI CaD results for only 4/8 endpoints. Conclusions Results of randomized analyses in WHI CaD were concordant with observational analyses for 5/8 endpoints in WHI CaD and 4/8 endpoints in WHI OS. PMID:26440516

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

Scattering of Internal Tides by Irregular Bathymetry of Large Extent

NASA Astrophysics Data System (ADS)

Mei, C.

2014-12-01

We present an analytic theory of scattering of tide-generated internal gravity waves in a continuously stratified ocean with a randomly rough seabed. Based on the linearized approximation, the idealized case of constant mean sea depth and Brunt-Vaisala frequency is considered. The depth fluctuation is assumed to be a stationary random function of space characterized by small amplitude and correlation length comparable to the typical wavelength. For both one- and two-dimensional topography the effects of scattering on wave phase over long distances are derived explicitly by the method of multiple scales. For one-dimensional topography, numerical results are compared with Buhler-& Holmes-Cerfon(2011) computed by the method of characteristics. For two-dimensional topography, new results are presented for both statistically isotropic and anisotropic cases. In thi talk we shall apply the perturbation technique of multiple scales to treat analytically the random scattering of internal tides by gently sloped bathymetric irregularities.The basic assumptions are: incompressible fluid, infinitestimal wave amplitudes, constant Brunt-Vaisala frequency, and constant mean depth. In addition, the depth disorder is assumed to be a stationary random function of space with zero mean and small root-mean-square amplitude. The correlation length can be comparable in order of magnitude as the dominant wavelength. Both one- and two-dimensional disorder will be considered. Physical effects of random scattering on the mean wave phase i.e., spatial attenuation and wavenumber shift will be calculated and discussed for one mode of incident wave. For two dimensional topographies, statistically isotropic and anisotropic examples will be presented.

Comparative Effectiveness of Web-Based vs. Educator-Delivered HIV Prevention for Adolescent Substance Users: A Randomized, Controlled Trial.

PubMed

Marsch, Lisa A; Guarino, Honoria; Grabinski, Michael J; Syckes, Cassandra; Dillingham, Elaine T; Xie, Haiyi; Crosier, Benjamin S

2015-12-01

Young people who engage in substance use are at risk for becoming infected with HIV and diseases with similar transmission dynamics. Effective disease prevention programs delivered by prevention specialists exist but are rarely provided in systems of care due to staffing/resource constraints and operational barriers-and are thus of limited reach. Web-based prevention interventions could possibly offer an effective alternative to prevention specialist-delivered interventions and may enable widespread, cost-effective access to evidence-based prevention programming. Previous research has shown the HIV/disease prevention program within the Web-based therapeutic education system (TES) to be an effective adjunct to a prevention specialist-delivered intervention. The present study was the first randomized, clinical trial to evaluate the comparative effectiveness of this Web-based intervention as a standalone intervention relative to a traditional, prevention specialist-delivered intervention. Adolescents entering outpatient treatment for substance use participated in this multi-site trial. Participants were randomly assigned to either a traditional intervention delivered by a prevention specialist (n=72) or the Web-delivered TES intervention (n=69). Intervention effectiveness was assessed by evaluating changes in participants' knowledge about HIV, hepatitis, and sexually transmitted infections, intentions to engage in safer sex, sex-related risk behavior, self-efficacy to use condoms, and condom use skills. Participants in the TES intervention achieved significant and comparable increases in HIV/disease-related knowledge, condom use self-efficacy, and condom use skills and comparable decreases in HIV risk behavior relative to participants who received the intervention delivered by a prevention specialist. Participants rated TES as easier to understand. This study indicates that TES is as effective as HIV/disease prevention delivered by a prevention specialist. Because technology-based interventions such as TES have high fidelity, are inexpensive and scalable, and can be implemented in a wide variety of settings, they have the potential to greatly increase access to effective prevention programming. Copyright © 2015 Elsevier Inc. All rights reserved.

Acupuncture and related therapies used as add-on or alternative to prokinetics for functional dyspepsia: overview of systematic reviews and network meta-analysis.

PubMed

Ho, Robin S T; Chung, Vincent C H; Wong, Charlene H L; Wu, Justin C Y; Wong, Samuel Y S; Wu, Irene X Y

2017-09-04

Prokinetics for functional dyspepsia (FD) have relatively higher number needed to treat values. Acupuncture and related therapies could be used as add-on or alternative. An overview of systematic reviews (SRs) and network meta-analyses (NMA) were performed to evaluate the comparative effectiveness of different acupuncture and related therapies. We conducted a comprehensive literature search for SRs of randomized controlled trials (RCTs) in eight international and Chinese databases. Data from eligible RCTs were extracted for random effect pairwise meta-analyses. NMA was used to explore the most effective treatment among acupuncture and related therapies used alone or as add-on to prokinetics, compared to prokinetics alone. From five SRs, 22 RCTs assessing various acupuncture and related therapies were included. No serious adverse events were reported. Two pairwise meta-analyses showed manual acupuncture has marginally stronger effect in alleviating global FD symptoms, compared to domperidone or itopride. Results from NMA showed combination of manual acupuncture and clebopride has the highest probability in alleviating patient reported global FD symptom. Combination of manual acupuncture and clebopride has the highest probability of being the most effective treatment for FD symptoms. Patients who are contraindicated for prokinetics may use manual acupuncture or moxibustion as alternative. Future confirmatory comparative effectiveness trials should compare clebopride add-on manual acupuncture with domperidone add-on manual acupuncture and moxibustion.

Meta-analysis of randomized controlled trials comparing 17α-hydroxyprogesterone caproate and vaginal progesterone for the prevention of recurrent spontaneous preterm delivery.

PubMed

Oler, Elizabeth; Eke, Ahizechukwu C; Hesson, Ashley

2017-07-01

Vaginal progesterone and 17α-hydroxyprogesterone (17α-OHP) are both used to prevent preterm delivery in women who have experienced spontaneous preterm delivery (SPTD) previously. Randomized trial data of the comparative effectiveness of these interventions have been mixed. To compare the efficacy of intramuscular 17α-OHP and vaginal progesterone in the prevention of recurrent SPTD. Cochrane Central Register of Controlled Trials, African Journals Online, Embase, Google Scholar, ISI Web of Science, LILACS, CINAHL, PubMed, and registers of ongoing trials were searched using keywords related to 17α-OHP, vaginal progesterone, and preterm delivery. Randomized controlled trials published between January 1, 1966, and November 30, 2016, comparing 17α-OHP and vaginal progesterone for the prevention of recurrent SPTD during singleton pregnancies were included. Study data were extracted and meta-analyses were performed when outcomes were comparable. The meta-analyses included data from three randomized trials. Lower rates of SPTD before 34 weeks (relative risk 0.71, 95% confidence interval 0.53-0.95) and before 32 weeks (relative risk 0.62, 95% confidence interval 0.40-0.94) of pregnancy were observed among patients treated with vaginal progesterone. Vaginal progesterone and 17α-OHP were comparable for the prevention of recurrent SPTD in singleton pregnancies; vaginal progesterone could be superior. © 2017 International Federation of Gynecology and Obstetrics.

Electrodialytic Transport Properties of Anion-Exchange Membranes Prepared from Poly(vinyl alcohol) and Poly(vinyl alcohol-co-methacryloyl aminopropyl trimethyl ammonium chloride).

PubMed

Jikihara, Atsushi; Ohashi, Reina; Kakihana, Yuriko; Higa, Mitsuru; Kobayashi, Kenichi

2013-01-02

Random-type anion-exchange membranes (AEMs) have been prepared by blending poly(vinyl alcohol) (PVA) and the random copolymer-type polycation, poly(vinyl alcohol-co-methacryloyl aminopropyl trimethyl ammonium chloride) at various molar percentages of anion-exchange groups to vinyl alcohol groups, Cpc, and by cross-linking the PVA chains with glutaraldehyde (GA) solution at various GA concentrations, CGA. The characteristics of the random-type AEMs were compared with blend-type AEMs prepared in our previous study. At equal molar percentages of the anion exchange groups, the water content of the random-type AEMs was lower than that of the blend-type AEMs. The effective charge density of the random-type AEMs increased with increasing Cpc and reached a maximum value. Further, the maximum value of the effective charge density increased with increasing CGA. The maximum value of the effective charge density, 0.42 mol/dm3, was obtained for the random-type AEM with Cpc = 4.2 mol % and CGA = 0.15 vol %. A comparison of the random-type and blend-type AEMs with almost the same Cpc showed that the random-type AEMs had lower membrane resistance than the blend-type ones. The membrane resistance and dynamic transport number of the random-type AEM with Cpc = 6.0 mol % and CGA = 0.15 vol % were 4.8 Ω cm2 and 0.83, respectively.

Electrodialytic Transport Properties of Anion-Exchange Membranes Prepared from Poly(vinyl alcohol) and Poly(vinyl alcohol-co-methacryloyl aminopropyl trimethyl ammonium chloride)

PubMed Central

Jikihara, Atsushi; Ohashi, Reina; Kakihana, Yuriko; Higa, Mitsuru; Kobayashi, Kenichi

2012-01-01

Random-type anion-exchange membranes (AEMs) have been prepared by blending poly(vinyl alcohol) (PVA) and the random copolymer-type polycation, poly(vinyl alcohol-co-methacryloyl aminopropyl trimethyl ammonium chloride) at various molar percentages of anion-exchange groups to vinyl alcohol groups, Cpc, and by cross-linking the PVA chains with glutaraldehyde (GA) solution at various GA concentrations, CGA. The characteristics of the random-type AEMs were compared with blend-type AEMs prepared in our previous study. At equal molar percentages of the anion exchange groups, the water content of the random-type AEMs was lower than that of the blend-type AEMs. The effective charge density of the random-type AEMs increased with increasing Cpc and reached a maximum value. Further, the maximum value of the effective charge density increased with increasing CGA. The maximum value of the effective charge density, 0.42 mol/dm3, was obtained for the random-type AEM with Cpc = 4.2 mol % and CGA = 0.15 vol %. A comparison of the random-type and blend-type AEMs with almost the same Cpc showed that the random-type AEMs had lower membrane resistance than the blend-type ones. The membrane resistance and dynamic transport number of the random-type AEM with Cpc = 6.0 mol % and CGA = 0.15 vol % were 4.8 Ω cm2 and 0.83, respectively. PMID:24958543

Combined Effect of Random Transmit Power Control and Inter-Path Interference Cancellation on DS-CDMA Packet Mobile Communications

NASA Astrophysics Data System (ADS)

Kudoh, Eisuke; Ito, Haruki; Wang, Zhisen; Adachi, Fumiyuki

In mobile communication systems, high speed packet data services are demanded. In the high speed data transmission, throughput degrades severely due to severe inter-path interference (IPI). Recently, we proposed a random transmit power control (TPC) to increase the uplink throughput of DS-CDMA packet mobile communications. In this paper, we apply IPI cancellation in addition to the random TPC. We derive the numerical expression of the received signal-to-interference plus noise power ratio (SINR) and introduce IPI cancellation factor. We also derive the numerical expression of system throughput when IPI is cancelled ideally to compare with the Monte Carlo numerically evaluated system throughput. Then we evaluate, by Monte-Carlo numerical computation method, the combined effect of random TPC and IPI cancellation on the uplink throughput of DS-CDMA packet mobile communications.

Micro and macro benefits of random investments in financial markets

NASA Astrophysics Data System (ADS)

Biondo, A. E.; Pluchino, A.; Rapisarda, A.

2014-10-01

In this paper, making use of recent statistical physics techniques and models, we address the specific role of randomness in financial markets, both at the micro and the macro level. In particular, we review some recent results obtained about the effectiveness of random strategies of investment, compared with some of the most used trading strategies for forecasting the behaviour of real financial indexes. We also push forward our analysis by means of a self-organised criticality model, able to simulate financial avalanches in trading communities with different network topologies, where a Pareto-like power law behaviour of wealth spontaneously emerges. In this context, we present new findings and suggestions for policies based on the effects that random strategies can have in terms of reduction of dangerous financial extreme events, i.e. bubbles and crashes.

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

PubMed

Djulbegovic, Benjamin; Cantor, Alan; Clarke, Mike

2003-01-01

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Analytical connection between thresholds and immunization strategies of SIS model in random networks

NASA Astrophysics Data System (ADS)

Zhou, Ming-Yang; Xiong, Wen-Man; Liao, Hao; Wang, Tong; Wei, Zong-Wen; Fu, Zhong-Qian

2018-05-01

Devising effective strategies for hindering the propagation of viruses and protecting the population against epidemics is critical for public security and health. Despite a number of studies based on the susceptible-infected-susceptible (SIS) model devoted to this topic, we still lack a general framework to compare different immunization strategies in completely random networks. Here, we address this problem by suggesting a novel method based on heterogeneous mean-field theory for the SIS model. Our method builds the relationship between the thresholds and different immunization strategies in completely random networks. Besides, we provide an analytical argument that the targeted large-degree strategy achieves the best performance in random networks with arbitrary degree distribution. Moreover, the experimental results demonstrate the effectiveness of the proposed method in both artificial and real-world networks.

Management options of chronic low back pain. A randomized blinded clinical trial.

PubMed

Nazzal, Mahmoud E; Saadah, Mohammed A; Saadah, Loai M; Al-Omari, Mahmoud A; Al-Oudat, Ziad A; Nazzal, Mohammed S; El-Beshari, Mahfoud Y; Al-Zaabi, Amani A; Alnuaimi, Yousif I

2013-04-01

To compare efficacies of 2 active programs in the management of chronic low back pain (CLBP). This prospective, stratified, randomized single-blinded controlled study was conducted in the Department of Rehabilitation Medicine, King Abdullah University Hospital, Irbid, Jordan, between February and December 2010. A total of 100 patients were randomized to either 6-weeks of multidisciplinary rehabilitation (group A) or therapist-assisted exercise (group B). At baseline and 6 weeks, the visual analogue scale (VAS) pain score was estimated, as a primary outcome measure. McGill pain score, Oswestry Disability Index (ODI), trunk forward flexion and extension, left and right lateral bending, were applied before and after treatment and were employed as secondary outcome measures. All outcome measures significantly improved in group A after treatment, compared with group B. The VAS, McGill, ODI scores, left and right lateral bending decreased significantly, whereas forward and backward bending increased. A significant number of patients returned to work in group A at the end of 6 weeks, compared with group B. These effects were maintained over 12 and 24 weeks of follow-up. Multidisciplinary rehabilitation improved functional indices and pain scale scores in group A compared with B. This would be an effective strategy in CLBP management.

Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials.

PubMed

Wang, Kang-Feng; Zhang, Li-Juan; Lu, Feng; Lu, Yong-Hui; Yang, Chuan-Hua

2016-06-01

To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. A comprehensive search [PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. RevMan 5.0 was used for data synthesis. Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio (OR): 5.89, 95% confidence interval (CI): 2.97 to 11.67, P<0.01, heterogeneity: χ(2) =3.81, P=0.70, I (2) =0% ]. One trial compared Ashi points stimulation with drug therapy. The result showed there was a significantly greater recovery rate in group of Ashi points stimulation (OR: 9.58, 95% CI: 2.69 to 34.12). One trial compared comprehensive treatment on the myofascial trigger points (MTrPs) with no treatment and the result was in favor of MTrPs. Ashi points stimulation might be superior to conventional acupuncture, drug therapy and no treatment for shoulder pain. However, due to the low methodological quality of included studies, a firm conclusion could not be reached until further studies of high quality are available.

Practice-based evidence study design for comparative effectiveness research.

PubMed

Horn, Susan D; Gassaway, Julie

2007-10-01

To describe a new, rigorous, comprehensive practice-based evidence for clinical practice improvement (PBE-CPI) study methodology, and compare its features, advantages, and disadvantages to those of randomized controlled trials and sophisticated statistical methods for comparative effectiveness research. PBE-CPI incorporates natural variation within data from routine clinical practice to determine what works, for whom, when, and at what cost. It uses the knowledge of front-line caregivers, who develop study questions and define variables as part of a transdisciplinary team. Its comprehensive measurement framework provides a basis for analyses of significant bivariate and multivariate associations between treatments and outcomes, controlling for patient differences, such as severity of illness. PBE-CPI studies can uncover better practices more quickly than randomized controlled trials or sophisticated statistical methods, while achieving many of the same advantages. We present examples of actionable findings from PBE-CPI studies in postacute care settings related to comparative effectiveness of medications, nutritional support approaches, incontinence products, physical therapy activities, and other services. Outcomes improved when practices associated with better outcomes in PBE-CPI analyses were adopted in practice.

A randomized prospective multicenter trial of a novel vascular sealant.

PubMed

Stone, William M; Cull, David L; Money, Samuel R

2012-11-01

Increasing use of anticoagulant medications, particularly antiplatelet therapies, can increase the difficulty in obtaining adequate suture line hemostasis. Multiple vascular sealants have been used as adjuncts to surgical procedures, but none of them have been universally successful. The aim of this study was to evaluate the safety and effectiveness of a new prophylactic vascular sealant in arterial surgery. A randomized prospective multi-institutional trial was undertaken comparing ArterX Vascular Sealant (AVS) with Gelfoam Plus during open arterial reconstruction. Three hundred thirty-one anastomotic sites in 217 patients were randomized. One hundred one of 167 (60.5%) anastomotic sites in the AVS group achieved immediate hemostasis compared with 65 of 164 (39.6%) in the control group (P = 0.001). In anastomoses with polytetrafluoroethylene grafts, 105 of 167 (62.5%) in the AVS group achieved immediate hemostasis compared with 56 of 164 (34.0%) in the control group (P < 0.001). No significant differences were noted in morbidity or mortality. Operative time was significantly less in the AVS group compared with the control group (3.2 vs. 3.8 hours, P < 0.01). Use of AVS results in superior hemostatic effectiveness compared with Gelfoam Plus, with no difference in safety. Although no cost analysis was performed, cost savings likely resulted from significantly decreased operative time. Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

Yoga Improves Academic Performance in Urban High School Students Compared to Physical Education: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Hagins, Marshall; Rundle, Andrew

2016-01-01

Yoga programs within schools have become more widespread but research regarding the potential effect on academic achievement remains limited. This study cluster-randomized 112 students within a single New York City public high school to participate in either school-based yoga or physical education (PE) for an entire academic year. The primary…

Efficacy of the Lexicon Pirate Strategy Therapy for Improving Lexical Learning in School-Age Children: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Motsch, Hans-Joachim; Marks, Dana-Kristin

2015-01-01

Lexicon Pirate was originally developed as a strategy intervention programme to treat lexical disorders of pre-school children. To evaluate the therapy's effectiveness for school-age students, a randomized controlled trial (RCT, N = 157) was conducted. Based on a pre--post-test design, the programme's impacts were compared with a control group…

A Randomized Controlled Trial of the Impact of Schema-Based Instruction on Mathematical Outcomes for Third-Grade Students with Mathematics Difficulties

ERIC Educational Resources Information Center

Jitendra, Asha K.; Dupuis, Danielle N.; Rodriguez, Michael C.; Zaslofsky, Anne F.; Slater, Susan; Cozine-Corroy, Kelly; Church, Chris

2013-01-01

This study compared the effects of delivering a supplemental, small-group tutoring intervention on the mathematics outcomes of third-grade students at risk for mathematics difficulties (MD) who were randomly assigned to either a schema-based instruction (SBI) or control group. SBI emphasized the underlying mathematical structure of additive…

Lucky in Life, Unlucky in Love? The Effect of Random Income Shocks on Marriage and Divorce

ERIC Educational Resources Information Center

Hankins, Scott; Hoekstra, Mark

2011-01-01

Economists have long been interested in the extent to which economic resources affect decisions to marry and divorce. However, this issue has been difficult to address empirically due to a lack of exogenous income shocks. We overcome this problem by exploiting the randomness of the Florida Lottery and comparing recipients of large prizes to those…

Sodium iodide associated to salicylic acid in the topical management of chronic oral candidiasis: a randomized trial.

PubMed

Petruzzi, M; Grassi, F R; Nardi, G M; Martinelli, D; Serpico, R; Luglie, P F; Baldoni, E

2010-01-01

Candidiasis is a relevant problem in oral medicine practice. We compared the antimycotic activity of nystatin with a solution of sodium iodide associated to salicylic acid (SISA) in the topical management of chronic candidiasis. Consecutive patients affected by chronic candidiasis were randomly allocated to SISA (group A) or nystatin (group B). VAS and swab scores were recorded at the beginning and at the end of the study while the healing index was evaluated at the end of the study only. Data were analyzed by STATA 10 MP. Forty patients (20 male, 20 female) were randomized. SIAS was as effective as nystatin in affecting VAS (p greater than 0.05) and swab score (p greater than 0.05). A statistically significant reduction (p less than 0.05) of healing index was observed in both groups. No side effects were reported. SISA topical application, shows a comparable efficacy to the nystatin in the management of chronic oral candidiasis. Its use could represent an adequate alternative to the nystatin above all in the cases of drug-resistance. Further large scale randomized trials are warranted to confirm these preliminary findings.

Preventing patient-to-worker violence in hospitals: outcome of a randomized controlled intervention

PubMed Central

Arnetz, Judith E.; Hamblin, Lydia; Russell, Jim; Upfal, Mark J.; Luborsky, Mark; Janisse, James; Essenmacher, Lynnette

2016-01-01

Objective To evaluate the effects of a randomized controlled intervention on the incidence of patient-to-worker (Type II) violence and related injury in hospitals. Methods Forty-one units across 7 hospitals were randomized into intervention (n=21) and control (n=20) groups. Intervention units received unit-level violence data to facilitate development of an action plan for violence prevention; no data were presented to control units. Main outcomes were rates of violent events and injuries across study groups over time. Results Six months post-intervention, incident rate ratios of violent events were significantly lower on intervention units compared to controls (IRR 0.48, 95% CI 0.29-0.80). At 24 months, the risk for violence-related injury was lower on intervention units, compared to controls (IRR 0.37, 95% CI 0.17-0.83). Conclusion This data-driven, worksite-based intervention was effective in decreasing risks of patient-to-worker violence and related injury. PMID:28045793

Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

PubMed Central

Wang, Jie; Xiong, Xingjiang; Xing, Yanwei; Liu, Zhen; Jiang, Wenrui; Huang, Junyi; Feng, Bo

2013-01-01

Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P = 0.01). Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P < 0.00001). Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P < 0.0001). Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P = 0.02). Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results. PMID:24454510

Pharmacoeconomic evidence of bosentan for pulmonary arterial hypertension.

PubMed

Strange, Geoff; Keogh, Anne; Dalton, Brad; Gabbay, Eli

2011-06-01

In this article, we review randomized controlled trials, open-label trials and pharmacoeconomic models of bosentan for the management of patients with pulmonary arterial hypertension. Bosentan consistently improves WHO functional class and quality of life, slows clinical worsening and is associated with improved survival compared with historical treatment. Although head-to-head trials are scarce, data directly comparing bosentan with sildenafil indicate no clinically significant differences between treatments as measured by the 6-min walk distance alone. Compared with historical care, bosentan treatment, over a 15-30-year period, increases the number of quality-adjusted life years (3.49 years). Economic modeling suggests that the cost-effectiveness of bosentan is similar to that of ambrisentan (US$43,725-57,778 per quality-adjusted life year), not as cost effective as sildenafil (at 20 mg three-times daily) and more cost effective than iloprost. More randomized controlled trials of longer duration are required to confirm the results from these economic models.

Ocular wavefront analysis of aspheric compared with spherical monofocal intraocular lenses in cataract surgery: Systematic review with metaanalysis.

PubMed

Schuster, Alexander K; Tesarz, Jonas; Vossmerbaeumer, Urs

2015-05-01

This review was conducted to compare the physical effect of aspheric IOL implantation on wavefront properties with that of spherical IOL implantation. The peer-reviewed literature was systematically searched in Medline, Embase, Web of Science, Biosis, and the Cochrane Library according to the Cochrane Collaboration method. Inclusion criteria were randomized controlled trials comparing the use of aspheric versus spherical monofocal IOL implantation that assessed visual acuity, contrast sensitivity, or quality of vision. A secondary outcome was ocular wavefront analysis; spherical aberration, higher-order aberrations (HOAs), coma, and trefoil were evaluated. Effects were calculated as standardized mean differences (Hedges g) and were pooled using random-effect models. Thirty-four of 43 studies provided data for wavefront analysis. Aspheric monofocal IOL implantation resulted in less ocular spherical aberration and fewer ocular HOAs than spherical IOLs. This might explain the better contrast sensitivity in patients with aspheric IOLs. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Iron and cardiac ischemia: a natural, quasi-random experiment comparing eligible with disqualified blood donors.

PubMed

Germain, Marc; Delage, Gilles; Blais, Claudia; Maunsell, Elizabeth; Décary, Francine; Grégoire, Yves

2013-06-01

The theory that elevated iron stores can induce vascular injury and ischemia remains controversial. We conducted a cohort study of the effect of blood donation on the risk of coronary heart disease (CHD) by taking advantage of the quasi-random exclusion of donors who obtained a falsely reactive test for a transmissible disease (TD) marker. Whole blood donors who were permanently disqualified because of a false-reactive test between 1990 and 2007 in the province of Quebec were compared to donors who remained eligible, matched for baseline characteristics. The incidence of CHD after entry into the study was determined through hospitalization and death records. We compared eligible and disqualified donors using an "intention-to-treat" framework. Overall, 12,357 donors who were permanently disqualified were followed for 124,123 person-years of observation, plus 50,889 donors who remained eligible (516,823 person-years). On average, donors who remained eligible made 0.36 donation/year during follow-up and had an incidence of hospitalizations or deaths attributable to CHD of 3.60/1000 person-years, compared to 3.52 among permanently disqualified donors (rate ratio, 1.02; 95% confidence interval, 0.92-1.13). Donors who remained eligible did not have a lower risk of CHD, compared to donors who were permanently disqualified due to a false-reactive TD marker. Because of the quasi-random nature of false-reactive screening tests, this natural experiment has a level of validity approaching that of a randomized trial evaluating the effect of regular blood donation on CHD risk. These results do not support the iron hypothesis. © 2013 American Association of Blood Banks.

Effects of large woody debris placement on stream channels and benthic macroinvertebrates

Treesearch

Robert H. Hilderbrand; A. Dennis Lemly; C. Andrew Dolloff; Kelly L. Harpster

1997-01-01

Large woody debris (LWD)was added as an experimental stream restoration techniquein two streams in southwest Virginia. Additions were designed to compare human judgement in log placements against a randomized design and an unmanipulated reach, &d also to compare effectiveness in a low- and a high-gradient stream. Pool area increased 146% in the systematic placement...

Comparing effects of fire modeling methods on simulated fire patterns and succession: a case study in the Missouri Ozarks

Treesearch

Jian Yang; Hong S. He; Brian R. Sturtevant; Brian R. Miranda; Eric J. Gustafson

2008-01-01

We compared four fire spread simulation methods (completely random, dynamic percolation. size-based minimum travel time algorithm. and duration-based minimum travel time algorithm) and two fire occurrence simulation methods (Poisson fire frequency model and hierarchical fire frequency model) using a two-way factorial design. We examined these treatment effects on...

The Promise of Andragogy and Experimental Learning to Improve Teaching of Nutrition Concepts to Culinary Arts Students

ERIC Educational Resources Information Center

Abdulsalam, N.; Condrasky, M.; Bridges, W.; Havice, P.

2017-01-01

This randomized controlled trial compared the effectiveness of traditional lecture (C), face-to-face demonstration (DP), on-line lecture capture (OP), and the combination of the last two (OP+DP) to enhance culinary arts students' application skills related to sodium usage in food preparation. Objectives were to compare relative effectiveness of…

A Comparative Study on the Effects of Negative Evidence and Enriched Input on Learning of Verb-Noun Collocations

ERIC Educational Resources Information Center

Okyar, Hatice; Yangin Eksi, Gonca

2017-01-01

This study compared the effectiveness of negative evidence and enriched input on learning the verb-noun collocations. There were 52 English as Foreign Language (EFL) learners in this research study and they were randomly assigned to the negative evidence or enriched input groups. While the negative evidence group (n = 27) was provided with…

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

PubMed Central

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

2016-01-01

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

Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

PubMed

Edwards, Meghan K; Loprinzi, Paul D

2018-03-01

No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

PubMed

Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

2017-11-01

This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

Randomized controlled trial for Salvia sclarea or Lavandula angustifolia: differential effects on blood pressure in female patients with urinary incontinence undergoing urodynamic examination.

PubMed

Seol, Geun Hee; Lee, Yun Hee; Kang, Purum; You, Ji Hye; Park, Mira; Min, Sun Seek

2013-07-01

The aim of this study was to investigate the effect of inhalation of Salvia sclarea (clary sage; clary) or Lavandula angustifolia (lavender) essential oil vapors on autonomic nervous system activity in female patients with urinary incontinence undergoing urodynamic assessment. STUDY DESIGN, LOCATION, AND SUBJECTS: This study was a double-blind, randomized, controlled trial carried out in 34 female patients with urinary incontinence. The subjects were randomized to inhale lavender, clary, or almond (control) oil at concentrations of 5% (vol/vol) each. Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and salivary cortisol were measured before and after inhalation of these odors for 60 minutes. The clary oil group experienced a significant decrease in systolic blood pressure compared with the control (p=0.048) and lavender oil (p=0.026) groups, a significant decrease in diastolic blood pressure compared with the lavender oil group (p=0.034) and a significant decrease in respiratory rate compared with the control group (p<0.001). In contrast, the lavender oil group tended to increase systolic and diastolic blood pressure compared with the control group. Compared with the control group, inhalation of lavender oil (p=0.045) and clary oil (p<0.001) resulted in statistically significant reductions in respiratory rate. These results suggest that lavender oil inhalation may be inappropriate in lowering stress during urodynamic examinations, despite its antistress effects, while clary oil inhalation may be useful in inducing relaxation in female urinary incontinence patients undergoing urodynamic assessments.

Randomized Controlled Trial for Salvia sclarea or Lavandula angustifolia: Differential Effects on Blood Pressure in Female Patients with Urinary Incontinence Undergoing Urodynamic Examination

PubMed Central

Lee, Yun Hee; Kang, Purum; You, Ji Hye; Park, Mira; Min, Sun Seek

2013-01-01

Abstract Objectives The aim of this study was to investigate the effect of inhalation of Salvia sclarea (clary sage; clary) or Lavandula angustifolia (lavender) essential oil vapors on autonomic nervous system activity in female patients with urinary incontinence undergoing urodynamic assessment. Study design, location, and subjects This study was a double-blind, randomized, controlled trial carried out in 34 female patients with urinary incontinence. Outcome measure The subjects were randomized to inhale lavender, clary, or almond (control) oil at concentrations of 5% (vol/vol) each. Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and salivary cortisol were measured before and after inhalation of these odors for 60 minutes. Results The clary oil group experienced a significant decrease in systolic blood pressure compared with the control (p=0.048) and lavender oil (p=0.026) groups, a significant decrease in diastolic blood pressure compared with the lavender oil group (p=0.034) and a significant decrease in respiratory rate compared with the control group (p<0.001). In contrast, the lavender oil group tended to increase systolic and diastolic blood pressure compared with the control group. Compared with the control group, inhalation of lavender oil (p=0.045) and clary oil (p<0.001) resulted in statistically significant reductions in respiratory rate. Conclusions These results suggest that lavender oil inhalation may be inappropriate in lowering stress during urodynamic examinations, despite its antistress effects, while clary oil inhalation may be useful in inducing relaxation in female urinary incontinence patients undergoing urodynamic assessments. PMID:23360656

The effectiveness of regular leisure-time physical activities on long-term glycemic control in people with type 2 diabetes: A systematic review and meta-analysis.

PubMed

Pai, Lee-Wen; Li, Tsai-Chung; Hwu, Yueh-Juen; Chang, Shu-Chuan; Chen, Li-Li; Chang, Pi-Ying

2016-03-01

The objective of this study was to systematically review the effectiveness of different types of regular leisure-time physical activities and pooled the effect sizes of those activities on long-term glycemic control in people with type 2 diabetes compared with routine care. This review included randomized controlled trials from 1960 to May 2014. A total of 10 Chinese and English databases were searched, following selection and critical appraisal, 18 randomized controlled trials with 915 participants were included. The standardized mean difference was reported as the summary statistic for the overall effect size in a random effects model. The results indicated yoga was the most effective in lowering glycated haemoglobin A1c (HbA1c) levels. Meta-analysis also revealed that the decrease in HbA1c levels of the subjects who took part in regular leisure-time physical activities was 0.60% more than that of control group participants. A higher frequency of regular leisure-time physical activities was found to be more effective in reducing HbA1c levels. The results of this review provide evidence of the benefits associated with regular leisure-time physical activities compared with routine care for lowering HbA1c levels in people with type 2 diabetes. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Treatment effect expressed as the novel Delay of Event measure is associated with high willingness to initiate preventive treatment - A randomized survey experiment comparing effect measures.

PubMed

Berglund, Erik; Westerling, Ragnar; Sundström, Johan; Lytsy, Per

2016-12-01

This study aimed to investigate patients' willingness to initiate a preventive treatment and compared two established effect measures to the newly developed Delay of Events (DoE) measure that expresses treatment effect as a gain in event-free time. In this cross-sectional, randomized survey experiment in the general Swedish population,1079 respondents (response rate 60.9%) were asked to consider a preventive cardiovascular treatment. Respondents were randomly allocated to one of three effect descriptions: DoE, relative risk reduction (RRR), or absolute risk reduction (ARR). Univariate and multivariate analyses were performed investigating willingness to initiate treatment, views on treatment benefit, motivation and importance to adhere and willingness to pay for treatment. Eighty-one percent were willing to take the medication when the effect was described as DoE, 83.0% when it was described as RRR and 62.8% when it was described as ARR. DoE and RRR was further associated with positive views on treatment benefit, motivation, importance to adhere and WTP. Presenting treatment effect as DoE or RRR was associated with a high willingness to initiate treatment. An approach based on the novel time-based measure DoE may be of value in clinical communication and shared decision making. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Ripening of the cervix with prostaglandin E2-gel. A randomized study with a new ready-to-use compound of triacetin-prostaglandin-E2-gel.

PubMed

Kristoffersen, M; Sande, H A; Sande, O S

1986-08-01

A randomized study with a group of patients treated with a new ready-to-use triacetin-prostaglandin E2-gel compared to a non-treated group was conducted. The gel-treated group showed a distinct difference in cervical score after 12 h and ten patients were delivered during this period without further induction attempt compared to none in the control group. There was a significantly lower need for oxytocin stimulation in the treated group (P less than 0.0005), but there was no difference in the cesarean section rate or instrumental delivery rate. No side-effects were seen. This new gel seems effective and safe.

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

Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families?

PubMed

Gross, Deborah A; Belcher, Harolyn M E; Ofonedu, Mirian E; Breitenstein, Susan; Frick, Kevin D; Chakra, Budhathoki

2014-03-01

Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children, their families, and society. Although parent training (PT) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems, they have been less effective for children from low-income and underserved racial and ethnic populations. The purpose of this randomized trial is to compare the effectiveness, cost, and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models: (1) The Chicago Parent Program (CPP), a group-based program developed in collaboration with a community advisory board of African-American and Latino parents; and (2) Parent-Child Interaction Therapy (PCIT), an individualized parent-child coaching model considered to be 'the gold standard' for parents of children with externalizing behavior problems. This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2- to 5-year-old children at a mental health clinic in Baltimore, MD (80% African-American or multi-racial; 97% receiving Medicaid). Using block randomization procedures, 262 parents are randomized to CPP or PCIT. Clinicians (n=13) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate. Primary outcomes of interest are reductions in child behavior problems, improvements in parenting, perceived value of the interventions from the perspective of parents and clinicians, and cost. Parent distress and family social risk are assessed as modifiers of treatment effectiveness. We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians. This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations (CPP) against a well-established program considered to be the 'the gold standard' (PCIT) with a high-risk population of parents. Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban, low-income families are discussed. NCT01517867.

Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families?

PubMed Central

2014-01-01

Background Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children, their families, and society. Although parent training (PT) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems, they have been less effective for children from low-income and underserved racial and ethnic populations. The purpose of this randomized trial is to compare the effectiveness, cost, and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models: (1) The Chicago Parent Program (CPP), a group-based program developed in collaboration with a community advisory board of African-American and Latino parents; and (2) Parent-Child Interaction Therapy (PCIT), an individualized parent-child coaching model considered to be ‘the gold standard’ for parents of children with externalizing behavior problems. Methods This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2- to 5-year-old children at a mental health clinic in Baltimore, MD (80% African-American or multi-racial; 97% receiving Medicaid). Using block randomization procedures, 262 parents are randomized to CPP or PCIT. Clinicians (n = 13) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate. Primary outcomes of interest are reductions in child behavior problems, improvements in parenting, perceived value of the interventions from the perspective of parents and clinicians, and cost. Parent distress and family social risk are assessed as modifiers of treatment effectiveness. We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians. Discussion This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations (CPP) against a well-established program considered to be the ‘the gold standard’ (PCIT) with a high-risk population of parents. Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban, low-income families are discussed. Trial registration NCT01517867 PMID:24581245

Tricyclic and Tetracyclic Antidepressants for the Prevention of Frequent Episodic or Chronic Tension-Type Headache in Adults: A Systematic Review and Meta-Analysis.

PubMed

Jackson, Jeffrey L; Mancuso, Josephine M; Nickoloff, Sarah; Bernstein, Rebecca; Kay, Cynthia

2017-12-01

Tension-type headaches are a common source of pain and suffering. Our purpose was to assess the efficacy of tricyclic (TCA) and tetracyclic antidepressants in the prophylactic treatment of tension-type headache. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the ISI Web of Science, and clinical trial registries through 11 March 2017 for randomized controlled studies of TCA or tetracyclic antidepressants in the prevention of tension-type headache in adults. Data were pooled using a random effects approach. Among 22 randomized controlled trials, eight included a placebo comparison and 19 compared at least two active treatments. Eight studies compared TCAs to placebo, four compared TCAs to selective serotonin reuptake inhibitors (SSRIs), and two trials compared TCAs to behavioral therapies. Two trials compared tetracyclics to placebo. Single trials compared TCAs to tetracyclics, buspirone, spinal manipulation, transcutaneous electrical stimulation, massage, and intra-oral orthotics. High-quality evidence suggests that TCAs were superior to placebo in reducing headache frequency (weighted mean differences (WMD): -4.8 headaches/month, 95% CI: -6.63 to -2.95) and number of analgesic medications consumed (WMD: -21.0 doses/month, 95% CI: -38.2 to -3.8). TCAs were more effective than SSRIs. Low-quality studies suggest that TCAs are superior to buspirone, but equivalent to behavioral therapy, spinal manipulation, intra-oral orthotics, and massage. Tetracyclics were no better than placebo for chronic tension-type headache. Tricyclic antidepressants are modestly effective in reducing chronic tension-type headache and are superior to buspirone. In limited studies, tetracyclics appear to be ineffective in the prophylactic treatment of chronic tension-type headache.

Comparative Evaluation of Effect of Nano-hydroxyapatite and 8% Arginine Containing Toothpastes in Managing Dentin Hypersensitivity: Double Blind Randomized Clinical Trial.

PubMed

Anand, Suresh; Rejula, Fathima; Sam, Joseph V G; Christaline, Ramakrishnan; Nair, Mali G; Dinakaran, Shiji

This double blind randomized clinical trial was conducted with the purpose of evaluating the effects of Nano-hydroxyapatite toothpaste as compared to 8% Arginine containing toothpaste in the management of Dentin hypersensitivity (DH). Patients (30 in each group) suffering from DH and eliciting a VAS score higher than 2 in air blast and tactile test were randomly allocated (block randomization) into either a group 1 (arginine toothpaste) or group 2 (nHA toothpaste). The primary outcome evaluated was the reduction of DH as measured by the electrical stimulus reading on the digital pulp tester. Current required for eliciting a VAS score of 2 was recorded before application of dentifrice. 1 cm of toothpaste was then expressed on the tooth surface for two minutes in each group and rinsed off. The electrical stimulus required to elicit a VAS score of 2 was recorded after 5 minutes, 1 week and 4 weeks. The desensitizing paste containing arginine provided a statistically significant reduction in DH and so did the paste containing nHA. Mean increase in amperage value (reduction in DH) was higher for nHA based than the arginine containing dentifrice. This difference was not statistically significant showing that both toothpastes are equally effective. The findings of the present study encourage the use of Nano-hydroxyapatite and arginine containing dentifrice as an effective desensitizing agent providing relief from symptoms 5 minutes after application and after 1 and 4 weeks.

Music in the cath lab: who should select it?

PubMed

Goertz, Wolfram; Dominick, Klaus; Heussen, Nicole; vom Dahl, Juergen

2011-05-01

The ALMUT study wants to evaluate the anxiolytic effects of different music styles and no music in 200 patients undergoing cardiac catheterization and to assess if there is a difference if patients select one of these therapies or are randomized to one of them. The anxiolytic and analgesic effects of music have been described in previous trials. Some authors have suggested to evaluate whether patient-selected music is more effective than the music selected by the physician in reducing anxiety and stress levels. After randomization 100 patients (group A) were allowed to choose between classical music, relaxing modern music, smooth jazz, and no music. One hundred patients (group B) were randomized directly to one of these therapies (n = 25 each). Complete data were available for 197 patients (65 ± 10 years; 134 male). Using the State-Trait Anxiety Inventory (STAI) all patients in group B who listened to music showed a significantly higher decrease of their anxiety level (STAI-State difference pre-post of 16.8 ± 10.2) compared to group A (13.3 ± 11.1; p = 0.0176). Patients without music (6.2 ± 6.7) had a significantly weaker reduction of anxiety compared to all music-listeners (14.9 ± 10.7, p < 0.0001). The positive effects of music in the cath lab support previous reports. Surprisingly, the hypothesis that the patient's choice of preferred music might yield higher benefits than a randomized assignment could be dismissed.

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

PubMed

Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

2013-09-01

We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P < 0.05. One hundred comparative evaluations of pulmonary auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P < 0.0001). Compared with Littmann Cardiology III, auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

Correction of confounding bias in non-randomized studies by appropriate weighting.

PubMed

Schmoor, Claudia; Gall, Christine; Stampf, Susanne; Graf, Erika

2011-03-01

In non-randomized studies, the assessment of a causal effect of treatment or exposure on outcome is hampered by possible confounding. Applying multiple regression models including the effects of treatment and covariates on outcome is the well-known classical approach to adjust for confounding. In recent years other approaches have been promoted. One of them is based on the propensity score and considers the effect of possible confounders on treatment as a relevant criterion for adjustment. Another proposal is based on using an instrumental variable. Here inference relies on a factor, the instrument, which affects treatment but is thought to be otherwise unrelated to outcome, so that it mimics randomization. Each of these approaches can basically be interpreted as a simple reweighting scheme, designed to address confounding. The procedures will be compared with respect to their fundamental properties, namely, which bias they aim to eliminate, which effect they aim to estimate, and which parameter is modelled. We will expand our overview of methods for analysis of non-randomized studies to methods for analysis of randomized controlled trials and show that analyses of both study types may target different effects and different parameters. The considerations will be illustrated using a breast cancer study with a so-called Comprehensive Cohort Study design, including a randomized controlled trial and a non-randomized study in the same patient population as sub-cohorts. This design offers ideal opportunities to discuss and illustrate the properties of the different approaches. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

The effects of Alkanna tinctoria Tausch on split-thickness skin graft donor site management: a randomized, blinded placebo-controlled trial.

PubMed

Kheiri, Aliasghar; Amini, Shahideh; Javidan, Abbas Norouzi; Saghafi, Mohammad Mehdi; Khorasani, Ghasemali

2017-05-08

A prospective, randomized, placebo-controlled clinical trial was conducted to compare the healing effectiveness of Alkanna tinctoria (L.) Tausch (Boraginaceae) with standard dressing on wound healing at the donor site after removal of the skin graft. Enrolled patients were randomly allocated to receive topicalA. tinctoria extract ointment (20%) or standard dressing (dressing with base ointment) daily. Wound healing was assessed using the Bates-Jenson assessment tool at the 2 nd and 4 th weeks after intervention. Decreases in wound score were significantly greater in the A. tinctoria group compared with the placebo group (P <0.05). The surface areas of graft donor sites in the A. tinctoria group were significantly reduced as compared with the control group at day 28 of the intervention (P < 0.05). The proportion of patients in the A. tinctoria group achieving complete wound healing within 2 to 4 weeks was 50% and 96.66%, respectively, significantly higher than in patients receiving standard care: 0% and 23.3%, respectively. This clinical study showed that A. tinctoria dressing accelerates wound healing after graft harvesting. IRCT ID: IRCT201511165781N2 .

Comparison of Address-based Sampling and Random-digit Dialing Methods for Recruiting Young Men as Controls in a Case-Control Study of Testicular Cancer Susceptibility

PubMed Central

Clagett, Bartholt; Nathanson, Katherine L.; Ciosek, Stephanie L.; McDermoth, Monique; Vaughn, David J.; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A.

2013-01-01

Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-phone numbers and address-based sampling (ABS), to recruit primarily white men aged 18–55 years into a study of testicular cancer susceptibility conducted in the Philadelphia, Pennsylvania, metropolitan area between 2009 and 2012. With few exceptions, eligible and enrolled controls recruited by means of RDD and ABS were similar with regard to characteristics for which data were collected on the screening survey. While we find ABS to be a comparably effective method of recruiting young males compared with landline RDD, we acknowledge the potential impact that selection bias may have had on our results because of poor overall response rates, which ranged from 11.4% for landline RDD to 1.7% for ABS. PMID:24008901

A Cognitive Behavioral Smoking Abstinence Intervention for Adults with Chronic Pain: A Randomized Controlled Pilot Trial

PubMed Central

Hooten, W. Michael; Townsend, Cynthia O.; Hays, J. Taylor; Ebnet, Kaye L.; Gauvin, Thomas R.; Gehin, Jessica M.; Laures, Heidi J.; Patten, Christi A.; Warner, David O.

2015-01-01

Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n = 30) or the control condition (n = 30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. PMID:24333035

A randomized trial comparing digital video disc with written delivery of falls prevention education for older patients in hospital.

PubMed

Hill, Anne-Marie; McPhail, Steven; Hoffmann, Tammy; Hill, Keith; Oliver, David; Beer, Christopher; Brauer, Sandra; Haines, Terry P

2009-08-01

To compare the effectiveness of a digital video disc (DVD) with that of a written workbook delivering falls prevention education to older hospital patients on self-perceived risk of falls, perception of falls epidemiology, knowledge of prevention strategies, and motivation and confidence to engage in self-protective strategies. To compare the effect of receiving either education approach versus no education on patients' perception of falls epidemiology. Randomized trial (DVD vs workbook) with additional quasi-experimental control group. Geriatric, medical, and orthopedic wards in Perth and Brisbane, Australia. One hundred (n=51 DVD, n=49 workbook) hospital inpatients aged 60 and older receiving an intervention (mean age 75.3+/-10.1) and 122 in the control group (mean age 79.3+/-8.3). Participants randomly assigned to receive identical educational material on falls prevention delivered on a DVD or in a workbook. Control group received usual care. Custom-designed survey addressing elements of the Health Belief Model of health behavior change. Participants randomized to DVD delivery had a higher self-perceived risk of falling (P=.04) and higher levels of confidence (P=.03) and motivation (P=.04) to engage in self-protective strategies than participants who received the workbook. A higher proportion of participants who received either form of the education provided "desired" responses than of control group participants across all knowledge items (P<.001). Delivery of falls prevention education on a DVD compared to a written workbook is more likely to achieve important changes in parameters likely to affect successful uptake of falls prevention messages in the hospital setting.

Generalized self-consistent method for predicting the effective elastic properties of composites with random hybrid structures

NASA Astrophysics Data System (ADS)

Pan'kov, A. A.

1997-05-01

The feasibility of using a generalized self-consistent method for predicting the effective elastic properties of composites with random hybrid structures has been examined. Using this method, the problem is reduced to solution of simpler special averaged problems for composites with single inclusions and corresponding transition layers in the medium examined. The dimensions of the transition layers are defined by correlation radii of the composite random structure of the composite, while the heterogeneous elastic properties of the transition layers take account of the probabilities for variation of the size and configuration of the inclusions using averaged special indicator functions. Results are given for a numerical calculation of the averaged indicator functions and analysis of the effect of the micropores in the matrix-fiber interface region on the effective elastic properties of unidirectional fiberglass—epoxy using the generalized self-consistent method and compared with experimental data and reported solutions.

The effects of educating mothers and girls on the girls' attitudes toward puberty health: a randomized controlled trial.

PubMed

Afsari, Atousa; Mirghafourvand, Mojgan; Valizadeh, Sousan; Abbasnezhadeh, Massomeh; Galshi, Mina; Fatahi, Samira

2017-04-01

The attitude of a girl toward her menstruation and puberty has a considerable impact on her role during motherhood, social adjustment, and future marital life. This study was conducted in 2014 with the aim of comparing the effects of educating mothers and girls on the attitudes of adolescent girls of Tabriz City, Iran, towards puberty health. This randomized control clinical trial was conducted on 364 adolescent girls who experienced menstruation. Twelve schools were selected randomly among 107 secondary schools for girls. One-third of the students of each school were selected randomly using a table of random numbers and socio-demographic and each participant was asked to answer the attitude questionnaires. The schools were randomly allocated to the groups of mother's education, girl's education, and no-intervention. The attitude questionnaire was filled out by the participants again 2 months after intervention. The general linear model, in which the baseline values were controlled, was employed to compare the scores of the three groups after the intervention. No significant differences were observed among the three groups in terms of the attitude score before intervention (p>0.05). Attitude score improvement after intervention in the girl's education group was significantly higher than the one of both mother's education (adjusted mean difference [AMD]: 1.8; [95% confidence interval (CI): 0.4-1.3]) and no-intervention groups (AMD: 1.3; [95% CI: 0.0-2.6]) by controlling the attitude score before intervention. Based on the findings, it is more effective to educate girls directly about puberty health to improve adolescent girls' attitudes than educating mothers and asking them to transfer information to the girls. Nevertheless, studies with longer training period and follow-up are proposed to determine the effects of educating girls (through their mothers) on their attitudes about puberty health.

A randomized controlled non-inferiority study comparing the antiemetic effect between intravenous granisetron and oral azasetron based on estimated 5-HT3 receptor occupancy.

PubMed

Endo, Junki; Iihara, Hirotoshi; Yamada, Maya; Yanase, Koumei; Kamiya, Fumihiko; Ito, Fumitaka; Funaguchi, Norihiko; Ohno, Yasushi; Minatoguchi, Shinya; Itoh, Yoshinori

2012-09-01

The acute antiemetic effect was compared between oral azasetron and intravenous granisetron based on the 5-hydroxytryptamine(3) (5-HT(3)) receptor occupancy theory. Receptor occupancy was estimated from reported data on plasma concentrations and affinity constants to 5-HT(3) receptor. A randomized non-inferiority study comparing acute antiemetic effects between oral azasetron and intravenous granisetron was performed in 105 patients receiving the first course of carboplatin-based chemotherapy for lung cancer. Azasetron exhibited the highest 5-HT(3) receptor occupancy among various first-generation 5-HT(3) antagonists. The complete response to oral azasetron was shown to be non-inferior to that of intravenous granisetron, in which the risk difference was 0.0004 (95% confidence interval: -0.0519-0.0527). The lower limit of the confidence intervals did not exceed the negative non-inferiority margin (-0.1). The complete response during the overall period was not different (68% versus 67%). Oral azasetron was found to be non-inferior to intravenous granisetron in the acute antiemetic effect against moderately emetogenic chemotherapy.

Baseline Serum Estradiol and Fracture Reduction During Treatment With Hormone Therapy: The Women’s Health Initiative Randomized Trial

PubMed Central

Cauley, Jane A.; LaCroix, Andrea Z.; Robbins, John A.; Larson, Joseph; Wallace, Robert; Wactawski-Wende, Jean; Chen, Zhao; Bauer, Douglas C.; Cummings, Steven R.; Jackson, Rebecca

2009-01-01

Purpose To test the hypothesis that the reduction in fractures with hormone therapy (HT) is greater in women with lower estradiol levels. Methods We conducted a nested case-control study within the Women’s Health Initiative HT Trials. The sample included 231 hip fracture case-control pairs and a random sample of 519 all fracture case-control pairs. Cases and controls were matched for age, ethnicity, randomization date, fracture history and hysterectomy status. Hormones were measured prior to randomization. Incident cases of fracture identified over an average follow-up of 6.53 years. Results There was no evidence that the effect of HT on fracture differed by baseline estradiol (E2) or sex hormone binding globulin (SHBG). Across all quartiles of E2 and SHBG, women randomized to HT had about a 50% lower risk of fracture including hip fracture, compared to placebo. Conclusion The effect of HT on fracture reduction is independent of estradiol and SHBG levels. PMID:19436934

Tubal anastomosis after previous sterilization: a systematic review.

PubMed

van Seeters, Jacoba A H; Chua, Su Jen; Mol, Ben W J; Koks, Carolien A M

2017-05-01

Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location. We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success. Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness. We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated. In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Comparing the effect of topical application of human milk and dry cord care on umbilical cord separation time in healthy newborn infants.

PubMed

Aghamohammadi, Azar; Zafari, Mandana; Moslemi, Leila

2012-06-01

Comparing the effect of topical human milk application and dry cord care on cord separation time. This research was a randomized clinical trial study on 130 singleton and mature newborns. Newborns were placed randomly in groups of topical application of human milk and dry cord care. The umbilical separation time was compared in the two groups. Data was analyzed by SPSS software. Independent Samples t-Test, χ(2), Fisher were used in this study. Median time of cord separation in human milk application group (150.95±28.68 hours) was significantly shorter than dry cord care group (180.93±37.42 hours) (P<0.001). Topical application of human milk on the remaining part of the cord reduces the cord separation time and it can be used as an easy, cheap and non invasive way for cord care.

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

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.

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

PubMed

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

2013-08-01

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

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

PubMed Central

Kim, Yoonsang; Emery, Sherry

2013-01-01

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

Probabilistic Material Strength Degradation Model for Inconel 718 Components Subjected to High Temperature, High-Cycle and Low-Cycle Mechanical Fatigue, Creep and Thermal Fatigue Effects

NASA Technical Reports Server (NTRS)

Bast, Callie C.; Boyce, Lola

1995-01-01

The development of methodology for a probabilistic material strength degradation is described. The probabilistic model, in the form of a postulated randomized multifactor equation, provides for quantification of uncertainty in the lifetime material strength of aerospace propulsion system components subjected to a number of diverse random effects. This model is embodied in the computer program entitled PROMISS, which can include up to eighteen different effects. Presently, the model includes five effects that typically reduce lifetime strength: high temperature, high-cycle mechanical fatigue, low-cycle mechanical fatigue, creep and thermal fatigue. Results, in the form of cumulative distribution functions, illustrated the sensitivity of lifetime strength to any current value of an effect. In addition, verification studies comparing predictions of high-cycle mechanical fatigue and high temperature effects with experiments are presented. Results from this limited verification study strongly supported that material degradation can be represented by randomized multifactor interaction models.

Dynamic probability of reinforcement for cooperation: Random game termination in the centipede game.

PubMed

Krockow, Eva M; Colman, Andrew M; Pulford, Briony D

2018-03-01

Experimental games have previously been used to study principles of human interaction. Many such games are characterized by iterated or repeated designs that model dynamic relationships, including reciprocal cooperation. To enable the study of infinite game repetitions and to avoid endgame effects of lower cooperation toward the final game round, investigators have introduced random termination rules. This study extends previous research that has focused narrowly on repeated Prisoner's Dilemma games by conducting a controlled experiment of two-player, random termination Centipede games involving probabilistic reinforcement and characterized by the longest decision sequences reported in the empirical literature to date (24 decision nodes). Specifically, we assessed mean exit points and cooperation rates, and compared the effects of four different termination rules: no random game termination, random game termination with constant termination probability, random game termination with increasing termination probability, and random game termination with decreasing termination probability. We found that although mean exit points were lower for games with shorter expected game lengths, the subjects' cooperativeness was significantly reduced only in the most extreme condition with decreasing computer termination probability and an expected game length of two decision nodes. © 2018 Society for the Experimental Analysis of Behavior.

Approaches to answering critical CER questions.

PubMed

Kinnier, Christine V; Chung, Jeanette W; Bilimoria, Karl Y

2015-01-01

While randomized controlled trials (RCTs) are the gold standard for research, many research questions cannot be ethically and practically answered using an RCT. Comparative effectiveness research (CER) techniques are often better suited than RCTs to address the effects of an intervention under routine care conditions, an outcome otherwise known as effectiveness. CER research techniques covered in this section include: effectiveness-oriented experimental studies such as pragmatic trials and cluster randomized trials, treatment response heterogeneity, observational and database studies including adjustment techniques such as sensitivity analysis and propensity score analysis, systematic reviews and meta-analysis, decision analysis, and cost effectiveness analysis. Each section describes the technique and covers the strengths and weaknesses of the approach.

Does ascorbic acid protect against contrast-induced acute kidney injury in patients undergoing coronary angiography: a systematic review with meta-analysis of randomized, controlled trials.

PubMed

Sadat, Umar; Usman, Ammara; Gillard, Jonathan H; Boyle, Jonathan R

2013-12-10

This study sought to perform a systematic review with meta-analysis of randomized controlled trials comparing the use of ascorbic acid with placebo or other treatment options for the treatment of contrast induced-acute kidney injury (CI-AKI) in patients undergoing coronary angiography. CI-AKI remains the most widely discussed and debated topic in cardiovascular medicine, with its incidence increasing due to an increasing number of contrast media-enhanced radiological procedures being performed. MEDLINE, Embase, and Cochrane central databases were searched from inception to May 2013, without language restrictions. For a study to be selected, it had to report the incidence of CI-AKI as an outcome measure. Studies were excluded if at least 1 study arm did not have ascorbic acid administered alone or with saline solution hydration. Data were extracted by 1 author, and random checks were made by another author. Nine randomized, controlled trials reported data on the incidence of CI-AKI in 1,536 patients who had completed the trial and were included in the final analysis. Patients receiving ascorbic acid had 33% less risk of CI-AKI compared with patients receiving placebo or an alternate pharmacological treatment (risk ratio by random-effects model: 0.672; 95% confidence interval, 0.466 to 0.969; p = 0.034). Ascorbic acid provides effective nephroprotection against CI-AKI and may form a part of effective prophylactic pharmacological regimens. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Effectiveness of a ketogenic diet in children with refractory epilepsy: a systematic review].

PubMed

Araya-Quintanilla, F; Celis-Rosati, A; Rodriguez-Leiva, C; Silva-Navarro, C; Silva-Pinto, Y; Toro-Jeria, B

2016-05-16

Epilepsy is a brain disorder that affects both children and adults. From the 1920s the ketogenic diet has gained prestige as another treatment option for patients with refractory epilepsy. A summary of the evidence will be made through a systematic review of randomized clinical trials that have compared a single ketogenic diet with other diet for the management of these patients. To determine the effectiveness of the ketogenic diet in reducing episodes of seizures in patients with refractory epilepsy. The search strategy included randomized controlled trials and controlled clinical trials. Databases used were Medline, LILACS, Central and CINAHL. Six articles that met our elegibility criteria. There is limited evidence that the ketogenic diet compared to the medium-chain triglyceride diet is more effective in reducing the frequency of seizures. There is also moderate evidence that classical ketogenic diet compared to the gradual diet (2.5:1 and 3:1) is more effective in reducing seizures. There is moderate evidence that classical ketogenic diet compared to Atkins diet is more effective in reducing the frequency of seizure. The decision to apply this type of diet should also be based on costs, preferences and safety of treatment. It should also take into account the likelihood that studies have indexing problems have been left out of the review.

A regulator's view of comparative effectiveness research.

PubMed

Temple, Robert

2012-02-01

'Comparative effectiveness' is the current enthusiasm, and for good reason. After knowing a treatment works, the most critical question is how it compares with alternatives. Comparative studies are not commonly conducted by drug companies and they represent a significant methodological challenge. Comparative data could include evidence of overall superiority to an alternative or advantages in identifiable subsets, for example, people who do not respond to or tolerate alternatives, or members of a genetic subset and could also include convincing evidence that there is little difference between two treatments. To describe regulations, guidance, and Food and Drug Administration experience related to studies of comparative effectiveness, including approaches to showing superiority and problems encountered in showing similarity. Review of Food and Drug Administration regulations and guidance and experience with showing superiority and similarity, particularly related to randomized trials and epidemiologic studies. Methods exist, and they have been successful for showing overall superiority of one drug over another, advantages in specific population subsets. Efforts to show true equivalence face problems of definition and very large sample sizes needed to rule out small differences. There is need for further discussion of what is meant by similarity or equivalence of two treatments. Comparative studies are challenging because differences between effective therapies are likely to be small and can be detected reliably only in randomized trials, often large ones. Despite the difficulties, comparative trials have been successful and we clearly would like to see more of them.

Including nonadditive genetic effects in mating programs to maximize dairy farm profitability.

PubMed

Aliloo, H; Pryce, J E; González-Recio, O; Cocks, B G; Goddard, M E; Hayes, B J

2017-02-01

We compared the outcome of mating programs based on different evaluation models that included nonadditive genetic effects (dominance and heterozygosity) in addition to additive effects. The additive and dominance marker effects and the values of regression on average heterozygosity were estimated using 632,003 single nucleotide polymorphisms from 7,902 and 7,510 Holstein cows with calving interval and production (milk, fat, and protein yields) records, respectively. Expected progeny values were computed based on the estimated genetic effects and genotype probabilities of hypothetical progeny from matings between the available genotyped cows and the top 50 young genomic bulls. An index combining the traits based on their economic values was developed and used to evaluate the performance of different mating scenarios in terms of dollar profit. We observed that mating programs with nonadditive genetic effects performed better than a model with only additive effects. Mating programs with dominance and heterozygosity effects increased milk, fat, and protein yields by up to 38, 1.57, and 1.21 kg, respectively. The inclusion of dominance and heterozygosity effects decreased calving interval by up to 0.70 d compared with random mating. The average reduction in progeny inbreeding by the inclusion of nonadditive genetic effects in matings compared with random mating was between 0.25 to 1.57 and 0.64 to 1.57 percentage points for calving interval and production traits, respectively. The reduction in inbreeding was accompanied by an average of A$8.42 (Australian dollars) more profit per mating for a model with additive, dominance, and heterozygosity effects compared with random mating. Mate allocations that benefit from nonadditive genetic effects can improve progeny performance only in the generation where it is being implemented, and the gain from specific combining abilities cannot be accumulated over generations. Continuous updating of genomic predictions and mate allocation programs are required to benefit from nonadditive genetic effects in the long term. The Authors. Published by the Federation of Animal Science Societies and Elsevier Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

Comparison of efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial.

PubMed

Mahatme, Mohini Sachin; Dakhale, Ganesh Natthuji; Tadke, Kanchan; Hiware, Sachin Keshaorao; Dudhgaonkar, S D; Wankhede, Sumit

2016-01-01

Allergic rhinitis (AR) is a global health problem. Almost 10%-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, and intranasal corticosteroids are the pillars in the management of AR. The combination therapy of montelukast with antihistaminic provides enhancing and complimentary effects, thereby reducing the symptoms effectively, but there are scanty data regarding the comparisons of combinations. Therefore, we aimed to compare the efficacy, safety, and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine combination in patients of AR. Seventy patients with AR participated in a prospective, randomized, double-blind, parallel, active-controlled, comparative 4-week trial. The patients between the age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent AR were included in the study. The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetirizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter. Evaluation of TNSS revealed significant difference ( P < 0.05) when compared from baseline to 4 th week in both groups. The mean change of TNSS, i.e., 9.46 was significant ( P < 0.05) in montelukast-fexofenadine group. The cost-effectiveness ratio was less in montelukast-levocetirizine group than in montelukast-fexofenadine group. The decrease in TNSS was more in montelukast-fexofenadine group, but the cost-effectiveness is more with montelukast-levocetirizine combination.

Tai Chi and Qi Gong

MedlinePlus

... Iversen MD, McAlindon T, et al. Assessing the comparative effectiveness of tai chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complementary ...

Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

PubMed

Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

2017-01-01

We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

The effectiveness of patient navigation to improve healthcare utilization outcomes: A meta-analysis of randomized controlled trials.

PubMed

Ali-Faisal, Sobia F; Colella, Tracey J F; Medina-Jaudes, Naomi; Benz Scott, Lisa

2017-03-01

To determine the effects of patient navigation (PN) on healthcare utilization outcomes using meta-analysis and the quality of evidence. Medical and social science databases were searched for randomized controlled trials published in English between 1989 and May 2015. The review process was guided by PRISMA. Included studies were assessed for quality using the Downs and Black tool. Data were extracted to assess the effect of navigation on: health screening rates, diagnostic resolution, cancer care follow-up treatment adherence, and attendance of care events. Random-effects models were used to compute risk ratios and I 2 statistics determined the impact of heterogeneity. Of 3985 articles screened, 25 articles met inclusion criteria. Compared to usual care, patients who received PN were significantly more likely to access health screening (OR 2.48, 95% CI, 1.93-3.18, P<0.00001) and attend a recommended care event (OR 2.55, 95% CI, 1.27-5.10, P<0.01). PN was favoured to increase adherence to cancer care follow-up treatment and obtain diagnoses. Most studies involved trained lay navigators (n=12) compared to health professionals (n=9). PN is effective to increase screening rates and complete care events. PN is an effective intervention for use in healthcare. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Suprapubic compared with transurethral bladder catheterization for gynecologic surgery: a systematic review and meta-analysis.

PubMed

Healy, Eibhlín F; Walsh, Colin A; Cotter, Amanda M; Walsh, Stewart R

2012-09-01

Suprapubic catheterization is commonly used for postoperative bladder drainage after gynecologic procedures. However, recent studies have suggested an increased rate of complications compared with urethral catheterization. We undertook a systematic review and meta-analysis of randomized controlled trials comparing suprapubic catheterization and urethral catheterization in gynecologic populations. PubMed, EMBASE, CINAHL, Google Scholar, and trial registries were searched from 1966 to March 2012 for eligible randomized controlled trials comparing postoperative suprapubic catheterization and urethral catheterization in gynecologic patients. We used these search terms: "catheter," "supra(-)pubic catheter," "urinary catheter," "gyn(a)ecological," "catheterization techniques gyn(a)ecological surgery," "transurethral catheter," and "bladder drainage." No language restrictions were applied. METHODS AND STUDY SELECTION: The primary outcome was urinary tract infection. Secondary outcomes were the need for recatheterization, duration of catheterization, catheter-related complications, and duration of hospital stay. Pooled effect size estimates were calculated using the random effects model from DerSimonian and Laird. In total, 12 eligible randomized controlled trials were included in the analysis (N=1,300 patients). Suprapubic catheterization was associated with a significant reduction in postoperative urinary tract infections (20% compared with 31%, pooled odds ratio [OR] 0.31, 95% confidence interval [CI] 0.185-0.512, P<.01) but an increased risk of complications (29% compared with 11%, pooled OR 4.14, 95% CI 1.327-12.9, P=.01). Complications were mostly related to catheter tube malfunction with no visceral injuries reported. No differences in the rate of recatheterization or hospital stay were demonstrated. Robust patient satisfaction and cost-effectiveness data are lacking. Based on the best available evidence, no route for bladder drainage in gynecologic patients is clearly superior. The reduced rate of infective morbidity with suprapubic catheterization is offset by a higher rate of catheter-related complications and crucially does not translate into reduced hospital stay. As yet, there are insufficient data to determine which route is most appropriate for catheterization; therefore, cost and patient-specific factors should be paramount in the decision. Minimally invasive surgery may alter the requirement for prolonged postoperative catheterization.

The Transfer of Cognitive Speed of Processing Training to Older Adults' Driving Mobility Across 5 Years.

PubMed

Ross, Lesley A; Edwards, Jerri D; O'Connor, Melissa L; Ball, Karlene K; Wadley, Virginia G; Vance, David E

2016-01-01

Multilevel models assessed the effects of cognitive speed of processing training (SPT) on older adults' self-reported driving using intention-to-treat (ITT, randomization to training or control conditions) and dosage (treatment-received via number of training sessions) analyses across 5 years. Participants randomized to SPT (n = 598) were compared with those randomized to either the no-contact control (n = 598) or memory training, which served as an active control (n = 610). Driving mobility (frequency, exposure, and space) was assessed over time. No significant effects were found within the ITT analyses. However, number of SPT sessions did affect driving mobility outcomes. In the full sample (N = 1,806), higher SPT doses were associated with maintained driving frequency as compared with both control groups, but no effects were found for driving exposure or space. Subsample analyses (n = 315) revealed that persons at-risk for mobility declines (i.e., poor initial processing speed) who received additional booster SPT sessions reported greater maintenance of both driving frequency and exposure over time as compared with the no-contact and active control groups. These results and prior research indicate that cognitive SPT transfers to prolonged driving mobility among older adults. Future research should investigate the mechanisms behind transfer effects to real-world activities, such as driving. © The Author 2015. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Effect of Sodium Hypochlorite and Chlorhexidine as Irrigant Solutions for Root Canal Disinfection: A Systematic Review of Clinical Trials.

PubMed

Gonçalves, Lucio Souza; Rodrigues, Renata Costa Val; Andrade Junior, Carlos Vieira; Soares, Renata G; Vettore, Mario Vianna

2016-04-01

This systematic review aimed to compare the effectiveness of sodium hypochlorite and chlorhexidine for root canal disinfection during root canal therapy. A literature search for clinical trials was made on the PubMed (MEDLINE), Web of Knowledge, SCOPUS, and Science Direct databases and in the reference lists of the identified articles up to January 2015. Quality assessment of the selected studies was performed according to the Consolidated Standards of Reporting Trials statement. One clinical trial and 4 randomized clinical trials were selected from the 172 articles initially identified. There was heterogeneity in the laboratory methods used to assess the root canal disinfection as well as in the concentrations of the irrigants used. Therefore, meta-analysis was not performed. Two studies reported effective and similar reductions in bacterial levels for both irrigants. Sodium hypochlorite was more effective than chlorhexidine in reducing microorganisms in 1 study, and another reported opposite findings. Both root irrigants were ineffective in eliminating endotoxins from necrotic pulp root canals in 1 study. Trial design and information regarding randomization procedures were not clearly described in the clinical trials. No study compared laboratory results with clinical outcomes. The available evidence on this topic is scarce, and the findings of studies were not consistent. Additional randomized clinical trials using clinical outcomes to compare the use of sodium hypochlorite and chlorhexidine during root canal therapy are needed. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A randomized clinical trial of cognitive behavioral therapy and interpersonal psychotherapy for panic disorder with agoraphobia.

PubMed

Vos, S P F; Huibers, M J H; Diels, L; Arntz, A

2012-12-01

Interpersonal psychotherapy (IPT) seems to be as effective as cognitive behavioral therapy (CBT) in the treatment of major depression. Because the onset of panic attacks is often related to increased interpersonal life stress, IPT has the potential to also treat panic disorder. To date, a preliminary open trial yielded promising results but there have been no randomized controlled trials directly comparing CBT and IPT for panic disorder. This study aimed to directly compare the effects of CBT versus IPT for the treatment of panic disorder with agoraphobia. Ninety-one adult patients with a primary diagnosis of DSM-III or DSM-IV panic disorder with agoraphobia were randomized. Primary outcomes were panic attack frequency and an idiosyncratic behavioral test. Secondary outcomes were panic and agoraphobia severity, panic-related cognitions, interpersonal functioning and general psychopathology. Measures were taken at 0, 3 and 4 months (baseline, end of treatment and follow-up). Intention-to-treat (ITT) analyses on the primary outcomes indicated superior effects for CBT in treating panic disorder with agoraphobia. Per-protocol analyses emphasized the differences between treatments and yielded larger effect sizes. Reductions in the secondary outcomes were equal for both treatments, except for agoraphobic complaints and behavior and the credibility ratings of negative interpretations of bodily sensations, all of which decreased more in CBT. CBT is the preferred treatment for panic disorder with agoraphobia compared to IPT. Mechanisms of change should be investigated further, along with long-term outcomes.

Learning Historical Thinking with Oral History Interviews: A Cluster Randomized Controlled Intervention Study of Oral History Interviews in History Lessons

ERIC Educational Resources Information Center

Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

2017-01-01

The present study examined the effectiveness of the oral history approach with respect to students' historical competence. A total of 35 ninth-grade classes (N = 900) in Germany were randomly assigned to one of four conditions--live, video, text, or a (nontreated) control group--in a pretest, posttest, and follow-up design. Comparing the three…

Impact of Cognitive Behavioral Therapy on Observed Autism Symptom Severity during School Recess: A Preliminary Randomized, Controlled Trial

ERIC Educational Resources Information Center

Wood, Jeffrey J.; Fujii, Cori; Renno, Patricia; Van Dyke, Marilyn

2014-01-01

This study compared cognitive behavioral therapy (CBT) and treatment-as-usual (TAU) in terms of effects on observed social communication-related autism symptom severity during unstructured play time at school for children with autism spectrum disorders (ASD). Thirteen children with ASD (7-11 years old) were randomly assigned to 32 sessions of CBT…

A Randomized Controlled Trial of a Home-Visiting Intervention Aimed at Preventing Relationship Problems in Depressed Mothers and Their Infants

ERIC Educational Resources Information Center

van Doesum, Karin T. M.; Riksen-Walraven, J. Marianne; Hosman, Clemens M. H.; Hoefnagels, Cees

2008-01-01

This study examined the effect of a mother-baby intervention on the quality of mother-child interaction, infant-mother attachment security, and infant socioemotional functioning in a group of depressed mothers with infants aged 1-12 months. A randomized controlled trial compared an experimental group (n = 35) receiving the intervention (8-10 home…

Buspirone versus Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder: A Double-Blind and Randomized Trial

ERIC Educational Resources Information Center

Davari-Ashtiani, Rozita; Shahrbabaki, Mahin Eslami; Razjouyan, Katayoon; Amini, Homayoun; Mazhabdar, Homa

2010-01-01

The efficacy and side effects of buspirone compared with methylphenidate (MPH) in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0.5 mg/kg/day) and methylphenidate…

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.

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Magnetoencephalography for the Detection of Intervention Effects of a Specific Nutrient Combination in Patients with Mild Alzheimer’s Disease: Results from an Exploratory Double-Blind, Randomized, Controlled Study

PubMed Central

van Straaten, Elisabeth C. W.; de Waal, Hanneke; Lansbergen, Marieke M.; Scheltens, Philip; Maestu, Fernando; Nowak, Rafal; Hillebrand, Arjan; Stam, Cornelis J.

2016-01-01

Synaptic loss is an early pathological finding in Alzheimer’s disease (AD) and correlates with memory impairment. Changes in macroscopic brain activity measured with electro- and magnetoencephalography (EEG and MEG) in AD indicate synaptic changes and may therefore serve as markers of intervention effects in clinical trials. EEG peak frequency and functional networks have shown, in addition to improved memory performance, to be sensitive to detect an intervention effect in mild AD patients of the medical food Souvenaid containing the specific nutrient combination Fortasyn® Connect, which is designed to enhance synapse formation and function. Here, we explore the value of MEG, with higher spatial resolution than EEG, in identifying intervention effects of the nutrient combination by comparing MEG spectral measures, functional connectivity, and networks between an intervention and a control group. Quantitative markers describing spectral properties, functional connectivity, and graph theoretical aspects of MEG from the exploratory 24-week, double-blind, randomized, controlled Souvenir II MEG sub-study (NTR1975, http://www.trialregister.nl) in drug naïve patients with mild AD were compared between a test group (n = 27), receiving Souvenaid, and a control group (n = 28), receiving an isocaloric control product. The groups were unbalanced at screening with respect to Mini-Mental State Examination. Peak frequencies of MEG were compared with EEG peak frequencies, recorded in the same patients at similar time points, were compared with respect to sensitivity to intervention effects. No consistent statistically significant intervention effects were detected. In addition, we found no difference in sensitivity between MEG and EEG peak frequency. This exploratory study could not unequivocally establish the value of MEG in detecting interventional effects on brain activity, possibly due to small sample size and unbalanced study groups. We found no indication that the difference could be attributed to a lack of sensitivity of MEG compared with EEG. MEG in randomized controlled trials is feasible but its value to disclose intervention effects of Souvenaid in mild AD patients needs to be studied further. PMID:27799918

Magnetoencephalography for the Detection of Intervention Effects of a Specific Nutrient Combination in Patients with Mild Alzheimer's Disease: Results from an Exploratory Double-Blind, Randomized, Controlled Study.

PubMed

van Straaten, Elisabeth C W; de Waal, Hanneke; Lansbergen, Marieke M; Scheltens, Philip; Maestu, Fernando; Nowak, Rafal; Hillebrand, Arjan; Stam, Cornelis J

2016-01-01

Synaptic loss is an early pathological finding in Alzheimer's disease (AD) and correlates with memory impairment. Changes in macroscopic brain activity measured with electro- and magnetoencephalography (EEG and MEG) in AD indicate synaptic changes and may therefore serve as markers of intervention effects in clinical trials. EEG peak frequency and functional networks have shown, in addition to improved memory performance, to be sensitive to detect an intervention effect in mild AD patients of the medical food Souvenaid containing the specific nutrient combination Fortasyn ® Connect, which is designed to enhance synapse formation and function. Here, we explore the value of MEG, with higher spatial resolution than EEG, in identifying intervention effects of the nutrient combination by comparing MEG spectral measures, functional connectivity, and networks between an intervention and a control group. Quantitative markers describing spectral properties, functional connectivity, and graph theoretical aspects of MEG from the exploratory 24-week, double-blind, randomized, controlled Souvenir II MEG sub-study (NTR1975, http://www.trialregister.nl) in drug naïve patients with mild AD were compared between a test group ( n  = 27), receiving Souvenaid, and a control group ( n  = 28), receiving an isocaloric control product. The groups were unbalanced at screening with respect to Mini-Mental State Examination. Peak frequencies of MEG were compared with EEG peak frequencies, recorded in the same patients at similar time points, were compared with respect to sensitivity to intervention effects. No consistent statistically significant intervention effects were detected. In addition, we found no difference in sensitivity between MEG and EEG peak frequency. This exploratory study could not unequivocally establish the value of MEG in detecting interventional effects on brain activity, possibly due to small sample size and unbalanced study groups. We found no indication that the difference could be attributed to a lack of sensitivity of MEG compared with EEG. MEG in randomized controlled trials is feasible but its value to disclose intervention effects of Souvenaid in mild AD patients needs to be studied further.

Seismic random noise attenuation method based on empirical mode decomposition of Hausdorff dimension

NASA Astrophysics Data System (ADS)

Yan, Z.; Luan, X.

2017-12-01

Introduction Empirical mode decomposition (EMD) is a noise suppression algorithm by using wave field separation, which is based on the scale differences between effective signal and noise. However, since the complexity of the real seismic wave field results in serious aliasing modes, it is not ideal and effective to denoise with this method alone. Based on the multi-scale decomposition characteristics of the signal EMD algorithm, combining with Hausdorff dimension constraints, we propose a new method for seismic random noise attenuation. First of all, We apply EMD algorithm adaptive decomposition of seismic data and obtain a series of intrinsic mode function (IMF)with different scales. Based on the difference of Hausdorff dimension between effectively signals and random noise, we identify IMF component mixed with random noise. Then we use threshold correlation filtering process to separate the valid signal and random noise effectively. Compared with traditional EMD method, the results show that the new method of seismic random noise attenuation has a better suppression effect. The implementation process The EMD algorithm is used to decompose seismic signals into IMF sets and analyze its spectrum. Since most of the random noise is high frequency noise, the IMF sets can be divided into three categories: the first category is the effective wave composition of the larger scale; the second category is the noise part of the smaller scale; the third category is the IMF component containing random noise. Then, the third kind of IMF component is processed by the Hausdorff dimension algorithm, and the appropriate time window size, initial step and increment amount are selected to calculate the Hausdorff instantaneous dimension of each component. The dimension of the random noise is between 1.0 and 1.05, while the dimension of the effective wave is between 1.05 and 2.0. On the basis of the previous steps, according to the dimension difference between the random noise and effective signal, we extracted the sample points, whose fractal dimension value is less than or equal to 1.05 for the each IMF components, to separate the residual noise. Using the IMF components after dimension filtering processing and the effective wave IMF components after the first selection for reconstruction, we can obtained the results of de-noising.

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

PubMed

Kawafha, Mariam M; Tawalbeh, Loai Issa

2015-04-01

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

A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

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

Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A.; Nikam, M.

Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technicalmore » success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.« less

Emergence of an optimal search strategy from a simple random walk

PubMed Central

Sakiyama, Tomoko; Gunji, Yukio-Pegio

2013-01-01

In reports addressing animal foraging strategies, it has been stated that Lévy-like algorithms represent an optimal search strategy in an unknown environment, because of their super-diffusion properties and power-law-distributed step lengths. Here, starting with a simple random walk algorithm, which offers the agent a randomly determined direction at each time step with a fixed move length, we investigated how flexible exploration is achieved if an agent alters its randomly determined next step forward and the rule that controls its random movement based on its own directional moving experiences. We showed that our algorithm led to an effective food-searching performance compared with a simple random walk algorithm and exhibited super-diffusion properties, despite the uniform step lengths. Moreover, our algorithm exhibited a power-law distribution independent of uniform step lengths. PMID:23804445

Emergence of an optimal search strategy from a simple random walk.

PubMed

Sakiyama, Tomoko; Gunji, Yukio-Pegio

2013-09-06

In reports addressing animal foraging strategies, it has been stated that Lévy-like algorithms represent an optimal search strategy in an unknown environment, because of their super-diffusion properties and power-law-distributed step lengths. Here, starting with a simple random walk algorithm, which offers the agent a randomly determined direction at each time step with a fixed move length, we investigated how flexible exploration is achieved if an agent alters its randomly determined next step forward and the rule that controls its random movement based on its own directional moving experiences. We showed that our algorithm led to an effective food-searching performance compared with a simple random walk algorithm and exhibited super-diffusion properties, despite the uniform step lengths. Moreover, our algorithm exhibited a power-law distribution independent of uniform step lengths.

Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma.

PubMed

Atefi, Najmolsadat; Dalvand, Behzad; Ghassemi, Mahammadreza; Mehran, Golnaz; Heydarian, Amir

2017-09-01

Few studies have focused on therapeutic as well as side effects of tranexamic acid (TXA) as a topical drug compared to other topical drugs in treating melasma. The present study aimed to assess and compare the beneficial therapeutic effects and also side effects of local TXA in comparison with hydroquinone in treating women with melasma. This randomized double-blinded clinical trial was performed on 60 women who suffered from melasma and were referred to the skin disorders clinic at the Rasoul-e-Akram hospital in Tehran in 2015. The patients were then randomly assigned via computerized randomization to two groups: group A received TXA%5 (topically twice a day for 12 weeks in the location of the melasma) and group B (received hydroquinone 2% with the same treatment order). Prior to intervention and at 12 weeks after intervention, the intensity and extension of melasma were assessed based on the Melasma Area and Severity Index (MASI) scoring method. The mean MASI score in both treatment groups decreased considerably after completion of treatment and was not significant between the two groups. No side effects were detected in group A, but 10% of those in group B complained of drug-related side effects including erythema and skin irritation (p = 0.131). Regarding the level of patient satisfaction, the patients in group A had a significantly higher level of satisfaction level of 33.3% compared with 6.7% in group B (p = 0.015) (Fig. 9). Multivariate linear regression modeling with the presence of age, history of systemic disorder, drug history, and family history of melasma demonstrated no difference in the mean MASI between the two groups. Topical use of TXA significantly reduced both melanin level and MASI score. Given its high efficiency and low drug side effects, this regimen results in high patient satisfaction compared with topical hydroquinone. IRCT code: IRCT2016040627220N2.

Mitral Valve Clip for Treatment of Mitral Regurgitation: An Evidence-Based Analysis

PubMed Central

Ansari, Mohammed T.; Ahmadzai, Nadera; Coyle, Kathryn; Coyle, Doug; Moher, David

2015-01-01

Background Many of the 500,000 North American patients with chronic mitral regurgitation may be poor candidates for mitral valve surgery. Objective The objective of this study was to investigate the comparative effectiveness, harms, and cost-effectiveness of percutaneous mitral valve repair using mitral valve clips in candidates at prohibitive risk for surgery. Data Sources We searched articles in MEDLINE, Embase, and the Cochrane Library published from 1994 to February 2014 for evidence of effectiveness and harms; for economic literature we also searched NHS EED and Tufts CEA registry. Grey literature was also searched. Review Methods Primary studies were sought from existing systematic reviews that had employed reliable search and screening methods. Newer studies were sought by searching the period subsequent to the last search date of the review. Two reviewers screened records and assessed study validity. We used the Cochrane risk of bias tool for randomized, generic assessment for non-randomized studies, and the Phillips checklist for economic studies. Results Ten studies including 1 randomized trial were included. The majority of the direct comparative evidence compared the mitral valve clip repair with surgery in patients not particularly at prohibitive surgical risk. Irrespective of degenerative or functional chronic mitral regurgitation etiology, evidence of effectiveness and harms is inconclusive and of very low quality. Very-low-quality evidence indicates that percutaneous mitral valve clip repair may provide a survival advantage, at least during the first 1 to 2 years, particularly in medically managed chronic functional mitral regurgitation. Because of limitations in the design of studies, the cost-effectiveness of mitral valve clips in patients at prohibitive risk for surgery also could not be established. Limitations Because of serious concerns of risk of bias, indirectness, and imprecision, evidence is of very low quality. Conclusions No meaningful conclusions can be drawn about the comparative effectiveness, harms, and cost-effectiveness of mitral valve clips in the population with chronic mitral regurgitation who are at prohibitive risk for surgery. PMID:26379810

Early or delayed provision of an ankle-foot orthosis in patients with acute and subacute stroke: a randomized controlled trial.

PubMed

Nikamp, Corien Dm; Buurke, Jaap H; van der Palen, Job; Hermens, Hermie J; Rietman, Johan S

2017-06-01

(1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects. Randomized controlled trial. Rehabilitation centre. Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke. Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9). 10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11. A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (-5.4 seconds, p = 0.087), compared with delayed provision. We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.

Group interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.

PubMed

Von Korff, Michael; Vitiello, Michael V; McCurry, Susan M; Balderson, Benjamin H; Moore, Amy L; Baker, Laura D; Yarbro, Patricia; Saunders, Kathleen; Keefe, Francis J; Rybarczyk, Bruce D

2012-07-01

Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). Persons with osteoarthritis age 60 or older were screened for osteoarthritis pain and insomnia severity via mailed survey. Primary outcomes were pain severity (pain intensity and interference ratings from the Graded Chronic Pain Scale) and insomnia severity (Insomnia Severity Index). Secondary outcomes were arthritis pain (AIMS-2 symptom scale) and sleep efficiency assessed by wrist actigraphy. Ancillary outcomes included: cognitive function, depression, and health care use. A clustered randomized design provided adequate power to identify moderate effects on primary outcomes (effect size>0.35). Modified intent to treat analyses, including all participants who attended the first session, assessed effects across CBT-PI, CBT-P, and EOC groups. Treatment effects were assessed post-intervention (2 months) and at 9 months, with durability of intervention effects evaluated at 18 months. The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting. Copyright © 2012 Elsevier Inc. All rights reserved.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

PubMed

Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

2016-01-01

Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

Effects of positive psychology interventions on risk biomarkers in coronary patients: A randomized, wait-list controlled pilot trial

PubMed Central

Nikrahan, Gholam Reza; Laferton, Johannes A. C.; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C.

2016-01-01

Background Among cardiac patients, positive psychological factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychological well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of three distinct PPIs on risk biomarkers in cardiac patients. Methods In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to a) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or b) a wait-list control group. Risk biomarkers were assessed at baseline, post-intervention (7 weeks), and at 15 week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Results Compared to the control group, participants randomized to the Seligman (B= −2.06; p= .02) and Fordyce PPI (B= −1.54; p= .04) had significantly lower high-sensitivity C-reactive protein (hs-CRP) levels at 7 weeks. Further, the Lyubomirsky PPI (B= −245.86; p= .04) was associated with a significantly lower cortisol awakening response (CARg) at 7 weeks compared to control participants. There were no other significant between-group differences. Conclusion Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. PMID:27129358

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.

Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

PubMed

Zhang, Ya-Jing; Cao, Hui-Juan; Li, Xin-Lin; Yang, Xiao-Ying; Lai, Bao-Yong; Yang, Guo-Yang; Liu, Jian-Ping

2017-01-01

Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included studies. Cupping therapy and acupuncture are potentially safe, and they have similar effectiveness in relieving pain. However, further rigorous studies investigating relevant pain-related conditions are warranted to establish comparative effectiveness analysis between these two therapies. Cost-effectiveness studies should be considered in the future studies to establish evidence for decision-making in clinical practice.

Psychoeducation and Problem Solving (PEPS) Therapy for Adults With Personality Disorder: A Pragmatic Randomized-Controlled Trial.

PubMed

McMurran, Mary; Day, Florence; Reilly, Joseph; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Moran, Paul; Crawford, Mike J

2017-12-01

We compared psychoeducation and problem solving (PEPS) therapy against usual treatment in a multisite randomized-controlled trial. The primary outcome was social functioning. We aimed to recruit 444 community-dwelling adults with personality disorder; however, safety concerns led to an early cessation of recruitment. A total of 154 people were randomized to PEPS and 152 to usual treatment. Follow-up at 72 weeks was completed for 68%. PEPS therapy was no more effective than usual treatment for improving social functioning (adjusted difference in mean Social Functioning Questionnaire scores = -0.73; 95% CI [-1.83, 0.38]; p = 0.19). PEPS therapy is not an effective treatment for improving social functioning of adults with personality disorder living in the community.

Methods of pushing during vaginal delivery and pelvic floor and perineal outcomes: a review.

PubMed

de Tayrac, Renaud; Letouzey, Vincent

2016-12-01

Over the past 20 years, several randomized studies have compared Valsalva and spontaneous pushing techniques during vaginal delivery. This review summarizes current medical knowledge concerning their maternal and fetal consequences, focusing on pelvic and perineal outcomes. We selected nine randomized controlled trials comparing Valsalva and spontaneous pushing, and a secondary analysis of a randomized controlled trial comparing different methods of perineal protection. Two trials showed that spontaneous pushing reduces the risk of perineal tears, but no firm conclusions can be drawn given the heterogeneity and inconsistent results of these studies. Conflicting results have been reported regarding the duration of the second stage of labor. Pushing technique does not seem to affect episiotomy, instrumental delivery or cesarean rates. Maternal satisfaction seems to be better after spontaneous pushing. Spontaneous pushing appears to have no adverse effects on neonatal well being, and one study showed a significant improvement in prenatal fetal parameters during the expulsive phase. Valsalva and spontaneous pushing techniques currently appear comparable in terms of duration, pelvic floor, perineal, and neonatal outcomes. In the absence of strong evidence in favor of either technique, the decision should be guided by patient preference and the clinical situation. Additional, well-designed randomized controlled trials are required.

Child-Parent Interventions for Childhood Anxiety Disorders: A Systematic Review and Meta-Analysis

ERIC Educational Resources Information Center

Brendel, Kristen Esposito; Maynard, Brandy R.

2014-01-01

Objective: This study compared the effects of direct child-parent interventions to the effects of child-focused interventions on anxiety outcomes for children with anxiety disorders. Method: Systematic review methods and meta-analytic techniques were employed. Eight randomized controlled trials examining effects of family cognitive behavior…

Effect of early amniotomy on dystocia risk and cesarean delivery in nulliparous women: a randomized clinical trial.

PubMed

Ghafarzadeh, Masoomeh; Moeininasab, Samira; Namdari, Mehrdad

2015-08-01

Artificial rupture of amniotic membranes (amniotomy) which induces or accelerates labor is the most common obstetrical procedure. There is controversy about the effect of early amniotomy on dystocia and cesarean delivery. The study aim was to determine the effect of early amniotomy on the risk of dystocia and cesarean delivery in nulliparous women. This randomized controlled clinical trial was conducted on 300 nulliparous women. They were randomly assigned into the experimental (early amniotomy; artificial amniotomy at cervical dilation ≤ 4 cm) and control (routine management) groups (each 150 women). Length of labor, dystocia, cesarean delivery, placental abruption, and umbilical cord prolapse were compared between the groups. Early amniotomy shortened labor duration significantly in experimental group (7.5 ± 0.7 h) compared to control group (9.9 ± 1.0 h) (P < 0.001). Dystocia (6.7 vs. 25.3 %, P < 0.0001), cesarean delivery (11.3 vs. 39.3 %, P < 0.001), and placental abruption (4.7 vs. 13.3 %, P = 0.009) were significantly lower in experimental group compared to the control group. Multiple logistic regression showed that early amniotomy decreased the odds of dystocia 80.6 % (95 % CI 58.6-90.1 %) and the odds of cesarean section 81.7 % (95 % CI 66.2-90.1 %). Early amniotomy was associated with lower rate of dystocia and cesarean delivery as well as shorter duration of labor.

The effect of standard dose multivitamin supplementation on disease progression in HIV-infected adults initiating HAART: a randomized double blind placebo-controlled trial in Uganda.

PubMed

Guwatudde, David; Wang, Molin; Ezeamama, Amara E; Bagenda, Danstan; Kyeyune, Rachel; Wamani, Henry; Manabe, Yukari C; Fawzi, Wafaie W

2015-08-19

Efficacy trials investigating the effect of multivitamin (MV) supplementations among patients on Highly Active Antiretroviral Therapy (HAART) have so far been inconclusive. We conducted a randomized, double blind, placebo controlled trial to determine the effect of one recommended daily allowance (RDA) of MV supplementation on disease progression in patients initiating HAART. Eligible subjects were randomized to receive placebo or MV supplementation including vitamins B-complex, C and E. Participants were followed for up to 18 months. Primary endpoints were: change in CD4 cell count, weight and quality of life (QoL). Secondary endpoints were: i) development of a new or recurrent HIV disease progression event, including all-cause mortality; ii) switching from first- to second-line antiretroviral therapy (ART); and iii) occurrence of an adverse event. Intent-to-treat analysis, using linear regression mixed effects models were used to compare changes over time in the primary endpoints between the study arms. Kaplan-Meier time-to-event analysis and the log-rank test was used to compare HIV disease progression events and all-cause mortality. Four hundred participants were randomized, 200 onto MV and 200 onto placebo. By month 18, the average change in CD4 cell count in the MV arm was 141 cells/uL compared to 147 cells/uL in the placebo arm, a mean difference of -6 · 17 [95 % CI -29 · 3, 16 · 9]. The average change in weight in the MV arm was 3 · 9 kg compared to 3 · 3 kg in the placebo arm, a mean difference of 0 · 54 [95 % CI -0 · 40, 1 · 48]; whereas average change in QoL scores in the MV arm was 6 · 8 compared to 8 · 8 in the placebo arm, a mean difference of -2.16 [95 % CI -4 · 59,0 · 27]. No significant differences were observed in these primary endpoints, or in occurrence of adverse events between the trial arms. One RDA of MV supplementation was safe but did not have an effect on indicators of disease progression among HIV infected adults initiating HAART. Clinical trials NCT01228578 , registered on 15th October 2010.

Causal Inference and the Comparative Interrupted Time Series Design: Findings from Within-Study Comparisons

ERIC Educational Resources Information Center

St. Clair, Travis; Hallberg, Kelly; Cook, Thomas D.

2014-01-01

Researchers are increasingly using comparative interrupted time series (CITS) designs to estimate the effects of programs and policies when randomized controlled trials are not feasible. In a simple interrupted time series design, researchers compare the pre-treatment values of a treatment group time series to post-treatment values in order to…

Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

PubMed Central

2010-01-01

Background Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137 PMID:20594308

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Bayesian random-effect model for predicting outcome fraught with heterogeneity--an illustration with episodes of 44 patients with intractable epilepsy.

PubMed

Yen, A M-F; Liou, H-H; Lin, H-L; Chen, T H-H

2006-01-01

The study aimed to develop a predictive model to deal with data fraught with heterogeneity that cannot be explained by sampling variation or measured covariates. The random-effect Poisson regression model was first proposed to deal with over-dispersion for data fraught with heterogeneity after making allowance for measured covariates. Bayesian acyclic graphic model in conjunction with Markov Chain Monte Carlo (MCMC) technique was then applied to estimate the parameters of both relevant covariates and random effect. Predictive distribution was then generated to compare the predicted with the observed for the Bayesian model with and without random effect. Data from repeated measurement of episodes among 44 patients with intractable epilepsy were used as an illustration. The application of Poisson regression without taking heterogeneity into account to epilepsy data yielded a large value of heterogeneity (heterogeneity factor = 17.90, deviance = 1485, degree of freedom (df) = 83). After taking the random effect into account, the value of heterogeneity factor was greatly reduced (heterogeneity factor = 0.52, deviance = 42.5, df = 81). The Pearson chi2 for the comparison between the expected seizure frequencies and the observed ones at two and three months of the model with and without random effect were 34.27 (p = 1.00) and 1799.90 (p < 0.0001), respectively. The Bayesian acyclic model using the MCMC method was demonstrated to have great potential for disease prediction while data show over-dispersion attributed either to correlated property or to subject-to-subject variability.

Application of Poisson random effect models for highway network screening.

PubMed

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

2014-02-01

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

Randomized controlled trial of supplemental augmentative and alternative communication versus voice rest alone after phonomicrosurgery.

PubMed

Rousseau, Bernard; Gutmann, Michelle L; Mau, Theodore; Francis, David O; Johnson, Jeffrey P; Novaleski, Carolyn K; Vinson, Kimberly N; Garrett, C Gaelyn

2015-03-01

This randomized trial investigated voice rest and supplemental text-to-speech communication versus voice rest alone on visual analog scale measures of communication effectiveness and magnitude of voice use. Randomized clinical trial. Multicenter outpatient voice clinics. Thirty-seven patients undergoing phonomicrosurgery. Patients undergoing phonomicrosurgery were randomized to voice rest and supplemental text-to-speech communication or voice rest alone. The primary outcome measure was the impact of voice rest on ability to communicate effectively over a 7-day period. Pre- and postoperative magnitude of voice use was also measured as an observational outcome. Patients randomized to voice rest and supplemental text-to-speech communication reported higher median communication effectiveness on each postoperative day compared to those randomized to voice rest alone, with significantly higher median communication effectiveness on postoperative days 3 (P=.03) and 5 (P=.01). Magnitude of voice use did not differ on any preoperative (P>.05) or postoperative day (P>.05), nor did patients significantly decrease voice use as the surgery date approached (P>.05). However, there was a significant reduction in median voice use pre- to postoperatively across patients (P<.001) with median voice use ranging from 0 to 3 throughout the postoperative week. Supplemental text-to-speech communication increased patient-perceived communication effectiveness on postoperative days 3 and 5 over voice rest alone. With the prevalence of smartphones and the widespread use of text messaging, supplemental text-to-speech communication may provide an accessible and cost-effective communication option for patients on vocal restrictions. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

PubMed

Becker, Annette; Held, Heiko; Redaelli, Marcus; Chenot, Jean F; Leonhardt, Corinna; Keller, Stefan; Baum, Erika; Pfingsten, Michael; Hildebrandt, Jan; Basler, Heinz-Dieter; Kochen, Michael M; Donner-Banzhoff, Norbert; Strauch, Konstantin

2012-04-15

Cost-effectiveness analysis alongside a cluster randomized controlled trial. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

Comparable effects of exercise and analgesics for pain secondary to knee osteoarthritis: a meta-analysis of trials included in Cochrane systematic reviews.

PubMed

Henriksen, Marius; Hansen, Julie B; Klokker, Louise; Bliddal, Henning; Christensen, Robin

2016-07-01

Evidence of comparative effectiveness of different treatment approaches is important for clinical decision-making, yet absent for most recommended treatments of knee osteoarthritis pain. The objective of this study was to estimate the comparative effectiveness of exercise versus orally administered analgesics for pain in patients with knee osteoarthritis. The Cochrane Database of systematic reviews was searched for meta-analyses of randomized controlled studies comparing exercise or analgesics with a control group (placebo or usual care) and with pain as an outcome. Individual study estimates were identified and effect sizes were calculated from group differences. We combined study-level effects on pain with a random effects meta-analysis and compared effect sizes between exercise trials and trials with analgesic interventions. We included six Cochrane reviews (four pharmacology, two exercise). From these, 54 trials were eligible (20 pharmacology, 34 exercise), with 9806 participants (5627 pharmacology, 4179 exercise). The pooled effect size of pharmacological pain interventions was 0.41 (95% CI: 0.23-0.59) and for exercise 0.46 standardized mean difference (95% CI: 0.34-0.59). There was no statistically significant difference between the two types of intervention (difference: 0.06 standardized mean difference [95% CI: -0.28-0.16; p = 0.61]). This meta-epidemiological study provides indirect evidence that for knee osteoarthritis pain, the effects from exercise and from oral analgesics are comparable. These results may support shared decision-making where a patient for some reason is unable to exercise or who consider exercise as unviable and analgesics as a more feasible choice. PROSPERO registration: CRD42013006924.

Reduction of calprotectin and phosphate during testosterone therapy in aging men: a randomized controlled trial.

PubMed

Pedersen, L; Christensen, L L; Pedersen, S M; Andersen, M

2017-05-01

To investigate the effect of testosterone treatment on biomarkers calprotectin, fibroblast growth factor 23 (FGF23), soluble Klotho, phosphate, calcium, parathyroid hormone, creatinine and estimated glomerular filtration rate. Randomized, double-blinded, placebo-controlled study. Odense Androgen Study-the effect of Testim and training in hypogonadal men. Men aged 60-78 years old with a low normal concentration of free of bioavailable testosterone <7.3 nmol/L and waist circumference >94 cm recruited from 2008 to 2009 (N = 48) by advertisement. Participants were randomized to receive 5-10 g gel/50-100 mg testosterone (Testim ® , Ipsen, France) or 5-10 g gel/placebo. The plasma levels of calprotectin and phosphate were significantly reduced in the group receiving testosterone therapy (gel) compared to the placebo group (p < 0.05). Testosterone treatment did not have any significant effect on plasma levels of FGF23 or soluble Klotho. The reduction in phosphate levels was inversely associated with bioavailable testosterone. Compared to the placebo group, 6 months of testosterone therapy (gel) reduced calprotectin and phosphate levels suggesting decreased inflammation and decreased cardiovascular risk.

Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

PubMed

Pradeep, A R; Agarwal, Esha; Naik, Savitha B

2012-06-01

Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

Comparison of effects of soft margarine, blended, ghee, and unhydrogenated oil with hydrogenated oil on serum lipids: A randomized clinical trail

PubMed Central

Mohammadifard, Noushin; Hosseini, Mohsen; Sajjadi, Firoozeh; Maghroun, Maryam; Boshtam, Maryam; Nouri, Fatemeh

2013-01-01

BACKGROUND Trans fatty acids (TFAs) are known as the most harmful type of dietary fats. Therefore, this study was done to compare the effects of some different oils including unhydrogenated, blended, ghee, and soft magazine with hydrogenated oil on serum lipid profile of healthy adults. METHODS This study was a randomized clinical trial conducted on 206 healthy participants of 20 to 60 years of age. Subjects were randomly divided into 5 groups and each of them was treated with a diet containing unhydrogenated oil, ghee, blended oil, soft margarine, or hydrogenated oil for 40 days. Fasting serum lipids were measured before and after the study. RESULTS Compared to hydrogenated oil, total cholesterol (TC) and triglyceride (TG) had a significant reduction in all groups, LDL-C declined in unhydrogenated oil and soft margarine groups, and apolipoprotein (Apo) B only in unhydrogenated oil group (all P < 0.05). However, there was a significant enhancement in ApoA of ghee oil (P < 0.001). CONCLUSION Consuming unhydrogenated oil, ghee, soft margarine, and blended oil had some beneficial effects on serum lipids. PMID:24575140

Role of 3D animation in periodontal patient education: a randomized controlled trial.

PubMed

Cleeren, Gertjan; Quirynen, Marc; Ozcelik, Onur; Teughels, Wim

2014-01-01

This randomized controlled parallel trial investigates the effect of 3D animation on the increase and recall of knowledge on periodontitis by patients with periodontitis. The effects of a 3D animation (3D animation group) were compared with narration and drawing (control group) for periodontal patient education. A total of 68 periodontitis patients were stratified according to educational level and then randomly allocated to control or 3D animation groups. All patients received: (1) a pre-test (baseline knowledge), (2) a patient education video (3D animation or control video), (3) a post-test (knowledge immediately after looking at the video), and (4) a follow-up test (knowledge recall after 2 weeks). Each test contained 10 multiple-choice questions. There was no significant difference in baseline knowledge. Patients receiving the 3D animations had significantly higher scores for both the post-test and the follow-up test, when compared with patients receiving sketch animations. 3D animations are more effective than real-time drawings for periodontal patient education in terms of knowledge recall. 3D animations may be a powerful tool for assisting in the information process. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A meta-analysis of comparative outcomes following cervical arthroplasty or anterior cervical fusion: results from 4 prospective multicenter randomized clinical trials and up to 1226 patients.

PubMed

McAfee, Paul C; Reah, Chris; Gilder, Kye; Eisermann, Lukas; Cunningham, Bryan

2012-05-15

Meta-analysis of 4 prospective randomized controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials. To maximize the information available from 4 IDE studies by analyzing the combined outcomes of cervical arthroplasty versus fusion at 24-month follow-up. To date, 4 randomized clinical trials have been completed in the United States under FDA IDE protocols to study cervical arthroplasty. Each trial reported arthroplasty to be at least as successful as fusion controls based on noninferiority trial designs. However, sample sizes in any given trial may not be sufficient to demonstrate superiority of treatment effect. Meta-analysis enables pooling of results from comparable trials, which may lead to more precise and statistically significant estimates of treatment effect. Four cervical arthroplasty randomized clinical trials with comparable enrollment criteria and outcome measures were conducted independently by 3 separate sponsors to study the following devices: Bryan, Prestige, ProDisc-C, and PCM cervical disc replacements. A total of 1608 patients were treated across 98 investigative sites. Data were available for 1352 treated patients, of which 1226 were evaluable at 24 months. Assessments included clinical success definitions based on neck disability index, maintenance or improvement of neurological status, subsequent surgery or intervention at the index level (survivorship), and a composite score comprising these as well as serious device-related adverse events. Trial endpoint comparisons were made at 24 months postoperatively. For each endpoint, a random-effects meta-analysis was performed to compare the success rates of cervical arthroplasty with anterior cervical discectomy and fusion (ACDF). Also, supportive frequentist and bayesian analyses were performed. The pooled primary overall success results indicated a statistically significant treatment effect favoring arthroplasty compared with ACDF. Overall success was achieved by 77.6% of the arthroplasty patients and by 70.8% of the ACDF patients (pooled odds ratio [OR]: 0.699, 95% confidence interval [CI]: 0.539-0.908, P = 0.007). The results of the individual subcomponent meta-analyses, all of which favored arthroplasty, were neck disability index success (OR: 0.786, 95% CI: 0.589-1.050, P = 0.103), neurological status (OR: 0.552, 95% CI: 0.364-0.835, P = 0.005), and survivorship (OR: 0.510, 95% CI: 0.275-0.946, P = 0.033). Only the survivorship endpoint suggested low heterogeneity. These findings suggest that cervical arthroplasty is superior to ACDF in overall success, neurological success, and survivorship outcomes at 24 months postoperatively.

Effects of modafinil on attention performance, short-term memory and executive function in university students: a randomized trial.

PubMed

Fernández, Alejandro; Mascayano, Franco; Lips, Walter; Painel, Andrés; Norambuena, Jonathan; Madrid, Eva

2015-06-30

Modafinil is a drug developed and used for the treatment of excessive lethargy. Even though very effective for sleep disorders, it is still controversial whether modafinil can improve performance in high-order cognitive processes such as memory and executive function. This randomized, double-blind, placebo-controlled, crossover trial was designed to evaluate the effect of modafinil (compared to placebo) on the cognitive functions of healthy students. 160 volunteers were recruited and allocated randomly to modafinil or placebo group, and were assessed using the Stroop Test, BCET test and Digit span test. We found a significant difference in favor of modafinil compared to placebo in the proportion of correct answers of Stroop Test in congruent situation. A significant shorter latency of modafinil group in the incongruent situation of Stroop test was also found. No differences were found in Digit Span, or BCET tests. The study demonstrated that modafinil does not enhance the global cognitive performance of healthy non-sleep deprived students, except regarding non-demanding tasks. In particular, this drug does not seem to have positive effects on mental processes that sustain studying tasks in the college population under normal conditions. We expect these findings to demystify the use of this drug and help decision making concerning pharmacological public policies.

A dynamic spatio-temporal model for spatial data

USGS Publications Warehouse

Hefley, Trevor J.; Hooten, Mevin B.; Hanks, Ephraim M.; Russell, Robin; Walsh, Daniel P.

2017-01-01

Analyzing spatial data often requires modeling dependencies created by a dynamic spatio-temporal data generating process. In many applications, a generalized linear mixed model (GLMM) is used with a random effect to account for spatial dependence and to provide optimal spatial predictions. Location-specific covariates are often included as fixed effects in a GLMM and may be collinear with the spatial random effect, which can negatively affect inference. We propose a dynamic approach to account for spatial dependence that incorporates scientific knowledge of the spatio-temporal data generating process. Our approach relies on a dynamic spatio-temporal model that explicitly incorporates location-specific covariates. We illustrate our approach with a spatially varying ecological diffusion model implemented using a computationally efficient homogenization technique. We apply our model to understand individual-level and location-specific risk factors associated with chronic wasting disease in white-tailed deer from Wisconsin, USA and estimate the location the disease was first introduced. We compare our approach to several existing methods that are commonly used in spatial statistics. Our spatio-temporal approach resulted in a higher predictive accuracy when compared to methods based on optimal spatial prediction, obviated confounding among the spatially indexed covariates and the spatial random effect, and provided additional information that will be important for containing disease outbreaks.

Protective effects of fermented honeybush (Cyclopia intermedia) extract (HU-018) against skin aging: a randomized, double-blinded, placebo-controlled study.

PubMed

Choi, Sun Young; Hong, Ji Yeon; Ko, Eun Jung; Kim, Beom Joon; Hong, Sung-Woon; Lim, Mi Hyoung; Yeon, Sung Hum; Son, Rak Ho

2018-02-01

Oxidative stress and photodamage resulting from ultraviolet radiation exposure play key roles in skin aging. Fermented Cyclopia intermedia, which is used to brew honeybush tea, exerts antioxidant and anti-wrinkle effects by inhibiting reactive oxygen species production and downregulating matrix metalloproteinase activity. This randomized, double-blinded, placebo-controlled study aimed to evaluate the efficacy and safety of fermented honeybush (Cyclopia intermedia) extract (HU-018) for skin rejuvenation. 120 Korean subjects with crow's feet wrinkles were randomized to receive either low-dose extract (400 mg/day), high-dose extract (800 mg/day), or placebo (negative control, only dextran) for 12 weeks. Wrinkles were evaluated using JANUS ® and PRIMO pico ® . Skin elasticity, hydration and transepidermal water loss were measured. Global skin wrinkle grade was significantly improved in both low-dose and high-dose groups compared to placebo group, as well as for skin hydration and elasticity. Both the low- and high-dose groups showed significantly decreased TEWL compared to the placebo group. There were no adverse effects during the entire study period. Our data indicate that HU-018 is effective for improving skin wrinkles, elasticity, and hydration. Therefore, daily supplementation with fermented honeybush could be helpful for protecting against skin aging.

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

PubMed

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

2016-01-01

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

No difference in joint awareness after mobile- and fixed-bearing total knee arthroplasty: 3-year follow-up of a randomized controlled trial.

PubMed

Schotanus, M G M; Pilot, P; Vos, R; Kort, N P

2017-12-01

To compare the patients ability to forget the artificial knee joint in everyday life who were randomized to be operated for mobile- or fixed-bearing total knee arthroplasty (TKA). This single-center randomized controlled trial evaluated the 3-year follow-up of the cemented mobile- and fixed-bearing TKA from the same brand in a series of 41 patients. Clinical examination was during the pre-, 6-week, 6-month, 1-, 2- and 3-year follow-up containing multiple patient-reported outcome measures (PROMs) including the 12-item Forgotten Joint Score (FJS-12) at 3 years. Effect size was calculated for each PROM at 3-year follow-up to quantify the size of the difference between both bearings. At 3-year follow-up, general linear mixed model analysis showed that there were no significant or clinically relevant differences between the two groups for all outcome measures. Calculated effect sizes were small (<0.3) for all the PROMs except for the FJS-12; these were moderate (0.5). The results of this study demonstrate that joint awareness was slightly lower in patients operated with the MB TKA with comparable improved clinical outcome and PROMs at 3-year follow-up. Measuring joint awareness with the FJS-12 is useful and provides more stringent information at 3-year follow-up compared to other PROMs and should be the PROM of choice at each follow-up after TKA. Level I, randomized controlled trial.

Combined use of intravenous and topical versus intravenous tranexamic acid in primary total joint arthroplasty: A meta-analysis of randomized controlled trials.

PubMed

Zhang, Xue-Qin; Ni, Jie; Ge, Wei-Hong

2017-02-01

To compare the safety and efficacy of combined use of intravenous and topical tranexamic acid with that of intravenous tranexamic acid in primary total joint arthroplasty. Literature was searched in PubMed, Cochrane Library, Embase, Medline, and China National Knowledge Infrastructure databases. Only randomized controlled trials were included in our study. Data were using fixed-effects or random-effects models with standard mean differences and risk ratios for continuous and dichotomous variables, respectively. Seven randomized controlled trials encompassing 683 patients were retrieved for this meta-analysis. Outcomes showed that when compared with intravenous tranexamic acid, combined use of intravenous and topical tranexamic acid could significantly reduce total blood loss by a mean of 138.70 mL [95% confidence interval (CI): -196.14 to -81.26, p < 0.001], transfusion rates (risk ratio 0.42, 95% CI: 0.2 to 0.85, p < 0.001). No significant difference in the occurrence of deep vein thrombosis, pulmonary embolism was found between the two groups. This meta-analysis indicated that comparing with only intravenous tranexamic acid, combined use of intravenous and topical tranexamic acid can significantly reduce blood loss and transfusion rate in primary total joint arthroplasty without increasing the risk of thrombotic complications. Therefore, we suggest that tranexamic acid should be intravenously combined with topically administered in primary total joint arthroplasty. Copyright © 2016. Published by Elsevier Ltd.

A randomized clinical trial comparing an extended-use hygroscopic condenser humidifier with heated-water humidification in mechanically ventilated patients.

PubMed

Kollef, M H; Shapiro, S D; Boyd, V; Silver, P; Von Harz, B; Trovillion, E; Prentice, D

1998-03-01

To determine the safety and cost-effectiveness of mechanical ventilation with an extended-use hygroscopic condenser humidifier (Duration; Nellcor Puritan-Bennett; Eden Prairie, Minn) compared with mechanical ventilation with heated-water humidification. Prospective randomized clinical trial. Medical and surgical ICUs of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred ten consecutive qualified patients undergoing mechanical ventilation. Patients requiring mechanical ventilation were randomly assigned to receive humidification with either an extended-use hygroscopic condenser humidifier (for up to the first 7 days of mechanical ventilation) or heated-water humidification. Occurrence of ventilator-associated pneumonia, endotracheal tube occlusion, duration of mechanical ventilation, lengths of intensive care and hospitalization, acquired multiorgan dysfunction, and hospital mortality. One hundred sixty-three patients were randomly assigned to receive humidification with an extended-use hygroscopic condenser humidifier, and 147 patients were randomly assigned to receive heated-water humidification. The two groups were similar at the time of randomization with regard to demographic characteristics, ICU admission diagnoses, and severity of illness. Risk factors for the development of ventilator-associated pneumonia were also similar during the study period for both treatment groups. Ventilator-associated pneumonia was seen in 15 (9.2%) patients receiving humidification with an extended-use hygroscopic condenser humidifier and in 15 (10.2%) patients receiving heated-water humidification (relative risk, 0.90; 95% confidence interval=0.46 to 1.78; p=0.766). No statistically significant differences for hospital mortality, duration of mechanical ventilation, lengths of stay in the hospital ICU, or acquired organ system derangements were found between the two treatment groups. No episode of endotracheal tube occlusion occurred during the study period in either treatment group. The total cost of providing humidification was $2,605 for patients receiving a hygroscopic condenser humidifier compared with $5,625 for patients receiving heated-water humidification. Our findings suggest that the initial application of an extended-use hygroscopic condenser humidifier is a safe and more cost-effective method of providing humidification to patients requiring mechanical ventilation compared with heated-water humidification.

Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

PubMed

Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

2015-02-01

In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

Efficacy and Safety of Morphine and Low Dose Ketamine for Pain Control of Patients with Long Bone Fractures: A Randomized, Double-Blind, Clinical Trial

PubMed Central

Jahanian, Fatemeh; Hosseininejad, Seyed Mohammad; Amini Ahidashti, Hamed; Bozorgi, Farzad; Goli Khatir, Iraj; Montazar, Seyyed Hosein; Azarfar, Vahideh

2018-01-01

Objective: To compare the effects of intravenous morphine and a low dose of ketamine on pain intensity of patients with traumatic fractures of the long bones. Methods: This randomized, controlled, double-blinded, clinical trial was conducted in the adult emergency department (ED) of Emam Khomeini hospital, a tertiary general hospital affiliated with Mazandaran University of Medical Sciences, in Northern Iran, during a 6-month period. Patients were randomly assigned to receive intravenous morphine (0.1 mg/kg) or low dose ketamine (0.5 mg/kg) for control of the pain in the emergency room. The pain intensity was checked by a nurse using the visual analogue scale (VAS) at 30, 60, 90, 120, 180 and 240, minutes after the intervention. Results: Overall we included a total number of 156 patients with mean age of 35.87±3.38 years. There were 111 (71.2%) men and 4 (28.8%) women among the patients. Patients were randomly assigned to receive intravenous morphine (n=78) or low dose ketamine (n=78). The pain intensity decreased significantly in both study groups after 240 minutes of intervention. However, there was no significant difference between the two study groups regarding the pain intensity at 30 (p=0.378), 60 (p=0.927), 90 (p=0.434), 120 (p=0.557), 180 (p=0.991) and 240 (p=0.829) minutes. The side effects were comparable while low dose ketamine was associated with higher need for rescue analgesic (p=0.036).    Conclusion: The results of the current study demonstrates that the intravenous low dose ketamine leads to successful pain control in patients with long bone fractures and the effects are comparable with intravenous morphine. PMID:29379807

Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial.

PubMed

Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria

2018-03-22

Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

PubMed

Walczuk, Imko; Eertmans, Frank; Rossel, Bart; Cegielska, Agnieszka; Stockfleth, Eggert; Antunes, Andre; Adriaens, Els

2018-06-01

Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze ® in Europe, Compound W ® Nitro-Freeze in the USA). This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner ® ; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie ® ; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. Oystershell Laboratories. Clinicaltrials.gov identifier, NCT03129373.

Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial.

PubMed

Waaler Bjørnelv, G M; Frihagen, F; Madsen, J E; Nordsletten, L; Aas, E

2012-06-01

We estimated the cost-effectiveness of hemiarthroplasty compared to internal fixation for elderly patients with displaced femoral neck fractures. Over 2 years, patients treated with hemiarthroplasty gained more quality-adjusted life years than patients treated with internal fixation. In addition, costs for hemiarthroplasty were lower. Hemiarthroplasty was thus cost effective. Estimating the cost utility of hemiarthroplasty compared to internal fixation in the treatment of displaced femoral neck fractures in the elderly. A cost-utility analysis (CUA) was conducted alongside a clinical randomized controlled trial at a university hospital in Norway; 166 patients, 124 (75%) women with a mean age of 82 years were randomized to either internal fixation (n = 86) or hemiarthroplasty (n = 80). Patients were followed up at 4, 12, and 24 months. Health-related quality of life was assessed with the EQ-5D, and in combination with time used to calculate patients' quality-adjusted life years (QALYs). Resource use was identified, quantified, and valued for direct and indirect hospital costs and for societal costs. Results were expressed in incremental cost-effectiveness ratios. Over the 2-year period, patients treated with hemiarthroplasty gained 0.15-0.20 more QALYs than patients treated with internal fixation. For the hemiarthroplasty group, the direct hospital costs, total hospital costs, and total costs were non-significantly less costly compared with the internal fixation group, with an incremental cost of €2,731 (p = 0.81), €2,474 (p = 0.80), and €14,160 (p = 0.07), respectively. Thus, hemiarthroplasty was the dominant treatment. Sensitivity analyses by bootstrapping supported these findings. Hemiarthroplasty was a cost-effective treatment. Trial registration, NCT00464230.

The cost effectiveness of elective laparoscopic sigmoid resection for symptomatic diverticular disease: financial outcome of the randomized control Sigma trial.

PubMed

Klarenbeek, Bastiaan R; Coupé, Veerle M H; van der Peet, Donald L; Cuesta, Miguel A

2011-03-01

Direct healthcare costs of patients with symptomatic diverticular disease randomized for either laparoscopic or open elective sigmoid resection are compared. Cost-effectiveness analysis of the laparoscopic approach compared with open sigmoid resections is presented. An economic evaluation of the randomized control Sigma trial was conducted, comparing elective laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) in patients with symptomatic diverticulitis. Prospective registration of detailed intervention units per patient resulted in actual resource use per individual patient. To avoid distributional assumptions, the nonparametric bootstrap was applied. For the cost-effectiveness analysis, differences in total cost between LSR and OSR were compared with the differences in VAS pain score, SF-36 values for general health, and complication rate. The difference in total healthcare costs between the group that received LSR (euro 9969) and the group that received OSR (euro 9366) was not statistically significant. The slight increase in total costs was determined mainly by the significantly higher operation costs of LSR (euro 6663 vs. euro 5306). Lower costs for hospitalization (euro 2983 vs. euro 3598), blood products (euro 87 vs. euro 240), paramedical services (euro 157 vs. euro 278), and emergency attendance (euro 72 vs. euro 115) in the LSR group partially compensated these increased operation costs. The incremental cost-effectiveness ratios (ICER) indicate that improvements in pain, quality of life, and complication rate could be achieved at limited costs. Total healthcare costs of laparoscopic and open elective sigmoid resections for symptomatic diverticular disease are similar. As the clinical outcomes are in favor of the LSR group, candidates for an elective sigmoid resection should preferably be approached laparoscopically.

Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

PubMed Central

Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy; Locher, Julie L.

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article. PMID:25424512

Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

PubMed

Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

The effect of interview method on self-reported sexual behavior and perceptions of community norms in Botswana.

PubMed

Anglewicz, Philip; Gourvenec, Diana; Halldorsdottir, Iris; O'Kane, Cate; Koketso, Obakeng; Gorgens, Marelize; Kasper, Toby

2013-02-01

Since self-reports of sensitive behaviors play an important role in HIV/AIDS research, the accuracy of these measures has often been examined. In this paper we (1) examine the effect of three survey interview methods on self-reported sexual behavior and perceptions of community sexual norms in Botswana, and (2) introduce an interview method to research on self-reported sexual behavior in sub-Saharan Africa. Comparing across these three survey methods (face-to-face, ballot box, and randomized response), we find that ballot box and randomized response surveys both provide higher reports of sensitive behaviors; the results for randomized response are particularly strong. Within these overall patterns, however, there is variation by question type; additionally the effect of interview method differs by sex. We also examine interviewer effects to gain insight into the effectiveness of these interview methods, and our results suggest that caution be used when interpreting the differences between survey methods.

Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial.

PubMed

Bowers, Karen J; McAllister, Kelly B; Ray, Meredith; Heitz, Corey

2017-06-01

This study had five objectives: 1) to measure and compare total opioid use and number of opioid doses in patients treated with opioids versus ketamine in conjunction with opioids; 2) to measure pain scores up to 2 hours after presentation in the ED patient with pain, comparing standard opioid pain control to ketamine in conjunction with opioids; 3) to compare patient satisfaction with pain control using opioids alone versus ketamine in conjunction with opioids; 4) to monitor and compare side effects in patients treated with opioids versus ketamine in conjunction with opioids; and 5) to identify effect variation between different subgroups of patients, with the purpose of focusing future research. We hypothesized that low-dose ketamine, compared to placebo, as an adjunctive treatment to opioids would result in better pain control over 2 hours and greater patient satisfaction with pain control; further, this protocol will result in a lower opioid dosage over 2 hours. This was a randomized, double-blinded, placebo-controlled trial at a single academic emergency department evaluating the use of ketamine versus placebo in conjunction with opioids for moderate to severe pain. Subjects with a continued high level of pain after an initial dose of opioid analgesia were randomized to receive either 0.1 mg/kg ketamine or placebo prior to protocol-based dosing of additional opioid analgesia, if required. Over 120 minutes, subjects were assessed for pain level (0-10), satisfaction with pain control (0-4), side effects, sedation level, and need for additional pain medication. Total opioid dose, including the initial dose, was compared between groups. Sixty-three subjects were randomized to the placebo group and 53 to the ketamine group. No significant differences were found in demographics between the groups. Patients receiving ketamine reported lower pain scores over 120 minutes than patients receiving placebo (p = 0.015). Total opioid dose was lower in the ketamine group (mean ± SD = 9.95 ± 4.83 mg) compared to placebo (mean ± SD = 12.81 ± 6.81 mg; p = 0.02). Satisfaction did not differ between groups. Fewer patients in the ketamine group required additional opioid doses. More patients reported light-headedness and dizziness in the ketamine group. Ketamine, as an adjunct to opioid therapy, was more effective at reducing pain over 120 minutes and resulted in a lower total opioid dose as well as fewer repeat doses of analgesia. More side effects were reported in the ketamine group (51% vs. 19%), but the side effect profile appears tolerable. © 2017 by the Society for Academic Emergency Medicine.

Security under Uncertainty: Adaptive Attackers Are More Challenging to Human Defenders than Random Attackers

PubMed Central

Moisan, Frédéric; Gonzalez, Cleotilde

2017-01-01

Game Theory is a common approach used to understand attacker and defender motives, strategies, and allocation of limited security resources. For example, many defense algorithms are based on game-theoretic solutions that conclude that randomization of defense actions assures unpredictability, creating difficulties for a human attacker. However, many game-theoretic solutions often rely on idealized assumptions of decision making that underplay the role of human cognition and information uncertainty. The consequence is that we know little about how effective these algorithms are against human players. Using a simplified security game, we study the type of attack strategy and the uncertainty about an attacker's strategy in a laboratory experiment where participants play the role of defenders against a simulated attacker. Our goal is to compare a human defender's behavior in three levels of uncertainty (Information Level: Certain, Risky, Uncertain) and three types of attacker's strategy (Attacker's strategy: Minimax, Random, Adaptive) in a between-subjects experimental design. Best defense performance is achieved when defenders play against a minimax and a random attack strategy compared to an adaptive strategy. Furthermore, when payoffs are certain, defenders are as efficient against random attack strategy as they are against an adaptive strategy, but when payoffs are uncertain, defenders have most difficulties defending against an adaptive attacker compared to a random attacker. We conclude that given conditions of uncertainty in many security problems, defense algorithms would be more efficient if they are adaptive to the attacker actions, taking advantage of the attacker's human inefficiencies. PMID:28690557

Meta-analysis of laparoscopic versus open repair of perforated peptic ulcer.

PubMed

Antoniou, Stavros A; Antoniou, George A; Koch, Oliver O; Pointner, Rudolph; Granderath, Frank A

2013-01-01

Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU.

Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer

PubMed Central

Antoniou, George A.; Koch, Oliver O.; Pointner, Rudolph; Granderath, Frank A.

2013-01-01

Background and Objectives: Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. Methods: We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Results: Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. Conclusion: In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU. PMID:23743368

Random parameter models of interstate crash frequencies by severity, number of vehicles involved, collision and location type.

PubMed

Venkataraman, Narayan; Ulfarsson, Gudmundur F; Shankar, Venky N

2013-10-01

A nine-year (1999-2007) continuous panel of crash histories on interstates in Washington State, USA, was used to estimate random parameter negative binomial (RPNB) models for various aggregations of crashes. A total of 21 different models were assessed in terms of four ways to aggregate crashes, by: (a) severity, (b) number of vehicles involved, (c) crash type, and by (d) location characteristics. The models within these aggregations include specifications for all severities (property damage only, possible injury, evident injury, disabling injury, and fatality), number of vehicles involved (one-vehicle to five-or-more-vehicle), crash type (sideswipe, same direction, overturn, head-on, fixed object, rear-end, and other), and location types (urban interchange, rural interchange, urban non-interchange, rural non-interchange). A total of 1153 directional road segments comprising of the seven Washington State interstates were analyzed, yielding statistical models of crash frequency based on 10,377 observations. These results suggest that in general there was a significant improvement in log-likelihood when using RPNB compared to a fixed parameter negative binomial baseline model. Heterogeneity effects are most noticeable for lighting type, road curvature, and traffic volume (ADT). Median lighting or right-side lighting are linked to increased crash frequencies in many models for more than half of the road segments compared to both-sides lighting. Both-sides lighting thereby appears to generally lead to a safety improvement. Traffic volume has a random parameter but the effect is always toward increasing crash frequencies as expected. However that the effect is random shows that the effect of traffic volume on crash frequency is complex and varies by road segment. The number of lanes has a random parameter effect only in the interchange type models. The results show that road segment-specific insights into crash frequency occurrence can lead to improved design policy and project prioritization. Copyright © 2013 Elsevier Ltd. All rights reserved.

A study of the influence of conductive paths and their directions in randomly generated conductor network.

NASA Astrophysics Data System (ADS)

Mandolesi, E.; Moorkamp, M.; Jones, A. G.

2014-12-01

Most electromagnetic (EM) geophysical methods focus on the electrical conductivity of rocks and sediments to determine the geological structure of the subsurface. Electric conductivity itself is measured in the laboratory with a wide range of instruments and techniques. These measurements seldom return a compatible result. The presence of partially-interconnected random pathways of electrically conductive materials in resistive hosts has been studied for decades, and recently with increasing interest. To comprehend which conductive mechanism scales from the microstructures up to field electrical conductivity measurements, two main branch of studies have been undertaken: statistical probability of having a conductive pathways and mixing laws. Several numerical approaches have been tested to understand the effects of interconnected pathways of conductors at field scale. Usually these studies were restricted in two ways: the sources are considered constant in time (i.e., DC) and the domain is, with few exception, two-dimensional. We simulated the effects of time-varying EM sources on the conductivity measured on the surface of a three-dimensional randomly generated body embedded in an uniform host by using electromagnetic induction equations. We modelled a two-phase mixture of resistive and conductive elements with the goal of comparing the conductivity measured on field scale with the one proper of the elements constituting the random rock, and to test how the internal structures influence the directionality of the responses. Moreover, we modelled data from randomly generated bodies characterized by coherent internal structures, to check the effect of the named structures on the anisotropy of the effective conductivity. We compared these values with the electrical conductivity limits predicted by Hashin-Shtrikman bounds and the effective conductivity predicted by the Archie's law, both cast in its classic form and in an updated that allow to take in account two materials. The same analysis was done for both the resistive and the conductive conductivity values for the anisotropic case.

Analysis of overdispersed count data by mixtures of Poisson variables and Poisson processes.

PubMed

Hougaard, P; Lee, M L; Whitmore, G A

1997-12-01

Count data often show overdispersion compared to the Poisson distribution. Overdispersion is typically modeled by a random effect for the mean, based on the gamma distribution, leading to the negative binomial distribution for the count. This paper considers a larger family of mixture distributions, including the inverse Gaussian mixture distribution. It is demonstrated that it gives a significantly better fit for a data set on the frequency of epileptic seizures. The same approach can be used to generate counting processes from Poisson processes, where the rate or the time is random. A random rate corresponds to variation between patients, whereas a random time corresponds to variation within patients.

Mesoscopic description of random walks on combs

NASA Astrophysics Data System (ADS)

Méndez, Vicenç; Iomin, Alexander; Campos, Daniel; Horsthemke, Werner

2015-12-01

Combs are a simple caricature of various types of natural branched structures, which belong to the category of loopless graphs and consist of a backbone and branches. We study continuous time random walks on combs and present a generic method to obtain their transport properties. The random walk along the branches may be biased, and we account for the effect of the branches by renormalizing the waiting time probability distribution function for the motion along the backbone. We analyze the overall diffusion properties along the backbone and find normal diffusion, anomalous diffusion, and stochastic localization (diffusion failure), respectively, depending on the characteristics of the continuous time random walk along the branches, and compare our analytical results with stochastic simulations.

Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial

PubMed Central

De Bruin, Eduard J.; van Steensel, Francisca J.A.; Meijer, Anne Marie

2016-01-01

Study Objectives: To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y Methods: Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Results: Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Conclusions: Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although effects were largely similar for both formats. Further studies in a clinical setting are warranted. Clinical Trial Registration: ID: ISRCTN33922163; trial name: Effectiveness of cognitive behavioral therapy for sleeplessness in adolescents; URL: http://www.isrctn.com/ISRCTN33922163 Citation: De Bruin EJ, van Steensel FJ, Meijer AM. Cost-effectiveness of group and internet cognitive behavioral therapy for insomnia in adolescents: results from a randomized controlled trial. SLEEP 2016;39(8):1571–1581. PMID:27306272

The effect of platelet-rich plasma on clinical outcomes in lateral epicondylitis.

PubMed

Ahmad, Zafar; Brooks, Roger; Kang, Sertaz-Niel; Weaver, Holly; Nunney, Ian; Tytherleigh-Strong, Graham; Rushton, Neil

2013-11-01

To evaluate the evidence for application of platelet-rich plasma (PRP) in lateral epicondylitis. We carried out a systematic review of the current evidence on the effects of PRP in lateral epicondylitis on clinical outcomes. We performed a comprehensive search of the PubMed, Medline, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases using various combinations of the commercial names of each PRP preparation and "lateral epicondylitis" (with its associated terms), looking specifically at human studies. Data validity was assessed and collected on clinical outcome. Nine studies met the inclusion criteria, of which 5 were randomized controlled trials. Two cohort studies showed that PRP improved clinical satisfaction scores. One case-control study showed that PRP yielded a significantly greater improvement in symptoms compared with bupivacaine. Two randomized controlled trials compared the effect of injections of PRP and blood. Only 1 of the studies noted a significant difference at the 6-week time point. Three randomized controlled trials compared corticosteroids with PRP. Two of the smaller trials, which had follow-up periods of 6 weeks and 3 months, showed no significant difference between treatment groups. The largest randomized controlled trial found that PRP had significant benefit compared with corticosteroids with regard to pain and Disabilities of the Arm, Shoulder and Hand scores at 1- and 2-year time points. This review highlights the limited but evolving evidence for the use of PRP in lateral epicondylitis; however, further research is required to understand the concentration and preparation that facilitate the best clinical outcome. Characterizing the timing of the intervention would optimize the health economics behind the decision to treat for the patient and health care provider. Level III, systematic review of Level I to III studies. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Randomized Trial of Smartphone-Based Evaluation for an Obstetrics and Gynecology Clerkship.

PubMed

Sobhani, Nasim C; Fay, Emily E; Schiff, Melissa A; Stephenson-Famy, Alyssa; Debiec, Katherine E

2017-12-19

We hypothesized that compared to paper evaluations, a smartphone-based quick response (QR) evaluation tool would improve timeliness of feedback, enhance efficacy of giving and receiving feedback, and be as easy to use. We performed a randomized controlled trial of student and instructor experience with two evaluation tools in the OB/GYN clerkship at University of Washington School of Medicine (UWSOM). Sites were randomized to the QR or paper tool; students at QR sites received individualized QR codes at the beginning of the clerkship. Instructors and students completed postintervention surveys regarding the evaluation tool and associated feedback. We compared responses between groups using chi-squared tests. Participating clerkship sites included primary, tertiary, private practice and institutional settings affiliated with the University of Washington in the Washington, Wyoming, Alaska, Montana and Idaho region. Of the 29 OB/GYN UWSOM clerkship sites, 18 agreed to participate and were randomized. Of 29 eligible instructors, 25 (86%) completed the survey, with n = 18 using QR and n = 7 using paper. Of 161 eligible students, 102 (63%) completed the survey, with n = 54 using QR and n = 48 using paper. Compared to those using paper evaluations, instructors using QR evaluations were significantly more likely to agree that the evaluation tool was easy to understand (100% QR vs 43% paper, p = 0.002), the tool was effective in providing feedback (78% QR vs 29% paper, p = 0.002), and they felt comfortable approaching students with the tool (89% QR vs 43% paper, p = 0.002). Compared to those using paper evaluations, students using QR evaluations were less likely to agree the tool was effective in eliciting feedback (QR 43% vs paper 55%, p = 0.042). Instructors found QR evaluations superior to paper evaluations for providing feedback to medical students, whereas students found QR evaluations less effective for feedback. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Promising effects of oxytocin on social and food-related behaviour in young children with Prader-Willi syndrome: a randomized, double-blind, controlled crossover trial.

PubMed

Kuppens, R J; Donze, S H; Hokken-Koelega, A C S

2016-12-01

Prader-Willi syndrome (PWS) is known for hyperphagia with impaired satiety and a specific behavioural phenotype with stubbornness, temper tantrums, manipulative and controlling behaviour and obsessive-compulsive features. PWS is associated with hypothalamic and oxytocinergic dysfunction. In humans without PWS, intranasal oxytocin administration had positive effects on social and eating behaviour, and weight balance. To evaluate the effects of intranasal oxytocin compared to placebo administration on social behaviour and hyperphagia in children with PWS. Randomized, double-blind, placebo-controlled, crossover study in a PWS Reference Center in the Netherlands. Crossover intervention with twice daily intranasal oxytocin (dose range 24-48 IU/day) and placebo administration, both during 4 weeks, in 25 children with PWS (aged 6 to 14 years). In the total group, no significant effects of oxytocin on social behaviour or hyperphagia were found, but in the 17 children younger than 11 years, parents reported significantly less anger (P = 0·001), sadness (P = 0·005), conflicts (P = 0·010) and food-related behaviour (P = 0·011), and improvement of social behaviour (P = 0·018) during oxytocin treatment compared with placebo. In the eight children older than 11 years, the items happiness (P = 0·039), anger (P = 0·042) and sadness (P = 0·042) were negatively influenced by oxytocin treatment compared to placebo. There were no side effects or adverse events. This randomized, double-blind, placebo-controlled study suggests that intranasal oxytocin administration has beneficial effects on social behaviour and food-related behaviour in children with PWS younger than 11 years of age, but not in those older than 11 years of age. © 2016 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.

The effects of nocturnal compared with conventional hemodialysis on mineral metabolism: A randomized-controlled trial.

PubMed

Walsh, Michael; Manns, Braden J; Klarenbach, Scott; Tonelli, Marcello; Hemmelgarn, Brenda; Culleton, Bruce

2010-04-01

Hyperphosphatemia is common among patients receiving dialysis and is associated with increased mortality. Nocturnal hemodialysis (NHD) is a long, slow dialytic modality that may improve hyperphosphatemia and disorders of mineral metabolism. We performed a randomized-controlled trial of NHD compared with conventional hemodialysis (CvHD); in this paper, we report detailed results of mineral metabolism outcomes. Prevalent patients were randomized to receive NHD 5 to 6 nights per week for 6to 10 hours per night or to continue CvHD thrice weekly for 6 months. Oral phosphate binders and vitamin D analogs were adjusted to maintain phosphate, calcium and parathyroid hormone (PTH) levels within recommended targets. Compared with CvHD patients, patients in the NHD group had a significant decrease in serum phosphate over the course of the study (0.49 mmol/L, 95% confidence interval 0.24-0.74; P=0.002) despite a significant reduction in the use of phosphate binders. Sixty-one percent of patients in the NHD group compared with 20% in the CvHD group had a decline in intact PTH (P=0.003). Nocturnal hemodialysis lowers serum phosphate, calcium-phosphate product and requirement for phosphate binders. The effects of NHD on PTH are variable. The impact of these changes on long-term cardiovascular and bone-related outcomes requires further investigation.

Paracetamol versus ibuprofen for the treatment of patent ductus arteriosus in preterm neonates: a meta-analysis of randomized controlled trials.

PubMed

Huang, Xintao; Wang, Fang; Wang, Kai

2018-08-01

Paracetamol has been suggested as an effective treatment for patent ductus arteriosus (PDA). However, the comparative efficacy and safety between paracetamol and ibuprofen were not determined. A meta-analysis of randomized controlled trials (RCTs) was performed. Relevant studies were identified via database searching. A fixed or random effect model was applied depending on the extent of heterogeneity. Five RCTs with 677 neonates were included. The efficacies for the primary (risk ratio [RR]: 1.03, p = .56) and overall PDA closure were comparable between the two medications (RR: 1.02, p = .62). Neonates of the two groups were comparable for the incidence of PDA complications, including necrotizing enterocolitis (RR: 0.86, p = .70), intraventricular hemorrhage (RR: 0.84, p = .55), bronchopulmonary dysplasia (RR: 0.69, p = .16), and retinopathy of prematurity (RR: 0.58, p = .15), and the risks of sepsis (RR = 0.88, p = .48) and death (RR: 1.45, p = .45) within hospitalization. However, treatment with paracetamol was associated with a trend of reduced risk of renal failure (RR: 0.20, p = .07), and a significantly reduced risk of gastrointestinal bleeding (RR: 0.28, p = .009). Paracetamol may confer comparable treatment efficacy for the closure of PDA as ibuprofen, although paracetamol is associated with lower risk of adverse events.

Prevention of pressure ulcers in the intensive care unit: a randomized trial of 2 viscoelastic foam support surfaces.

PubMed

Ozyurek, Pakize; Yavuz, Meryem

2015-01-01

The aim of this study is to compare whether differences exist between 2 viscoelastic foam support surfaces in the development of new pressure ulcers. There is evidence to support the use of viscoelastic foam over standard hospital foam to reduce pressure. A comparative effectiveness study was done to compare 2 viscoelastic foam support surfaces. A randomized controlled trial was carried out. The study was performed in 2 intensive care units between October 1, 2008, and January 4, 2010. Patients (n = 105) admitted to intensive care unit were randomly assigned to viscoelastic foam 1 (n = 53) or viscoelastic foam 2 support surface (n = 52). In total, 42.8% of all patients developed a new pressure ulcer of stage 1 or worse. By stages, pressure ulcer incidence was 28.6%, 13.3%, and 1.0% for stages 1, 2, and 3, respectively. There was no significant difference in pressure ulcer incidence between the viscoelastic foam 1 and 2 groups (X2 = 0.07, df = 1, P > .05). No difference was found between 2 different viscoelastic foam surfaces in the prevention of pressure ulcers in patients treated in intensive care. Pressure ulcer incidence in critically ill patients remains high. Nurses must compare current products for effectiveness and develop innovative systems, processes, or devices to deliver best practices.

A randomized comparative trial of two decision tools for pregnant women with prior cesareans.

PubMed

Eden, Karen B; Perrin, Nancy A; Vesco, Kimberly K; Guise, Jeanne-Marie

2014-01-01

Evaluate tools to help pregnant women with prior cesareans make informed decisions about having trials of labor. Randomized comparative trial. A research assistant with a laptop met the women in quiet locations at clinics and at health fairs. Pregnant women (N = 131) who had one prior cesarean and were eligible for vaginal birth after cesarean (VBAC) participated one time between 2005 and 2007. Women were randomized to receive either an evidence-based, interactive decision aid or two evidence-based educational brochures about cesarean delivery and VBAC. Effect on the decision-making process was assessed before and after the interventions. Compared to baseline, women in both groups felt more informed (F = 23.8, p < .001), were more clear about their birth priorities (F = 9.7, p = .002), felt more supported (F = 9.8, p = .002, and overall reported less conflict (F = 18.1, p < 0.001) after receiving either intervention. Women in their third trimesters reported greater clarity around birth priorities after using the interactive decision aid than women given brochures (F = 9.8, p = .003). Although both decision tools significantly reduced conflict around the birth decision compared to baseline, more work is needed to understand which format, the interactive decision aid or paper brochures, are more effective early and late in pregnancy. © 2014 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Effects of media campaign messages targeting parents on adolescent sexual beliefs: a randomized controlled trial with a national sample.

PubMed

Palen, Lori-Ann; Ashley, Olivia Silber; Gard, Jennifer C; Kan, Marni L; Davis, Kevin C; Evans, W Douglas

2011-01-01

Using a randomized controlled trial, this study evaluated the effects of media messages targeting parents on the sexual beliefs of 404 adolescents. The messages aimed to increase parent-child communication about waiting to initiate sexual activity. Compared with children of unexposed parents, children of parents exposed to media messages were more likely to believe that teen sexual activity is psychologically harmful. However, effects varied by parent and adolescent gender; treatment effects were only significant among adolescents whose opposite-sex parent was exposed. Parent exposure strengthened beliefs that teen sexual activity is physically harmful only among adolescents with at least 1 sexually active friend.

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.

Covariance functions for body weight from birth to maturity in Nellore cows.

PubMed

Boligon, A A; Mercadante, M E Z; Forni, S; Lôbo, R B; Albuquerque, L G

2010-03-01

The objective of this study was to estimate (co)variance functions using random regression models on Legendre polynomials for the analysis of repeated measures of BW from birth to adult age. A total of 82,064 records from 8,145 females were analyzed. Different models were compared. The models included additive direct and maternal effects, and animal and maternal permanent environmental effects as random terms. Contemporary group and dam age at calving (linear and quadratic effect) were included as fixed effects, and orthogonal Legendre polynomials of animal age (cubic regression) were considered as random covariables. Eight models with polynomials of third to sixth order were used to describe additive direct and maternal effects, and animal and maternal permanent environmental effects. Residual effects were modeled using 1 (i.e., assuming homogeneity of variances across all ages) or 5 age classes. The model with 5 classes was the best to describe the trajectory of residuals along the growth curve. The model including fourth- and sixth-order polynomials for additive direct and animal permanent environmental effects, respectively, and third-order polynomials for maternal genetic and maternal permanent environmental effects were the best. Estimates of (co)variance obtained with the multi-trait and random regression models were similar. Direct heritability estimates obtained with the random regression models followed a trend similar to that obtained with the multi-trait model. The largest estimates of maternal heritability were those of BW taken close to 240 d of age. In general, estimates of correlation between BW from birth to 8 yr of age decreased with increasing distance between ages.

Effect of expanding medicaid for parents on children's health insurance coverage: lessons from the Oregon experiment.

PubMed

DeVoe, Jennifer E; Marino, Miguel; Angier, Heather; O'Malley, Jean P; Crawford, Courtney; Nelson, Christine; Tillotson, Carrie J; Bailey, Steffani R; Gallia, Charles; Gold, Rachel

2015-01-01

In the United States, health insurance is not universal. Observational studies show an association between uninsured parents and children. This association persisted even after expansions in child-only public health insurance. Oregon's randomized Medicaid expansion for adults, known as the Oregon Experiment, created a rare opportunity to assess causality between parent and child coverage. To estimate the effect on a child's health insurance coverage status when (1) a parent randomly gains access to health insurance and (2) a parent obtains coverage. Oregon Experiment randomized natural experiment assessing the results of Oregon's 2008 Medicaid expansion. We used generalized estimating equation models to examine the longitudinal effect of a parent randomly selected to apply for Medicaid on their child's Medicaid or Children's Health Insurance Program (CHIP) coverage (intent-to-treat analyses). We used per-protocol analyses to understand the impact on children's coverage when a parent was randomly selected to apply for and obtained Medicaid. Participants included 14409 children aged 2 to 18 years whose parents participated in the Oregon Experiment. For intent-to-treat analyses, the date a parent was selected to apply for Medicaid was considered the date the child was exposed to the intervention. In per-protocol analyses, exposure was defined as whether a selected parent obtained Medicaid. Children's Medicaid or CHIP coverage, assessed monthly and in 6-month intervals relative to their parent's selection date. In the immediate period after selection, children whose parents were selected to apply significantly increased from 3830 (61.4%) to 4152 (66.6%) compared with a nonsignificant change from 5049 (61.8%) to 5044 (61.7%) for children whose parents were not selected to apply. Children whose parents were randomly selected to apply for Medicaid had 18% higher odds of being covered in the first 6 months after parent's selection compared with children whose parents were not selected (adjusted odds ratio [AOR]=1.18; 95% CI, 1.10-1.27). The effect remained significant during months 7 to 12 (AOR=1.11; 95% CI, 1.03-1.19); months 13 to 18 showed a positive but not significant effect (AOR=1.07; 95% CI, 0.99-1.14). Children whose parents were selected and obtained coverage had more than double the odds of having coverage compared with children whose parents were not selected and did not gain coverage (AOR=2.37; 95% CI, 2.14-2.64). Children's odds of having Medicaid or CHIP coverage increased when their parents were randomly selected to apply for Medicaid. Children whose parents were selected and subsequently obtained coverage benefited most. This study demonstrates a causal link between parents' access to Medicaid coverage and their children's coverage.

Cost-effectiveness analysis should continually assess competing health care options especially in high volume environments like cataract surgery.

PubMed

Khan, Ashiya; Amitava, Abadan Khan; Rizvi, Syed Ali Raza; Siddiqui, Ziya; Kumari, Namita; Grover, Shivani

2015-06-01

Cost-effectiveness analysis should continually assess competing health care options especially in high volume environments like cataract surgery. To compare the cost effectiveness of phacoemulsification (PE) versus manual small-incision cataract surgery (MSICS). Prospective randomized controlled trial. Tertiary care hospital setting. A total of 52 consenting patients with age-related cataracts, were prospectively recruited, and block randomized to PE or MSICS group. Preoperative and postoperative LogMAR visual acuity (VA), visual function-14 (VF-14) score and their quality-adjusted life years (QALYs) were obtained, and the change in their values calculated. These were divided by the total cost incurred in the surgery to calculate and compare the cost effectiveness and cost utility. Surgery duration was also compared. Two group comparison with Student's t-test. Significance set at P < 0.05; 95% confidence interval (CI) quoted where appropriate. Both the MSICS and PE groups achieved comparative outcomes in terms of change (difference in mean [95% CI]) in LogMAR VA (0.03 [-0.05-0.11]), VF-14 score (7.92 [-1.03-16.86]) and QALYs (1.14 [-0.89-3.16]). However, with significantly lower costs (INR 3228 [2700-3756]), MSICS was more cost effective, with superior cost utility value. MSICS was also significantly quicker (10.58 min [6.85-14.30]) than PE. MSICS provides comparable visual and QALY improvement, yet takes less time, and is significantly more cost-effective, compared with PE. Greater push and penetration of MSICS, by the government, is justifiably warranted in our country.

The Effectiveness of Cognitive Behavioral Therapy versus Psychoeducation in the Management of Depression among Patients Undergoing Haemodialysis.

PubMed

Al Saraireh, Faris A; Aloush, Sami M; Al Azzam, Manar; Al Bashtawy, Mohammed

2018-01-25

The aim of this randomized controlled trial was to compare the effectiveness of psychoeducation versus cognitive behavioral therapy (CBT) in the management of depression among renal dialysis patients. A sample of 130 dialysis patients participated in the study and they were assigned at random to one of two therapies: psychoeducation (N = 65) or CBT (N = 65). Hamilton depression rating scale was completed by the participants in both groups prior to the therapies and after completion. Both therapies were effective in the management of depression, although psychoeducation was superior. Psychoeducation is recommended over CBT in the management of depression among renal dialysis patients.

Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures.

PubMed

Bhandari, Mohit; Tornetta, Paul; Ellis, Thomas; Audige, Laurent; Sprague, Sheila; Kuo, Jonathann C; Swiontkowski, Marc F

2004-01-01

There have been a number of non-randomized studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. However, there remains considerable debate about whether the results of non-randomized studies are consistent with the results of randomized, controlled trials. Given the economic burden of hip fractures, it remains essential to identify therapies to improve outcomes; however, whether data from non-randomized studies of an intervention should be used to guide patient care remains unclear. We aimed to determine whether the pooled results of mortality and revision surgery among non-randomized studies were similar to those of randomized trials in studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. We conducted a Medline search from 1969 to June 2002, identifying both randomized and non-randomized studies comparing internal fixation with arthroplasty in patients with femoral neck fractures. Additional strategies to identify relevant articles included Cochrane database, SCISEARCH, textbooks, annual meeting programs, and content experts. We abstracted information on mortality and revision rates in each study and compared the pooled results between non-randomized and randomized studies. In addition, we explored potential reasons for dissimilar results between the two study designs. We identified 140 citations that addressed the general topic of comparison of arthroplasty and internal fixation for hip fracture. Of these, 27 studies met the eligibility criteria, 13 of which were non-randomized studies and 14 of which were randomized trials. Mortality data was available in all 13 non-randomized studies ( n=3108 patients) and in 12 randomized studies ( n=1767 patients). Non-randomized studies overestimated the risk of mortality by 40% when compared with the results of randomized trials (relative risk 1.44 vs 1.04, respectively). Information on revision risk was available in 9 non-randomized studies ( n=2764 patients) and all 14 randomized studies ( n=1901 patients). Both estimates from non-randomized and randomized studies revealed a significant reduction in the risk of revision surgery with arthroplasty compared with internal fixation (relative risk 0.38 vs 0.23, respectively). The reduction in the risk of revision surgery with arthroplasty compared with internal fixation was 62% for non-randomized studies and 77% for randomized trials. Thus, non-randomized studies underestimated the relative benefit of arthroplasty by 19.5%. Non-randomized studies with point estimates of relative risk similar to the pooled estimate for randomized trials all controlled for patient age, gender, and fracture displacement in their comparisons of mortality. We were unable to identify reasons for differences in the revision rate results between the study designs. Similar to other reports in medical subspecialties, non-randomized studies provided results dissimilar to randomized trials of arthroplasty vs internal fixation for mortality and revision rates in patients with femoral neck fractures. Investigators should be aware of these discrepancies when evaluating the merits of alternative surgical interventions, especially when both randomized trials and non-randomized comparative studies are available.

Effects of aromatherapy massage on face-down posture-related pain after vitrectomy: a randomized controlled trial.

PubMed

Adachi, Naho; Munesada, Minako; Yamada, Noriko; Suzuki, Haruka; Futohashi, Ayano; Shigeeda, Takashi; Kato, Satoshi; Nishigaki, Masakazu

2014-06-01

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Metformin for the prevention of hypertensive disorders of pregnancy in women with gestational diabetes and obesity: a systematic review and meta-analysis.

PubMed

Kalafat, Erkan; Sukur, Yavuz Emre; Abdi, Abdulkadir; Thilaganathan, Basky; Khalil, Asma

2018-05-10

Metformin has been reported to reduce the risk of preeclampsia. It is also known to influence soluble fms-like tyrosine kinase-1 (sFlt-1) levels, which correlate significantly with the gestation of onset and severity of preeclampsia. The main aim of this systematic review and meta-analysis was to determine whether metformin use is associated with the incidence of hypertensive disorders of pregnancy (HDP). MEDLINE (1947 - September 2017), Scopus (1970 - September 2017) and the Cochrane Library (since inception - September 2017) were searched for relevant citations in English language. Randomized controlled trials on metformin use, reporting the incidence of preeclampsia or pregnancy induced hypertension were included. Studies on populations with a high probability of metformin use prior to randomization (type II diabetes or polycystic ovary syndrome) were excluded. Random-effects models with Mantel-Haenszel were used for subgroup analyses. Moreover, a Bayesian random-effects meta-regression was used to synthesize the evidence. In total, 3337 citations matched the search criteria. After evaluating the abstracts and full text review, 15 studies were included in the review. Metformin use was associated with a reduced risk of pregnancy induced hypertension when compared to insulin (RR: 0.56, 95% CI: 0.37-0.85, I^ 2 =0, 1260 women) and a non-significantly reduced risk of preeclampsia (RR: 0.83, 95% CI: 0.60-1.14, I^ 2 =0%, 1724 women). When compared to placebo, metformin use was associated with a non-significant reduction of preeclampsia (RR: 0.74, 95% CI: 0.09-6.28, I^ 2 =86%, 840 women). Metformin use was also associated with a non-significant reduction of any HDP (RR: 0.71, 95% CI: 0.41-1.25, I^ 2 =0, 556 women) when compared to glyburide. When studies were combined with Bayesian random-effects meta-regression using treatment type as a covariate, the posterior probabilities of metformin having a beneficial effect for the prevention of preeclampsia, pregnancy induced hypertension and any HDP were 92.7%, 92.8% and 99.2%, respectively when compared to any other treatment or placebo. There is a high probability that metformin use is associated with a reduced HDP incidence when compared to other treatments and placebo. The small number of studies included in the analysis, the low quality of evidence and the clinical heterogeneity preclude the generalization of these results to broader populations. Given the clinical importance of this topic and the magnitude of effect observed in this meta-analysis, further prospective trials are urgently needed. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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...

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

PubMed

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

Information on center characteristics as costs' determinants in multicenter clinical trials: is modeling center effect worth the effort?

PubMed

Petrinco, Michele; Pagano, Eva; Desideri, Alessandro; Bigi, Riccardo; Ghidina, Marco; Ferrando, Alberto; Cortigiani, Lauro; Merletti, Franco; Gregori, Dario

2009-01-01

Several methodological problems arise when health outcomes and resource utilization are collected at different sites. To avoid misleading conclusions in multi-center economic evaluations the center effect needs to be taken into adequate consideration. The aim of this article is to compare several models, which make use of a different amount of information about the enrolling center. To model the association of total medical costs with the levels of two sets of covariates, one at patient and one at center level, we considered four statistical models, based on the Gamma model in the class of the Generalized Linear Models with a log link, which use different amount of information on the enrolling centers. Models were applied to Cost of Strategies after Myocardial Infarction data, an international randomized trial on costs of uncomplicated acute myocardial infarction (AMI). The simple center effect adjustment based on a single random effect results in a more conservative estimation of the parameters as compared with approaches which make use of deeper information on the centers characteristics. This study shows, with reference to a real multicenter trial, that center information cannot be neglected and should be collected and inserted in the analysis, better in combination with one or more random effect, taking into account in this way also the heterogeneity among centers because of unobserved centers characteristics.

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

PubMed

Ewald, H; Kirby, J; Rees, K; Robertson, W

2014-09-01

An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Radiofrequency and Microwave Ablation Compared to Systemic Chemotherapy and to Partial Hepatectomy in the Treatment of Colorectal Liver Metastases: A Systematic Review and Meta-Analysis.

PubMed

Meijerink, Martijn R; Puijk, Robbert S; van Tilborg, Aukje A J M; Henningsen, Kirsten Holdt; Fernandez, Llenalia Garcia; Neyt, Mattias; Heymans, Juanita; Frankema, Jacqueline S; de Jong, Koert P; Richel, Dick J; Prevoo, Warner; Vlayen, Joan

2018-04-17

To assess safety and outcome of radiofrequency ablation (RFA) and microwave ablation (MWA) as compared to systemic chemotherapy and partial hepatectomy (PH) in the treatment of colorectal liver metastases (CRLM). MEDLINE, Embase and the Cochrane Library were searched. Randomized trials and comparative observational studies with multivariate analysis and/or matching were included. Guidelines from National Guideline Clearinghouse and Guidelines International Network were assessed using the AGREE II instrument. The search revealed 3530 records; 328 were selected for full-text review; 48 were included: 8 systematic reviews, 2 randomized studies, 26 comparative observational studies, 2 guideline-articles and 10 case series; in addition 13 guidelines were evaluated. Literature to assess the effectiveness of ablation was limited. RFA + systemic chemotherapy was superior to chemotherapy alone. PH was superior to RFA alone but not to RFA + PH or to MWA. Compared to PH, RFA showed fewer complications, MWA did not. Outcomes were subject to residual confounding since ablation was only employed for unresectable disease. The results from the EORTC-CLOCC trial, the comparable survival for ablation + PH versus PH alone, the potential to induce long-term disease control and the low complication rate argue in favour of ablation over chemotherapy alone. Further randomized comparisons of ablation to current-day chemotherapy alone should therefore be considered unethical. Hence, the highest achievable level of evidence for unresectable CRLM seems reached. The apparent selection bias from previous studies and the superior safety profile mandate the setup of randomized controlled trials comparing ablation to surgery.

Effects of active/passive interventions on pain, anxiety, and quality of life in women with fibromyalgia: Randomized controlled pilot trial.

PubMed

Ekici, Gamze; Unal, Edibe; Akbayrak, Turkan; Vardar-Yagli, Naciye; Yakut, Yavuz; Karabulut, Erdem

2017-01-01

The authors of this study compared the effects of pilates exercises and connective tissue massage (CTM) on pain intensity; pain-pressure threshold; and tolerance, anxiety, progress, and health-related quality of life in females with fibromyalgia. It was a pilot, assessor masked, randomized controlled trial conducted between January and August of 2013. Twenty-one women with fibromyalgia were randomly assigned to the pilates exercise program (six of whom did not complete the program), and 22 were randomly assigned to CTM (one of whom did not complete this program). Each group received the assigned intervention three times per week during a 4-week period. The Visual Analogue Scale, algometry, State-Trait Anxiety Inventory, Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of treatments. Significant improvements were found in both groups for all parameters. However, the scores for pain-pressure threshold were significantly elevated and the symptoms of anxiety were significantly diminished in the exercise group compared to the massage group. Thus, exercise and massage might be used to provide improvements in women with fibromyalgia. The exercise group showed more advantages than the massage group and thus might be preferred for patients with fibromyalgia. However, an adequately powered trial is required to determine this with certainty.

Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine.

PubMed

Smith, Kimberly Y; Tierney, Camlin; Mollan, Katie; Venuto, Charles S; Budhathoki, Chakra; Ma, Qing; Morse, Gene D; Sax, Paul; Katzenstein, David; Godfrey, Catherine; Fischl, Margaret; Daar, Eric S; Collier, Ann C

2014-02-01

We aimed to evaluate treatment responses to atazanavir plus ritonavir (ATV/r) or efavirenz (EFV) in initial antiretroviral regimens among women and men, and determine if treatment outcomes differ by sex. We performed a randomized trial of open-label ATV/r or EFV combined with abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) in 1857 human immunodeficiency virus type 1-infected, treatment-naive persons enrolled between September 2005 and November 2007 at 59 sites in the United States and Puerto Rico. Associations of sex with 3 primary study endpoints of time to virologic failure, safety, and tolerability events were analyzed using Cox proportional hazards models. Model-based population pharmacokinetic analysis was performed using nonlinear mixed effects modeling (NONMEM version VII). Of 1857 participants, 322 were women. Women assigned to ATV/r had a higher risk of virologic failure with either nucleoside reverse transcriptase inhibitor backbone than women assigned to EFV, or men assigned to ATV/r. The effects of ATV/r and EFV upon safety and tolerability risk did not differ significantly by sex. With ABC/3TC, women had a significantly higher (32%) safety risk compared to men; with TDF/FTC, the safety risk was 20% larger for women compared to men, but not statistically significant. Women had slower ATV clearance and higher predose levels of ATV compared to men. Self-reported adherence did not differ significantly by sex. This is the first randomized clinical trial to identify a significantly earlier time to virologic failure in women randomized to ATV/r compared to women randomized to EFV. This finding has important clinical implications given that boosted protease inhibitors are often favored over EFV in women of childbearing potential. NCT00118898.

Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials

PubMed Central

Geng, Hua; Wang, Chengzhong

2017-01-01

Background To assess the efficacy and safety of oxcarbazepine (OXC) in the treatment of children with epilepsy. Methods Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China), and Chinese National Knowledge Infrastructure (China) database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR) with 95% confidence intervals (95% CIs) was calculated using fixed-effects or random-effects model. Results Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo), OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P=0.366) and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P=0.310; for 50%–75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P=0.301; for <50% reduction: RR =0.79, 95% CI: 0.56, 1.12; P=0.179). Moreover, patients treated with OXC had a comparable incidence of adverse events compared with those treated with other antiepileptic drugs (RR =1.01, 95% CI: 0.92, 1.11; P=0.760). Conclusion OXC showed similar effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings. PMID:28293110

Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials.

PubMed

Geng, Hua; Wang, Chengzhong

2017-01-01

To assess the efficacy and safety of oxcarbazepine (OXC) in the treatment of children with epilepsy. Randomized controlled trials (RCTs) published in PubMed, Embase, Web of Science, Cochrane Library, Scopus, SinoMed (Chinese BioMedical Literature Service System, China), and Chinese National Knowledge Infrastructure (China) database were systematically reviewed. Eligible studies were those that compared the efficacy and safety of OXC with other antiepileptic drugs in epilepsy. Risk ratio (RR) with 95% confidence intervals (95% CIs) was calculated using fixed-effects or random-effects model. Eleven RCTs with a total of 1,241 patients met the inclusion criteria and were included in this meta-analysis. Compared with other antiepileptic drugs (sodium valproate, levetiracetam, phenytoin, and placebo), OXC was associated with similar seizure-free rate (RR =1.06, 95% CI: 0.94, 1.20; P =0.366) and percentage reduction from baseline in seizure frequency (for ≥75% reduction: RR =1.15, 95% CI: 0.88, 1.49; P =0.310; for 50%-75% reduction: RR =1.12, 95% CI: 0.90, 1.39; P =0.301; for <50% reduction: RR =0.79, 95% CI: 0.56, 1.12; P =0.179). Moreover, patients treated with OXC had a comparable incidence of adverse events compared with those treated with other antiepileptic drugs (RR =1.01, 95% CI: 0.92, 1.11; P =0.760). OXC showed similar effects and safety as other antiepileptic drugs in the treatment of children with epilepsy. Further well-conducted, large-scale RCTs are needed to validate these findings.

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

The Effect of Improved Water Supply on Diarrhea Prevalence of Children under Five in the Volta Region of Ghana: A Cluster-Randomized Controlled Trial.

PubMed

Cha, Seungman; Kang, Douk; Tuffuor, Benedict; Lee, Gyuhong; Cho, Jungmyung; Chung, Jihye; Kim, Myongjin; Lee, Hoonsang; Lee, Jaeeun; Oh, Chunghyeon

2015-09-25

Although a number of studies have been conducted to explore the effect of water quality improvement, the majority of them have focused mainly on point-of-use water treatment, and the studies investigating the effect of improved water supply have been based on observational or inadequately randomized trials. We report the results of a matched cluster randomized trial investigating the effect of improved water supply on diarrheal prevalence of children under five living in rural areas of the Volta Region in Ghana. We compared the diarrheal prevalence of 305 children in 10 communities of intervention with 302 children in 10 matched communities with no intervention (October 2012 to February 2014). A modified Poisson regression was used to estimate the prevalence ratio. An intention-to-treat analysis was undertaken. The crude prevalence ratio of diarrhea in the intervention compared with the control communities was 0.85 (95% CI 0.74-0.97) for Krachi West, 0.96 (0.87-1.05) for Krachi East, and 0.91 (0.83-0.98) for both districts. Sanitation was adjusted for in the model to remove the bias due to residual imbalance since it was not balanced even after randomization. The adjusted prevalence ratio was 0.82 (95% CI 0.71-0.96) for Krachi West, 0.95 (0.86-1.04) for Krachi East, and 0.89 (0.82-0.97) for both districts. This study provides a basis for a better approach to water quality interventions.

The Effect of Improved Water Supply on Diarrhea Prevalence of Children under Five in the Volta Region of Ghana: A Cluster-Randomized Controlled Trial

PubMed Central

Cha, Seungman; Kang, Douk; Tuffuor, Benedict; Lee, Gyuhong; Cho, Jungmyung; Chung, Jihye; Kim, Myongjin; Lee, Hoonsang; Lee, Jaeeun; Oh, Chunghyeon

2015-01-01

Although a number of studies have been conducted to explore the effect of water quality improvement, the majority of them have focused mainly on point-of-use water treatment, and the studies investigating the effect of improved water supply have been based on observational or inadequately randomized trials. We report the results of a matched cluster randomized trial investigating the effect of improved water supply on diarrheal prevalence of children under five living in rural areas of the Volta Region in Ghana. We compared the diarrheal prevalence of 305 children in 10 communities of intervention with 302 children in 10 matched communities with no intervention (October 2012 to February 2014). A modified Poisson regression was used to estimate the prevalence ratio. An intention-to-treat analysis was undertaken. The crude prevalence ratio of diarrhea in the intervention compared with the control communities was 0.85 (95% CI 0.74–0.97) for Krachi West, 0.96 (0.87–1.05) for Krachi East, and 0.91 (0.83–0.98) for both districts. Sanitation was adjusted for in the model to remove the bias due to residual imbalance since it was not balanced even after randomization. The adjusted prevalence ratio was 0.82 (95% CI 0.71–0.96) for Krachi West, 0.95 (0.86–1.04) for Krachi East, and 0.89 (0.82–0.97) for both districts. This study provides a basis for a better approach to water quality interventions. PMID:26404337

The comparative effects of 0.12% chlorhexidine and herbal oral rinse on dental plaque-induced gingivitis: A randomized clinical trial

PubMed Central

Bhate, Devaki; Jain, Sanjay; Kale, Rahul; Muglikar, Sangeeta

2015-01-01

Background: Chlorhexidine (CHX) is considered as a gold standard of antimicrobial rinses. Various herbal oral rinses are available in the market. However, little is known of its effectiveness. Aim: The aim of this study was to evaluate the clinical changes after the usage of herbal oral rinse and 0.12% CHX. Materials and Methods: In a randomized clinical trial, 76 patients with dental plaque-induced gingivitis were assigned to Group I (Herbal Oral Rinse - Hiora®) and 76 patients with dental plaque-induced gingivitis to Group II (0.12% Chlorhexidine-Peridex®). Gingival index and Plaque index scores were recorded at baseline and 21 days after scaling. Results: Intragroup comparison in both groups showed that plaque index and gingival index scores were statistically significant after 21 days as compared to baseline. Intergroup comparison showed that plaque index scores and gingival index scores were statistically significant in Group II as compared to Group I. Conclusion: When herbal oral rinse was compared to 0.12% CHX, 0.12% CHX mouth rinse effectively reduced the clinical symptoms of plaque-induced gingivitis. PMID:26392686

Training Individuals in Army Units: Comparative Effectiveness of Selected TEC Lessons and Conventional Methods

DTIC Science & Technology

1975-12-01

test for each course was given all participants after the training to measure the comparative effectiveness of each... tested in all five courses ; National Guardsmen were trained and tested in the four infantry courses . For each course , participants were randomly divided...performance and higher than the BL group in the LAW and M16A1 Rifle courses . The performance tests for the

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…

Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

PubMed

Luce, Bryan R; Connor, Jason T; Broglio, Kristine R; Mullins, C Daniel; Ishak, K Jack; Saunders, Elijah; Davis, Barry R

2016-09-20

Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs. To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research. Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design. Comparative effectiveness trial of antihypertensive medications. Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data. Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions. The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier. This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered. In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups. National Heart, Lung, and Blood Institute.

Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

PubMed

Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa

2014-04-29

Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions. Studies of observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and modifications of existing designs, including both randomized and observational, are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population.A systematic analysis of study design features, risk of bias, parameter interpretation, and effect size for all types of randomized and non-experimental observational studies is needed to identify specific differences in design types and potential biases. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. To assess the impact of study design (including RCTs versus observational study designs) on the effect measures estimated.To explore methodological variables that might explain any differences identified.To identify gaps in the existing research comparing study designs. We searched seven electronic databases, from January 1990 to December 2013.Along with MeSH terms and relevant keywords, we used the sensitivity-specificity balanced version of a validated strategy to identify reviews in PubMed, augmented with one term ("review" in article titles) so that it better targeted narrative reviews. No language restrictions were applied. We examined systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions tested in trials with those tested in observational studies. Comparisons included RCTs versus observational studies (including retrospective cohorts, prospective cohorts, case-control designs, and cross-sectional designs). Reviews were not eligible if they compared randomized trials with other studies that had used some form of concurrent allocation. In general, outcome measures included relative risks or rate ratios (RR), odds ratios (OR), hazard ratios (HR). Using results from observational studies as the reference group, we examined the published estimates to see whether there was a relative larger or smaller effect in the ratio of odds ratios (ROR).Within each identified review, if an estimate comparing results from observational studies with RCTs was not provided, we pooled the estimates for observational studies and RCTs. Then, we estimated the ratio of ratios (risk ratio or odds ratio) for each identified review using observational studies as the reference category. Across all reviews, we synthesized these ratios to get a pooled ROR comparing results from RCTs with results from observational studies. Our initial search yielded 4406 unique references. Fifteen reviews met our inclusion criteria; 14 of which were included in the quantitative analysis.The included reviews analyzed data from 1583 meta-analyses that covered 228 different medical conditions. The mean number of included studies per paper was 178 (range 19 to 530).Eleven (73%) reviews had low risk of bias for explicit criteria for study selection, nine (60%) were low risk of bias for investigators' agreement for study selection, five (33%) included a complete sample of studies, seven (47%) assessed the risk of bias of their included studies,Seven (47%) reviews controlled for methodological differences between studies,Eight (53%) reviews controlled for heterogeneity among studies, nine (60%) analyzed similar outcome measures, and four (27%) were judged to be at low risk of reporting bias.Our primary quantitative analysis, including 14 reviews, showed that the pooled ROR comparing effects from RCTs with effects from observational studies was 1.08 (95% confidence interval (CI) 0.96 to 1.22). Of 14 reviews included in this analysis, 11 (79%) found no significant difference between observational studies and RCTs. One review suggested observational studies had larger effects of interest, and two reviews suggested observational studies had smaller effects of interest.Similar to the effect across all included reviews, effects from reviews comparing RCTs with cohort studies had a pooled ROR of 1.04 (95% CI 0.89 to 1.21), with substantial heterogeneity (I(2) = 68%). Three reviews compared effects of RCTs and case-control designs (pooled ROR: 1.11 (95% CI 0.91 to 1.35)).No significant difference in point estimates across heterogeneity, pharmacological intervention, or propensity score adjustment subgroups were noted. No reviews had compared RCTs with observational studies that used two of the most common causal inference methods, instrumental variables and marginal structural models. Our results across all reviews (pooled ROR 1.08) are very similar to results reported by similarly conducted reviews. As such, we have reached similar conclusions; on average, there is little evidence for significant effect estimate differences between observational studies and RCTs, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions. Factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of RCTs and observational studies. Our results underscore that it is important for review authors to consider not only study design, but the level of heterogeneity in meta-analyses of RCTs or observational studies. A better understanding of how these factors influence study effects might yield estimates reflective of true effectiveness.

A pragmatic randomized comparative effectiveness trial of transitional care for a socioeconomically diverse population: Design, rationale and baseline characteristics.

PubMed

Schaeffer, Christine; Teter, Caroline; Finch, Emily A; Hurt, Courtney; Keeter, Mary Kate; Liss, David T; Rogers, Angela; Sheth, Avani; Ackermann, Ronald

2018-02-01

Transitional care programs have been widely used to reduce readmissions and improve the quality and safety of the handoff process between hospital and outpatient providers. Very little is known about effective transitional care interventions among patients who are uninsured or with Medicaid. This paper describes the design and baseline characteristics of a pragmatic randomized comparative effectiveness trial of transitional care. Northwestern Medical Group- Transitional Care (NMG-TC) care model was developed to address the needs of patients with multiple medical problems that required lifestyle changes and were amenable to office-based management. We present the design, evaluation methods and baseline characteristics of NMG-TC trial patients. Baseline demographic characteristics indicate that our patient population is predominantly male, Medicaid insured and non-white. This study will evaluate two methods for implementing an effective transitional care model in a medically complex and socioeconomically diverse population. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2014-01-01

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

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

PubMed

Hilton, Said; Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

2018-02-01

Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement

PubMed Central

Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

2018-01-01

BACKGROUND Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. OBJECTIVE To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. MATERIALS AND METHODS Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. RESULTS A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. CONCLUSION Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect. PMID:29059146

HETEROGENEITY IN TREATMENT EFFECT AND COMPARATIVE EFFECTIVENESS RESEARCH.

PubMed

Luo, Zhehui

2011-10-01

The ultimate goal of comparative effectiveness research (CER) is to develop and disseminate evidence-based information about which interventions are most effective for which patients under what circumstances. To achieve this goal it is crucial that researchers in methodology development find appropriate methods for detecting the presence and sources of heterogeneity in treatment effect (HTE). Comparing with the typically reported average treatment effect (ATE) in randomized controlled trials and non-experimental (i.e., observational) studies, identifying and reporting HTE better reflect the nature and purposes of CER. Methodologies of CER include meta-analysis, systematic review, design of experiments that encompasses HTE, and statistical correction of various types of estimation bias, which is the focus of this review.

Effect of aerobic exercises versus laser acupuncture in treatment of postmenopausal hot flushes: a randomized controlled trial.

PubMed

Elhosary, Eman Abdelfatah Mohamed; Ewidea, Mahmoud Mohamed; Ahmed, Hamada Ahmed Hamada; El Khatib, Ayman

2018-02-01

[Purpose] To compare the effect of aerobic exercises versus laser acupuncture in treatment of postmenopausal hot flushes. [Subjects and Methods] This study was designed as single blind randomized controlled trial. A total of 48 postmenopausal women complained of hot flushes. Their ages ranged between 45 to 55 years and were randomly assigned into 2 equal groups: group (A), which received an aerobic exercises, and group (B), which received laser acupuncture. Both groups recieved 3 sessions per week for two months. The level of follicular stimulating hormone, lutelizing hormone, and hot flushes dairy card were assessed the severity of hot flahes before and after treatment program. [Results] There were Significant reduction in FSH, LH, and menopausal daily hot flush scale in group A compared with group B at the post treatment. [Conclusion] Eight week program of an aerobic exercises yields improvement in FSH, LH, and decrease in severity of hot flushes assessed by hot flush dairy card than laser acupuncture in the treatment of postmenopausal hot flashes.

Quantification of moving target cyber defenses

NASA Astrophysics Data System (ADS)

Farris, Katheryn A.; Cybenko, George

2015-05-01

Current network and information systems are static, making it simple for attackers to maintain an advantage. Adaptive defenses, such as Moving Target Defenses (MTD) have been developed as potential "game-changers" in an effort to increase the attacker's workload. With many new methods being developed, it is difficult to accurately quantify and compare their overall costs and effectiveness. This paper compares the tradeoffs between current approaches to the quantification of MTDs. We present results from an expert opinion survey on quantifying the overall effectiveness, upfront and operating costs of a select set of MTD techniques. We find that gathering informed scientific opinions can be advantageous for evaluating such new technologies as it offers a more comprehensive assessment. We end by presenting a coarse ordering of a set of MTD techniques from most to least dominant. We found that seven out of 23 methods rank as the more dominant techniques. Five of which are techniques of either address space layout randomization or instruction set randomization. The remaining two techniques are applicable to software and computer platforms. Among the techniques that performed the worst are those primarily aimed at network randomization.

The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

PubMed

Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2018-01-01

This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial.

PubMed

Conklin, Heather M; Lawford, Joanne; Jasper, Bruce W; Morris, E Brannon; Howard, Scott C; Ogg, Susan W; Wu, Shengjie; Xiong, Xiaoping; Khan, Raja B

2009-07-01

To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels. Childhood cancer survivors (N = 103) identified as having attention and learning problems completed a randomized, double-blind, 3-week, home-crossover trial of placebo, low-dose methylphenidate (0.3 mg/kg; 10 mg twice daily maximum) and moderate-dose methylphenidate (0.6 mg/kg; 20 mg twice daily maximum). Caregivers completed the Barkley Side Effects Rating Scale (SERS) at baseline and each week during the medication trial. Siblings of cancer survivors (N = 49) were recruited as a healthy comparison group. There was a significantly higher number and severity of symptoms endorsed on the SERS when patients were taking moderate dose compared with placebo or low dose, but not low dose compared with placebo. The number of side effects endorsed on the SERS was significantly lower during all 3 home-crossover weeks (placebo, low dose, moderate dose) when compared with baseline symptom scores. The severity of side effects was also significantly lower, compared with baseline screening, during placebo and low-dose weeks but not moderate-dose weeks. Both the number and severity of symptoms endorsed at baseline were significantly higher for patients compared with siblings. Female gender and lower IQ were associated with higher adverse effect levels. Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial

USDA-ARS?s Scientific Manuscript database

Background: Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients ...

Nicotine Replacement: Effects on Postcessation Weight Gain.

ERIC Educational Resources Information Center

Gross, Janet; And Others

1989-01-01

Examined nicotine replacement effects on postcessation weight gain in smoking cessation volunteers. Randomly assigned abstinent subjects to active nicotine or placebo gum conditions for 10 weeks. Analyses revealed strong evidence for gum effect on weight gain, with active gum users gaining mean total of 3.8 pounds compared with 7.8 pounds for…

Depressive Symptoms Negate the Beneficial Effects of Physical Activity on Mortality Risk

ERIC Educational Resources Information Center

Lee, Pai-Lin

2013-01-01

The aim of this study is to: (1) compare the association between various levels of physical activity (PA) and mortality; and (2) examine the potential modifying effect of depressive symptoms on the PA-mortality associations. Previous large scale randomized studies rarely assess the association in conjunction with modifying effects of depressive…

Simulation of wave propagation in three-dimensional random media

NASA Astrophysics Data System (ADS)

Coles, Wm. A.; Filice, J. P.; Frehlich, R. G.; Yadlowsky, M.

1995-04-01

Quantitative error analyses for the simulation of wave propagation in three-dimensional random media, when narrow angular scattering is assumed, are presented for plane-wave and spherical-wave geometry. This includes the errors that result from finite grid size, finite simulation dimensions, and the separation of the two-dimensional screens along the propagation direction. Simple error scalings are determined for power-law spectra of the random refractive indices of the media. The effects of a finite inner scale are also considered. The spatial spectra of the intensity errors are calculated and compared with the spatial spectra of

Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

PubMed

Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

2016-09-01

To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p < 0.0001] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Regression Discontinuity and Randomized Controlled Trial Estimates: An Application to The Mycotic Ulcer Treatment Trials.

PubMed

Oldenburg, Catherine E; Venkatesh Prajna, N; Krishnan, Tiruvengada; Rajaraman, Revathi; Srinivasan, Muthiah; Ray, Kathryn J; O'Brien, Kieran S; Glymour, M Maria; Porco, Travis C; Acharya, Nisha R; Rose-Nussbaumer, Jennifer; Lietman, Thomas M

2018-08-01

We compare results from regression discontinuity (RD) analysis to primary results of a randomized controlled trial (RCT) utilizing data from two contemporaneous RCTs for treatment of fungal corneal ulcers. Patients were enrolled in the Mycotic Ulcer Treatment Trials I and II (MUTT I & MUTT II) based on baseline visual acuity: patients with acuity ≤ 20/400 (logMAR 1.3) enrolled in MUTT I, and >20/400 in MUTT II. MUTT I investigated the effect of topical natamycin versus voriconazole on best spectacle-corrected visual acuity. MUTT II investigated the effect of topical voriconazole plus placebo versus topical voriconazole plus oral voriconazole. We compared the RD estimate (natamycin arm of MUTT I [N = 162] versus placebo arm of MUTT II [N = 54]) to the RCT estimate from MUTT I (topical natamycin [N = 162] versus topical voriconazole [N = 161]). In the RD, patients receiving natamycin had mean improvement of 4-lines of visual acuity at 3 months (logMAR -0.39, 95% CI: -0.61, -0.17) compared to topical voriconazole plus placebo, and 2-lines in the RCT (logMAR -0.18, 95% CI: -0.30, -0.05) compared to topical voriconazole. The RD and RCT estimates were similar, although the RD design overestimated effects compared to the RCT.

Brief Strategic Family Therapy Versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

PubMed Central

Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, José

2012-01-01

Objective To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at 8 community treatment agencies nationwide. Randomization encompassed both adolescents’ families (n = 480) and the agency therapists (n = 49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post randomization. Secondary outcomes included treatment engagement (≥2 sessions), retention (≥8 sessions), and participants’ reports of family functioning 4, 8, and 12 months following randomization. Results No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher, χ2(1) = 5.40, p < .02, in TAU (Mdn = 3.5, interquartile range [IQR] = 11) than BSFT (Mdn = 2, IQR = 9) at the final observation point. BSFT was significantly more effective than TAU in engaging, χ2(1) = 11.33, p < .001, and retaining, χ2(1) = 5.66, p < .02, family members in treatment and in improving parent reports of family functioning, χ2(2) = 9.10, p < .011. Conclusions We discuss challenges in treatment implementation in community settings and provide recommendations for further research. PMID:21967492

Open transinguinal preperitoneal mesh repair of inguinal hernia: a targeted systematic review and meta-analysis of published randomized controlled trials

PubMed Central

Sajid, Muhammad S.; Craciunas, L.; Singh, K.K.; Sains, P.; Baig, M.K.

2013-01-01

Objective: The objective of this article is to systematically analyse the randomized, controlled trials comparing transinguinal preperitoneal (TIPP) and Lichtenstein repair (LR) for inguinal hernia. Methods: Randomized, controlled trials comparing TIPP vs LR were analysed systematically using RevMan® and combined outcomes were expressed as risk ratio (RR) and standardized mean difference. Results: Twelve randomized trials evaluating 1437 patients were retrieved from the electronic databases. There were 714 patients in the TIPP repair group and 723 patients in the LR group. There was significant heterogeneity among trials (P < 0.0001). Therefore, in the random effects model, TIPP repair was associated with a reduced risk of developing chronic groin pain (RR, 0.48; 95% CI, 0.26, 0.89; z = 2.33; P < 0.02) without influencing the incidence of inguinal hernia recurrence (RR, 0.18; 95% CI, 0.36, 1.83; z = 0.51; P = 0.61). Risk of developing postoperative complications and moderate-to-severe postoperative pain was similar following TIPP repair and LR. In addition, duration of operation was statistically similar in both groups. Conclusion: TIPP repair for inguinal hernia is associated with lower risk of developing chronic groin pain. It is comparable with LR in terms of risk of hernia recurrence, postoperative complications, duration of operation and intensity of postoperative pain. PMID:24759818

Sequential causal inference: Application to randomized trials of adaptive treatment strategies

PubMed Central

Dawson, Ree; Lavori, Philip W.

2009-01-01

SUMMARY Clinical trials that randomize subjects to decision algorithms, which adapt treatments over time according to individual response, have gained considerable interest as investigators seek designs that directly inform clinical decision making. We consider designs in which subjects are randomized sequentially at decision points, among adaptive treatment options under evaluation. We present a sequential method to estimate the comparative effects of the randomized adaptive treatments, which are formalized as adaptive treatment strategies. Our causal estimators are derived using Bayesian predictive inference. We use analytical and empirical calculations to compare the predictive estimators to (i) the ‘standard’ approach that allocates the sequentially obtained data to separate strategy-specific groups as would arise from randomizing subjects at baseline; (ii) the semi-parametric approach of marginal mean models that, under appropriate experimental conditions, provides the same sequential estimator of causal differences as the proposed approach. Simulation studies demonstrate that sequential causal inference offers substantial efficiency gains over the standard approach to comparing treatments, because the predictive estimators can take advantage of the monotone structure of shared data among adaptive strategies. We further demonstrate that the semi-parametric asymptotic variances, which are marginal ‘one-step’ estimators, may exhibit significant bias, in contrast to the predictive variances. We show that the conditions under which the sequential method is attractive relative to the other two approaches are those most likely to occur in real studies. PMID:17914714

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.

MicroRNA array normalization: an evaluation using a randomized dataset as the benchmark.

PubMed

Qin, Li-Xuan; Zhou, Qin

2014-01-01

MicroRNA arrays possess a number of unique data features that challenge the assumption key to many normalization methods. We assessed the performance of existing normalization methods using two microRNA array datasets derived from the same set of tumor samples: one dataset was generated using a blocked randomization design when assigning arrays to samples and hence was free of confounding array effects; the second dataset was generated without blocking or randomization and exhibited array effects. The randomized dataset was assessed for differential expression between two tumor groups and treated as the benchmark. The non-randomized dataset was assessed for differential expression after normalization and compared against the benchmark. Normalization improved the true positive rate significantly in the non-randomized data but still possessed a false discovery rate as high as 50%. Adding a batch adjustment step before normalization further reduced the number of false positive markers while maintaining a similar number of true positive markers, which resulted in a false discovery rate of 32% to 48%, depending on the specific normalization method. We concluded the paper with some insights on possible causes of false discoveries to shed light on how to improve normalization for microRNA arrays.

MicroRNA Array Normalization: An Evaluation Using a Randomized Dataset as the Benchmark

PubMed Central

Qin, Li-Xuan; Zhou, Qin

2014-01-01

MicroRNA arrays possess a number of unique data features that challenge the assumption key to many normalization methods. We assessed the performance of existing normalization methods using two microRNA array datasets derived from the same set of tumor samples: one dataset was generated using a blocked randomization design when assigning arrays to samples and hence was free of confounding array effects; the second dataset was generated without blocking or randomization and exhibited array effects. The randomized dataset was assessed for differential expression between two tumor groups and treated as the benchmark. The non-randomized dataset was assessed for differential expression after normalization and compared against the benchmark. Normalization improved the true positive rate significantly in the non-randomized data but still possessed a false discovery rate as high as 50%. Adding a batch adjustment step before normalization further reduced the number of false positive markers while maintaining a similar number of true positive markers, which resulted in a false discovery rate of 32% to 48%, depending on the specific normalization method. We concluded the paper with some insights on possible causes of false discoveries to shed light on how to improve normalization for microRNA arrays. PMID:24905456

The FOAM study: is Hysterosalpingo foam sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women? Study protocol for a randomized controlled trial.

PubMed

van Rijswijk, Joukje; van Welie, Nienke; Dreyer, Kim; van Hooff, Machiel H A; de Bruin, Jan Peter; Verhoeve, Harold R; Mol, Femke; Kleiman-Broeze, Kimiko A; Traas, Maaike A F; Muijsers, Guido J J M; Manger, Arentje P; Gianotten, Judith; de Koning, Cornelia H; Koning, Aafke M H; Bayram, Neriman; van der Ham, David P; Vrouenraets, Francisca P J M; Kalafusova, Michaela; van de Laar, Bob I G; Kaijser, Jeroen; van Oostwaard, Miriam F; Meijer, Wouter J; Broekmans, Frank J M; Valkenburg, Olivier; van der Voet, Lucy F; van Disseldorp, Jeroen; Lambers, Marieke J; Peters, Henrike E; Lier, Marit C I; Lambalk, Cornelis B; van Wely, Madelon; Bossuyt, Patrick M M; Stoker, Jaap; van der Veen, Fulco; Mol, Ben W J; Mijatovic, Velja

2018-05-09

Tubal pathology is a causative factor in 20% of subfertile couples. Traditionally, tubal testing during fertility work-up is performed by hysterosalpingography (HSG). Hysterosalpingo-foam sonography (HyFoSy) is a new technique that is thought to have comparable accuracy as HSG, while it is less expensive and more patient friendly. HyFoSy would be an acceptable alternative for HSG, provided it has similar effectiveness in terms of patient outcomes. We aim to compare the effectiveness and costs of management guided by HyFoSy or by HSG. Consenting women will undergo tubal testing by both HyFoSy and HSG in a randomized order during fertility work-up. The study group will consist of 1163 subfertile women between 18 and 41 years old who are scheduled for tubal patency testing during their fertility work-up. Women with anovulatory cycles not responding to ovulation induction, endometriosis, severe male subfertility or a known contrast (iodine) allergy will be excluded. We anticipate that 7 % (N = 82) of the participants will have discordant test results for HyFoSy and HSG. These participants will be randomly allocated to either a management strategy based on HyFoSy or a management strategy based on HSG, resulting in either a diagnostic laparoscopy with chromopertubation or a strategy that assumes tubal patency (intrauterine insemination or expectant management). The primary outcome is ongoing pregnancy leading to live birth within 12 months after randomization. Secondary outcomes are patient pain scores, time to pregnancy, clinical pregnancy, miscarriage rate, multiple pregnancy rate, preterm birth rate and number of additional treatments. Costs will be estimated by counting resource use and calculating unit prices. This trial will compare the effectiveness and costs of HyFoSy versus HSG in assessing tubal patency in subfertile women. Dutch Trial Register (NTR 4746, http://www.trialregister.nl ). Date of registration: 19 August 2014.

Raloxifene for women with Alzheimer disease: A randomized controlled pilot trial.

PubMed

Henderson, Victor W; Ala, Tom; Sainani, Kristin L; Bernstein, Allan L; Stephenson, B Sue; Rosen, Allyson C; Farlow, Martin R

2015-12-01

To determine whether raloxifene, a selective estrogen receptor modulator, improves cognitive function compared with placebo in women with Alzheimer disease (AD) and to provide an estimate of cognitive effect. This pilot study was conducted as a randomized, double-blind, placebo-controlled trial, with a planned treatment of 12 months. Women with late-onset AD of mild to moderate severity were randomly allocated to high-dose (120 mg) oral raloxifene or identical placebo provided once daily. The primary outcome compared between treatment groups at 12 months was change in the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog). Forty-two women randomized to raloxifene or placebo were included in intent-to-treat analyses (mean age 76 years, range 68-84), and 39 women contributed 12-month outcomes. ADAS-cog change scores at 12 months did not differ significantly between treatment groups (standardized difference 0.03, 95% confidence interval -0.39 to 0.44, 2-tailed p = 0.89). Raloxifene and placebo groups did not differ significantly on secondary analyses of dementia rating, activities of daily living, behavior, or a global cognition composite score. Caregiver burden and caregiver distress were similar in both groups. Results on the primary outcome showed no cognitive benefits in the raloxifene-treated group. This study provides Class I evidence that for women with AD, raloxifene does not have a significant cognitive effect. The study lacked the precision to exclude a small effect. © 2015 American Academy of Neurology.

A Randomized Controlled Trial of Clinician-Supported Problem-Solving Bibliotherapy for Family Caregivers of People With First-Episode Psychosis.

PubMed

Chien, Wai Tong; Thompson, David R; Lubman, Dan I; McCann, Terence V

2016-11-01

Family interventions for first-episode psychosis (FEP) are an integral component of treatment, with positive effects mainly on patients' mental state and relapse rate. However, comparatively little attention has been paid to the effects of family interventions on caregivers' stress coping and well-being, especially in non-Western countries. We aimed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy (CSPSB) for Chinese family caregivers of people with FEP in improving family burden and carers' problem-solving and caregiving experience, and in reducing psychotic symptoms and duration of re-hospitalizations, compared with those only received usual outpatient family support (UOFS). A randomized controlled trial was conducted across 2 early psychosis clinics in Hong Kong, where there might be inadequate usual family support services for FEP patients. A total of 116 caregivers were randomly selected, and after baseline measurement, randomly assigned to the CSPSB or UOFS. They were also assessed at 1-week and 6- and 12-month post-intervention. Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience, and reductions in severity of psychotic symptoms and duration of re-hospitalizations, than the UOFS group at 6- and 12-month follow-up. CSPSB produces moderate long-term benefits to caregivers and FEP patients, and is a low-cost adjunct to UOFS. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

PubMed Central

Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

2013-01-01

Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

Effect of a brief smoking cessation intervention on adult tobacco smokers with pulmonary tuberculosis: A cluster randomized controlled trial from North India.

PubMed

Goel, Sonu; Kathiresan, Jeyashree; Singh, Preeti; Singh, Rana J

2017-09-01

An association between smoking and poor tuberculosis (TB) treatment outcomes has been globally established. Various smoking cessation interventions (SCIs) have been proven worldwide to curb smoking behavior. There is a need for evidence to assess if SCI increases the chance of successful treatment outcome among TB patients. To assess the effectiveness of a brief SCI; The Ask, Brief, Cessation support (ABC) package, on treatment outcomes and smoking cessation in smear-positive adult pulmonary TB patients. A cluster, randomized controlled trial was conducted wherein 17 designated microscopic centers of Chandigarh, India were randomly assigned using a computer-generated randomization sequence to receive SCI within directly observed treatment, short (DOTS) services, or existing standard of care. Eligible and consenting smokers (15 + years) registered as smear-positive pulmonary TB for DOTS (n = 156) between January and June 2013 were enrolled. Smoking cessation (self-reported) was assessed at intervals till the end of treatment. End TB treatment outcomes were extracted from patient records. Treatment success was lower in intervention arm (83.6%) as compared control arm (88.2%), but the difference was statistically insignificant (P = 0.427). Smoking cessation was higher in intervention arm (80.2%) compared to comparison arm (57.5%) (adjusted incidence risk ratio = 1.56; 95% confidence interval = 1.24-1.93; P < 0.0001). SCI is effective in inducing smoking cessation among TB patients. No association of SCI with TB treatment outcomes could be detected.

The effect of prognostic data presentation format on perceived risk among surrogate decision makers of critically ill patients: a randomized comparative trial.

PubMed

Chapman, Andy R; Litton, Edward; Chamberlain, Jenny; Ho, Kwok M

2015-04-01

The purpose of this study is to determine whether varying the format used to present prognostic data alters the perception of risk among surrogate decision makers in the intensive care unit (ICU). This was a prospective randomized comparative trial conducted in a 23-bed adult tertiary ICU. Enrolled surrogate decision makers were randomized to 1 of 2 questionnaires, which presented hypothetical ICU scenarios, identical other than the format in which prognostic data were presented (eg, frequencies vs percentages). Participants were asked to rate the risk associated with each prognostic statement. We enrolled 141 surrogate decision makers. The perception of risk varied significantly dependent on the presentation format. For "quantitative data," risks were consistently perceived as higher, when presented as frequencies (eg, 1 in 50) compared with equivalent percentages (eg, 2%). Framing "qualitative data" in terms of chance of "death" rather than "survival" led to a statistically significant increase in perceived risks. Framing "quantitative" data in this way did not significantly affect risk perception. Data format had a significant effect on how surrogate decision makers interpreted risk. Qualitative statements are interpreted widely and affected by framing. Where possible, multiple quantitative formats should be used for presenting prognostic information. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study

PubMed Central

Luce, Bryan R; Broglio, Kristine R; Ishak, K Jack; Mullins, C Daniel; Vanness, David J; Fleurence, Rachael; Saunders, Elijah; Davis, Barry R

2013-01-01

Background Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. Purpose Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a ‘proof of concept’ to stimulate investment in Bayesian adaptive designs for future CER trials. Methods We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT. Results We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. Limitations While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. Conclusion This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data. PMID:23983160

Excimer Laser Versus Phakic Intraocular Lenses for Myopia and Astigmatism: A Meta-Analysis of Randomized Controlled Trials.

PubMed

Chen, Haiting; Liu, Yu; Niu, Guangzeng; Ma, Jingxue

2018-05-01

Meta-analysis of randomized controlled trials (RCTs) which compared excimer laser refractive surgery and phakic intraocular lenses (PIOLs) for the treatment of myopia and astigmatism. An electronic literature search was performed using the PubMed, EBSCO, CNKI, and Cochrane Library database to identify prospective RCTs which compared excimer laser refractive surgery and PIOL with a follow-up time of at least 12 months. Efficacy, accuracy, safety outcomes, and complications were analyzed by standardized mean difference, risk ratio, and the pooled estimates according to a fixed effect model or random effect model. This review included 5 RCTs with a sum of 405 eyes. The range of myopia was 6.0 to 20.0 D with up to 4.0 D of astigmatism. The PIOL group was more likely to achieve a spherical equivalence within±1.0 D of target refraction at 12 months postoperatively (P=0.009), and was less likely to lose one or more lines of best spectacle corrected visual acuity than the LASER group (P=0.002). On the whole, there is no significant difference in efficacy and complications between the two kinds of surgeries. This meta-analysis indicated that PIOLs were safer and more accurate within 12 months of follow-up compared with excimer laser surgical for refractive errors.

Double-blind, randomized, multicenter study comparing the effect of betahistine and flunarizine on the dizziness handicap in patients with recurrent vestibular vertigo.

PubMed

Albera, Roberto; Ciuffolotti, Roberto; Di Cicco, Maurizio; De Benedittis, Giuseppe; Grazioli, Irene; Melzi, Gabriella; Mira, Eugenio; Pallestrini, Eugenio; Passali, Desiderio; Serra, Agostino; Vicini, Claudio

2003-06-01

The aim of this double-blind, randomized, multicenter study was to compare the efficacy of betahistine dihydrochloride (BH) and flunarizine (FL) using the Dizziness Handicap Inventory (DHI), a validated self-assessment questionnaire that has not previously been used in a clinical trial to evaluate antivertigo drugs. Patients with recurrent vertigo of peripheral vestibular origin and who were severely handicapped by vertigo were randomized to an 8-week course of treatment with oral BH 48 mg daily or oral FL 10 mg daily. The efficacy endpoints were the total DHI score and the physical, functional and emotional subscores. Fifty-two patients completed the study. After 8 weeks of treatment the mean total DHI score and the physical subscore were significantly lower in the BH group compared to the FL group (7.5 and 3.6 points, respectively). The mean total DHI score as well as the three subscores decreased significantly after 4 and 8 weeks in both treatment groups. This study showed that at 8 weeks BH is significantly more effective than FL in terms of improving the total DHI score and the physical subscore. It was also established that the DHI is a useful and reliable method for evaluating the efficacy of antivertigo drugs.

A Controlled, Randomized-Blinded Clinical Trial to Assess the Efficacy of a Nitric Oxide Releasing Patch in the Treatment of Cutaneous Leishmaniasis by Leishmania (V.) panamensis

PubMed Central

López-Jaramillo, Patricio; Rincón, Melvin Y.; García, Ronald G.; Silva, Sandra Y.; Smith, Erin; Kampeerapappun, Piyaporn; García, Carlos; Smith, Daniel J.; López, Marcos; Vélez, Iván D.

2010-01-01

A topical nanofiber nitric oxide (NO) releasing patch (≈3.5 μmol NO/cm2/day for 20 days, NOP) was compared with intramuscular meglumine antimoniate (Glucantime, 20 mg/kg/day for 20 days) for the treatment of cutaneous leishmaniasis (CL) caused by Leishmania (V.) panamensis in Santander and Tolima, Colombia. A double-blind, randomized, placebo-controlled, clinical trial was conducted to determine whether the NOP is as effective as Glucantime for the treatment of CL. Patients were randomly assigned to Glucantime and placebo patches or NOP and placebo of Glucantime. The cure rates after a 3-month follow-up were 94.8% for the group that received Glucantime compared with 37.1% in the NOP group. Despite the lower efficacy of the NOP versus Glucantime, a significantly lower frequency of non-serious adverse events and a reduced variation in serum markers were observed in patients treated with NOP. Treatment of CL with NOP resulted in a lower effectiveness compared with Glucantime; however, the low frequency of adverse events and the facility of topic administration justify the development of new generations of NOP systems for the treatment of CL. PMID:20595484

Fractional CO2 laser is an effective therapeutic modality for xanthelasma palpebrarum: a randomized clinical trial.

PubMed

Esmat, Samia M; Elramly, Amany Z; Abdel Halim, Dalia M; Gawdat, Heba I; Taha, Hanaa I

2014-12-01

Xanthelasma palpebrarum (XP) is a common cosmetic concern. Although there is a wide range of therapeutic modalities for XP, there is no general consensus on the optimal treatment for such condition. Compare the efficacy and safety of super pulsed (SP) and fractional CO2 lasers in the treatment of XP. This prospective randomized comparative clinical study included 20 adult patients with bilateral and symmetrical XP lesions. Xanthelasma palpebrarum lesions were randomly assigned to treatment by either single session of ablative SP CO2 laser or 3 to 5 sessions of ablative fractional CO2 laser with monthly intervals. All patients were assessed using digital photography and optical coherence tomography images. Xanthelasma palpebrarum lesions on both sides were successfully removed with significant improvement in size, color, and thickness. Although lesions treated by SP CO2 laser showed significantly better improvement regarding color and thickness of the lesions, downtime and patient satisfaction were significantly better for lesions treated with fractional CO2 laser. Scarring and recurrence were significantly higher in lesions treated by SP CO2 laser. Ablative fractional CO2 laser is an effective and safe therapeutic option for XP with significantly shorter downtime and higher patient satisfaction compared with SP CO2 laser.

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

PubMed

Vierhout, Bastiaan P; Saleem, Ben R; Ott, Alewijn; van Dijl, Jan Maarten; de Kempenaer, Ties D van Andringa; Pierie, Maurice E N; Bottema, Jan T; Zeebregts, Clark J

2015-09-14

Access for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. Percutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections. NTR4257 10 November 2013, NL44578.042.13.

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 lidocaine on random skin flap survival in rats.

PubMed

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

2015-01-01

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

Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial.

PubMed

Smallwood, J; Brown, R; Coulter, F; Irvine, E; Copland, C

2001-10-01

A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size. Copyright 2001 John Wiley & Sons, Ltd.

Effects of green tea catechin extract on serum lipids in postmenopausal women: a randomized, placebo-controlled clinical trial12

PubMed Central

Samavat, Hamed; Newman, April R; Wang, Renwei; Yuan, Jian-Min; Wu, Anna H; Kurzer, Mindy S

2016-01-01

Background: Green tea has been suggested to improve cardiovascular disease risk factors, including circulating lipid variables. However, current evidence is predominantly based on small, short-term randomized controlled trials conducted in diverse populations. Objective: The aim of this study was to examine the efficacy and impact of green tea extract (GTE) supplementation high in epigallocatechin gallate (EGCG) on blood lipids in healthy postmenopausal women. Design: This was an ancillary study of a double-blind, randomized, placebo-controlled, parallel-arm trial investigating the effects of a GTE supplement containing 1315 mg catechins (843 mg EGCG) on biomarkers of breast cancer risk. Participants were randomly assigned to receive GTE (n = 538) or placebo (n = 537) and were stratified by catechol-O-methyltransferase (COMT) genotype activity (high COMT compared with low or intermediate COMT genotype activity). They consumed either 4 GTE or identical placebo capsules daily for 12 mo. A total of 936 women completed this substudy. Circulating lipid panels including total cholesterol (TC), HDL cholesterol, and triglycerides were measured at baseline and at months 6 and 12. Results: Compared with placebo, 1-y supplementation with GTE capsules resulted in a significant reduction in circulating TC (−2.1% compared with 0.7%; P = 0.0004), LDL cholesterol (−4.1% compared with 0.9%; P < 0.0001) and non-HDL cholesterol (−3.1% compared with 0.4%; P = 0.0032). There was no change in HDL-cholesterol concentration, but triglyceride concentrations increased by 3.6% in the GTE group, whereas they decreased by 2.5% in the placebo group (P = 0.046). A significant reduction in TC was observed only among women with high (i.e., ≥200 mg/dL) baseline TC concentrations (P-interaction = 0.01) who consumed GTE capsules. The effect of GTE on the increase in triglycerides was mainly observed among obese women and statin users (P-interaction = 0.06). Conclusion: Supplementation with GTE significantly reduced circulating TC and LDL-cholesterol concentrations, especially in those with elevated baseline TC concentrations. This trial was registered at clinicaltrials.gov as NCT00917735. PMID:27806972

An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions.

PubMed

Steventon, Adam; Grieve, Richard; Bardsley, Martin

2015-11-01

Policy makers require estimates of comparative effectiveness that apply to the population of interest, but there has been little research on quantitative approaches to assess and extend the generalizability of randomized controlled trial (RCT)-based evaluations. We illustrate an approach using observational data. Our example is the Whole Systems Demonstrator (WSD) trial, in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care. First, we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of nonparticipants who received usual care. We matched on 65 baseline variables obtained from the electronic medical record. Second, we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether "usual care" is defined by the RCT control group or nonparticipants. Thus, we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched nonparticipants. For some endpoints, such as the number of outpatient attendances, the placebo tests passed, and the effectiveness estimates were robust to the choice of comparison group. However, for other endpoints, such as emergency admissions, the placebo tests failed and the estimates of treatment effect differed markedly according to whether telehealth patients were compared with RCT controls or matched nonparticipants. The proposed placebo tests indicate those cases when estimates from RCTs do not generalize to routine clinical practice and motivate complementary estimates of comparative effectiveness that use observational data. Future RCTs are recommended to incorporate these placebo tests and the accompanying sensitivity analyses to enhance their relevance to policy making. © The Author(s) 2015.

Dietary Weight Loss and Exercise Effects on Serum Biomarkers of Angiogenesis in Overweight Postmenopausal Women: A Randomized Controlled Trial.

PubMed

Duggan, Catherine; Tapsoba, Jean de Dieu; Wang, Ching-Yun; McTiernan, Anne

2016-07-15

Obese and sedentary persons have an increased risk for cancer, but underlying mechanisms are poorly understood. Angiogenesis is common to adipose tissue formation and remodeling, and to tumor vascularization. A total of 439 overweight/obese, healthy, postmenopausal women [body mass index (BMI) > 25 kg/m(2)] ages 50-75 years, recruited between 2005 and 2008 were randomized to a 4-arm 12-month randomized controlled trial, comparing a caloric restriction diet arm (goal: 10% weight loss, N = 118), aerobic exercise arm (225 minutes/week of moderate-to-vigorous activity, N = 117), a combined diet + exercise arm (N = 117), or control (N = 87) on circulating levels of angiogenic biomarkers. VEGF, plasminogen activator inhibitor-1 (PAI-1), and pigment epithelium-derived factor (PEDF) were measured by immunoassay at baseline and 12 months. Changes were compared using generalized estimating equations, adjusting for baseline BMI, age, and race/ethnicity. Participants randomized to the diet + exercise arms had statistically significantly greater reductions in PAI-1 at 12 months compared with controls (-19.3% vs. +3.48%, respectively, P < 0.0001). Participants randomized to the diet and diet + exercise arms had statistically significantly greater reductions in PEDF (-9.20%, -9.90%, respectively, both P < 0.0001) and VEGF (-8.25%, P = 0.0005; -9.98%, P < 0.0001, respectively) compared with controls. There were no differences in any of the analytes in participants randomized to the exercise arm compared with controls. Increasing weight loss was statistically significantly associated with linear trends of greater reductions in PAI-1, PEDF, and VEGF. Weight loss is significantly associated with reduced circulating VEGF, PEDF, and PAI-1, and could provide incentive for reducing weight as a cancer prevention method in overweight and obese individuals. Cancer Res; 76(14); 4226-35. ©2016 AACR. ©2016 American Association for Cancer Research.

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.

Comparative Effectiveness and Implementation Research: Directions for Neurology

PubMed Central

Vickrey, Barbara G.; Hirtz, Deborah; Waddy, Salina; Cheng, Eric M.; Johnston, S. Claiborne

2013-01-01

There is an enormous unmet need for knowledge about how new insights from discovery and translational research can yield measurable, population-level improvements in health and reduction in mortality among those having or at risk for neurological disease. Once several, well-conducted randomized controlled trials establish the efficacy of a given therapy, implementation research can generate new knowledge about barriers to uptake of the therapy into widespread clinical care, and what strategies are effective in overcoming those barriers and in addressing health disparities. Comparative effectiveness research aims to elucidate the relative value (including clinical benefit, clinical harms, and/or costs) of alternative efficacious management approaches to a neurological disorder, generally through direct comparisons, and may include comparisons of methodologies for implementation. Congress has recently appropriated resources and established an institute to prioritize funding for such research. Neurologists and neuroscientists should understand the scope and objectives of comparative effectiveness and implementation research, their range of methodological approaches (formal literature syntheses, randomized trials, observational studies, modeling), and existing research resources (centers for literature synthesis, registries, practice networks) relevant to research for neurological conditions, in order to close the well-documented “evidence-to-practice gap.” Future directions include building this research resource capacity, producing scientists trained to conduct rigorous comparative effectiveness and implementation research, and embracing innovative strategies to set research priorities in these areas. PMID:22718542

High intensity training in obesity: a Meta‐analysis

PubMed Central

Theel, W.; Kasteleyn, M. J.; Franssen, F. M. E.; Hiemstra, P. S.; Rudolphus, A.; Taube, C.; Braunstahl, G. J.

2017-01-01

Summary Introduction High Intensity training (HIT) is a time‐effective alternative to traditional exercise programs in adults with obesity, but the superiority in terms of improving cardiopulmonary fitness and weight loss has not been demonstrated. Objective to determine the effectiveness of HIT on cardiopulmonary fitness and body composition in adults with obesity compared to traditional (high volume continuous) exercise. Methods A systematic search of the main health science databases was conducted for randomized controlled trials comparing HIT with traditional forms of exercise in people with obesity. Eighteen studies were included in the meta‐analysis. The (unstandardized) mean difference of each outcome parameters was calculated and pooled with the random effects model. Results HIT resulted in greater improvement of cardiopulmonary fitness (VO2max) (MD 1.83, 95% CI 0.70, 2.96, p<0.005; I2=31%) and a greater reduction of %body fat (MD ‐1.69, 95% CI ‐3.10, ‐0.27, p=0.02, I2=30%) compared to traditional exercise. Overall effect for BMI was not different between HIT and traditional exercise. Conclusion Training at high intensity is superior to improve cardiopulmonary fitness and to reduce %body fat in adults with obesity compared to traditional exercise. Future studies are needed to design specific HIT programs for the obese with regard to optimal effect and long‐term adherence. PMID:29071102

Problem-based learning in dental education: a systematic review of the literature.

PubMed

Bassir, Seyed Hossein; Sadr-Eshkevari, Pooyan; Amirikhorheh, Shaden; Karimbux, Nadeem Y

2014-01-01

The purpose of this systematic review was to compare the effectiveness of problem-based learning (PBL) with that of traditional (non-PBL) approaches in dental education. The search strategy included electronic and manual searches of studies published up to October 2012. The PICO (Population, Intervention, Comparator, and Outcome) framework was utilized to guide the inclusion or exclusion of studies. The search strategy identified 436 articles, seventeen of which met the inclusion criteria. No randomized controlled trial was found comparing the effectiveness of PBL with that of lecture-based approach at the level of an entire curriculum. Three randomized controlled trials had evaluated the effectiveness of PBL at a single course level. The quality assessment rated four studies as being of moderate quality, while the other studies were assessed as being of weak quality. This review concludes that there are a very limited number of well-designed controlled studies evaluating the effectiveness of PBL in dental education. The data in those studies reveal that PBL does not negatively influence the acquisition of factual knowledge in dental students and PBL enhances the ability of students in applying their knowledge to clinical situations. In addition, PBL positively affects students' perceived preparedness.

Bioavailability of epicatechin and effects on nitric oxide metabolites of an apple flavanol-rich extract supplemented beverage compared to a whole apple puree: a randomized, placebo-controlled, crossover trial.

PubMed

Hollands, Wendy J; Hart, David J; Dainty, Jack R; Hasselwander, Oliver; Tiihonen, Kirsti; Wood, Richard; Kroon, Paul A

2013-07-01

Flavanol-rich foods are known to exert beneficial effects on cardiovascular health. The biological effects depend on bioavailability of flavanols which may be influenced by food matrix and dose ingested. We compared the bioavailability and dose-response of epicatechin from whole apple and an epicatechin-rich extract, and the effects on plasma and urinary nitric oxide (NO) metabolites. In a randomized, placebo-controlled, crossover trial, subjects consumed drinks containing 70 and 140 mg epicatechin from an apple extract and an apple puree containing 70 mg epicatechin. Blood and urine samples were collected for 24 h post ingestion. Maximum plasma concentration, AUC(0-24 h) , absorption and urinary excretion were all significantly higher after ingestion of both epicatechin drinks compared with apple puree (p < 0.05). Time to maximum plasma concentration was significantly later for the puree compared with the drinks (p < 0.01). Epicatechin bioavailability was >2-fold higher after ingestion of the 140 mg epicatechin drink compared to the 70 mg epicatechin drink (p < 0.05). Excretion of NO metabolites was higher for all test products compared with placebo, which was significant for the high dose drink (p = 0.016). Oral bioavailability of apple epicatechin increases at higher doses, is reduced by whole apple matrix and has the potential to increase NO bioavailability. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Can tailored interventions increase mammography use among HMO women?

PubMed

Lipkus, I M; Rimer, B K; Halabi, S; Strigo, T S

2000-01-01

Telephone counseling and tailored print communications have emerged as promising methods for promoting mammography screening. However, there has been little research testing, within the same randomized field trial, of the efficacy of these two methods compared to a high-quality usual care system for enhancing screening. This study addressed the question: Compared to usual care, is tailored telephone counseling more effective than tailored print materials for promoting mammography screening? Three-year randomized field trial. One thousand ninety-nine women aged 50 and older recruited from a health maintenance organization in North Carolina. Women were randomized to 1 of 3 groups: (1) usual care, (2) tailored print communications, and (3) tailored telephone counseling. Adherence to mammography screening based on self-reports obtained during 1995, 1996, and 1997. Compared to usual care alone, telephone counseling promoted a significantly higher proportion of women having mammograms on schedule (71% vs 61%) than did tailored print (67% vs 61%) but only after the first year of intervention (during 1996). Furthermore, compared to usual care, telephone counseling was more effective than tailored print materials at promoting being on schedule with screening during 1996 and 1997 among women who were off-schedule during the previous year. The effects of the intervention were most pronounced after the first intervention. Compared to usual care, telephone counseling seemed particularly effective at promoting change among nonadherent women, the group for whom the intervention was developed. These results suggest that telephone counseling, rather than tailored print, might be the preferred first-line intervention for getting nonadherent women on schedule for mammography screening. Many questions would have to be answered about why the tailored print intervention was not more powerful. Nevertheless, it is clear that additional interventions will be needed to maintain women's adherence to mammography. Medical Subject Headings (MeSH): mammography screening, telephone counseling, tailored print communications, barriers.

A Randomized Comparative Effectiveness Trial of Novel Endoscopic Techniques and Approaches for Barrett's Esophagus Screening in the Community

PubMed Central

Sami, Sarmed S.; Dunagan, Kelly T.; Johnson, Michele L.; Schleck, Cathy D.; Shah, Nilay D.; Zinsmeister, Alan R.; Wongkeesong, Louis-Michel; Wang, Kenneth K.; Katzka, David A.; Ragunath, Krish; Iyer, Prasad G.

2015-01-01

Objectives To compare participation rates and clinical effectiveness of sedated endoscopy (sEGD) versus unsedated transnasal endoscopy (uTNE) for esophageal assessment and Barrett's esophagus (BE) screening in a population-based cohort. Methods Prospective, randomized, controlled trial in a community population. Subjects, ≥ 50 years of age who previously completed validated gastrointestinal symptom questionnaires were randomized (stratified by age, sex and reflux symptoms) to one of three screening techniques (either sEGD, or uTNE in a mobile research van (muTNE), or uTNE in a hospital outpatient endoscopy suite (huTNE)) and invited to participate. Results 209 of 459 (46%) subjects agreed to participate (muTNE n=76, huTNE n=72, sEGD n=61). Participation rates were numerically higher in the unsedated arms of muTNE (47.5%) and huTNE (45.7%) compared to the sEGD arm (40.7%), but were not statistically different (p=0.27). Complete evaluation of the esophagus was similar using muTNE (99%), huTNE (96%) and sEGD (100%) techniques (p=0.08). Mean recovery times (minutes) were longer for sEGD (67.3) compared to muTNE (15.5) and huTNE (18.5) (p<0.001). Approximately, 80% of uTNE subjects were willing to undergo the procedure again in future. 29% and 7.8% of participating subjects had esophagitis and BE respectively. Conclusions Mobile van and clinic uTNE screening had comparable clinical effectiveness with similar participation rates and safety profile to sEGD. Evaluation time with uTNE was significantly shorter. Prevalence of BE and esophagitis in community subjects ≥ 50 years of age was substantial. Mobile and outpatient unsedated techniques may provide an effective alternative strategy to sEGD for esophageal assessment and BE screening. PMID:25488897

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL.

PubMed

Freeman, James V; Hutton, David W; Barnes, Geoffrey D; Zhu, Ruo P; Owens, Douglas K; Garber, Alan M; Go, Alan S; Hlatky, Mark A; Heidenreich, Paul A; Wang, Paul J; Al-Ahmad, Amin; Turakhia, Mintu P

2016-06-01

Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice. © 2016 American Heart Association, Inc.

Randomized trials published in Chinese or Western journals: comparative empirical analysis.

PubMed

Purgato, Marianna; Cipriani, Andrea; Barbui, Corrado

2012-06-01

A major concern to the inclusion in systematic reviews of studies originating in China and published in Chinese journals refers to the quality of study reporting. In this systematic survey of randomized trials, we compared the characteristics of studies published in Chinese journals with those of studies published in Western journals. We included 69 studies comparing citalopram with other antidepressant drugs in the treatment of major depression. Of these, 37 (54%) were published in Chinese journals. The standard of reporting was generally poor in both Western and Chinese studies. In some Chinese studies, the generation of the randomization sequence raised concern about their experimental nature, and in almost all included studies, the concealment of allocation was not properly described. Blinding was seldom adopted in Chinese studies, and the risk of sponsorship bias was uncertain because Chinese studies did not report any financial support. In most Western studies, outcome data were selectively and incompletely reported. Pooling together all trials revealed that citalopram was similarly effective in comparison with all other antidepressant drugs both in Western studies (standardized mean difference, -0.04; 95% confidence interval, -0.15 to 0.06) and in Chinese studies (standardized mean difference, -0.08, 95% confidence interval, -0.18 to 0.02). Randomized controlled trials published in Chinese journals represent most of the studies included in this review. This suggests that omitting to search biomedical databases originating from China would systematically exclude a relevant proportion of randomized trials published in Chinese journals, with a risk of random error or bias. The increasing inclusion of Chinese studies in systematic reviews reinforces the need to check the quality of randomized trials that are meta-analyzed.

Randomized Controlled Trial of Supplemental Augmentative and Alternative Communication versus Voice Rest Alone after Phonomicrosurgery

PubMed Central

Rousseau, Bernard; Gutmann, Michelle L.; Mau, I-fan Theodore; Francis, David O.; Johnson, Jeffrey P.; Novaleski, Carolyn K.; Vinson, Kimberly N.; Garrett, C. Gaelyn

2015-01-01

Objective This randomized trial investigated voice rest and supplemental text-to-speech communication versus voice rest alone on visual analog scale measures of communication effectiveness and magnitude of voice use. Study Design Randomized clinical trial. Setting Multicenter outpatient voice clinics. Subjects Thirty-seven patients undergoing phonomicrosurgery. Methods Patients undergoing phonomicrosurgery were randomized to voice rest and supplemental text-to-speech communication or voice rest alone. The primary outcome measure was the impact of voice rest on ability to communicate effectively over a seven-day period. Pre- and post-operative magnitude of voice use was also measured as an observational outcome. Results Patients randomized to voice rest and supplemental text-to-speech communication reported higher median communication effectiveness on each post-operative day compared to those randomized to voice rest alone, with significantly higher median communication effectiveness on post-operative day 3 (p = 0.03) and 5 (p = 0.01). Magnitude of voice use did not differ on any pre-operative (p > 0.05) or post-operative day (p > 0.05), nor did patients significantly decrease voice use as the surgery date approached (p > 0.05). However, there was a significant reduction in median voice use pre- to post-operatively across patients (p < 0.001) with median voice use ranging from 0–3 throughout the post-operative week. Conclusion Supplemental text-to-speech communication increased patient perceived communication effectiveness on post-operative days 3 and 5 over voice rest alone. With the prevalence of smartphones and the widespread use of text messaging, supplemental text-to-speech communication may provide an accessible and cost-effective communication option for patients on vocal restrictions. PMID:25605690

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

PubMed

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

2016-01-01

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

Testing feedback message framing and comparators to address prescribing of high-risk medications in nursing homes: protocol for a pragmatic, factorial, cluster-randomized trial.

PubMed

Ivers, Noah M; Desveaux, Laura; Presseau, Justin; Reis, Catherine; Witteman, Holly O; Taljaard, Monica K; McCleary, Nicola; Thavorn, Kednapa; Grimshaw, Jeremy M

2017-07-14

Audit and feedback (AF) interventions that leverage routine administrative data offer a scalable and relatively low-cost method to improve processes of care. AF interventions are usually designed to highlight discrepancies between desired and actual performance and to encourage recipients to act to address such discrepancies. Comparing to a regional average is a common approach, but more recipients would have a discrepancy if compared to a higher-than-average level of performance. In addition, how recipients perceive and respond to discrepancies may depend on how the feedback itself is framed. We aim to evaluate the effectiveness of different comparators and framing in feedback on high-risk prescribing in nursing homes. This is a pragmatic, 2 × 2 factorial, cluster-randomized controlled trial testing variations in the comparator and framing on the effectiveness of quarterly AF in changing high-risk prescribing in nursing homes in Ontario, Canada. We grouped homes that share physicians into clusters and randomized these clusters into the four experimental conditions. Outcomes will be assessed after 6 months; all primary analyses will be by intention-to-treat. The primary outcome (monthly number of high-risk medications received by each patient) will be analysed using a general linear mixed effects regression model. We will present both four-arm and factorial analyses. With 160 clusters and an average of 350 beds per cluster, assuming no interaction and similar effects for each intervention, we anticipate 90% power to detect an absolute mean difference of 0.3 high-risk medications prescribed. A mixed-methods process evaluation will explore potential mechanisms underlying the observed effects, exploring targeted constructs including intention, self-efficacy, outcome expectations, descriptive norms, and goal prioritization. An economic analysis will examine cost-effectiveness analysis from the perspective of the publicly funded health care system. This protocol describes the rationale and methodology of a trial testing manipulations of theory-informed components of an audit and feedback intervention to determine how to improve an existing intervention and provide generalizable insights for implementation science. NCT02979964.

Panel Estimates of Male-Female Earnings Functions.

ERIC Educational Resources Information Center

Kim, Moon-Kak; Polachek, Solomon W.

1994-01-01

Application of single and simultaneous equation fixed-effects and random-effects shows that earnings appreciation with experience and depreciation with labor market interruptions are comparable for men and women. Adjusting for heterogeneity reduces the wage gap to 20%; adjusting for endogeneity reduces it nearly to zero. (SK)

Modeling and Compensation of Random Drift of MEMS Gyroscopes Based on Least Squares Support Vector Machine Optimized by Chaotic Particle Swarm Optimization.

PubMed

Xing, Haifeng; Hou, Bo; Lin, Zhihui; Guo, Meifeng

2017-10-13

MEMS (Micro Electro Mechanical System) gyroscopes have been widely applied to various fields, but MEMS gyroscope random drift has nonlinear and non-stationary characteristics. It has attracted much attention to model and compensate the random drift because it can improve the precision of inertial devices. This paper has proposed to use wavelet filtering to reduce noise in the original data of MEMS gyroscopes, then reconstruct the random drift data with PSR (phase space reconstruction), and establish the model for the reconstructed data by LSSVM (least squares support vector machine), of which the parameters were optimized using CPSO (chaotic particle swarm optimization). Comparing the effect of modeling the MEMS gyroscope random drift with BP-ANN (back propagation artificial neural network) and the proposed method, the results showed that the latter had a better prediction accuracy. Using the compensation of three groups of MEMS gyroscope random drift data, the standard deviation of three groups of experimental data dropped from 0.00354°/s, 0.00412°/s, and 0.00328°/s to 0.00065°/s, 0.00072°/s and 0.00061°/s, respectively, which demonstrated that the proposed method can reduce the influence of MEMS gyroscope random drift and verified the effectiveness of this method for modeling MEMS gyroscope random drift.

Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

PubMed

Malmivaara, Antti

2015-06-01

The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

A new simple technique for improving the random properties of chaos-based cryptosystems

NASA Astrophysics Data System (ADS)

Garcia-Bosque, M.; Pérez-Resa, A.; Sánchez-Azqueta, C.; Celma, S.

2018-03-01

A new technique for improving the security of chaos-based stream ciphers has been proposed and tested experimentally. This technique manages to improve the randomness properties of the generated keystream by preventing the system to fall into short period cycles due to digitation. In order to test this technique, a stream cipher based on a Skew Tent Map algorithm has been implemented on a Virtex 7 FPGA. The randomness of the keystream generated by this system has been compared to the randomness of the keystream generated by the same system with the proposed randomness-enhancement technique. By subjecting both keystreams to the National Institute of Standards and Technology (NIST) tests, we have proved that our method can considerably improve the randomness of the generated keystreams. In order to incorporate our randomness-enhancement technique, only 41 extra slices have been needed, proving that, apart from effective, this method is also efficient in terms of area and hardware resources.

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.

Scattering by a slab containing randomly located cylinders: comparison between radiative transfer and electromagnetic simulation.

PubMed

Roux, L; Mareschal, P; Vukadinovic, N; Thibaud, J B; Greffet, J J

2001-02-01

This study is devoted to the examination of scattering of waves by a slab containing randomly located cylinders. For the first time to our knowledge, the complete transmission problem has been solved numerically. We have compared the radiative transfer theory with a numerical solution of the wave equation. We discuss the coherent effects, such as forward-scattering dip and backscattering enhancement. It is seen that the radiative transfer equation can be used with great accuracy even for optically thin systems whose geometric thickness is comparable with the wavelength. We have also shown the presence of dependent scattering.

Paraspinous Lidocaine Injection for Chronic Nonspecific Low Back Pain: A Randomized Controlled Clinical Trial.

PubMed

Imamura, Marta; Imamura, Satiko Tomikawa; Targino, Rosa Alves; Morales-Quezada, León; Onoda Tomikawa, Luis C; Onoda Tomikawa, Luis G; Alfieri, Fabio M; Filippo, Thais R; da Rocha, Ivan D; Neto, Raul Bolliger; Fregni, Felipe; Battistella, Linamara Rizzo

2016-05-01

In this large, sham-controlled, randomized trial, we examined the efficacy of the combination of standard treatment and paraspinous lidocaine injection compared with standard therapy alone in subjects with chronic low back pain. There is little research-based evidence for the routine clinical use of paraspinous lidocaine injection for low back pain. A total of 378 subjects with nonspecific chronic low back pain were randomized to 3 groups: paraspinous lidocaine injection, analgesics, and exercises (group 1, LID-INJ); sham paraspinous lidocaine injection, analgesics, and exercises (group 2, SH-INJ); and analgesics and exercises (group 3, STD-TTR). A blinded rater assessed the study outcomes at 3 time points: baseline, after treatment, and after 3 months of follow-up. There were increased frequency of pain responses and better low back functional scores in the LID-INJ group compared with the SH-INJ and STD-TTR groups. These effects remained at the 3-month follow-up but differed between all 3 groups. There were significant changes in pain threshold immediately after treatment, supporting the effects of this intervention in reducing central sensitization. Paraspinous lidocaine injection therapy is not associated with a higher risk of adverse effects compared with conventional treatment and sham injection. Its effects on hyperalgesia might correlate with changes in central sensitization. NCT02387567. There are few data to support paraspinous lidocaine injection use in patients with nonspecific chronic low back pain. Our results show that this therapy when combined with standard therapy significantly increases the number of responders versus standard treatment alone. Its effects on hyperalgesia might correlate with a change in central sensitization. Copyright © 2016. Published by Elsevier Inc.

Efficacy and Safety of Levosulpiride Versus Haloperidol Injection in Patients With Acute Psychosis: A Randomized Double-Blind Study.

PubMed

Lavania, Sagar; Praharaj, Samir Kumar; Bains, Hariender Singh; Sinha, Vishal; Kumar, Abhinav

2016-01-01

Injectable antipsychotics are frequently required for controlling agitation and aggression in acute psychosis. No study has examined the use of injectable levosulpiride for this indication. To compare the efficacy and safety of injectable levosulpiride and haloperidol in patients with acute psychosis. This was a randomized, double-blind, parallel-group study in which 60 drug-naive patients having acute psychosis were randomly assigned to receive either intramuscular haloperidol (10-20 mg/d) or levosulpiride (25-50 mg/d) for 5 days. All patients were rated on Brief Psychiatric Rating Scale (BPRS), Overt Agitation Severity Scale (OASS), Overt Aggression Scale-Modified (OAS-M) scores, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS). Repeated-measures ANOVA for BPRS scores showed significant effect of time (P < 0.001) and a trend toward greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.076). Repeated-measures ANOVA for OASS showed significant effect of time (P < 0.001) but no group × time interaction. Repeated-measures ANOVA for OAS-M scores showed significant effect of time (P < 0.001) and greater reduction in scores in haloperidol group as shown by group × time interaction (P = 0.032). Lorazepam requirement was much lower in haloperidol group as compared with those receiving levosulpiride (P = 0.022). Higher rates of akathisia and extrapyramidal symptoms were noted in the haloperidol group. Haloperidol was more effective than levosulpiride injection for psychotic symptoms, aggression, and severity of agitation in acute psychosis, but extrapyramidal adverse effects were less frequent with levosulpiride as compared with those receiving haloperidol.

Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials.

PubMed

Yu, Changhe; Ji, Kangshou; Cao, Huijuan; Wang, Ying; Jin, Hwang Hye; Zhang, Zhe; Yang, Guanlin

2015-03-28

The purpose of this systematic review is to assess the effectiveness of acupuncture for angina pectoris. Eleven electronic databases were searched until January 2013. The study included randomized controlled trials that the effectiveness of acupuncture alone was compared to anti-angina medicines (in addition to conventional treatment) and the effectiveness of a combination of acupuncture plus anti-angina medicines was compared to anti-angina medicines alone. The trial selection, data extraction, quality assessment and data analytic procedures outlined in the 2011 Cochrane Handbook were involved. The study included 25 randomized controlled trials (involving 2,058 patients) that met our inclusion criteria. The pooled results showed that the number of patients with ineffectiveness of angina relief was less in the combined acupuncture-anti-angina treatment group than in the anti-angina medicines alone group (RR 0.33, 95% CI 0.23-0.47, p < 0.00001, I2 = 0%). Similarly, compared to the anti-angina medicines alone group, fewer patients in the combined treatment group showed no ECG improvement (RR 0.50, 95% CI 0.40-0.62, p < 0.00001, I2 = 0%). However, no differences were observed between acupuncture treatment alone and anti-angina medicines alone for both outcome measures. Only four trials mentioned adverse effects. One trial found no significant difference between acupuncture and Chinese medicine, and three reported no adverse events. The quality of the trials was found to be low. The findings showed very low evidence to support the use of acupuncture for improving angina symptoms and ECG of angina patients. However, the quality of the trials included in this study was low. Large and rigorously designed trials are needed to confirm the potential benefit and adverse events of acupuncture.

[Comparative Study on Bowel Preparation Efficacy of Ascorbic Acid Containing Polyethylene Glycol by Adding Either Simethicone or 1 L of Water in Health Medical Examination Patients: A Prospective Randomized Controlled Study].

PubMed

Yeo, Se Hwan; Kwak, Jae Hoon; Kim, Yeo Un; Kwon, Tae Ho; Park, Jeong Bae; Park, Jun Hyung; Lee, Yong Kook; Lim, Yun Jeong; Yang, Chang Heon

2016-04-25

There are no studies that looked into the bubble eliminating efficacy of polyethylene glycol with ascorbic acid (PEGA), which has been one of the shortcomings of polyethylene glycol (PEG). In this study, we compared newly introduced PEGA regimen by adding either simethicone or 1 L of water. A prospective randomized controlled study was carried out at Dongguk Universtiy Gyeongju Hospital from July 2014 to September 2014. A total of 90 patients were randomly assigned to 3 groups; PEGA group (n=30) which served as control, simethicone addition group (n=30) to which simethicone 400 mg was additionally prescribed, and water addition group (n=30) to whom additional 1 L of water was given. Cleansing effectiveness, gas elimination efficacy, side effects, and patient satisfaction were compared between the groups. PEGA group demonstrated the highest cleansing effectiveness, but there was no statistically significant difference among the groups. Simethicone addition group showed significantly lesser amount of bubbles than the other groups (2.57±2.05 vs. 1.10±1.83 vs. 2.60±2.84, p=0.017). The rates of side effects in each group were 20.00% vs. 16.77% vs. 53.33%. Water addition group had significantly more side effects than the PEGA group and the simethicone addition group (p=0.003). The patient satisfaction score of each group was 3.37±0.85 vs. 3.73±0.74 vs. 3.20±0.66 with simethicone addition group showing significantly higher satisfaction than water addition group (p=0.020). PEGA bowel preparation agent showed satisfactory bowel cleansing despite the decrease in dosage, and addition of simethicone resulted in better bubble elimination.

Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction: A meta-analysis of randomized clinical trials.

PubMed

Campo, Gianluca; Pavasini, Rita; Morciano, Giampaolo; Lincoff, A Michael; Gibson, C Michael; Kitakaze, Masafumi; Lonborg, Jacob; Ahluwalia, Amrita; Ishii, Hideki; Frenneaux, Michael; Ovize, Michel; Galvani, Marcello; Atar, Dan; Ibanez, Borja; Cerisano, Giampaolo; Biscaglia, Simone; Neil, Brandon J; Asakura, Masanori; Engstrom, Thomas; Jones, Daniel A; Dawson, Dana; Ferrari, Roberto; Pinton, Paolo; Ottani, Filippo

2017-10-01

To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo. Odds ratios (OR) were computed from individual studies and pooled with random-effect meta-analysis. Fifteen studies were identified involving 5680 patients. When compared with placebo, drugs targeting mitochondrial component/pathway were not associated with significant reduction of cardiovascular and all-cause mortality (OR 0.9, 95% CI 0.7-1.17 and OR 0.92, 95% CI 0.69-1.23, respectively). However, these agents significantly reduced hospital admission for heart failure (HF) (OR 0.64; 95% CI 0.45-0.92) and increased left ventricular ejection fraction (LVEF) (OR 1.44; 95% CI 1.15-1.82). After analysis for subgroups according to the mechanism of action, drugs with direct/selective action did not reduce any outcome. Conversely, those with indirect/unspecific action showed a significant effect on cardiovascular mortality (0.65, 95% CI 0.46-0.92), all-cause mortality (OR 0.69, 95% CI 0.52-0.92), hospital readmission for HF (OR 0.41, 95% CI 0.28-0.6) and LVEF (OR 1.49, 95% CI 1.09-2.05). Administration of drugs targeting mitochondrial function in STEMI patients undergoing primary PCI appear to have no effect on mortality, but may reduce hospital readmission for HF. The drugs with a broad-spectrum mechanism of action seem to be more effective in reducing adverse events. Copyright © 2017 Elsevier B.V. All rights reserved.

Estimating the optimal dynamic antipsychotic treatment regime: Evidence from the sequential multiple assignment randomized CATIE Schizophrenia Study

PubMed Central

Shortreed, Susan M.; Moodie, Erica E. M.

2012-01-01

Summary Treatment of schizophrenia is notoriously difficult and typically requires personalized adaption of treatment due to lack of efficacy of treatment, poor adherence, or intolerable side effects. The Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) Schizophrenia Study is a sequential multiple assignment randomized trial comparing the typical antipsychotic medication, perphenazine, to several newer atypical antipsychotics. This paper describes the marginal structural modeling method for estimating optimal dynamic treatment regimes and applies the approach to the CATIE Schizophrenia Study. Missing data and valid estimation of confidence intervals are also addressed. PMID:23087488

Importance of Virtual Reality to Virtual Reality Exposure Therapy, Study Design of a Randomized Trial.

PubMed

McLay, Robert N; Baird, Alicia; Murphy, Jennifer; Deal, William; Tran, Lily; Anson, Heather; Klam, Warren; Johnston, Scott

2015-01-01

Post Traumatic Stress Disorder (PTSD) can be a debilitating problem in service members who have served in Iraq or Afghanistan. Virtual Reality Exposure Therapy (VRET) is one of the few interventions demonstrated in randomized controlled trials to be effective for PTSD in this population. There are theoretical reasons to expect that Virtual Reality (VR) adds to the effectiveness of exposure therapy, but there is also added expense and difficulty in using VR. Described is a trial comparing outcomes from VRET and a control exposure therapy (CET) protocol in service members with PTSD.

Effects of Sex Education and Kegel Exercises on the Sexual Function of Postmenopausal Women: A Randomized Clinical Trial.

PubMed

Nazarpour, Soheila; Simbar, Masoumeh; Ramezani Tehrani, Fahimeh; Alavi Majd, Hamid

2017-07-01

The sex lives of women are strongly affected by menopause. Non-pharmacologic approaches to improving the sexual function of postmenopausal women might prove effective. To compare two methods of intervention (formal sex education and Kegel exercises) with routine postmenopausal care services in a randomized clinical trial. A randomized clinical trial was conducted of 145 postmenopausal women residing in Chalus and Noshahr, Iran. Their sexual function statuses were assessed using the Female Sexual Function Index (FSFI) questionnaire. After obtaining written informed consents, they were randomly assigned to one of three groups: (i) formal sex education, (ii) Kegel exercises, or (iii) routine postmenopausal care. After 12 weeks, all participants completed the FSFI again. Analysis of covariance was used to compare the participants' sexual function before and after the interventions, and multiple linear regression analysis was used to determine the predictive factors for variation in FSFI scores in the postintervention stage. Sexual function was assessed using the FSFI. There were no statistically significant differences in demographic and socioeconomic characteristics and FSFI total scores among the three study groups at the outset of the study. After 12 weeks, the scores of arousal in the formal sex education and Kegel groups were significantly higher compared with the control group (3.38 and 3.15 vs 2.77, respectively). The scores of orgasm and satisfaction in the Kegel group were significantly higher compared with the control group (4.43 and 4.88 vs 3.95 and 4.39, respectively). Formal sex education and Kegel exercises were used as two non-pharmacologic approaches to improve the sexual function of women after menopause. The main strength of this study was its design: a well-organized randomized trial using precise eligibility criteria with a small sample loss. The second strength was the methods of intervention used, namely non-pharmacologic approaches that are simple, easily accessible, and fairly inexpensive. The main limitation of the study was our inability to objectively assess the participants' commitment to exercise and the sexual function of their partners. Sex education programs and Kegel exercises could cause improvements in some domains of sexual function-specifically arousal, orgasm, and satisfaction-in postmenopausal women. Nazarpour S, Simbar M, Tehrani FR, Majd HA. Effects of Sex Education and Kegel Exercises on the Sexual Function of Postmenopausal Women: A Randomized Clinical Trial. J Sex Med 2017;14:959-967. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Therapist Adherence and Competence with Manualized Cognitive-Behavioral Therapy for PTSD Delivered via Videoconferencing Technology

ERIC Educational Resources Information Center

Frueh, B. Christopher; Monnier, Jeannine; Grubaugh, Anouk L.; Elhai, Jon D.; Yim, Eunsil; Knapp, Rebecca

2007-01-01

Using secondary analyses from a randomized trial comparing the effectiveness of manualized cognitive-behavioral therapy for posttraumatic stress disorder, we compared ratings of therapist competency and adherence between two service delivery modes: telepsychiatry (TP) and same room (SR). Patients were 38 male treatment-seeking veterans recruited…

A Randomized Clinical Trial Comparison Between Pivotal Response Treatment (PRT) and Structured Applied Behavior Analysis (ABA) Intervention for Children with Autism

PubMed Central

Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaee, Mohammad; Rafiee, Seyed Majid

2014-01-01

Accumulating studies are documenting specific motivational variables that, when combined into a naturalistic teaching paradigm, can positively influence the effectiveness of interventions for children with autism spectrum disorder (ASD). The purpose of this study was to compare two ABA intervention procedures, a naturalistic approach, Pivotal Response Treatment (PRT) with a structured ABA approach in a school setting. A Randomized Clinical Trial design using two groups of children, matched according to age, sex and mean length of utterance was used to compare the interventions. The data showed that the PRT approach was significantly more effective in improving targeted and untargeted areas after three months of intervention. The results are discussed in terms of variables that produce more rapid improvements in communication for children with ASD. PMID:24840596

Addition of atropine to submaximal exercise stress testing in patients evaluated for suspected ischaemia with SPECT imaging: a randomized, placebo-controlled trial.

PubMed

Manganelli, Fiore; Spadafora, Marco; Varrella, Paola; Peluso, Giuseppina; Sauro, Rosario; Di Lorenzo, Emilio; Rosato, Giuseppe; Daniele, Stefania; Cuocolo, Alberto

2011-02-01

To evaluate the effects of the addition of atropine to exercise testing in patients who failed to achieve their target heart rate (HR) during stress myocardial perfusion imaging with single-photon emission computed tomography (SPECT). The study was a prospective, randomized, placebo-controlled design. Patients with suspected or known coronary artery disease who failed to achieve a target HR (≥85% of maximal predicted HR) during exercise SPECT imaging were randomized to receive intravenous atropine (n=100) or placebo (n=101). The two groups of patients did not differ with respect to demographic or clinical characteristics. A higher proportion of patients in the atropine group achieved the target HR compared to the placebo group (60% versus 3%, p<0.0001). SPECT imaging was abnormal in a higher proportion of patients in the atropine group as compared to the placebo group (57% versus 42%, p<0.05). Stress-induced myocardial ischaemia was present in more patients in the atropine group as compared to placebo (47% versus 29%, p<0.01). In both groups of patients, no major side effects occurred. The addition of atropine at the end of exercise testing is more effective than placebo in raising HR to adequate levels, without additional risks of complications. The use of atropine in patients who initially failed to achieve their maximal predicted HR is associated with a higher probability of achieving a diagnostic myocardial perfusion study.

The effect of cannabis on tremor in patients with multiple sclerosis.

PubMed

Fox, P; Bain, P G; Glickman, S; Carroll, C; Zajicek, J

2004-04-13

Disabling tremor is common in patients with multiple sclerosis (MS). Data from animal model experiments and subjective and small objective studies involving patients suggest that cannabis may be an effective treatment for tremor associated with MS. To our knowledge, there are no published double-blind randomized controlled trials of cannabis as a treatment for tremor in MS patients. The authors conducted a randomized double-blind placebo-controlled crossover trial to examine the effect of oral cannador (cannabis extract) on 14 patients with MS with upper limb tremors. There were eight women and six men, with a mean age of 45 years and mean Expanded Disability Status Scale score of 6.25. Patients were randomly assigned to receive each treatment and the doses escalated over a 2-week period before each assessment. The primary outcome was change on a tremor index, measured using a validated tremor rating scale. The study was powered to detect a functionally significant 50% improvement in the tremor index. Secondary outcomes included accelerometry, an ataxia scale, spiral drawing, finger tapping, and nine-hole pegboard test performance. Analysis of the data showed no significant improvement in any of the objective measures of upper limb tremor with cannabis extract compared to placebo. Finger tapping was faster on placebo compared to cannabis extract (p < 0.02). However, there was a nonsignificant trend for patients to experience more subjective relief from their tremors while on cannabis extract compared to placebo. Cannabis extract does not produce a functionally significant improvement in MS-associated tremor.

Source-Independent Quantum Random Number Generation

NASA Astrophysics Data System (ADS)

Cao, Zhu; Zhou, Hongyi; Yuan, Xiao; Ma, Xiongfeng

2016-01-01

Quantum random number generators can provide genuine randomness by appealing to the fundamental principles of quantum mechanics. In general, a physical generator contains two parts—a randomness source and its readout. The source is essential to the quality of the resulting random numbers; hence, it needs to be carefully calibrated and modeled to achieve information-theoretical provable randomness. However, in practice, the source is a complicated physical system, such as a light source or an atomic ensemble, and any deviations in the real-life implementation from the theoretical model may affect the randomness of the output. To close this gap, we propose a source-independent scheme for quantum random number generation in which output randomness can be certified, even when the source is uncharacterized and untrusted. In our randomness analysis, we make no assumptions about the dimension of the source. For instance, multiphoton emissions are allowed in optical implementations. Our analysis takes into account the finite-key effect with the composable security definition. In the limit of large data size, the length of the input random seed is exponentially small compared to that of the output random bit. In addition, by modifying a quantum key distribution system, we experimentally demonstrate our scheme and achieve a randomness generation rate of over 5 ×103 bit /s .